A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Phase: PHASE2
Conditions: Influenza, Human, COVID-19
Sponsor: BioNTech SE

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1
A P H A S E 1/ 2 M A S T E R P R O T O C O L
T O E V A L U A T E T H E S A F E T Y, 
T O L E R A BI LI T Y, A N D I M M U N O G E NI CI T Y O F C O M BI N E D M O DI FI E D R N A 
V A C CI N E C A N DI D A T E S A G AI N S T C O VI D -1 9 A N D I N F L U E N Z A I N H E A L T HY 
I N DI VI D U A L S
St u d y S p o ns or:
Bi o N Tec h
St u d y C o n d ucte d b y:
Pfizer
St u d y I nter ve nti o n N u m ber:
P F -0 7 9 2 6 3 0 7 
St u d y I nter ve nti o n N a me:
C o m bi nati o n C O VI D- 1 9 a n d I nfl ue nza 
m o d R N A Vacci ne
U S I N D N u m ber:
2 8 9 1 7
E u dr a C T / E U C T N u m ber:
N ot a p plica ble
Cli nic al Tri als. g o v I D:
N C T 0 5 5 9 6 7 3 4
Pe di atric I n vesti g ati o n al Pl a n N u m ber:
N ot a p plica ble
Pr ot oc ol N u m ber:
C 5 2 6 1 0 0 1
P h ase:
1/ 2
Brief Title:
A St u d y  t o E val uate t he Safet y, T olera bility, a n d I m m u n o ge nicit y of C o m bi ne d M o difie d 
R N A Vacci ne Ca n di dates A gai nst C O VI D -1 9 a n d I nfl ue nza
T his d oc u me nt a n d acc o m pa n yi n g materials c o ntai n c o nfi de ntial i nf or mati o n bel o n gi n g t o Pfizer.  E xce pt as 
ot her wise a gree d t o i n writi n g, b y acce pti n g or re vie wi n g t hese d oc u me nts, y o u a gree t o h ol d t his i nf or mati o n 
i n c o nfi de nce a n d n ot c o p y or discl ose it t o ot hers (e xce pt w here re q uire d b y a p plica ble la w) or use it f or 
u na ut h orize d p ur p oses.  I n t he e ve nt of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfizer m ust be 
pr o m ptl y n otifie d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2
D oc u me nt Hist or y
D oc u me nt
Versi o n D ate
A me n d me nt 6
0 9 Fe br uar y 2 0 2 4
A me n d me nt 5
1 5 A u g ust 2 0 2 3
A me n d me nt 4
1 6 A pril 2 0 2 3
A me n d me nt 3
1 5 Fe br uar y 2 0 2 3
A me n d me nt 2
0 9 Dece m ber 2 0 2 2
A me n d me nt 1
1 8 Oct o ber 2 0 2 2
Ori gi nal pr ot oc ol
1 7 Se pte m ber 2 0 2 2
T his a me n d me nt i nc or p orates all re visi o ns t o date, i ncl u di n g a me n d me nts ma de at t he 
re q uest of c o u ntr y healt h a ut h orities a n d I R Bs/ E Cs a n d a n y P A C L (s).
Pr ot oc ol A me n d me nt S u m m ar y of C h a n ges T a ble
A m e n d me nt 6 ( 0 9 Fe b r u ar y 2 0 2 4)
O ver all R ati o n al e f or t he A me n d me nt:  
Pr ot oc ol re visi o ns t o re m o ve partici pa nts ≥6 5 y ears of a ge fr o m S u bst u d y B a n d t o re vise
S u bst u d y  A e n d p oi nts , m o vi n g W ee ks 1 a n d 8 fr o m pri mar y  t o e x pl orat or y.  
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or
N o ns u bst a nti al
T hr o u g h o ut
Re m o ve d refere nce t o i nitial -e nr oll me nt
a n d e x pa n de d -e nr oll me nt gr o u ps
T o ali g n wit h re m o val 
of t he ≥6 5 -year a ge
c o h ort i n S u bst u d y B 
S u bsta ntial
T hr o u g h o ut
C orrecte d i nsta nces of C O VI D -1 9 a n d 
S A R S -C o V -2 use d i nc orrectl y
T o ali g n wit h g ui da nce 
t o refer t o t he vir us as 
S A R S -C o V -2 a n d t o 
t he disease or vacci ne 
as C O VI D -1 9
N o ns u bsta ntial
T hr o u g h o ut
U p date d m R N A t o m o d R N A
T o sta n dar dize acr oss 
t he pr ot oc ol
N o ns u bsta ntial
T hr o u g h o ut
U p date d s u bst u d y hea di n gs t o reflect 
t he rele va nt s u bst u d y
T o sta n dar dize acr oss 
t he pr ot oc ol
N o ns u bsta ntial
Title pa ge
U p date d title t o reflect t hat t his is a 
master pr ot oc ol
T o ali g n wit h c urre nt 
g ui da nce
N o ns u bsta ntial
T hr o u g h o ut
Re vise d te xt t o ali g n wit h t he re m o val 
of t he i nitial -e nr oll me nt a n d e x pa n de d -
e nr oll me nt gr o u ps
T o ali g n wit h re m o val 
of t he ≥6 5 -year a ge
c o h ort i n S u bst u d y B
S u bsta ntial
T hr o u g h o ut
Re m o ve d a n y te xt referri n g t o m ore 
t ha n 1 d ose (e g , “at least,” “t he first ,”
“eac h d ose” ) 
T o e ns ure t hat 
ver bia ge reflects o nl y 
1 vacci nati o n i n t he 
st u dies
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or
N o ns u bst a nti al
Secti o n 1. 1 S y n o psis 
Re m o ve d cr oss-refere nces t o f oll o w 
pr ot oc ol te m plate g ui deli nes
T o ali g n wit h t he 
pr ot oc ol te m plate
N o ns u bsta ntial
Secti o n 1. 1 S y n o psis 
a n d Secti o n 2. 1 St u d y 
Rati o nale
A d de d la n g ua ge re gar di n g t he W H O 
rec o m me n dati o n f or t he 2 0 2 4-2 0 2 5 
i nfl ue nza seas o n
T o ali g n wit h 
f or m ulati o ns use d i n
t he st u d y
S u bsta ntial
Secti o n s 1. 1 S y n o psis 
a n d 1 0. 1 2. 6. 1 St u d y 
I nter ve nti o n(s) 
A d mi nistere d f or 
S u bst u d y B
Re m o ve d ar ms c o ntai ni n g place b o fr o m 
S u bst u d y B i nter ve nti o ns
T o ali g n wit h re m o val 
of p orti o ns of 
S u bst u d y B
S u bsta ntial
Secti o n s 1. 1 S y n o psis, 
1 0. 1 1. 3 O bjecti ves, 
E n d p oi nts , a n d 
Esti ma n ds 
( S u bst u d y A) , a n d 
1 0. 1 1. 9 Statistical 
C o nsi derati o ns –
S u bst u d y A
U p date d S u bst u d y A o bjecti ves, 
e n d p oi nts, a n d esti ma n ds t o m o ve 
W ee k 1 a n d W ee k 8 i m m u ne res p o nses 
t o e x pl orat or y
U p date d f or ne w  
desi g n
N o ns u bsta ntial
Secti o n 2. 2. 1
S A R S -C o V -2
Re m o ve d la n g ua ge re gar di n g X B B
T o ali g n wit h re m o val 
of S u bst u d y C
S u bsta ntial
Secti o n 2. 2. 3. 2
I nfl ue nza
A d de d la n g ua ge t o u p date c urre nt 
C 4 7 8 1 0 0 4 st u d y n u m bers as well as t o 
r e mo ve A a n d B strai n i nf or mati o n t hat 
wa s n ot necessar y f or t his st u d y
T o u p date c urre nt 
n u m bers a n d ali g n 
wit h w hat is use d i n 
t his st u d y
N o ns u bsta ntial
Secti o n 6 St u d y 
I nter ve nti o n(s) a n d 
C o nc o mita nt T hera p y
U p date d T a ble 2 t o reflect vacci nes 
use d i n t he st u dies
T o ali g n wit h w hat 
wa s use d i n eac h st u d y
N o ns u bsta ntial
Secti o n 1 0. 1. 6
Disse mi nati o n of 
Cli nical St u d y Data
A d de d w e bsite i nf or mati o n f or 
C li nical Trials. g o v a n d Pfizer.
T o ali g n wit h t he
c urre nt pr ot oc ol 
te mplate
N o ns u bsta ntial
Secti o n 1 0. 1 0. 4
Rec or di n g/ Re p orti n g 
a n d F oll o w-U p of 
Me dical De vice 
Deficie ncies
U p date d la n g ua ge t o t he c urre nt 
pr ot oc ol te m plate
T o ali g n wit h t he 
c urre nt pr ot oc ol 
te mplate
N o ns u bsta ntial
Secti o n 1 0. 5. 2 Fe male 
Partici pa nt 
Re pr o d ucti ve I ncl usi o n 
Criteria
A d de d t he secti o n
T o ali g n wit h u p dates 
t o t he pr ot oc ol 
te mplate
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4
T A B L E O F C O N T E N T S
LI S T O F T A B L E S ...................................................................................................................1 2
1. P R O T O C O L  S U M M A R Y................................................................................................... 1 3
1. 1. S y n o psis .................................................................................................................. 1 3
1. 2. Sc he ma .................................................................................................................... 4 2
1. 3. Sc he d ule of Acti vities ............................................................................................. 4 3
2. I N T R O D U C TI O N ............................................................................................................... 4 3
2. 1. St u d y  Rati o nale....................................................................................................... 4 3
2. 2. Bac k gr o u n d ............................................................................................................. 4 5
2. 2. 1. S A R S -C o V -2.............................................................................................. 4 5
2. 2. 2. I nfl ue nza ..................................................................................................... 4 5
2. 2. 3. Cli nical O ver vie w ....................................................................................... 4 6
2. 2. 3. 1. S A R S -C o V -2............................................................................. 4 6
2. 2. 3. 2. I nfl ue nza .................................................................................... 4 8
2. 2. 3. 3. C o m bi ne d I nfl ue nza a n d C O VI D-1 9 Vacci nes ......................... 4 9
2. 3. Be nefit/ Ris k Assess me nt ......................................................................................... 5 0
2. 3. 1. Ris k Assess me nt ......................................................................................... 5 0
2. 3. 2. Be nefit Assess me nt ..................................................................................... 5 2
2. 3. 3. O verall Be nefit/ Ris k C o ncl usi o n ................................................................ 5 2
3. O BJ E C TI V E S, E N D P O I N T S, A N D E S TI M A N D S ........................................................... 5 3
4. S T U D Y D E SI G N ................................................................................................................. 5 3
4. 1. O verall Desi g n ......................................................................................................... 5 3
4. 2. Scie ntific Rati o nale f or St u d y  Desi g n..................................................................... 5 3
4. 2. 1. Di versit y  of St u d y P o p ulati o n ....................................................................5 3
4. 2. 2. C h oice of C o ntrace pti o n/ Barrier Re q uire me nts .........................................5 3
4. 3. J ustificati o n f or D ose ..............................................................................................5 3
4. 3. 1. Bi vale nt B N T 1 6 2 b 2 ( Ori gi nal/ O mi B A. 4/ B A. 5) .......................................5 3
4. 3. 2. qI R V ........................................................................................................... 5 4
4. 3. 3. qI R V/ Bi vale nt B N T 1 6 2 b 2 ( Ori gi nal/ O mi B A. 4/ B A. 5) ............................. 5 4
4. 3. 4. tI R V/ Bi vale nt B N T 1 6 2 b 2 ( Ori gi nal/ O mi B A. 4/ B A. 5) .............................. 5 4
4. 3. 5. bI R V/ Bi vale nt B N T 1 6 2 b 2 ..........................................................................5 5
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5
4. 4. E n d of St u d y  Defi niti o n .......................................................................................... 5 5
5. S T U D Y P O P U L A T I ON ...................................................................................................... 5 5
5. 1. I n c l usi o n Criteria..................................................................................................... 5 6
5. 2. E xcl usi o n Criteria .................................................................................................... 5 6
5. 3. L ifest yle C o nsi derati o ns.......................................................................................... 5 6
5. 3. 1. C o ntrace pti o n ..............................................................................................5 6
5. 4. Scr ee n Fail ures ........................................................................................................ 5 6
5. 5. Criteria f or Te m p oraril y  Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/ A d mi nistrati o n of St u d y  Inter ve nti o n ........................... 5 6
6. S T U D Y I N T E R V E N TI O N( S) A N D C O N C O MI T A N T T H E R A P Y ................................. 5 7
6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d ........................................................................ 6 1
6. 1. 1. A d mi nistrati o n ............................................................................................ 6 1
6. 1. 2. Me dical De vices ......................................................................................... 6 2
6. 2. Pre parati o n, Ha n dli n g, St ora ge, a n d Acc o u nta bilit y ............................................... 6 2
6. 2. 1. Pre parati o n a n d Dis pe nsi n g ........................................................................ 6 3
6. 3. Assi g n me nt t o St u d y I nter ve nti o n ........................................................................... 6 3
6. 4. Bli n di n g ................................................................................................................... 6 3
6. 4. 1. Bli n di n g of Partici pa nts .............................................................................. 6 4
6. 4. 2. Bli n di n g of Site Pers o n nel .......................................................................... 6 4
6. 4. 3. Bli n di n g of t he S p o ns or .............................................................................. 6 4
6. 4. 4. Brea ki n g t he Bli n d ...................................................................................... 6 4
6. 5. St u d y  Inter ve nti o n C o m plia nce ............................................................................... 6 4
6. 6. D ose M o dificati o n ................................................................................................... 6 4
6. 7. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d of t he St u d y ...................... 6 4
6. 8. Treat me nt of O ver d ose ............................................................................................ 6 4
6. 9. Pri or a n d C o nc o mita nt T hera p y .............................................................................. 6 5
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L ........................................................................... 6 5
7. 1. Disc o nti n uati o n of St u d y  Inter ve nti o n .................................................................... 6 5
7. 2. Partici pa nt Disc o nti n ua ti o n/ Wit h dra wal Fr o m t he St u d y....................................... 6 5
7. 2. 1. Wit h dra wal of C o nse nt ...............................................................................6 6
7. 3. L ost t o F oll o w -U p ................................................................................................... 6 6
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S ...............................................................6 7
8. 1. A d mi nistrati ve Pr oce d ures ...................................................................................... 6 7
8. 2. Efficac y  a n d/ or I m m u n o ge nicit y Assess me nts....................................................... 6 7
8. 2. 1. Bi ol o gical Sa m ples ..................................................................................... 6 7
8. 3. Safet y Assess me nts ................................................................................................. 6 8
8. 3. 1. P h y sical E xa mi nati o ns ................................................................................ 6 8
8. 3. 2. Vital Si g ns .................................................................................................. 6 8
8. 3. 3. Electr ocar di o gra ms ..................................................................................... 6 9
8. 3. 4. Cli nical Safet y  La b orat or y Assess me nts.................................................... 6 9
8. 3. 5. Electr o nic Diar y .......................................................................................... 7 0
8. 3. 5. 1. Gra di n g Scales ........................................................................... 7 0
8. 3. 5. 2. L ocal Reacti o ns ......................................................................... 7 0
8. 3. 5. 3. S y ste mic E ve nts ........................................................................7 1
8. 3. 5. 4. Fe ver .......................................................................................... 7 2
8. 3. 5. 5. A nti p y retic Me dicati o n ............................................................. 7 3
8. 3. 6. Pre g na nc y  Testi n g ...................................................................................... 7 3
8. 4. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her Safet y Re p orti n g ................. 7 3
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y  f or C ollecti n g A E a n d S A E I nf or mati o n....... 7 4
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer Safet y ............................................... 7 5
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F ................... 7 5
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es .......................................................... 7 5
8. 4. 3. F oll o w -U p of A Es a n d S A Es ...................................................................... 7 5
8. 4. 4. Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es........................................... 7 6
8. 4. 5. E n vir o n me ntal E x p os ure, E x p os ure D uri n g Pre g na nc y  or 
Breastfee di n g, a n d Occ u pati o nal E x p os ure ..................................................... 7 6
8. 4. 5. 1. E x p os ure D uri n g Pre g na nc y ...................................................... 7 6
8. 4. 5. 2. E x p os ure D u ri n g Breastfee di n g ................................................ 7 8
8. 4. 5. 3. Occ u pati o nal E x p os ure ............................................................. 7 8
8. 4. 6. Car di o vasc ular a n d Deat h E ve nts ...............................................................7 9
8. 4. 7. A d verse E ve nts of S pecial I nterest............................................................. 7 9
8. 4. 7. 1. Lac k of Efficac y ........................................................................ 8 0
8. 4. 8. Me dical De vice Deficie ncies ......................................................................8 0
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7
8. 4. 8. 1. Ti me Peri o d f or Detecti n g Me dical De vice Deficie ncies ......... 8 0
8. 4. 8. 2. Re g ulat or y  Re p orti n g f or De vice Deficie ncies......................... 8 0
8. 4. 9. Vacci nati o n Err ors ...................................................................................... 8 1
8. 5. P har mac o ki netics .................................................................................................... 8 2
8. 6. Ge netics ................................................................................................................... 8 2
8. 6. 1. S pecifie d Ge netics ...................................................................................... 8 2
8. 7. Bi o mar kers .............................................................................................................. 8 2
8. 8. I m m u n o ge nicit y Assess me nts ................................................................................. 8 2
8. 9. Healt h Ec o n o mics ................................................................................................... 8 2
9. S T A TI S TI C A L C O N SI D E R A TI O N S ................................................................................ 8 2
9. 1. Statistical H y p ot heses ............................................................................................. 8 2
9. 1. 1. Esti ma n ds .................................................................................................... 8 3
9. 1. 2. M ulti plicit y  A dj ust me nt.............................................................................. 8 3
9. 2. A nal y sis Sets ........................................................................................................... 8 3
9. 3. Statistical A nal y ses ................................................................................................. 8 3
9. 3. 1. Ge neral C o nsi derati o ns ............................................................................... 8 3
9. 3. 1. 1. A nal y ses f or Bi nar y Data.......................................................... 8 4
9. 3. 1. 2. A nal y ses f or C o nti n u o us Data................................................... 8 4
9. 4. I nteri m A nal ys es ..................................................................................................... 8 5
9. 5. Sa m ple Size Deter mi nati o n ..................................................................................... 8 5
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L 
C O N SI D E R A TI O N S .......................................................................................................... 8 6
1 0. 1. A p pe n di x 1: Re g ulat or y , Et hical, a n d St u d y O versi g ht C o nsi derati o ns............... 8 6
1 0. 1. 1. Re g ulat or y a n d Et hical C o nsi derati o ns .................................................... 8 6
1 0. 1. 1. 1. Re p orti n g of Safet y  Iss ues a n d Seri o us Breac hes of t he 
Pr ot oc ol or I C H G C P ......................................................................... 8 6
1 0. 1. 2. Fi na ncial Discl os ure .................................................................................8 7
1 0. 1. 3. I nf or me d C o nse nt Pr ocess ........................................................................8 7
1 0. 1. 3. 1. Electr o nic C o nse nt .................................................................. 8 8
1 0. 1. 4. Data Pr otecti o n ......................................................................................... 8 8
1 0. 1. 5. C o m mittees Str uct ure ............................................................................... 8 9
1 0. 1. 5. 1. Data M o nit ori n g C o m mittee ................................................... 8 9
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8
1 0. 1. 6. Disse mi nati o n of Cli nical St u d y  Data ...................................................... 8 9
1 0. 1. 7. Data Q ualit y Ass ura nce ............................................................................ 9 0
1 0. 1. 8. S o urce D oc u me nts .................................................................................... 9 1
1 0. 1 . 9. St u d y a n d Site Start a n d Cl os ure ..............................................................9 2
1 0. 1. 1 0. P u blicati o n P olic y ................................................................................... 9 3
1 0. 1. 1 1. S p o ns or’s Me dicall y  Q ualifie d I n di vi d ual.............................................. 9 3
1 0. 2. A p pe n di x 2: Cli nical La b orat or y  Tests................................................................. 9 5
1 0. 3. A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E val uati n g, F oll o w -U p, a n d Re p orti n g ..................................................................... 9 6
1 0. 3. 1. Defi niti o n of A E ....................................................................................... 9 6
1 0. 3. 2. Defi niti o n of a n S A E ................................................................................ 9 7
1 0. 3. 3. Rec or di n g/ Re p orti n g a n d F oll o w -U p of A Es a n d/ or S A Es D uri n g 
t he Acti ve C ollecti o n Peri o d............................................................................ 9 9
1 0. 3. 4. Re p orti n g of S A Es .................................................................................. 1 0 2
1 0. 4. A p pe n di x 4: Ge netics .......................................................................................... 1 0 4
1 0. 5. A p pe n di x 5: C o ntrace pti ve a n d Barrier G ui da nce .............................................. 1 0 5
1 0. 5. 1. Male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria .................................. 1 0 5
1 0. 5. 2. Fe male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria ............................... 1 0 5
1 0. 5. 3. W o ma n of C hil d beari n g P ote nt ial .......................................................... 1 0 6
1 0. 5. 4. C o ntrace pti o n Met h o ds ........................................................................... 1 0 7
1 0. 6. A p pe n di x 6: L i ver Safet y: S u g geste d Acti o ns a n d F oll o w-U p Assess me nts ..... 1 0 9
1 0. 7. A p pe n di x 7: Ki d ne y  Safet y M o nit ori n g G ui deli nes ........................................... 1 1 1
1 0. 7. 1. La b orat or y  Assess me nt of C ha n ge i n Ki d ne y F u ncti o n a n d 
Detecti o n of Ki d ne y  Inj ur y ............................................................................ 1 1 1
1 0. 7. 2. A ge -S pecific Ki d ne y  F u ncti o n Calc ulati o n Rec o m me n dati o ns ............. 1 1 1
1 0. 7. 2. 1. A d ults ( 1 8 Years a n d A b o ve) – 2 0 2 1 C K D -E PI 
E q uati o ns......................................................................................... 1 1 1
1 0. 7. 3. A d verse E ve nt Gra di n g f or Ki d ne y  Safety La b orat or y  
A b n or malities ................................................................................................. 1 1 1
1 0. 8. A p pe n di x 8: Criteria f or All o wi n g I ncl usi o n of Partici pa nts Wit h C hr o nic 
Sta ble HI V, H C V, or H B V I nfecti o n ...................................................................... 1 1 2
1 0. 9. A p pe n di x 9: E C G Fi n di n gs of P ote ntial Cli nical C o ncer n ................................. 1 1 3
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9
1 0. 1 0. A p pe n di x 1 0: A Es, A D Es, S A E s, S A D Es, U S A D Es, a n d De vice 
Deficie ncies: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, E val uati n g, F oll o w -
U p, a n d Re p orti n g i n Me dical De vice St u dies........................................................ 1 1 5
1 0. 1 0. 1. Defi niti o n of A E a n d A D E ................................................................... 1 1 5
1 0. 1 0. 2. Defi niti o n of S A E, S A D E, a n d U S A D E .............................................. 1 1 5
1 0. 1 0. 3. Defi niti o n of De vice Deficie nc y ........................................................... 1 1 6
1 0. 1 0. 4. Rec or di n g/ Re p orti n g a n d F oll o w -U p of Me dical De vice 
Deficie ncies .................................................................................................... 1 1 6
1 0. 1 0. 5. Re p orti n g of S A Es ................................................................................ 1 1 8
1 0. 1 0. 6. Re p orti n g of S A D Es ............................................................................. 1 1 9
1 0. 1 1. A p pe n di x 1 1: S u bst u d y  A ( P hase 1)................................................................. 1 2 0
1 0. 1 1. 1. S o A – S u bst u d y  A ( P hase 1) ................................................................ 1 2 0
1 0. 1 1. 2. I ntr o d ucti o n f or S u bst u d y  A................................................................. 1 2 2
1 0. 1 1. 2. 1. S u bst u d y  A Rati o nale.......................................................... 1 2 2
1 0. 1 1. 2. 2. Bac k gr o u n d f or S u bst u d y  A................................................ 1 2 2
1 0. 1 1. 2. 3. Be nefit/ Ris k Assess me nt f or S u bst u d y A ........................... 1 2 2
1 0. 1 1. 3. O bjecti ves, E n d p oi nts, a n d Esti ma n ds ( S u bst u d y  A)........................... 1 2 3
1 0. 1 1. 4. S u bst u d y  A Desi g n............................................................................... 1 2 6
1 0. 1 1. 4. 1. O verall Desi g n f or S u bst u d y  A........................................... 1 2 6
1 0. 1 1. 4. 2. Scie ntific Rati o nale f or St u d y Desi g n f or S u bst u d y A ....... 1 2 7
1 0. 1 1. 4. 3. J ustificati o n f or D ose f or S u bst u d y A ................................. 1 2 7
1 0. 1 1. 4. 4. E n d of S u bst u d y  Defi niti o n f or S u bst u d y A ....................... 1 2 7
1 0. 1 1. 5. S u bst u d y  A P o p ulati o n......................................................................... 1 2 7
1 0. 1 1. 5. 1. S u bst u d y  A I ncl usi o n Criteria............................................. 1 2 7
1 0. 1 1. 5. 2. S u bst u d y  A E xcl usi o n Criteria............................................ 1 2 8
1 0. 1 1. 5. 3. Criteria f or Te m p oraril y  Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/ A d mi nistrati o n of St u d y  
I nter ve nti o n f or S u bst u d y A............................................................ 1 3 0
1 0. 1 1. 6. S u bst u d y  A I nter ve nti o n a n d C o nc o mita nt T hera p y............................ 1 3 1
1 0. 1 1. 6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d f or S u bst u d y  A........... 1 3 1
1 0. 1 1. 6. 2. Bli n di n g f or S u bst u d y  A ..................................................... 1 3 4
1 0. 1 1. 6. 3. St u d y  Inter ve nti o n C o m plia nce f or S u bst u d y  A................. 1 3 4
1 0. 1 1. 6. 4. D ose M o dificati o n f or S u bst u d y  A ..................................... 1 3 4
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0
1 0. 1 1. 6. 5. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d 
of t he St u d y  f or S u bst u d y A............................................................1 3 4
1 0. 1 1. 6. 6. Treat me nt of O ver d ose f or S u bst u d y  A .............................. 1 3 4
1 0. 1 1. 6. 7. Pri or a n d C o nc o mita nt T hera p y f or S u bst u d y  A................. 1 3 5
1 0. 1 1. 7. Disc o nti n uati o n of S u bst u d y  A I nter ve nti o n a n d Partici pa nt 
Disc o nti n uati o n/ Wit h dra wal .......................................................................... 1 3 6
1 0. 1 1. 8. S u bst u d y  A Assess me nts a n d Pr oce d ures............................................. 1 3 6
1 0. 1 1. 8. 1. I m m u n o ge nicit y  Assess me nts f or S u bst u d y A.................... 1 3 6
1 0. 1 1. 8. 2. N -Bi n di n g A nti b o d y  Test f or S u bst u dy A .......................... 1 3 6
1 0. 1 1. 8. 3. Bi ol o gical Sa m ples f or S u bst u d y  A.................................... 1 3 6
1 0. 1 1. 8. 4. Safet y Assess me nts f or S u bst u d y A .................................... 1 3 7
1 0. 1 1. 8. 5. Cli nical Safet y L a b orat or y Assess me nts f or S u bst u d y A ... 1 3 7
1 0. 1 1. 8. 6. St o p pi n g R ules f or S u bst u d y  A........................................... 1 3 8
1 0. 1 1. 8. 7. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her 
Safet y  Re p orti n g f or S u bst u d y A .................................................... 1 3 9
1 0. 1 1. 8. 8. St u d y  Pr oce d ures f or S u bst u d y A ....................................... 1 3 9
1 0. 1 1. 9. Statistical C o nsi derati o ns – S u bst u d y  A............................................... 1 4 9
1 0. 1 1. 9. 1. Statistical H y p ot heses f or S u bst u d y  A................................ 1 4 9
1 0. 1 1. 9. 2. A nal y sis Sets f or S u bst u d y A.............................................. 1 4 9
1 0. 1 1. 9. 3. Statistical A nal y ses f or S u bst u d y A.................................... 1 5 0
1 0. 1 1. 9. 4. I nteri m A nal yses f or S u bst u d y A ........................................ 1 5 3
1 0. 1 1. 9. 5. Sa m ple Size Deter mi nati o n f or S u bst u d y A ........................ 1 5 3
1 0. 1 2. A p pe n di x 1 2: S u bst u d y  B ( P hase 1/ 2) ..............................................................1 5 5
1 0. 1 2. 1. S o A – S u bst u d y  B ( P hase 1/ 2)..............................................................1 5 5
1 0. 1 2. 2. I ntr o d ucti o n f or S u bst u d y  B ................................................................. 1 5 7
1 0. 1 2. 2. 1. S u bst u d y  B Rati o nale.......................................................... 1 5 7
1 0. 1 2. 2. 2. Bac k gr o u n d f or S u bst u d y  B................................................ 1 5 7
1 0. 1 2. 2. 3. Be nefit/ Ris k Assess me nt f or S u bst u d y B ............................ 1 5 7
1 0. 1 2. 3. O bjecti ves, E n d p oi nts, a n d Esti ma n ds ( S u bst u d y  B)........................... 1 5 8
1 0. 1 2. 4. S u bst u d y  B Desi g n ...............................................................................1 5 9
1 0. 1 2. 4. 1. O verall Desi g n f or S u bst u d y B ........................................... 1 5 9
1 0. 1 2. 4. 2. Scie ntific Rati o nale f or St u d y Desi g n f or S u bst u d y B ........ 1 6 1
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1
1 0. 1 2. 4. 3. J ustificati o n f or D ose f or S u bst u d y B................................. 1 6 1
1 0. 1 2. 4. 4. E n d of St u d y  Defi niti o n f or Su bst u d y  B............................. 1 6 1
1 0. 1 2. 5. S u bst u d y  B P o p ulati o n ......................................................................... 1 6 2
1 0. 1 2. 5. 1. S u bst u d y  B I ncl usi o n Criteria ............................................. 1 6 2
1 0. 1 2. 5. 2. S u bst u d y  B E xcl usi o n Criteria............................................ 1 6 3
1 0. 1 2. 5. 3. Criteria f or Te m p oraril y  Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/ A d mi nistrati o n of St u d y  
I nter ve nti o n f or S u bst u d y B ............................................................ 1 6 4
1 0. 1 2. 6. S u bst u d y  B I nter ve nti o n a n d C o nc o mita nt T hera p y ............................ 1 6 6
1 0. 1 2. 6. 1. St u d y  Inter ve nti o n(s) A d mi n istere d f or S u bst u d y B........... 1 6 6
1 0. 1 2. 6. 2. Bli n di n g f or S u bst u d y  B...................................................... 1 6 8
1 0. 1 2. 6. 3. St u d y  Inter ve nti o n C o m plia nce f or S u bst u d y  B ................. 1 6 9
1 0. 1 2. 6. 4. D ose M o dificati o n f or S u bst u d y  B...................................... 1 6 9
1 0. 1 2. 6. 5. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d 
of t he St u d y  f or Su bst u d y  B ............................................................ 1 6 9
1 0. 1 2. 6. 6. Treat me nt of O ver d ose f or S u bst u d y  B............................... 1 6 9
1 0. 1 2. 6. 7. Pri or a n d C o nc o mita nt T hera p y f or S u bst u d y  B................. 1 6 9
1 0. 1 2. 7. Disc o nti n uati o n of S u bst u d y  B I nter ve nti o n a n d Partici pa nt 
Disc o nti n uati o n/ Wit h dra wal .......................................................................... 1 7 0
1 0. 1 2. 8. S u bst u d y  B Assess me nts a n d Proce d ures f or S u bst u d y  B.................... 1 7 0
1 0. 1 2. 8. 1. Tele healt h Visits f or S u bst u d y  B ........................................ 1 7 0
1 0. 1 2. 8. 2. H o me Healt h Visits f or S u bst u d y  B.................................... 1 7 1
1 0. 1 2. 8. 3. I m m u n o ge nicit y  Assess me nts f or S u bst u d y B.................... 1 7 1
1 0. 1 2. 8. 4. Bi ol o gical Sa m ples f or S u bst u d y  B .................................... 1 7 1
1 0. 1 2. 8. 5. Safet y Assess me nts f or S u bst u d y B .................................... 1 7 1
1 0. 1 2. 8. 6. Cli nical Safet y L a b orat or y Assess me nts f or S u bst u d y B.... 1 7 2
1 0. 1 2. 8. 7. St o p pi n g R ules f or S u bst u d y  B Gr o u ps 2, 6, 7, 8, 9, 1 0, 
1 1, a n d 1 2 ........................................................................................ 1 7 2
1 0. 1 2. 8. 8. A d verse E ve nts, Seri o us A d verse E ve nt s, a n d Ot her 
Safet y  Re p orti n g f or S u bst u d y B..................................................... 1 7 4
1 0. 1 2. 8. 9. St u d y  Pr oce d ures f or S u bst u d y B........................................ 1 7 4
1 0. 1 2. 8. 1 0. A d diti o nal Pr oce d ures f or M o nit ori n g of P ote ntial 
M y ocar ditis or Pericar ditis f or S u bst u d y  B..................................... 1 8 2
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2
1 0. 1 2. 8. 1 1. A d diti o nal Pr oce d ures f or M o nit ori n g of P ote ntial 
Me nstr ual C y cle Dist ur ba nces f or S u bst u d y B ...............................1 8 3
1 0. 1 2. 8. 1 2. A d diti o nal Pr oce d ures f or M o nit ori n g of P ote ntial 
M y ocar ditis or Pericar ditis f or S u bst u d y  B..................................... 1 8 4
1 0. 1 2. 8. 1 3. A d diti o nal Pr oce d ures f or M o nit ori n g of P ote ntial 
Me nstr ual C y cle Dist ur ba nces f or S u bst u d y B ............................... 1 8 5
1 0. 1 2. 9. Statistical C o nsi derati o ns – S u bst u d y  B............................................... 1 8 5
1 0. 1 2. 9. 1. Statistical H y p ot heses f or S u bst u d y  B................................1 8 5
1 0. 1 2. 9. 2. A nal y sis Sets f or S u bst u d y B.............................................. 1 8 6
1 0. 1 2. 9. 3. Statistical A nal y ses f or S u bst u d y B.................................... 1 8 6
1 0. 1 2. 9. 4. I nteri m A nal yses f or S u bst u d y B........................................ 1 8 9
1 0. 1 2. 9. 5. A nal y sis Ti mi n g f or S u bst u d y B......................................... 1 8 9
1 0. 1 2. 9. 6. Sa m ple Size Deter mi nati o n f or S u bst u d y B ........................ 1 9 0
1 0. 1 3. A p pe n di x 1 3: Pr ot oc ol A me n d me nt Hist or y ..................................................... 1 9 1
1 0. 1 4. A p pe n di x 1 4: A b bre viati o ns ............................................................................. 2 0 9
1 1. R E F E R E N C E S ................................................................................................................ 2 1 4
LI S T O F T A B L E S
Ta ble 1.
S u bst u d y  A: qIR V/ Bi vale nt B N T 1 6 2 b 2 ( Ori gi nal/ O mi B A. 4/ B A. 5) 
D ose -Le vel C o m bi nati o ns........................................................................ 5 8
Ta ble 2.
S u bst u d y  B: All Vacci ne Gr o u ps..............................................................5 9
Ta ble 3.
S u bst u d y  A a n d S u bst u d y B: Vacci ne Details.......................................... 6 1
Ta ble 4.
L ocal Reacti o n Gra di n g Scale.................................................................. 7 1
Ta ble 5.
S y ste mic E ve nt Gra di n g Scale.................................................................. 7 2
Ta ble 6.
Scale f or Fe ver .......................................................................................... 7 3
Ta ble 7.
Pr o ba bilit y  of O bser vi n g at Least 1 A E b y Ass u me d Tr ue E ve nt 
Rate ......................................................................................................... 1 5 4
Ta ble 8.
S u bst u d y  B E nr oll me nt C o h orts............................................................. 1 60
Ta ble 9.
Pr o ba bilit y  of O bser vi n g at Least 1 A E b y Ass u me d Tr ue E ve nt 
Rate ......................................................................................................... 1 9 0
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3
1. P R O T O C O L S U M M A R Y
1. 1. S y n o psis
Pr ot oc ol Title:
A P hase 1/ 2 Master Pr ot oc ol
t o E val uate t he Safet y, T olera bilit y, a n d I mm u n o ge nicit y  of 
C o m bi ne d M o difie d R N A Vacci ne Ca n di dates A gai nst C O VI D -1 9 a n d I nfl ue nza i n Healt hy 
I n di vi d uals
Brief Title:
A St u d y  t o E val uate t he Safet y, T olera bility, a n d I m m u n o ge nicit y of C o m bi ne d M o difie d 
R N A Vacci ne Ca n di dates A gai nst C O VI D -1 9 a n d I nfl ue nza
Re g ul at or y A ge nc y I de ntific ati o n N u m ber(s):
U S I N D N u m ber:
2 8 9 1 7
E u dr a C T / E U C T N u m ber:
N ot a p plica ble
Cli nic al Tri als. g o v I D:
N C T 0 5 5 9 6 7 3 4
Pe di atric I n vesti g ati o n al Pl a n N u m ber:
N ot a p plica ble
Pr ot oc ol N u m ber:
C 5 2 6 1 0 0 1
P h ase:
1/ 2
R ati o n ale:
T his master pr ot oc ol descri bes t he i n vesti gati o nal pla n of a c o m bi nati o n vacci ne c o ntai ni n g
m o difie d R N A c o m p o ne nts e nc o di n g pr otei ns of t he S A R S -C o V -2 pref usi o n s pi ke a n d 
i nfl ue nza H A a nti ge ns . T his c o m bi nati o n vacci ne ai ms t o si m plif y vacci nati o n practices f or
t he pre ve nti o n of 2 p ote ntiall y  seri o us res pirat or y ill nesses: i nfl ue nza a n d C O VI D- 1 9.    
B N T 1 6 2 b 2 ( C o mir nat y ® ) is a m o d R N A -base d vacci ne t hat, as of Ja n uar y 2 0 2 3, has bee n 
gra nte d f ull mar keti n g a ut h orizati o n, c o n diti o nal mar keti n g a ut h orizati o n, E U A, or 
te m p orar y a ut h orizati o n i n a t otal of m ore t ha n 1 8 4 c o u ntries f or t he pre ve nti o n of 
C O VI D -1 9 ca use d b y S A R S -C o V - 2.  T he ori gi nal versi o n of B N T 1 6 2 b 2 e nc o des t he 
ancestral W u ha n -H u -1 strai n s pi ke gl yc o pr otei n.   I n t he U S, it has bee n f ull y lice nse d f or use 
i n i n di vi d uals 1 2 years of a ge a n d a b o ve as of 0 8 J ul y 2 0 2 2.  Fr o m 1 8 A pril 2 0 2 3 u ntil 
1 1 Se pte m ber 2 0 2 3 , t he bi vale nt ori gi nal * / O micr o n B A. 4/ B A. 5 C O VI D-1 9 vacci n e had bee n 
a ut h orize d f or use f or all d oses a d mi nistere d t o i n di vi d ua ls 6 m o nt hs of a ge a n d ol der.
All versi o ns of t he vacci ne e nc o de t he S A R S -C o V - 2 pref usi o n s pi ke pr otei n(s) i n m o d R N A
e nca ps ulate d i n R N A -L N Ps , w hic h has de m o nstrate d p ote nt i m m u n o ge nicit y , hi g h V E, a n d a 
fa v ora ble safet y pr ofile i n P hase 1, 2, a n d 3 h u ma n trials, as well as i n real-w orl d usa ge.  As 
S A R S -C o V -2 c o nti n ues t o circ ulate, at ver y hi g h le vels, Pfizer/ Bi o N Tec h are i n vesti gati n g
R N A -base d C O VI D- 1 9 vacci nes t o f urt her pr otect a gai nst C O VI D -1 9 ca use d b y  e mer ge nt
a n d p ote ntiall y m ore a nti ge nically di verse varia nts .  T heref ore, b i vale nt B N T 1 6 2 b 2 
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4
( ori gi nal* / O mi B A. 4/ B A. 5), c o nsisti n g of t he ori gi nal S A R S -C o V -2 pref usi o n s pi ke pr otei n 
m o d R N A, tar geti n g t he a ncestral strai n of t he vir us, i n c o m bi nati o n wit h m o d R N A e nc o di n g 
t he s pi ke pr otei n of t he O micr o n varia nt ( B A. 4/ B A. 5 s u bli nea ge), will be use d i n t his st u d y .
Pfizer als o has a q ua dri vale nt m o d R N A- base d i nfl ue nza vacci ne, q I RV, c urre ntl y i n P hase 3
de vel o p me nt.  qI R V e nc o des t he H A a nti ge n of
i nfl ue nza strai ns (
 
) rec o m me n de d seas o nall y b y  W H O f or t he i nfl ue nza seas o n. Base d o n P hase 2 safet y 
a n d i m m u n o ge nicit y data, t he d ose le vel of qI R V bei n g st u d ie d i n t he P hase 3 C 47 8 1 0 0 4 
st u d y, b y  a ge strat u m, is
µ g f or partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge a n d 
 µ g f or 
partici pa nts ≥6 5 y ears of a ge.
T he W H O rec o m me n dati o n f or t he c o m p ositi o n of i nfl ue nza vacci nes i n t he 2 0 2 3- 2 0 2 4 
n ort her n he mis p here i nfl ue nza seas o n i ncl u des b ot h a q ua dri vale nt vacci ne a n d a tri vale nt 
vacci ne , t he latter wit h o ut t he B/ Ya ma gata li nea ge, w hic h has n ot bee n see n i n circ ulati o n 
si nce Marc h 2 0 2 0. Base d o n t he 0 5 Oct o ber 2 0 2 3 V R B P A C rec o m me n dati o ns, t he 
c o m mittee v ote d t o e xcl u de t he B/ Ya ma gata li nea ge a nti ge n c o m p o ne nt fr o m q ua dri vale nt 
i nfl ue nza vacci nes as s o o n as p ossi ble. T he st u d y  desi g n t heref ore i ncl u des a q ua dri vale nt 
i nfl ue nza vacci ne ( qIR V) a n d a tri vale nt i nfl ue nza vacci ne (tIR V) w he n c o m bi ne d wit h 
B N T 1 6 2 b 2 (t he Pfizer- Bi o N Tec h C O VI D- 1 9 vacci ne ).
Gi ve n t hat a n n ual vacci ne pr o gra ms i n t he U S a n d li kel y ot her parts of t he w orl d a gai nst b ot h 
i nfl ue nza a n d C O VI D - 1 9 ma y  be c o n d ucte d i n t he f ut ure at a si milar ti me of year, 
de vel o pi n g a c o m bi ne d vacci ne tar geti n g b ot h vir uses is li kel y t o ge nerate o verall hi g her 
vacci nati o n rates f or b ot h vir uses b y all o wi n g f or m ore c o n ve nie nt sc he d uli n g t ha n if t hese 
vacci nes were t o be a d mi nistere d se paratel y. He nce, t his st u d y  will e val uate t he safet y, 
t olera bilit y, a n d i m m u n o ge nicit y of a m o d R N A vacci ne a gai nst i nfl ue nza w he n c o m bi ne d 
wit h B N T 1 6 2 b 2 (bi vale nt ori gi nal * / O mi B A. 4/ B A. 5 ). T his e val uati o n will i nitiall y  be 
c o n d ucte d t hr o u g h t he f oll o wi n g s u bst udies :

S u bst u d y  A: A P hase 1 s u bst u d y i n u p t o a p pr o xi matel y 3 6 0 partici pa nts 
( 1 8 0 partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge a n d 1 8 0 partici pa nts ≥6 5 y ears of a ge) t o 
descri be t he safet y of q I R V a n d bi vale nt B N T 1 6 2 b 2 ( ori gi nal* / O mi B A. 4/ B A. 5) at 
3 d ose -le vel c o m bi nati o ns.

S u bst u d y  B: A P hase 1/2 s u bst u d y  t o descri be t he safety a n d i m m u n o ge nicit y  of I R V
( qIR V or tIR V) w he n a d mi nistere d i n c o m bi nati o n wit h bi vale nt B N T 1 6 2 b 2 
( ori gi nal* / O mi B A. 4/ B A. 5) , a n d lice nse d QI V gi ve n c o nc urre ntl y wit h bI R V/ bi vale nt 
B N T 1 6 2 b 2 ( ori gi nal* / O mi B A. 4/ B A. 5) i n healt h y a d ults 1 8 t hr o u g h 6 4 ye ars of a ge.
* Ori gi nal refers t o t he a ncestral strai n ( W u ha n -H u -1; U S A -W A 1/ 2 0 2 0), als o referre d t o i n 
t his pr ot oc ol as t he refere nce strai n.
Base d o n preli mi nar y  data fr o m S u bst u d y A, S u bst u d y  B will st u d y a d diti o nal c o m bi nati o n s
of C O VI D -1 9/i nfl ue nza m o d R N A vacci ne s, i ncl u di n g tIR V: 
µ g 
 
 pl us
µ g bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5), bI R V : 
µ g 
 pl us
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5
µ g bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) gi ve n c o nc urre ntl y wit h QI V i n t he 
o p p osite ar m , a n d a d diti o nal n o vel c o m bi nati o ns of qIR V
µ g 
 
. T his is s u p p orte d b y  a n acce pta ble t olera bilit y 
pr ofile f or a d ose u p t o 
µ g of a c o m bi nati o n of i nfl ue nza m o d R N A a n d C O VI D - 1 9 
m o d R N A , wit h op p ort u nit y  t o i ncrease t he i m m u ne res p o nse a gai nst b ot h C O VI D-1 9 a n d 
i nfl ue nza strai ns.
F oll o wi n g a th or o u g h re vie w of safet y  data fr o m S u bst u d y  A f or b ot h t he 1 8 - t hr o u g h
6 4- ye ar a ge gr o u p a n d t he ≥6 5 -year a ge gr o u p b y  t he s p o ns or’s I R C i n Marc h 2 0 2 3 a n d 
Ma y
2 0 2 3, c o nti n ue d use of C O VI D -1 9/i nfl ue nza c o m bi nati o n vacci nes u p t o
µ g
ma xi m u m R N A d ose was c o nsi dere d acce pta ble f or c o nti n uati o n i nt o S u bst u d y  B.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6
O bjecti ves, E n d p oi nts, a n d Esti m a n ds:
S u bst u d y A ( P h ase 1)
O bjecti ves
Esti m a n ds
E n d p oi nts
Pri m ar y S afet y
Pri m ar y S afet y
Pri m ar y S afet y
T o descri be t he safet y a n d t olera bilit y of 
qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) at vari o us 
d ose -le vel c o m bi nati o ns i n partici pa nts 
≥1 8 years of a ge
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge, 
se paratel y a n d c o m bi ne d, recei vi n g 1 d ose of st u d y i nter ve nti o n, t he 
perce nta ge of partici pa nts re p orti n g:

L ocal reacti o ns f or u p t o 7 da ys f oll o wi n g vacci nati o n

S yste mic e ve nts f or u p t o 7 da ys f oll o wi n g vacci nati o n

A E s fr o m vacci nati o n t hr o u g h 4 wee ks after vacci nati o n

S A Es fr o m t he first vacci nati o n t hr o u g h 6 m o nt hs after 
vacci nati o n

L ocal reacti o ns ( pai n at t he i njecti o n site, re d ness, a n d 
s welli n g)

S yste mic e ve nts (fe ver, fati g ue, hea dac he, c hills, 
v o miti n g, diarr hea, ne w or w orse ne d m uscle pai n, a n d 
ne w or w orse ne d j oi nt pai n)

A Es

S A Es
T he perce nta ge of partici pa nts wit h:

A b n or mal tr o p o ni n I la b orat or y val ues 2 da ys a n d 1 wee k after 
vacci nati o n
Tr o p o ni n I la b orat or y para meters detaile d i n t he pr ot oc ol
T he perce nta ge of partici pa nts wit h:

Ne w E C G a b n or malities 2 da ys a n d 1 wee k after vacci n ati o n
E C G a b n or malities c o nsiste nt wit h pr o ba ble or p ossi ble 
m y o car ditis or pericar ditis as defi ne d i n t he pr ot oc ol
Sec o n d ar y
Sec o n d ar y
Sec o n d ar y
T o descri be t he i m m u ne res p o nses elicite d 
b y qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) at vari o us 
d ose -le vel c o m bi nati o ns i n partici pa nts 
≥1 8 years of a ge
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge, 
se paratel y, c o m pl yi n g wit h t he ke y pr ot oc ol criteria (e val ua ble 
partici pa nts):

G M Ts bef ore vacci nati o n a n d at 4 wee ks after vacci nati o n

G M F R fr o m bef ore vacci nati o n t o 4 wee ks after vacci nati o n

T he pr o p orti o n of partici pa nts ac hie vi n g H AI ser oc o n versi o n a
f or eac h strai n at 4 wee ks after vacci nati o n

T he perce nta ge of partici pa nts wit h H AI titers ≥1: 4 0 f or eac h 
strai n bef ore vacci nati o n a n d at 4 wee ks after vacci nati o n

T he perce nta ge of partici pa nts ac hie vi n g H AI ser oc o n versi o n f or 
all strai ns at 4 wee ks after vacci nati o n

T he perce nta ge of partici pa nts wit h H AI titers ≥1: 4 0 f or all 
strai ns at 4 wee ks after vacci nati o n
H AI titers f or t he matc he d seas o nal strai ns ( 
 
rec o m me n de d b y W H O
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7
S u bst u d y A ( P h ase 1)
O bjecti ves
Esti m a n ds
E n d p oi nts
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge, 
se paratel y, ha vi n g recei ve d qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) a n d c o m pl yi n g wit h t h e ke y pr ot oc ol 
criteria (e val ua ble partici pa nts): 

G M Ts bef ore vacci nati o n a n d at 4 wee ks after vacci nati o n f or 
eac h strai n

G M F R fr o m bef ore vacci nati o n t o 4 wee ks after vacci nati o n f or 
eac h strai n

Perce nta ges of partici pa nts wit h ser ores p o nseb at 4 wee ks after 
vacci nati o n f or eac h strai n

S A R S -C o V -2 O micr o n B A. 4/ B A. 5 – ne utralizi n g titers

S A R S -C o V -2 refere nce -strai n– ne utralizi n g titers
E x pl or at or y
E x pl or at or y
E x pl or at or y
T o descri be t he i m m u ne res p o nses elicite d 
b y qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) at vari o us 
d ose -le vel c o m bi nati o ns i n partici pa nts 
≥1 8 years of a ge
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge, 
se paratel y, c o m pl yi n g wit h t he ke y pr ot oc ol criteria (e val ua ble 
partici pa nts):

G M Ts bef ore vacci nati o n a n d at 1 a n d 8 wee k s after vacci nati o n

G M F R fr o m bef ore vacci nati o n t o 1 wee k after vacci nati o n

T he pr o p orti o n of partici pa nts ac hie vi n g H AI ser oc o n versi o n a
f or eac h strai n at 1 a n d 8 wee k s after vacci nati o n

T he perce nta ge of partici pa nts wit h H AI titers ≥1: 4 0 f or eac h 
strai n bef ore vacci nati o n a n d at 1 a n d 8 wee k s after vacci nati o n

T he perce nta ge of partici pa nts ac hie vi n g H AI ser oc o n versi o n f or 
all strai ns at 1 a n d 8 wee k s after vacci nati o n

T he perce nta ge of partici pa nts wit h H AI titers ≥1: 4 0 f or all 
strai ns at 1 a n d 8 wee k s after vacci nati o n
H AI titers f or t he matc he d seas o nal strai ns  
) 
rec o m me n de d b y W H O
T o descri be t he i m m u ne res p o nses elicite d 
b y qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) at vari o us 
d ose -le vel c o m bi nati o ns i n partici pa nts 
≥1 8 years of a ge
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge, 
se paratel y, ha vi n g recei ve d qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) a n d c o m pl yi n g wit h t he ke y pr ot oc ol 
criteria (e val ua ble partici pa nts): 

G M Ts bef ore vacci nati o n a n d at 1 a n d 8 wee k s after vacci nati o n 
f or eac h strai n

G M F R fr o m bef ore vacci nati o n t o 1 a n d 8 wee k s after 
vacci nati o n f or eac h strai n

Perce nta ges of partici pa nts wit h ser ores p o nse b at 1 a n d 8 wee k s
after vacci nati o n f or eac h strai n

S A R S -C o V -2 O micr o n B A. 4/ B A. 5 – ne utralizi n g titers

S A R S -C o V -2 refere nce -strai n– ne utralizi n g titers
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8
S u bst u d y A ( P h ase 1)
O bjecti ves
Esti m a n ds
E n d p oi nts
T o descri be t he i m m u ne res p o nse t o 
e mer gi n g V O Cs i n partici pa nts ≥1 8 years 
of a ge

S A R S -C o V -2 ne utralizi n g titers f or V O Cs n ot alrea d y 
s pecifie d
a.
Ser oc o n versi o n is defi ne d as a n H AI titer < 1: 1 0 pri or t o vacci nati o n a n d ≥1: 4 0 at t he ti me p oi nt of i nterest, or a n H AI titer of ≥1: 1 0 pri or t o vacci nati o n 
wit h at least a 4 -f ol d rise at t he ti me p oi nt of i nterest.
b.
Ser ores p o nse is defi ne d as ac hie vi n g a ≥4 -f ol d rise fr o m baseli ne ( bef ore t he st u d y vacci nati o n).  If t he baseli ne meas ure me nt is bel o w t he L L O Q, t he 
p ost vacci nati o n meas ure of ≥4 × L L O Q is c o nsi dere d ser ores p o nse.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9
S u bst u d y B ( P h ase 1/ 2)
O bjecti ves
Esti m a n ds
E n d p oi nts
Pri m ar y S afet y
Pri m ar y S afet y
Pri m ar y S afet y
T o descri be t he safet y a n d t olera bilit y of st u d y 
i nter ve nti o ns i n partici pa nts 1 8 thr o u g h 6 4 ye ars of 
a ge
I n partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge recei vi n g at least 
1 d ose of st u d y i nter ve nti o n, t he perce nta ge of partici pa nts 
wit h:

A b n or mal tr o p o ni n I la b orat or y val ues 2 da ys a n d 
1 wee k after vacci nati o n

Tr o p o ni n I la b orat or y para meters detaile d i n
t he pr ot oc ol
I n partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge recei vi n g at least 
1 d ose of st u d y i nter ve nti o n, t he perce nta ge of partici pa nts 
wit h:

Ne w E C G a b n or malities 2 da ys a n d 1 wee k after 
vacci nati o n

E C G a b n or malities c o nsiste nt wit h pr o ba ble or 
p ossi ble m y ocar ditis or pericar ditis as defi ne d i n t he
pr ot oc ol
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge recei vi n g at least 
1  d ose of st u d y i nter ve nti o n, t he perce nta ge of partici pa nts 
re p orti n g:
L ocal reacti o ns f or u p t o 7 da ys f oll o wi n g vacci nati o n i n 
t he ri g ht ar m o nl y
S yste mic e ve nts f or u p t o 7 da ys f oll o wi n g vacci nati o n i n 
t he ri g ht ar m
A Es fr o m vacci nati o n t hr o u g h 4  wee ks after eac h
vacci nati o n
S A Es fr o m vacci nati o n t hr o u g h 6 m o nt hs after t he first 
vacci nati o n

L ocal reacti o ns ( pai n at t he i njecti o n site, re d ness, a n d 
s welli n g) i n t he ri g ht ar m o nl y

S yste mic e ve nts (fe ver, fati g ue, hea dac he, c hills, 
v o miti n g, diarr hea, ne w or w orse ne d m uscle pai n, a n d 
ne w or w orse ne d j oi nt pai n)

A Es

S A Es
Sec o n d ar y I m m u n o ge nicit y a
Sec o n d ar y I m m u n o ge nicit ya
Sec o n d ar y I m m u n o ge nicit ya
T o descri be t he i m m u ne res p o nses t o S A R S- C o V -2 
a n d i nfl ue nza elicite d b y eac h st u d y i nter ve nti o n
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge c o m pl yi n g wit h 
t he ke y pr ot oc ol criteria (e val ua ble partici pa nts):

G M Ts bef ore vacci nati o n a n d at eac h bl o o d sa m pli n g 
ti me p oi nt after i nfl ue nza vacci nati o n   

G M F R fr o m bef ore vacci nati o n t o eac h bl o o d sa m pli n g 
ti me p oi nt after i nfl ue nza vacci nati o n

T he pr o p orti o n of partici pa nts ac hie vi n g H AI 
ser oc o n versi o n b f or eac h strai n at eac h bl o o d sa m pli n g 
ti me p oi nt after i nfl ue nza vacci nati o n   

T he perce nta ge of partici pa nts wit h H AI titers ≥1: 4 0 f or 
eac h strai n bef ore vacci nati o n a n d at eac h bl o o d 
sa m pli n g ti me p oi nt after i nfl ue nza vacci nati o n 

H AI titers f or t he matc he d seas o nal strai ns 
rec o m me n de d b y W H O
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0
S u bst u d y B ( P h ase 1/ 2)
O bjecti ves
Esti m a n ds
E n d p oi nts
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge c o m pl yi n g wit h 
t he ke y pr ot oc ol criteria (e val ua ble partici pa nts):

G M Ts bef ore vacci nati o n a n d at eac h bl o o d sa m pli n g 
ti me p oi nt after vacci nati o n f or eac h strai n

G M F R fr o m bef ore S A R S -C o V - 2 vacci nati o n t o eac h 
bl o o d sa m pli n g ti me p oi nt after vacci nati o n f or eac h 
strai n

Perce nta ges of partici pa nts wit h ser ores p o nse c at eac h 
bl o o d sa m pli n g ti me p oi nt after S A R S -C o V - 2
vacci nati o n f or eac h strai n

S A R S -C o V - 2 –ne utralizi n g titers b y strai n
Terti ar y/ E x pl or at or y
Terti ar y/ E x pl or at or y
Terti ar y/ E x pl or at or y
T o descri be t he i m m u ne res p o nse t o e mer gi n g varia nts 
( u n der m o nit ori n g, of i nterest, a n d/ or of c o ncer n) i n 
partici pa nts 1 8 t hr o u g h 6 4 years of a ge
As detaile d i n t he S A P

S A R S -C o V -2 ne utralizi n g titers f or e mer gi n g
varia nts ( u n der m o nit ori n g, of i nterest , a n d/ or of 
c o ncer n)
T o descri be t he tr o p o ni n a n d E C G a b n or malities 
detecte d i n partici pa nts w h o are e val uate d f or p ossi ble 
car diac s y m pt o ms  
As detaile d i n t he S A P

Tr o p o ni n I la b orat or y para meters detaile d i n
t he pr ot oc ol

E C G a b n or malities c o nsiste nt wit h pr o ba ble or 
p ossi ble m y ocar ditis or pericar ditis as defi ne d i n t he
pr ot oc ol
a.
T here are n o pri mar y i m m u n o ge nicit y o bjecti ves i n t his st u d y.
b.
Ser oc o n versi o n is defi ne d as a n H AI titer < 1: 1 0 pri or t o vacci nati o n a n d ≥1: 4 0 at t he ti me p oi nt of i nterest, or a n H AI titer of ≥1: 1 0 pri or t o vacci nati o n 
wit h at least a 4 -f ol d rise at t he ti me p oi nt of i nterest.
c.
Ser ores p o nse is defi ne d as ac hie vi n g a ≥4 -f ol d rise fr o m baseli ne ( bef ore t he st u d y vacci nati o n). If t he baseli ne meas ure me nt is bel o w t he L L O Q, t he 
p ost vacci nati o n meas ure of ≥4 × L L O Q is c o nsi dere d ser ores p o nse.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 1
O ver all Desi g n:
T his st u d y i ncl udes 2 s u bst u dies (S u bst u d ies A a n d B) . 
S u bst u dies A a n d B are desi g ne d t o descri be t he safet y, t olera bilit y, a n d i m m u n o ge nicity of 
se veral vacci nes t hat i ncl u de c o m bi ne d or sta n dal o ne m o d R N A e nc o di n g 3 or 4 i nfl ue nza
strai ns* a n d/ or m o d R N A e nc o di n g 1 or m ore S A R S -C o V -2 strai ns. T he st u d y  i nter ve nti o ns 
e val uate d i n S u bst u d y A are s h o w n i n t he ta ble title d S u bst u d y  A: qI R V/ Bi vale nt B N T 1 6 2 b 2 
( Ori gi nal/ O mi B A. 4/ B A. 5) D ose-Le vel C o m bi nati o ns . The st u d y  i nter ve nti o ns e val uate d i n 
S u bst u d y  B are s h o w n i n t he ta ble title d S u bst u d y  B: All Vacci ne Gr o u ps .
Eac h of t hese s u bst u dies i ncl u des t he use of lice nse d/a ut h orize d sta n dal o ne i nfl ue nza vacci ne 
( QI V) a n d C O VI D-1 9 vacci nes as c o m parat ors.  I n S u bst u d y  A a n d S u bst u d y  B, bi vale nt 
B N T 1 6 2 b 2 (ori gi na l/O mi B A . 4/ B A.5 ) re prese nts t he C O VI D-1 9 c o m parat or . Bi vale nt 
B N T 1 6 2 b 2 ( o ri gi nal/ O mi B A. 4/ B A. 5) use d i n S u bst u dies A a n d B was rec o m me n de d b y 
A CI P i n 2 0 2 2 - 2 0 2 3. I n S u bst u d y A, t he QI V c o m parat or is Fl uz o ne S D.  In S u bst u d y  B, t he 
QI V c o m parat or is Fl ucel va x.
* I nfl ue nza strai ns use d i n S u bst u d y  A a n d S u bst u d y  B were base d o n t he W H O 
rec o m me n dati o ns f or use i n t he n ort her n he mis p here i n 2 0 2 2- 2 0 2 3.  
S u bst u d y A: qI R V/ Bi v ale nt B N T 1 6 2 b 2 ( Ori gi n al/ O mi B A. 4/ B A. 5) D ose -Le vel C o m bi n ati o ns
D ose -Le vel 
C o m bi n ati o n
qI R V D ose
Bi v ale nt B N T 1 6 2 b 2 ( Ori gi n al/
O m i B A. 4/ B A. 5) D ose
T ot al 
m o d R N A 
D ose
1
 µ g, ie,
µ g , ie,

µ g of ori gi nal B N T 1 6 2 b 2 a n d

µ g of B N T 1 6 2 b 2 O micr o n 
( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5)
µ g
2
µ g , ie,
µ g , ie,

µ g of ori gi nal B N T 1 6 2 b 2 a n d

µ g of B N T 1 6 2 b 2 O micr o n 
( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5)
µ g
3
µ g , ie,
µ g , ie,

µ g of ori gi nal B N T 1 6 2 b 2 a n d

µ g of B N T 1 6 2 b 2 O micr o n 
( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5)
µ g
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 2
S u bst u d y B: All V acci ne Gr o u ps 
S u bst u d y B 
V acci ne
Gr o u p
qI R V/ Bi v ale nt 
B N T 1 6 2 b 2
D ose -Le vel 
C o m bi n ati o ns a
qI R V, tI R V, or bI R V
Bi v ale nt 
B N T 1 6 2 b 2 b
Lice nse d QI V
L N P
D ose
T ot al m o d R N A
D ose
A p pr o xi m ate 
N u m ber of 
P artici p a nts
1
N/ A
N/ A
µ g 
Lice nse d QI V
m g
µ g
3 0
2 c
N/ A
µ g bI R V
)
µ g 
Lice nse d QI V
m g
µ g
3 0
3
1
µ g qI R V
(
)
µ g 
N/ A
m g
µ g
1 2 0
4 d
2
µ g qI R V (
(
 
)
µ g
N/ A
m g
 µ g
1 2 0
5
3
µ g qI R V
(
 
)
µ g 
N/ A
m g
µ g
1 2 0
6
4
µ g qI R V
(
 
)
µ g
N/ A
m g
µ g
3 0
7
5
µ g qI R V
(
 
)
µ g 
N/ A
m g
µ g
3 0
8
6
µ g qI R V
(
 
)
µ g 
N/ A
m g
µ g
3 0
9
7
µ g qI R V
(
 
µ g 
N/ A
m g
µ g
3 0
1 0
8
µ g qI R V
(
 
)
µ g 
N/ A
m g
µ g
3 0
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 3
S u bst u d y B: All V acci ne Gr o u ps 
S u bst u d y B 
V acci ne
Gr o u p
qI R V/ Bi v ale nt 
B N T 1 6 2 b 2
D ose -Le vel 
C o m bi n ati o ns a
qI R V, tI R V, or bI R V
Bi v ale nt 
B N T 1 6 2 b 2 b
Lice nse d QI V
L N P
D ose
T ot al m o d R N A
D ose
A p pr o xi m ate 
N u m ber of 
P artici p a nts
1 1 c
N/ A
µ g tI R V
(
)
µ g 
N/ A
m g
µ g
3 0
1 2 d
N/ A
qI R V
(
N/ A
N/ A
m g 
µ g
3 0
a.
F or qI R V/ bi vale nt B N T 1 6 2 b 2 ( o ri gi nal/ O mi B A . 4/ B A. 5) t hat is
 mI R Vs e nc o di n g H A f or eac h A a n d B strai n will be
t o ge nerate qI R V 
at t he d ose-le vel c o m bi nati o n s h o w n; t he res ulta nt qI R V will t he n be
wit h bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) pri or t o a d mi nistrati o n.  Please 
see t he I P M f or f urt her details.
b.
F or bi vale nt B N T 1 6 2 b 2 f or m ulati o ns: 
µ g t otal d ose i ncl u des 
 µ g of O micr o n B A. 4/ B A. 5 a n d  
µ g of t he a ncestral S A R S -C o V - 2 strai n;
µ g t otal d ose i ncl u des 
µ g of O micr o n B A. 4/ B A. 5 a n d  
µ g of t he a ncestral S A R S- C o V -2 strai n. Ori gi nal refers t o t he a ncestral strai n ( W u ha n- H u -1; U S A- W A 1/ 2 0 2 0), als o referre d t o i n 
t his pr ot oc ol as t he refere nce strai n.
c.
Gr o u ps 2 a n d 1 1 : bI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) a n d tI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) are 
d.
Gr o u ps 4 a n d 1 2 : qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) a n d qI R V are
N ote: T he f oll o wi n g i nfl ue nza strai ns are i ncl u de d i n t he I R V i n eac h gr o u p at t he d ose le vel n ote d:
Gr o u p 
Gr o u ps t hr o u g h  a n d  
 
 
 
Gr o u p 
Gr o u p 
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C C
I
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 4
S u bst u d y A ( P h ase 1)
T his is a P hase 1 ra n d o mize d, o pe n -la bel s u bst u d y t o descri be t he safety a n d i m m u n o ge nicit y 
of u p t o 3 d ose- le vel c o m bi nati o ns of qIR V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5).  
A p pr o xi matel y  3 6 0 partici pa nts will be e nr olle d acr oss 2 a ge strata: a p pr o xi matel y  
1 8 0 partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge a n d a p pr o xi matel y 1 8 0 partici pa nts ≥6 5 y ears of 
a ge will be ra n d o mize d e q uall y (a p pr o xi matel y 3 0 partici pa nts per gr o u p) t o eac h gr o u p t o 
recei ve a d ose of eit her:

qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal */ O mi B A. 4/ B A. 5), at 1 of t he 3 d ose- le vel 
c o m bi nati o ns s h o w n i n t he ta ble a b o ve title d S u bst u d y  A: qI R V/ Bi vale nt B N T 1 6 2 b 2 
( Ori gi nal/ O mi B A. 4/ B A. 5) D ose -Le vel C o m bi nati o ns ,

 µ g qI R V, 

µ g qI R V, or

 µ g Bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) a d mi nistere d c o nc urre ntl y i n 
t he o p p osite ar m t o lice nse d QI V
* Ori gi nal refers t o t he a ncestral strai n ( W u ha n -H u -1; U S A -W A 1/ 2 0 2 0), als o referre d t o i n 
t his pr ot oc ol as t he refere nce strai n.
Saf et y a n d i m m u n o ge nicit y data fr o m st u dies pre vi o usl y c o n d ucte d i n partici pa nts of a 
si milar a ge ra n ge ha vi n g recei ve d 1 d ose of B N T 1 6 2 b 2 at a d ose le vel of 
µ g a n d  
µ g 
ma y  be use d as a c o ntr ol d uri n g t he s u bst u d y a nal ysis.
E nr oll me nt i n eac h a ge strat u m will be c o ntr olle d s uc h t hat n o m ore t ha n 1 0 partici pa nts 
(se nti nel ≤1 0 partici pa nts) ca n be vacci nate d o n t he first da y ; vacci nati o n of t he re mai ni n g 
partici pa nts will c o m me nce n o s o o ner t ha n 2 4 h o urs after t he te nt h partici pa nt recei ve d his or 
her vacci nati o n.
St o p pi n g r ules f or partici pa nts i n S u bst u d y A will a p pl y  t o gr o u ps recei vi n g t he c o m bi nati o n 
bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) a n d qI R V as detaile d i n t he pr ot oc ol .
After c o nfir mati o n of eli gi bilit y  b y t he in vesti gat or, partici pa nts will be e nr olle d, 
ra n d o mize d, a n d will recei ve a d mi nistrati o n of 1 or 2 d oses of st u d y i nter ve nti o n.  W here 
2 d oses of st u d y  i nter ve nti o n are gi ve n, 1 d ose will be gi ve n i n eac h ar m.  All st u d y  
i nter ve nti o ns will be a d mi nistere d via i ntra m usc ular i njecti o n i nt o t he delt oi d m uscle.
All partici pa nts will be as ke d t o c o m plete a react o ge nicit y  e-diar y  f or 7 da ys f oll o wi n g eac h 
vacci nati o n.  Bl o o d sa m ples of a p pr o xi matel y  5 0 m L  will be c ollecte d f or i m m u n o ge nicity 
assess me nts pri or t o V acci nati o n 1 a n d at 1, 4, a n d 8 wee ks after vacci nati o n.  All 
partici pa nts will be as ke d t o pr o vi de a n a d diti o nal bl o o d sa m ple of a p pr o xi matel y  2. 5 m L at 
ti me p oi nts s pecifie d i n t he pr ot oc ol f or assess me nt of tr o p o ni n I.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 5
Safet y  a n d i m m u n o ge nicit y data acc u m ulate d f or at least 4 wee k s f oll o wi n g vacci nati o n i n 
eac h a ge strat u m will be re vie we d b y t he s p o ns or’s I R C t o deter mi ne if e nr oll me nt i n eac h 
a ge strat u m of S u bst u d y  B ma y pr ocee d.  Base d o n re vie w of safet y or i m m u n o ge nicit y data 
of a n y st u d y i nter ve nt i o n gr o u p, at Pfizer’s discreti o n, s u bse q ue nt c ollecti o n of bl o o d 
sa m ples fr o m partici pa nts i n t hat gr o u p ma y be halte d a n d/ or bl o o d sa m ples ma y  n ot be 
a nal yz e d, a n d st u d y visits or ot her pr oce d ures ma y be disc o nti n ue d.
T he t otal d urati o n of t he st u d y  f or eac h partici pa nt will be u p t o a p pr o xi matel y  6 m o nt hs.
S u bst u d y B ( P h ase 1/ 2)
T his is a P hase 1/ 2 s u bst u d y  t o descri be t he safet y, t olera bilit y , a n d i m m u n o ge nicit y of I RV
(qI R V , tIR V, or bI R V) w he n a d mi nistere d i n c o m bi nati o n wit h bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5).  Bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) will be use d 
d uri n g t he s u bst u d y, as detaile d i n t he ta ble title d S u bst u d y B: All Vacci ne Gr o u ps.
S u bst u d y  B will be si n gle -bli n d (s p o ns or -u n bli n de d). I n S u bst u d y  B, u p t o a p pr o xi matel y
6 3 0 partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge will be e nr olle d .  Ra n d o mizati o n will be 
c o n d ucte d acr oss 3 e nr oll me nt c o h orts i n de pe n de ntl y d ue t o lice nse d QI V a vaila bilit y, wit h 
e nr oll me nt i n t hese c o h orts bei n g c o n d ucte d eit her c o nc urre n tl y or at differe nt ti mes as 
re q uire d base d o n o perati o nal c o nsi derati o ns, as s h o w n i n t he ta ble bel o w.
S u bst u d y B: E nr oll me nt C o h orts
E nr oll me nt 
C o h ort
T ot al 
N u m ber of 
P artici p a nts
N u m ber of 
P artici p a nts 
per V acci ne 
Gr o u p
V acci ne 
Gr o u p 
N u m ber
V acci ne Gr o u p Descri pti o ns
1
6 0
3 0
1
Lice nse d QI V (Fl ucel va x ) a d mi nistere d 
c o nc urre ntl y i n t he o p p osite ar m t o 
 µ g 
bi vale nt B N T 1 6 2 b 2 ( ori gi nal */ O mi 
B A. 4/ B A. 5)
2
Lice nse d QI V (Fl ucel va x ) a d mi nistere d 
c o nc urre ntl y i n t he o p p osite ar m t o 
bI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5)
2
3 6 0
U p t o 1 2 0
3
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) at d ose -le vel c o m bi nati o n 1a
4
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) at d ose -le vel c o m bi nati o n 2a
5
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) at d ose -le vel c o m bi nati o n 3a
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 6
S u bst u d y B: E nr oll me nt C o h orts
E nr oll me nt 
C o h ort
T ot al 
N u m ber of 
P artici p a nts
N u m ber of 
P artici p a nts 
per V acci ne 
Gr o u p
V acci ne 
Gr o u p 
N u m ber
V acci ne Gr o u p Descri pti o ns
3
2 1 0
3 0
6
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) at d ose -le vel c o m bi nati o n 4a
7
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) at d ose -le vel c o m bi nati o n 5a
8
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) at d ose -le vel c o m bi nati o n 6a
9
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) at d ose -le vel c o m bi nati o n 7a
1 0
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) at d ose -le vel c o m bi nati o n 8a
1 1
tI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5)
1 2
qI R V
a.
C o m bi nati o n as s h o w n i n t he ta ble title d S u bst u d y B: All Vacci ne Gr o u ps.
N ote: * Ori gi nal refers t o t he a ncestral strai n ( W u ha n -H u -1; U S A -W A 1/ 2 0 2 0), als o referre d t o i n t his 
pr ot oc ol as t he refere nce strai n.
E nr oll me nt of partici pa nts ( Gr o u ps 2, 6, 7, 8, 9, 1 0, 1 1, a n d 1 2) will be c o ntr olle d s uc h t hat 
n o m ore t ha n 1 0 partici pa nts (se nti nel partici pa nts) ca n be vacci nate d o n t he first da y ; 
vacci nati o n of t he re mai ni n g partici pa nts will c o m me nce n o s o o ner t ha n 2 4 h o urs after t his
safety p a use.
St o p pi n g r ules will a p pl y t o all gr o u ps as detaile d i n t he pr ot oc ol.
Safet y  data acc u m ulate d at least 4 wee ks f oll o wi n g vacci natio n of partici pa nts 1 8 t hr o u g h 
6 4 ye ars of a ge i n S u bst u d y  B will be re vie we d b y t he s p o ns or’s I R C, a n d if t hese data are 
dee me d acce pta ble, t he I R C will e val uate w hic h gr o u ps ( as detaile d i n t he ta ble title d 
S u bst u d y  B: E nr oll me nt C o h orts a b o ve) are acce pta b le f or f urt her st u d y. 
I m m u n o ge nicit y Bl o o d Dr a ws i n S u bs t u d y B:
Bl o o d sa m ples of a p pr o xi matel y  1 5 m L will be c ollecte d f or i m m u n o ge nicit y assess me nts 
pri or t o vacci nati o n a n d at 4 wee ks after vacci nati o n. U p t o 2 0 partici pa nts i n Gr o u ps 3, 4, 
a n d 5 i n t he 1 8- t hr o u g h 6 4-ye ar a ge strat u m will be as ke d t o c o nse n t t o alter nati vely 
pr o vi di n g 5 0 -m L , rat her t ha n 1 5-m L , bl o o d sa m ples at t he sa me ti me p oi nts, w hic h will be 
use d f or i m m u n o ge nicit y assess me nts as well as assa y de vel o p me nt / mai nte na nce.  
F or S u bst u d y  B bl o o d dra ws (as detaile d a b o ve), t he hi g her - v ol u me bl o o d dra ws of 5 0 m L 
will be d o ne i n u p t o 2 0 partici pa nts w h o are e nr olle d first a n d gi ve c o nse nt.
A ll partici pa nts will be as ke d t o c o m plete a react o ge nicit y e-diar y  f or 7 da ys f oll o wi n g eac h 
vacci nati o n .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 7
F oll o wi n g vacci nati o n, A E s will be c ollecte d fr o m i nf or me d c o nse nt si g ni n g t hr o u g h 
4 wee ks f oll o wi n g eac h vacci nati o n, a n d S A Es will be c ollecte d fr o m i nf or me d c o nse nt 
si g ni n g t hr o u g h 6 m o nt hs after t he first vacci nati o n. I n a d diti o n, AE s will be c ollecte d t hat 
occ ur u p t o 4 8 h o u rs after bl o o d dra ws. 
N u m ber of P artici p a nts:
U p t o a p pr o xi matel y  9 9 0 partici pa nts will be e nr olle d acr oss all s u bst u dies.
S u bst u d y A ( P h ase 1)
U p t o a p pr o xi matel y  3 6 0 partici pa nts ( n = 3 0 per d ose le vel per gr o u p ) will be e nr olle d acr oss 
2 a ge strata: a p p r o xi matel y 1 8 0 partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge a n d a p pr o xi matel y 
1 8 0 partici pa nts ≥6 5 ye ars of a ge i n S u bst u d y A.
S u bst u d y B ( P h ase 1/ 2)
U p t o a p pr o xi matel y  6 3 0 partici pa nts 1 8 t hr o u g h 6 4 y ears of a ge will be e nr olle d i n 
S u bst u d y B.
N ote : “ E nr olled” mea ns a partici pa nt, or t heir le gall y  a ut h orize d re prese ntati ve, has a gree d t o 
partici pate i n a cli nical st u d y  f oll o wi n g c o m pleti o n of t he i nf or me d c o nse nt pr ocess a n d 
ra n d o mizati o n.
St u d y P o p ul ati o n: 
S u bst u d y A ( P h ase 1)
I ncl usi o n Criteri a
I ncl usi o n criteria f or S u bst u d y A ca n als o be f o u n d i n t he pr ot oc ol .
Partici pa nts are eli gi ble t o be i ncl u de d i n S u bst u d y  A o nly if all of t he f oll o wi n g criteria 
a p pl y:
A ge a n d Se x:
1.
Male or fe male partici pa nts ≥1 8 y ears of a ge ( or t he mi ni m u m a ge of c o nse n t i n 
acc or da nce wit h l ocal re g ulati o ns) at Visit 1 ( Da y 1).

Refer t o A p pe n di x 5 f or re pr o d ucti ve criteria f or male a n d fe male partici pa nts i n 
t he pr ot oc ol.
Dise ase C h ar acteristics:
N ot a p plica ble.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 8
Ot her I ncl usi o n Criteri a:
2.
Partici pa nts w h o are willi n g a n d a ble t o c o m pl y wit h all sc he d ule d visits, i n vesti gati o nal 
pla n, la b orat or y  tests, lifest yle c o nsi derati o ns, a n d ot her st u d y pr oce d ures.
3.
Healt h y partici pa nts w h o are deter mi ne d b y me dical hist or y, p h ys ical e xa mi nati o n 
(if re q uire d), a n d cli nical j u d g me nt of t he i n vesti gat or t o be eli gi ble f or i ncl usi o n i n t he 
st u d y.
N ote: Healt h y partici pa nts wit h pree xisti n g sta ble disease, defi ne d as disease n ot 
re q uiri n g si g nifica nt c ha n ge i n t hera py or h os pitalizati o n f or w orse ni n g disease 
d uri n g t he 6 wee ks bef ore e nr oll me nt, ca n be i ncl u de d.  S pecific criteria f or 
partici pa nts wit h k n o w n sta ble i nfecti o n wit h HI V, H C V, or H B V ca n be f o u n d i n 
t he pr ot oc ol .
4.
Ca pa ble of gi vi n g si g ne d i nf or me d c o nse nt as descri be d i n t he pr ot oc ol, w hic h i ncl u des 
c o m plia nce wit h t he re q uire me nts a n d restricti o ns liste d i n t he I C D a n d i n t his pr ot oc ol.
5.
F or p artici p a nts 1 8 t hr o u g h 6 4 ye ars of a ge: partici pa nts w h o ha ve recei ve d 3 pri or 
d oses of 3 0 µ g B N T 1 6 2 b 2, wit h t he last d ose bei n g 1 5 0 da ys t o 3 6 5 da y s bef ore Visit 1 
( Da y 1).
F or p artici p a nts ≥6 5 ye ars of a ge: partici pa nts w h o ha ve recei ve d 4 or 5 pri or d oses of 
a m o d R N A S A R S -C o V - 2 vacci ne, wit h t he last d ose bei n g a bi vale nt vacci ne, 9 0 da y s t o 
3 6 5 da y s bef ore Visit 1 ( Da y 1).
N ote: D oc u me nte d c o nfir mati o n of pri or d oses of m o d R N A S A R S -C o V - 2 vacci nes
recei ve d m ust be o btai ne d pri or t o ra n d o mizati o n.
6.
F or p artici p a nts ≥6 5 ye ars of a ge: recei pt of lice nse d i nfl ue nza vacci nati o n f or t he 
2 0 2 2- 2 0 2 3 n ort her n he mis p here seas o n ≥1 2 0 da y s bef ore st u d y i nter ve nti o n 
a d mi nistrati o n.
E xcl usi o n Criteri a
E xcl usi o n criteria f or S u bst u d y  A ca n als o be f o u n d i n t he pr ot oc ol .
Partici pa nts are e xcl u de d fr o m S u bst u d y  A if a ny of t he f oll o wi n g criteria a p pl y :
Me dic al C o n diti o ns:
1.
Hist or y  of se vere a d verse reacti o n ass ociate d wit h a n y vacci ne a n d/ or se vere aller gic 
reacti o n (e g, a na p hyl a xis) t o a n y c o m p o ne nt of t he st u d y i nter ve nti o n(s).
2.
I m m u n oc o m pr o mise d i n di vi d uals wit h k n o w n or s us pecte d i m m u n o deficie nc y, as 
deter mi ne d b y hist or y  a n d/ or la b orat or y/ p h ysical e xa mi nati o n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 9
3.
Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d blee di n g t hat w o ul d, i n t he 
o pi ni o n of t he i n vesti gat or, c o ntrai n dicate i ntra m usc ular i njecti o n.
4.
W o me n w h o are pre g na nt or breastfee di n g.
5.
Aller g y  t o e g g pr otei ns (e g g or e g g pr o d ucts) or c hic ke n pr otei ns.
6.
Ot her me dical or ps y c hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he past year) or acti ve 
s uici dal i deati o n/ be ha vi or or la b orat or y a b n or malit y t hat ma y i ncrease t he ris k of st u d y 
partici pati o n or, i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt i na p pr o pr iate f or 
t he st u d y.
Pri or/ C o nc o mit a nt T her a p y:
7.
Recei pt of c hr o nic s ys te mic treat me nt wit h k n o w n i m m u n os u p pressa nt me dicati o ns 
(i ncl u di n g c yt ot o xic a ge nts or s yste mic c ortic oster oi ds), or ra di ot hera p y, wit hi n 6 0 da ys 
bef ore e nr oll me nt t hr o u g h c o ncl usi o n of t he st u d y.
N ote: S y ste mic c ortic oster oi ds are defi ne d as t h ose a d mi nistere d f or ≥1 4 da y s at a d ose 
of ≥2 0 m g/ da y  of pre d nis o ne or e q ui vale nt (e g, f or ca ncer or a n a ut oi m m u ne 
disease) or pla n ne d recei pt t hr o u g h o ut t he st u d y.  I n hale d/ ne b ulize d, i ntra -
artic ular, i ntra b ursal, or t o pical (s ki n or e yes) c ortic oster oi ds are per mitte d.
8.
Recei pt of bl o o d/ plas ma pr o d ucts, i m m u n o gl o b uli n, or m o n ocl o nal a nti b o dies, fr o m 
6 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he 
st u d y.
9.
F or p arti ci p a nts 1 8 t hr o u g h 6 4 ye ars of a ge: vacci nati o n wit h a n y i n vesti gati o nal or 
lice nse d i nfl ue nza vacci ne wit hi n 6 m o nt hs ( 1 7 5 da y s) bef ore st u d y i nter ve nti o n 
a d mi nistrati o n.
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
1 0. Partici pati o n i n ot her st u dies i n v ol vi n g a st u d y i nter ve nti o n wit hi n 2 8 da ys bef ore 
ra n d o mizati o n.  A ntici pate d partici pati o n i n ot her st u dies wit hi n 2 8 da ys after recei pt of 
st u d y i nter ve nti o n i n t his st u d y.
Di a g n ostic Assess me nts:
N ot a p plica ble.
Ot her E xcl usi o n Criteri a:
1 1. I n vesti gat or site staff directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site staff ot her wise s u per vise d b y t he i n vesti gat or, a n d s p o ns or a n d s p o ns or 
dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 0
1 2. Partici pat i o n i n stre n u o us or e n d ura nce e xercise t hr o u g h Visit 3.
1 3. Pri or hist or y  of heart disease.
1 4. A n y  a b n or mal scree ni n g tr o p o ni n I la b orat or y val ue.
1 5. Scree ni n g 1 2 -lea d E C G t hat, as j u d ge d b y t he i n vesti gat or, is c o nsiste nt wit h pr o ba ble or 
p ossi ble m y ocar ditis or pe ricar ditis, or de m o nstrates cli nicall y rele va nt a b n or malities 
t hat ma y affect partici pa nt safety or i nter pretati o n of st u d y res ults.  Partici pa nts wit h a 
scree ni n g 1 2-lea d E C G t hat s h o ws a n a vera ge Q Tc F i nter val > 4 5 0 msec, c o m plete left 
b u n dle bra nc h bl oc k , si g ns of a n ac ute or i n deter mi nate-a ge m y ocar dial i nfarcti o n, S T -T 
i nter val c ha n ges s u g gesti ve of m yocar dial isc he mia, sec o n d - or t hir d - de gree A V bl oc k, 
or seri o us bra d ya rr hyt h mias or tac h y arr h yt h mias s h o ul d be e xcl u de d fr o m st u d y 
partici pati o n.
S u bst u d y B ( P h ase 1/ 2)
I ncl usi o n Criteri a
I ncl usi o n criteria f or S u bst u d y B ca n als o be f o u n d i n t he pr ot oc ol.
Partici pa nts are eli gi ble t o be i ncl u de d i n S u bst u d y  B o nl y if all of t he f oll o wi n g criteria 
a p pl y:
A ge a n d Se x:
1.
Male or fe male partici pa nts 1 8
t hr o u g h 6 4 ye ars of a ge ( or t he mi ni m u m a ge of c o nse nt 
i n acc or da nce wit h l ocal re g ulati o ns) at Visit 2 0 1 ( Da y 1).

Refer t o A p pe n di x 5 f or re pr o d ucti ve criteria f or male a n d fe male partici pa nts i n t he 
pr ot oc ol .
Dise ase C h ar acteristics:
N ot a p plica ble.
Ot her I ncl usi o n Criteri a:
2.
Partici pa nts w h o are willi n g a n d a ble t o c o m pl y wit h all sc he d ule d visits, i n vesti gati o nal 
pla n, la b orat or y  tests, lifest yle c o nsi derati o ns, a n d ot her st u d y pr oce d ures.
3.
Healt h y partici pa nts w h o are deter mi ne d b y me dic al hist or y, p h ysical e xa mi nati o n 
(if re q uire d), a n d cli nical j u d g me nt of t he i n vesti gat or t o be eli gi ble f or i ncl usi o n i n t he 
st u d y.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 1
N ote: Healt h y partici pa nts wit h pree xisti n g sta ble disease, defi ne d as disease n ot re q uiri n g 
si g nifica nt c ha n ge i n t hera p y or h os pitalizati o n f or w orse ni n g disease d uri n g t he 6 wee ks 
bef ore e nr oll me nt, ca n be i ncl u de d.  S pecific criteria f or partici pa nts wit h k n o w n sta ble 
i nfecti o n wit h HI V, H C V, or H B V ca n be f o u n d i n t he pr ot oc ol.
4.
Ca pa ble of gi vi n g si g ne d i nf or me d c o nse nt as descri be d i n t he pr ot oc ol, w hic h i ncl u des
c o m plia nce wit h t he re q uire me nts a n d restricti o ns liste d i n t he I C D a n d i n t his pr ot oc ol.
5.
Partici pa nts w h o ha ve recei ve d at least 3 pri or U S -a ut h orize d m o d R N A C O VI D - 1 9 
vacci nes, wit h t he last d ose bei n g a n u p date d ( bi vale nt) vacci ne gi ve n at least 1 5 0 da ys 
bef ore Visit 2 0 1 ( Da y 1). A n y  d ose of m o d R N A C O VI D - 1 9 vacci ne recei ve d after 
0 1 Se pte m ber 2 0 2 2 ma y  be c o nsi dere d t o be a bi vale nt vacci ne i n t he U S.
N ote: D oc u me nte d c o nfir mati o n of pri or d oses of S A R S -C o V -2 vacci ne recei ve d m ust be 
o btai ne d pri or t o ra n d o mizati o n.
E xcl usi o n Criteri a
E xcl usi o n criteria f or S u bst u d y  B ca n als o be f o u n d i n t he pr ot oc ol.
Partici pa nts are e xcl u de d fr o m S u bst u d y  B if a ny of t he f oll o wi n g criteria a p pl y :
Me dic al C o n diti o ns:
1.
Me dical
or ps yc hiatric c o n diti o n, i ncl u di n g rece nt ( wit hi n t he past year) or acti ve s uici dal 
i deati o n/ be ha vi or or la b orat or y a b n or malit y, t hat ma y i ncrease t he ris k of st u d y 
partici pati o n or, i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt i na p pr o priate f or t he 
st u d y.
2.
Hist or y  of se vere a d verse reacti o n ass ociate d wit h a n y vacci ne a n d/ or se vere aller gic 
reacti o n (e g, a na p h yla xis) t o a n y c o m p o ne nt of t he st u d y i nter ve nti o n(s).
3. I m m u n oc o m pr o mise d i n di vi d uals wit h k n o w n or s us pecte d i m m u n o deficie nc y , as 
deter mi ne d b y  hist or y a n d/ or la b orat or y/ p h ysical e xa mi nati o n.
4.
Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d blee di n g t hat w o ul d, i n t he 
o pi ni o n of t he i n vesti gat or, c o ntrai n dicate i ntra m usc ular i njecti o n.
5.
W o me n w h o are pre g na nt or breastfee di n g .
6.
Hist or y  of my o car ditis or pericar ditis .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 2
Pri or/ C o nc o mit a nt T her a p y:
7.
Recei pt of c hr o nic me dicati o ns wit h k n o w n s yste mic i m m u n os u p pressa nt effects
(i ncl u di n g c yt ot o xic a ge nts or s yste mic c ortic oster oi ds), or ra di ot hera p y, wit hi n 6 0 da ys 
bef ore e nr oll me nt t hr o u g h c o ncl usi o n of t he st u d y.
N ote: S y ste mic c ortic oster oi ds are defi ne d as t h ose a d mi nistere d f or ≥1 4 da y s at a d ose of 
≥2 0 m g/ da y  of pre d nis o ne or e q ui vale nt (e g, f or ca ncer or a n a ut oi m m u ne disease) or 
pla n ne d recei pt t hr o u g h o ut t he st u d y .  I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or 
t o pical (s ki n or e yes) c ortic oster oi ds are per mitte d.
8.
Recei pt of bl o o d/ plas ma pr o d ucts, i m m u n o gl o b uli n, or m o n ocl o nal a nti b o dies use d f or 
t he treat me nt or pre ve nti o n of C O VI D-1 9 or t h ose t hat are c o nsi dere d 
i m m u n os u ppressi ve , fr o m 6 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n, or pla n ne d 
recei pt t hr o u g h o ut t he st u d y.
9.
Vacci nati o n wit h a n y  i n vesti gati o nal or lice nse d i nfl ue nza vacci ne wit hi n 6 m o nt hs 
( 1 7 5 d a y s) bef ore st u dy i nter ve nti o n a d mi nistrati o n, or o n g oi n g rec ei pt of c hr o nic 
a nti viral t hera p y wit h acti vit y  a gai nst i nfl ue nza.
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
1 0. Partici pati o n i n ot her st u dies i n v ol vi n g a d mi nistrati o n of a st u d y  i nter ve nti o n wit hi n 
2 8 da y s pri or t o, a n d/ or d uri n g, partici pati o n i n t his st ud y .
N ote: I n a d diti o n t o a d mi nistrati o n of i n vesti gati o nal pr o d ucts, st u d y i nter ve nti o ns ma y 
i ncl u de a d diti o nal pr oce d ures, s uc h as c ollecti o n of bi ol o gical sa m ples. T heref ore, 
partici pa nts ma y  n ot be i n a n ot her st u d y w here by pr oce d ures, s uc h as res pirat or y 
ill ness visits, ma y i nterfere wit h c o m plia nce wit h t his st u d y’s pr ot oc ol.
Di a g n ostic Assess me nts:
N ot a p plica ble.
Ot her E xcl usi o n Criteri a:
1 1. I n vesti gat or site staff directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site sta ff ot her wise s u per vise d b y t he i n vesti gat or, a n d s p o ns or a n d s p o ns or 
dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers.
1 2. Partici pati o n i n stre n u o us or e n d ura nce e xercise t hr o u g h Visit 2 0 3.
1 3. Pri or hist or y  of heart disease of c o ncer n: hist or y  of m yocar ditis, pericar ditis, 
car di o m y o pat h y, c or o nar y arter y disease (i ncl u di n g hist or y of m y ocar dial i nfarcti o n, 
u nsta ble a n gi na), N Y H A Class III a n d a b o ve heart fail ure, or si g nifica nt arr h y t h mias.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 3
1 4. A n y  a b n or mal scree ni n g tr o p o ni n I la b orat or y val ue.
1 5. Scree ni n g 1 2 -lea d E C G t hat, as j u d ge d b y t he i n vesti gat or, is c o nsiste nt wit h pr o ba ble or 
p ossi ble m y ocar ditis or pericar ditis, or de m o nstrates cli nicall y  rele va nt a b n or malities 
t hat ma y affect partici pa nt safety or i nter pretati o n of st u d y  res ults.  Partici pa nts wit h a 
scree ni n g 1 2-lea d E C G t hat s h o ws a n a vera ge Q Tc F i nter val > 4 5 0 msec, c o m plete 
L B B B , si g ns of a n ac ute or i n deter mi nate-a ge m y ocar dial i nfarcti o n, S T -T i nter val 
c ha n ges s u g gesti ve of m y ocar dial isc he mia, sec o n d - or t hir d - de gree A V bl oc k, or 
seri o us bra dya rr hyt h mias or tac h y arr h yt h mias s h o ul d be e xcl u de d fr o m st u d y 
partici pati o n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 4
St u d y Ar ms a n d D ur ati o n:
St u d y I nter ve nti o ns A d mi nistere d 
S u bst u d y A ( P h ase 1)
T he t otal d urati o n of S u bst u d y  A f or eac h partici pa nt will be u p t o a p pr o xi matel y 6 m o nt hs. 
St u d y  i nter ve nti o ns f or S u bst u d y A will i ncl u de:
I nter ve nti o n 
N a m e
Bi vale nt B N T 1 6 2 b 2 
( ori gi nala/ O mi B A . 4/ B A. 5) 
( ori gi nal B N T 1 6 2 b 2 a n d 
B N T 1 6 2 b 2 O micr o n 
[ B. 1. 1. 5 2 9 s u blinea ge 
B A. 4/ B A. 5])
 
qI R V 
qI R V/ b i vale nt 
B N T 1 6 2 b 2 
( ori gi nal/
O m i B A. 4/ B A. 5)
QI V
A r m  N a me
( gr o u p of 
p artici p a nts 
recei vi n g a 
s pecific st u d y 
i nter ve nti o n or 
n o st u d y 
i nter ve nti o n)
qI R V/ b i vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A . 4/ B A. 5)
or
Lice nse d QI V + bi vale nt 
B N T 1 6 2 b 2 ( ori gi nal/
O m i B A. 4/ B A. 5)
qI R V/ b i vale nt 
B N T 1 6 2 b 2 
( ori gi nal/
O m i B A . 4/ B A. 5)
or
µ g qI R V 
or
µ g qI R V
qI R V/ b i vale nt 
B N T 1 6 2 b 2 
( ori gi nal/
O m i B A . 4/ B A. 5)
Lice nse d QI V + 
bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5)
T ar gete d 
I nfl ue nz a 
Str ai ns
N/ A
F or eac h seas o n, 
strai ns as 
rec o m me n de d b y 
W H O f or 
rec o m bi na nt or 
cell-base d 
i nfl ue nza vacci nes
F or eac h seas o n, 
strai ns as 
rec o m me n de d b y 
W H O f or 
rec o m bi na nt or 
cell-base d 
i nfl ue nza vacci nes
F or eac h seas o n, 
strai ns as 
rec o m me n de d b y 
W H O 
T y pe
Vacci ne
Vacci ne
Vacci ne  
Vacci ne
D ose 
F o r m ul ati o n
m o d R N A
m o d R N A
m o d R N A
U nit D ose 
Stre n gt h(s)
As detaile d i n t he I P M
As detaile d i n t he 
I P M
As detaile d i n t he 
I P M
As detaile d i n t he 
I P M
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 5
D os a ge Le vel(s)
µ g or 
 µ g
( 
µ g ori gi nal B N T 1 6 2 b 2 
a n d 
µ g B N T 1 6 2 b 2 O micr o n 
[B. 1. 1. 5 2 9 s u bli nea ge 
B A. 4/ B A. 5])
( 
µ g ori gi nal B N T 1 6 2 b 2 
a n d 
µ g B N T 1 6 2 b 2 O micr o n 
[B. 1. 1. 5 2 9 s u bli nea ge 
B A. 4/ B A. 5])
µ g 
( 
 μ g per strai n)
 µ g 
μ g per strai n)
D ose -le vel 
c o m bi nati o n 1 as 
s h o w n i n t he ta ble 
title d S u bst u d y A:
qI R V/ Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/
O m i B A. 4/ B A. 5) 
D ose -Le vel 
C o m bi nati o ns
 µ g
qI R V 
 µ g 
( 
μ g per strai n)
B N T 1 6 2 b 2
µ g 
( 
µ g ori gi nal 
B N T 1 6 2 b 2 a n d 
µ g B N T 1 6 2 b 2 
O m icr o n 
[B. 1. 1. 5 2 9 s u bli ne
a ge B A. 4/ B A. 5 ])
D ose -le vel 
c o m bi nati o n 2 as 
s h o w n i n t he ta ble 
title d S u bst u d y A:
qI R V/ Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/
O m i B A. 4/ B A. 5) 
D ose -Le vel 
C o m bi nati o ns
µ g 
qI R V
µ g 
( 
μ g per strai n)
B N T 1 6 2 b 2
µ g 
( 
µ g ori gi nal 
B N T 1 6 2 b 2 a n d 
µ g B N T 1 6 2 b 2 
O m icr o n 
[B. 1. 1. 5 2 9 s u bli ne
a ge B A. 4/ B A. 5 ])
D ose -le vel 
c o m bi nati o n 3 as 
s h o w n i n t he ta ble 
title d S u bst u d y A:
qI R V/ Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 6
O m i B A. 4/ B A. 5) 
D ose -Le vel 
C o m bi nati o ns
µ g
qI R V
µ g 
( 
μ g per strai n)
B N T 1 6 2 b 2
µ g 
(  µ g ori gi nal 
B N T 1 6 2 b 2 a n d 
µ g B N T 1 6 2 b 2 
O m icr o n 
[B. 1. 1. 5 2 9 s u bli ne
a ge B A. 4/ B A. 5 ])
R o ute of 
A d mi nistr ati o n
I ntra m usc ular i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular 
i njecti o n
Use
E x peri me ntal
E x peri me ntal 
E x peri me ntal
C o m parat or
I M P or 
NI M P/ A x M P
I M P
I M P
I M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y 
Pfizer
Pr o vi de d ce ntrall y 
b y Pfizer
St u d y i nter ve nti o n 
will be ge nerate d 
b y mi xi n g t he 
f oll o wi n g at t he 
site at t he 
d ose -le vel 
c o m bi nati o ns 
detaile d a b o ve:

qI R V

Bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5)
Pr o vi de d ce ntrall y 
b y Pfizer
P ac k a gi n g a n d 
L a beli n g
St u d y i nter ve nti o n will be 
pr o vi de d i n a glass vial as 
o pe n -la bel s u p pl y.  Eac h 
vial will be la bele d per 
c o u ntr y re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d i n 
a glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d as 
eit her a P F S or a 
glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c o u ntr y 
re q uire me nt.
a.
Ori gi nal refers t o t he a ncestral strai n ( W u ha n -H u -1; U S A -W A 1/ 2 0 2 0), als o referre d t o i n t his pr ot oc ol as 
t he refere nce strai n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 7
S u bst u d y A ( P h ase 1)
St u d y  ar ms f or S u bst u d y A will i ncl u de:
St u d y Ar ms
Gr o u p 
N u m ber
1
2
3
4 
5
6
Ar m Title
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5)
D ose -le vel 
c o m bi nati o n 1 as 
s h o w n i n t he 
ta ble title d
S u bst u d y A:
qI R V/ Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/ O mi 
B A. 4/ B A. 5) 
D ose -Le vel 
C o m bi nati o ns
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5)
D ose -le vel 
c o m bi nati o n 2 
as s h o w n i n 
t he ta ble title d
S u bst u d y A: 
qI R V/ Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/ O mi 
B A. 4/ B A. 5) 
D ose -Le vel 
C o m bi nati o ns
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5)
D ose -le vel 
c o m bi nati o n 3 
as s h o w n i n
t he ta ble title d
S u bst u d y A: 
qI R V/ Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/ O mi 
B A. 4/ B A. 5) 
D ose -Le vel 
C o m bi nati o ns
 µ g qI R V
µ g qI R V
Lice nse d QI V + 
bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5)
Ar m T y pe
E x peri me ntal
E x peri me ntal
E x peri me ntal
E x peri me ntal
E x peri me ntal
E x peri me ntal
Ar m 
Descri pti o n
Partici pa nts will 
recei ve 
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5) at 
d ose -le vel 
c o m bi nati o n 1 as 
s h o w n i n t he 
ta ble title d
S u bst u d y A : 
qI R V/ Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/ O mi 
B A. 4/ B A. 5) 
D ose -Le vel 
C o m bi nati o ns
Partici pa nts 
will recei ve 
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5) at 
d ose -le vel 
c o m bi nati o n 2 
as s h o w n i n 
t he ta ble title d
S u bst u d y A:
qI R V/ Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/ O mi 
B A. 4/ B A. 5) 
D ose -Le vel 
C o m bi nati o ns
Partici pa nts 
will recei ve 
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5) at 
d ose -le vel 
c o m bi nati o n 3 
as s h o w n i n 
t he ta ble title d
S u bst u d y A:
qI R V/ Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/ O mi 
B A. 4/ B A. 5) 
D ose -Le vel 
C o m bi nati o ns
Partici pa nts 
will recei ve 
µ g of 
qI R V
Partici pa nts 
will recei ve 
µ g of 
qI R V
Partici pa nts will recei ve 
µ g of 
bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) 
a d mi nistere d c o nc urre ntl y 
i n t he o p p osite ar m t o 
QI V
Ass oci ate d 
I nter ve nti o n 
L a bels
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5)
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5)
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5)
qI R V 
qI R V
Bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5)
a n d QI V
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 8
S u bst u d y B ( P h ase 1/ 2)
T he t otal d urati o n of S u bst u d y B f or eac h partici pa nt will be u p t o a p pr o xi matel y  6 m o nt hs fr o m t he first vacci nati o n . St u d y  
i nter ve nti o ns f or S u bst u d y B will i ncl u de:
I nter ve nti o n N a me
B N T 1 6 2 b 2 a
 
qI R V
qI R V b/ B N T 1 6 2 b 2a
tI R Vc/ B N T 1 6 2 b 2a
bI R V c/ B N T 1 6 2 b 2a
QI V
Ar m N a me
( gr o u p of p artici p a nts 
recei vi n g a s pecific 
st u d y i nter ve nti o n or 
n o st u d y i nter ve nti o n)
Lice nse d QI V +
B N T 1 6 2 b 2 a
qI R V
qI R V/ B N T 1 6 2 b 2 a
tI R V/ B N T 1 6 2 b 2a
bI R V/ B N T 1 6 2 b 2 a + 
lice nse d QI V
Lice nse d QI V + 
B N T 1 6 2 b 2 a
or
Lice nse d QI V + 
bI R V/ B N T 1 6 2 b 2 a
T ar gete d I nfl ue nz a 
Str ai ns
N/ A
Strai ns as 
rec o m me n de d b y 
W H O f or rec o m bi na nt 
or cell -base d i nfl ue nza 
vacci nes
Strai ns as 
rec o m me n de d b y 
W H O f or rec o m bi na nt 
or cell -base d i nfl ue nza 
vacci nes
Strai ns as 
rec o m me n de d b y 
W H O f or rec o m bi na nt 
or cell -base d i nfl ue nza 
vacci nes
Strai ns as 
rec o m me n de d b y 
W H O f or rec o m bi na nt 
or cell -base d i nfl ue nza 
vacci nes
F or eac h seas o nal strai n 
as rec o m me n de d b y 
W H O
T y pe
m o d R N A vacci ne
m o d R N A vacci ne
m o d R N A vacci ne
m o d R N A vacci ne
m o d R N A vacci ne
Vacci ne
D ose F or m ul ati o n
m o d R N A
m o d R N A
m o d R N A
m o d R N A
m o d R N A
U nit D ose Stre n gt h(s)
µ g
B N T 1 6 2 b 2 a
µ g qI R V f or 
partici pa nts 
1 8 t hr o u g h 6 4 years of 
a ge (as detaile d i n t he 
I M P)
µ g or 
µ g or
µ g i n d ose-le vel 
c o m bi nati o ns as 
descri be d i n t he ta bles 
title d S u bst u d y B: All 
I Vacci ne Gr o u ps 
µ g tI R V/
µ g 
B N T 1 6 2 b 2 a  
µ g bI R V/
µ g
B N T 1 6 2 b 2 a  
µ g bI R V/
µ g
B N T 1 6 2 b 2 a
As detaile d i n t he I P M
R o ute of 
A d mi nistr ati o n
I ntra m usc ular i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular i njecti o n
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 3 9
Use
E x peri me ntal
E x peri me ntal 
E x peri me ntal 
E x peri me ntal 
E x peri me ntal 
E x peri me ntal
I M P or NI M P/ A x M P
I M P
I M P
I M P
I M P
I M P
I M P
P ac k a gi n g a n d 
L a beli n g
St u d y i nter ve nti o n will be 
pr o vi de d i n a glass vial as 
o pe n -la bel s u p pl y.  Eac h 
vial will be la bele d per 
c o u ntr y re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d i n a 
glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d i n a 
glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d i n a 
glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d i n a 
glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n will 
be pr o vi de d as eit her a 
P F S or a glass/ plastic 
vial as o pe n -la bel 
s u p pl y.  Eac h P F S or vial 
will be la bele d per 
c o u ntr y re q uire me nt.
a.
Bi vale nt B N T 1 6 2 b 2 ( ori gi nal */ O mi B A. 4/ B A. 5) w ill be use d d uri n g S u bst u d y B . * Ori gi nal refers t o t he a ncestral strai n ( W u ha n-H u -1; U S A -W A 1/ 2 0 2 0), 
als o referre d t o i n t his pr ot oc ol as t he refere nce strai n.
b.
Will ha ve f or m ulati o ns t hat are
 per t he I P M a n d
c.
F or m ulati o ns will be
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 0
St atistic al Met h o ds:
S u bst u d y A ( P h ase 1)
Si nce t his s u bst u d y  is descri pti ve i n nat ure, t he pla n ne d sa m ple size f or t he s u bst u d y is n ot 
base d o n a n y statistical h y p ot hesis testi n g.
Safet y  a n d i m m u n o ge nicit y data fr o m st u dies pre vi o usl y c o n d ucte d i n partici pa nts of a 
si milar a ge ra n ge ha vi n g recei ve d 1 d ose of B N T 1 6 2 b 2 at a d ose le vel of  
µ g a n d  
µ g 
ma y  be use d as a c o ntr ol d uri n g t he st u d y a nalys is.
T he pri mar y  safety o bjecti ve f or t he st u d y will be e val uate d b y descri pti ve s u m mar y  statistics 
f or l ocal reacti o ns, sys te mic e ve nts, a n d A Es/ S A Es for eac h vacci ne gr o u p b y  a ge strat u m 
(1 8 t hr o u g h 6 4 a n d ≥6 5 years of a ge) a n d o verall ( ≥1 8 y ears of a ge).  A b n or mal tr o p o ni n I
la b orat or y para meters a n d E C G a b n or malities c o nsiste nt wit h pr o ba ble or p ossi ble 
m y ocar ditis or pericar ditis will als o be descri p ti vel y s u m marize d f or b y a ge strat u m 
( 1 8 t hr o u g h 6 4 a n d ≥6 5 years of a ge) a n d o verall ( ≥1 8 y ears of a ge).
T he sec o n dar y  (i m m u n o ge nicit y) o bjecti ve will be e val uate d descri pti vel y b y a ge strat u m 
( 1 8 t hr o u g h 6 4 a n d ≥6 5 years of a ge) b y  G M T a n d G M F R of b ot h HAI  a n d S A R S-C o V - 2 
ne utralizi n g titers, as well as:

t he perce nta ge of partici pa nts ac hie vi n g ser oc o n versi o n meas ure d by H AI, a n d 
pr o p orti o n of partici pa nts wit h H AI titers ≥1: 4 0, f or eac h strai n at t he vari o us ti me 
p oi nts.

t he perce nta ge of partici pa nts with ser ores p o nse of S A R S -C o V -2 ne utralizi n g titers at 
t he vari o us ti me p oi nts.
S u bst u d y B ( P h ase 1/ 2)
T here is n o f or mal sa m ple size calc ulati o n f or t he pla n ne d sa m ple size i n S u bst u d y B, as
t here is n o f or mal hy p ot hesis testi n g.
T he i m m u n o ge nicit y o bjecti ve s will be e val uate d descri pti vely b y G M T, G M F R, perce nta ge 
of partici pa nts ac hie vi n g ser oc o n versi o n, perce nta ge of partici pa nts wit h ser ores p o nse , a n d 
t he ass ociate d 9 5 % CIs, at t he vari o us ti me p oi nts. 
T he pri mar y  safety o bjecti ve will be e val uate d b y de scri pti ve s u m mar y statistics f or l ocal 
reacti o ns, sys te mic e ve nts, a n d AE s/ S A Es f or eac h st u d y i nter ve nti o n. 
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 1
Et hic al C o nsi der ati o ns:
T he a vaila ble safet y a n d i m m u n o ge nicit y data fr o m o n g oi n g cli nical trials a n d real -w orl d 
effecti ve ness a n d safet y data f o r B N T 1 6 2 b 2, c o m bi ne d wit h a vaila ble n o ncli nical data wit h 
B N T 1 6 2 vacci nes, as well as data fr o m n o ncli nical a n d cli nical trials wit h qI R V, s u p p ort a 
fa v ora ble be nefit/ris k pr ofile a n d s u p p ort cli nical de vel o p me nt of a vacci ne c o m bi ni n g t hese 
c o m p o ne nts. Ta ki n g i nt o acc o u nt t he meas ures t o mi ni mize ris k t o st u d y  partici pa nts, t he 
p ote ntial ris ks i de ntifie d i n ass ociati o n wit h t he st u d y  i nter ve nti o n are j ustifie d b y t he 
a ntici pate d be nefits t hat ma y be aff or de d t o healt h y partici pa nts.
As I R V f or m ulati o ns ( bI R V, tIR V , a n d q I RV) a n d bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) ha ve t he sa me m o d R N A a n d L N P platf or m as B N T 1 6 2 b 2, t heir safet y pr ofiles 
are e x pecte d t o be si milar t o t hat of B N T 1 6 2 b 2.  Base d o n t he e x perie nce wit h B N T 1 6 2 b 2, 
t he p ote ntial ris ks f or IR V f or m ulati o ns c o m bi ne d wit h bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi 
B A. 4/ B A. 5) i ncl u de t he f oll o wi n g:

L ocal reacti o ns, s uc h as i njecti o n site re d ness, i njecti o n site s welli n g, a n d i njecti o n 
site pai n, a n d s yste mic e ve nts, s uc h as fe ver, fati g ue, hea dac he, c hills, m uscle pai n, 
a n d j oi nt pai n.

Ver y  rare cases of m yocar ditis a n d pericar ditis ha ve bee n re p orte d after a ut h orizati o n 
i n reci pie nts of B N T 1 6 2 b 2.

Cases of a na p h yl a xis ha ve bee n re p orte d; h o we ver, t he fre q ue nc y  is n ot esti ma ble 
fr o m t he a vaila ble data.
T he st u d y pr oce d ure – relate d ris ks i ncl u de t he f oll o wi n g:

Ve ni p u nct ure will be perf or me d d uri n g t he st u d y. 
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 2
1. 2. Sc he m a
S u bst u d y B Sc he m a:
S u bst u d y B 
E nr oll me nt C o h ort 1
E nr oll me nt C o h ort 2 
E nr oll me nt C o h ort 3
A ge Strat u m 
1 8 -6 4 Years
Vacci ne g r o u pa 1
( n = ~ 3 0)
Vacci ne g r o u pa 2 
( n = ~ 3 0)
Vacci ne g r o u pa 3 
( n = ~ ≤1 2 0 )
Vac ci ne g r o u pa 4 
( n = ~ ≤1 2 0 )
Vacci ne g r o u pa 5 
( n = ~ ≤1 2 0 )
Vacci ne g r o u pa 6
( n = ~ 3 0)
Vacci ne g r o u pa 7 
( n = ~ 3 0)
Vacci ne g r o u pa 8 
( n = ~ 3 0)
Vacci ne g r o u pa 9 
( n = ~ 3 0)
Vacc i ne g r o u pa 1 0 
( n = ~ 3 0)
Vacci ne g r o u pa 1 1
( n = ~ 3 0)
Vacci ne g r o u pa 1 2 
( n = ~ 3 0)
Se nti nel b
≤1 0 partici pa nts 
fr o m gr o u p 2
F ull
~ 5 0 partici pa nts
F ull 
~ 3 3 0 partici pa nts
Se nti nel b
≤1 0 partici pa nts 
per gr o u p
F ull
~ 1 4 0 partici pa nts
a.
Please see Ta ble 2 f or details o n t he vacci ne gr o u p s.
b.  
A s afet y re vie w will be c o n d ucte d o n 2 4 h o urs of p ost vacci nati o n safet y data fr o m se nti nel partici pa nts 
bef ore f ull e nr oll me nt of t he r e mai ni n g partici pa nts i n eac h vacci ne gr o u p , wit h t he e xce pti o n of G r o u ps 
1, 3, 4, a n d 5 , as e nr oll me nt of t h ose gr o u ps occ urre d u n der a pri or pr ot oc ol versi o n .
N ote: T he arr o w  re prese nts t he 2 4-h o ur safet y pa use .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 3
1. 3. Sc he d ule of Acti vities
T he S o A  ta ble pr o vi des a n o ver vie w of t he pr ot oc ol visits a n d pr oce d ures.  Refer t o t he 
S T U D Y  AS S E S S M E N T S A N D P R O C E D U R E S secti o n of t he pr ot oc ol f or detaile d 
i nf or mati o n o n eac h pr oce d ure a n d assess me nt re q uire d f or c o m plia nce wit h t he pr ot oc ol.
T he i n vesti gat or ma y  sc he d ule visits ( u n pla n ne d visits) i n a d diti on t o t h ose liste d i n t he S o A 
ta ble, i n or der t o c o n d uct e val uati o ns or assess me nts re q uire d t o pr otect t he well-bei n g of t he 
partici pa nt.
See Secti o n 1 0. 1 1. 1 f or t he S u bst u d y A S o A.
See Secti o n 1 0. 1 2. 1 f or t he S u bst u d y B S o A.
2. I N T R O D U C TI O N
2. 1. St u d y R ati o n ale
T his master pr ot oc ol descri bes t he i n vesti gati o nal pla n of a c o m bi nati o n vacci ne c o ntai ni n g 
m o difie d R N A c o m p o ne nts e nc o di n g pr otei ns o f t he S A R S-C o V -2 pref usi o n s pi ke a n d 
i nfl ue nza H A a nti ge ns. T his c o m bi nati o n vacci ne ai ms t o si m plif y  vacci nati o n practices f or 
t he pre ve nti o n of 2 p ote ntiall y seri o us res pirat or y ill nesses: i nfl ue nza a n d C O VI D- 1 9.    
B N T 1 6 2 b 2 ( C o mir nat y ® ) is a m o d R N A -base d vacci ne t hat, as of Ja n uar y 2 0 2 3, has bee n 
gra nte d f ull mar keti n g a ut h orizati o n, c o n diti o nal mar keti n g a ut h orizati o n, E U A, or 
te m p orar y a ut h orizati o n i n a t otal of m ore t ha n 1 8 4 c o u ntries f or t he pre ve nti o n of 
C O VI D -1 9 ca use d b y S A R S -C o V - 2.1 T he ori gi nal versi o n of B N T 1 6 2 b 2 e nc o des t he 
a ncestral W u ha n -H u - 1 strai n s pi ke gl yc o pr otei n. I n t he U S, it has bee n f ull y lice nse d f or use 
i n i n di vi d uals 1 2 years of a ge a n d a b o ve as of 0 8 J ul y  2 0 2 2.2
Fr o m 1 8 A pril 2 0 2 3 u ntil 1 1 Se pte m ber 2 0 2 3, t he bi vale nt ori gi nal*/ O micr o n B A. 4/ B A. 5 
C O VI D -1 9 vacci ne ha d bee n a ut h orize d f or use f or all d oses a d mi nistere d t o i n di vi d uals 6 
m o nt hs of a ge a n d ol der. 3
* Ori gi nal refers t o t he a ncestral strai n ( W u ha n -H u -1; U S A -W A 1/ 2 0 2 0), als o referre d t o i n 
t his pr ot oc ol as t he refere nce strai n.
A bi vale nt f or m ulati o n of t he vacci ne B N T 1 6 2 b 2 ( bi vale nt B N T 1 6 2 b 2 
[ ori gi nal/ Omi B A. 4/ B A. 5 ]) has bee n gra nte d E U A i n t he U S as a si n gle b o oster d ose i n 
i n di vi d uals 1 2 years of a ge a n d ol der, t o be a d mi nistere d at least 2 m o nt hs after eit her 
c o m pleti o n of pri mar y vacci nati o n or recei pt of t he m ost rece nt b o oster d ose wit h a n 
a ut h orize d or a p pr o ve d m o n o vale nt C O VI D -1 9 vacci ne. 4
All versi o ns of t he vacci ne e nc o de t he S A R S -C o V - 2 pref usi o n s pi ke pr otei n(s) i n m o d R N A
e nca ps ulate d i n R N A -L N P s, w hic h has de m o nstrate d p ote nt i m m u n o ge nicit y , hi g h V E, a n d a 
fa v ora ble safet y pr ofile i n P hase 1, 2, a n d 3 h u ma n trials,5 as well as i n real-w orl d usa ge. 6  As 
S A R S -C o V -2 c o nti n ues t o circ ulate, 7 at ver y hi g h le vels, Pfizer/ Bi o N Tec h are i n vesti gati n g
R N A -base d C O VI D -1 9 vacci nes t o f urt her pr otect a gai nst C O VI D -1 9 ca use d b y  e mer ge nt
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 4
a n d p ote ntiall y m ore a nti ge nically di verse vari a nts .  T heref ore, b i vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5) , c o nsisti n g of t he ori gi nal S A R S -C o V - 2 pref usi o n s pi ke pr otei n 
m o d R N A, tar geti n g t he a ncestral strai n of t he vir us, i n c o m bi nati o n wit h m o d R N A e nc o di n g 
t he s pi ke pr otei n of t he O micr o n varia nt ( B A. 4/ B A. 5 s u bli nea ge), will be use d i n t his st u d y .
Pfizer als o has a q ua dri vale nt m o d R N A -base d i nfl ue nza vacci ne, q I RV, i n P hase 3 
de vel o p me nt.  qI R V e nc o des H A of
strai ns (
) seas o nally 
rec o m me n de d b y  W H O f or t he i nfl ue nza seas o n.8 Base d o n P hase 2 safet y a n d 
i m m u n o ge nicity data, t he d ose le vel of qI R V bei n g st u d ie d i n t he P hase 3 C 4 7 8 1 0 0 4 pr ot oc ol 
b y a ge strat u m is
µ g f or partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d  
µ g f or partici pa nts 
≥6 5 y ears of a ge.
T he W H O rec o m me n dati o n f or t he c o m p ositi o n of i nfl ue nza vacci nes i n t he 2 0 2 4- 2 0 2 5
n ort her n he mis p here i nfl ue nza seas o n i ncl u des b ot h a q ua dri vale nt vacci ne a n d a tri vale nt 
vacci ne , t he latter wit h o ut t he B/ Ya ma gata li nea ge, w hic h has n ot bee n see n i n circ ulati o n 
si nce Marc h 2 0 2 0. Base d o n t he 0 5 Oct o ber 2 0 2 3 V R B P A C rec o m me n dati o ns, t h e 
c o m mittee v ote d t o e xcl u de t he B/ Ya ma gata li nea ge a nti ge n c o m p o ne nt fr o m q ua dri vale nt 
i nfl ue nza vacci nes as s o o n as p ossi ble.9 T he st u d y  desi g n t heref ore i ncl u des a q ua dri vale nt 
i nfl ue nza vacci ne ( qI R V) a n d a tri vale nt i nfl ue nza vacci ne (tIR V) w he n c o m b i ne d wit h 
B N T 1 6 2 b 2 (t he Pfizer- Bi o N Tec h C O VI D- 1 9 vacci ne ).
Gi ve n t hat a n n ual vacci ne pr o gra ms i n t he U S a n d li kel y  ot her parts of t he w orl d a gai nst b ot h 
i nfl ue nza a n d S A R S-C o V -2 ma y  be c o n d ucte d i n t he f ut ure at a si milar ti me of year, 
de vel o pi n g a c o m bi ne d vacci ne tar geti n g b ot h vir uses is li kel y  t o ge nerate o verall hi g her 
vacci nati o n rates f or b ot h vir uses b y all o wi n g f or m ore c o n ve nie nt sc he d uli n g t ha n if t hese 
vacci n es were t o be a d mi nistere d se paratel y. He nce, t his st u d y  will e val uate t he safet y, 
t olera bilit y, a n d i m m u n o ge nicit y of a m o difie d R N A vacci ne a gai nst i nfl ue nza w he n 
c o m bi ne d wit h B N T 1 6 2 b 2 ( bi vale nt ori gi nal/ O mi B A. 4/ B A. 5 ).
This e val uati o n will i nitiall y  
be c o n d ucte d t hr o u g h t he f oll o wi n g s u bst u dies:

S u bst u d y  A: A P hase 1 s u bst u d y  i n u p t o a p pr o xi matel y 3 6 0 partici pa nts 
( 1 8 0 partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge a n d 1 8 0 partici pa nts ≥6 5 y ears of a ge) t o 
descri be t he safet y of q I R V a n d bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) at 
3 d ose -le vel c o m bi nati o ns as s h o wn i n Ta ble 1 .

S u bst u d y  B: T his is a n e x pl orat or y P hase 1/ 2 s u bst u d y  t o descri be t he safet y a n d 
i m m u n o ge nicity of I R V (qI R V , tI R V, or bI R V ) w he n a dmi nistere d i n c o m bi nati o n 
wit h bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5), a n d l ice nse d QI V gi ve n 
c o nc urre n tly wit h bI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5 ) i n healt h y 
a d ults 1 8 t hr o u g h 6 4 ye ars of a ge. Base d o n preli mi nar y  data fr o m S u bst u d y A, 
S u bst u d y  B will st u d y a d diti o nal c o m bi nati o ns of C O VI D - 1 9/i nfl ue nza m o d R N A
vacci nes , i ncl u di n g tIR V: 
 µ g (
 
) pl us 
 µ g bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5);
bI R V: 
 µ g (
) pl us 
µ g bi vale nt 
B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) gi ve n c o nc urre ntl y wit h QI V i n t he o p p osite 
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 5
ar m; a n d a d diti o nal n o vel c o m bi nati o ns of qI R V :
µ g (
 
).
F oll o wi n g a t h or o u g h re vie w of safet y  data fr o m S u bst u d y A f or b ot h t he 
1 8- t hr o u g h 6 4-ye ar a ge gr o u p a n d t he ≥6 5 -ye ar a ge gr o u p b y  t he s p o ns or’s IR C i n 
Marc h
2 0 2 3 a n d Ma y  2 0 2 3, c o nti n ue d use of C O VI D- 1 9/i nfl ue nza c o m bi nati o n vacci nes 
u p t o
µ g ma xi m u m R N A d ose was c o nsi dere d acce pta ble f or c o nti n uati o n i nt o 
S u bst u d y  B.
* Ori gi nal refers t o t he a ncestral strai n ( W u ha n -H u -1; U S A -W A 1/ 2 0 2 0), als o referre d t o i n 
t his pr ot oc ol as t he refere nce strai n.
2. 2. B ac k gr o u n d
2. 2. 1. S A R S -C o V - 2
S A R S -C o V -2, a n o vel β- c or o na vir us, is a hi g hl y t ra ns missi ble a n d pat h o ge nic res pirat or y 
vir us res p o nsi ble f or t he o n g oi n g C O VI D -1 9 pa n de mic.  St u dies of S A R S -C o V -2 a n d 
S A R S -C o V, a cl osel y  relate d c or o na vir us t hat ca use d t he 2 0 0 3 S A R S pa n de mic, 
de m o nstrate d t hat effecti ve a nti b o d y  pr otecti o n c o ul d be ac hie ve d t hr o u g h s pi ke-s pecific 
a nti b o dies. 1 0 ,1 1  T heref ore, v acci nes tar geti n g t he s pi ke pr otei n of S A R S -C o V -2 ha ve bee n 
use d as a critical miti gati o n strate g y  of t he C O VI D-1 9 pa n de mic. H o we ver, wa ni n g 
effecti ve ness of t he a ut h oriz e d vacci nes has bee n s h o w n t o occ ur o ver ti me a n d is s us pecte d 
t o be d ue t o wa ni n g of vacci ne -i n d uce d i m m u nit y as well as t he e mer ge nce of V O Cs.
2. 2. 2. I nfl ue nz a
I nfl ue nza is a maj or ca use of m or bi dit y a n d m ortalit y w orl d wi de, occ urri n g i n a n n ual 
seas o nal e pi de mics a n d occasi o nall y i n gl o bal pa n de mics. 1 2  S y m pt o matic i nfl ue nza i nfecti o n 
ca uses a fe brile ill ness wit h res pirat or y  a n d sys te mic s ym pt o ms, 1 3 alt h o u g h it ma y ofte n be 
as ym pt o matic. 1 4  T he ris k of c o m plicati o ns a n d h os pitalizati o n fr o m i nfl ue nza are hi g her i n
pe o ple ≥6 5 y ears of a ge, yo u n g c hil dre n, a n d pe o ple wit h certai n u n derl yi n g me dical 
c o n diti o ns.  In t he U S, a n a vera ge of > 2 0 0, 0 0 0 h os pitalizati o ns per y ear are relate d t o 
i nfl ue nza,1 5 w hile t he a n n ual gl o bal n u m ber of deat hs is esti mate d t o ra n ge fr o m al m ost 
3 0 0, 0 0 0 t o o ver 6 0 0, 0 0 0. 1 6
I nfl ue nza vir uses are part of t he Ort h o myx oviri d ae fa mil y a n d are di vi de d i nt o 3 ge nera or 
t ypes ( A, B, a n d C) base d u p o n a nti ge nic differe nces i n t he n ucle o pr otei n a n d t he matri x 
pr otei n.  I nfl ue nza A vir uses are f urt her clas sifie d i nt o s u bt ypes base d u p o n t he me m bra ne 
gl yc o pr otei ns, H A a n d N A. 1 7  T he R N A ge n o me is se g me nte d, w hic h all o ws ge netic 
reass ort me nt a m o n g vir uses of t he sa me ty pe. 1 7  T his ge netic i nsta bilit y  ca n res ult i n t he 
p he n o me n o n k n o w n as a nti ge nic s hift, i n v ol vi n g a maj or c ha n ge i n 1 or b ot h of t he H A s a n d 
N A s, w hic h, if efficie ntl y tra ns missi ble, ca n res ult i n a pa n de mic.  M ore c o m m o n are 
m ulti ple p oi nt m utati o ns i n t he ge n o me, lea di n g t o m ore mi n or c ha n ges i n t he H A a n d N A, 
k n o w n as a nti ge nic drift. 1 5  T his ge netic i nsta bilit y is w hat necessitates vacci nes t hat are 
tail ore d a n n ually. 1 5
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 6
2. 2. 3. Cli nic al O ver vie w
2. 2. 3. 1. S A R S -C o V - 2
St u d y  C 4 5 9 1 0 0 1 ( N C T 0 4 3 6 8 7 2 8) is a n o n goi n g P hase 1/ 2 / 3 trial i n ~ 4 6, 0 0 0 partici pa nts 
desi g ne d t o ge nerate safet y , t olera bility, i m m u n o ge nicit y, a n d efficac y data fr o m a n o vel 
R N A - base d vacci ne ca n di date.1 8  T he trial is bei n g c o n d ucte d i n a heter o ge ne o us st u d y  
p o p ulati o n: eli gi ble partici pa nts ≥1 2 y ears of a ge, healt h y partici pa nts, i ncl u di n g t h ose 
partici pa nts wit h sta ble c hr o nic me dical c o n diti o ns, i ncl u di n g HI V -, H C V-, a n d 
H B V -p ositi ve partici pa nts.  
A vaila ble i m m u n o ge nicit y data fr o m P hase 1 partici pa nts s h o we d t hat B N T 1 6 2 b 2 i n d uce d a 
r o b ust I g G-bi n di n g res p o nse t o S 1 a n d a S A R S -C o V -2 ne utralizi n g res p o nse.  
I m m u n o ge nicity s u bsta ntiall y  i ncrease d f oll o wi n g t he sec o n d d ose of vacci ne.  B N T 1 6 2 b 2 
i n d uces a str o n g a nti ge n-s pecific T h 1-s ke we d C D 4 + res p o nse a n d a str o n g a nti ge n-s pecific 
C D 8 + res p o nse. 
I n a mi d– N o ve m ber 2 0 2 0 a nal ys is of 3 6, 6 2 1 partici pa nts ra n d o mize d 1: 1 t o vacci ne or 
place b o a n d w h o were i ncl u de d i n t he per -pr ot oc ol efficac y  a nal ysis p o p ulati o n of 
partici pa nts wit h o ut e vi de nce of S A R S -C o V -2 i nfecti o n pri or t o 7 d a y s after c om pleti o n of 
t he vacci nati o n sc he d ule, t he efficac y i n pre ve nti n g c o nfir me d C O VI D-1 9 occ urri n g at least 
7 da y s after t he sec o n d d ose of vacci ne was 9 5. 0 %, wit h 8 C O VI D -1 9 cases i n t he acti ve 
vacci ne gr o u p a n d 1 6 2 C O VI D - 1 9 cases i n t he place b o gr o u p. 
I n a s u bse q ue nt a nalys is of 9 2 7 c o nfir me d sy m pt o matic cases of C O VI D -1 9, a n efficac y  rate 
of 9 1. 3 % was o bser ve d f or B N T 1 6 2 b 2 i n pre ve nti n g s uc h cases occ urri n g bet wee n 7 da y s 
a n d 6 m o nt hs after t he sec o n d d ose. 1 9  F urt her m ore, fr o m t he sa me a nal ys is, B N T 1 6 2 b 2 was 
s h o w n t o ha ve a n efficac y of: 

1 0 0 % i n pre ve nti n g se vere disease as defi ne d b y t he C D C.

9 5. 3 % i n pre ve nti n g se vere disease as defi ne d b y t he F D A.

1 0 0 % i n pre ve nti n g C O VI D -1 9 cases i n S o ut h Africa, w here t he B. 1. 3 5 1 li nea ge was 
pre vale nt at t he ti me of a n al ysis.
Safet y  data fr o m a p pr o xi matel y 3 8, 0 0 0 partici pa nts at least 1 6 years of a ge ra n d o mize d 1: 1 
t o vacci ne or place b o wit h a me dia n of 2 m o nt hs of f oll o w-u p after t he sec o n d d ose 
de m o nstrate d a fa v ora ble safet y pr ofile.  A vaila ble safet y data fr o m all p artici pa nts e nr olle d 
t hr o u g h t he 1 4 N o ve m ber 2 0 2 0 data c ut off ( N = 4 3, 2 5 2), w hic h i ncl u des late e nr oll me nt of 
a d diti o nal a d olesce nt a n d a d ult partici pa nts, were c o nsiste nt wit h t he safet y pr ofile f or t he 
a p pr o xi matel y 3 8, 0 0 0 partici pa nts wit h a me dia n f ollo w- u p of 2 m o nt hs a n d als o di d n ot 
raise s pecific safety c o ncer ns. 1 8
O n 2 2 Se pte m ber 2 0 2 1, base d o n safet y a n d i m m u n o ge nicit y data fr o m a p pr o xi matel y 
3 0 0 i m m u n oc o m pete nt a d ult b o oster d ose reci pie nts fr o m St u d y C 4 5 9 1 0 0 1, t he F D A iss ue d 
t he E U A f or a si n gle b o oster d ose of B N T 1 6 2 b 2 3 0 µ g f or:
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 7
1.
i n di vi d uals 6 5 years of a ge a n d ol der; 
2.
i n di vi d uals 1 8 t hr o u g h 6 4 years of a ge at hi g h ris k of se vere C O VI D- 1 9; a n d 
3.
i n di vi d uals 1 8 t hr o u g h 6 4 years of a ge w h ose fre q ue nt i nstit uti o nal or occ u pati o nal 
e x p os ure t o S A R S -C o V -2 p uts t he m at hi g h ris k of seri o us c o m plicati o ns of 
C O VI D -1 9, i ncl u di n g se vere C O VI D - 1 9.2 0
O n 1 9 N o ve m ber 2 0 2 1, t he F D A a me n de d t he E U A, a ut h orizi n g use of a si n gle b o oster d ose
f or all i n di vi d uals 1 8 years of a ge a n d ol der after c o m pleti o n of pri mar y vacci nati o n wit h a n 
F D A -a p pr o ve d C O VI D-1 9 vacci ne. 2 1  O n 0 9 Dece m ber 2 0 2 1, t he F D A a gai n a me n de d t he 
E U A t o a ut h orize t he use of a si n gle b o oster d ose f or a d mi nistrati o n t o i n di vi d uals 1 6 a n d 
1 7 ye ars of a ge at least 6 m o nt hs after c o m pleti o n of pri mar y  vacci nati o n wit h B N T 1 6 2 b 2.  
I n a d diti o n, a b o oster d ose of t he vacci ne is a ut h or ize d i n t he E U a n d ot her c o u ntries, wit h 
rec o m me n dati o ns f or p o p ulati o ns var yi n g base d o n l ocal healt h a ut h ority g ui da nce.
C 4 5 9 1 0 3 1 S u bst u d y  E is a n o n g oi n g P hase 3 trial i n a p pr o xi matel y 2 9 0 0 partici pa nts
1 8 ye ars of a ge a n d ol der w h o ha ve pre vi o usl y  recei ve d 3 d oses of B N T 1 6 2 b 2 ( 3 0-μ g d ose).   
Partici pa nts i n t his s u bst u d y  recei ve d a f o urt h d ose of eit her B N T 1 6 2 b 2 or B N T 1 6 2 b 2
O micr o n ( B A. 1 s u bli nea ge) or a c o m bi nati o n of b ot h at a t otal d ose le vel of eit her 3 0 μ g or
6 0 μ g. Fr o m t he a vaila ble safet y data f r o m t his st u d y, t he t olera bilit y a n d safety pr ofile of
bi vale nt B N T 1 6 2 b 2 3 0 μ g, bi vale nt B N T 1 6 2 b 2 6 0 μ g, a n d m o n o vale nt B N T 1 6 2 b 2 6 0 μ g u p
t o 1 m o nt h after st u d y vacci nati o n (t o t he data c ut off date) was acce pta ble a n d c o nsiste nt
wit h t he k n o w n safet y pr ofi le of B N T 1 6 2 b 2 a n d t he pre vi o usl y re p orte d A E pr ofile f or 
O micr o n B A. 1 – m o difie d B N T 1 6 2 b 2 vacci nes. I n partici pa nts > 1 8 t hr o u g h 5 5 years of a ge,
m o n o vale nt a n d bi vale nt O micr o n -m o difie d vacci nes at t he 3 0 -μ g  d ose le vel s h o we d a
si milar l ocal reacti o n a n d sys te mic e ve nt pr ofile as t he pr ot ot y pe B N T 1 6 2 b 2. I n t he ol der 
a ge gr o u p at t he 6 0 - μ g d ose le vel, mil d t o m o derate i njecti o n site pai n, fati g ue, a n d m uscle 
pai n were m ore c o m m o n c o m pare d t o t he react o ge nicit y  wit h t he 3 0-μ g  d ose le vel.  Fr o m t he 
i m m u n o ge nicity data, i n partici pa nts > 5 5 ye ars of a ge wit h o ut e vi de nce of C O VI D - 1 9 
i nfecti o n, O micr o n B A. 1 ne utralizati o n acti vit y s u bsta ntiall y i ncrease d wit h
O micr o n - m o difie d bi vale nt vacci nes as a f o urt h d ose. A d diti o nall y , a nal ysis of
i m m u n o ge nicity data fr o m t his st u d y  de m o nstrate d a r o b ust O micr o n B A. 1 a n d
refere nce-strai n vacci ne- elicite d i m m u ne res p o nse t o b ot h m o n o vale nt a n d bi vale nt
O micr o n B A. 1 – m o difie d vacci nes w he n a d mi nistere d as a f o urt h d ose t o
B N T 1 6 2 b 2 -e x perie nce d partici pa nts 1 8 t hr o u g h 5 5 y ears of a ge.
C o nsi deri n g t he wa ni n g effecti ve ness of t he pri mar y  series of B N T 1 6 2 b 2 as well as t he
c o nti n u o us e mer ge nce of varia nts wit h c u m ulati ve m utati o ns i n t he s pi ke pr otei n t hat are
resilie nt t o t he e xisti n g i m m u ne res p o nse, de vel o p me nt of e n hance d varia nt -s pecific vacci nes
t hat c o ul d ge nerate i m pr o ve d i m m u ne res p o nses a gai nst t he varia nts has bec o me i m perati ve,
as t his c o ul d hel p better pr otect i n di vi d uals a gai nst C O VI D- 1 9. T his nee d has bee n
ree m p hasize d b y t he F D A si nce J u ne 2 0 2 2 w he n it cal le d f or trials wit h m o difie d vacci nes
c o ntai ni n g a n O micr o n B A. 4/ B A. 5 c o m p o ne nt at e mer ge nce of t hat strai n. 2 2
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 8
Relate d t o t his series of de vel o p me nts is t he C 4 5 9 1 0 4 4 st u d y ( N C T 0 5 4 7 2 0 3 8).
T his is a n
o n g oi n g P hase 2/ 3, ra n d o mize d, acti ve -c o ntr olle d st u d y t o e val uate t he safet y, t olera bility,
a n d i m m u n o ge nicit y of ne w bi vale nt varia nt vacci nes at t he sta n dar d or hi g her d ose. T he
st u d y e val uates bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) gi ve n as a f o urt h d ose i n
partici pa nts 1 2 t hr o u g h 1 7, 1 8 t hr o u g h 5 5, a n d > 5 5 y ears of a ge. Preli mi nar y  data
de m o nstrate d t hat t he safet y  pr ofile wit hi n 1 m o nt h after vacci nati o n ( D ose 4) wit h bi vale nt
B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) at t he 3 0 -μ g  d ose le vel was fa v ora ble acr oss all a ge
gr o u ps, wit h m ostl y  mil d or m o derate react o ge nicit y, a n d fe w partici pa nts re p orte d A Es.
A nal y sis of i m m u n o ge nicit y data at 1 m o nt h after vacci nati o n i n t he e val ua ble
i m m u n o ge nicity p o p ulati o n wit h or wit h o ut e vi de nce of i nfecti o n u p t o 1 m o nt h afte r st u d y
vacci nati o n f or B N T 1 6 2 b 2 -e x perie nce d partici pa nts 1 8 t hr o u g h 5 5 ye ars a n d > 5 5 years of
a ge w h o recei ve d a f o urt h d ose wit h bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) 3 0 μ g
de m o nstrate d a r o b ust vacci ne- elicite d i m m u ne res p o nse. S u peri orit y  of bi vale nt B N T 1 6 2 b 2
( ori gi nal/ O mi B A. 4/ B A. 5) 3 0 μ g t o B N T 1 6 2 b 2 3 0 μ g i n t he > 5 5-ye ar a ge gr o u p fr o m
C 4 5 9 1 0 3 1 S u bst u d y  E wit h res pect t o a nti – O micr o n B A. 4/ B A. 5 ne utralizi n g titers was met.
N o ni nferi orit y base d o n ser ores p o nse f or bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5)
3 0 μ g t o B N T 1 6 2 b 2 3 0 μ g i n t he > 5 5 -year a ge gr o u p was als o met. A d diti o nall y ,
n o ni nferi orit y  of a nti– refere nce-strai n i m m u ne res p o nse base d o n t he G M R of bi vale nt
B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) 3 0 μ g t o B N T 1 6 2 b 2 3 0 μ g i n t he > 5 5 -ye ar a ge gr o u p
was met. T he res ults s u g gest a n a ntici pate d i m pr o ve d cli nical be nefit a gai nst C O VI D- 1 9 d ue
t o O micr o n B A. 4/ B A. 5 wit h bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) c o m pare d t o
B N T 1 6 2 b 2 as a f o urt h d ose.
2. 2. 3. 2. I nfl ue nz a
I nfl ue nza m o d R N A has bee n e val uate d i n 2 Pf izer-s p o ns ore d cli nical trials: C 4 7 8 1 0 0 1 a n d 
C 4 7 8 1 0 0 4.  
C 4 7 8 1 0 0 1:  T his is a P hase 1 /2 st u d y  c o n d ucte d fr o m first partici pa nt first visit
(Se pte m ber 2 0 2 1) t o last partici pa nt l ast v isit (Ja n uar y 2 0 2 3).  T he st u d y e val uate d 
m o n o vale nt, bi vale nt, a n d q ua dri vale nt i nfl ue nza vacci nes i n healt h y  a d ults 
1 8 t hr o u g h 8 5 y ears of a ge.  T he f i nal st u d y re p ort is pe n di n g.  
T he st u d y  e val uate d m o n o vale nt R N A e nc o di n g i nfl ue nza strai ns i n d oses u p t o
µ g, 
bi vale nt R N A e nc o di n g 2 i nfl ue nza strai ns i n d oses u p t o  
µg/strai n ( =
µ g t otal R N A 
d ose), q ua dri vale nt R N A e nc o di n g 4 i nfl ue nza strai ns i n d oses u p t o
µ g/strai n 
( = 
µ g t otal R N A d ose), a n d c o m bi nati o ns of m o n o vale nt a n d bi vale nt R N A vacci nes 
gi ve n c o nc o mita ntl y  or sta g gere d wit h lice nse d i nfl ue nza vacci nes.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 4 9
T he data gat here d t o date i n t his st u d y  hav e de m o nstrate d t hat a si n gle d ose of qI R V 
µ g or
µ g ) was well t olerate d a n d elicite d i m m u ne res p o nses a gai nst i nfl ue nza i n 
partici pa nts 1 8 t hr o u g h 8 5 y ears of a ge. T o get her, t hese data s u p p orte d pr o gressi o n t o 
P hase 3 cli nical de vel o p me nt of qI R V ( 
µ g) f or a d ults ≥6 5 y ears of a ge a n d qIR V ( 
µ g) 
f or a d ults 1 8 t hr o u g h 6 4 years of a ge. Base d o n i m m u n o ge nicit y data o bser ve d i n 
St u d y C 4 7 8 1 0 0 1, P hase 3 St u d y  C 4 7 8 1 0 0 4 was desi g ne d t o e val uate t he efficac y a n d 
i m m u n o ge nicit y t o deter mi ne effecti ve ness, al o n g wit h safety a nal ys es t o assess t olera bilit y 
a n d ris k, of qI R V w he n a d mi nistere d t o a lar ge c o h ort of a d ults at t he a ge gr o u p – selecte d 
d ose le v els.
C 4 7 8 1 0 0 4:  A P hase 3 st u d y t hat i nitiate d d osi n g i n a d ults 1 8 years of a ge a n d ol der i n
Se pte m ber 2 0 2 2.  T h e st u d y is o n g oi n g a n d has d ose d a n esti mate d 5 3, 2 0 0 a d ults acr oss t he
n ort her n a n d s o ut her n h e mis p here s.  T he st u dy is e val uati n g d oses of 
µ g a n d 
µ g 
q ua dri vale nt m o d R N A i nfl ue nza vacci nes i n a d ults 1 8 t hr o u g h 6 4 y ears of a ge a n d ≥6 5 y ears
of a ge , res pecti vely.  Base d o n t he ra n d o mizati o n sc he me, t his reflects a safet y data base of 
o ver  
partici pa nts i n eac h a ge c o h ort w h o ha ve recei ve d a d ose of m o d R N A i nfl ue nza 
vacci ne at eac h d ose le vel.  O n g oi n g re vie w of safet y  data fr o m t his st u d y b y a n i n de pe n de nt 
D M C has e n d orse d c o nti n ue d st u d y  e nr oll me nt.  
F or m ore details o n t hese st u dies a n d n o n – Pfizer -s p o ns ore d st u dies wit h m o d R N A i nfl ue nza, 
see t he I B.
T he latest safet y  a n d im m u n o ge nicit y res ults ca n be f o u n d i n t he I B f or qI R V.  
T he rati o nale f or t he d ose le vel selecte d f or eac h st u d y i nter ve nti o n use d i n t his st u d y is 
pr o vi de d i n Secti o n 4. 3 .
2. 2. 3. 3. C o m bi ne d I nfl ue nz a a n d C O VI D -1 9 V acci nes
As reflecte d i n ot her secti o ns of t his d oc u me nt, b ot h S A R S -C o V -2 a n d i nfl ue nza c o nti n ue t o 
ca use si g nifica nt healt hcare b ur de n d ue t o gl o bal circ ulati o n. 4 ,1 2 Vacci nati o n re mai ns a n 
i m p orta nt mea ns of re d uci n g t he ris k of si g nifica nt m orbi dit y  a n d m ortalit y.1 5  
C oa d mi nistrati o n of vacci nes a gai nst b ot h of t hese pat h o ge ns c o ul d pr o vi de si g nifica nt 
a d va nta ges t o b ot h patie nts a n d care gi vers i n ter ms of si m plif y i n g care. T his cli nical 
de vel o p me nt pr o gra m is i nte n de d t o deter mi ne if 2 m o difie d m o d R N A vacci nes desi g ne d t o 
tar get i nfl ue nza a n d t he S A R S -C o V -2 vir us ca n de m o nstrate a n acce pta ble safet y a n d 
i m m u n o ge nicity pr ofile.
T he differ e nt vacci ne gr o u ps t o be e val uate d i n t his cli nical trial will deter mi ne t he 
i m m u n o ge nicity a n d safet y pr ofile of differe nt d oses of t he i nfl ue nza a n d S A R S -C o V - 2 
a nti ge ns, of differe nt met h o ds of vacci ne c o m bi nati o n
 
 
 
 T he s u m mar y  of t hese gr o u ps is 
i ncl u de d i n Ta ble 2 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 0
2. 3. Be nefit/ Ris k Assess me nt
T he a vaila ble safet y a n d i m m u n o ge nicit y data fr o m o n g oi n g cli nical trials a n d real -w orl d 
effecti ve ness a n d safet y data f or B N T 1 6 2 b 2, c o m bi ne d wit h a vaila ble n o ncli nical data wit h 
B N T 1 6 2 vacci nes, as well as data fr o m n o ncli nical a n d cli nical trials wit h qI R V , s u p p ort a 
fa v ora ble be nefit/ris k pr ofile a n d s u p p ort cli nical de vel o p me nt of a vacci ne c o m bi ni n g t hese 
c o m p o ne nts.  Ta ki n g i nt o acc o u nt t he meas ures t o mi ni mize ris k t o st u d y  partici pa nts, t he 
p ote ntial ris ks i de ntifie d i n ass ociati o n wit h t he st u d y  i nter ve nti o n are j ustifie d b y t he 
a ntici pate d be nefits t hat ma y be aff or de d t o healt h y partici pa nts.
C li nical i n vesti gati o n is j ustifie d, gi ve n:

T he t hreat p ose d b y c o nti n u o us ne w o ut brea ks of S A R S -C o V- 2 i nfecti o ns w orl d wi de .

T he t hreat p ose d b y t he S A R S -C o V -2 varia nts e mer gi n g w orl d wi de.

T he p ote ntial nee d f or e n ha nci n g i m m u ne res p o nses t o o verc o me wa ni n g i m m u nit y .

T he p ote ntial a d va nta ges a n d c o n ve nie nce t o i n di vi d uals i n de vel o pi n g a c o m bi ne d 
vacci ne a gai nst S A R S- C o V - 2 a n d i nfl ue nza t hat w o ul d ali g n wit h t he rece nt F D A 
rec o m me n dati o ns f or a n a n n ual C O VI D- 1 9 vacci nati o n a p pr oac h , si milar t o t hat f or 
i nfl ue nza.
M ore detaile d i nf or mati o n a b o ut t he k n o w n a n d e x pecte d be nefits a n d ris ks a n d reas o na bl y 
e x pecte d A E s of I RV ( qI R V , bI R V , or t I RV )/ B N T 1 6 2 b 2 (ori gi nal / O mi B A. 4/ B A. 5 ), I RV, 
a n d B N T 1 6 2 b 2 m a y  be f o u n d i n t he I Bs, res pecti vel y, w hic h are t he S R S Ds f or t his st u d y.  
T he S R S D f or S u bst u d y A is t he lice nse d Fl uz o ne S D U S PI , a n d t he S R S D f or S u bst u d y B is 
t he lice nse d Fl ucel va x U S PI .
2. 3. 1. Ris k Assess me nt
P ote nti al Ris k of Cli nic al Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k
Miti g ati o n Str ate g y
St u d y I nter ve nti o n(s): I R V/ Bi v ale nt B N T 1 6 2 b 2 ( Ori gi n al/ O m i B A. 4/ B A. 5), 
I R V, a n d B N T 1 6 2 b 2 O m icr o n (B A. 4/ B A. 5)
F or I R V:
L ocal a n d s yste mic reacti o ns t o t he 
vacci ne ma y occ ur (i njecti o n site 
re d ness, i njecti o n site s welli n g, a n d 
i njecti o n site pai n; fe ver, fati g ue, 
hea dac he, c hills, v o m iti n g, diarr hea, 
m uscle pai n, a n d j oi nt pai n) f oll o w i n g
vacci nati o n.
T hese are c o m m o n a d verse reacti o ns 
see n wit h ot her vacci nes, 2 3 as well as t he 
C O VI D -1 9 vacci ne B N T 1 6 2 b 2, w hic h is 
als o base d o n m o d R N A. T he m o st 
c o m m o n e ve nts re p orte d i n a lar ge -scale
efficac y st u d y wit h B N T 1 6 2 b 2
( C 4 5 9 1 0 0 1) were mi l d t o m o derate pai n 
at t he i njecti o n site, fati g ue, a n d 
hea dac he. 1 8
1- Wee k f oll o w -u p react o ge nicit y data of
1 9 4 partici pa nts w h o recei ve d mI R V,
bI R V, or qI R V i n C 4 7 8 1 0 0 1 S u bst u d y A 
T he st u d y e m pl o ys t he use 
of a react o ge nicit y e-diar y,
w hic h all o ws t he 
i n vesti gat or t o m o nit or l ocal 
reacti o ns a n d s yste mic 
e ve nts i n real ti me after 
eac h vacci nati o n t hr o u g h a n 
electr o nic p ortal. Se vere 
reacti o ns will re q uire a n 
u nsc he d ule d tele p h o ne call, 
a n d visit if re q uire d, t o be 
c o n d ucte d per pr ot oc ol.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 1
P ote nti al Ris k of Cli nic al Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k
Miti g ati o n Str ate g y
a n d 1 2 0 partici pa nts fr o m C 4 7 8 1 0 0 1 
S u bst u d y B s h o we d most e ve nts t o be 
mil d t o m o derate i n se verit y, wit h t he 
m o st c o m m o n e ve nts bein g pai n at t he 
i njecti o n site, fati g ue, a n d hea dac he.
All st u d y partici pa nts will 
be o bser ve d f or at least 
3 0 mi n utes after 
vacci nati o n.
T he safet y pr ofile of a n o vel vacci ne is 
n ot yet f ull y c haracterize d.
Alt h o u g h I R Vs are n o vel vacci nes, t he y 
are base d o n t he sa me platf or m
( mo d R N A) as t he C O VI D -1 9 vacci ne 
B N T 1 6 2 b 2, w hic h has bee n s h o w n t o
ha ve a p ositi ve be nefit/ris k pr ofile.
A E a n d S A E re p orts w ill be 
c ollecte d fr o m t he si g ni n g 
of t he I C D t hr o u g h 4 w ee ks 
a n d 6 m o nt hs after 
vacci nati o n (f or all 
s u bst u dies).
All partici pa nts will be
o bser ve d f or at least
3 0 mi n utes after 
vacci nati o n.
F or B N T 1 6 2 b 2 O micr o n ( B A. 4/ B A. 5)
T his vacci ne has t he sa me m o d R N A 
platf or m ( wit h se q ue nce c ha n ges 
li mite d t o t h ose t hat are 
O m icr o n-s pecific) a n d L N P f or m ulati o n 
as B N T 1 6 2 b 2; t heref ore, t he safet y 
pr ofile is e x pecte d t o be si milar t o t hat 
of B N T 1 6 2 b 2, ie, local reacti o ns, s uc h 
as i njectio n site re d ness, i njecti o n site 
s welli n g, a n d i njecti o n site pai n, a n d 
s yste mic e ve nts, s uc h as fe ver, fati g ue, 
hea dac he, c hills, v o m iti n g, diarr hea, 
m uscle pai n, a n d j oi nt pai n.
Ot her ke y ris ks i de ntifie d f or 
B N T 1 6 2 b 2 are l y m p ha de n o pat h y; 
h y perse nsiti vit y reacti o ns, s uc h as ras h, 
pr urit us, urticaria, a n gi oe de ma, a n d 
a na p h yla xis; a n d m y ocar ditis a n d 
pericar ditis.
T hese are c o m m o n a d verse reacti o ns 
see n wit h ot her vacci nes as well as t he 
C O VI D -1 9 vacci ne.
Data a vaila ble fr o m t he C 4 5 9 1 0 0 1 st u d y 
( wit h B N T 1 6 2 b 2) s h o we d l o w i nci de nce 
of se vere or seri o us e ve nts a n d n o 
cli nicall y c o ncer ni n g safet y o bser vati o ns 
acr oss t he safet y p o p ulati o n a n d wit hi n 
de m o gra p hic s u b gr o u ps base d o n a ge, 
se x, race/et h nicit y, c o u ntr y, a n d baseli ne 
S A R S -C o V -2 stat us. 1 8
1- Wee k f oll o w -u p react o ge nicit y data of 
1 9 4 partici pa nts w h o recei ve d mI R V, 
bI R V, or qI R V i n C 4 7 8 1 0 0 1 S u bst u d y A 
a n d 1 2 0 partici pa nts fr o m C 4 7 8 1 0 0 1 
S u bst u d y B s h o we d most e ve nts t o be 
mil d t o m o derate i n se verit y, wit h t he 
m o st c o m m o n e ve nts bei n g pai n at t he 
i njecti o n site, fati g ue, a n d hea dac he.
A na p h yla xis: Fre q ue nc y n ot k n o w n.
M y ocar ditis a n d pericar ditis: Ver y rare 
cases of m y ocar ditis a n d pericar ditis 
ha ve bee n re p orte d f oll o wi n g 
vacci nati o n wit h m o d R N A 
S A R S -C o V - 2 vacci nes after 
a ut h orizati o n.  T y picall y, t he cases ha ve 
occ urre d m ore ofte n i n y o u n ger me n a n d 
after t he sec o n d d ose of t he vacci ne a n d 
wit hi n 1 4 da ys after vacci nati o n.  T hese 
are ge nerall y mil d cases, a n d i n di vi d uals 
te n d t o rec o ver wit hi n a s h ort ti me 
L ocal reacti o ns a n d 
s yste mic e ve nts will be 
rec or de d usi n g a 
react o ge nicit y e-diar y t o 
m o nit or l ocal reacti o ns a n d 
s yste mic e ve nts i n real ti me
after vacci nati o n.
C ollecti o n of A E s fr o m t he 
si g ni n g of t he I C D t hr o u g h 
4 we e ks after vacci nati o n ,
a n d S A Es t hr o u g h 6 m o nt hs 
after Visit 1/ 2 0 1 .
S pecific refere nce t o t hese 
ris ks is ma de wit hi n t he 
I C D, wit h i nstr ucti o n t o 
c o ntact a healt hcare 
pr ofessi o nal if a case is 
s us pecte d.
F or a na p h yla xis, t here is a n 
o n -site 3 0-mi n ute 
o bser vati o n peri o d after 
vacci nati o n.
I nstr ucti o ns f or ha n dli n g 
s us pecte d cases of 
m y ocar ditis a n d pericar ditis 
are f o u n d i n
Secti o n 1 0. 1 1. 8. 8. 1 0 a n d 
Secti o n 1 0. 1 2. 8. 1 2 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 2
P ote nti al Ris k of Cli nic al Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k
Miti g ati o n Str ate g y
f oll o wi n g sta n dar d treat me nt a n d rest.  
Healt hcare pr ofessi o nals s h o ul d be alert 
t o t he si g ns a n d s y m pt o ms of 
m y ocar ditis a n d pericar ditis i n vacci ne 
reci pie nts.
P osta ut h orizati o n safet y data 
s urveilla nce has c o nfir me d t he safet y 
pr ofile o bser ve d i n St u d y C 4 5 9 1 0 0 1 a n d 
has res ulte d i n i de ntificati o n of s o me 
a d diti o nal a d verse reacti o ns (ris ks) as 
n ote d i n t he S R S D.
St u d y I nter ve nti o n(s): QI V – Fl uz o ne S D a n d QI V – Fl ucel v a x
L ocal a n d s yste mic reacti o ns t o t he 
vacci ne ma y occ ur (i njecti o n site
re d ness, i njecti o n site s welli n g, a n d
i njecti o n site pai n; fe ver, fati g ue,
hea dac he, c hills, v o miti n g, diarr hea,
ne w or w orse ne d m uscle pai n, 
ne w or w orse ne d j oi nt pai n , G uillai n-
Barr é s y n dr o me, a n d s y nc o pe)
f oll o wi n g vacci nati o n.
T hese are c o m m o n a d verse reacti o ns 
see n wit h ot her vacci nes. 2 4 ,2 5 ,2 6
T he st u d y e m pl o ys t he use 
of a react o ge nicit y e-diar y
after vacci nati o n, w hic h 
all o ws t he i n vesti gat or t o 
m o nit or l ocal reacti o ns a n d 
s yste mic e ve nts i n real ti me 
t hr o u g h a n electr o nic p ortal.  
Se vere reacti o ns will 
re q uire a n u nsc he d ule d 
tele p h o ne call, an d visit if 
re q uire d, t o be c o n d ucte d 
per pr ot oc ol.
All st u d y partici pa nts will 
be o bser ve d f or at least 
3 0 mi n utes after 
vacci nati o n .
St u d y Pr oce d ures
Ve ni p u nct ure will be perf or me d d uri n g 
t he st u d y.
T here is t he ris k of blee di n g, br uisi n g, 
he mat o ma f or mati o n, a n d i nfecti o n at 
t he ve ni p u nct ure site.
O nl y a p pr o priatel y 
q ualifie d pers o n nel will 
o btai n t he bl o o d dra w .
2. 3. 2. Be nefit Assess me nt
Be nefits t o i n di vi d ual partici pa nts e nr olle d i n S u b st u d y A are detaile d i n Secti o n 1 0. 1 1. 2. 3 .
Be nefits t o i n di vi d ual partici pa nts e nr olle d i n S u bst u d y  B are detaile d i n Secti o n 1 0. 1 2. 2. 3 .
2. 3. 3. O ver all Be nefit/ Ris k C o ncl usi o n
Ta ki n g i nt o acc o u nt t he meas ures t o mi ni mize ris k t o st u d y  partici pa nts as state d i n 
Secti o n 2. 3. 1 , t he p ote ntial ris ks i de ntifie d i n ass ociati o n wit h all acti ve st u d y i nter ve nti o ns
are j ustifie d b y t he a ntici pate d be nefits t hat ma y be aff or de d t o healt h y partici pa nts.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 3
3. O B J E C TI V E S, E N D P OI N T S, A N D E S TI M A N D S
See Secti o n 1 0. 1 1. 3 f or t he Su bst u d y  A o bjecti ves, e n d p oi nts, a n d esti ma n ds.
See Secti o n 1 0. 1 2. 3 f or t he S u bst u d y B o bjecti ves, e n d p oi nts, a n d esti ma n ds.
4. S T U D Y D E SI G N
4. 1. O ver all Desi g n
See Secti o n 1 0. 1 1. 4 f or t he Su bst u d y  A desi g n.
See Secti o n 1 0. 1 2. 4 f or t he S u bst u d y B desi g n.
4. 2. Scie ntific R ati o n ale f or St u d y Desi g n
See Secti o n 2. 1 .
4. 2. 1. Di versit y of St u d y P o p ul ati o n
See Secti o n 5 .
4. 2. 2. C h oice of C o ntr ace pti o n/ B arrier Re q uire me nts
H u ma n re pr o d ucti ve safet y  data are n ot a vaila ble f or t he m o d R N A i nfl ue nza vacci nes use d i n 
t his st u d y, b ut t here is n o s us pici o n of h u ma n terat o ge nicit y base d o n t he i nte n de d 
p har mac ol o g y  of t he c o m p o u n d.  T he use of a hi g hly effecti ve met h o d of c o ntrace pti o n is 
re q uire d f or se x ual i nterc o urse i n v ol vi n g a W O C B P (see Secti o n 1 0. 5 ).
4. 3. J ustific ati o n f or D ose
4. 3. 1. Bi v ale nt B N T 1 6 2 b 2 ( Ori gi n al / Omi B A. 4/ B A. 5 )
Base d o n data fr o m t he P hase 1 c o m p o ne nt of cli nical trial C 4 5 9 1 0 0 1 a n d a vaila ble 
n o ncli nical data, t he m o d R N A B N T 1 6 2 b 2 vacci ne ca n di date was selecte d at a d ose of 3 0 µ g 
f or P hase 2 a n d 3 e val uati o n of safet y, i m m u n o ge nicit y , a n d efficac y after 2 d oses 
a d mi nistere d 3 wee ks a part.  T his is t he d ose t hat was s h o w n t o be effecti ve a n d has bee n 
a p pr o ve d i n m ulti ple c o u ntries w orl d wi de.
I n N o ve m ber 2 0 2 1, t he F D A iss ue d a n E U A f or a si n gle b o oster d ose of bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) at a d ose le vel of 3 0 µ g ( 1 5 µ g ori gi nal B N T 1 6 2 b 2 a n d 
1 5 µ g B N T 1 6 2 b 2 O micr o n [ B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5]) i n i n di vi d uals ≥1 8 ye ars of 
a ge, a n d t his d ose le vel is bei n g use d i n t his st u d y w he n bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) is a d mi nistere d al o ne.2 7
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 4
4. 3. 2. qI R V
Preli mi nar y  res ults a m o n g 4 5 partici pa nts i n St u d y C 4 7 8 1 0 0 1 e x p ose d t o eit her
µ g or
-µ g qI R V n ote d t hat t he c o m bi nati o n is well t olerate d wit h mai nl y mil d t o m o derate l ocal 
reacti o ns a n d s ys te mic e ve nts c o nsiste nt wit h rates o bser ve d wit h B N T 1 6 2 b 2.  Base d o n 
P hase 2 safet y a n d i m m u n o ge nicit y data, t he d ose le vel of qI R V bei n g st u die d i n t he P hase 3 
C 4 7 8 1 0 0 4 pr ot oc ol b y  a ge strat u m is 
µ g f or partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d 
µ g f or partici pa nts ≥6 5 y ears of a ge.
He nce, d oses of 
µ g  a n d 
µ g qI R V , i n a d diti o n t o a mi d p oi nt d ose of
µ g qI R V , will 
be e val uate d i n S u bst u dies A a n d B w he n a d mi nistere d al o ne or i n c o m bi nati o n wit h bi vale nt 
B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5).
4. 3. 3. qI R V/ Bi v ale nt B N T 1 6 2 b 2 ( O ri gi n al/ O mi B A. 4/ B A. 5)
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) at d ose -le vel c o m bi nati o ns n ot 
e xcee di n g 
µ g will be e val uate d i n S u bst u dies A a n d B .
I n S u bst u d y A, d ose -le vel c o m bi nati o ns 1 t hr o u g h 3 as s h o w n i n Ta ble 1 w ill be e val uate d .  
S u bst u d y  B will e val uate vari o us d ose -le vel c o m bi nati o ns i n partici pa nts 1 8 t hro u g h 6 4 ye ars 
of a ge (Ta ble 2 ) (as detaile d i n Secti o n 1 0. 1 2. 4. 1 ).
These d ose -le vel c o m bi nati ons i n 
S u bst u d y  B were
 
 
 
 
Base d o n P hase 2 C 4 7 8 1 0 0 4 safety a n d i m m u n o ge nicit y  data, t he d ose le vel of qIR V bei n g 
st u die d i n t he P hase 3 C 4 7 8 1 0 0 4 st u d y, b y  a ge strat u m, is 
µ g f or partici pa nts 1 8 t hr o u g h 
6 4 ye ars of a ge a n d 
µ g f or partici pa nts ≥6 5 y ears of a ge ; he nce, t he c orres p o n di n g d ose 
le vel will be use d i n qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) a d mi nistere d 
d uri n g S u bst u d y B t o partici pa nts 1 8 t hr o u g h 6 4 years of a ge.  Base d o n preli mi nar y  data 
fr o m S u bst u d y A, S u bst u d y B will st u d y a d diti o nal c o m bi nati o ns of C O VI D- 1 9/i nfl ue nza 
m o d R N A .
T his is s u p p orte d b y a n acce pta ble t olera bilit y pr ofile f or a d ose u p t o 
µ g of a 
c o m binati o n of i nfl ue nza m o d R N A a n d C O VI D-1 9 m o d R N A , wit h o p p ort u nit y t o i ncrease 
t he i m m u ne res p o nse a gai nst b ot h C O VID- 1 9 a n d i nfl ue nza strai ns.
4. 3. 4. tI R V/Bi v ale nt B N T 1 6 2 b 2 ( Ori gi n al/ O mi B A. 4/ B A. 5)
tIR V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) at d ose- le vel c o mbi nati o ns n ot 
e xcee di n g 
 µ g will be e val uate d i n t his st u d y  as e x pl orat or y o bjecti ves , base d o n 
i m m u n o ge nicity data fr o m S u bst u d y  A a n d S u bst u d y B.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 5
Base d o n preli mi nar y  data fr o m S u bst u d y A, S u bst u d y B will st u d y a differe nt c o m bi nati o n 
of C O VI D - 1 9/i nfl ue nza m o d R N A vacci ne i n t he f or m of tI R V:
µ g (
 
, a n d 
 a n d
µ g  bi vale nt B N T 1 6 2 b 2 
(o ri gi nal/ O mi B A. 4/ B A. 5). T his is s u p p orte d b y  a n acce pta ble t olera bilit y pr ofile f or a d ose
u p t o 
µ g of a c o m bi nati o n of i nfl ue nza m o d R N A a n d C O VI D - 1 9 m o d R N A , wit h 
o p p ort u nit y  t o i ncrease t he i m m u ne res p o nse a gai nst b ot h C O VID -1 9 a n d i nfl ue nza strai ns . 
4. 3. 5. bI R V /Bi v ale nt B N T 1 6 2 b 2
b I RV/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) at d ose-le vel c o m binati o ns n ot 
e xcee di n g
µ g will be e val uate d i n S u bst u d y  B as e x pl orat or y o bjecti ves , base d o n 
i m m u n o ge nicity data fr o m S u bst u d y  A.
Base d o n preli mi nar y data fr o m S u bst u d y  A, S u bst u d y B will st u d y a differe nt c o m bi nati o n 
of C O VI D - 1 9/i nfl ue nza m o d R N A vacci ne i n t he f or m of bI R V gi ve n c o nc urre ntl y wit h QI V 
i n t he o p p osite ar m: 
µ g (
 a n d
µ g b i vale nt 
B N T 1 6 2 b 2 ( o ri gi nal/ O mi B A. 4/ B A. 5). T his is s u p p orte d b y  a n acce pta ble t olera bilit y pr ofile 
f or a d ose u p t o 
 µ g ma xi m u m a n d o p p ort u nit y t o i ncrease t he i m m u ne res p o nse.
4. 4. E n d of St u d y Defi niti o n
T he e n d of t he st u d y is defi ne d as t he date of t he last visit of t he last partici pa nt i n 
S u bst u d y B.
A partici pa nt is c o nsi dere d t o ha ve c o m plete d t he st u d y  if he/s he has c o m plete d all peri o ds of 
t he st u d y, i ncl u di n g t he last visit.
5. S T U D Y P O P U L A TI O N
T his st u d y  ca n f ulfill its o bjecti ves o nl y if a p pr o priate partici pa nt s are e nr olle d, i ncl u di n g 
partici pa nts acr oss di verse a n d re prese ntati ve racial a n d et h nic bac k gr o u n ds. If a 
prescree n i n g t o ol is utilize d f or st u dy recr uit me nt p ur p oses , it will i ncl u de c ollecti o n of 
i nf or mati o n t hat reflects t he e nr oll me nt of a di verse partici pa nt p o p ulati o n i ncl u di n g, w here 
per mitte d u n der l ocal re g ulati o ns, a ge, se x, race, a n d et h nicit y . T he f oll o wi n g eli gi bilit y  
criteria are desi g ne d t o select partici pa nt s f or w h o m partici pati o n i n t he st u d y  is c o nsi dere d 
a p pr o priate. All rele va nt me dical a n d n o n me dical c o n diti o ns s h o ul d be ta ke n i nt o 
c o nsi derati o n w he n deci di n g w het her a partic ular partici pa nt is s uita ble f or t his pr ot oc ol.
Pr os pecti ve a p pr o val of pr ot oc ol de viati o ns t o recr uit me nt a n d e nr oll me nt criteria , als o 
k n o w n as pr ot oc ol wai vers or e xe m pti o ns, is n ot per mitte d.
N ote : “E nr olle d ” mea ns a partici pa nt ’s, or t heir le gally a ut h orize d re prese ntati ve’s, 
a gree me nt t o partici pate i n a cli nical st u d y  f oll owi n g c o m pleti o n of t he i nf or me d c o nse nt 
pr ocess a n d ra n d o mizati o n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 6
5. 1. I ncl usi o n Criteri a
See Secti o n 1 0. 1 1. 5. 1 f or t he S u bst u d y  A i ncl usi o n criteria.
See Secti o n 1 0. 1 2. 5. 1 f or t he S u bst u d y B i ncl usi o n criteria. 
5. 2. E xcl usi o n Criteri a
See Secti o n 1 0. 1 1. 5. 2 f or t he S u bst u d y  A e xcl usi o n criteria.
See Secti o n 1 0. 1 2. 5. 2 f or t he S u bst u d y B e xcl usi o n criteria.
5. 3. Lifest yle C o nsi der ati o ns
5. 3. 1. C o ntr ace pti o n
T he i n vesti gat or or t heir desi g nee, i n c o ns ultati o n wit h t he partici pa nt, will c o nfir m t hat t he 
partici pa nt is utilizi n g a n a p pr o priate met h o d of c o ntrace pti o n f or t he i n di vi d ual partici pa nt 
a n d t heir part ner(s) fr o m t he per mitte d list of c o ntrace pti o n met h o ds (see A p pe n di x 5 ,
Secti o n 1 0. 5. 4 ) a n d will c o nfir m t hat t he partici pa nt has bee n i nstr ucte d i n its c o nsiste nt a n d 
c orrect use. At ti me p oi nts i n dica te d i n t he S o As , t he i n vesti gat or or desi g nee will i nf or m t he 
partici pa nt of t he nee d t o use acce pta ble eff ecti ve c o ntrace pti o n c o nsiste ntl y a n d c orrectl y 
a n d d oc u me nt t he c o n versati o n a n d t he partici pa nt ’s affir mati o n i n t he partici pa nt’s c hart.
P artici pa nts nee d t o affir m t heir c o nsiste nt a n d c orrect use of at least 1 of t he selecte d 
met h o ds of c o ntrace pti o n , c o nsi deri n g t hat t heir ris k f or pre g na nc y ma y ha ve c ha n ge d si nce 
t he last visit.
I n a d diti o n, t he i n vesti gat or or desi g nee will i nstr uct t he partici pa nt t o call i m me diatel y if t he 
selecte d c o ntrace pti o n met h o d is disc o nti n ue d a n d d oc u me nt t he re q uire me nt t o use a n 
alter nate pr ot oc ol-s pecifie d met h o d, i ncl u di n g if t he partici pa nt will n o l o n ger use a bsti ne nce 
as t he selecte d c o ntrace pti o n met h o d, or if pre g na nc y is k n o w n or s us pecte d i n t he partici pa nt 
or part ner.
5. 4. Scree n F ail ures
Scree n fail ures are defi ne d as partici pa nts w h o c o nse nt t o partici pate i n t he cli nical st u d y  b ut 
are n ot s u bse q ue ntl y e nr olle d i n t he st u d y. A mi ni mal set of scree n fail ure i nf or mati o n is 
re q uire d t o e ns ure tra ns pare nt re p orti n g of scree n fail ure partici pa nts t o meet t he C O N S O R T 
p u blis hi n g re q uire me nts a n d t o res p o n d t o q ueries fr o m re g ulat or y a ut h orities. Mi ni mal 
i nf or mati o n i ncl u des de m o gra p hy,  scree n fail ure details, a n d a ny S A Es.
I n di vi d uals w h o d o n ot meet t he criteria f or partici pati o n i n t his st u d y  (scree n fail ures) ma y 
be rescree ne d.
5. 5. Criteri a f or Te m p or aril y Del a yi n g E nr oll me nt/ R a n d o miz ati o n/ A d mi nistr at i o n of 
St u d y I nter ve nti o n
See Secti o n 1 0. 1 1. 5. 3 f or te m p orar y dela y criteria f or S u bst u d y A.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 7
See Secti o n 1 0. 1 2. 5. 3 f or te m p orar y dela y criteria f or S u bst u d y B.
6. S T U D Y I N T E R V E N TI O N( S ) A N D C O N C O MI T A N T T HE R A P Y
St u d y  i nter ve nti o ns are all pres pecifie d i n vesti gati o nal a n d me dical de vices, a n d ot her 
i nter ve nti o ns (e g, s ur gical a n d be ha vi oral), i nte n de d t o be a d mi nistere d t o t he st u d y 
partici pa nts d uri n g t he st u d y c o n d uct.
F or t he p ur p oses of t his pr ot oc ol, st u d y  i nter ve nti o n refers t o: 

qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal / O mi B A. 4/ B A. 5), w hic h is a c o m bi nati o n of t he 
f oll o wi n g, a d mi nistere d at t he d ose -le vel c o m bi nati o ns s h o w n i n Ta ble 1 f or 
S u bst u d y A a n d Ta ble 2 f or S u bst u d y  B.

qI R V e nc o di n g H A of 4 strai ns as seas o nally rec o m me n de d f or t he i nfl ue nza 
seas o n (
) or 
, wit h t he 
strai n c o m bi nati o ns as s h o w n i n Ta ble 1 f or S u bst u d y A a n d Ta ble 2 f or 
S u bst u d y B.

Bi vale nt B N T 1 6 2 b 2 (ori gi nal / O mi B A. 4/ B A. 5), w hic h c o ntai ns ori gi nal 
B N T 1 6 2 b 2 a n d B N T 1 6 2 b 2 O micr o n ( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5), at a 
d ose of eit her:

 µ g, ie, 
 µ g of ori gi nal B N T 1 6 2 b 2 a n d  
µ g of B N T 1 6 2 b 2 O micr o n 
( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5), or

µ g, ie,  
µ g of ori gi nal B N T 1 6 2 b 2 a n d 
µ g of B N T 1 6 2 b 2 O micr o n
( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5)

tI RV/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5), w hic h is a c o m bi nati o n of t he 
f oll o wi n g, a d mi nistere d at t he d ose-le vel c o m bi nati o ns s h o w n i n Ta ble 2 :

µ g tI RV e nc o di n g H A of 3 strai ns as seas o nall y rec o m me n de d f or t he 
i nfl ue nza seas o n (
a n d 
 
)

µ g Bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5), w hic h c o ntai ns ori gi nal 
B N T 1 6 2 b 2 a n d B N T 1 6 2 b 2 O micr o n ( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5)

b I RV/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5), w hic h is a c o m bi nati o n of t he 
f oll o wi n g, a d mi nistere d at t he d ose-le vel c o m bi nati o ns s h o w n i n Ta ble 2 :

µ g b I R V e nc o di n g H A of 
 as seas o nall y rec o m me n de d f or t he 
i nfl ue nza seas o n 
)
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 8

 µ g Bi vale n t B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5), w hic h c o ntai ns ori gi nal 
B N T 1 6 2 b 2 a n d B N T 1 6 2 b 2 O micr o n ( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5)

µ g qI R V, ie, e nc o di n g H A of 4 strai ns as seas o nall y rec o m me n de d f or t he 
i nfl ue nza seas o n 
)

µ g qI R V, ie, e nc o di n g H A of 4 strai ns as seas o nall y rec o m me n de d f or t he 
i nfl ue nza seas o n 
)

Lice nse d QI V
Ta ble 3 de scri bes the vacci ne details f or eac h of t he c o nstit ue nt parts of t he st u d y 
i nter ve nti o ns.
T a ble 1.
S u bst u d y A : qI R V/ Bi v ale nt B N T 1 6 2 b 2 ( Ori gi n al/ O mi B A. 4/ B A. 5) 
D ose -Le vel C o m bi n ati o ns
S u bst u d y A
V acci ne Gr o u p
qI R V D ose
Bi v ale nt B N T 1 6 2 b 2 
( Ori gi n al* / O mi B A. 4/ B A. 5) D ose
T ot al 
m o d R N A D ose
1
µ g , ie,
 
µ g , ie,

µ g of ori gi nal B N T 1 6 2 b 2 a n d

µ g of B N T 1 6 2 b 2 O micr o n 
( B. 1. 1. 5 2 9 s u bli nea ge B A . 4/ B A. 5)
µ g
2
µ g , ie,
 
µ g , ie,

µ g of ori gi nal B N T 1 6 2 b 2 a n d

µ g of B N T 1 6 2 b 2 O micr o n 
( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5)
µ g
3
µ g , ie,
 
 µ g, ie,

µ g of ori gi nal B N T 1 6 2 b 2 a n d

µ g of B N T 1 6 2 b 2 O micr o n 
( B. 1. 1. 5 2 9 s u bli nea ge B A. 4/ B A. 5)
µ g
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 5 9
T a ble 2.
S u bst u d y B: All V acci ne Gr o u ps 
S u bst u d y B 
V acci ne
Gr o u p
qI R V/ Bi v ale nt 
B N T 1 6 2 b 2
D ose -Le vel 
C o m bi n ati o ns a
qI R V, tI R V, or bI R V
Bi v ale nt 
B N T 1 6 2 b 2 b
Lice nse d QI V
L N P
D ose
T ot al m o d R N A
D ose
A p pr o xi m ate 
N u m ber of 
P artici p a nts
1
N / A
N/ A
µ g 
Lice nse d QI V
m g
µ g
3 0
2 c
N / A
µ g bI R V
(
µ g 
Lice nse d QI V
m g
µ g
3 0
3
1
µ g qI R V
(
)
µ g 
N/ A
m g
µ g
1 2 0
4 d
2
µ g qI R V (
(
 
)
µ g
 
N/ A
m g
µ g
1 2 0
5
3
µ g qI R V
(
 
)
µ g 
N/ A
m g
µ g
1 2 0
6
4
µ g qI R V
(
 
)
µ g
N/ A
m g
µ g
3 0
7
5
 µ g qI R V
(
 
)
µ g 
N/ A
m g
µ g
3 0
8
6
µ g qI R V
(
 
)
µ g 
N/ A
m g
µ g
3 0
9
7
µ g qI R V
(
 
)
µ g 
N/ A
m g
µ g
3 0
1 0
8
µ g qI R V
(
 
)
µ g 
N/ A
m g
µ g
3 0
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 0
T a ble 2.
S u bst u d y B: All V acci ne Gr o u ps 
S u bst u d y B 
V acci ne
Gr o u p
qI R V/ Bi v ale nt 
B N T 1 6 2 b 2
D ose -Le vel 
C o m bi n ati o ns a
qI R V, tI R V, or bI R V
Bi v ale nt 
B N T 1 6 2 b 2 b
Lice nse d QI V
L N P
D ose
T ot al m o d R N A
D ose
A p pr o xi m ate 
N u m ber of 
P artici p a nts
1 1 c
N/ A
µ g tI R V
(
)
µ g 
N/ A
m g
µ g
3 0
1 2 d
N/ A
qI R V
N/ A
N/ A
m g 
µ g 
3 0
a.
F or qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) t hat
mI R Vs e nc o di n g H A f or eac h A a n d B strai n will be
t o ge nerate qI R V 
at t he d ose-le vel c o m bi nati o n s h o w n; t he res ulta nt qI R V will t he n be
wit h bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) pr i or t o a d mi nistrati o n.  Please 
see t he I P M f or f urt her details.
b.
F or bi vale nt B N T 1 6 2 b 2 f or m ulati o ns: 
µ g t otal d ose i ncl u des 
µ g of O micr o n B A. 4/ B A. 5 a n d  
µ g of t he a ncestral S A R S -C o V - 2 strai n;
µ g t otal d ose i ncl u des 
µ g of O micr o n B A. 4/ B A. 5 a n d 
µ g of t he a ncestral S A R S- C o V -2 strai n. Ori gi nal refers t o t he a ncestral stra i n ( W u ha n-H u - 1; U S A- W A 1/ 2 0 2 0), als o referre d t o i n 
t his pr ot oc ol as t he refere nce strai n.
c.
Gr o u ps 2 a n d 1 1: bI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) a n d tI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) are
d.
Gr o u ps 4 a n d 1 2: qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) a n d qI R V are
N ote: T he f oll o wi n g i nfl ue nza strai ns are i ncl u de d i n t he I R V i n eac h gr o u p at t he d ose le vel n ote d:
Gr o u p 
Gr o u ps t hr o u g h 
a n d  : 
 
 
Gr o u p 
Gr o u p 
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 1
T a ble 3.
S u bst u d y A a n d S u bst u d y B: V acci ne Det ails
V acci ne Pre p ar ati o n
V acci ne A nti ge n
Str ai n
P F -0 7 8 2 9 8 5 5 I nfl ue nza m o d R N A S us pe nsi o n f or 
I njecti o n, 0. 1 m g/ m L I nfl ue nza S us pe nsi o n f or 
a
I nfl ue nza A
P F -0 7 9 6 6 7 3 1 I nfl ue nza m o d R N A S us pe nsi o n f or 
I njecti o n, 0. 1 m g/ m L
I nfl ue nza A
P F -0 7 8 3 6 2 5 8 I nfl ue nza m o d R N A S us pe nsi o n f or 
I njecti o n, 0. 1 m g / m L
I nfl ue nza A
P F -0 7 8 7 1 8 5 3 I nfl ue nza m o d R N A S us pe nsi o n f or 
I njecti o n, 0. 1 m g/ m L
I nfl ue nza A
P F -0 7 8 7 2 9 6 3 I nfl ue nza m o d R N A S us pe nsi o n f or 
I njecti o n, 0. 1 m g/ m L
I nfl ue nza B
P F -0 7 8 3 6 2 5 9 I nfl ue nza m o d R N A S us pe nsi o n f or 
I njecti o n, 0. 1 m g/ m L
I nfl ue nza B
P F -0 7 8 7 1 9 9 2 Q ua dri vale nt I nfl ue nza m o d R N A 
S us pe nsi o n f or I njecti o n, 0. 0 6 m g/ m L b
2 0 2 2/ 2 0 2 3 n ort her n 
h e mis p here,
µ g d ose
P F -0 7 8 7 1 9 9 2 Q ua dri vale nt I nfl ue nza m o d R N A 
S us pe nsi o n f or I njecti o n, 0. 1 2 m g/ m L b
2 0 2 2/ 2 0 2 3 n ort her n 
h e mis p here
µ g d ose
B N T 1 6 2 b 2 bi vale nt [ W T a n d O micr o n ( B A. 4/ B A. 5)
varia nt] 1 0 0 µ g/ m L
2 0 2 2/ 2 0 2 3 n ort her n 
h e mis p here C O VI D -1 9
C O VI D -1 9
a.
T his A strai n will be u p date d t o
base d o n t he 2 0 2 3 -2 0 2 4 n ort her n h e mis p here 
seas o nal i nfl ue nza strai n selecti o n i n S u bst u d y B.
b.
6. 1. St u d y I nter ve nti o n(s) A d mi nistere d
See Secti o n 1 0. 1 1. 6. 1 f or st u d y i nter ve nti o ns t o be a d mi nistere d d uri n g S u bst u d y A.
See Secti o n 1 0. 1 2. 6. 1 f or st u d y i nter ve nti o ns t o be a d mi nistere d d uri n g S u bst u d y B.
6. 1. 1. A d mi nistr ati o n
Sta n dar d vacci nati o n practices m ust be o bser ve d a n d vacci ne s m ust n ot be i njecte d i nt o 
bl o o d vessels. A p pr o pri ate me dicati o n a n d ot her s u p p orti ve meas ures f or ma na ge me nt of a n 
ac ute h y perse nsiti vit y  reacti o n s h o ul d be a vaila ble i n acc or da nce wit h l ocal g ui deli nes f or 
sta n dar d i m m u nizati o n practices.
A d mi nistrati o n of st u d y i nter ve nti o ns s h o ul d be perf or me d by a n a p pr o priatel y q ualifie d, 
trai ne d, a n d vacci ne-e x perie nce d me m ber of t he st u d y staff (e g, p hys icia n, n urse, p h ysicia n’s 
assista nt, n urse practiti o ner, p har macist, or me dical assista nt) as all o we d b y l ocal, state, a n d 
i nstit uti o nal g ui da nce.
St u d y  i nter ve nti o n a d mi nistrati o n details will be rec or de d o n t he C R F.
See Secti o n 1 0. 1 1. 6. 1. 1 ( S u bst u d y A) f or st u d y i nter ve nti o n a d mi nistrati o n details.
See Secti o n 1 0. 1 2. 6. 1. 1 ( S u bst u d y B) f or st u d y i nter ve nti o n a d mi nistrati o n details.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C
CI
C C
I
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 2
6. 1. 2. Me dic al De vices
QI V ma y  be pr o vi de d as P F Ss a n d, i n w hic h case, s h o ul d be c o nsi dere d a me dical de vice.
All me dical de vice deficie ncies (i ncl u di n g malf u ncti o n, use err or, a n d i na de q uate la beli n g) 
s hall be d oc u me nte d a n d re p orte d by t he i n vesti gat or t hr o u g h o ut t he c li nical i n vesti gati o n 
(see Secti o n 8. 4. 8 ) a n d a p pr o priately ma na ge d b y t he s p o ns or.
6. 2. Pre p ar ati o n , H a n dli n g , St or a ge , a n d Acc o u nt a bilit y
1.
T he i n vesti gat or or desi g nee m ust c o nfir m t hat a p pr o priate c o n diti o ns (e g, te m perat ure) 
ha ve bee n mai ntai ne d d uri n g tra nsit f or all st u d y  i nter ve nti o ns recei ve d a n d a n y 
discre pa ncies are re p orte d a n d res ol ve d bef ore use of t he st u d y  i nter ve nti o n.
2.
O nl y  partici pa nts e nr olle d i n t he st u d y  ma y recei ve st u d y i nter ve nti o n a n d o nl y 
a ut h orize d site staff ma y  s u p pl y, pre pare, a n d/or a d mi nister st u d y  i nter ve nti o n.
3.
All st u d y  i nter ve nti o ns m ust be st ore d i n a sec ure, e n vir o n me ntall y  c o ntr olle d, a n d 
m o nit ore d ( ma n ua l or a ut o mate d rec or di n g) area i n acc or da nce wit h t he la bele d st ora ge 
c o n diti o ns wit h access li mite d t o t he i n vesti gat or a n d a ut h orize d site staff. At a 
mi ni m u m, dail y  mi ni m u m a n d ma xi m u m te m perat ures f or all site st ora ge l ocati o ns m ust 
be d oc u me nte d a n d a vaila ble u p o n re q uest. Data f or n o n w or ki n g da y s m ust i n dicate t he 
mi ni m u m a n d ma xi m u m te m perat ure s si nce pre vi o usl y  d oc u me nte d u p o n ret ur n t o 
b usi ness.
4.
A n y  e xc ursi o ns fr o m t he st u d y i nter ve nti o n la bel st ora ge c o n diti o ns s h o ul d be re p orte d t o 
Pfizer u p o n disc o ver y  al o n g wit h acti o ns ta ke n. T he site s h o ul d acti vel y p urs ue o pti o ns 
f or ret ur ni n g t he st u dy i nter ve nti o n t o la bele d st ora ge c o n diti o ns, as s o o n as p ossi ble. 
O nce a n e xc ursi o n is i de ntifie d, t he st u d y i nter ve nti o n m ust be q uara nti ne d a n d n ot use d 
u ntil Pfizer pr o vi des per missi o n t o use t he st u d y  i nter ve nti o n. S pecific details re gar di n g 
t he e xc ursi o n defi niti o n a n d i nf or mati o n t o re p ort f or eac h e xc ursi o n will be pr o vi de d t o 
t he site i n t he IP M.
5.
A n y  st ora ge c o n diti o ns state d i n t he S R S D will be s u perse de d b y t he st ora ge c o n diti o ns 
state d o n t he la bel. See t he I P M f or st ora ge c o n diti o ns of t he pre pare d st u d y i nter ve nti o n .
6.
St u d y  i nter ve nti o ns s h o ul d be st ore d i n t heir ori gi nal c o ntai ners.
7.
T he i n vesti gat or, i nstit uti o n, hea d of t he me dical i nstit uti o n ( w here a p plica ble), or 
a ut h orize d site staff is res p o nsi ble f or st u d y i nter ve nti o n acc o u nta bilit y, rec o nciliati o n, 
a n d rec or d mai nte na nce (ie, recei pt, rec o nciliati o n, a n d fi nal dis p ositi o n rec or ds) , s uc h as 
t he IP A L or s p o ns or -a p pr o ve d e q ui vale nt . All s t u d y i nter ve nti o ns will be acc o u nte d f or 
usi n g a st u d y i nter ve nti o n acc o u nta bilit y f or m/rec or d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 3
8.
F urt her g ui da nce a n d i nf or mati o n f or t he fi nal dis p ositi o n of u n use d st u d y  i nter ve nti o ns 
are pr o vi de d i n t he IP M. All destr ucti o n m ust be a de q uatel y d oc u me nte d . If destr ucti o n 
is a ut h orize d t o ta ke place at t he i n vesti gat or site, t he i n vesti gat or m ust e ns ure t hat t he 
materials are destr o ye d i n c o m plia nce wit h a p plica ble e n vir o n me ntal re g ulati o ns, 
i nstit uti o nal p olic y, a n d a n y s pecial i nstr ucti o ns pr o vi de d b y Pfizer.
U p o n i de ntificati o n of a pr o d uct c o m plai nt, n otif y t he s p o ns or w it hi n 1 b usi ness da y  of 
disc o ver y as descri be d i n t he IP M.
6. 2. 1. Pre p ar ati o n a n d Dis pe nsi n g
See t he I P M f or i nstr ucti o ns o n h o w t o pre pare t he st u d y  i nter ve nti o n f or a d mi nistrati o n.  
St u d y  i nter ve nti o n s h o ul d be pre pare d , verifie d, a n d dis pe nse d b y  a n a p pr o priatel y q ualifie d 
a n d e x perie nce d me m ber of t he st u d y  staff (e g, p h ysicia n, n urse, p h ysicia n’s assista nt, n urse 
practiti o ner, p har mac y  assista nt/tec h nicia n, or p har macist) as all o we d b y l ocal, state, a n d 
i nstit uti o nal g ui da nce. A sec o n d staff me m ber (e g, p h ysicia n, n urse, p h ysicia n’s assista nt, 
n urse practiti o ner, p har mac y  assista nt/tec h nicia n, or p har macist) will verif y  t he dis pe nsi n g.
See Secti o n 1 0. 1 1. 6. 1. 3. 1 f or f urt her details re gar di n g pre parati o n a n d dis pe nsi n g f or 
S u bst u d y A.
Se e Secti o n 1 0. 1 2. 6. 1. 3. 1 f or f urt her details re gar di n g pre parati o n a n d dis pe nsi n g f or 
S u bst u d y B .
6. 3. Assi g n me nt t o St u d y I nter ve nti o n
All ocati o n (ra n d o mizati o n) of partici pa nts t o vacci ne gr o u ps will pr ocee d t hr o u g h t he use of 
a n IR T s ys te m (IW R) .  T he site pers o n nel (st u dy c o or di nat or or s pecifie d desi g nee) will be 
re q uire d t o e nter or select i nf or mati o n i ncl u di n g, b ut n ot li mite d t o, t he user’s I D a n d 
pass w or d, t he pr ot oc ol n u m ber, a n d t he partici pa nt n u m ber.  T he s ite pers o n nel will t he n be 
pr o vi de d wit h a ra n d o mizati o n n u m ber.  T he I R T s y ste m will pr o vi de a c o nfir mati o n re p ort 
c o ntai ni n g t he partici pa nt n u m ber, ra n d o mizati o n n u m ber, a n d st u d y i nter ve nti o n all ocati o n 
assi g ne d.  T his re p ort will be pr o vi de d t o bli n de d or u n bli n de d site staff as a p pr o priate o n t he 
r ole/ per missi o n t he user is gra nte d a n d m ust be st ore d i n t he site’s bli n de d or u n bli n de d files 
as a p pr o priate.
St u d y  i nter ve nti o n will be dis pe nse d at t he st u d y visits s u m marize d i n t he S o As .
6. 4. Bli n di n g
See Secti o n 1 0. 1 1. 6. 2 f or S u bst u d y A bli n di n g arra n ge me nts.
See Secti o n 1 0. 1 2. 6. 2 f or S u bst u d y B bli n di n g arra n ge me nts.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 4
6. 4. 1. Bli n di n g of P artici p a nts
S u bst u d y  A bli n di n g arra n ge me nts f or partici pa nts are detaile d i n Secti o n 1 0. 1 1. 6. 2. 1 .
S u bst u d y  B bli n di n g arra n ge me nts f or partici pa nts are detaile d i n Secti o n 1 0. 1 2. 6. 2. 1 .
6. 4. 2. Bli n di n g of Site Pers o n nel
S u bst u d y  A bli n di n g arra n ge me nts f or site pers o n nel are detaile d i n Secti o n 1 0. 1 1. 6. 2. 2 .
S u bst u d y  B bli n di n g arra n ge me nts f or site pers o n nel are detaile d i n Secti o n 1 0. 1 2. 6. 2. 2 .
6. 4. 3. Bli n di n g of t he S p o ns or
S u bst u d y  A bli n di n g arra n ge me nts f or t he s p o ns or are detaile d i n Secti o n 1 0. 1 1. 6. 2. 3 .
S u bst u d y  B bli n di n g arra n ge me nts f or t he s p o ns or are detaile d i n Secti o n 1 0. 1 2. 6. 2. 3 .
6. 4. 4. Bre a ki n g t he Bli n d 
See Secti o n 1 0. 1 1. 6. 2. 4 f or details o n bli n d-brea ki n g pr oce d ures f or S u bst u d y  A.
See Secti o n 1 0. 1 2. 6. 2. 4 f or details o n bli n d-brea ki n g pr oce d ures f or S u b st u d y B.
6. 5. St u d y I nter ve nti o n C o m pli a nce
W he n partici pa nts are d ose d at t he site, t he y  will recei ve st u d y i nter ve nti o n directl y fr o m t he 
i n vesti gat or or desi g nee, u n der me dical s u per visi o n.  T he date a n d ti me of eac h d ose 
a d mi nistere d i n t he cli nic will be r ec or de d i n t he s o urce d oc u me nts a n d rec or de d i n t he C R F.  
T he d ose of st u d y i nter ve nti o n a n d st u d y partici pa nt i de ntificati o n will be c o nfir me d at t he 
ti me of d osi n g by a me m ber of t he st u d y site staff ot her t ha n t he pers o n a d mi nisteri n g t he 
st u d y i nter ve nti o n.
6. 6. D ose M o dific ati o n
N ot a p plica ble.
6. 7. C o nti n ue d Access t o St u d y I nter ve nti o n A fter t he E n d of t he St u d y
N o st u d y i nter ve nti o n will be pr o vi de d t o partici pa nts at t he e n d of t heir st u d y partici pati o n.
6. 8. Tre at me nt of O ver d ose
F or t his st u d y , a n y d ose of st u d y i nter ve nti o n greater t ha n 1 d ose of st u d y i nter ve nti o n wit hi n 
a 2 4- h o ur ti me peri o d will be c o nsi dere d a n o ver d ose.
Pfizer d oes n ot rec o m me n d s pecific treat me nt f or a n o ver d ose.
I n t he e ve nt of a n o ver d ose, t he i n vesti gat or s h o ul d:
1.
C o ntact t he st u d y me dical m o nit or wit hi n 2 4 h o urs.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 5
2.
Cl osel y  m o nit or t he partici pa nt f or a ny A E s/ S A Es a n d la b orat or y a b n or malities as 
me dicall y  a p pr o priate a n d at least u ntil t he ne xt sc he d ule d f oll o w - u p.
3.
D oc u me nt t he q ua ntit y of t he e xcess d ose as well as t he d urati o n of t he o ver d ose i n t he 
C R F.
4.
O ver d ose is re p orta ble t o Pfizer Safet y  o nl y w he n ass oci ate d wit h a n S A E.
6. 9. Pri or a n d C o nc o mit a nt T her a p y
See Secti o n 1 0. 1 1. 6. 7 f or S u bst u d y A pri or a n d c o nc o mita nt t hera p y.
See Secti o n 1 0. 1 2. 6. 7 f or S u bst u d y B pri or a n d c o nc o mita nt t hera p y.
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L
7. 1. Disc o nti n u ati o n of St u d y I nter ve nti o n
Si nce t his is a si n gle -d ose st u d y, t his secti o n is n ot a p plica ble.
7. 2. P artici p a nt Disc o nti n u ati o n/ Wit h dr a w al
F r o m t he St u d y
A partici pa nt ma y  wit h dra w fr o m t he st u d y at a ny ti me at their o w n re q uest . Reas o ns f or 
disc o nti n uati o n fr o m t he st u d y  i ncl u de t he f oll o wi n g:

Ref use d f urt her st u d y pr oce d ures;

L ost t o f oll o w - u p;

Deat h;

St u d y  ter minate d b y s p o ns or;

React o ge nicit y e ve nt;

A E s;

Partici pa nt re q uest; 

I n vesti gat or re q uest;

Select pr ot oc ol de viati o ns ( e g, recei pt of a C O VI D-1 9 vacci ne o utsi de of t he 
st u d y-s pecifie d ti me p oi nts ). See Secti o n 1 0. 1 1 f or S u bst u d y  A a n d Secti o n 1 0. 1 2 f or 
S u bst u d y  B.
If a partici pa nt wit h dra ws fr o m t he st u d y , t he y ma y  re q uest destr ucti o n of a n y re mai ni n g 
sa m ples ta ke n a n d n ot teste d, a n d the i n vesti gat or m ust d oc u me nt a n y  s uc h re q uests i n t he 
site st u d y rec or ds a n d n otif y t he s p o ns or acc or di n gl y.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 6
If t he partici pa nt wit h dra ws fr o m t he st u d y a n d als o wit h dra ws c o nse nt (see Secti o n 7. 2 ) f or 
discl os ure of f ut ure i nf or mati o n, n o f urt her e val uati o ns will be perf or me d a n d n o a d diti o nal 
data will be c ollecte d. T he s p o ns or ma y  retai n a n d c o nti n ue t o use a n y data c ollecte d bef ore 
s uc h wit h dra wal of c o nse nt.
7. 2. 1. Wit h dr a w al of C o nse nt
Partici pa nt s wh o re q uest t o disc o nti n ue recei pt of st u d y  i nter ve nti o n will re mai n i n t he st u d y  
a n d m ust c o nti n ue t o be f oll o we d f or pr ot oc ol -s pecifie d f oll o w-u p pr oce d ures. T he o nl y 
e xce pti o n t o t his is w he n a partici pa nt s pecifically wit h dra ws c o nse nt f or a n y f urt her c o ntact 
wit h t he m or pers o ns pre vi o usl y  a ut h orize d b y t he partici pa nt t o pr o vi de t his i nf or mati o n. 
Partici pa nt s s h o ul d n otif y t he i n vesti gat or i n writi n g of t he decisi o n t o wit h dra w c o nse nt 
fr o m f ut ure f oll o w-u p, w he ne ver p ossi ble. T he wit h dra wal of c o ns e nt s h o ul d be e x plai ne d i n 
detail i n t he me dical rec or ds b y  t he i n vesti gat or, as t o w het her t he wit h dra wal is o nl y fr o m 
f urt her recei pt of st u d y i nter ve nti o n or als o fr o m st u d y  pr oce d ures a n d/ or p ostvacci nati o n
st u d y f oll o w-u p, a n d e ntere d o n t he a p pr o priate C R F pa ge. I n t he e ve nt t hat vital stat us 
( w het her t he partici pa nt is ali ve or dea d) is bei n g meas ure d, p u blicly a vaila ble i nf or mati o n 
s h o ul d be use d t o deter mi ne vital stat us o nl y as a p pr o priately directe d i n acc or da nce wit h 
l ocal la w.
7. 3. L ost t o F ol l o w- U p
A partici pa nt will be c o nsi dere d l ost t o f oll o w -u p if t he partici pa nt re peate dl y fails t o ret ur n 
f or sc he d ule d visits a n d is u na ble t o be c o ntacte d b y t he st u d y site.
T he f oll o wi n g acti o ns m ust be ta ke n if a partici pa nt fails t o ret ur n t o t he cli nic f or a re q uire d 
st u d y visit:

T he site m ust atte m pt t o c o ntact t he partici pa nt a n d resc he d ule t he misse d visit as s o o n as 
p ossi ble .
Co u nsel t he partici pa nt o n t he i m p orta nce of mai ntai ni n g t he assi g ne d visit 
sc he d ule, a n d ascertai n w het her t he partici pa nt wis hes t o a n d/ or s h o ul d c o nti n ue i n t he 
st u d y;

Bef ore a partici pa nt is dee me d l ost t o f oll o w- u p, t he i n vesti gat or or desi g nee m ust ma ke 
e ver y eff ort t o re gai n c o ntact wit h t he partici pa nt ( w here p ossi ble, 3 tele p h o ne calls a n d, 
if necessar y, a certifie d letter t o t he partici pa nt’s last k n o w n maili n g a d dress or l ocal 
e q ui vale nt met h o ds). T hese c o ntact atte m pts s h o ul d be d oc u me nte d i n t he partici pa nt’s 
me dical rec or d ;

S h o ul d t he partici pa nt c o nti n ue t o be u nreac ha ble, t he partici pa nt will be c o nsi dere d t o 
ha ve wit h dra w n fr o m t he st u d y .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 7
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S
8. 1. A d mi nistr ati ve Pr oce d ures
T he i n vesti gat or ( or a n a p pr o priate dele gate at t he i n vesti gat or site) m ust o btai n a si g ne d a n d 
date d I C D bef ore perf or mi n g a n y  st u d y-s pecific pr oce d ures.
T he date of birt h will be c ollecte d t o criticall y  e val uate t he i m m u ne res p o nse a n d safet y 
pr ofile b y a ge.
St u d y  pr oce d ures a n d t heir ti mi n g are s u m marize d i n t he S o As . Pr ot oc ol wai vers or 
e xe m pti o ns ar e n ot all o we d.
A d here nce t o t he st u d y desi g n re q uire me nts, i ncl u di n g t h ose s pecifie d i n t he S o As , is 
esse ntial a n d re q uire d f or st u d y c o n d uct.
All scree ni n g e val uati o ns m ust be c o m plete d a n d re vie we d t o c o nfir m t hat p ote ntial 
par tici pa nts meet all eli gi bilit y criteria. T he i n vesti gat or will mai ntai n a scree ni n g l o g t o 
rec or d details of all partici pa nts scree ne d a n d t o c o nfir m eli gi bilit y or rec or d reas o ns f or 
scree ni n g fail ure, as a p plica ble.
E ver y ef f ort s h o ul d be ma de t o e ns ure t hat pr ot oc ol-re q uire d tests a n d pr oce d ures are 
c o m plete d as descri be d. H o we ver , it is a ntici pate d t hat fr o m ti me t o ti me t here ma y be 
circ u msta nces o utsi de t he c o ntr ol of t he i n vesti gat or t hat ma ke it u nfeasi ble t o perf or m t he 
test. I n t hese cases, t he i n vesti gat or m ust ta ke all ste ps necessar y t o e ns ure t he safety a n d 
well -bei n g of t he partici pa nt . W he n a pr ot oc ol -re q uire d test ca n n ot be perf or me d, t he 
i n vesti gat or will d oc u me nt t he reas o n f or t he misse d test a n d a ny c orrecti ve a n d pre ve nti ve 
acti o ns t hat t he y ha ve ta ke n t o e ns ure t hat re q uire d pr ocesses are a d here d t o as s o o n as 
p ossi ble. T he st u d y  tea m m ust be i nf or me d of t hese i nci de nts i n a ti mel y ma n ner.
F or sa m ples bei n g c ollecte d a n d s hi p pe d, detaile d c ollecti o n, pr ocessi n g, st ora ge, a n d 
s hi p ment i nstr ucti o ns a n d c o ntact i nf or mati o n will be pr o vi de d t o t he i n vesti gat or site pri or 
t o i nitiati o n of t he st u d y.
8. 2. Effic ac y a n d/ or I m m u n o ge nicit y Assess me nts
See Secti o n 1 0. 1 1. 8. 1 f or S u bst u d y  A i m m u n o ge nicit y assess me nts.
See Secti o n 1 0. 1 2. 8. 3 f or S u bst u d y B i m m u n o ge nicit y assess me nts.
8. 2. 1. Bi ol o gic al S a m ples
Bl o o d a n d mi dt ur bi nate s wa b sa m ples will be use d o nl y f or scie ntific researc h.  Eac h sa m ple 
will be la bele d wit h a c o de s o t hat t he la b orat or y  a nalys t testi n g t he sa m ples will n ot k n o w 
t he partici pa nt’s i de ntity,  st u d y visit, or st u d y c o h ort ass ociate d wit h t he sa m ple. Sa m ples 
t hat re mai n after perf or mi n g assa ys o utli ne d i n t he pr ot o c ol ma y be st ore d b y Pfizer. U nless 
a ti me li mitati o n is re q uire d b y l ocal re g ulati o ns or et hical re q uire me nts, t he sa m ples will be 
st ore d f or u p t o 1 5 ye ars after t he e n d of t he st u d y a n d t he n destr o ye d. If all o we d by t he 
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 8
I C D, st ore d sa m ples ma y be use d f or a d diti o nal testi n g t o better u n dersta n d t he i m m u ne 
res p o nses t o t he vacci ne(s) u n der st u dy i n t his pr ot oc ol, t o i nf or m t he de vel o p me nt of ot her 
vacci nes or vacci ne -relate d pr o d ucts, a n d/ or f or vacci ne-relate d assa y w or k s u p p orti n g 
vacci ne pr o gra ms. N o testi n g of t he partici pa nt’s D N A will be perf or me d.
T he partici pa nt ma y  re q uest t hat t heir sa m ples, if still i de ntifia ble, be destr o ye d at a n y ti me; 
h o we ver, a n y data alrea d y c ollecte d fr o m t h ose sa m ples will still be use d f or t his researc h. 
T he bi ol o gi cal sa m ples ma y be s hare d wit h ot her researc hers as l o n g as c o nfi de ntialit y is 
mai ntai ne d a n d n o testi n g of t he partici pa nt’s D N A is perf or me d .
8. 3. S afet y Assess me nts
Pla n ne d ti me p oi nts f or all safet y  assess me nts are pr o vi de d i n t he S o As . U nsc he d ule d safety 
meas ure me nts m a y  be o btai ne d at a n y ti me d uri n g t he st u d y t o assess a n y percei ve d safet y 
iss ues.
A cli nical assess me nt, i ncl u di n g me dical hist or y , will be perf or me d o n all partici pa nts at t heir 
first visit t o esta blis h a baseli ne.  Si g nifica nt me dical hist or y a n d o bser vati o ns fr o m a n y 
p h y sical e xa mi nati o n, if perf or me d, will be d oc u me nte d i n t he C R F.
A Es a n d S A Es are c ollecte d, rec or de d, a n d re p orte d as defi ne d i n Secti o n 8. 4 .
Ac ute reacti o ns wit hi n t he first 3 0 mi n utes after a d mi nistrati o n of t he st u d y  i nter ve nti o n will 
be assesse d a n d d oc u me nte d i n t he A E C R F.
Safet y  para meters als o i ncl u de react o ge nicity e -di ar y re p orts of l ocal reacti o ns , s yste mic 
e ve nts (i ncl u di n g fe ver), a n d use of a nti p yr etic me dicati o n t hat occ ur i n t he 7 da y s after 
a d mi nistrati o n of t he st u d y i nter ve nti o n.  T hese pr os pecti vely self -c ollecte d occ urre nces of 
l ocal reacti o ns a n d sys te mic e ve nts are gra de d as descri be d i n Secti o n 8. 3. 5 .
8. 3. 1. P h ysic al E x a mi n ati o ns
I n S u bst u d y  A, a p h y sical e xa mi nati o n will be perf or me d at t he scree ni n g visit a n d, if 
cli nicall y i n dicate d, pri or t o t he partici pa nt’s first vacci nati o n (at Visit 1 i n S u bst u d y A).  I n 
S u bst u d y  B, a p hys ical e xa mi nati o n will be perf or me d at t he scree ni n g visit a n d, if cli nicall y 
i n dicate d, pri or t o t he partici pa nt’s first vacci nati o n (at Visit 2 0 1).
P h y sical e xa mi nati o n fi n di n gs c ollecte d d uri n g t he st u d y will be c o nsi dere d s o urce data a n d 
will n ot be re q uire d t o be rep orte d , u nless ot her wise n ote d. A n y u nt o war d p h y sical 
e xa mi nati o n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d meet t he 
defi niti o n of a n A E or S A E (A p pe n di x 3 ) m ust be re p orte d acc or di n g t o the pr ocesses i n 
Secti o ns 8. 4. 1 t o 8. 4. 3 .
8. 3. 2. Vit al Si g ns
F or S u bst u d y  A, the partici pa nt’s oral te m perat ure, p ulse rate, a n d seate d bl o o d press ure will 
be meas ure d at scree ni n g, pri or t o vacci nati o n at Visit 1 , Visit 2, a n d Visit 3.  A d diti o nall y , 
wei g ht a n d hei g ht will be meas ure d at scree ni n g.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 6 9
F or S u bst u d y  B, t he partici pa nt’s oral te m perat ure, p ulse rate, a n d seate d bl o o d press ure will 
be meas ure d at scree ni n g, pri or t o vacci nati o n at Visit 2 0 1, at Visit 2 0 2, a n d at Visit 2 0 3 .
A d dit i o nall y, wei g ht a n d hei g ht will be meas ure d at scree ni n g. 
A n y  u nt o war d vital si g n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d 
meet t he defi niti o n of a n A E or S A E ( A p pe n di x 3 ) m ust be re p orte d acc or di n g t o t he 
pr ocesses i n Secti o ns 8. 4. 1 t o 8. 4. 3 .
8. 3. 3. Electr oc ar di o gr a ms
See Secti o n 1 0. 1 1. 8. 4. 1 f or S u bst u d y  A E C G re q uire me nts.
See Secti o n 1 0. 1 2. 8. 5. 1 f or S u bst u d y B E C G re q uire me nts.
8. 3. 4. Cli nic al S afet y L a b or at or y Assess me nts
Cli nical safet y  la b orat or y assess me nts will be c o n d ucte d i n S u bst u d y  A a n d S u bst u d y B.
See A p pe n di x 2 f or t he list of cli nical safety la b orat or y tests t o be perf or me d a n d t he 
S u bst u d y  A/ B S o A f or t he ti mi n g a n d fre q ue nc y. All pr ot oc ol -re q uire d la b orat or y 
assess me nts, as defi ne d i n A p pe n di x 2 , m ust be c o n d ucte d i n acc or da nce wit h t he la b orat or y 
ma n ual a n d t he S u bst u d y A / B S o A . U nsc he d ule d cli nical la b orat or y  meas ure me nts ma y be 
o btai ne d at a n y ti me d uri n g t he st u d y t o assess a n y percei ve d safet y iss ues.
T he i n vesti gat or m ust re vie w t he la b orat or y  re p ort, d oc u me nt t his re vie w, a n d rec or d a ny 
cli nicall y si g nifica nt c ha n ges occ urri n g d uri n g t he st u d y  i n t he A E secti o n of t he C R F .
Cli nicall y  si g nifica nt a b n or mal la b orat or y test fi n di n gs are t h ose t hat are n ot ass ociate d wit h 
t he u n derlyi n g disease, u nless j u d ge d b y  t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or 
t he partici pa nt’s c o n diti o n.
All la b orat or y  tests wit h val ues c o nsi dere d cli nicall y si g nifica nt a n d a b n or mal d uri n g 
partici pati o n i n t he st u d y  or wit hi n 2 8 da y s after t he last d ose of st u d y i nter ve nti o n s h o ul d be 
re peate d u ntil t he val ues ret ur n t o n or mal or baseli ne or are n o l o n ger c o nsi dere d cli nicall y  
si g nifica nt by t he i n vesti gat or or st u d y me dical m o nit or .
If s uc h val ues d o n ot ret ur n t o n or mal/ baseli ne wit hi n a peri o d of ti me j u d ge d reas o na ble b y 
t he i n vesti gat or, t he eti ol o g y s h o ul d be i de ntifie d a n d t he s p o ns or notifie d.
See Secti o n 1 0. 6 f or s u g geste d acti o ns a n d f oll o w-u p assess me nts i n t he e ve nt of p ote ntial 
DI LI .
See Secti o n 1 0. 7 f or i nstr ucti o ns f or la b orat or y testi n g t o m o nit or ki d ne y f u ncti o n a n d 
re p orti n g la b orat or y test a b n or malities.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 0
8. 3. 5. Electr o nic Di ar y
All p artici pa nts will be re q uire d t o c o m plete a react o ge nicit y e -diar y  after eac h vacci nati o n 
gi ve n at V isits 1 a n d 2 0 1 t hr o u g h a n a p plicati o n i nstalle d o n a pr o visi o ne d de vice or o n t he 
partici pa nt’s o w n pers o nal de vice.  All partici pa nts will be as ke d t o m o nit or a n d rec or d l ocal 
reacti o ns, sys te mic e ve nts, a n d use of a nti p yretic me dicati o n f or 7 d a y s fr o m t he da y of 
a d mi nistrati o n of t he st u d y i nter ve nti o n gi ve n at V isits 1 a n d 2 0 1 .  T he react o ge nicity e -diar y  
all o ws rec or di n g of t hese assess me nts o nl y wit hi n a fi xe d ti me wi n d o w, t h us pr o vi di n g t he 
acc urate re prese ntati o n of t he partici pa nt’s e x perie nce at t hat ti me.  Data o n l ocal reacti o ns 
a n d s yste mic e ve nts re p orte d i n t he react o ge nicity e-diar y  will be tra nsferre d electr o nicall y t o 
a t hir d-part y ve n d or, w here t he y will be a vaila ble f or re vie w b y i n vesti gat ors a n d t he Pfizer 
cli nicia ns at all ti mes via a n i nter net- base d p ortal.
At i nter vals a gree d t o b y t he ve n d or a n d Pfizer, t hese data will be tra nsferre d electr o nically 
i nt o Pfizer’s data base f or a nal ys is a n d re p orti n g.  T hese data d o n ot nee d t o be re p orte d b y 
t he i n vesti gat or i n t he C R F, u nless t he partici pa nt misse d a n e-diar y  e ntr y a n d t he partici pa nt 
e x perie nce d a pr o m pte d l ocal reacti o n or s ys te mic e ve nt, i n w hic h case a ny misse d e ntries 
s h o ul d be i ncl u de d i n t he A E C R F.
I n vesti gat ors ( or desi g nee) will be re q uire d t o re vie w t he react o ge nicit y e-diar y  data o nli ne at 
fre q ue nt i nter vals as part of t he o n g oi n g safety re vie w.
T he i n vesti gat or or desi g nee m ust o btai n st o p dates fr o m t he partici pa nt f or a n y  o n g oi n g 
l ocal reacti o ns, s yste mic e ve nts, or use of a nti p yretic me dicati o n o n t he last da y t hat t he 
react o ge nicit y e-diar y  was c o m plete d.  T he st o p dates s h o ul d be d oc u me nte d i n t he s o urce 
d oc u me nts a n d t he i nf or mati o n e ntere d i n t he C R F.
8. 3. 5. 1. Gr a di n g Sc ales
T he gra di n g scales use d i n t his st u d y  t o assess l ocal reacti o ns a n d s yste mic e ve nts as 
descri be d bel o w are deri ve d fr o m t he F D A C B E R g ui deli nes o n t o xicit y  gra di n g scales f or 
healt h y  a d ult v ol u nteers e nr olle d i n pre ve nti ve vacci ne cli nical trials.2 3
8. 3. 5. 2. L oc al Re acti o ns
F oll o wi n g vacci nati o n ( w here Da y  1 is t he da y of vacci nati o n), partici pa nts will be as ke d t o 
assess re d ness, s welli n g, a n d pai n at t he i njecti o n site a n d t o rec or d t he sy m pt o ms i n t he 
react o ge nicit y e-diar y dail y .  I n S u bst u dies A a n d B , l oc al re acti o ns will be assesse d at t he 
i njecti o n site o n t he ri g ht ar m o nl y after v acci n ati o n s gi ve n at V isits 1 a n d 2 0 1.
If a l ocal reacti o n persists be y o n d t he e n d of t he react o ge nicit y  e-diar y  peri o d f oll o wi n g 
vacci nati o n, t he partici pa nt will be re q ueste d t o re p ort t hat i nf or mati o n.  T he i n vesti gat or will 
e nter t his a d diti o nal i nf or mati o n i n t he C R F.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 1
Partici pa nts will be pr o vi de d wit h a mea s uri n g de vice.  Re d ness a n d s welli n g will be 
meas ure d a n d rec or de d i n meas uri n g de vice u nits (ra n ge: 1 t o 2 1) a n d t he n cate g orize d 
d uri n g a nal ys is as a bse nt, mil d, m o derate, or se vere base d o n t he gra di n g scale i n Ta ble 4.  
Meas uri n g de vice u nits ca n be c o n verte d t o ce nti meters acc or di n g t o t he f oll o wi n g f or m ula: 
1 meas uri n g de vice u nit = 0. 5 c m.  Pai n at t he i njecti o n site will be assesse d b y  t he 
partici pa nt as a bse nt, mil d, m o derate, or se vere acc or di n g t o t he gra di n g scale i n Ta ble 4.
If a Gra de 3 l ocal reacti o n is re p orte d i n t he react o ge nicit y e-diar y , a tele p h o ne c o ntact 
s h o uld occ ur t o ascertai n f urt her details a n d deter mi ne w het her a site visit is cli nicall y  
i n dicate d.  O nly a n i n vesti gat or or me dicall y q ualifie d pers o n is a ble t o classif y  a 
partici pa nt’s l ocal reacti o n as Gra de 4.  If a partici pa nt e x perie nces a c o nfir me d Gr a de 4 l ocal 
reacti o n, t he i n vesti gat or m ust i m me diatel y n otif y t he s p o ns or.
T a ble 4.
L oc al Re acti o n Gr a di n g Sc ale
Mil d 
( Gr a de 1)
M o der ate 
( Gr a de 2)
Se vere 
( Gr a de 3)
P ote nti all y 
Life -T hre ate ni n g 
( Gr a de 4)
Pai n at t he 
i njecti o n site
D oes n ot i nterfere 
wit h acti vit y
I nterferes wit h acti vit y
Pre ve nts dail y 
acti vit y 
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere pai n
Re d ness
> 2. 0 c m t o 5. 0 c m 
( 5 t o 1 0 meas uri n g 
de vice u nits)
> 5. 0 c m t o 1 0. 0 c m 
( 1 1 t o 2 0 meas uri n g 
de vice u nits)
> 1 0 c m 
(≥2 1 meas uri n g 
de vice u nits)
Necr osis or e xf oliati ve 
der matitis
S welli n g
> 2. 0 c m t o 5. 0 c m 
( 5 t o 1 0 meas uri n g 
de vice u nits)
> 5. 0 c m t o 1 0. 0 c m 
( 1 1 t o 2 0 meas uri n g 
de vice u nits)
> 1 0 c m 
(≥2 1 meas uri n g 
de vice u nits)
Necr osis
8. 3. 5. 3. S yste mic E ve nts
D uri n g t he react o ge nicit y e -diar y  re p orti n g peri o d, partici pa nts will be as ke d t o assess 
v o miti n g, diarr hea, hea dac he, fati g ue, c hills, ne w or w orse ne d m uscle pai n, a n d ne w or 
w orse ne d j oi nt pai n a n d t o rec or d t he s y m pt o ms i n t he react o ge nicit y e - diar y.  T he sy m pt o ms 
will be assesse d b y t he partici pa nt as a bse nt, mil d, m o derate, or se vere acc or di n g t o t he 
gra di n g scale i n Ta ble 5 .
If a Gra de 3 sys te mic e ve nt is re p orte d i n t he react o ge nicit y e-diar y , a tele p h o ne c o ntact 
s h o ul d occ ur t o ascertai n f urt her details a n d deter mi ne w het her a site visit is cli nicall y 
i n dicate d.  O nly a n i n vesti gat or or me dicall y q ualifie d pers o n is a ble t o classif y  a 
partici pa nt’s s ys te mic e ve nt as Gra de 4.  If a partici pa nt e x perie nces a c o nfir me d Gra de 4 
s yste mic e ve nt, t he i n vesti gat or m ust i m me diatel y n otif y t he s p o ns or.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 2
T a ble 5.
S yste mic E ve nt Gr a di n g Sc ale
Mil d 
( Gr a de 1)
M o der ate 
( Gr a de 2)
Se vere 
( Gr a de 3)
P ote nti all y Life -
T hre ate ni n g 
( Gr a de 4)
V o m iti n g
1- 2 ti mes i n 
2 4 h o urs
> 2 ti mes i n 
2 4 h o urs
Re q uires I V 
h y drati o n
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
h y p ote nsi ve s h oc k
Diarr hea
2 t o 3 l o ose st o ols 
i n 2 4 h o urs
4 t o 5 l o ose st o ols 
i n 2 4 h o urs
6 or m ore l o ose st o ols 
i n 2 4 h o urs
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere diarr hea
Hea dac he
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere hea dac he
Fati g ue/tire d ness
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere fati g ue
C hills
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere c hills
N e w  or worse ne d 
m uscle pai n
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere new or w orse ne d 
m uscle pai n
N e w  or worse ne d 
j oi nt pai n
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere new or w orse ne d 
j oi nt pai n
8. 3. 5. 4. Fe ver
I n or der t o rec or d i nf or mati o n o n fe ver, a t her m o meter will be gi ve n t o partici pa nts wit h 
i nstr ucti o ns o n h o w t o meas ure oral te m perat ure at h o me.  Te m perat ure will be c ollecte d i n 
t he react o ge nicity e -diar y i n t he e ve ni n g dail y f or 7 da ys f oll o wi n g vacci nati o n ( w here Da y 1 
is t he da y of vacci nati o n). It will als o be c ollecte d at a n y ti me d uri n g t he react o ge nicity 
e-diar y  data c ollecti o n peri o ds w he n fe ver is s us pecte d.  Fe ver is defi ne d as a n oral 
te m perat ure ≥3 8. 0° C ( ≥1 0 0. 4° F).  T he hi g hest te m perat ure f or eac h da y will be rec or de d i n 
t he react o ge nicity e -diar y.  Te m perat ure will be meas ure d a n d rec or de d t o 1 deci mal place.  
Te m perat ures rec or de d i n de grees Fa hre n heit will be pr o gra m maticall y  c o n verte d t o de grees 
Celsi us a n d t he n cate g orize d acc or di n g t o t he scale s h o w n i n Ta ble 6 d uri n g a nal ys is.
If a fe ver of ≥3 9. 0° C ( ≥1 0 2. 1° F) is re p orte d i n t he react o ge nicit y  e-diar y , a tele p h o ne c o ntact 
s h o ul d occ ur t o ascertai n f urt her details a n d deter mi ne w het her a site visit is cli nicall y 
i n dicate d.  O nly a n i n vesti gat or or me dicall y q ualifie d pers o n is a ble t o c o nfir m a 
partici pa nt’s fe ver as > 4 0. 0° C ( > 1 0 4. 0° F).  If a partici pa nt e x perie nces a c o nfir me d fe ver 
> 4 0. 0° C ( > 1 0 4. 0° F), t he i n vesti gat or m ust i m me diatel y  n otif y t he s p o ns or.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 3
T a ble 6.
Sc ale f or Fe ver
≥3 8. 0 -3 8. 4° C ( 1 0 0. 4 -1 0 1. 1° F)
> 3 8. 4 -3 8. 9° C ( 1 0 1. 2 -1 0 2. 0° F)
> 3 8. 9 -4 0. 0° C ( 1 0 2. 1 -1 0 4. 0° F)
> 4 0. 0° C ( > 1 0 4. 0° F)
8. 3. 5. 5. A nti p yretic Me dic ati o n
T he use of a nti p yretic me dicati o n t o treat sy m pt o ms ass ociate d wit h st u d y  i nter ve nti o n 
a d mi nistrati o n will be rec or de d i n t he react o ge nicit y  e-diar y  dail y d uri n g t he re p orti n g peri o d 
( Da y 1 t hr o u g h Da y 7).
8. 3. 6. Pre g n a nc y Testi n g
P re g na nc y tests ma y be uri ne or ser u m tests, b ut m ust ha ve a se nsiti vit y of at least 
2 5 mI U/ m L. Pre g na nc y  tests will be perf or me d i n W O C B P  at t he ti mes liste d i n t he S o As ,
i m me diatel y bef ore t he a d mi nistrati o n of t he st u d y i nter ve nti o n d ose . A ne gati ve pre g na nc y  
test res ult will be re q uire d pri or t o t he partici pa nt’s recei vi n g t he st u d y i nter ve nti o n. 
Pre g na nc y  tests ma y als o be re peate d if re q ueste d b y IR Bs/ E C s or if re q uire d b y l ocal 
re g ulati o ns. I n t he case of a p ositi ve c o nfir me d pre g na nc y, t he partici pa nt will be wit h dra w n 
fr o m a d mi nistrati o n of st u d y i nter ve nti o n b ut ma y re mai n i n t he st u d y.
8. 4. A d verse E ve nts , Seri o us A d verse E ve nts , a n d Ot her S afet y Re p orti n g
T he defi niti o ns of a n A E a n d a n S A E ca n be f o u n d i n A p pe n di x 3 .
A E s ma y arise fr o m sy m pt o ms or ot her c o m plai nts re p orte d t o t he i n vesti gat or b y  t he 
partici pa nt ( or , w he n a p pr o priate, b y a care gi ver, s urr o gate, or t he partici pa nt’s le gall y 
a ut h orize d re prese ntati ve), or t he y  ma y arise fr o m cli nical fi n di n gs of t he in vesti gat or or 
ot her healt hcare pr o vi ders (cli nical si g ns, test res ults, etc).
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detecti n g, d oc u me nti n g, a n d 
rec or di n g e ve nts t hat meet t he defi niti o n of a n A E or S A E a n d re mai n res p o nsi ble t o p urs ue 
a n d o btai n a de q uate i nf or mati o n b ot h t o deter mi ne t he o utc o me a n d t o assess w het her t he 
e ve nt meets t he criteria f or classificati o n as a n S A E or ca use d t he partic i pa nt t o disc o nti n ue 
t he st u d y (see Secti o n 7. 1 ).
D uri n g t he acti ve c ollecti o n peri o d as descri be d i n S ecti o n 8. 4. 1 , eac h partici pa nt will be 
q uesti o ne d a b o ut t he occ urre nce of A E s i n a n o nlea di n g ma n ner.
I n a d diti o n, t he i n vesti gat or ma y be re q ueste d b y Pfizer Safety t o o btai n s pecific f oll o w - u p 
i nf or mati o n i n a n e x pe dite d fas hi o n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 4
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y f or C ollecti n g A E a n d S A E I nf or m ati o n
S u bst u d y A
T he ti me peri o d f or acti vel y  eliciti n g a n d c ollecti n g A E s a n d S A Es (“acti ve c ollecti o n 
peri o d ”) f or eac h partici pa nt be gi ns fr o m t he ti me t he partici pa nt pr o vi des i nf or me d c o nse nt, 
w hic h is o btai ne d bef ore t he partici pa nt ’s partici pati o n i n t he st u d y (ie, bef ore u n der g oi n g 
a n y st u d y-relate d pr oce d ure a n d/ or recei vi n g st u d y i nter ve nti o n), t hr o u g h a n d i ncl u di n g 
Vi sit 4 ( 4 -wee k f oll o w -u p visit).  A d diti o nall y , a n y AE s occ urri n g u p t o 4 8 h o urs after t he 
bl o o d dra ws at Visits 4 a n d 5 m ust be rec or de d o n t he C R F.
S A Es will be c ollecte d fr o m t he ti me t he partici pa nt pr o vi des i nf or me d c o nse nt t o 
a p pr o xi matel y 6 m o nt hs after t he partici pa nt’s last st u d y vacci nati o n ( Visit 6).
S u bst u d y B
T he ti me peri o d f or acti vel y  eliciti n g a n d c ollecti n g AE s a n d S A Es (“acti ve c ollecti o n 
peri o d”) f or eac h partici pa nt be gi ns fr o m t he ti me t he partici pa nt pr o vi des i nf or me d c o nse nt, 
w hic h is o btai ne d bef ore t he partici pa nt’s partici pati o n i n t he st u d y  (ie, bef ore u n der g oi n g 
a n y st u d y-relate d pr oce d ure a n d/ or recei vi n g st u d y i nter ve nti o n), t hr o u g h a n d i ncl u di n g 
Visit 2 0 4 .  A d diti o nall y, a n y AE s occ urri n g u p t o 4 8 h o urs after t he bl o o d dra ws at Visit 20 4
i n S u bst u d y  B (if eli gible as per Secti o n 1 0. 1 2. 1 ) m ust be rec or de d o n t he C R F.
S A Es will be c ollecte d fr o m t he ti me t he partici pa nt pr o vi des i nf or me d c o nse nt t o 
a p pr o xi matel y 6 m o nt hs after t he partici pa nt’s first st u d y vacci nati o n ( Visit 2 05).
F oll o w -u p b y  t he i n vesti gat or c o nti n ues t hr o u g h o ut t he acti ve c ollecti o n peri o d a n d u ntil t he 
A E or S A E or its se q uelae res ol ve or sta bilize at a le vel acce pta ble t o t he i n vesti gat or .
W he n a cli nicall y  i m p orta nt A E re mai ns o n g oi n g at t he e n d of t he acti ve c ollecti o n peri o d, 
f oll o w-u p b y  t he i n vesti gat or c o nti n ues u ntil t he A E or S A E or its se q uelae res ol ve or 
sta bilize at a le vel acce pta ble t o t he i n vesti gat or a n d Pfizer c o nc urs wit h t hat assess me nt.
F or partici pa nts w h o are scree n fail ures, t he act i ve c ollecti o n peri o d e n ds w he n scree n fail ure 
stat us is deter mi ne d.
If t he partici pa nt wit h dra ws fr o m t he st u d y a n d als o wit h dra ws c o nse nt f or t he c ollecti o n of 
f ut ure i nf or mati o n, t he acti ve c ollecti o n peri o d e n ds w he n c o nse nt is wit h dra w n.
If a partici pa nt per ma ne ntl y disc o nti n ues or te m p oraril y disc o nti n ues st u d y beca use of a n A E 
or S A E, t he A E or S A E m ust be rec or de d o n t he C R F a n d t he S A E re p orte d usi n g t he 
Va cci ne S A E Re p ort F or m .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 5
I n vesti gat ors are n ot o bli gate d t o acti vely see k i nf or mati o n on A Es or S A E s after t he 
partici pa nt has c o ncl u de d st u d y partici pati o n. H o we ver , if t he i n vesti gat or lear ns of a n y 
S A E, i ncl u di n g a deat h, at a n y  ti me after a partici pa nt has c o m plete d t he st u d y, a n d t he y
c o nsi der t he e ve nt t o be reas o na bl y relate d t o t he st u d y i nter ve nti o n, t he i n vesti gat or m ust 
pr o m ptl y  re p ort t he S A E t o Pfizer usi n g t he Va cci ne S A E Re p ort F or m .
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer S afet y
All S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d as descri be d i n
Secti o n 8. 4. 1 are re p orte d t o Pfizer Safet y o n t he Vacci ne S A E Re p ort F or m i m me diatel y 
u p o n a ware ness a n d u n der n o circ u msta nce s h o ul d t his e xcee d 2 4 h o urs, as i n dicate d i n 
A p pe n di x 3 . T he i n vesti gat or will s u b mit a n y  u p date d S A E data t o t he s p o ns or wit hi n 
2 4 h o urs of it s bei n g a vaila ble.
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F
All n o nseri o us A Es a n d S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d, 
w hic h be gi ns after o btai ni n g i nf or me d c o nse nt as descri be d i n Secti o n 8. 4. 1 , will be rec or de d 
o n t he A E secti o n of t he C R F .
T he i n vesti gat or is t o rec or d o n t he C R F all directl y  o bser ve d a n d all s p o nta ne o usl y re p orte d 
A E s a n d S A Es re p orte d b y t he partici pa nt.
As part of o n g oi n g safet y re vie ws c o n d ucte d b y t he s p o ns or, a n y n o nseri o us A E t hat is 
deter mi ne d b y t he s p o ns or t o be seri o us will be re p orte d b y t he s p o ns or as a n S A E. T o assist 
i n t he deter mi nati o n of case seri o us ness, f urt her i nf or mati o n ma y be re q ueste d fr o m t he 
i n vesti gat or t o pr o vi de clarit y a n d u n dersta n di n g of t he e ve nt i n t he c o nte xt of t he cli nical 
st u d y.
8. 4. 2.
Met h o d of Detecti n g A E s a n d S A Es
T he met h o d o f rec or di n g, e val uati n g, a n d assessi n g ca usalit y of A Es a n d S A Es a n d t he 
pr oce d ures f or c o m pleti n g a n d tra ns mitti n g S A E re p orts are pr o vi de d i n A p pe n di x 3 .
Care will be ta ke n n ot t o i ntr o d uce bias w he n detecti n g A E s a n d/ or S A Es. O pe n -e n de d a n d 
n o nlea di n g ver bal q uesti o ni n g of t he partici pa nt is t he preferre d met h o d t o i n q uire a b o ut 
A E occ urre nces.
8. 4. 3. F oll o w - Up of A E s a n d S A Es
After t he i nitial A E or S A E re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y  f oll o w eac h 
partici pa nt at s u bse q ue nt visits/c o ntacts. F or eac h e ve nt, t he i n vesti gat or m ust p urs ue a n d 
o btai n a de q uate i nf or mati o n u ntil res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, 
or t he partici pa nt is l ost t o f oll o w -u p (as defi ne d i n Secti o n 7. 3 ).
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 6
I n ge neral, f oll o w- u p i nf or mati o n will i ncl u de a descri pti o n of t he e ve nt i n s ufficie nt detail t o 
all o w f or a c o m plete me dical assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of 
p ossi ble ca usalit y. A n y i nf or mati o n rele va nt t o t he e ve nt, s uc h as c o nc o mita nt me dicati o ns 
a n d ill nesses, m ust be pr o vi de d. I n t he case of a partici pa nt deat h, a s u m mar y of a vaila ble 
a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o Pfizer Safet y.
F urt her i nf or mati o n o n f oll o w -u p pr oce d ures is pr o vi de d i n A p pe n di x 3 .
8. 4. 4. Re g ul at or y Re p orti n g Re q uire me nts f or S A Es
Pr o m pt n otificati o n b y  t he i n vesti gat or t o t he s p o ns or of an S A E is esse ntial s o t hat le gal 
o bli gati o ns a n d et hical res p o nsi bilities t o war d t he safet y of partici pa nts a n d t he safet y of a 
st u d y i nter ve nti o n u n der cli nical i n vesti gati o n are met.
T he s p o ns or has a le gal res p o nsi bilit y  t o n otif y b ot h t he l ocal re g ulat or y a ut h orit y a n d ot her 
re g ulat or y a ge ncies a b o ut t he safety of a st u d y i nter ve nti o n u n der cli nical i n vesti gati o n. T he 
s p o ns or will c o m pl y wit h c o u ntr y-s pecific re g ulat or y re q uire me nts relati n g t o safety 
re p orti n g t o t he re g ulat or y a ut h ority,  IR B s/ ECs , a n d i n vesti gat ors.
I n vesti gat or safet y re p orts m ust be pre pare d f or S U S A Rs acc or di n g t o l ocal re g ulat or y 
re q uire me nts a n d s p o ns or p olic y a n d f or war de d t o i n vesti gat ors as necessar y.
A n i n vesti gat or w h o recei ves S U S A R s or ot her s pecific safet y i nf or mati o n (e g, s u m mar y or 
listi n g of S A Es) fr o m t he s p o ns or will re vie w a n d t he n file it al o n g wit h t he S R S D (s) f or t he 
st u d y a n d will n otif y t he I R B/ E C, if a p pr o priate acc or di n g t o l ocal re q uire me nts.
8. 4. 5. E n vir o n me nt al E x p os ure, E x p os ure D uri n g Pre g n a nc y or Bre astfee di n g, a n d 
Occ u p ati o n al E x p os ure
E n vir o n me ntal e x p os ure occ urs w he n a pers o n n ot e nr olle d i n t he st u d y as a partici pa nt 
recei ves u n pla n ne d direct c o ntact wit h or e x p os ure t o t he st u d y i nter ve nti o n. S uc h e x p os ure 
ma y  or ma y n ot lea d t o t he occ urre nce of a n A E or S A E. Pers o ns at ris k f or e n vir o n me ntal 
e x p os ure i ncl u de healt hcare pr o vi ders, fa mil y me m bers, a n d ot hers w h o ma y be e x p ose d . A n 
e n vir o n me ntal e x p os ure ma y i ncl u de E D P , E D B, a n d occ u pati o nal e x p os ure .
A n y  s uc h ex p os ure s t o t he st u d y i nter ve nti on u n der st u d y  are re p orta ble t o Pfizer Safet y 
wit hi n 2 4 h o urs of i n vesti gat or a ware ness.
8. 4. 5. 1. E x p os ure D uri n g Pre g n a nc y
A n E D P  occ urs if:

A fe male partici pa nt is f o u n d t o be pre g na nt w hile recei vi n g or after disc o nti n ui n g st u d y  
i nter ve nti o n.

A male partici pa nt w h o is recei vi n g or has disc o nti n ue d st u d y  i nter ve nti o n i nse mi nates a 
fe male part ner.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 7

A fe male n o n partici pa nt is f o u n d t o be pre g na nt w hile bei n g e x p ose d or ha vi n g bee n 
e x p ose d t o st u d y i nter ve nti o n beca use of e n vir o n me ntal e x p os ure. Bel o w are e xa m ples 
of e n vir o n me ntal E D P :

A fe male fa mil y  me m ber or healt hcare pr o vi der re p orts t hat s he is pre g na nt after 
ha vi n g bee n e x p ose d t o t he st u d y  i nter ve nti o n b y i n halati o n or s ki n c o ntact.

A male fa mil y me m ber or healt hcare pr o vi der w h o has bee n e x p ose d t o t he st u d y  
i nter ve nti o n b y i n halati o n or s ki n c o ntact t he n i nse mi nates his fe male part ner pri or t o 
or ar o u n d t he ti me of c o nce pti o n.
T he i n vesti gat or m ust re p ort E D P  t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vestigat or ’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nitial i nf or mati o n s u b mitte d 
s h o ul d i ncl u de t he a ntici pate d date of deli ver y (see bel o w f or i nf or mati o n relate d t o 
ter mi nati o n of pre g na nc y).

If E D P occ urs i n a partici pa nt/partici pa nt’s part ner, t he i n vesti gat or m ust re p ort t his 
i nf or mati o n t o Pfizer Safet y o n t he Vacci ne S A E Re p ort F or m a n d a n E D P S u p ple me ntal 
F or m, re gar dless of w het her a n S A E has occ urre d. Details of t he pre g na nc y will be 
c ollecte d after t he start of st u d y  i nter ve ntio n a n d u ntil 2 8 da y s after t he st u d y 
i nter ve nti o n.

If E D P occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, t he i n vesti gat or m ust re p ort 
i nf or mati o n t o Pfizer Safet y usi n g t he Vacci ne S A E Re p ort F or m a n d E D P S u p ple me ntal 
F or m. Si nce t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d i n t he 
st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; h o we ver, a c o p y of t he c o m plete d 
Vacci ne S A E Re p ort F or m is mai ntai ne d i n t he i n vesti gat or site file.
F oll o w -u p is c o n d ucte d t o o btai n ge neral i nf or mati o n o n t he pre g na nc y a n d its o utc o me f or 
all E D P re p orts wit h a n u n k n o w n o utc o me. T he i n vesti gat or will f oll o w t he pre g na nc y  u ntil 
c o m pleti o n ( or u ntil pre g na nc y  ter mi nati o n) a n d n otif y Pfizer Safety of t he o utc o me as a 
f oll o w- up t o t he i nitial E D P  S u p ple me ntal F or m. I n t he case of a li ve birt h, t he str uct ural 
i nte grity of t he ne o nate ca n be assesse d at t he ti me of birt h. I n t he e ve nt of a ter mi nati o n, t he 
reas o n(s) f or ter mi nati o n s h o ul d be s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural 
i nte grity of t he ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual i ns pecti o n ( u nless 
pre pr oce d ure test fi n di n gs are c o ncl usi ve f or a c o n ge nital a n o mal y a n d t he fi n di n gs are 
re p orte d).
A b n or mal pre g na nc y  o utc o mes are c o nsi dere d S A Es. If t he o utc o me of t he pre g na nc y meets 
t he criteria f or a n S A E (ie, ect o pic pre g na nc y, s p o nta ne o us a b orti o n, i ntra uteri ne fetal 
de mise, ne o natal deat h, or c o n ge nital a n o mal y) , t he i n vesti gat or s h o ul d f oll o w t he pr oce d ures 
f or re p orti n g S A Es. A d diti o nal i nf o r mati o n a b o ut pre g na nc y o utc o mes t hat are re p orte d t o 
Pfizer Safet y  as S A Es f oll o ws: 
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 8

S p o nta ne o us a b orti o n i ncl u d i n g miscarria ge a n d misse d a b orti o n s h o ul d be re p orte d 
as a n S A E ; Ne o natal deat hs t hat occ ur wit hi n 1 m o nt h of birt h s h o ul d be re p orte d, 
wit h o u t re gar d t o ca usalit y, as S A Es. I n a d diti o n, i nfa nt deat hs after 1 m o nt h s h o ul d 
be re p orte d as S A Es w he n t he i n vesti gat or assesses t he i nfa nt deat h as relate d or 
p ossi bl y  relate d t o e x p os ure t o t he st u d y i nter ve nti o n.
A d diti o nal i nf or mati o n re gar di n g t he E D P  ma y be re q ueste d b y t he s p o ns or. F urt her 
f oll o w- u p of birt h o utc o mes will be ha n dle d o n a case-b y -case basis (e g, f oll o w- u p o n 
preter m i nfa nts t o i de ntif y de vel o p me ntal dela y s). I n t he case of pater nal e x p os ure, t he 
i n vesti gat or will pr o vi de t he partici pa nt wit h t he Pre g na nt Part ner Release of I nf or mati o n 
F or m t o deli ver t o his part ner . T he i n vesti gat or m ust d oc u me nt i n t he s o urce d oc u me nts t hat 
t he partici pa nt was gi ve n t he Pre g na nt Part ner Release of I nf or mati o n F or m t o pr o vi de t o his 
part ner.
8. 4. 5. 2. E x p o s ure D uri n g Bre astfee di n g
A n E D B occ urs if:

A fe male partici pa nt is f o u n d t o be breastfee di n g w hile recei vi n g or after 
disc o nti n ui n g st u d y  i nter ve nti o n.

A fe male n o n partici pa nt is f o u n d t o be breastfee di n g w hile bei n g e x p ose d or ha vi n g 
bee n e x p ose d t o st u d y  i nter ve nti o n (ie, e n vir o n me ntal e x p os ure). A n e xa m ple of 
e n vir o n me ntal E D B is a fe male fa mily me m ber or healt hcare pr o vi der w h o re p orts 
t hat s he is breastfee di n g after ha vi ng bee n e x p ose d t o t he st u d y  i nter ve nti o n b y
i n halati o n or s ki n c o ntact.
T he i n vesti gat or m ust re p ort E D B t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nf or mati o n m ust be re p orte d 
usi n g t he Va cci ne S A E Re p ort F or m . W he n E D B occ urs i n t he setti n g of e n vir o n me ntal 
e x p os ure, t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d i n t he st u d y, 
s o t he i nf or mati o n is n ot rec or de d o n a C R F. H o we ver , a c o p y of t he c o m plete d Va ccine 
S A E Re p ort F or m is mai ntai ne d i n t he i n vesti gat or site file.
A n E D B re p ort is n ot create d w he n a Pfizer dr u g s pecifically a p pr o ve d f or use i n 
breastfee di n g w o me n (e g, vita mi ns) is a d mi nistere d i n acc or d a nce wit h a ut h orize d use. 
H o we ver , if t he i nfa nt ex perie nces a n S A E ass ociate d wit h s uc h a dr u g, t he S A E is re p orte d 
t o get her wit h t he E D B .
8. 4. 5. 3. Occ u p ati o n al E x p os ure
T he i n vesti gat or m ust re p ort a n y i nsta nce of occ u pati o nal e x p os ure t o Pfizer Safety wit hi n 
2 4 h o urs of t he i n vesti gat or ’s a ware ness usi n g t he Va cci ne S A E Re p ort F or m , re gar dless of 
w het her t here is a n ass ociate d S A E. Si nce t he i nf or mati o n a b o ut t he occ u pati o nal e x p os ure
d oes n ot pertai n t o a partici pa nt e nr olle d i n t he st u d y, t he i nf or mati o n is n ot rec or de d o n a 
C R F; h o we ver , a c o p y of t he c o m plete d Va cci ne S A E Re p ort F or m m ust be mai ntai ne d i n t he 
i n vesti gat or site file.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 7 9
8. 4. 6. C ar di o v asc ul ar a n d De at h E ve nts
Deat hs will be rec or de d t hr o u g h o ut t he st u d y as detaile d i n Secti o n 8. 4. 1 .
Car di o vasc ular e ve nts will be rec or de d t hr o u g h o ut t he st u d y as detaile d i n Secti o n 8. 4. 1 .
8. 4. 7. A d verse E ve nts of S peci al I nterest
T he f oll o wi n g e ve nts are c o nsi dere d A E SI s:
F or S u bst u d y  A:

A c o nfir me d dia g n osis of i nfl ue nza.

C o nfir me d dia g n osis of m y ocar ditis or pericar ditis occ urri n g wit hi n 4 wee ks after 
vacci nati o n.  See Secti o n 1 0. 1 1. 8. 8. 1 0 .

C o nfir me d C O VI D -1 9 dia g n osis after Visit 1 t hr o u g h t he e n d of t he st u d y (cli nical 
si g ns/s ym pt o ms per C D C 2 8 a n d p ositi ve S A R S -C o V - 2 N A A T or ra pi d a nti ge n test
res ult).
F or S u bst u d y  B:

A c o nfir me d dia g n osis of i nfl ue nza.

C o nfir me d dia g n osis of m y ocar ditis or pericar ditis occ urri n g wit hi n 6 wee ks after 
vacci nati o n .  See Secti o n 1 0. 1 2. 8. 1 2.

C o nfir me d C O VI D -1 9 dia g n osis after Visit 2 0 1 t hr o u g h t he e n d of t he st u d y  (cli nical 
si g ns/s ym pt o ms per C D C 2 8 a n d p ositi ve S A R S -C o V -2 N A A T or ra pi d a nti ge n test res ult)
(e xcl u di n g G r o u p 1 2).

P ote ntial me nstr ual c y cle dist ur ba nces. See Secti o n 1 0. 1 2. 8. 1 1 .
A E SI s are e xa mi ne d as part of r o uti ne safet y data re vie w pr oce d ures t hr o u g h o ut t he cli nical 
trial a n d as part of si g nal detecti o n pr ocesses. S h o ul d a n a g gre gate a nal y sis i n dicate t hat 
t hese pres pecifie d e ve nts occ ur m ore fre q ue ntly t ha n e x pecte d, e g , base d o n e pi de mi ol o gical 
data, literat ure, or ot her data, t he n t his will be s u b mitte d a n d re p orte d i n acc or da nce wit h 
Pfizer’s safet y re p orti n g re q uire me nts. A g gre gate a nal ys es of safet y data will be perf or me d 
o n a re g ular basis per i nter nal S O Ps .
All A E SI s m ust be re p orte d as a n A E or S A E f oll o wi n g t he pr oce d ures descri be d i n 
Secti o n 8. 4. 1 t hr o u g h 8. 4. 4 . A n A E SI  is t o be rec or de d as a n A E or S A E o n t he C R F . I n 
a d diti o n, a n A E SI t hat is als o a n S A E m ust be re p orte d usi n g t he Va cci ne S A E Re p ort F or m .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 0
8. 4. 7. 1. L ac k of Effic ac y
T he i n vesti gat or m ust re p ort si g ns, s y m pt o ms, a n d/ or cli nical se q uelae res ulti n g fr o m lac k of 
efficac y.  Lac k of ef ficac y or fail ure of e x pecte d p har mac ol o gical acti o n is re p orta ble t o 
Pfizer Safet y  o nl y if ass oci a te d wit h a n S A E.
8. 4. 8. Me dic al De vice Deficie ncies
Me dical de vices bei n g pr o vi de d f or use i n t his st u d y
are t h ose liste d i n Secti o n 6. 1. 2 . 
I n or der t o f ulfill re g ulat or y re p orti n g o bli gati o ns w orl d wi de, t he u n bli n de d site staff is 
res p o nsi ble f or t he detecti o n a n d d oc u me ntati o n of e ve nts meeti n g t he defi niti o ns of de vice 
deficie nc y  t hat occ ur d uri n g t he st u d y wit h s uc h de vices.
T he defi niti o n of a me dical de vice deficie nc y  ca n be f o u n d i n Secti o n 1 0. 1 0 .
N ote: A Es a n d/ or S A Es t hat are ass ociate d wit h a me dical de vice d eficie nc y will f oll o w t he 
sa me pr ocesses as ot her A Es or S A Es, as o utli ne d i n Secti o n s 8. 4. 1 t hr o u g h 8. 4. 4 a n d 
Secti o n 1 0. 3 of t he pr ot oc ol.
8. 4. 8. 1. Ti me Peri o d f or Detecti n g Me dic al De vice Deficie ncies
Me dical de vice deficie ncies t hat res ult i n a n i nci de nt will be detecte d, d oc u me nte d, a n d 
re p orte d d uri n g all peri o ds of t he st u d y  i n w hic h t he me dical de vice is use d.
I m p orta ntl y, re p orta ble de vice deficie ncies are n ot li mite d t o pr o ble ms wit h t he de vice itself 
b ut als o i ncl u de i nc orrect or i m pr o per use of t he de vice a n d e ve n i nte nti o nal mis use, etc.
If t he u n bli n de d site staff lear ns of a ny de vice deficie nc y  at a n y ti me after a partici pa nt has 
bee n disc har ge d fr o m t he st u d y, a n d s uc h deficie nc y is c o nsi dere d reas o na bl y relate d t o a 
me dical de vice pr o vi de d f or t he st u d y , t he u n bli n de d site staff will pr o m ptl y n otif y  t he 
s p o ns or.
Refer t o Secti o n 1 0. 1 0. 4 f or i nstr ucti o ns f or d oc u me nti n g a n d re p orti n g me dical de vice 
deficie ncies. 
8. 4. 8. 2. Re g ul at or y Re p orti n g f or De vice Deficie ncies
T he u n bli n de d site staff will pr o m ptl y  re p ort all de vice deficie ncies occ urri n g wit h a n y 
me dical de vice pr o vi de d f or use i n t he st u d y i n or der f or t he s p o ns or t o f ulfill t he le gal 
res p o nsi bilit y t o n otif y a p pr o priate re g ulat or y a ut h orities a n d ot her e ntities a b o ut certai n 
safety i nf or mati o n relati n g t o me dical de vices bei n g use d i n cli nical st u dies.
T he u n bli n de d site staff, or res p o nsi ble pers o n acc or di n g t o l ocal re q uire me nts (e g, t he hea d 
of t he me dical i nstit uti o n), will c o m pl y  wit h t he a p plica ble l ocal re g ulat or y re q uire me nts 
relati n g t o t he re p orti n g of de vice deficie ncies t o t he IR B/ E C.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 1
N ote: T here are a d diti o nal re p orti n g o bli gati o ns f or me dical de vice deficie ncies t hat are 
p ote ntiall y  relate d t o S A Es (ie, a n S A D E) t hat m ust f ulfill t he le gal res p o nsi bilit y t o n otif y 
a p pr o priate re g ulat or y a ut h orities a n d ot her e ntities a b o ut certai n safety i nf or mati o n relati n g 
t o me dical de vices bei n g use d i n cli nical st u dies.

A n y  de vice deficie nc y t hat is ass ociate d wit h a n S A E m ust be re p orte d t o t he s p o ns or 
wit hi n 2 4 h o urs after t he i n vesti gat or deter mi nes t hat t he e ve nt meets t he defi niti o n of a 
de vice deficie nc y .

T he s p o ns or s hall re vie w all de vice deficie ncies a n d deter mi ne a n d d oc u me nt i n writi n g 
w het her t he y  c o ul d ha ve le d t o a n S A E. T hese s hall be re p orte d t o t he re g ulat or y  
a ut h orities a n d I R Bs/ E Cs as re q uire d b y nati o nal re g ulati o ns.
8. 4. 9. V acci n ati o n Err ors
Va cci nati o n err ors ma y res ult fr o m t he a d mi nistrati o n or c o ns u m pti o n of t he st u d y 
i nter ve nti o n b y  t he wr o n g part ici pa nt, or at t he wr o n g ti me, or at t he wr o n g d osa ge stre n gt h.
Va cci nati o n err ors are rec or de d a n d re p orte d as f oll o ws:
Rec or de d o n t he 
V acci n ati o n Err or P a ge 
of t he C R F
Rec or de d o n t he 
A d verse E ve nt P a ge 
of t he C R F
Re p orte d o n t he V acci ne 
S A E Re p ort F or m t o Pfizer 
S afet y Wit hi n 2 4 H o urs of 
A w are ness
All (re gar dless of w het her 
ass ociate d wit h a n A E)
A n y  A E or S A E ass ociate d 
wit h t he vacci nati o n err or
O nl y  if ass ociate d wit h a n 
S A E
Va cci nati o n err ors i ncl u de:

Vacci nati o n err ors i n v ol vi n g partici pa nt e x p os ure t o t he st u d y i nter ve nti o n;

P ote ntial vacci nati o n err ors or uses o utsi de of w hat is f oresee n i n t he pr ot oc ol t hat d o 
or d o n ot i n v ol ve t he st u d y partici pa nt ;

T he a d mi nistrati o n of e x pire d st u d y  i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect st u d y i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect d osa ge;

T he a d mi nistrati o n of st u d y  i nter ve nti o n t hat has u n der g o ne te m perat ure e xc ursi o n 
fr o m t he s pecifie d st ora ge ra n ge, u nless it is deter mi ne d b y t he s p o ns or t hat t he st u d y 
i nter ve nti o n u n der q uesti o n is acce pta ble f or use.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 2
S uc h vacci nati o n err ors occ urri n g t o a st u d y partici pa nt are t o be ca pt ure d o n t he vacci nati o n
err or pa ge of t he C R F, w hic h is a s pecific versi o n of t he A E pa ge.
W het her or n ot t he vacci nati o n err or is acc o m pa nie d b y a n A E, as d eter mi ne d b y t he 
i n vesti gat or, t he vacci nati o n err or is rec or de d o n t he vacci nati o n err or pa ge of t he C R F a n d, 
if a p plica ble, a ny ass ociate d A E(s), seri o us a n d n o nseri o us, are rec or de d o n t he A E pa ge of 
t he C R F.
I n t he e ve nt of a vacci nati o n d osi n g err or , t he s p o ns or s h o ul d be n otifie d wit hi n 2 4 h o urs .
Va cci nati o n err ors s h o ul d be re p orte d t o Pfizer Safet y  wit hi n 2 4 h o urs o n a Va cci ne S A E 
Re p ort F or m o nl y w he n ass oci ate d wit h a n S A E.
8. 5. P h ar m ac o ki netics
P har mac o ki netic para meters are n ot e val uate d i n t his st u d y.
8. 6. Ge netics
8. 6. 1. S pecifie d Ge netics
See Secti o n 1 0. 4 f or i nf or mati o n re gar di n g ge netic researc h. Details o n pr ocesses f or 
c ollecti o n a n d s hi p me nt of t hese sa m ples will be pr o vi de d se paratel y.
8. 7. Bi o m ar kers
Bi o mar kers are n ot e val uate d i n t his st u d y.
8. 8. I m m u n o ge nicit y Assess me nts
See Secti o n 1 0. 1 1. 8. 1 f or S u bst u d y A.
Se e Secti o n 1 0. 1 2. 8. 3 f or S u bst u d y B.
8. 9. He alt h Ec o n o mics
Healt h ec o n o mics/ me dical res o urce utilizati o n a n d healt h ec o n o mics para meters are n ot 
e val uate d i n S u bst u d y A or S u bst u d y  B.
9. S T A TI S TI C A L C O N SI D E R A TI O N S
M et h o d ol o g y f or s u m mar y a n d statistical a nalys es of t he data c ollecte d i n t his st u d y is 
descri be d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or. T he 
S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc ol w here a p pr o priate; h o we ver, a n y maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
9. 1. St atistic al H y p ot heses
T here are n o statistical h y p ot heses i n eit her S u bst u d y  A or S ubst u d y  B.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 3
9. 1. 1. Esti m a n ds
Refer t o Secti o n 1 0. 1 1. 9. 1. 1 f or t he esti ma n ds i n S u bst u d y A.
Refer t o Secti o n 1 0. 1 2. 9. 1. 1 f or t he esti ma n ds i n S u bst u d y B.
9. 1. 2. M ulti plicit y A dj ust me nt
Refer t o Secti o n 1 0. 1 1. 9. 1. 2 f or m ulti plicit y  a dj ust me nt i n S u bst u d y A.
Refer t o Secti o n 1 0. 1 2. 9. 1. 2 f or m ulti plicit y a dj ust me nts i n S u bst u d y B.
9. 2. A n al ysis Sets
Refer t o Secti o n 1 0. 1 1. 9. 2 f or a nalys is sets i n S u bst u d y A.
Refer t o Secti o n 1 0. 1 2. 9. 2 f or a nalys is sets i n S u bst u d y B.
9. 3. St atistic al A n al yses
T he S A P will be de vel o pe d a n d fi nalize d bef ore a n y a nalys es are p erf or me d a n d will 
descri be t he a nal ys es a n d pr oce d ures f or acc o u nti n g f or missi n g, u n use d, a n d s p uri o us data.
T his secti o n is a s u m mar y of t he pla n ne d statistical a nal yses of t he pri mar y a n d sec o n dar y 
e n d p oi nts.
Statistical a nal y ses f or S u bst u d y A are detaile d i n Secti o n 1 0. 1 1. 9. 3 .
Statistical a nal y ses f or S u bst u d y B are detaile d i n Secti o n 1 0. 1 2. 9. 3 .
9. 3. 1. Ge ner al C o nsi der ati o ns
C Is f or all e n d p oi nts i n t he statistical a nalys is will be prese nte d as 2-si de d at t he 9 5 % le vel 
u nless s pecifie d ot her wise.
T he safet y a nal ys es are base d o n t he safet y p o p ulati o n. Partici pa nts will be s u m marize d b y  
vacci ne gr o u p acc or di n g t o t he st u d y  i nter ve nti o ns t he y act ually recei ve d. C o m pletel y  
missi n g react o ge nicit y e -diar y  data will n ot be i m p ute d; missi n g A E dates will be ha n dle d 
acc or di n g t o t he Pfizer safet y r ules. M issi n g e-diar y  data n ot rec or de d i n t he e-diar y will be 
rec or de d o n t he A E C R F . T heref ore, t he pri mar y  a nalys is will use react o ge nicit y rec or de d as 
A Es i n t he C R F t o i m p ute t he missi n g e- diar y  data.
F or all t he i m m u n o ge nicit y  e n d p oi nts, t he a nal ysis will be base d o n t he e val ua ble 
i m m u n o ge nicity p o p ulati o n. A nti b o d y  titers bel o w t he L L O Q or de n ote d as B L Q will be set 
t o 0. 5 × L L O Q f or i m m u n o ge nicit y a nal ys is.  N o ot her missi n g assa y data will be i m p ute d i n 
t he a nalys es.  All i m m u n o ge nicit y a nalys es will be perf or me d after t he i m p utati o n of t he 
a nti b o d y c o nce ntrati o ns or a nti b o d y titers t hat are bel o w t he L L O Q.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 4
A n a d diti o nal a nal ys is ma y be perf or me d base d o n t he mIT T i m m u n o ge nicit y p o p ulati o n if 
t here is a lar ge e n o u g h differe nce i n sa m ple size bet wee n t he mI T T i m m u n o ge nicit y 
p o p ulati o n a n d t he e val ua ble i m m u n o ge nicit y  p o p ulati o n. Partici pa nts will be s u m marize d 
acc or di n g t o t he vacci ne gr o u p t o w hic h t he y  were ra n d o mize d.  Missi n g ser ol o g y data will 
n ot be i m p ute d.
9. 3. 1. 1. A n al yses f or Bi n ar y D at a
Descri pti ve statistics f or bi nar y  varia bles (e g, pr o p orti o ns) are t he perce nta ge ( %), t he 
n u merat or ( n) a n d t he de n o mi nat or ( N) use d i n t he perce nta ge calc ulati o n, a n d t he 9 5 % C Is 
w here a p plica ble.
T he e xact 9 5 % CI s f or bi nar y e n d p oi nts f or eac h gr o u p will be c o m p ute d usi n g t he 
F distri b uti o n ( Cl o p per -Pears o n).
9. 3. 1. 2. A n al yses f or C o nti n u o us D at a
U nless ot her wise state d, descri pti ve statistics f or c o nti n u o us varia bles are n, mea n, me dia n, 
sta n dar d de viati o n, mi ni m u m, a n d ma xi m u m.
9. 3. 1. 2. 1. Ge o metric Me a n Titers
T he G M Ts will be calc ulate d as t he mea n of t he assa y  res ults after ma ki n g t he l o garit h m 
tra nsf or mati o n a n d t he n e x p o ne ntiati n g t he mea n t o e x press res ults o n t he ori gi nal scale.
T w o -si de d 9 5 % CIs will be o btai ne d b y ta ki n g l o g tra nsf or ms of assa y res ults, calc ulati n g t he 
9 5 % CI  wit h refere nce t o t he St u de nt t distri b uti o n, a n d t he n e x p o ne ntiati n g t he c o nfi de nce 
li mits.
9. 3. 1. 2. 2. Ge o metric Me a n F ol d Rises
F ol d rises are defi ne d as rati os of t he res ults after vacci nati o n t o t he res ults bef ore 
vacci nati o n. T he calc ulati o ns of f ol d rises are li mite d t o partici pa nts wit h n o n missi n g val ues 
at b ot h ti me p oi nts.
G M F Rs will be calc ulate d as t he mea n of t he differe nce of l o garit h micall y t ra nsf or me d assa y 
res ults (later ti me p oi nt mi n us earlier ti me p oi nt) a n d e x p o ne ntiati n g t he mea n. T he 
ass ociate d 2-si de d 9 5 % CIs will be o btai ne d by c o nstr ucti n g C Is usi n g t he St u de nt
t distri b uti o n f or t he mea n differe nce o n t he l o garit h m scale a n d e x p o ne ntiati n g t he 
c o nfi de nce li mits.
9. 3. 1. 2. 3. Re verse C u m ul ati ve Distri b uti o n C ur ve s
E m pirical R C D Cs will pl ot pr o p orti o n s of partici pa nts wit h val ues e q ual t o or e xcee di n g a 
s pecifie d assa y val ue vers us t he i n dicate d assa y val ue, f or all o bser ve d assa y val ues.  Data 
p oi nts will be j oi ne d b y  a ste p f u ncti o n wit h t he li ne first g oi n g d o w n a n d t he n t o t he ri g ht t o 
t he ne xt assa y val ue.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 5
9. 4. I nteri m A n al yses
Details f or i nteri m a nal y ses will be pr o vi de d i n Secti o n 1 0. 1 1. 9. 4 f or S u bst u d y A a n d
Secti o n 1 0. 1 2. 9. 4 f or S u bst u d y B.
9. 5. S a m ple Size Deter mi n ati o n
Refer t o Secti o n 1 0. 1 1. 9. 5 f or sa m ple size deter mi nati o n relate d t o S u bst u d y A.
Refer t o Secti o n 1 0. 1 2. 9. 6 f or sa m ple size deter mi nati o n relate d t o S u bst u d y B.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 6
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L C O N SI D E R A TI O N S
1 0. 1. A p pe n di x 1: Re g ul at or y, Et hic al, a n d St u d y O versi g ht C o nsi der ati o ns
1 0. 1. 1. Re g ul at or y a n d Et hic al C o nsi der ati o ns
T his st u d y  will be c o n d ucte d i n acc or da nce wit h t he pr ot oc ol a n d wit h t he f oll o wi n g:

C o nse ns us et hical pri nci ples deri ve d fr o m i nter nati o nal g ui deli nes , i ncl u di n g t he 
Declarati o n of Helsi n ki a n d CI O M S I nter nati o nal Et hical G ui de li nes;

A p plica ble I C H G C P g ui deli nes ;

A p plica ble la ws a n d re g ulati o ns , i ncl u di n g a p plica ble pri vac y la ws.
T he pr ot oc ol, pr ot oc ol a me n d me nts, I C D, S R S D(s) , a n d ot her rele va nt d oc u me nts 
(e g, a d vertise me nts) m ust be re vie we d a n d a p pr o ve d b y t he s p o ns or, s u b mitte d t o a n IR B/ E C 
b y  t he i n vesti gat or, a n d re vie we d a n d a p pr o ve d b y  t he I R B/ E C bef ore t he st u d y is i nitiate d.
A n y  a me n d me nts t o t he pr ot oc ol will re q uire I R B/ E C a p pr o val bef ore i m ple me ntati o n of 
c ha n ges ma de t o t he st u d y desi g n, e xce pt f or c ha n ges necessar y  t o eli mi nate a n i m me diate 
hazar d t o st u d y  partici pa nts.
Pr ot oc ols a n d a n y s u bsta ntial a me n d me nts t o t he pr ot oc ol will re q uire healt h a ut h orit y  
a p pr o val pri or t o i nitiati o n e xce pt f or c ha n ges necessar y t o eli mi nate a n i m me diate hazar d t o 
st u d y partici pa nts.
T he i n vesti gat or will be res p o nsi ble f or t he f oll o wi n g:

Pr o vi di n g writte n s u m maries of t he stat us of t he st u d y  t o t he I R B/ E C a n n uall y or 
m ore fre q ue ntl y  i n acc or da nce wit h t he re q uire me nts, p olicies, a n d pr oce d ures 
esta blis he d b y t he I R B/ E C;

N ot if yi n g t he I R B/ E C of S A Es or ot her si g nifica nt safety fi n di n gs as re q uire d b y 
I RB/ E C pr oce d ures ;

Pr o vi di n g o versi g ht of t he c o n d uct of t he st u d y at t he site a n d a d here nce t o 
re q uire me nts of 2 1 C F R, I C H G C P g ui deli nes, t he I R B/ E C, E ur o pea n R e g ulati o n 
5 3 6/ 2 0 1 4 f or cli nical st u dies, E ur o pea n M D R 2 0 1 7/ 7 4 5 f or cli nical de vice researc h, 
a n d all ot her a p plica ble l ocal re g ulati o ns .
1 0. 1. 1. 1. Re p orti n g of S afet y Iss ues a n d Seri o us Bre a c hes of t he Pr ot oc ol or I C H G C P
I n t he e ve nt of a ny pr o hi biti o n or restricti o n i m p ose d (ie, cli nical h ol d) b y a n a p plica ble 
re g ulat or y a ut h ority i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n t hat mi g ht i nfl ue nce t he e val uati o n of t he be nefits a n d ris ks of t he st u d y 
i nter ve nti o n, Pfizer s h o ul d be i nf or me d i m me diatel y.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 7
I n a d diti o n, t he i n vesti gat or will i nf or m Pfizer i m me diatel y of a n y ur ge nt safety meas ures 
ta ke n by t he i n vesti gat or t o pr otect t he st u d y partici pa nt s a gai nst a ny i m me diate hazar d, a n d 
of a n y seri o us breac hes of t his pr ot oc ol or of t he I C H G C P g ui del i nes t hat t he i n vesti gat or 
bec o mes a ware of.
1 0. 1. 2. Fi n a nci al Discl os ure
I n vesti gat ors a n d s u bi n vesti gat ors will pr o vi de t he s p o ns or wit h s ufficie nt, acc urate fi na ncial 
i nf or mati o n as re q ueste d t o all o w t he s p o ns or t o s u b mit c o m plete a n d acc urate fi na ncial 
certificati o n or discl os ure state me nts t o t he a p pr o priate re g ulat or y a ut h orities. I nvesti gat ors 
are res p o nsi ble f or pr o vi di n g i nf or mati o n o n fi na ncial i nterests d uri n g t he c o urse of t he st u d y 
a n d f or 1 ye ar after c o m pleti o n of t he st u d y .
1 0. 1. 3. I nf or me d C o nse nt Pr ocess
T he i n vesti gat or or t he i n vesti gat or’s re prese ntati ve will e x plai n t he nat ure of t he st u d y, 
i ncl u di n g t he ris ks a n d be nefits, t o t he partici pa nt a n d a ns wer all q uesti o ns re gar di n g t he 
st u d y. T he partici pa nt s h o ul d be gi ve n s ufficie nt ti me a n d o p p ort u nit y  t o as k q uesti o ns a n d 
t o deci de w het her or n ot t o partici pate i n t he trial.
Partici pa nts m ust be i nf or me d t hat t heir partici pati o n is v ol u ntar y . Partici pa nts will be 
re q uire d t o si g n a state me nt of i nf or me d c o nse nt t hat meets t he re q uire me nts of 2 1 C F R 5 0, 
l ocal re g ulati o ns, I C H g ui deli nes, pri vac y  a n d data pr otecti o n re q uire me nts, w here 
a p plica ble, a n d t he I R B/ E C or st u d y  ce nter.
T he i n vesti gat or m ust e ns ure t hat eac h partici pa nt is f ull y i nf or me d a b o ut t he nat ure a n d 
o bjecti ves of t he st u d y, the s hari n g of data relate d t o t he st u d y, a n d p ossi ble ris ks ass ociate d 
wit h partici pati o n, i ncl u di n g t he ris ks ass ociate d wit h t he pr ocessi n g of t he partici pa nt ’s 
pers o nal data.
T he partici pa nt m ust be i nf or me d t hat t heir pers o nal st u d y -relate d data will be use d b y t he 
s p o ns or i n acc or da nce wit h l ocal data pr otecti o n la w. T he le vel of discl os ure m ust als o be 
e x plai ne d t o t he partici pa nt.
T he partici pa nt m ust be i nf or me d t hat t heir me dical rec or ds ma y  be e xa mi ne d b y Cli nical 
Q ualit y  Ass ura nce a u dit ors or other a ut h orize d pers o n nel a p p oi nte d b y  t he s p o ns or, b y 
a p pr o priate I RB/ E C me m bers, a n d b y i ns pect ors fr o m re g ulat or y a ut h orities.
T he i n vesti gat or f urt her m ust e ns ure t hat eac h st u d y  partici pa nt is f ull y i nf or me d a b o ut t heir
ri g ht t o access a n d c orrect t heir pers o nal data a n d t o wit h dra w c o nse nt f or t he pr ocessi n g of 
t heir pers o nal data.
T he me dical rec or d m ust i ncl u de a state me nt t hat writte n i nf or me d c o nse nt was o btai ne d 
bef ore t he partici pa nt was e nr olle d i n t he st u d y  a n d t he date o n w hic h t he writte n c o nse nt was 
o btai ne d. T he a ut h orize d pers o n o btai ni n g t he i nf or me d c o nse nt m ust als o si g n t he I C D.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 8
Partici pa nts m ust be rec o nse nte d t o t he m ost c urre nt versi o n of t he I R B/ E C-a p pr o ve d I CD (s) 
d uri n g t heir partici pati o n i n t he st u d y as re q uire d per l ocal re g ul ati o ns.
A c o p y of t he I C D (s) m ust be pr o vi de d t o t he partici pa nt.
Partici pa nts w h o are rescree ne d are re q uire d t o si g n a ne w I C D.
1 0. 1. 3. 1. Electr o nic C o nse nt
Partici pa nts ma y  be a ble t o e x perie nce t he i nf or me d c o nse nt pr ocess b y electr o nic mea ns 
(e C o nse nt). T he e C o nse nt pr ocess i ncl u des a n electr o nic prese ntati o n of t he I CD (eIC D), 
cli nical trial e d ucati o nal c o m p o ne nts (as a p plica ble), a n d electr o nic si g nat ures (if all o we d b y 
l ocal re g ulati o ns). T he use of e C o nse nt d oes n ot re place or alter t he I C D c o nte nt o r i nf or me d 
c o nse nt pr ocess as descri be d a b o ve. T he e C o nse nt pr ocess c o m plies wit h a p plica ble 
re g ulati o ns a n d s p o ns or p olicies t o e ns ure relia bilit y a n d data pri vac y. 
1 0. 1. 4. D at a Pr otecti o n
All parties will c o m pl y  wit h all a p plica ble la ws, i ncl u di n g la ws re gar di n g t he i m ple me ntati o n 
of or ga nizati o nal a n d tec h nical meas ures t o e ns ure pr otecti o n of partici pa nt data.
Partici pa nts ’ pers o nal data will be st ore d at t he st u d y  site i n e ncr ypte d electr o nic a n d/ or pa per
f or m a n d will be pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o e ns ure t hat o nl y 
a ut h orize d st u d y staff ha ve access. T he st u d y site will i m ple me nt a p pr o priate tec h nical a n d 
or ga nizati o nal meas ures t o e ns ure t hat t he pers o nal data ca n be rec o vere d i n t he e ve nt of 
disaster. I n the e ve nt of a p ote ntial pers o nal data breac h, t he st u d y site will be res p o nsi ble f or 
deter mi ni n g w het her a pers o nal data breac h has i n fact occ urre d a n d, if s o, pr o vi di n g breac h 
n otificati o ns as re q uire d b y  la w.
To  pr otect t he ri g hts a n d free d o ms of partic i pa nts wit h re gar d t o t he pr ocessi n g of pers o nal 
data, partici pa nts will be assi g ne d a si n gle, partici pa nt -s pecific n u merical c o de. A n y 
partici pa nt rec or ds or data sets t hat are tra nsferre d t o t he s p o ns or will c o ntai n t he n u merical 
c o de; partici pa nt na mes will n ot be tra nsferre d. All ot her i de ntifia ble data tra nsferre d t o t he 
s p o ns or will be i de ntifie d b y t his si n gle, partici pa nt -s pecific c o de. T he st u d y  site will 
mai ntai n a c o nfi de ntial list of partici pa nt s w h o partici pate d i n t he st u d y, li n ki n g eac h 
pa rtici pa nt’s n u merical c o de t o t heir act ual i de ntit y a n d me dical rec or d I D. I n case of data 
tra nsfer, t he s p o ns or will pr otect t he c o nfi de ntialit y of partici pa nt s’ pers o nal data c o nsiste nt 
wit h t he c li nical st u d y agree me nt a n d a p plica ble pri vac y  la ws.
I nf or mati o n tec h n ol o g y s yste ms use d t o c ollect, pr ocess, a n d st ore st u d y-relate d data are 
sec ure d by t ec h nical a n d or ga nizati o nal sec urit y m eas ures desi g ne d t o pr otect s uc h data 
a gai nst acci de ntal or u nla wf ul l oss, alterati o n, or u na ut h orize d discl os ure or acc ess.
T he s p o ns or mai ntai ns S O Ps o n h o w t o res p o n d i n t he e ve nt of u na ut h orize d access, use, or 
discl os ure of s p o ns or i nf or mati o n or s y ste ms.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 8 9
1 0. 1. 5. C o m mittees Str uct ure
1 0. 1. 5. 1. D at a M o nit ori n g C o m mittee
S u bst u d ies A a n d B will use a n I R C . T he I R C is i n de pe n de nt of t he st u dy t ea m a n d i ncl u des 
o nl y  i nter nal me m bers. T he I RC c harter descri bes t he r ole of t he I R C i n m ore detail.
T he I RC will be res p o nsi ble f or o n g oi n g m o nit ori n g of t he safet y of partici pa nts i n t he st u d y  
acc or di n g t o t he c harter. T h e rec o m me n dati o ns ma de b y t he I R C will be f or war de d t o t he 
a p pr o priate a ut h orize d Pfizer pers o n nel f or re view a n d fi nal decisi o n. Pfizer will 
c o m m u nicate s uc h decisi o ns, w hic h ma y i ncl u de s u m maries of a g gre gate a nal yses of safety 
data, t o re g ulat or y  a ut h orities a n d i n vesti gat ors, as a p pr o priate.
T he res p o nsi bilities of t he I R C will i ncl u de at a mi ni m u m:

Re vie w of safet y data i n t he case of a st o p pi n g r ule bei n g met i n S u bst u d y  A a n d 
S u bst u d y  B.

Re vie w of safet y data a n d i m m u n o ge nicit y acc u m ulate d f or at least 4 wee k s f oll o wi n g 
vacci nati o n i n S u bst u d y A a n d S u bst u d y  B.
1 0. 1. 6. Disse mi n ati o n of Cli nic al St u d y D at a
Pfizer f ulfills its c o m mit me nt t o p u blicl y  discl ose cli nical st u d y res ults t hr o u g h p osti n g t he 
res ults of st u dies o n w w w .cli nicaltrials. g o v ( Cli nical Trials. g o v), t he E u dra C T/ C TIS , a n d/ or 
w w w . pfizer.c o m, a n d ot her p u blic re gistries a n d we bsites i n acc or da nce wit h a p plica ble l ocal 
la ws/re g ulati o ns. I n a d diti o n, Pfizer re p orts st u d y res ults o utsi de of t he re q uire me nts of l ocal 
la ws/re g ulati o ns p urs ua nt t o its S O Ps.
I n all cases, st u dy res ults are re p orte d b y Pfizer i n a n o bjecti ve, acc urate, bala nce d, a n d 
c o m plete ma n ner a n d are re p orte d re gar dless of t h e o utc o me of t he st u d y or t he c o u ntr y i n 
w hic h t he st u d y  was c o n d ucte d.
w w w.cli nicaltrials. g o v
Pfizer p osts cli nical trial res ults o n w w w .cli nicaltrials. g o v f or Pfizer-s p o ns ore d i nter ve nti o nal 
st u dies (c o n d ucte d i n patie nts) t hat e val uate t he safet y a n d/ or efficac y of a pr o d uct, 
re gar dless of t he ge o gra p hical l ocati o n i n w hic h t he st u d y is c o n d ucte d. T hese r es ults are 
s u b mitte d f or p osti n g i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y U S la w.
E u dra C T / C TIS
Pfizer p osts cli nical trial res ults o n E u dra C T / C TIS f or Pfizer-s p o ns ore d i nter ve nti o nal st u dies 
i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y E U re q uire me nts.
w w w. pfizer.c o m
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 0
Pfizer p osts C S R s y n o p ses a n d plai n-la n g ua ge st u d y res ults s u m maries o n w w w . pfizer.c o m
f or Pfizer-s p o ns ore d i nter ve nti o nal st u dies at t he sa me ti me t he c orres p o n di n g st u d y res ults 
are p oste d t o w w w.cli nicaltrials . g o v. C S R s y n o pses will ha ve pers o nall y  i de ntifia ble 
i nf or mati o n a n o ny m ize d.
D oc u me nts wit hi n mar keti n g a p plicati o ns
Pfizer c o m plies wit h a p plica ble l ocal la ws/re g ulati o ns t o p u blis h cli nical d oc u me nts i ncl u de d 
i n mar keti n g a p plicati o ns. Cli nical d oc u me nts i ncl u de s u m mar y  d oc u me nts a n d C S Rs 
i ncl u di n g t he pr ot oc ol a n d pr ot oc ol a me n d me nts, sa m ple C R Fs, a n d S A P s. Cli nical 
d oc u me nts will ha ve per s o nall y i de ntifia ble i nf or mati o n a n o n ymize d.
Data shari n g
Pfizer pr o vi des researc hers sec ure access t o partici pa nt -le vel data or f ull C S Rs f or t he 
p ur p oses of “b o na -fi de scie ntific researc h” t hat c o ntri b utes t o t he scie ntific u n dersta n di n g of 
t he disease, tar get, or c o m p o u n d class. Pfizer will ma ke data fr o m t hese trials a vaila ble 
2 4 m o nt hs after st u d y  c o m pleti o n. Partici pa nt -le vel data will be a n o ny m ize d i n acc or da nce 
wit h a p plica ble pri vac y  la ws a n d re g ulati o ns. C S Rs will ha ve pers o nall y i de ntifia ble 
i nf or mati o n a n o n y m ize d.
Data re q uests are c o nsi dere d fr o m q ualifie d researc hers wit h t he a p pr o priate c o m pete ncies t o 
perf or m t he pr o p ose d a nal y ses. Researc h tea ms m ust i ncl u de a bi ostatisticia n. Data will n ot 
be pr o vi de d t o a p plica nts wit h si g nifica nt c o nflicts of i nterest, i ncl u di n g i n di vi d uals 
re q uesti n g access f or c o m mercial/c o m petiti ve or le gal p ur p oses.
1 0. 1. 7. D at a Q u alit y Ass ur a nce
All partici pa nt data relati n g t o t he st u d y will be rec or de d o n pri nte d or elec tr o nic C R F u nless 
tra ns mitte d t o t he s p o ns or or desi g nee electr o nicall y (e g, la b orat or y data). T he i n vesti gat or is 
res p o nsi ble f or verif yi n g t hat data e ntries are acc urate a n d c orrect b y p h ysicall y or 
electr o nicall y si g ni n g t he C R F.
G ui da nce o n c o m pleti o n of C R Fs will be pr o vi de d i n t he C R F C o m pleti o n Re q uire me nts 
d oc u me nt .
T he i n vesti gat or m ust e ns ure t hat t he C R Fs are sec urel y st ore d at t he st u d y site i n e ncr ypte d 
electr o nic a n d/ or pa per f or m a n d are pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o 
pre ve nt access b y u na ut h orize d t hir d parties.
Q T L s are pre defi ne d para meters t hat are m o nit ore d d uri n g t he st u d y . I m p orta nt de viati o ns 
fr o m t he Q T Ls a n d a n y re me dial acti o ns ta ke n will be s u m marize d i n t he C S R .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 1
T he i n vesti gat or m ust per mit st u d y-relate d m o nit ori n g, a u dits, I R B/ E C re vie w, a n d 
re g ulat or y a ge nc y i ns pecti o ns a n d pr o vi de direct access t o s o urce rec or ds a n d d oc u me nts.
T his verificati o n ma y  als o occ ur after st u d y c o m pleti o n. It is i m p orta nt t hat t he 
i n vesti gat or(s) a n d t heir rele va nt pers o nnel are a vaila ble d uri n g t he m o nit ori n g visits a n d 
p ossi ble a u dits or i ns pecti o ns a n d t hat s uf ficie nt ti me is de v ote d t o t he pr ocess.
M o nit ori n g details descri bi n g strate g y , i ncl u di n g defi niti o n of st u d y-critical data ite ms a n d 
pr ocesses (e g, -ris k-base d i nitiati ves i n o perati o ns a n d q ualit y s uc h as ris k m a na ge me nt a n d 
m iti gati o n strate gies a n d anal yt ical ris k- base d m o nit ori n g), met h o ds, res p o nsi bilities , a n d 
re q uire me nts, i ncl u di n g ha n dli n g of n o nc o m plia nce iss ues a n d m o nit ori n g tec h ni q ues 
(ce ntral, virt ual , or o n-site m o nit ori n g), are pr o vi de d i n t he data ma na ge me nt pla n a n d 
m o nit ori n g p la n mai ntai ne d a n d utilize d b y  t he s p o ns or or desi g nee.
T he s p o ns or or desi g nee is res p o nsi ble f or t he data ma na ge me nt of t his st u d y , i ncl u di n g 
q ualit y  c hec ki n g of t he data.
Rec or ds a n d d oc u me nts, i ncl u di n g si g ne d I C D s, pertai ni n g t o t he c o n d uct of t his st u d y m ust 
be retai ne d b y t he i n vesti gat or f or 1 5 ye ars after st u d y c o m pleti o n u nless l ocal re g ulati o ns or 
i nstit uti o nal p olicies re q uire a l o n ger rete nti o n peri o d. N o rec or ds ma y  be destr o ye d d uri n g 
t he rete nti o n peri o d wit h o ut t he writte n a p pr o val of t he s p o ns or. N o rec or ds ma y  be 
tra nsferre d t o a n ot her l ocati o n or party wit h o ut writte n n otificati o n t o t he s p o ns or . T he 
i n vesti gat or must e ns ure t hat t he rec or ds c o nti n ue t o be st ore d sec urel y f or as l o n g as t he y are 
mai ntai ne d.
W he n partici pa nt data are t o be delete d, t he i n vesti gat or will e ns ure t hat all c o pies of s uc h 
data are pr o m ptl y  a n d irre v oca bly delete d fr o m all s yste ms.
T he i n v esti gat or(s) will n otif y t he s p o ns or or its a ge nts i m me diatel y of a n y re g ulat or y 
i ns pecti o n n otificati o n i n relati o n t o t he st u d y. F urt her m ore, t he i n vesti gat or will c o o perate 
wit h t he s p o ns or or its a ge nts t o pre pare t he i n vesti gat or site f or t he i ns pecti o n a n d will all o w 
t he s p o ns or or its a ge nt, w he ne ver feasi ble, t o be prese nt d uri n g t he i ns pecti o n. T he 
i n vesti gat or site a n d i n vesti gat or will pr o m ptl y res ol ve a n y discre pa ncies t hat are i de ntifie d 
bet wee n t he st u d y data a n d t he partici pa nt ’s me dical rec or ds. T he i n vesti gat or will pr o m ptl y  
pr o vi de c o pies of t he i ns pecti o n fi n di n gs t o t he s p o ns or or its a ge nt. Bef ore res p o nse 
s u b missi o n t o t he re g ulat or y a ut h orities, t he i n vesti gat or will pr o vi de t he s p o ns or or its 
a ge nts wit h a n o p p ort u nit y t o re vie w a n d c o m me nt o n res p o nses t o a n y s uc h fi n di n gs.
1 0. 1. 8. S o urce D oc u me nts
S o urce d oc u me nts pr o vi de e vi de nce f or t he e xiste nce of t he partici pa nt a n d s u bsta ntiate t he 
i nte grity of t he data c ollecte d. S o urce d oc u me nt s are file d at t he i n vesti gat or site.
Da ta re p orte d o n t he C R F or e ntere d i n t he e C R F t hat are fr o m s o urce d oc u me nts m ust be 
c o nsiste nt wit h t he s o urce d oc u me nts or t he discre pa ncies m ust be e x plai ne d . T he 
i n vesti gat or ma y nee d t o re q uest pre vi o us me dical rec or ds or tra nsfer rec or ds, de pe n di n g o n 
t he st u d y. Als o, c urre nt me dical rec or ds m ust be a vaila ble.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 2
Defi niti o n of w hat c o nstit utes s o urce data a n d its ori gi n ca n be f o u n d i n t he S o urce 
D oc u me nt L ocat or , w hic h is mai ntai ne d b y t he s p o ns or.
Descri pti o n of t he use of t he c o m p uterize d s yste m is d oc u me nte d i n t he d ata m a na ge me nt 
p la n, w hic h is mai ntai ne d b y t he s p o ns or.
T he i n vesti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce data) t hat s u p p orts t he 
i nf or mati o n e ntere d i n t he C R F.
T he s p o ns or or desi g nee will perf or m m o nit ori n g t o c o nfir m t hat data e ntere d i nt o t he C R F 
b y  a ut h orize d site pers o n nel are acc urate, c o m plete, a n d verifia ble fr o m s o urce d oc u me nts; 
t hat t he safety a n d ri g hts of partici pa nts are bei n g pr otecte d; a n d t hat t he st u d y is bei n g 
c o n d ucte d i n acc or da nce wit h t he c urre ntl y a p pr o ve d pr ot oc ol a n d a n y  ot her st u d y 
a gree me nts, IC H G C P g ui deli nes , a n d all a p plica ble re g ulat or y re q uire me nts.
1 0. 1. 9. St u d y a n d Site St art a n d Cl os ure
T he st u d y  start date is t he date of t he first partici pa nt’s first visit.
T he s p o ns or desi g nee reser ves t he ri g h t t o cl ose t he st u d y site or ter mi nate t he st u d y at a n y 
ti me f or a ny reas o n at t he s ole discreti o n of t he s p o ns or , i ncl u di n g ( b ut n ot li mite d t o) 
re g ulat or y a ut h ority decisi o n, c ha n ge i n o pi ni o n of t he I R B/ E C, or c ha n ge i n be nefit -ris k 
assess me nt . St u d y  sites will be cl ose d u p o n st u d y c o m pleti o n. A st u d y site is c o nsi dere d 
cl ose d w he n all re q uire d d oc u me nts a n d st u d y  s u p plies ha ve bee n c ollecte d a n d a st u d y-site 
cl os ure visit has bee n perf or me d.
T he i n vesti gat or ma y  i nitiate st u d y-site cl os ure at an y  ti me u p o n n otificati o n t o t he s p o ns or 
or desi g nee/ C R O if re q ueste d t o d o s o b y t he res p o nsi ble IR B/ E C or if s uc h ter mi nati o n is 
re q uire d t o pr otect t he healt h of st u d y partici pa nts.
Reas o ns f or t he earl y cl os ure of a st u d y site b y t he s p o ns or ma y i ncl u d e b ut are n ot li mite d 
t o:

Fail ure of t he i n vesti gat or t o c o m pl y  wit h t he pr ot oc ol, t he re q uire me nts of t he 
I RB/ E C or l ocal healt h a ut h orities, t he s p o ns or ’s pr oce d ures, or t he I CH G C P 
g ui deli nes ;

I na de q uate recr uit me nt of partici pa nts b y  t he i n vesti gat or;

Disc o nti n uati o n of f urt her st u d y  i nter ve nti o n de vel o p me nt.
If t he st u dy is pre mat urel y ter mi nate d or s us pe n de d, t he s p o ns or s hall pr o m ptl y i nf or m t he 
in vesti gat ors, t he E Cs /IR Bs, t he re g ulat or y  a ut h orities, a n d a n y C R O (s) use d i n t he st u d y of 
t he reas o n for ter mi nati o n or s us pe nsi o n, as s pecifie d b y  t he a p plica ble re g ulat or y 
re q uire me nts. T he in vesti gat or s hall pr o m ptl y  i nf or m t he partici pa nt a n d s h o ul d ass ure 
a p pr o priate partici pa nt t hera p y a n d/ or f oll o w- u p.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 3
St u d y  ter mi nati o n is als o pr o vi de d f or i n t he cli nical st u d y a gree me nt. If t here is a ny c o nflict 
bet wee n t he c o ntract a n d t his pr ot oc ol, t he c o ntract will c o ntr ol as t o ter mi nati o n ri g hts.
1 0. 1. 1 0. P u blic ati o n P olic y
F or m ultice nter trials, t he pri mar y  p u blicati o n will be a j oi nt p u blicati o n de vel o pe d b y t he 
i n vesti gat or a n d Pfizer re p orti n g t he pri mar y e n d p oi nt(s) of t he st u d y c o veri n g all st u d y sites. 
T he i n vesti gat or a grees t o refer t o t he pri mar y  p u blicati o n i n a n y s u bse q ue nt p u blicati o ns. 
Pfizer will n ot pr o vi de a n y fi na ncial c o m pe nsati o n f or t he i n vesti gat or’s partici pati o n i n t he 
pre parati o n of t he pri mar y c o n gress a bstract, p oster, prese ntati o n, or pri mar y ma n uscri pt f or 
t he st u d y.
I n vesti gat ors are free t o p u blis h i n di vi d ual ce nter res ults t hat t he y dee m t o be cli nicall y 
mea ni n gf ul after p u blicati o n of t he o verall res ults of t he st u d y  or 1 2 m o nt hs after pri mar y 
c o m pleti o n date or st u d y c o m pleti o n at all sites, w hic he ver occ urs first, s u bject t o t he ot her 
re q uire me nts descri be d i n t his secti o n.
T he i n vesti g at or will pr o vi de Pfizer a n o p p ort u nit y  t o re vie w a n y pr o p ose d p u blicati o n or 
a n y ot her ty pe of discl os ure of t he st u d y res ults (c ollecti vel y, “ p u blicati o n”) bef ore it is 
s u b mitte d or ot her wise discl ose d a n d will s u b mit all p u blicati o ns t o Pfizer 3 0 da y s bef ore 
s u b missi o n. If a ny pate nt acti o n is re q uire d t o pr otect i ntellect ual pr o pert y ri g hts, t he 
i n vesti gat or a grees t o dela y t he discl os ure f or a peri o d n ot t o e xcee d a n a d diti o nal 6 0 da ys 
u p o n re q uest fr o m Pfizer. T his all o ws Pfizer t o pr otect pr o prieta r y i nf or mati o n a n d t o 
pr o vi de c o m me nts, a n d t he i n vesti gat or will, o n re q uest, re m o ve a n y pre vi o usl y u n discl ose d 
c o nfi de ntial i nf or mati o n bef ore discl os ure, e xce pt f or a n y st u d y i nter ve nti o n or Pfizer -relate d 
i nf or mati o n necessar y f or t he a p pr o priate scie ntific prese ntati o n or u n dersta n di n g of t he 
st u d y res ults.  F or j oi nt p u blicati o ns, s h o ul d t here be disa gree me nt re gar di n g i nter pretati o n 
a n d/ or prese ntati o n of s pecific a nal ys is res ults, res ol uti o n of, a n d res p o nsi bilit y f or, s uc h 
disa gree me nts will be t he c ollecti ve res p o nsi bilit y of all a ut h ors of t he p u blicati o n.
F or all p u blicati o ns relati n g t o t he st u d y, t he i n vesti gat or a n d Pfizer will c o m pl y wit h 
rec o g nize d et hical sta n dar ds c o ncer ni n g p u blicati o ns a n d a ut h ors hi p, i ncl u di n g t h ose 
esta blis he d b y t he Inter nati o nal C o m mittee of Me dical J o ur nal E dit ors. T he i n vesti gat or will 
discl ose a n y relati o ns hi p wit h Pfizer a n d a n y rele va nt p ote ntial c o nflicts of i nterest, i ncl u di n g 
a n y fi na ncial or pers o nal relati o ns hi p wit h Pfizer, i n a n y p u blicati o ns. All a ut h or s will ha ve 
access t o t he rele va nt statistical ta bles, fi g ures, a n d re p orts (i n t heir ori gi nal f or mat) re q uire d 
t o de vel o p t he p u blicati o n .
1 0. 1. 1 1. S p o ns or’s Me dic all y Q u alifie d I n di vi d u al 
T he c o ntact i nf or mati o n f or t he s p o ns or ’s M QI
f or t he st u d y is d oc u me nte d i n t he st u d y 
c o ntact list l ocate d i n t he su p p orti n g st u d y d oc u me ntati o n/st u d y  p ortal or ot her electr o nic 
s yste m.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 4
To  facilitate access t o t heir i n vesti gat or a n d t he s p o ns or’s M QI f or st u d y-relate d me dical 
q uesti o ns or pr o ble ms fr o m n o nst u d y healt hcare pr ofessi o nals, partici pa nts are pr o vi de d wit h 
a n E C C at t he ti me of i nf or me d c o nse nt. T he E C C c o ntai ns, at a mi ni m u m, (a) pr ot oc ol a n d 
st u d y i nter ve nti o n i de ntifiers, ( b) partici pa nt’s st u d y i de ntificati o n n u m ber, (c) site 
e mer ge nc y p h o ne n u m ber acti ve 2 4 h o urs/ da y, 7 da ys per wee k, a n d ( d) Pfizer C all C e nter 
n u m ber.
T he E C C is i nte n de d t o a u g me nt, n ot re place, t he esta blis he d c o m m u nicati o n pat h wa y s 
bet wee n t he partici pa nt a n d t heir i n vesti gat or a n d site staff, a n d bet wee n t he i n vesti gat or a n d 
s p o ns or st u d y tea m. T he E C C is o nl y  t o be use d b y healt hcare pr ofessi o nals n ot i n v ol ve d i n 
t he researc h st u d y, as a mea ns of reac hi n g t he i n vesti gat or or site staff relate d t o t he care of a 
partici pa nt. T he Pfizer Call Ce nter n u m ber is to be use d w he n t he i n vesti gat or a n d site staff 
are u na vaila ble. T he Pfizer Call Ce nter n u m ber is n ot f or use b y  t he partici pa nt directly;  if a 
partici pa nt calls t hat n u m ber directl y , t he y will be directe d bac k t o t he i n vesti gat or site.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 5
1 0. 2. A p pe n di x 2: Cli nic a l L a b or at or y Tests
T he f oll o wi n g safet y la b orat or y test will be perf or me d at ti mes defi ne d i n Secti o n 1 0. 1 1. 1 f or 
S u bst u d y  A a n d Secti o n 1 0. 1 2. 1 f or S u bst u d y B of t his pr ot oc ol. A d diti o nal la b orat or y  
res ults ma y be re p orte d o n t hese sa m ples as a res ult of t he met h o d of a nal ysis or t he t y pe of 
a nal yz er use d b y t he cli nical la b orat or y, or as deri ve d fr o m calc ulate d val ues. T hese 
a d diti o nal tests w o ul d n ot re q uire a d diti o nal c ollecti o n of bl o o d. U nsc he d ule d cli nical 
la b orat or y meas ure me nts ma y be o btai ne d at an y  ti me d uri n g t he st u dy t o assess a n y 
percei ve d safet y  iss ues.
I n vesti gat ors m ust d oc u me nt t heir re vie w of eac h la b orat or y safety re p ort.
S u bst u d y A a n d S u bst u d y B 
H e m at ol o g y
C he mistr y
N/ A
Car diac tr o p o ni n I
Please refer t o t he la b orat or y  n or mal ra n ges ( pr o vi de d se parately) f or gra di n g scales f or 
a b n or malities.
T he i n vesti gat or m ust re vie w t he la b orat or y  re p ort, d oc u me nt t his re vie w, a n d rec or d a ny 
cli nicall y rele va nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E secti o n of t he C R F .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 6
1 0. 3. A p pe n di x 3: A d v erse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E v al u ati n g, F oll o w - Up, a n d Re p orti n g
1 0. 3. 1. Defi niti o n of A E
A E Defi niti o n

A n A E is a n y u nt o war d me dical occ urre nce i n a patie nt or cli nical st u d y partici pa nt, 
te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n, w het her or n ot c o nsi dere d 
relate d t o t he st u dy i nter ve nti o n.

N ote : A n A E ca n t heref ore be a ny u nfa v ora ble a n d u ni nte n de d si g n (i ncl u di n g a n 
a b n or mal la b orat or y fi n di n g), sy m pt o m, or disease ( ne w or e xacer bate d) te m p orall y  
ass ociate d wit h t he use of st u d y  i nter ve nti o n.
E ve nts Meeti n g
t he A E Defi niti o n

A n y  a b n or mal la b orat or y test res ults ( he mat ol o g y, cli nical c he mistr y, or uri nal ysis) 
or ot her safet y assess me nts (e g, E C G, ra di ol o gical sca ns, vital si g n meas ure me nts), 
i ncl u di n g t h ose t hat w orse n fr o m baseli ne, c o nsi dere d cli nicall y si g nifica nt i n t he 
me dical a n d scie ntific j u d g me nt of t he i n vesti gat or . A n y a b n or mal la b orat or y test 
res ults t hat meet a ny of t he c o n diti o ns bel o w m ust be rec or de d as a n A E:

Is ass ociate d wit h acc o m pa n yi n g s ym pt o ms .

Re q uires a d diti o nal dia g n ostic testi n g or me dical/s ur gical i nter ve nti o n .

Lea ds t o a c ha n ge i n st u d y  d osi n g ( o utsi de of a n y pr ot oc ol-s pecifie d d ose 
a dj ust me nts) or disc o nti n uati o n fr o m t he st u d y , si g nifica nt a d diti o nal 
c o nc o mita nt dr u g treat me nt, or ot her t hera p y.

E xacer bati o n of a c hr o nic or i nter mitte nt pree xisti n g c o n diti o n, i ncl u di n g a n 
i ncrease i n eit her fre q ue nc y a n d/ or i nte nsit y of t he c o n diti o n.

Ne w c o n diti o n detecte d or dia g n ose d after st u d y i nter ve nti o n a d mi nistrati o n , e ve n 
t h o u g h it ma y ha ve bee n prese nt bef ore t he start of t he st u d y .

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d dr u g -dr u g i nteracti o n.

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d o ver d ose of eit her st u d y  
i nter ve nti o n or a c o nc o mita nt me dicati o n. O v er d ose per se will n ot be re p orte d as 
a n A E or S A E u nless it is a n i nte nti o nal o ver d ose ta ke n wit h p ossi ble 
s uici dal/self- har mi n g i nte nt. S uc h o ver d oses s h o ul d be re p orte d re gar dless of 
se q uelae.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 7
E ve nts N O T Meeti n g t he A E Defi niti o n

A n y  cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs or ot her a b n or mal safety 
assess me nts t hat are ass ociate d wit h t he u n derl yi n g disease, u nless j u d ge d b y  t he 
i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he partici pa nt’s c o n diti o n.

T he disease/ dis or der bei n g st u die d or e x pecte d pr o gressi o n, si g ns, or s y m pt o ms of 
t he disease/ dis or der bei n g st u die d, u nless m ore se vere t ha n e x pecte d f or t he 
partici pa nt’s c o n diti o n.

Me dical or s ur gical pr oce d ure (e g, e n d osc o p y, a p pe n dect o m y): t he c o n diti o n t hat 
lea ds to t he pr oce d ure is t he A E.

Sit uati o ns i n w hic h a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).

A ntici pate d da y -t o-d a y  fl uct uati o ns of pree xisti n g disease(s) or c o n diti o n(s) prese nt 
or detecte d at t he start of t he st u d y  t hat d o n ot w orse n.
1 0. 3. 2. Defi niti o n of a n S A E
A n S A E is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at a n y d ose , meets o ne or 
m o re of t he criteri a liste d bel o w :
a.
Res ults i n de at h
b.
Is life-t hre ate ni n g
T he ter m “life-t hreate ni n g” i n t he defi niti o n of “seri o us” refers t o a n e ve nt i n w hic h t he 
partici pa nt was at ris k of deat h at t he ti me of t he e ve nt. It d oes n ot refer t o a n e ve nt t hat
h y p ot heticall y  mi g ht ha ve ca use d deat h if it were m ore se vere.
c.
Re q uires i n p atie nt h os pit aliz ati o n or pr ol o n g ati o n of e xisti n g h os pit aliz ati o n
I n ge neral, h os pitalizati o n si g nifies t hat t he partici pa nt has bee n a d mitte d ( us uall y 
i n v ol vi n g at least a n o ver ni g ht sta y) at t he h os pital or e mer ge nc y war d f or o bser vati o n 
a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he p h y sicia n’s office or 
o ut patie nt setti n g. C o m plicati o ns t hat occ ur d uri n g h os pitalizati o n are A Es.
If a 
c o m plicati o n pr ol o n gs h os pitalizati o n or f ulfills a n y ot her seri o us criteria, t he e ve nt is 
seri o us. W he n i n d o u bt as t o w het her “h os pitalizati o n ” occ urre d or was necessar y, t he 
A E s h o ul d be c o nsi dere d seri o us.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 8
H os pitalizati o n f or electi ve treat me nt of a pree xisti n g c o n diti o n t hat di d n ot w orse n 
fr o m baseli ne is n ot c o nsi dere d a n A E.
d.
Res ults i n persiste nt or si g ni fic a nt dis a bilit y/i nc a p acit y

T he ter m disa bilit y mea ns a s u bsta ntial disr u pti o n of a pers o n’s a bilit y  t o c o n d uct 
n or mal life f u ncti o ns.

T his defi niti o n is n ot i nte n de d t o i ncl u de e x perie nces of relati vel y mi n or me dical 
si g nifica nce, s uc h as u nc o m plicate d hea dac he, na usea, v o miti n g, diarr hea, i nfl ue nza, 
a n d acci de ntal tra u ma (e g, s prai ne d a n kle) , t hat ma y  i nterfere wit h or pre ve nt 
e ver yd a y  life f u ncti o ns b ut d o n ot c o nstit ute a s u bsta ntial disr u pti o n.
e.
Is a c o n ge nit al a n o m al y/ birt h defect
f.
Is a s us pecte d tr a ns missi o n vi a a Pfizer pr o d uct of a n i nfecti o us a ge nt, p at h o ge nic 
or n o n p at h o ge nic
T he e ve nt ma y  be s us pecte d fr o m cli nical sy m pt o ms or la b orat or y  fi n di n gs i n dicati n g a n 
i nfecti o n i n a partici pa nt e x p ose d t o a Pfizer pr o d uct. T he ter ms “s us pecte d 
tra ns missi o n” a n d “tra ns missi o n” are c o nsi dere d s yn o n y m o us. T hese cases are 
c o nsi dere d u ne x pecte d a n d ha n dle d as seri o us e x pe dite d cases b y p har mac o vi gila nce 
pers o n nel. S uc h cases are als o c o nsi dere d f or re p orti n g as pr o d uct defects, if 
a p pr o priate.
g.
Ot her sit u ati o ns:

Me dical or scie ntific j u d g me nt s h o ul d be e xercise d b y  t he i n vesti gat or i n deci di n g 
w het her S A E re p orti n g is a p pr o priate i n ot her sit uati o ns, s uc h as si g nifica nt me dical 
e ve nts t hat ma y je o par dize t he partici pa nt or ma y re q uire me dical or s ur gical 
i nter ve nti o n t o pre ve nt o ne of t he ot her o utc o mes liste d i n t he a b o ve defi niti o n.
T hese e ve nts s h o ul d us uall y  be c o nsi dere d seri o us.

E xa m ples of s uc h e ve nts i ncl u de i n vasi ve or mali g na nt ca ncers, i nte nsi ve treat me nt 
i n a n e mer gen c y  r o o m or at h o me f or aller gic br o nc h os pas m, bl o o d d yscrasias or
c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n , or de vel o p me nt of dr u g de pe n de nc y 
or dr u g a b use.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 9 9
1 0. 3. 3. Rec or di n g / Re p orti n g a n d F oll o w - Up of A Es a n d/ or S A E s D uri n g t he Acti ve 
C olle cti o n Peri o d 
A E a n d S A E Rec or di n g / Re p orti n g
T he ta ble bel o w s u m marizes t he re q uire me nts f or rec or di n g A Es o n t he C R F a n d f or 
re p orti n g S A E s o n t he Vacci ne S A E Re p ort F or m t o Pfizer Safet y t hr o u g h o ut t he acti ve 
c ollecti o n peri o d. T hese re q uire me nts are deli neate d f or 3 t y pes of e ve nts: ( 1) S A Es; 
( 2) n o nseri o us A Es ; a n d ( 3) e x p os ure t o t he st u d y i nter ve nti o n u n der st u d y d uri n g 
pre g na nc y  or breastfee di n g, a n d occ u pati o nal e x p os ure.
It s h o ul d be n ote d t hat t he Vacci ne S A E Re p ort F or m f or re p orti n g of S A E i nf or mati o n is 
n ot t he sa me as t he A E pa ge of t he C R F. W he n t he sa me data are c ollecte d, t he f or ms m ust 
be c o m plete d i n a c o nsiste nt ma n ner. A Es s h o ul d be rec or de d usi n g c o ncise me dical 
ter mi n ol o g y a n d t he sa me A E ter m s h o ul d be use d o n b ot h t he C R F a n d t he Vacci ne S A E 
Re p ort F or m f or re p orti n g of S A E i nf or mati o n.
S afet y E ve nt
Rec or de d o n t he C R F
Re p orte d o n t he V acci ne 
S A E Re p ort F or m t o 
Pfizer S afet y Wit hi n 
2 4 H o urs of A w are ness
S A E
All
All
N o nseri o us A E
All
N o ne
E x p os ure t o t he st u d y 
i nter ve nti o n u n der st u d y 
d uri n g pre g na nc y  or 
breastfee di n g 
All A E s or S A Es ass ociate d 
wit h E D P or E D B
N ote: I nsta nces of E D P or 
E D B n ot ass ociate d wit h a n 
A E or S A E are n ot ca pt ure d 
i n t he C R F
All i nsta nces of E D P are 
re p orte d ( w het her or n ot 
t here is a n ass ociate d S A E) *
All i nsta nces of E D B are 
re p orte d ( w het her or n ot 
t here is a n ass ociate d 
S A E) * *
E n vir o n me ntal or 
occ u pati o nal e x p os ure t o 
t he pr o d uct u n der st u dy t o 
a n o n partici pa nt ( n ot 
i n v ol vi n g E D P or E D B)
N o ne. E x p os ure t o a st u d y  
n o n partici pa nt is n ot 
c ollecte d o n t he C R F
T he e x p os ure ( w het her or 
n ot t here is a n ass ociate d 
A E or S A E) m ust be 
re p orte d * * *
*
E D P ( wit h or wit h o ut a n ass ociate d A E or S A E): a n y pre g na nc y i nf or mati o n is re p orte d t o Pfizer 
Safet y usi n g t he Vacci ne S A E Re p ort F or m a n d E D P S u p ple me ntal F or m; if t he E D P is ass ociate d 
wit h a n S A E, t he n t he S A E is re p orte d t o Pfizer Safet y usi n g t he Vacci ne S A E Re p ort F or m .
* * E D B is re p orte d t o Pfizer Safet y usi n g t he Vacci ne S A E Re p ort F or m , w hic h w o ul d als o i ncl u de 
details of a n y S A E t hat mi g ht be ass ociate d w it h t he E D B.
* * * E n vir o n me nt al or o cc u p ati o n al e x p os ure: A E s or S A Es ass ociate d wit h occ u pati o nal e x p os ure are 
re p orte d t o Pfizer Safet y usi n g t he Vacci ne S A E Re p ort F or m .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 0

W he n a n A E
or S A E occ urs, it is t he res p o nsi bilit y  of t he i n vesti gat or t o re vie w all 
d oc u me ntati o n (e g, h os pital pr o gress n otes, la b orat or y  re p orts, a n d dia g n ostic 
re p orts) relate d t o t he e ve nt.

T he i n vesti gat or will t he n rec or d all rele va nt A E or S A E i nf or mati o n i n t he C R F.

It is n ot acce pta ble f or t he i n ves ti gat or t o se n d p h ot oc o pies of t he partici pa nt’s 
me dical rec or ds t o Pfizer Safet y  i n lie u of c o m pleti o n of t he Vacci ne S A E Re p ort 
F or m / A E or S A E C R F pa ge.

T here ma y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are 
re q ueste d by Pfizer Safet y . I n t his case, all partici pa nt i de ntifiers, wit h t he 
e xce pti o n of t he partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he me dical 
rec or ds bef ore s u b missi o n t o Pfizer Safet y .

T he i n vesti gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n si g ns, 
s ym pt o ms, a n d/ or ot her cli nical i nf or mati o n. W he ne ver p ossi ble, t he dia g n osis 
( n ot t he i n di vi d ual si g ns/s ym pt o ms) will be d oc u me nte d as t he A E or S A E.
Assess me nt of I nte nsit y
T he i n vesti gat or will ma ke a n assess me nt of i nte nsit y f or eac h A E a n d S A E re p orte d d uri n g 
t he st u d y a n d assi g n it t o 1 of t he f oll o wi n g cate g ories: 
G R A D E 
If re q uire d o n t he A E pa ge of t he C R F, t he i n vesti gat or will use t he a djecti ves 
MI L D, M O D E R A T E, S E V E R E, or LI F E -T H R E A T E NI N G t o descri be t he 
ma xi m u m i nte nsit y  of t he A E.  F or p ur p oses of c o nsiste nc y , t hese i nte nsit y 
gra des are defi ne d as f oll o ws:
1
MI L D
D oes n ot i nterfere wit h partici pa nt ’s us ual 
f u ncti o n.
2
M O D E R A T E
I nterferes t o s o me e xte nt wit h partici pa nt ’s us ual 
f u ncti o n.
3
S E V E R E
I nterferes si g nifica ntly wit h partici pa nt ’s us ual 
f u ncti o n.
4
LI F E -T H R E A T E NI N G
Life -t hreate ni n g c o nse q ue nces; ur ge nt 
i nter ve nti o n i n dicate d.
A n e ve nt is defi ne d as “seri o us” w he n it meets at least 1 of t he pre defi ne d o utc o mes as 
descri be d i n t he defi niti o n of a n S A E, N O T w he n it is rate d as se vere.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 1
Assess me nt of C a us alit y

T he i n vesti gat or is o bli gate d t o assess t he relati o ns hi p bet wee n st u d y i nter ve nti o n 
a n d eac h occ urre nce of eac h A E or S A E. T he i n vesti gat or will use cli nical 
j u d g me nt t o deter mi ne t he relati o ns hi p.

A “reas o na ble p ossi bilit y” of a relati o ns hi p c o n ve ys t hat t here are facts, e vi de nce, 
a n d/ or ar g u me nts t o s u g gest a ca usal relati o ns hi p, rat her t ha n a relati o ns hi p ca n n ot 
be r ule d o ut.

A lter nati ve ca uses, s uc h as u n derlyi n g disease(s), c o nc o mita nt t hera p y, a n d ot her 
ris k fact ors, as well as t he te m p oral relati o ns hi p of t he e ve nt t o st u d y i nter ve nti o n 
a d mi nistrati o n , will be c o nsi dere d a n d i n vesti gate d.

T he i n vesti gat or will als o c o ns ult t he I B a n d/ or p r o d uct inf or mati o n, f or mar kete d 
pr o d ucts, i n t heir assess me nt.

F or eac h A E or S A E, t he i n vesti gat or m ust d oc u me nt i n t he me dical n otes t hat t he y 
ha ve re vie we d t he A E or S A E a n d ha ve pr o vi de d a n assess me nt of ca usalit y.

T here ma y  be sit uati o ns i n w hic h a n S A E has occ urre d a n d t he i n vesti gat or has 
mi ni mal i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o t he s p o ns or. H o we ver, it is 
ver y i m p ort a nt t h at t he i n vesti g at or al w a ys m a ke a n assess me nt of c a us alit y f or 
e ver y e ve nt b ef ore t he i niti al tr a ns missi o n of t he S A E d at a t o t he s p o ns or.

T he i n vesti gat or ma y  c ha n ge t heir o pi ni o n of ca usalit y  i n li g ht of f oll o w-u p 
i nf or mati o n a n d se n d an S A E f oll o w -u p re p ort wit h t he u p date d ca usalit y  
assess me nt.

T he ca usalit y  assess me nt is o ne of t he criteria use d w he n deter mi ni n g re g ulat or y  
re p orti n g re q uire me nts.

If t he i n vesti gat or d oes n ot k n o w w het her or n ot t he st u d y i nter ve nti o n ca use d t he 
e ve nt, t he n t he e ve nt will be ha n dle d as “relate d t o st u d y i nter ve nti o n” f or re p orti n g 
p ur p oses, as defi ne d b y  t he s p o ns or. I n a d diti o n, if t he i n vesti gat or deter mi nes t hat 
a n S A E is ass ociate d wit h st u d y  pr oce d ures, t he i n vesti gat or m ust rec or d t his ca usal 
relati o ns hi p i n t he s o urce d oc u me nts a n d C R F, a n d re p ort s uc h a n assess me nt i n t he 
de dicate d sect i o n of t he Vacci ne S A E Re p ort F or m a n d i n acc or da nce wit h t he S A E 
re p orti n g re q uire me nts.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 2
F oll o w - Up of A Es a n d S A Es

T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uati o ns, as me dicall y i n dicate d or as re q ueste d b y t he 
s p o ns or, t o el uci date t he nat ure a n d/ or ca usality of t he A E or S A E as f ull y as 
p ossi ble. T his ma y  i ncl u de a d diti o nal la b orat or y tests or i n vesti gati o ns, 
hist o pat h ol o gical e xa mi nati o ns, or c o ns ultati o n wit h ot her healt hcare pr o vi ders .

If a partici pa nt dies d uri n g partici pati o n i n t he st u d y or d uri n g a rec o g nize d 
f oll o w-u p peri o d, t he i n vesti gat or will pr o vi de Pfizer Safet y wit h a c o p y of a n y 
p ost m orte m fi n di n gs , i ncl u di n g hist o pat h ol o g y.

Ne w or u p date d i nf or mat i o n will be rec or de d i n t he ori gi nall y s u b mitte d d oc u me nts.

T he i n vesti gat or will s u b mit a n y  u p date d S A E data t o t he s p o ns or wit hi n 2 4 h o urs of 
recei pt of t he i nf or mati o n.
1 0. 3. 4. Re p orti n g of S A Es
S A E Re p orti n g t o Pfizer S afet y vi a a n Electr o nic D C T

T he pri mar y  mec ha nis m f or re p orti n g a n S A E t o Pfizer Safet y will be t he electr o nic 
D C T .

If t he electr o nic sys te m is u na vaila ble, t he n t he site will use t he pa per S A E D C T
(see ne xt secti o n) t o re p ort t he e ve nt wit hi n 2 4 h o urs.

T he site will e nter t he S A E da ta i nt o t he electr o nic D C T (e g, e S A E or P S S A) or 
pa per f or m (as a p plica ble) as s o o n as t he data bec o me a vaila ble.

After t he st u d y is c o m plete d at a gi ve n site, t he electr o nic D C T will be ta ke n off -li ne 
t o pre ve nt t he e ntr y of ne w data or c ha n ges t o e xisti ng data.

If a site recei ves a re p ort of a ne w S A E fr o m a st u d y partici pa nt or recei ves u p date d 
data o n a pre vi o usl y  re p orte d S A E after t he electr o nic D C T has bee n ta ke n off- li ne, 
t he n t he site ca n re p ort t his i nf or mati o n o n a pa per S A E f or m (see ne xt secti on) or t o 
Pfizer Safet y  b y tele p h o ne.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 3
S A E Re p orti n g t o Pfizer S afet y vi a t he V acci ne S A E Re p ort F or m

Facsi mile tra ns missi o n of t he Vacci ne S A E Re p ort F or m is t he preferre d met h o d t o 
tra ns mit t his i nf or mati o n t o Pfizer Safet y.

I n circ u msta nces w he n t he facsi mile is n ot w or ki n g, a n alter nati ve met h o d s h o ul d be 
use d, e g, sec ure d ( Tra ns p ort La y er Sec urit y) or pass w or d - pr otecte d e mail.  If n o ne 
of t hese met h o ds ca n be use d, n otificati o n b y  tele p h o ne is acce pta ble wit h a c o p y of 
t he Vacci ne S A E Re p ort F or m sent b y  o ver ni g ht mail or c o urier ser vice.

I nitial n otificati o n via tele p h o ne d oes n ot re place t he nee d f or t he i n vesti gat or t o 
c o m plete a n d si g n t he Vacci ne S A E Re p ort F or m pa ges wit hi n t he desi g nate d 
re p orti n g ti me fra mes.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 4
1 0. 4. A p pe n di x 4: Ge netics
Use/ A n al ysis of D N A

Ge netic variati o n ma y  i m pact a partici pa nt’s res p o nse t o st u d y i nter ve nti o n a n d 
s usce pti bilit y t o a n d se verit y a n d pr o gressi o n of disease. T heref ore, w here l ocal 
re g ulati o ns a n d I R Bs/ ECs all o w, a bl o o d sa m ple will be c ollecte d f or D N A a n d/ or R N A 
a nal ys is. I nfl ue nza strai n se q ue nci n g of L CI cases a n d S A R S-C o V -2 strai n se q ue nci n g 
of c o nfir me d C O VI D -1 9 cases usi n g ne xt -ge nerati o n se q ue nci n g tec h n ol o g y ma y  als o be 
c o n d ucte d fr o m t he mi dt ur bi nate s wa b sa m ples c ollecte d.

T he res ults of ge net ic a nal yses ma y be re p orte d i n t he C S R or i n a se parate st u d y 
s u m mar y, or ma y be use d f or i nter nal decisi o n-ma ki n g wit h o ut bei n g i ncl u de d i n a st u d y  
re p ort.

T he s p o ns or will st ore t he D N A a n d/ or R N A sa m ples i n a sec ure st ora ge s pace wit h 
a de q uate meas ures t o pr otect c o nfi de ntiality.

T he sa m ples will be retai ne d as i n dicate d:

Sa m ples f or s pecifie d ge netic a nal ys is (see Secti o n 8. 6. 1 ) wi ll be st ore d f or u p t o 
1 5 ye ars or ot her peri o d as per l ocal re q uire me nts.

Sa m ples f or ge netic researc h will be la bele d wit h a c o de. T he ke y  bet wee n t he c o de a n d 
t he partici pa nt’s pers o nall y i de ntif yi n g i nf or mati o n (e g, na me, a d dress) will be hel d 
sec urely at t he st u d y site.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 5
1 0. 5. A p pe n di x 5 : C o ntr ace pti ve a n d B arrier G ui d a nce
1 0. 5. 1. M ale P artici p a nt Re pr o d ucti ve I ncl usi o n Criteri a
Male partici pa nts are eli gi ble t o partici pate if t he y  a gree t o t he f oll o wi n g re q uire me nts d uri n g 
t he i nter ve nti o n peri o d a n d f or at least 2 8 d a y s after t he last d ose of st u d y i nter ve nti o n , w hic h 
c orres p o n ds t o t he ti me nee de d t o eli mi nate re pr o d ucti ve safet y ris k of t he st u d y 
i nter ve nti o n(s):

Refrai n fr o m d o nati n g s per m .
P L U S eit her :

Be a bsti ne nt fr o m heter ose x ual i nterc o urse as t heir prefe rre d a n d us ual lifest yle 
(a bsti ne nt o n a l o n g-ter m a n d persiste nt basis) a n d a gree t o re mai n a bsti ne nt.
O R

M ust a gree t o use c o ntrace pti o n/ barrier as detaile d bel o w:

A gree t o use a male c o n d o m a n d s h o ul d als o be a d vise d of t he be nefit f or a 
fe male part ner t o use a hi g hly effecti ve met h o d of c o ntrace pti o n as a c o n d o m ma y 
brea k or lea k w he n ha vi n g se x ual i nterc o urse wit h a w o ma n of c hil d beari n g 
p ote ntial w h o is n ot c urre ntl y  pre g na nt.
O R

Be vasect o mize d, wit h t he a bse nce of s per m ha vi n g bee n c o nfir me d.
1 0. 5. 2. Fe m ale P artici p a nt Re pr o d ucti ve I ncl usi o n Criteri a
T he criteria bel o w are part of incl usi o n criteri o n 1 ( A ge a n d Se x; Secti o n 5. 1 ) a n d s pecif y t he 
repr o d ucti ve re q uire me n ts f or i ncl u di ng fe male partici pa nts. Refer t o Secti o n 1 0. 5. 4 f or a 
c o m plete list of c o ntrace pti ve met h o ds per mitte d i n t he st u d y .
A fe male partici pa nt is eli gi ble t o partici pate if s he is n ot pre g na nt or breastfee di n g a n d at 
least 1 of t he f oll o wi n g c o n diti o ns a p plies:

Is n ot a W O C B P (see defi niti o ns bel o w i n Secti o n 1 0. 5. 3 ).
O R

Is a W O C B P a n d a grees t o use a n acce pta ble c o ntrace pti ve met h o d d uri n g t he 
i nter ve nti o n peri o d (f or a mi ni m u m of 2 8 da y s after t he last d ose of st u d y 
i nter ve nti o n).  T he i n vesti gat or s h o ul d e val uate t he effecti ve ness of t he c o ntrace pti ve 
met h o d i n relati o ns hi p t o t he first d ose of st u d y i nter ve nti o n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 6
T he i n vesti gat o r is res p o nsi ble f or re vie w of me dical hist or y, me nstr ual hist or y, a n d rece nt 
se x ual acti vit y t o decrease t he ris k f or i ncl usi o n of a w o ma n wit h a n early u n detecte d 
pre g na nc y .
1 0. 5. 3. W o m a n
of C hil d be ari n g P ote nti al
A w o ma n is c o nsi dere d fertile f oll o wi n g me narc he a n d u ntil bec o mi n g p ost me n o pa usal 
u nless per ma ne ntl y sterile (see bel o w).
If fertilit y is u nclear (e g, a me n orr hea i n a d olesce nts or at hletes) a n d a me nstr ual c ycle ca n n ot 
be c o nfir me d bef ore t he first d ose of st u d y i nter ve nti o n, a d diti o nal e val uati o n s h o ul d be 
c o nsi dere d.
Wo me n i n t he f oll o wi n g cate g ories are n ot c o nsi dere d W O C B P:
1.
Pre me n o pa usal fe male wit h 1 of t he f oll o wi n g:

D oc u me nte d h ys terect o m y;

D oc u me nte d bilateral sal pi n gect o m y ;

D oc u me nte d bilateral o o p h orect o m y.
F or i n di vi d uals wit h per ma ne nt i nfer tilit y d ue t o a me dical ca use ot her t ha n t he a b o ve
(e g, m ulleria n a ge nesis, a n dr o ge n i nse nsiti vit y), i n vesti gat or discreti o n s h o ul d be a p plie d t o 
deter mi ni n g st u d y e ntr y.
N ote: D oc u me ntati o n f or a n y of t he a b o ve cate g ories ca n c o me fr o m t he site pers o n nel ’s 
re vie w of t he partici pa nt’s me dical rec or ds, me dical e xa mi nati o n, or me dical hist or y 
i nter vie w. T he met h o d of d oc u me ntati o n s h o ul d be rec or de d i n t he partici pa nt’s me dical 
rec or d f or t he st u d y.
2.
P ost me n o pa usal fe male :

A p ost me n o pa usal state is defi ne d as n o me nses f or 1 2 m o nt hs wit h o ut a n alter nati ve 
me dical ca use.
I n a d diti o n:

A hi g h F S H le vel i n t he p ost me n o pa usal ra n ge m ust be use d t o c o nfir m a 
p ost me n o pa usal state i n w o me n u n der 6 0 ye ars of a ge a n d n ot usi n g h or m o nal 
c o ntrace pti o n or H R T.

A f e male o n H R T a n d w h ose me n o pa usal stat us is i n d o u bt will be re q uire d t o use 
o ne of t he hi g hl y  effecti ve n o nestr o ge n h or m o nal c o ntrace pti o n met h o ds if s he
wis h es t o c o nti n ue her H R T d uri n g t he st u d y .
Ot her wise, s he m ust disc o nti n ue 
H R T t o all o w c o nfir mati o n of p ost me n o pa usal stat us bef ore st u d y e nr oll me nt.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 7
1 0. 5. 4. C o ntr ace pti o n Met h o ds
C o ntrace pti ve use b y me n or w o me n s h o ul d be c o nsiste nt wit h l ocal a vaila bilit y /re g ulati o ns 
re gar di n g t he use of c o ntrace pti ve met h o ds f or t h ose partici pati n g i n cli nical trials.
T he f oll o wi n g c o ntrace pti ve met h o ds are a p pr o priate f or t his st u d y:
Hi g hl y Effecti ve Met h o ds T hat H a ve L o w User De pe n de nc y
1.
I m pla nta ble pr o gest o ge n-o nl y  h or m o ne c o ntrace pti o n ass ociate d wit h i n hi biti o n of 
o v ulati o n.
2.
I ntra uteri ne de vice.
3.
I ntra uteri ne h or m o ne-releasi n g sys te m.
4.
Bilateral t u bal occl usi o n.
5.
Vasect o mize d part ner:

Vasect o mize d part ner is a hi g hl y effecti ve c o ntrace pti ve met h o d pr o vi de d t hat t he 
part ner is t he s ole se x ual part ner of t he W O C B P a n d t he a bse nce of s per m has bee n 
c o nfir me d. If n ot, a n a d diti o nal hi g hl y effecti ve met h o d of c o ntrace pti o n s h o ul d be 
use d. T he s per mat o ge nesis c y cle is a p pr o xi matel y 9 0 da ys.
Hi g hl y Effecti ve Met h o ds T hat A re User De pe n de nt
6.
C o m bi ne d (estr o ge n - a n d pr o gest o ge n -c o ntai ni n g) h or m o nal c o ntrace pti o n ass o ciate d 
wit h i n hi biti o n of o v ulati o n:

Oral;

I ntra va gi nal;

Tra ns der mal.
7.
Pr o gest o ge n - o nly h or m o ne c o ntrace pti o n ass ociate d wit h i n hi biti o n of o v ulati o n:

Oral;

I njecta ble.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 8
Se x ual A bsti ne nce
8.
Se x ual a bsti ne nce is c o nsi dere d a hi g hl y effecti ve met h o d o nl y  if define d as refrai ni n g 
fr o m heter ose x ual i nterc o urse d uri n g t he e ntire peri o d of ris k ass ociate d wit h t he st u d y 
i nter ve nti o n. T he relia bilit y  of se x ual a bsti ne nce nee ds t o be e val uate d i n relati o n t o t he 
d urati o n of t he st u d y  a n d t he preferre d a n d us ual lifestyl e of t he partici pa nt.
Ot her Effecti ve Met h o ds
9.
Pr o gest o ge n - o nly oral h or m o nal c o ntrace pti o n w here i n hi biti o n of o v ulati o n is n ot t he 
pri mar y  m o de of acti o n.
1 0.
Male or fe male c o n d o m, wit h or wit h o ut s per mici de.
1 1. Cer vical ca p, dia p hra g m , or s p o n ge wit h s per mic i de.
1 2. A c o m bi nati o n of male c o n d o m wit h eit her cer vical ca p, dia p hra g m, or s p o n ge wit h 
s per mici de ( d o u ble-barrier met h o ds).
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 0 9
1 0. 6. A p pe n di x 6 : Li ver S afet y: S u g geste d Acti o ns a n d F oll o w-U p Assess me nts
P ote nti al C ases of Dr u g -I n d uce d Li ver I nj ur y
H u ma ns e x p ose d t o a dr u g w h o s h o w n o si g n of li ver i nj ur y  (as deter mi ne d b y ele vati o ns i n 
tra nsa mi nases) are ter me d “t olerat ors,” w hile t h ose w h o s h o w tra nsie nt li ver i nj ur y  b ut a da pt 
are ter me d “a da pt ors.” I n s o me partici pa nt s, tra nsa mi nase ele vati o ns are a har bi n ger of a 
m ore seri o us p ote ntial o utc o me. T hese partici pa nt s fail t o a da pt a n d t heref ore are 
“s usce pti ble” t o pr o gressi ve a n d seri o us li ver i nj ur y, c o m m o nl y referre d t o as DI LI. 
Partici pa nt s w h o e x perie nce a tra nsa mi nase ele vati o n a b o ve 3 × U L N s h o ul d be m o nit ore d 
m ore fre q ue ntl y  t o deter mi ne if t he y are “a da pt or s” or are “s usce pti ble.”
L F T s are n ot re q uire d as a r o uti ne safet y m o nit ori n g pr oce d ure i n t his st u d y. H o we ver , 
s h o ul d a n i n vesti gat or dee m it necessar y t o assess L F Ts beca use a partici pa nt prese nts wit h 
cli nical si g ns/s y m pt o ms, s uc h L F T  res ults s h o ul d be ma na ge d a n d f oll o we d as descri be d 
bel o w.
I n t he maj orit y of DI LI cases, ele vati o ns i n A S T a n d/ or A L T prece de T b ili ele vati o ns 
( > 2 × U L N) by se veral da ys or wee ks. T he i ncrease i n T b ili t ypicall y occ urs w hile 
A S T/ A L T is/are still ele vate d a b o ve 3 × U L N (ie, A S T/ A L T a n d T bili val ues will be ele vate d 
wit hi n t he sa me la b orat or y sa m ple). I n rare i nsta nces, by t he ti me T bili ele vati o ns are 
detecte d, A S T/ A L T v al ues mi g ht ha ve decrease d. T his occ urre nce is still re gar de d as a 
p ote ntial DI LI. T heref ore, a b n or mal ele vati o ns i n eit her A S T  O R A L T i n a d diti o n t o T b ili 
t hat meet t he criteria o utli ne d bel o w are c o nsi dere d p ote ntial DI LI (assesse d per H y’s la w 
criteria) cases a n d s h o ul d al wa ys be c o nsi dere d i m p orta nt me dical e ve nts, e ve n bef ore all 
ot her p ossi ble ca uses of li ver i nj ur y  ha ve bee n e xcl u de d.
T he t hres h ol d of la b orat or y  a b n or malities f or a p ote ntial DI LI case de pe n ds o n t he 
partici pa nt ’s i n di vi d ual baseline val ues a n d u n derl y i n g c o n diti o ns. Partici pa nt s w h o prese nt 
wit h t he f oll o wi n g la b orat or y  a b n or malities s h o ul d be e val uate d f urt her as p ote ntial DI LI 
( Hy’ s la w) cases t o defi niti vel y deter mi ne t he eti ol o g y of t he a b n or mal la b orat or y val ues:

Partici pa nt s wit h A S T/ A L T a n d T bili baseli ne val ues wit hi n t he n or mal ra n ge w h o 
s u bse q ue ntl y prese nt wit h A S T O R A LT val ues ≥3 × U L N A N D a T b ili val ue 
≥2 × U L N wit h n o e vi de nce of he m ol ys is a n d a n al kali ne p h os p hatase val ue 
< 2 × U L N or n ot a vaila ble.

F or partici pa nt s wit h baseli ne A S T O R A L T O R T b ili val ues a b o ve t he U L N, t he 
f oll o wi n g t hres h ol d val ues are use d i n t he defi niti o n me nti o ne d a b o ve, as nee de d, 
de pe n di n g o n w hic h val ues are a b o ve t he U L N at baseli ne:

Pree xisti n g A S T or A L T baseli ne val ues a b o ve t he n or ma l ra n ge: A S T or A L T 
val ues ≥2 ti mes t he baseli ne val ues A N D ≥3 × U L N; or ≥8 × U L N ( w hic he ver is 
s maller).
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 0

Pree xisti n g val ues of T b ili a b o ve t he n or mal ra n ge: T b ili le vel i ncrease d fr o m 
baseli ne val ue b y a n a m o u nt of ≥1 × U L N or if t he val ue reac hes ≥3 × U L N 
( w hic he ver is s maller).
Rises i n A S T/ A L T a n d T b ili se parate d b y m ore t ha n a fe w wee ks s h o ul d be assesse d 
i n di vi d uall y base d o n cli nical j u d g me nt; a n y case w here u ncertai nt y re mai ns as t o w het her it 
re prese nts a p ote ntial H y’s la w case s h o ul d be re vie we d wit h t he s p o ns or.
T he partici pa nt s h o ul d ret ur n t o t he i n vesti gat or site a n d be e val uate d as s o o n as p ossi ble, 
prefera bl y wit hi n 4 8 h o urs fr o m a ware ness of t he a b n or mal res ults. T his e val uati o n s h o ul d 
i ncl u de la b orat or y tests, detaile d hist or y, a n d p hy sical assess me nt.
I n a d diti o n t o re peati n g meas ure me nts of A S T  a n d A L T a n d T b ili f or s us pecte d H y’s la w
cases , a d diti o nal la b orat or y tests s h o ul d i ncl u de al b u mi n, C K, direct a n d i n direct bilir u bi n, 
G G T , P T/IN R, t otal bile aci ds, a n d al kali ne p h os p hatase. C o nsi derati o n s h o ul d als o be gi ve n 
t o dra wi n g a se parate t u be of cl otte d bl o o d a n d a n a ntic oa g ulate d t u be of bl o o d f or f urt her 
testi n g, as nee de d, f or f urt her c o nte m p ora ne o us a nal yses at t he ti me of t he rec o g nize d i nitial 
a b n or malities t o deter mi ne eti ol o g y. A detaile d hist or y, i ncl u di n g rele va nt i nf or mati o n, s uc h 
as re vie w of et ha n ol, aceta mi n o p he n / paraceta m ol (eit her b y itself or as a c of or m ulate d 
pr o d uct i n prescri pti o n or o ver -t he-c o u nter me dicati o ns), recreati o nal dr u g, or s u p ple me nt 
( her bal) use a n d c o ns u m pti o n, fa mil y hist or y, se x ual hist or y, tra vel hist or y, hist or y of c o ntact 
wit h a ja u n dice d pers o n, s ur ger y, bl o o d tra nsf usi o n, hist or y of li ver or aller gic disease, a n d 
p ote ntial occ u pati o nal e x p os ure t o c he micals, s h o ul d be c ollecte d. F urt her test i n g f or ac ute 
he patitis A, B, C, D, a n d E i nfecti o n , li ver i ma gi n g (e g, biliar y tract), a n d c ollecti o n of ser u m 
sa m ples f or aceta mi n o p he n/ paraceta m ol dr u g a n d/ or pr otei n a d d uct le vels ma y  be warra nte d.
All cases de m o nstrate d o n re peat testi n g as meeti n g t h e la b orat or y criteria of A S T/ A L T a n d 
T b ili ele vati o n defi ne d a b o ve s h o ul d be c o nsi dere d p ote ntial DI LI ( H y’s la w) cases if n o 
ot her reas o n f or t he L F T  a b n or malities has yet bee n f o u n d. S uc h p ote nti al DI LI ( H y’s l a w) 
c ases are t o be re p orte d as S A Es, irre s pecti ve of a v ail a bilit y of all t he res ults of t he 
i n vesti g ati o ns perf or me d t o deter mi ne eti ol o g y of t he L F T a b n or m alities.
A p ote ntial DI LI ( H y ’s la w) case bec o mes a c o nfir me d case o nly after all res ults of 
reas o na ble i n vesti gati o ns ha ve bee n recei ve d a n d ha ve e xcl u de d a n alter nati ve eti ol o g y.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 1
1 0. 7. A p pe n di x 7 : Ki d ne y S afet y M o nit ori n g G ui deli nes
1 0. 7. 1. L a b or at or y Assess me nt of C h a n ge i n Ki d ne y F u ncti o n a n d Detecti o n of Ki d ne y 
I nj ur y
Sta n dar d ki d ne y  safet y m o nit ori n g re q uires assess me nt of baseli ne a n d p ost baseli ne ser u m 
creati ni ne (Scr meas ure me nt t o e G F R [ Scr-base d e G F R ] or [e Cr Cl]). Baseli ne a n d 
p ost baseli ne Sc y s ma kes it feasi ble t o disti n g uis h A KI fr o m ot her ca uses of Scr i ncrease. If 
Scr i ncrease is c o nfir me d after baseli ne, t he n refle x meas ure me nt of Sc y s is i n dicate d t o 
esti mate t he c o m bi ne d Scr-S c y s e G F R calc ulati o n (f or a d ults o nly).
Re gar dless of w het her ki d ne y  f u ncti o n m o nit ori n g tests are re q uire d as a r o uti ne safety 
m o nit ori n g pr oce d ure i n t he st u d y , if t he i n vesti gat or or s p o ns or dee ms it necessar y t o f urt her 
assess ki d ne y safet y a n d q ua ntif y ki d ne y f u ncti o n, t he n t hese test res ults s h o ul d be ma na ge d 
a n d f oll o we d per sta n dar d of care.
1 0. 7. 2. A ge -S pecific Ki d ne y F u ncti o n C alc ul ati o n Rec o m me n d ati o ns
1 0. 7. 2. 1. A d ults ( 1 8 Y e ars a n d A b o ve) – 2 0 2 1 C K D- E P I E q u ati o ns
2 0 2 1 C K D - E PI 
Scr O nl y
Scr
( mg/ d L)
Sc ys
( mg/ L)
Rec o m me n de d e G F R E q u ati o n
Fe male
if ≤ 0. 7
N/ A
e G F R = 1 4 3 × ( Scr/ 0. 7) -0. 2 4 1  ×  ( 0. 9 9 3 8) A ge
Fe male
if > 0. 7
N/ A
e G F R = 1 4 3 × ( Scr/ 0. 7) -1. 2 0 0  ×  ( 0. 9 9 3 8) A ge
Male
if ≤ 0. 9
N/ A
e G F R = 1 4 2 × ( Scr/ 0. 9) -0. 3 0 2  × ( 0. 9 9 3 8)A ge
Male
if > 0. 9
N/ A
e G F R = 1 4 2 × ( Scr/ 0. 9) -1. 2 0 0  ×  ( 0. 9 9 3 8) A ge
2 0 2 1 C K D -E PI
Scr- Sc ys 
C o m bi ne d
Scr
( mg/ d L)
Sc ys
( mg/ L)
Rec o m me n de d e G F R E q u ati o n
Fe male
if ≤ 0. 7
if ≤ 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) -0. 2 1 9  × ( Sc ys/ 0. 8) - 0. 3 2 3  × ( 0. 9 9 6 1) A ge
Fe male
if ≤ 0. 7
if > 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) -0. 2 1 9  × ( Sc ys/ 0. 8) - 0. 7 7 8  × ( 0. 9 9 6 1) A ge
Fe male
if > 0. 7
if ≤ 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) -0. 5 4 4  × ( Sc ys/ 0. 8) - 0. 3 2 3  × ( 0. 9 9 6 1) A ge
Fe male
if > 0. 7 
if > 0. 8
e G F R = 1 3 0 × ( Scr/ 0. 7) -0. 5 4 4  × ( Sc ys/ 0. 8) - 0. 7 7 8  × ( 0. 9 9 6 1) A ge
Male
if ≤ 0. 9
if ≤ 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) -0. 1 4 4  × ( Sc ys/ 0. 8) - 0. 3 2 3  × ( 0. 9 9 6 1) A ge
Male
if ≤ 0. 9
if > 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) -0. 1 4 4  × ( Sc ys/ 0. 8) - 0. 7 7 8  × ( 0. 9 9 6 1) A ge
Male
if > 0. 9
if ≤ 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) -0. 5 4 4  × ( Sc ys/ 0. 8) - 0. 3 2 3  × ( 0. 9 9 6 1) A ge
Male
if > 0. 9 
if > 0. 8
e G F R = 1 3 5 × ( Scr/ 0. 9) -0. 5 4 4  × ( Sc ys/ 0. 8) - 0. 7 7 8  × ( 0. 9 9 6 1) A ge
I n ker L A et al. N E n gl J Me d. 2 0 2 1; 3 8 5: 1 7 3 7-4 9.
1 0. 7. 3. A d verse E ve nt Gr a di n g f or Ki d ne y S afet y L a b or at or y A b n or m alities
A E gra di n g f or decli ne i n ki d ne y  f u ncti o n (ie, e G F R or e Cr Cl) will be acc or di n g t o 
C T C A E/ K DI G O criteria.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 2
1 0. 8. A p pe n di x 8 : Criteri a f or All o wi n g I ncl usi o n of P artici p a nts Wit h C hr o nic St a ble 
HI V, H C V, or H B V I nfecti o n
P ote ntial partici pa nts wit h c hr o nic sta ble H I V, H C V, or H B V i nfecti o n ma y be c o nsi dere d 
f or i ncl usi o n if t he y f ulfill t he f oll o wi n g res pecti ve criteria.
K n o w n HI V i nfecti o n

C o nfir me d sta ble HI V disease defi ne d as d oc u me nte d viral l oa d < 5 0 c o pies/ m L  a n d C D 4 
c o u nt > 2 0 0 cells/ m m 3 wit hi n 6 m o nt hs bef ore e nr oll me nt, a n d o n sta ble a ntiretr o viral 
t hera py f or at least 6 m o nt hs.
K n o w n H C V i nfecti o n

Hist or y of c hr o nic H C V wit h e vi de nce of s ustai ne d vir ol o gical res p o nse ( defi ne d as 
u n detecta ble H C V R N A) f or ≥1 2 wee ks f oll o wi n g H C V treat me nt or wit h o ut e vi de nce of 
H C V R N A vire mia ( u n detecta ble H C V viral l oa d).
K n o w n H B V i nfecti o n

C o nfir me d i nacti ve c hr o nic H B V i nfecti o n, defi ne d as H b s A g prese nt f or ≥6 m o nt hs a n d 
t he f oll o wi n g:

H b e A g ne gati ve, a nti-H b e p ositi ve

Ser u m H B V D N A < 2 0 0 0 I U/ m L

Persiste ntl y  n or mal A L T a n d/ or A S T le vels

I n t h ose w h o ha ve ha d a li ver bi o ps y perf or me d, fi n di n gs t hat c o nfir m t he a bse nce of 
si g nifica nt necr oi nfla m mati o n
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 3
1 0. 9. A p pe n di x 9 : E C G Fi n di n gs of P ote nti al Cli nic al C o ncer n
E C G Fi n di n gs T h at M a y Q u alif y as A Es

Mar ke d si n us b ra dyc ar dia (rate < 4 0 b p m) lasti n g mi n utes .

Ne w P R i nter val pr ol o n gati o n > 2 8 0 ms.

Ne w pr ol o n gati o n of Q Tc F t o > 4 8 0 ms (a bs ol ute) or b y  ≥6 0 ms fr o m baseli ne .

Ne w -o nset atrial fl utter or fi brillati o n, wit h c o ntr olle d ve ntric ular res p o nse rate: 
ie, rate < 1 2 0 b p m .

Ne w -o nset ty pe I sec o n d - de gree ( We nc ke bac h) A V b l oc k of > 3 0 sec o n ds’ d urati o n .

Fre q ue nt P V Cs, tri plets, or s h ort i nter vals ( < 3 0 sec o n ds) of c o nsec uti ve ve ntric ular 
c o m ple xes .
E C G Fi n di n gs T h at M a y Q u alif y as S A Es

Q Tc F pr ol o n gati o n > 5 0 0 ms .

Ne w S T -T c ha n ges s u g gesti ve of m yocar dial isc he mia .

Ne w - onset L B B B ( Q R S c o m ple x > 1 2 0 ms) .

Ne w -o nset ri g ht b u n dle b ra nc h b l oc k ( Q R S c o m ple x > 1 2 0 ms) .

S y m pt o matic b ra dyc ar dia.

As y st ole:

I n a wa ke, sy m pt o m -free partici pa nts i n si n us r h yt h m, wit h d oc u me nte d peri o ds 
of as ys t ole ≥3. 0 sec o n ds or a n y esca pe rate < 4 0 b p m, or wit h a n esca pe r h yt h m 
t hat is bel o w t he A V n o de; 

I n a wa ke, sy m pt o m -free partici pa nts wit h atrial fi brillati o n a n d bra d yc ar dia wit h 
1 or m ore pa uses of at least 5 sec o n ds or l o n ger ; 

Atrial fl utter or fi brillati on, wit h ra pi d ve ntric ular res p o nse rate: ra pi d = rate 
> 1 2 0 b p m.

S ustai ne d su pra ve ntric ular tac h yc ar dia (rate > 1 2 0 b p m) ( “s ustai ne d” = s h ort 
d urati o n wit h rele va nt s y m pt o ms or lasti n g > 1 mi n ute) .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 4

Ve ntric ular r h y t h ms > 3 0 sec o n ds’ d urati o n, i ncl u di n g i di o ve ntric ular r hyt h m 
(H R < 4 0 b p m), accelerate d i di o ve ntric ular r h yt h m ( H R 4 0 b p m t o < 1 0 0 b p m), a n d 
m o n o m or p hic/ p ol y m or p hic ve ntric ular tac h ycar dia ( H R > 1 0 0 b p m [s uc h as torsa des 
de p oi ntes ]).

T y pe II sec o n d- de gree ( M o bitz II) A V b l oc k.

C o m plete (t hir d -de gree) h eart b l oc k.
E C G Fi n di n gs T h at Q u alif y as S A Es

C ha n ge i n patter n s u g gesti ve of ne w m y ocar dial i nfarcti o n .

S ustai ne d v e ntric ular ta c h yarr h yt h mias ( > 3 0 sec o n ds’ d urati o n) .

Sec o n d - or t hir d - de gree A V bl oc k re q uiri n g pace ma ker place me nt.

As y st olic pa uses re q uiri n g pace ma ker place me nt.

Atrial fl utter or fi brillati o n wit h ra pi d ve ntric ular res p o nse re q uiri n g car di o versi o n .

Ve ntric ular fi brillati o n/fl utter.

At t he discreti o n of t he i n vesti gat or, a n y arr h yt h mia classifie d as a n a d verse 
e x perie nce.
T he e n u merate d list of maj or e ve nts of p ote ntial cli nical c o ncer n are rec o m me n de d as “alerts” or 
n otificati o ns fr o m t he c ore E C G la borat or y t o t he i n vesti gat or a n d Pfizer st u d y tea m, a n d n ot t o be 
c o nsi dere d as all-i ncl usi ve of w hat t o be re p orte d as AEs / S AEs.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 5
1 0. 1 0. A p pe n di x 1 0 : AE s, A D Es, S A Es, S A D Es, U S A D Es, a n d De vice Deficie ncies: 
Defi niti o ns a n d Pr oce d ures f or Rec or di n g, E v al u ati n g, F oll o w -U p, a n d Re p orti n g i n 
Me dic al De vice St u dies
Defi niti o ns of a Me dic al De vice Deficie nc y
T he defi niti o ns a n d pr oce d ures detaile d i n t his a p pe n di x are i n acc or da nce wit h I S O 1 4 1 5 5 
a n d t he E ur o pea n M D R 2 0 1 7/ 7 4 5 f or cli nical de vice researc h (if a p plica ble).
B ot h t he i n vesti gat or a n d t he s p o ns or will c o m pl y  wit h all l ocal re p orti n g re q uire me nts f or 
me dical de vices.
T he detecti o n a n d d oc u me ntati o n pr oce d ures descri be d i n t his pr ot oc ol a p pl y  t o all s p o ns or 
me dical de vices pr o vi de d f or use i n t he st u d y (see Secti o n 6. 1. 2 f or t he list of s p o ns or 
me dical de vices).
1 0. 1 0. 1. Defi niti o n of A E a n d A D E
A E a n d A D E Defi niti o n

A n A E is defi ne d i n A p pe n di x 3 ( Secti o n 1 0. 3. 1 ).

A n A D E is defi ne d as a n A E relate d t o t he use of a n i n vesti gati o nal me dical de vice.
T his defi niti o n i ncl u des a n y  AEs res ulti n g fr o m i ns ufficie nt or i na de q uate 
i nstr ucti o ns f or use, de pl o y me nt, i m pla ntati o n, i nstallati o n, or o perati o n, or a n y  
malf u ncti o n of t he i n vesti gati o nal me dical de vice as well as a n y e ve nt res ulti n g 
fr o m use err or or fr o m i nte nti o nal mis use of t he i n vesti gati o nal me dical de vice.
1 0. 1 0. 2. Defi niti o n of S A E, S A D E, a n d U S A D E
S A E Defi niti o n

A n S A E is defi ne d i n A p pe n di x 3 ( Secti o n 1 0. 3. 2 ).
S A D E Defi niti o n

A n S A D E is defi ne d as a n A D E t hat has res ulte d i n a n y  of t he c o nse q ue nces 
c haracteristic of a n S A E.

A n y  de vice deficie nc y t hat mi g ht ha ve le d t o a n S A E if a p pr o priate acti o n ha d n ot 
bee n ta ke n, i nter ve nti o n ha d n ot occ urre d, or circ u msta nces ha d bee n less f ort u nate.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 6
U S A D E Defi niti o n

A U S A D E (als o i de ntifie d as U A D E i n U S Re g ulati o ns 2 1 C F R 8 1 3. 3) is a n S A D E 
t hat b y its nat ure, i nci de nce, se verit y, or o utc o me has n ot bee n i de ntifie d i n t he 
c urre nt versi o n of t he ris k a nal ys is ma na ge me nt file.
1 0. 1 0. 3. Defi niti o n of De vice Deficie nc y
De vice Deficie nc y Defi niti o n

A de vice deficie nc y  is a n i na de q uac y of a me dical de vice wit h res pect t o its i de ntit y, 
q ualit y , d ura bility, relia bilit y , safety, or perf or ma nce. De vice deficie ncies i ncl u de 
malf u ncti o ns, use err ors, a n d i na de q uate i nf or mati o n s u p plie d b y t he ma n ufact urer.
1 0. 1 0. 4. Rec or di n g/ Re p orti n g a n d F oll o w -U p of Me dic al De vice Deficie ncies
De vice Deficie nc y Rec or di n g

W he n a de vice deficie nc y  occ urs, it is t he res p o nsi bilit y of t he u n bli n de d site staff t o 
re vie w all d oc u me ntati o n (e g, h os pital pr o gress n otes, la b orat or y  re p orts, a n d 
dia g n ostic re p orts) relate d t o t he e ve nt.

T he u n bli n de d site staff will t he n rec or d all rele va nt de vice deficie nc y  i nf or mati o n 
i n t he partici pa nt’s me dical rec or ds, i n acc or da nce wit h t he i n vesti gat or’s n ormal 
cli nical practice.

If a n A E (eit her seri o us or n o nseri o us) ass ociate d wit h t he de vice deficie nc y occ urs, 
t he n t he A E m ust be e ntere d i nt o t he A E secti o n of t he C R F.

T he u n bli n de d site staff will n otif y  t he s p o ns or st u d y tea m b y tele p h o ne or e mail 
wit hi n 1 b usi ness da y  of deter mi ni n g t hat t he i nci de nt meets t he pr ot oc ol defi niti o n 
of a me dical de vice deficie nc y .

T he s p o ns or st u d y  tea m will ca pt ure t he re q uire d i nf or mati o n o n t he Me dical De vice 
C o m plai nt f or m al o n g wit h a n y  ass ociate d A E (eit her seri o us or n o nseri o us) w he n 
a p plica ble a n d se n d t o t he a p pr o priate pr o d uct q ualit y  c o m plai nt gr o u p.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 7

If t he u n bli n de d site staff deter mi nes t hat t he me dical de vice deficie nc y ma y ha ve 
i nj ure d t he partici pa nt (ie, t he me dical de vice deficie nc y is ass ociate d wit h a n AE or 
S A E), t he n t he u n bli n de d site staff will atte m pt t o esta blis h a dia g n osis of t he e ve nt 
base d o n si g ns, s y m pt o ms, a n d/ or ot her cli nical i nf or mati o n.  W he ne ver p ossi ble, 
t he dia g n osis will be d oc u me nte d i n t he partici pa nt’s me dical rec or d a n d rec or de d as 
t he A E or S A E rat her t ha n t he i n di vi d ual si g ns/s y m pt o ms. All rele va nt details 
relate d t o t he r ole of t he de vice i n re gar d t o t he S A E m ust be i ncl u de d i n t he 
Vacci ne S A E Re p ort F or m as o utli ne d i n Secti o ns 8. 4. 1. 1 a n d 8. 4. 1. 2 . 

T here ma y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are 
re q ueste d by Pfizer Safet y. I n t his case, all partici pa nt i de ntifiers, wit h t he 
e xce pti o n of t he partici pa nt n u m b er, will be re dacte d o n t he c o pies of t he me dical 
rec or ds bef ore s u b missi o n t o Pfizer Safet y. Refer t o Secti o n 1 0. 1. 8 f or acti o ns t hat 
m ust be ta ke n w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or desi g nee.

F or de vice deficie ncies, it is ver y  i m p orta nt t hat t he u n bli n de d site staff descri bes 
a n y c orrecti ve or re me dial acti o ns ta ke n t o pre ve nt rec urre nce of t he i nci de nt.

A re me dial acti o n is a ny acti o n ot her t ha n r o uti ne mai nte na nce or ser vici n g of a 
me dical de vice w here s uc h acti o n is necessar y  t o pre ve nt rec urre nce of a de vice 
deficie nc y .  T his i ncl u des a n y a me n d me nt t o t he de vice desi g n t o pre ve nt 
rec urre nce.
Assess me nt of C a us alit y Occ urri n g i n C o nj u ncti o n Wit h a Me dic al De vice Deficie nc y

If a n A E or S A E has occ urre d i n c o nj u ncti o n wit h a me dical de vice deficie nc y, t he 
i n vesti gat or m ust assess t he relati o ns hi p bet wee n eac h occ urre nce of t he A E or S A E 
a n d t he me dical device deficie nc y . T he i n vesti gat or will use cli nical j u d g me nt t o 
deter mi ne t he relati o ns hi p.

A “reas o na ble p ossi bilit y” of a relati o ns hi p c o n ve ys t hat t here are facts, e vi de nce, 
a n d/ or ar g u me nts t o s u g gest a ca usal relati o ns hi p, rat her t ha n a relati o ns hi p ca n n ot 
be r ule d o ut.

Alter nati ve ca uses, s uc h as u n derl yi n g disease(s), c o nc o mita nt t hera p y, a n d ot her 
ris k fact ors, as well as t he te m p oral relati o ns hi p of t he e ve nt t o st u d y i nter ve nti o n 
a d mi nistrati o n will be c o nsi dere d a n d i n vesti gate d.

T he i n vesti gat or will als o c o ns ult t he I B a n d/ or pr o d uct i nf or mati o n, f or mar kete d 
pr o d ucts i n t heir assess me nt.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 8

F or eac h de vice deficie nc y , t he i n vesti gat or m ust d oc u me nt i n t he me dical n otes 
t hat t he y ha ve re vie we d t he de vice deficie nc y a n d ha ve pr o vi de d a n assess me nt of 
ca usalit y.

T here ma y  be sit uati o ns i n w hic h a n S A E has occ urre d a n d t he i n vesti gat or has 
mi ni mal i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o t he s p o ns or. H o we ver, it is 
ver y  i m p orta nt t hat t he i n vesti gat or al wa ys ma ke a n assess me nt of causalit y f or 
e ver y e ve nt bef ore t he i nitial tra ns missi o n of t he S A E data t o t he s p o ns or.

T he i n vesti gat or ma y  c ha n ge t heir o pi ni o n of ca usalit y i n li g ht of f oll o w-u p 
i nf or mati o n a n d se n d a n S A E f oll o w-u p re p ort wit h t he u p date d ca usalit y  
assess me nt.

T he ca u salit y assess me nt is o ne of t he criteria use d w he n deter mi ni n g re g ulat or y 
re p orti n g re q uire me nts.
F oll o w - U p of Me dic al De vice Deficie nc y

F oll o w -u p a p plies t o all partici pa nts, i ncl u di n g t h ose w h o disc o nti n ue st u d y  
i nter ve nti o n.

T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uati o ns, as me dicall y  i n dicate d or as re q ueste d b y t he 
s p o ns or t o el uci date t he nat ure a n d/ or ca usality of t he de vice deficie nc y  as f ull y as 
p ossi ble. T his ma y i ncl u de a d diti o nal la b orat or y tests or i n vesti gati o ns, 
hist o pat h ol o gical e xa mi nati o ns, or c o ns ultati o n wit h ot her healt hcare pr o vi ders.

Ne w or u p date d i nf or mati o n re gar di n g t he nat ure of t he de vice deficie nc y  will be 
rec or de d i n t he ori gi nally c o m plete d Me dical D e vice C o m plai nt f or m b y  t he s p o ns or 
st u d y tea m.

Ne w or u p date d i nf or mati o n re gar di n g a n y S A E t hat was p ote ntiall y ass ociate d wit h 
t he me dical de vice deficie nc y will be s u b mitte d t o Pfizer Safet y o n t he Vacci ne S A E 
Re p ort F or m wit hi n 2 4 h o urs of recei pt of t he i nf or mati o n, acc or di n g t o t he 
re q uire me nts pr o vi de d i n A p pe n di x 3 .
1 0. 1 0. 5. Re p orti n g of S A Es
Re p orti n g of a n S A E t o Pfizer Safet y  m ust be perf or me d acc or di n g t o t he pr ocesses 
descri be d i n Secti o n 1 0. 3. 4 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 1 9
1 0. 1 0. 6. Re p orti n g of S A D Es
S A D E Re p orti n g t o Pfizer S afet y
N ote: T here are a d diti o nal re p orti n g o bli gati o ns f or me dical de vice deficie ncies t hat are 
p ote ntiall y  relate d t o S A Es (ie, a n S A D E) t hat m ust f ulfill t he le gal res p o nsi bilit y t o n otif y 
a p pr o priate re g ulat or y a ut h orities a n d ot her e ntities a b o ut certai n safety i nf or mati o n relati n g 
t o me dical de vices bei n g use d i n cli nical st u dies.

A n y  de vice deficie nc y  t hat is ass ociate d wit h a n S A E m ust be re p orte d t o t he 
s p o ns or wit hi n 2 4 h o urs after t he i n vesti gat or deter mi nes t hat t he e ve nt meets t he 
defi niti o n of a de vice deficie nc y .

T he s p o ns or s hall re vie w all de vice deficie ncies a n d deter mi ne a n d d oc u me nt i n 
writi n g w het her t he y  c o ul d ha ve le d t o a n S A E.  T hese s hall be re p orte d t o t he 
re g ulat or y a ut h orities a n d IR Bs/ E C s as re q uire d b y nati o nal re g ulati o ns.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 0
1 0. 1 1. A p pe n di x 1 1 : S u bst u d y A ( P h ase 1)
1 0. 1 1. 1. S o A – S u bst u d y A ( P h ase 1)
Visit N u m ber
Scree ni n g
1
2
3
4
5
6
Visit Descri pti o n
Scree ni n g V acci n ati o n
D a y 3 
F oll o w -
U p 
Visit
1- Wee k
F oll o w -
U p 
Visit
4- Wee k 
F oll o w -
U p 
Visit
8- Wee k 
F oll o w -
U p 
Visit
6- M o nt h 
Tele p h o ne 
C o nt act
Visit Wi n d o w ( D a ys)
0 t o 2 8 
D a ys 
Bef ore 
Visit 1
D a y 1
2 t o 4
D a ys 
After 
Visit 1
6 t o 8
D a ys 
After 
Visit 1
2 6 t o 
3 0
D a ys 
After
Visit 1
5 2 t o 
6 0
D a ys 
After
Visit 1
1 7 5 t o 1 8 9 
D a ys 
After 
Visit 1
O btai n i nf or me d c o nse nt
X
Assi g n partici pa nt n u m ber 
X
O btai n de m o gra p h y a n d me dical 
hist or y data (i ncl u di n g c o nfir me d 
C O VI D -1 9 dia g n osis or as y m pt o matic 
p ositi ve S A R S -C o V -2 test res ult
[N A A T or a nti ge n test ])
X
O btai n details of me dicati o ns 
c urre ntl y ta ke n
X
Perf or m p h ysical e xa mi nati o n
X
Perf or m cli nical assess me nt a
X
Meas ure hei g ht a n d w ei g ht
X
Meas ure vital si g ns (i ncl u di n g oral 
t e mperat ure)
X  
X  
X  
X
Perf or m 1 2 -lea d tri plicate E C G
X  
X  
X  
X
C ollect bl o o d sa m ple f or tr o p o ni n I 
la b orat or y testi n g
~ 2. 5 m L 
~ 2. 5 m L b
~ 2. 5 
m L
~ 2. 5 
m L
Uri ne pre g na nc y test (if a p pr o priate)
X  
X
C o nfir m use of c o ntrace pti ves 
(if a p pr o priate)
X  
X  
X  
X  
X
C ollect pri or C O VI D -1 9 a n d 
p ne u m oc occal vacci ne i nf or mati o n
X
C ollect details of a n y lice nse d 
i nfl ue nza vacci ne recei ve d i n t he pri or 
1 2 m o nt hs 
X
C ollect n o nst u d y vacci ne i nf or mati o n 
X  
X  
X  
X  
X  
X  
X
C ollect pr o hi bite d me dicati o n use
X  
X  
X  
X  
X
Re vie w tr o p o ni n I a n d E C G res ults
X  
X  
X  
X
C o nfir m eli gi bilit y
X  
X
O btai n ra n d o mizati o n n u m ber a n d 
st u d y i nter ve nti o n all ocati o n
X
Nasal ( mi dt ur bi nate) s wa b f or 
S A R S -C o V -2 N A A T
X
C ollect bl o o d sa m ple f or 
i m m u n o ge nicit y assess me nt 
~ 5 0 m L b
~ 5 0 m L ~ 5 0 m L ~ 5 0 m L
A d mi nister st u d y i nter ve nti o n
X
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 1
Visit N u m ber
Scree ni n g
1
2
3
4
5
6
Visit Descri pti o n
Scree ni n g V acci n ati o n
D a y 3 
F oll o w -
U p 
Visit
1- Wee k
F oll o w -
U p 
Visit
4- Wee k 
F oll o w -
U p 
Visit
8- Wee k 
F oll o w -
U p 
Visit
6- M o nt h 
Tele p h o ne 
C o nt act
Visit Wi n d o w ( D a ys)
0 t o 2 8 
D a ys 
Bef ore 
Visit 1
D a y 1
2 t o 4
D a ys 
After 
Visit 1
6 t o 8
D a ys 
After 
Visit 1
2 6 t o 
3 0
D a ys 
After
Visit 1
5 2 t o 
6 0
D a ys 
After
Visit 1
1 7 5 t o 1 8 9 
D a ys 
After 
Visit 1
Assess ac ute reacti o ns f or at least 
3 0 mi n utes after st u d y i nter ve nti o n 
a d mi nistrati o n
X
E x plai n t o t he partici pa nt e -diar y 
c o m pleti o n re q uire me nts a n d assist t he 
partici pa nt wit h d o w nl oa di n g t he 
a p p licati o n or iss ue pr o visi o ne d 
de vice if re q uire d
X
Pr o vi de t her m o meter a n d meas uri n g 
de vice
X
Re vie w react o ge nicit y e-diar y data 
( dail y re vie w is o pti mal d uri n g t he 
acti ve diar y peri o d)
Re vie w o n g oi n g react o ge nicit y e -diar y 
s y m pt o ms a n d o btai n st o p dates 
X  
X
C ollect A Es a n d S A Es as a p pr o priate c
X  
X  
X  
X  
X  
X  
X
C ollect e -diar y or assist t he partici pa nt 
wit h deleti n g a p plicati o n
X  
X
a.
I ncl u di n g, if i n dicate d, a p h ysical e xa mi nati o n.
b.
Pri or t o vacci nati o n at Visit 1.
c.  
A E s are c ollecte d fr o m t he c o m pleti o n of i nf or me d c o nse nt t hr o u g h Visit 4.  S A Es are c ollecte d fr o m t he 
c o m pleti o n of i nf or me d c o nse nt t hr o u g h t he e n d of st u d y partici pati o n.  A d diti o nall y, a n y A E s occ urri n g 
u p t o 4 8 h o urs after bl o o d dra ws at Visits 4 a n d 5 m ust be rec or de d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 2
1 0. 1 1. 2. I ntr o d ucti o n f or S u bst u d y A
1 0. 1 1. 2. 1. S u bst u d y A R ati o n ale
T his is a P hase 1 ra n d o mize d, o pe n -la bel s u bst u d y t o descri be t he safety a n d i m m u n o ge nicit y 
of u p t o 3 d ose -le vel c o m bi nati o ns of qIR V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal / O mi B A. 4/ B A. 5 ).
1 0. 1 1. 2. 2. B ac k gr o u n d f or S u bst u d y A
See Secti o n 2. 2 .
1 0. 1 1. 2. 3. Be nefit/ Ris k Assess me nt f or S u bst u d y A
See Secti o n 2. 3. 1 f or o verall st u d y ris ks.  N o u ni q ue ris ks are i de ntifie d f or S u bst u d y  A.
B e nefits t o i n di vi d ual partici pa nts e nr olle d i n S u bst u d y  A ma y be:

Recei pt of a d ose of a n efficaci o us or p ote ntiall y efficaci o us C O VI D -1 9 vacci ne t hat ma y  
c o n ve y better pr otecti o n a gai nst t he S A R S-C o V - 2 W T
(a ncestral) strai n a n d V O Cs 
d uri n g a gl o bal pa n de m ic.

Recei pt of a p ote ntiall y efficaci o us i nfl ue nza vacci ne at n o c ost t o t he partici pa nt, a n d 
pr o visi o n of t he i m m u n o ge nicit y  res ults i n partici pa nts.

Access t o C O VI D -1 9 dia g n ostic testi n g.

C o ntri b uti n g t o researc h t o hel p ot hers i n a ti me of gl o bal pa n de mic.
Please see Secti o n 2. 3 f or details of t he S R S Ds relati n g t o st u d y i nter ve nti o n use d i n 
S u bst u d y  A.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 3
1 0. 1 1. 3. O bjecti ves, E n d p oi nts, a n d Esti m a n ds ( S u bst u d y A)
O bjecti ves
Esti m a n ds
E n d p oi nts
Pri m ar y S afet y
P ri mar y S afet y
Pri m ar y S afet y
T o descri be t he safet y a n d t olera bilit y of 
qI R V/ bi vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5) at vari o us 
d ose -le vel c o m bi nati o ns i n partici pa nts 
≥1 8 years of a ge
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge ,
se paratel y a n d c o m bi ne d, recei vi n g at least 1 d ose of st u d y 
i nter ve nti o n, t he perce nta ge of partici pa nts re p orti n g:

L ocal reacti o ns f or u p t o 7 da ys f oll o wi n g vacci nati o n

S yste mic e ve nts f or u p t o 7 da ys f oll o wi n g vacci nati o n

A E s fr o m t he first vacci nati on t hr o u g h 4 wee ks after vacci nati o n

S A Es fr o m t he first vacci nati o n t hr o u g h 6 m o nt hs after 
vacci nati o n

L ocal reacti o ns ( pai n at t he i njecti o n site, re d ness, a n d 
s welli n g)

S yste mic e ve nts (fe ver, fati g ue, hea dac he, c hills, 
v o miti n g, diarr hea, ne w or w orse ne d m uscle pai n, a n d 
ne w or w orse ne d j oi nt pai n)

A Es

S A Es
T he perce nta ge of partici pa nts wit h:

A b n or mal tr o p o ni n I la b orat or y val ues 2 da ys a n d 1 wee k after 
vacci nati o n
Tr o p o ni n I la b orat or y para meters detaile d i n Secti o n 1 0. 2
T he perce nta ge of partici pa nts wit h:

Ne w E C G a b n or malities 2 da ys a n d 1 wee k after vacci nati o n
E C G a b n or malities c o nsiste nt wit h pr o ba ble or p ossi ble 
m y o car ditis or pericar ditis as defi ne d i n
Secti o n 1 0. 1 1. 8. 4. 1
Sec o n d ar y
Sec o n d ar y
Sec o n d ar y
T o descri be t he i m m u ne res p o nses 
elicite d b y qI R V/bi vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5) at vari o us 
d ose -le vel c o m bi nati o ns i n partici pa nts 
≥1 8 years of a ge
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge ,
se paratel y, c o m pl yi n g wit h t he ke y pr ot oc ol criteria (e val ua ble
partici pa nts):

G M Ts bef ore vacci nati o n a n d at 4 wee ks after vacci nati o n

G M F R fr o m bef ore vacci nati o n t o 4 wee ks after vacci nati o n

T he pr o p orti o n of partici pa nts ac hie vi n g H AI ser oc o n versi o n a f or 
eac h strai n at 4 wee ks after vacci nati o n 

T he perce nta ge of partici pa nts wit h H AI titers ≥1: 4 0 f or eac h 
strai n bef ore vacci nati o n a n d at 4 wee ks after vacci nati o n

T he perce nta ge of partici pa nts ac hie vi n g H AI ser oc o n versi o n f or 
all strai ns at 4 wee ks after vacci nati o n

T he perce nta ge of partici pa nts wit h H AI titers ≥1: 4 0 f or all strai ns 
at 4 wee ks after vacci nati o n
H AI titers f or t he matc he d seas o nal strai ns ( 
) 
rec o m me n de d b y W H O 
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 4
O bjecti ves
Esti m a n ds
E n d p oi nts
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge ,
se paratel y, ha vi n g recei ve d qI R V/ bi vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5 ) a n d c o m pl yi n g wit h t he ke y pr ot oc ol 
criteria (e val ua ble partici pa nts): 

G M Ts bef ore vacci nati o n a n d at 4 wee ks after vacci nati o n f or 
eac h strai n

G M F R fr o m bef ore vacci nati o n t o 4 wee ks after vacci nati o n f or 
eac h strai n

Perce nta ges of partici pa nts wit h ser ores p o nse b at 4 wee ks after 
vacci nati o n f or eac h strai n

S A R S -C o V -2 O micr o n B A. 4/ B A. 5 – ne utralizi n g titers

S A R S -C o V -2 refere nce -strai n– ne utralizi n g titers
E x pl or at or y
E x pl or at or y
E x pl or at or y
T o descri be t he i m m u ne res p o nses 
elicite d b y qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) at vari o us 
d ose -le vel c o m bi nati o ns i n partici pa nts 
≥1 8 years of a ge
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge, 
se paratel y, c o m pl yi n g wit h t he ke y pr ot oc ol criteria (e val ua ble 
partici pa nts):

G M Ts bef ore vacci nati o n a n d at 1 a n d 8 wee k s after vacci nati o n

G M F R fr o m bef ore vacci nati o n t o 1 a n d 8 wee k s after vacci nati o n

T he pr o p orti o n of partici pa nts ac hie vi n g H AI ser oc o n versi o n a f or 
eac h strai n at 1 a n d 8 wee k s after vacci nati o n

T he perce nta ge of partici pa nts wit h H AI titers ≥1: 4 0 f or eac h 
strai n bef ore vacci nati o n a n d at 1 a n d 8 wee k s after vacci nati o n

T he perce nta ge of partici pa nts ac hie vi n g H AI ser oc o n versi o n f or 
all strai ns at 1 a n d 8 wee k s after vacci nati o n

T he perce nta ge of partici pa nts wit h H AI titers ≥1: 4 0 f or all strai ns 
at 1 a n d 8 wee k s after vacci nati o n

H AI titers f or t he matc he d seas o nal strai ns 
( 
 rec o m me n de d b y W H O
T o descri be t he i m m u ne res p o nses 
elicite d b y qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) at vari o us 
d ose -le vel c o m bi nati o ns i n partici pa nts 
≥1 8 years of a ge
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge a n d ≥6 5 years of a ge, 
se paratel y, ha vi n g recei ve d qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) a n d c o m pl yi n g wit h t he ke y pr ot oc ol 
criteria (e val ua ble partici pa nts): 

G M Ts bef ore vacci nati o n a n d at 1 a n d 8 wee k s after vacci nati o n 
f or eac h strai n

G M F R fr o m bef ore vacci nati o n t o 1 a n d 8 wee k s after vacci nati o n 
f or eac h strai n

Perce nta ges of partici pa nts wit h ser ores p o nse b at 1 a n d 8 wee k s
after vacci nati o n f or eac h strai n

S A R S -C o V -2 O micr o n B A. 4/ B A. 5 – ne utralizi n g titers

S A R S -C o V -2 refere nce -strai n– ne utralizi n g titers
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 5
O bjecti ves
Esti m a n ds
E n d p oi nts
T o descri be t he i m m u ne res p o nse t o 
e mer gi n g V O Cs i n partici pa nts ≥1 8 years 
of a ge

S A R S -C o V - 2 ne utralizi n g titers f or V O Cs n ot alrea d y 
s pecifie d
a.
Ser oc o n versi o n is defi ne d as a n H AI titer < 1: 1 0 pri or t o vacci nati o n a n d ≥1: 4 0 at t he ti me p oi nt of i nterest, or a n H AI titer of ≥1: 1 0 pri or t o vacci nati o n wit h at least a 
4-f ol d rise at t he ti me p oi nt of i nterest.
b. 
Ser ores p o nse is defi ne d as ac hie vi n g at least a ≥4 -f ol d rise fr o m baseli ne ( bef ore t he st u d y vacci nati o n).  If t he baseli ne meas ure me nt is bel o w t he L L O Q, t he 
p ost va cci nati o n meas ure of ≥4 × L L O Q is c o nsi dere d ser ores p o nse.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 6
1 0. 1 1. 4. S u bst u d y A Desi g n
1 0. 1 1. 4. 1. O ver all Desi g n f or S u bst u d y A
T his is a P hase 1 ra n d o mize d, o pe n -la bel s u bst u d y t o descri be t he safety a n d i m m u n o ge nicit y 
of u p t o 3 d ose- le vel c o m bi nati o ns of qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal / O mi B A. 4/ B A. 5).
Bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) use d was rec o m me n de d b y  A CI P i n 
2 0 2 2- 2 0 2 3. 2 9 ,3 0 A p pr o xi matel y  3 6 0 partici pa nts will be e nr olle d acr oss 2 a ge strata:
a p pr o xi matel y 1 8 0 partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge a n d a p pr o xi matel y 
1 8 0 partici pa nts ≥6 5 y ears of a ge .  Partici pa nts i n eac h stratu m will be ra n d o mize d e q uall y  
( 3 0 partici pa nts per gr o u p) t o eac h gr o u p t o recei ve a d ose of eit her:

qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal * / O mi B A. 4/ B A. 5), at 1 of t he 3 d ose -le vel 
c o m bi nati o ns s h o w n i n Ta ble 1 ,

 µ g qI R V, 

 µ g qI R V, or

 µ g B i vale nt B N T 1 6 2 b 2 ( ori gi nal / Omi B A. 4/ B A. 5) a d mi nistere d c o nc urre ntl y  i n t he 
o p p osite ar m t o lice nse d QI V.
* Ori gi nal refers t o t he a ncestral strai n ( W u ha n -H u -1; U S A -W A 1/ 2 0 2 0), als o referre d t o i n 
t his pr ot oc ol as t he refere nce strai n.
E nr oll me nt i nt o eac h of t he 2 a ge strata ( 1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge) ma y occur 
i n de pe n de ntly.
Safet y  a n d i m m u n o ge nicit y data fr o m st u dies pre vi o usl y c o n d ucte d i n partici pa nts of a 
si milar a ge ra n ge ha vi n g recei ve d 1 d ose of B N T 1 6 2 b 2 at a d ose le vel of 
µ g a n d 
µ g 
ma y be use d as a c o ntr ol d uri n g t he s u bst u d y  a nal ysis.
E nr oll me n t i n eac h a ge stratu m will be c o ntr olle d s uc h t hat n o m ore t ha n 1 0 partici pa nts 
(c o nsi dere d t he se nti nel partici pa nts) ca n be vacci nate d o n t he first da y ; vacci nati o n of t he 
re mai ni n g partici pa nts will c o m me nce n o s o o ner t ha n 2 4 h o urs after t he te nt h partici pa nt
recei ve d his or her vacci nati o n.
St o p pi n g r ules will a p pl y t o gr o u ps recei vi n g c o m bi nati o n bi vale nt B N T 1 6 2 b 2 
(o ri gi nal/ O mi B A. 4/ B A. 5) a n d qI R V as detaile d i n Secti o n 1 0. 1 1. 8. 6.
All partici pa nts will be as ke d t o c o m plete a react o ge nicit y  e-diar y  f or 7 da ys f oll o wi n g eac h 
vacci nati o n.  Bl o o d sa m ples of a p pr o xi matel y  5 0 m L  will be c ollecte d f or i m m u n o ge nicity 
assess me nts pri or t o Vacci nati o n 1 a n d at 1, 4 , a n d 8 wee ks after vacci nati o n.  All 
partici pa nts will be as ke d t o pr o vi de a n a d diti o nal bl o o d sa m ple of a p pr o xi matel y  2. 5 m L  at 
ti me p oi nts s pecifie d i n Secti o n 1 0. 1 1. 1 f or assess me nt of tr o p o ni n I.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 7
Safet y  a n d i m m u n o ge nicit y data acc u m ulate d f or at least 4 wee k s f oll o wi n g vacci nati o n i n 
eac h a ge stratu m will be re vie we d b y t he s p o ns or’s I R C t o deter mi ne if e nr ol lme nt i n eac h 
a ge strat u m i n S u bst u d y B ma y pr ocee d. Base d o n re vie w of safet y or i m m u n o ge nicit y data 
of a n y st u d y i nter ve nti o n gr o u p, at Pfizer’s discreti o n, s u bse q ue nt c ollecti o n of bl o o d 
sa m ples fr o m partici pa nts i n t hat gr o u p ma y be halte d a n d/ or bl o o d sa m ples ma y  n ot be 
a nal yz e d, a n d st u d y visits or ot her pr oce d ures ma y be disc o nti n ue d.
T he t otal d urati o n of t he st u d y  f or eac h partici pa nt will be u p t o a p pr o xi matel y 6 m o nt hs.
1 0. 1 1. 4. 2. Scie ntific R ati o n ale f or St u d y Desi g n f or S u bst u d y A
See Secti o n 2. 1 .
1 0. 1 1. 4. 3. J ustific ati o n f or D ose f or S u bst u d y A
See Secti o n 4. 3 .
1 0. 1 1. 4. 4. E n d of S u bs t u d y Defi niti o n f or S u bst u d y A
T he e n d of S u bst u d y A is defi ne d as t he date of t he last visit of t he last partici pa nt i n t he 
s u bst u d y. 
A partici pa nt is c o nsi dere d t o ha ve c o m plete d t he s u bst u d y if he/s he has c o m plete d all 
peri o ds of t he s u bst u d y, i ncl u di n g t he last visit.
1 0. 1 1. 5. S u bst u d y A P o p ul ati o n
1 0. 1 1. 5. 1. S u bst u d y A I ncl usi o n Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n S u b st u d y A o nl y if all of t he f oll o wi n g criteria 
a p pl y:
A ge a n d Se x:
1.
Male or fe male partici pa nts ≥1 8 y ears of a ge ( or t he mi ni m u m a ge of c o nse nt i n 
acc or da nce wit h l ocal re g ulati o ns) at Visit 1 ( Da y 1).

Refer t o A p pe n di x 5 f or re pr o d ucti ve criteria f or male ( Secti o n 1 0. 5. 1 ) a n d fe male 
(Secti o n 1 0. 5. 2 ) partici pa nts.
Dise ase C h ar acteristics:
N ot a p plica ble.
Ot her I ncl usi o n Criteri a:
2.
Partici pa nts w h o are willi n g a n d a ble t o c o m pl y wit h all sc he d ule d visits, i n vesti gati o nal 
pla n, la b orat or y  tests, lifest yle c o nsi derati o ns, a n d ot her st u d y pr oce d ures.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 8
3.
Healt h y partici pa nts w h o are deter mi ne d b y me dical hist or y, p h ys ical e xa mi nati o n 
(if re q uire d), a n d cli nical j u d g me nt of t he i n vesti gat or t o be eli gi ble f or i ncl usi o n i n t he 
st u d y.
N ote: Healt h y partici pa nts wit h pree xisti n g sta ble disease, defi ne d as dise ase n ot 
re q uiri n g si g nifica nt c ha n ge i n t hera py or h os pitalizati o n f or w orse ni n g disease 
d uri n g t he 6 wee ks bef ore e nr oll me nt, ca n be i ncl u de d. S pecific criteria f or 
partici pa nts wit h k n o w n sta ble i nfecti o n wit h HI V, H C V, or H B V ca n be f o u n d i n 
Secti o n 1 0. 8 .
4.
Ca pa ble of gi vi n g si g ne d i nf or me d c o nse nt as descri be d i n t he pr ot oc ol, w hic h i ncl u des 
c o m plia nce wit h t he re q uire me nts a n d restri cti o ns liste d i n t he IC D a n d i n t his pr ot oc ol.
5.
F or p artic ip a nts 1 8 t hr o u g h 6 4 ye ars of a ge: p artici pa nts w h o ha ve recei ve d 3 pri or 
d oses of 3 0 µ g B N T 1 6 2 b 2, wit h t he last d ose bei n g 1 5 0 d a y s t o 3 6 5 da ys bef ore Visit 1 
( Da y 1).
F or p artici p a nts ≥6 5 ye ars of a ge: partici pa nts w h o ha ve recei ve d 4 or 5 pri or d oses of 
a m o d R N A S A R S -C o V - 2 vacci ne, wit h t he last d ose bei n g a bi vale nt vacci ne, 9 0 d a y s t o 
3 6 5 da y s bef ore Visit 1 ( Da y 1). A n y f o urt h or fift h d ose ( b o oster d ose) of m o d R N A 
S A R S -C o V - 2 vacci ne recei ve d after 0 1 Se pte m ber 2 0 2 2 ma y  be c o nsi dere d t o be a 
bi vale nt vacci ne i n t he U S.
N ote: D oc u me nte d c o nfir mati o n of pri or d oses of m o d R N A S A R S -C o V - 2 vacci ne s recei ve d 
m ust be o btai ne d pri or t o ra n d o miza ti o n.
6.
F or p artici p a nts ≥6 5 ye ars of a ge: recei pt of lice nse d i nfl ue nza vacci nati o n f or t he 
2 0 2 2- 2 0 2 3 n ort her n h e mis p here seas o n ≥1 2 0 da y s bef ore st u d y i nter ve nti o n 
a d mi nistrati o n.
1 0. 1 1. 5. 2. S u bst u d y A E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m S u b st u d y A if a ny of t he f oll o wi n g criteria a p pl y :
Me dic al C o n diti o ns:
1.
Hist or y  of se vere a d verse reacti o n ass ociate d wit h a n y vacci ne a n d/ or se vere aller gic 
reacti o n (e g, a na p hyl a xis) t o a n y c o m p o ne nt of t he st u d y i nter ve nti o n(s).
2.
I m m u n oc o m pr o mise d i n di vi d uals wit h k n o w n or s us pecte d i m m u n o deficie nc y, as 
deter mi ne d b y hist or y  a n d/ or la b orat or y/ p h ysical e xa mi nati o n.
3.
Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d blee di n g t hat w o ul d, i n t he 
o pi ni o n of t he i n vesti gat or, c o ntrai n dicate i ntra m usc ular i njecti o n.
4.
W o me n w h o are pre g na nt or breastfee di n g.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 2 9
5.
Aller g y  t o e g g pr otei ns (e g g or e g g pr o d ucts) or c hic ke n pr otei ns.
6.
Ot her me dical or ps y c hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he past year) or acti ve 
s uici dal i deati o n/ be ha vi or or la b orat or y a b n or malit y t hat m a y  i ncrease t he ris k of st u d y 
partici pati o n or, i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt i na p pr o priate f or t he 
st u d y.
Pri or/ C o nc o mit a nt T her a p y:
7.
Recei pt of c hr o nic s ys te mic treat me nt wit h k n o w n i m m u n os u p pressa nt me dicati o ns 
(i ncl u di n g c yt ot o xic a ge nts or s yste mic c ortic oster oi ds), or ra di ot hera p y, wit hi n 6 0 da y s 
bef ore e nr oll me nt t hr o u g h c o ncl usi o n of t he st u d y.
N ote : S yste mic c ortic oster oi ds are defi ne d as t h ose a d mi nistere d f or ≥1 4 da y s at a d ose 
of ≥2 0 m g/ da y  of pre d nis o ne or e q ui vale nt (e g, f or ca ncer or a n a ut oi m m u ne disease) or 
pla n ne d recei pt t hr o u g h o ut t he st u d y . I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or 
t o pical (s ki n or e yes) c ortic oster oi ds are per mitte d.
8.
Recei pt of bl o o d/ plas ma pr o d ucts, i m m u n o gl o b uli n, or m o n ocl o nal a nti b o dies, fr o m 
6 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he st u d y.
9.
F or p artic ip a nts 1 8 t hr o u g h 6 4 ye ars of a ge: v acci nati o n wit h a n y i n vesti gati o nal or 
lice nse d i nfl ue nza vacci ne wit hi n 6 m o nt hs ( 1 7 5 da y s) bef ore st u d y i nter ve nti o n 
a d mi nistrati o n.
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
1 0. Partici pati o n i n ot her st u dies i n v ol vi n g a st u d y i nter ve nti o n wit hi n 2 8 da ys bef ore 
ra n d o mizati o n. A ntici pate d partici pati o n i n ot her st u dies wit hi n 2 8 da y s after recei pt of 
st u d y i nter ve nti o n i n t his st u d y.
Di a g n ostic Assess me nts:
N ot a p plica ble.
Ot her E xcl usi o n Criteri a:
1 1. I n vesti gat or site staff directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site staff ot her wise s u per vise d b y t he i n vesti gat or, a n d s p o ns or a n d s p o ns or 
dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers.
1 2. Partici pati o n i n stre n u o us or e n d ura nce e xercise t hr o u g h Visit 3.
1 3. Pri or hist or y  of heart disease.
1 4. A n y  a b n or mal scree ni n g tr o p o ni n I la b orat or y val ue.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 0
1 5. Scree ni n g 1 2 -lea d E C G t hat, as j u d ge d b y t he i n vesti gat or, is c o nsiste nt wit h pr o ba ble or 
p ossi ble m y ocar ditis or pericar ditis, or de m o nstrates cli nicall y  rele va nt a b n or malities t hat 
ma y  affect partici pa nt safet y or i nter pretati o n of st u d y res ults.  Partici pa nts wit h a 
scree ni n g 1 2-lea d E C G t hat s h o ws a n a vera ge Q Tc F i nter val > 4 5 0 msec, c o m plete left 
b u n dle bra nc h bl oc k, si g ns of a n ac ute or i n deter mi nate -a ge m y ocar dial i nfarcti o n, S T -T 
i nter val c ha n ges s u g gesti ve of m yocar dial isc he mia, sec o n d - or t hir d - degree A V bl oc k, or 
seri o us bra dya rr hyt h mias or tac h y arr h yt h mias s h o ul d be e xcl u de d fr o m st u d y 
partici pati o n.
1 0. 1 1. 5. 3. Criteri a f or Te m p or aril y Del a yi n g 
E nr oll me nt/ R a n d o miz ati o n/ A d mi nistr ati o n of St u d y I nter ve nti o n f or S u bst u d y A
T he f oll o wi n g c o n diti o ns ma y  all o w a partici pa nt t o be ra n d o mize d o nce t he c o n diti o ns ha ve 
res ol ve d a n d t he partici pa nt is ot her wise c o nsi dere d eli gi ble.  Partici pa nts meeti n g t hese 
criteria at Visit 1 will be c o nsi dere d scree n fail ures if e nr oll me nt has cl ose d o nce t he 
c o n diti o n(s) has/ ha ve res ol ve d.
1.
A p ositi ve S A R S -C o V -2 test res ult ( N A A T or ra pi d a nti ge n test) wit hi n t he pre vi o us 
2 8 da y s.
2.
C urre nt fe brile ill ness ( oral te m perat ure ≥3 8. 0° C [ ≥1 0 0. 4° F]) or ot her ac ute ill ness wit hi n 
4 8 h o urs bef ore st u d y  i nter ve nti o n a d mi nistrati o n.  T his i ncl udes s y m pt o ms t hat c o ul d 
re prese nt a p ote ntial C O VI D-1 9 ill ness (refer t o Secti o n 8. 4. 7 ).
N ote: T he partici pa nt s h o ul d be directe d t o see k a d diti o nal testi n g t hr o u g h his/ her 
pri mar y  healt hcare pr o vi der at a lice nse d cli nical la b orat or y w he n e x hi biti n g p ote ntial 
C O VI D - 1 9 sy m pt o ms or ot her wise recei vi n g a p ositi ve res ult a n d c o u nsele d o n w het her 
t o ta ke a ny preca uti o nar y meas ures pe n di n g c o nfir mat or y testi n g, as per l ocal g ui da nce.
3.
Recei pt of a n y n o nst u d y vacci ne wit hi n 2 8 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n 
at Visit 1.
4.
A ntici pate d recei pt of a n y n o nst u d y vacci ne wit hi n 2 8 da y s after st u d y i nter ve nti o n 
a d mi nistrati o n at Visit 1.
5.
Recei pt of s h ort -ter m ( < 1 4 da ys) s yste mic c ortic oster oi ds.  St u d y i nter ve nti o n 
a d mi nistrati o n s h o ul d be dela y e d u ntil s yste mic c ortic oster oi d use has bee n disc o nti n ue d 
f or at least 2 8 da ys.  I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical (s ki n or 
e yes) c ortic oster oi ds are per mitte d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 1
1 0. 1 1. 6. S u bst u d y A I nter ve nti o n a n d C o nc o mit a nt T her a p y
1 0. 1 1. 6. 1. St u d y I nter ve nti o n(s) A d mi nistere d f or S u bst u d y A
St u d y  i nter ve nti o ns f or S u bst u d y A will i ncl u de:
I nter ve nti o n 
N a me
Bi vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5) 
(ori gi nal a B N T 1 6 2 b 2 a n d 
B N T 1 6 2 b 2 O micr o n
[ B. 1. 1. 5 2 9 s u bli nea ge 
B A. 4/ B A. 5])
qI R V
qI R V/ bi vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5 )
QI V
Ar m N a me
( gr o u p of 
p artici p a nts 
recei vi n g a 
s pecific st u d y 
i nter ve nti o n or 
n o st u d y 
i nter ve nti o n)
qI R V/ bi vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5 )
or
Lice nse d QI V + 
bi vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5)
qI R V/ bi vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5 )
or
µ g qI R V
or
µ g qI R V
qI R V/ bi vale nt B N T 1 6 2 b 2 
(ori gi nal / Omi B A. 4/ B A. 5)
Lice nse d QI V 
+ bi vale nt 
B N T 1 6 2 b 2 
( ori gi nal/ O mi 
B A. 4/ B A. 5)
T ar gete d 
I nfl ue nz a 
Str ai ns
N/ A
F or eac h seas o n , strai ns as 
rec o m me n de d b y W H O 
f or rec o m bi na nt or cell-
base d i nfl ue nza vacci nes
F or eac h seas o n , strai ns as 
rec o m me n de d b y W H O f or 
rec o m bi na nt or cell-base d 
i nfl ue nza vacci nes
F or eac h 
seas o n,
strai ns as 
rec o m me n de d 
b y W H O 
T y pe
Vacci ne
Vacci ne
Vacci ne
Vacci ne
D ose 
F or m ul ati o n
m o d R N A
m o d R N A
m o d R N A
U nit D ose 
Stre n gt h(s)
As detaile d i n t he I P M  
As detaile d i n t he I P M  
As detaile d i n t he I P M  
As detaile d i n 
t he I P M
D os a ge 
Le vel(s)
µ g or
µ g
(  µ g ori gi nal 
B N T 1 6 2 b 2 a n d 
 µ g B N T 1 6 2 b 2 
O m icr o n
[B. 1. 1. 5 2 9 s u bli nea ge 
B A. 4/ B A. 5])
µ g o ri gi nal 
B N T 1 6 2 b 2 a n d 
µ g B N T 1 6 2 b 2 
O m icr o n
[B. 1. 1. 5 2 9 s u bli nea ge 
B A. 4/ B A. 5])
µ g 
(
µ g 
(
)
D ose -le vel c o m bi nati o n 1 as 
descri be d in Ta ble 1
µ g
qI R V 
µ g 
(
)
B N T 1 6 2 b 2 
µ g 
( 
µ g ori gi nal B N T 1 6 2 b 2 a n d 
µ g B N T 1 6 2 b 2 O m icr o n
[B. 1. 1. 5 2 9 s u bli nea ge 
B A. 4/ B A. 5 ])
D ose -le vel c o m bi nati o n 2 as 
descri be d in Ta ble 1
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 2
µ g 
qI R V
µ g 
)
B N T 1 6 2 b 2 
µ g 
(  µ g ori gi nal B N T 1 6 2 b 2 a n d 
µ g B N T 1 6 2 b 2 O m icr o n
[B. 1. 1. 5 2 9 s u bli nea ge 
B A. 4/ B A. 5 ])
D ose -le vel c o m bi nati o n 3 as 
descri be d in Ta ble 1
µ g
qI R V 
µ g 
(
)
B N T 1 6 2 b 2
µ g 
( 
µ g ori gi nal B N T 1 6 2 b 2 a n d 
µ g B N T 1 6 2 b 2 O m icr o n
[B. 1. 1. 5 2 9 s u bli nea ge 
B A. 4/ B A. 5 ])
R o ute of 
A d mi nistr ati o n
I ntra m usc ular i njecti o n 
I ntra m usc ular i njecti o n 
I ntra m usc ular i njecti o n
I ntra m usc ular 
i njecti o n
Use
E x peri me ntal
E x peri me ntal
E x peri me ntal
C o m parat or
I M P or 
NI M P/ A x M P
I M P
I M P
I M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y 
Pf izer
Pr o vi de d ce ntrall y b y 
Pf izer
St u d y i nter ve nti o n will be 
ge nerate d b y  
 
 at t he d ose-
le vel c o m bi nati o ns detaile d 
a b o ve:

qI R V

Bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5)
Pr o vi de d 
ce ntrall y b y 
Pf izer
P ac k a gi n g a n d 
L a beli n g
St u d y i nter ve nti o n will be 
pr o vi de d i n a glass vial as 
o pe n -la bel s u p pl y.  Eac h 
vial will be la bele d per 
c o u ntr y re q uire me nt.
St u d y i nter ve nti o n will be 
pr o vi de d i n a glass vial as 
o pe n -la bel s u p pl y.  Eac h 
vial will be la bele d per 
c o u ntr y re q uire me nt.
St u d y 
i nter ve nti o n 
will be 
pr o vi de d as 
eit her a P F S 
or a glass vial 
as o pe n -la bel 
s u p pl y.  Eac h 
vial will be 
la bele d per 
c o u ntr y 
re q uire me nt.
a.  
Ori gi nal refers t o t he a ncestral strai n ( W u ha n-H u -1; U S A -W A 1/ 2 0 2 0), als o referre d t o i n t his pr ot oc ol as t he 
refere nce strai n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 3
St u d y Ar ms
Gr o u p 
N u m ber
1
2
3
4
5
6
Ar m Title
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
D ose -le vel 
co m bi nati o n 1 as 
descri be d in 
Ta ble 1
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
D ose -le vel 
co m bi nati o n 2 as 
descri be d in 
Ta ble 1
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
D ose -le vel 
co m bi nati o n 3 as 
descri be d i n
Ta ble 1
µ g qI R V
µ g qI R V
Lice nse d QI V + 
bi vale nt B N T 1 6 2
b 2 ( ori gi nal /
O mi B A. 4/ B A. 5)
Ar m T y pe
E x peri me ntal 
E x peri me ntal 
E x peri me ntal 
E x peri me ntal 
E x peri me ntal 
E x peri me ntal
Ar m 
Descri pti o n
Partici pa nts will 
recei ve 
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
at d ose-le vel 
c o m bi nati o n 1 as 
descri be d in 
Ta ble 1
Partici pa nts will 
recei ve 
q I R V/bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
at d ose-le vel 
c o m bi nati o n 2 as 
descri be d in 
Ta ble 1
Partici pa nts will 
recei ve 
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
at d ose-le vel 
c o m bi nati o n 3 as 
descri be d in 
Ta ble 1
Partici pa nts 
will recei ve 
µ g of 
qI R V
Partici pa nts 
will recei ve 
µ g of 
qI R V
Partici pa nts will 
recei ve
µ g of 
bi vale nt B N T 1 6 2
b 2 ( ori gi nal / Omi
B A. 4/ B A. 5) 
a d mi nistere d 
c o nc urre ntl y i n 
t he o p p os ite ar m 
t o QI V
Ass oci ate d 
I nter ve nti o n 
L a bels
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
qI R V/ bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
qI R V 
qI R V
Bi vale nt 
B N T 1 6 2 b 2 
(ori gi nal / Omi
B A. 4/ B A. 5)
a n d QI V
1 0. 1 1. 6. 1. 1. A d mi nistr ati o n f or S u bst u d y A
See Secti o n 6. 1. 1 .
D uri n g S u bst u d y A, partici pa nts will recei ve 1 d ose of st u d y  i nter ve nti o n at Visit 1 i n a n
o pe n -la bel ma n ner i n acc or da nce wit h t he S o A (Secti o n 1 0. 1 1. 1 ).  Ot her t ha n QI V, a ll st u d y 
i nter ve nti o ns f or S u bst u d y  A s h o ul d be a d mi nistere d i ntra m usc ularly i nt o t he delt oi d m uscle 
of t he ri g ht ar m; w he n QI V is c oa d mi nistere d wit h bi vale nt B N T 1 6 2 b 2 
(ori gi nal / O mi B A. 4/ B A. 5), QI V s h o ul d be a d mi nistere d i ntra m usc ularl y i nt o t he delt oi d 
m uscle of t he left ar m.
1 0. 1 1. 6. 1. 2. Me dic al De vices f or S u bst u d y A
See Secti o n 6. 1. 2 .
1 0. 1 1. 6. 1. 3. Pre p ar ati o n, H a n dli n g, St or a ge, a n d Acc o u nt a bilit y f or S u bst u d y A
See Secti o n 6. 2 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 4
1 0. 1 1. 6. 1. 3. 1. Pre p ar ati o n a n d Dis pe nsi n g f or S u bst u d y A
See Secti o n 6. 2. 1 .
D uri n g S u bst u d y A, st u d y i nter ve nti o n will be pre pare d b y q ualifie d u n bli n de d site pers o n nel 
acc or di n g t o t he I PM or pac ka ge i nsert a n d t he st u d y  i nter ve nti o n a d mi nistere d i n a n 
o pe n -la bel ma n ner.
1 0. 1 1. 6. 1. 4. All oc ati o n t o St u d y I nter ve nti o n f or S u bst u d y A
See Secti o n 6. 3 .
All ocati o n of st u d y  i nter ve nti o n at Visit 1 i n S u bst u d y A will be c o n d ucte d via t he I RT.
1 0. 1 1. 6. 2. Bli n di n g f or S u bst u d y A
1 0. 1 1. 6. 2. 1. Bli n di n g of P artici p a nts f or S u bst u d y A
Partici pa nts will be u n bli n de d t o t heir assi g ne d st u d y i nter ve nti o n.
1 0. 1 1. 6. 2. 2. Bli n di n g of Site Pers o n nel f or S u bst u d y A
T his st u d y  is a n o pe n-la bel s u bst u d y, s uc h t hat all site pers o n nel, i ncl u di n g t he i n vesti gat or, 
i n vesti gat or staff, a n d st u d y staff recei vi n g, st ori n g, dis pe nsi n g, pre pari n g, a n d a d mi nisteri n g 
t he st u d y i nter ve nti o ns will be u n bli n de d.
1 0. 1 1. 6. 2. 3. Bli n di n g of t he S p o ns or f or S u bst u d y A
T o facilitate ra pi d re vie w of data i n real ti me, s p o ns or staff will be u n bli n de d t o st u d y  
i nter ve nti o n all ocati o n f or t he partici pa nts t hr o u g h o ut S u bst u d y A.
1 0. 1 1. 6. 2. 4. Br e a ki n g t he Bli n d f or S u bst u d y A
N ot a p plica ble.
1 0. 1 1. 6. 3. St u d y I nter ve nti o n C o m pli a nce f or S u bst u d y A
See Secti o n 6. 5.
1 0. 1 1. 6. 4. D ose M o dific ati o n f or S u bst u d y A
N ot a p plica ble.
1 0. 1 1. 6. 5. C o nti n ue d Access t o St u d y I nter ve nti o n After t he E n d of t he St u d y f or 
S u bst u d y A
See Secti o n 6. 7.
1 0. 1 1. 6. 6. Tre at me nt of O ver d ose f or S u bst u d y A
See Secti o n 6. 8.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 5
1 0. 1 1. 6. 7. Pri or a n d C o nc o mit a nt T her a p y f or S u bst u d y A
F or S u bst u d y  A, t he f oll o wi n g c onc o mita nt me dicati o ns a n d vacci nati o ns will be rec or de d i n 
t he C R F:

Pri or recei pt of a n y C O VI D -1 9 vacci ne.

Pri or recei pt of a n y p ne u m oc occal vacci ne.

Lice nse d i nfl ue nza vacci ne, if recei ve d d uri n g t he 1 2 m o nt hs pri or t o e nr oll me nt.

A n y  vacci nati o ns recei ved fr o m 2 8 da y s pri or t o st u d y e nr oll me nt u ntil t he last visit 
( Visit 6).

Pr o hi bite d me dicati o ns liste d i n Secti o n 1 0. 1 1. 6. 7. 1 , if ta ke n, will be rec or de d a n d 
i ncl u de start a n d st o p dates, na me of t he me dicati o n, d ose, u nit, r o ute, a n d fre q ue nc y.
1 0. 1 1. 6. 7. 1. Pr o hi bite d D uri n g t he St u d y f or S u bst u d y A
Recei pt of t he f oll o wi n g vacci nes a n d me dicati o ns d uri n g t he ti me peri o ds liste d bel o w ma y  
e xcl u de a partici pa nt fr o m t he per - pr ot oc ol a nalysis fr o m t hat p oi nt o n war d; h o we ver, it is 
a ntici pate d t hat t he partici pa nt w o ul d n ot be wit h dra w n fr o m t he st u d y  (see Secti o n 7) .  
Me dicati o ns s h o ul d n ot be wit h hel d if re q uire d f or a partici pa nt’s me dical care.

U nless c o nsi dere d me dicall y  necessar y, n o vacci nes ot her t ha n st u d y i nter ve nti o n s h o ul d 
be a d mi nistere d wit hi n 2 8 da y s bef ore a n d 2 8 da ys after st u d y vacci nati o n at Visit 1.

Recei pt of a n y ot her ( n o nst u d y ) c or o na vir us vacci ne fr o m e nr oll me nt t hr o u g h Visit 5 
( 8- wee k foll o w - u p visit) is pr ohi bite d.

Recei pt of a n y ot her ( n o nst u d y ) seas o nal i nfl ue nza vacci ne fr o m e nr oll me nt t hr o u g h
Visit 5 ( 8 - wee k foll o w -u p v isit) is pr o hi bite d.

Recei pt of c hr o nic s ys te mic treat me nt wit h k n o w n i m m u n os u p pressa nt me dicati o ns, or 
ra di ot hera py, wit hi n 6 0 da ys bef ore e nr oll me nt t hr o u g h c o ncl usi o n of t he st u d y  is 
pr o hi bite d.

Recei pt of s ys te mic c ortic oster oi ds (≥2 0 m g/ da y  of pre d nis o ne or e q ui vale nt) f or 
≥1 4 da y s is pr o hi bite d fr o m 2 8 da ys pri or t o e nr oll me nt t hr o u g h 2 8 da ys after 
a d mi nistrati o n of t he st u d y i nter ve nti o n.

Recei pt of bl o o d/ plas ma pr o d ucts, i m m u n o gl o b uli ns, or m o n ocl o nal a nti b o dies, fr o m 
6 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n t hr o u g h c o ncl usi o n of t he st u d y.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 6

Pr o p h y lactic a nti p yretics a n d ot her pai n me dicati o n t o pre ve nt sy m pt o ms ass ociate d wit h 
st u d y i nter ve nti o n a d mi nistrati o n are n ot per mitte d.  H o we ver, if a partici pa nt is ta ki n g a 
me dicati o n f or a n ot her c o n diti o n, e ve n if it ma y  ha ve a nti p yretic or pai n-relie vi n g 
pr o perties, it s h o ul d n ot be wit h hel d pri or t o st u d y vacci nati o n.
1 0. 1 1. 6. 7. 2. Per mitte d D uri n g t he St u d y f or S u bst u d y A

Me dicati o n ot her t ha n t hat descri be d as pr o hi bite d i n Secti o n 1 0. 1 1. 6. 7. 1 re q uire d f or 
treat me nt of pree xisti n g c o n diti o ns or ac ute ill ness is per mitte d.

I n hale d, t o pical, or l ocalize d i njecti o ns of c ortic oster oi ds (e g, i ntra-artic ular or i ntra b ursal 
a d mi nistrati o n) are per mitte d.
1 0. 1 1. 7. Disc o nti n u ati o n of S u bst u d y A I nter ve nti o n a n d P artici p a nt 
Disc o nti n u a ti o n/ Wit h dr a w al
See Secti o n 7 .
1 0. 1 1. 8. S u bst u d y A Assess me nts a n d Pr oce d ures
F or S u bst u d y  A, t he mi ni mal bl o o d sa m pli n g v ol u me f or all i n di vi d ual partici pa nts i n t his 
st u d y is a p pr o xi matel y 2 1 0 m L.
F or all partici pa nts i n S u bst u d y  A, ot her a d diti o nal bl o o d sa m ples ma y be ta ke n f or safety 
assess me nts, pr o vi de d t he t otal v ol u me ta ke n d uri n g t he st u d y  d oes n ot e xcee d 5 5 0 m L  
d uri n g a n y peri o d of 6 0 c o nsec uti ve da ys.
1 0. 1 1. 8. 1. I m m u n o ge nicit y Assess me nts f or S u bst u d y A
Sa m ples will be c ollecte d at ti me p oi nts as s pecifi e d i n Secti o n 1 0. 1 1. 1 fr o m all partici pa nts,
a n d t he f oll o wi n g assa ys r u n:

H AI titers f or t he matc he d seas o nal strai ns ( 
) rec o m me n de d b y W H O 

S A R S -C o V -2 ne utralizati o n assa y  (refere nce strai n)

S A R S -C o V -2 ne utralizati o n assa y s (O micr o n B A. 4, O micr o n B A. 5; ot her V O Cs of 
i nterest, i ncl u di n g ot her O micr o n s u bli nea ges, ma y als o be e val uate d)
1 0. 1 1. 8. 2. N- Bi n di n g A nti b o d y Test f or S u bst u d y A
T he N -bi n di n g a nti b o d y  test will be perf or me d by t he ce ntral la b orat or y o n eac h bl o o d 
sa m ple t o esta blis h pri or e x p os ure t o S A R S-C o V - 2 u p t o eac h ti me p oi nt.  T hese data will be 
use d f or st u d y a nal ys es.
1 0. 1 1. 8. 3. Bi ol o gic al S a m ples f or S u bst u d y A
See Secti o n 8. 2. 1 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 7
1 0. 1 1. 8. 4. S afet y Assess me nts f or S u bst u d y A
See Secti o n 8. 3 .
N ote, f or Su bst u d y  A, l ocal reacti o ns will be assesse d at t he i njecti o n site o n t he ri g ht ar m 
o nl y  (see Secti o n 8. 3. 5 ).
1 0. 1 1. 8. 4. 1. E C Gs f or S u bst u d y A
E C Gs will be c ollecte d at t he ti mes s pecifie d i n Secti o n 1 0. 1 1. 1 .
All sc he d ule d 1 2 -lea d E C Gs s h o ul d be perf or me d after t he partici pa nt has reste d q uietl y f or 
at least 1 0 mi n utes i n a s u pi ne p ositi o n.  T he E C Gs s h o ul d be o btai ne d pri or t o bl o o d 
c ollecti o n, meas ure me nt of bl o o d press ure, a n d meas ure me nt of p ulse rate.  E C Gs will be 
perf or me d i n tri plicate.
E C G data will be s u b mitte d t o a ce ntral la b orat or y f or e val uati o n .  T he fi nal E C G re p ort fr o m 
t he ce ntral la b orat or y s h o ul d be mai ntai ne d i n t he partici pa nt’s s o urce d oc u me ntati o n a n d be 
t he fi nal i nter pretati o n of t he E C G rec or di n g.  A n y cli nicall y si g nifica nt c ha n ges fr o m t he 
baseli ne/ Da y  1 E C G ma y p ote ntiall y be AE s (see Secti o n 1 0. 3 ) a n d s h o ul d be e val uate d 
f urt her, as cli nically warra nte d.
I n s o me cases, it ma y be a p pr o priate t o re peat a b n or mal E C Gs t o r ule o ut i m pr o per lea d 
place me nt as c o ntri b uti n g t o t he E C G a b n or malit y.  It is i m p orta nt t hat lea d place me nt be i n 
t he sa me p ositi o n eac h ti me d uri n g eac h assess me nt visit i n or der t o ac hie ve precise E C G 
rec or di n gs.
E C G a b n or malities c o nsiste nt wit h pr o ba ble or p ossi ble m y ocar ditis or pericar ditis are t h ose 
j u d ge d as s uc h by a car di ol o gist, i ncl u di n g :

S ustai ne d atrial or ve ntric ular arr h yt h mias

Sec o n d -de gree M o bitz T y pe II or w orse A V bl oc k, ne w b u n dle bra nc h bl oc k

Diff use S T -se g me nt ele vati o n or P R-se g me nt i n versi o n, c o m pati ble wit h pericar ditis
Ec h ocar di o gra ms ma y  be perf or me d as detaile d i n Secti o n 1 0. 1 1. 8. 8. 1 0 .
E C G val ues of p ote ntial cli nical c o ncer n are liste d i n Secti o n 1 0. 9 .
1 0. 1 1. 8. 5. Cli nic al S afet y L a b or at or y Assess me nts f or S u bst u d y A
Please see Secti o n 8. 3. 4 .  A d diti o nall y, see Secti o n 1 0. 2 f or t he list of cli nical safety 
la b orat or y tests t o be perf or me d a n d t he S o A f or t he ti mi n g a n d fre q ue nc y.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 8
1 0. 1 1. 8. 6. St o p pi n g R ules f or S u bst u d y A
T he f oll o wi n g st o p pi n g r ules are i n place f or partici pa nts i n gr o u ps recei vi n g c o m bi nati o n 
bi vale nt B N T 1 6 2 b 2 ( o ri gi nal/ O mi B A. 4/ B A. 5) a n d qIR V i n S u bst u d y A , base d o n A E, 
E C G, a n d la b orat or y  data re vie w.  T hese data will be re vie we d o n a n o n g oi n g basis b y t he 
i n vesti gat or ( or me dicall y q ualifie d desi g nee) a n d s p o ns or i n or der t o pr o m ptl y i de ntif y a n d 
flag a n y e ve nt t hat p ote ntiall y c o ntri b utes t o a st o p pi n g r ule.
T he s p o ns or st u d y  tea m will be u n bli n de d, s o will be a ble t o assess w het her or n ot a st o p pi n g 
r ule has bee n met o n t he basis of a partici pa nt’s i n di vi d ual st u d y i nter ve nti o n all ocati o n.
I n t he e ve nt t hat s p o ns or pers o n nel c o nfir m t hat a st o p pi n g r ule is met, t he f oll o wi n g acti o ns 
will c o m me nce:

T he I R C will re vie w all a p pr o priate data.

T he st o p pi n g r ule will P A U S E ra n d o mizati o n a n d st u d y  i nter ve nti o n a d mi nistrati o n 
f or t he bi vale nt B N T 1 6 2 b 2 ( o ri gi nal/ O mi B A. 4/ B A. 5)/ qIR V vacci ne gr o u p(s) at t he 
affecte d a n d, if a p plica ble, hi g her t otal d ose le vel 
 or  
µ g).

St u d y  i nter ve nti o n a d mi nistrati o n ma y c o nti n ue d uri n g t he pa use i n vacci ne gr o u ps 
recei vi n g qI R V al o ne, or QI V a d mi nistere d c o nc urre ntl y wit h bi vale nt B N T 1 6 2 b 2 
(ori gi nal/ O mi B A. 4/ B A. 5 ).

F or all partici pa nts alrea d y  vacci nate d, all ot her r o uti ne st u d y c o n d uct acti vities, 
i ncl u di n g o n g oi n g data e ntr y, re p orti n g of AE s, partici pa nt e-diar y c o m pleti o n, bl o o d 
sa m ple c ollecti o n, a n d partici pa nt f oll o w- u p, will c o nti n ue d uri n g t he pa use.
A st o p pi n g r ule is met if a n y  of t he f oll o wi n g r ules occ ur wit hi n 4 wee ks after a d mi nistrati o n 
of bi vale nt B N T 1 6 2 b 2 ( o ri gi nal/ O mi B A. 4/ B A. 5)/qI R V . Eac h bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5)/ qIR V d ose le vel will be e val uate d f or c o ntri b uti o n t o st o p pi n g 
r ules i n de pe n de ntly.
St o p pi n g R ule Criteria:
1.
If a ny partici pa nt vacci nate d de vel o ps:

A ne w E C G a b n or malit y  t hat a car di ol o gist j u d ges c o nsiste nt wit h pr o ba ble or 
p ossi ble m y ocar ditis or pericar ditis, i ncl u di n g:

S ustai ne d atrial or ve ntric ular arr h yt h mias

Sec o n d -de gree M o bitz T y pe II or w orse A V bl oc k, ne w b u n dle bra nc h bl oc k

Diff use S T -se g me nt ele vati o n or P R-se g me nt i n versi o n, c o m pati ble wit h 
pericar ditis
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 3 9

A n a b n or mal tr o p o ni n I val ue t hat is c o nfir me d a b n or mal o n re peat testi n g, assesse d 
as relate d t o st u d y i nter ve nti o n b y t he i n vesti gat or.
2.
If ≥1 partici pa nt vacci nate d de vel o ps c o nfir me d m y ocar ditis or pericar ditis.
3.
If a ny partici pa nt vacci nate d dies.
4.
≥1 part ici pa nt vacci nate d e x perie nces a Gra de 4 u ns olicite d A E, or S A E of a n y se verity, 
assesse d as relate d b y t he i n vesti gat or.
5.
≥2 partici pa nts vacci nate d wit h bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4 / B A. 5)/qI R V at 
t he sa me d ose le vel de vel o p t he sa me or si milar Gra de 3 or hi g her u ns olicite d A E, ot her 
t ha n m yocar ditis/ pericar ditis, assesse d as relate d t o st u d y  i nter ve nti o n by t he i n vesti gat or.  
N ote t hat t he l ocal reacti o ns, s y ste mic e ve nts, a n d fe ver s pecifie d i n Secti o n 8. 3. 5 , 
re p orte d wit hi n 7 da ys fr o m t he da y of a d mi nistrati o n of t he st u d y i nter ve nti o n, 
irres pecti ve of w het her t he y  are rec or de d i n t he e-diar y  or as AE s, are e xcl u de d fr o m t his 
st o p pi n g r ule.
1 0. 1 1. 8. 7. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her S afet y Re p orti n g f or 
S u bst u d y A
See Secti o n 8. 4 .
1 0. 1 1. 8. 8. St u d y Pr oce d ur es f or S u bst u d y A
1 0. 1 1. 8. 8. 1. Scree ni n g ( 0 t o 2 8 D a ys Bef ore Visit 1) f or S u bst u d y A
Bef ore e nr oll me nt a n d bef ore a n y st u d y- relate d pr oce d ures are perf or me d, v ol u ntar y, writte n, 
st u d y-s pecific i nf or me d c o nse nt will be o btai ne d fr o m t he partici pa nt.  Eac h si g nat ure o n t he 
I C D m ust be pers o nally date d b y t he si g nat or y.  T he i n vesti gat or or his or her desi g nee will 
als o si g n t he I C D.  A c o p y of t he si g ne d a n d date d IC D m ust be gi ve n t o t he partici pa nt.  T he 
s o urce data m ust reflect t hat t he i nf or me d c o nse nt was o btai ne d bef ore partici pati o n i n t he 
st u d y.
It is a ntici pate d t hat t he pr oce d ures bel o w will be c o n d ucte d i n a ste p wise ma n ner.

Assi g n a partici pa nt n u m ber usi n g t he I R T s ys te m.  

O btai n t he partici pa nt’s de m o gra p h y (i ncl u di n g date of birt h, se x, race, a n d et h nicit y).  
T he f ull date of birt h will be c ollecte d t o criticall y e val uate t he i m m u ne res p o nse a n d 
safety pr ofile b y a ge.

O btai n me dical hist or y , i ncl u di n g c o nfir me d C O VI D-1 9 dia g n osis (see Secti o n 8. 4. 7 ) or 
as ym pt o matic p ositi ve S A R S -C o V -2 test res ult ( N A A T or a nti ge n test), a n d a n y  ot her 
me dical hist or y  of cli nical si g nifica nce.

O btai n details of a n y me dicati o ns c urre ntl y ta ke n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 0

Perf or m 1 2 -lea d tri plicate E C G.

Perf or m p h ys ical e xa mi nati o n, i ncl u di n g vital si g ns ( wei g ht, hei g ht, oral te m perat ure, 
p ulse rate, a n d seate d bl o o d press ure), e val uati n g a n y  cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g b o d y  s yste ms: ge neral a ppeara nce; s ki n; hea d, e y es, ears, n ose, a n d 
t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ne ur ol o gical; a n d l ym p h 
n o des.

C ollect a bl o o d sa m ple of a p pr o xi matel y  2. 5 m L as detaile d i n t he la b orat or y ma n ual f or 
tr o p o ni n I la b orat or y testi n g as descri be d i n Secti o n 8. 3. 4.

Perf or m uri ne pre g na nc y test o n W O C B P as descri be d i n Secti o n 8. 3. 6 .

Disc uss c o ntrace pti ve use as descri be d i n Secti o n 5. 3. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 1. 6. 7 .

Re vie w d oc u me ntati o n of all pri or C O VI D - 1 9 vacci nati o ns.  All vacci nes m ust be 
a ut h orize d f or use i n t he U S.  Rec or d pri or recei pt of a n y C O VI D -1 9 vacci ne as 
descri be d i n Secti o n 1 0. 1 1. 6. 7 .

Rec or d pri or recei pt of a n y  p ne u m oc occal vacci ne as descri be d i n Secti o n 1 0. 1 1. 6. 7 .

Rec or d details of a n y lice nse d i nfl ue nza vacci ne recei ve d i n t he pri or 1 2 m o nt hs, as 
descri be d i n Secti o n 1 0. 1 1. 6. 7 .

E ns ure a n d d oc u me nt t hat all of t he i ncl usi o n criteria a n d n o ne of t he e xcl usi o n criteria 
are met.

Rec or d A E s as descri be d i n Secti o n 8. 4. 1 .

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R F.
1 0. 1 1. 8. 8. 2. Visit 1 – V acci n ati o n ( D a y 1) f or S u bst u d y A

It is a ntici pate d t hat t he pr oce d ures bel o w will be c o n d ucte d i n a ste p wise ma n ner.

Disc uss c o ntrace pti ve use as descri be d i n Secti o n 5. 3. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 1. 6. 7 .

Re vie w scree ni n g la b orat or y  res ults (tr o p o ni n I) a n d E C G res ults.

Perf or m 1 2 -lea d tri plicate E C G.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 1

Perf or m a cli nical assess me nt.  If t he cli nical assess me nt i n dicates t hat a p h y sical 
e xa mi nati o n is necessar y t o c o m pre he nsi vel y e val uate t he partici pa nt, perf or m a p h ys ical 
e xa mi nati o n a n d rec or d a n y fi n di n gs i n t he s o urce d oc u me nts a n d, if cli nicall y 
si g nifica nt, recor d o n t he me dical hist or y  C R F or o n t he A E C R F as per Secti o n 1 0. 3 .

Meas ure vital si g ns, i ncl u di n g oral te m perat ure, p ulse rate, a n d seate d bl o o d press ure.

Perf or m uri ne pre g na nc y test o n W O C B P as descri be d i n Secti o n 8. 3. 6 .

E ns ure t hat t he partici pa nt c o nti n ues t o meet all of t he i ncl usi o n criteria a n d n o ne of t he 
e xcl usi o n criteria.

E ns ure t hat t he partici pa nt meets n o ne of t he te m p orar y  dela y criteria as descri be d i n 
Secti o n 5. 5 .

O btai n t he partici pa nt’s ra n d o mizati o n n u m ber a n d st u d y  i nter ve nti o n all ocati o n usi n g 
t he IR T s ys te m.

O n t he da y  of a n d bef ore vacci nati o n, o btai n a nasal ( mi dt ur bi nate) s wa b (c ollecte d by 
site staff).

C ollect a bl o o d sa m ple of a p pr o xi matel y  2. 5 m L as detaile d i n t he la b orat or y ma n ual f or 
tr o p o ni n I la b orat or y testi n g as descri be d i n Secti o n 8. 3. 4 .

C ollect a bl o o d sa m ple (a p pr o xi matel y  5 0 m L), bef ore a d mi nistrati o n of st u d y 
i nter ve nti o n, f or i m m u n o ge nicit y assess me nt.

Site staff me m ber(s) will dis pe nse/a d mi nister 1 d ose of st u d y  i nter ve nti o n i nt o t he delt oi d 
m uscle.  Ot her t ha n QI V, a ll st u d y i nter ve nti o ns f or S u bst u d y  A s h o ul d be a d mi nistere d 
i ntra m usc ularly i nt o t he delt oi d m uscle of t he ri g ht ar m; w he n QI V is c oa d mi nistere d 
wit h bi vale nt B N T 1 6 2 b 2 ( ori gi nal / O mi B A. 4/ B A. 5) , QI V s h o ul d be a d mi nistere d 
i ntra m usc ularly i nt o t he delt oi d m uscle of t he left ar m.  Please refer t o t he I P M
f or f urt her 
i nstr ucti o n o n t his pr ocess.

Site staff m ust o bser ve t he partici pa nt f or at least 3 0 mi n utes after st u d y  i nter ve nti o n 
a d mi nistrati o n f or an y  ac ute reacti o ns.  Rec or d a n y ac ute reacti o ns (i ncl u di n g ti me of 
o nset) i n t he partici pa nt’s s o urce d oc u me nts a n d o n t he A E pa ge of t he C R F, a n d o n a n 
S A E f or m as a p plica ble.

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns at t he i njecti o n site a n d a
t her m o meter f or rec or di n g daily te m perat ures a n d pr o vi de i nstr ucti o ns o n t heir use.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 2

E x plai n t he e -diar y  c o m pleti o n re q uire me nt t o t he partici pa nt a n d assist t he partici pa nt 
wit h d o w nl oa di n g t he st u d y  a p plicati o n o nt o t he partici pa nt’s o w n de vice or iss ue a 
pr o visi o ne d de vice if re q uire d.  Pr o vi de i nstr ucti o ns o n e- diar y  c o m pleti o n a n d as k t he 
partici pa nt t o c o m plete t he react o ge nicit y e -diar y  fr o m Da y 1 t hr o u g h D a y  7, wit h Da y 1 
bei n g t he da y  of vacci nati o n.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diately if he or s he 
e x perie nces a n y of t he f oll o wi n g fr o m Da y  1 t hr o u g h D a y  7 after vacci nati o n 
( w here Da y 1 is t he da y  of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y 
visit is re q uire d:

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness o r s welli n g at t he i njecti o n site meas uri n g greater t ha n 1 0 c m 
( > 2 0 meas uri n g de vice u nits).

Se vere pai n at t he i njecti o n site.

A n y  se vere sys te mic e ve nt.

Rec or d A E s as descri be d i n Secti o n 8. 4. 1 .

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dicall y atte n de d e ve nt 
(e g, d oct or’s visit, e mer ge nc y r o o m visit) or h os pitalizati o n occ urs.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if t he partici pa nt 
e x perie nces ac ute c hest pai n, s h ort ness of breat h, or pal pitati o ns 
(see Secti o n 1 0. 1 1. 8. 8. 1 0 ).

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

Re mi n d t he partici pa nt t o bri n g t he e -diar y  t o t he ne xt visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs a n d u p dates t he st u d y  
i nter ve nti o n acc o u nta bilit y rec or ds.

T he i n vesti gat or or a p pr o priatel y  q ualifie d desi g nee re vie ws t he react o ge nicit y 
e-diar y  data o nli ne f oll o wi n g vacci nati o n t o e val uate partici pa nt c o m plia nce a n d as part 
of t he o n g oi n g safet y re vie w.  Dail y re vie w is o pti mal d uri n g t he acti ve diar y peri o d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 3
1 0. 1 1. 8. 8. 3. Visit 2 – D a y 3 F oll o w -U p Visit ( After V acci n ati o n) – 2 t o 4 D a ys After 
Visit 1 f or S u bst u d y A

Rec or d A E s as descri be d i n Secti o n 8. 4. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 1. 6. 7 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 1 0. 1 1. 6. 7. 1 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or c o ntrace pti o n as 
descri be d i n Secti o n 5. 3. 1 .

Re vie w la b orat or y  res ults (tr o p o ni n I) a n d E C G res ults.  A n y a b n or mal tr o p o ni n I le vel 
m ust res ult i n f urt her assess me nts as o utli ne d i n Secti o n 1 0. 1 1. 8. 8. 1 0 .

Perf or m 1 2 -lea d tri plicate E C G.  A n y ne w E C G a b n or malit y (c o m pare d t o baseli ne) 
c o nsiste nt wit h pr o ba ble or p ossi ble m y ocar ditis or pericar ditis (as liste d i n
Secti o n 1 0. 1 1. 8. 4. 1 ) m ust res ult i n f urt her assess me nts as o utli ne d i n 
Secti o n 1 0. 1 1. 8. 8. 1 0 .

Meas ure vital si g ns, i ncl u di n g oral te m perat ure, p ulse rate, a n d seate d bl o o d press ure.

C ollect a bl o o d sa m ple of a p pr o xi matel y  2. 5 m L as detaile d i n t he la b orat or y ma n ual f or 
tr o p o ni n I la b orat or y testi n g as descri be d i n Secti o n 8. 3. 4 .

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diately i f he or s he 
e x perie nces a n y of t he f oll o wi n g fr o m Da y  1 t hr o u g h D a y  7 after vacci nati o n 
( w here Da y 1 is t he da y  of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y 
visit is re q uire d:

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness or s welli n g at t he i njecti o n site meas uri n g greater t ha n 1 0 c m 
( > 2 0 meas uri n g de vice u nits).

Se vere pai n at t he i njecti o n site.

A n y  se vere sys te mic e ve nt.

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dicall y atte n de d 
e ve nt (e g, d oct or’s visit, e mer ge nc y r o o m visit) or h os pitalizati o n occ urs.

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diately if t he 
partici pa nt e x perie nces ac ute c hest pai n, s h ort ness of breat h, or pal pitati o ns 
(see Secti o n 1 0. 1 1. 8. 8. 1 0 ).
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 4

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
1 0. 1 1. 8. 8. 4. Visit 3 – 1- Wee k F oll o w- U p Visit ( After V acci n ati o n) – 6 t o 8 D a ys After 
Visit 1 f or S u bst u d y A

Rec or d A E s as descri be d i n Secti o n 8. 4. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 1. 6. 7 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Sec ti o n 1 0. 1 1. 6. 7. 1 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or c o ntrace pti o n as 
descri be d i n Secti o n 5. 3. 1 .

Re vie w la b orat or y  res ults (tr o p o ni n I) a n d E C G res ults.  A n y a b n or mal tr o p o ni n I le vel 
m ust res ult i n f urt her assess me nts as o utli ne d i n Secti o n 1 0. 1 1. 8. 8. 1 0 .

Perf or m 1 2 -lea d tri plicate E C G.  A n y ne w E C G a b n or malit y (c o m pare d t o baseli ne) 
c o nsiste nt wit h pr o ba ble or p ossi ble m y ocar ditis or pericar ditis (as liste d i n 
Secti o n 1 0. 1 1. 8. 4. 1 ) m ust res ult i n f urt her assess me nts as o utli ne d i n 
Secti o n 1 0. 1 1. 8. 8. 1 0 .

Meas ure vital si g ns, i ncl u di n g oral te m perat ure, p ulse rate, a n d seate d bl o o d press ure.

C ollect a bl o o d sa m ple of a p pr o xi matel y  2. 5 m L as detaile d i n t he la b orat or y ma n ual f or 
tr o p o ni n I la b orat or y testi n g as descri be d i n Secti o n 8. 3. 4 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  5 0 m L  f or i m m u n o ge nicity testi n g.

Re vie w t he partici pa nt’s react o ge nicit y  e-diar y  data.  If t he e-diar y  c ollecti o n peri o d is 
c o m plete:

C ollect st o p dates of a n y react o ge nicit y e-diar y  e ve nts o n g oi n g o n t he last da y 
t hat t he react o ge nicity e -diar y  was c o m plete d a n d rec or d st o p dates i n t he C R F if 
re q uire d.

C ollect t he partici pa nt’s e- diar y  or assist t he partici pa nt wit h re m o vi n g t he st u d y 
a p plicati o n fr o m his or her o w n pers o nal de vice (if t he visit is c o n d ucte d after 
D a y  7).
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 5

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diately i f he or s he 
e x perie nces a n y of t he f oll o wi n g fr o m Da y  1 t hr o u g h D a y  7 after vacci nati o n 
( w here Da y 1 is t he da y of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y 
visit is re q uire d:

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness or s welli n g at t he i njecti o n site meas uri n g greater t ha n 1 0 c m 
( > 2 0 meas uri n g de vice u nits).

Se vere pai n at t he i njecti o n site.

A n y  se vere sys te mic e ve nt.

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dicall y atte n de d 
e ve nt (e g, d oct or’s visit, e mer ge nc y  r o o m visit) or h os pitalizati o n occ urs.

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diately if t he 
partici pa nt e x perie nces ac ute c hest pai n, s h ort ness of breat h, or pal pitati o ns 
(see Secti o n 1 0. 1 1. 8. 8. 1 0 ).

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
1 0. 1 1. 8. 8. 5. Visit 4 – 4- Wee k F oll o w- U p Visit ( After V acci n ati o n) – 2 6 t o 3 0 D a ys After 
Visit 1 f or S u bst u d y A

Rec or d A E s as descri be d i n Secti o n 8. 4. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n S ecti o n 1 0. 1 1. 6. 7 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 1 0. 1 1. 6. 7. 1 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or c o ntrace pti o n as 
descri be d i n Secti o n 5. 3. 1 .

Re vie w la b orat or y  res ults (tr o p o ni n I) a n d E C G res ults.  A n y a b n or mal tr o p o ni n I le vel 
m ust res ult i n f urt her assess me nts as o utli ne d i n Secti o n 1 0. 1 1. 8. 8. 1 0 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  5 0 m L  f or i m m u n o ge nicity testi n g.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 6

Re vie w t he partici pa nt’s react o ge nicit y  e-diar y  data.  C ollect st o p dates of a n y 
react o ge nicit y e-diar y  e ve nts o n goi n g o n t he last da y  t hat t he react o ge nicit y e-diar y  was 
c o m plete d a n d rec or d st o p dates i n t he C R F if re q uire d.

If n ot alrea dy c o m plete d, c ollect t he partici pa nt’s e -diar y  or assist t he partici pa nt wit h 
re m o vi n g t he st u dy a p plicati o n fr o m his or her o w n p ers o nal de vice.

Rec or d a n y A E s t hat occ ur wit hi n t he 4 8 h o urs after t he bl o o d dra w as descri be d i n 
Secti o n 8. 4. 1 .
1 0. 1 1. 8. 8. 6. Visi t 5 – 8- Wee k F oll o w- U p Visit ( After V acci n ati o n) – 5 2 t o 6 0 D a ys After 
Visit 1 f or S u bst u d y A

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 1. 6. 7 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 1 0. 1 1. 6. 7. 1 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  5 0 m L  f or i m m u n o ge nicity testi n g.

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dicall y atte n de d 
e ve nt (e g, d oct or’s visit, e mer ge nc y  r o o m visit) or h os pitalizati o n occurs.

Rec or d A E s as descri be d i n Secti o n 8. 4. 1 .

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.

Rec or d a n y A Es t hat occ ur wit hi n t he 4 8 h o urs after t he bl o o d dra w as descri be d i n 
Secti o n 8. 4. 1 .

Partici pa nts w h o ha ve n ot recei ve d lice nse d QI V at Visit 1 ma y  recei ve t his, if dee me d as 
re q uire d by t he i n vesti gat or.
1 0. 1 1. 8. 8. 7. Visit 6 – 6- M o nt h Tele p h o ne C o nt act – 1 7 5 t o 1 8 9 D a ys After L ast St u d y 
V acci n ati o n f or S u bst u d y A

C o ntact t he partici pa nt b y  tele p h o ne.

Rec or d S A Es as descri be d i n Secti o n 8. 4. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 1. 6. 7 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 1 0. 1 1. 6. 7. 1 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 7

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
1 0. 1 1. 8. 8. 8. S A R S -C o V -2 N A A T Res ults f or S u bst u d y A

A nasal ( mi dt ur bi nate) s wa b f or S A R S -C o V -2 N A A T is o btai ne d at t he vacci nati o n visit 
( Visit 1/ Da y 1).
Researc h la b orat or y – ge nerate d p ositi ve res ults fr o m t he vacci nati o n visit s wa bs will be 
pr o vi de d t o t he site o nce a vaila ble, b ut t his will n ot be i n real ti me a n d ca n n ot be relie d u p o n 
t o direct cli nical care.  T heref ore, t he partici pa nt s h o ul d be directe d t o see k a d diti o nal testi n g 
t hr o u g h his/ her pri mar y healt hcare pr o vi der at a lice nse d cli nical la b orat or y w he n e x hi biti n g 
p ote ntial C O VI D - 1 9 sy m pt o ms or ot her wise recei vi n g a p ositi ve res ult a n d c o u nsele d o n 
w het her t o ta ke a n y preca uti o nar y  meas ures pe n di n g c o nfir mat or y testi n g, as per l ocal 
g ui da nce.
1 0. 1 1. 8. 8. 9. U nsc he d ule d Visit f or a Gr a de 3 or S us pecte d Gr a de 4 Re acti o n f or 
S u bst u d y A
If a Gra de 3 l ocal reacti o n (Secti o n 8. 3. 5. 2 ), sys te mic e ve nt (Secti o n 8. 3. 5. 3 ), or fe ver 
(Secti o n 8. 3. 5. 4 ) is re p orte d i n t he react o ge nicity e -diar y , a tele p h o ne c o ntact s h o ul d occ ur t o 
ascertai n f urt her details a n d deter mi ne w het her a site visit is cli nicall y  i n dicate d.  If a 
s us pecte d Gra de 4 l ocal reacti o n (Secti o n 8. 3. 5. 2 ), s yste mic e ve nt (Secti o n 8. 3. 5. 3 ), or fe ver 
(Secti o n 8. 3. 5. 4 ) is re p orte d i n t he react o ge nicity e -diar y , a tele p h o ne c o ntact or site visit 
s h o ul d occ ur t o c o nfir m w het her t he e ve nt meets Gra de 4 criteria.
A s ite visit m ust be sc he d uled as s o o n as p ossi ble t o assess t he partici pa nt u nless a n y of t he 
f oll o wi n g is tr ue:

T he partici pa nt is u na ble t o atte n d t he u nsc he d ule d visit.

T he l ocal reacti o n/s ys te mic e ve nt is n o l o n ger prese nt at t he ti me of t he tele p h o ne 
c ontact.

T he partici pa nt rec or de d a n i nc orrect val ue i n t he react o ge nicit y  e-diar y  (c o nfir mati o n of 
a react o ge nicit y e -diar y  data e ntr y err or).

T he PI  or a ut h orize d desi g nee deter mi ne d it was n ot nee de d.
T his tele p h o ne c o ntact will be rec or de d i n t he partici pa nt’s s o urce d oc u me ntati o n a n d t he 
C R F.
If t he partici pa nt is u na ble t o atte n d t he u nsc he d ule d visit, or t he PI or a ut h orize d desi g nee 
deter mi ne d it was n ot nee de d, a n y o n g oi n g l ocal reacti o ns/s y ste mic e ve nts m ust be assesse d 
at t he ne xt st u d y visit.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 8
D uri n g t he u nsc he d ule d visit, t he reacti o ns s h o ul d be assesse d b y t he i n vesti gat or or a 
me dicall y  q ualifie d me m ber of t he st u d y staff, s uc h as a st u d y p h ysicia n or a st u d y n urse, as 
a p plica ble t o t he i n vesti gat or’s l ocal practice, w h o will:

Meas ure b o d y t e m perat ure (°F/ °C).

Meas ure mi ni m u m a n d ma xi m u m dia meters of re d ness (if prese nt).

Meas ure mi ni m u m a n d ma xi m u m dia meters of s welli n g (if prese nt).

Assess i njecti o n site pai n (if prese nt) i n acc or da nce wit h t he gra des pr o vi de d i n 
Sec ti o n 8. 3. 5. 2 .

Assess s y ste mic e ve nts (if prese nt) i n acc or da nce wit h t he gra des pr o vi de d i n 
Secti o n 8. 3. 5. 3 .

Assess ot her fi n di n gs ass ociate d wit h t he reacti o n a n d rec or d t his o n t he A E pa ge of t he 
C R F if a p pr o priate.

T he i n vesti gat or or a n a ut h orize d desi g nee will c o m plete t he u nsc he d ule d visit 
assess me nt pa ge of t he C R F.
1 0. 1 1. 8. 8. 1 0. A d diti o n al Pr oce d ures f or M o nit ori n g of P ote nti al M y oc ar ditis or 
Peric ar ditis f or S u bst u d y A
A n y  st u d y partici pa nt w h o re p orts ac ute c hest pai n, s h ort ness of breat h, pal pitati o ns, or a n y 
ot her s y m pt o m(s) t hat mi g ht be i n dicati ve of my ocar ditis or pericar ditis wit hi n 4 wee ks after 
st u d y vacci nati o n m ust be s pecificall y e val uate d b y a car di ol o gist f or p ossi ble m yocar ditis or 
pericar ditis.  T he sa me a p plies f or a n y partici pa nt i n w h o m a ne w E C G a b n or malit y  
(c o m pare d t o baseli ne) c o nsiste nt wit h pr o ba ble or p ossi ble m yocar ditis or pericar ditis 
(as liste d i n Secti o n 1 0. 1 1. 8. 4. 1 ) or a b n or mal tr o p o ni n I le vel is o bser ve d at Visit 2 or 3.
I n a d diti o n t o a cli nical e val uati o n, t he f oll o wi n g s h o ul d be perf or me d:

E C G a n d

Meas ure me nt of t he tr o p o ni n le vel
F or a n y partici pa nt i n w h o m a ne w E C G a b n or malit y  (c o m pare d t o baseli ne) c o nsiste nt wit h 
pr o ba ble or p ossi ble m y o car ditis or pericar ditis (as liste d i n Secti o n 1 0. 1 1. 8. 4. 1 ) or a b n or mal 
tr o p o ni n I le vel is o bser ve d at Visit 2 or 3, t his s h o ul d be ac hie ve d b y re peati n g t he 
assess me nts wit h t he ce ntral ve n d or(s).
If m yocar ditis or pericar ditis is s us pecte d base d u p o n t he i nitial e val uati o n, t he f oll o wi n g 
s h o ul d als o be perf or me d:

Car diac ec h ocar di o gra m a n d/ or
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 4 9

Car diac ma g netic res o na nce st u d y
Details of t he s y m pt o ms re p orte d, a n d res ults of t he i n vesti gati o ns perf or me d, will be 
rec or de d i n t he C R F.
1 0. 1 1. 9. St atistic al C o n si der ati o ns – S u bst u d y A
M et h o d ol o g y f or s u m mar y a n d statistical a nalys es of t he data c ollecte d i n t his s u bst u d y is 
descri be d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or. T he 
S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc o l w here a p pr o priate; h o we ver, a n y maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
1 0. 1 1. 9. 1. St atistic al H y p ot heses f or S u bst u d y A
T here are n o statistical h y p ot heses i n S u bst u d y A.
1 0. 1 1. 9. 1. 1. Esti m a n ds for S u bst u d y A
T he esti ma n ds c orres p o n di n g t o t he pri mar y a n d sec o n dar y o bjecti ves are descri be d i n t he 
ta ble i n Secti o n 1 0. 1 1. 3 .
1 0. 1 1. 9. 1. 2. M ulti plicit y A dj ust me nt
f or S u bst u d y A
T here is n o m ulti plicit y a dj ust me nt f or S u b st u d y A as all a nal ys es are descri pti ve i n nat ure.
1 0. 1 1. 9. 2. A n al ysis Sets f or S u bst u d y A
F or p ur p oses of a nal y sis, t he f oll o wi n g a nalys is sets are defi ne d i n S u bst u d y A:
P o p ul ati o n
Descri pti o n
Scree ne d
All partici pa nts w h o si g n t he I C D.
Ra n d o ml y  assi g ne d t o 
st u d y i nter ve nti o n
All partici pa nts w h o are assi g ne d a ra n d o mizati o n n u m ber i n 
t he IW R s y ste m re gar dless of w het her or n ot t he st u d y  
i nter ve nti o n was a d mi nistere d.
E val ua ble i m m u n o ge nicit y
All partici pa nts w h o are eli gi ble, recei ve t he st u d y 
i nter ve nti o n t o w hic h t he y were ra n d o mize d, ha ve bl o o d 
dra w n f or assa y  testi n g wit hi n t he s pecifie d ti me fra me after 
vacci nati o n, ha ve at least 1 vali d a n d deter mi nate assa y  res ult 
at t he 4- wee k p ost vacci nati o n visit, a n d ha ve n o maj or 
pr ot oc ol vi olati o ns.
mI T T i m m u n o ge nicit y  
All ra n d o mize d partici pa nts w h o recei ve t he st u d y 
i nter ve nti o n a n d ha ve at least 1 vali d a n d deter mi nate assa y 
res ult after vacci nati o n.
Safet y
All partici pa nts w h o recei ve t he st u d y  i nter ve nti o n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 0
1 0. 1 1. 9. 3. St atistic al A n al yses f or S u bst u d y A
T he S A P will be de vel o pe d a n d fi nalize d bef ore a n y  a nalys es are perf or me d a n d will 
descri be t he a nal ys es a n d pr oce d ures f or acc o u nti n g f or missi n g, u n use d, a n d s p uri o us data. 
T his secti o n is a s u m mar y of t he pla n ne d statistical a nal y ses of t he pri mar y a n d sec o n dar y 
e n d p oi nts.
1 0. 1 1. 9. 3. 1. Ge ner al C o nsi der ati o ns f or S u bst u d y A
Refer t o Secti o n 9 f or ge neral c o nsi derati o ns of statistical a nalys es.
1 0. 1 1. 9. 3. 2. Pri m ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis f or S u bst u d y A
E n d p oi nt
St atistic al A n al ysis Met h o ds
S afet y

P oi nt esti mates a n d t he ass ociate d e xact 2 -si de d 9 5 % CIs will be
calc ulate d usi n g t he Cl o p per -Pears o n met h o d f or t he pr o p orti o n 
of partici pa nts re p orti n g eac h e ve nt (l ocal reacti o ns, s yste mic
e ve nts, AE s, a n d S A Es) f or eac h st u d y i nter ve nti o n b y  a ge 
strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge ) a n d o verall
(≥1 8 ye ars of a ge ).

P oi nt esti mates a n d t he ass ociate d e xact 2 -si de d 9 5 % CIs will be
calc ulate d usi n g t he Cl o p per -Pears o n met h o d f or t he pr o p orti o n 
of partici pa nts re p orti n g ab n or mal tr o p o ni n I la b orat or y  val ues
f or eac h st u d y i nter ve nti o n at 2 d a y s a n d 1 wee k after 
vacci nati o n b y  a ge strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of 
a ge) a n d o verall (≥1 8 y ears of a ge ).

P oi nt esti mates a n d t he ass ociate d e xact 2- si de d 9 5 % C Is will be
calc ulate d usi n g t he Cl o p per -Pears o n met h o d f or t he pr o p orti o n 
of partici pa nts wit h ne w E C G a b n or malities f or eac h st u d y
i nter ve nti o n at 2 wee ks a n d 1 wee k after vacci nati o n b y  a ge 
strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge ) a n d o verall 
(≥1 8 ye ars of a ge ).
1 0. 1 1. 9. 3. 3. Sec o n d ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis f or S u bst u d y A
E n d p oi nt
St atistic al A n al ysis Met h o ds
Sec o n d ar y /
i m m u n o ge nicit y

H AI G M Ts a n d t he ass ociate d 2 -si de d 9 5 % CIs will be pr o vi de d f or 
eac h strai n, b y st u d y i nter ve nti o n, bef ore vacci nati o n a n d 4 wee ks 
after recei pt of t he st u d y i nter ve nti o n b y  a ge strat u m (1 8 t hr o u g h 6 4 
a n d ≥6 5 y ears of a ge ).
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 1
E n d p oi nt
St atistic al A n al ysis Met h o ds

H AI G M F Rs fr o m bef ore vacci nati o n t o 4 wee ks after vacci nati o n 
a n d t he ass ociate d 2 -si de d 9 5 % CIs will be pr o vi de d f or eac h strai n ,
b y st u d y i nter ve nti o n, f or eac h a ge strat u m (1 8 t hr o u g h 6 4 a n d 
≥6 5 y ears of a ge ).

T he pr o p orti o n of partici pa nts ac hie vi n g H AI ser oc o n versi o n at
4 a n d 8 wee ks after vacci nati o n, a n d t he pr o p orti o n of partici pa nts 
wit h H AI titers ≥1: 4 0 bef ore vacci nati o n a n d at 4 wee ks after 
vacci nati o n, a n d t he ass ociate d 2 -si de d Cl o p per-Pears o n 9 5 % CIs,
will be pr o vi de d f or eac h strai n , b y st u d y i nter ve nti o n, f or eac h a ge 
strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge ).

T he pr o p orti o n of partici pa nts ac hie vi n g H AI ser oc o n v ersi o n at
4 a n d 8 wee ks after vacci nati o n a n d t he pr o p orti o n of partici pa nts 
wit h H AI titers ≥1: 4 0 bef ore vacci nati o n a n d at 4 wee ks after 
vacci nati o n, a n d t he ass ociate d 2 -si de d Cl o p per-Pears o n 9 5 % CIs,
will be pr o vi de d f or all strai ns b y st u d y i nter ve nti o n f or eac h a ge 
strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge ).

T he strai ns me nti o ne d a b o ve refer t o t he matc he d seas o nal strai ns
(
) rec o m me n de d b y W H O.

G M Ts a n d t he ass ociate d 2-si de d 9 5 % CIs will be pr o vi de d f or eac h 
strai n-s pecific ne utralizi n g titer bef ore vacci nati o n a n d 4 wee ks after 
vacci nati o n b y  st u d y i nter ve nti o n f or eac h a ge strat u m (1 8 t hr o u g h 
6 4 a n d ≥6 5 y ears of a ge ).

G M F R fr o m bef ore vacci nati o n t o 4 wee ks after vacci nati o n a n d t h e
ass ociate d 2- si de d 9 5 % CIs will be pr o vi de d f or eac h strai n -s pecific 
ne utralizi n g titer b y  st u d y i nter ve nti o n f or eac h a ge strat u m 
(1 8 t hr o u g h 6 4 a n d ≥6 5 years of a ge ).

Perce nta ges of partici pa nts wit h ser ores p o nse a n d t he ass ociate d 
2 -si de d Cl o p per -Pears o n 9 5 % CI s will be pr o vi de d at 4 wee ks after 
vacci nati o n f or eac h strai n titer , b y  st u d y i nter ve nti o n, f or eac h a ge 
strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge ).

T he strai n me nti o ne d a b o ve refers t o t he S A R S -C o V - 2 
O micr o n B A. 4/ B A. 5 or S A R S -C o V -2 refere nce strai n.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 2
1 0. 1 1. 9. 3. 4. E x pl or at or y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis f or S u bst u d y A
I m m u ne res p o nse 
t o e mer gi n g V O Cs 

G M Ts of S A R S- C o V - 2 ne utralizi n g titers f or V O Cs n ot alrea dy 
s pecifie d, al o n g wit h t he ass ociate d 2-si de d 9 5 % CIs, will be 
pr o vi de d at s pecific ti me p oi nts f or eac h vacci ne gr o u p b y  a ge 
strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge ).

G M F Rs fr o m baseli ne ( bef ore t he st u d y  vacci nati o n) t o eac h 
s u bse q ue nt ti me p oi nt, perce nta ge of partici pa nts wit h ser ores p o nse 
at eac h ti me p oi nt after vacci nati o n, al o n g wit h t he ass ociate d 
2- si de d 9 5 % C Is, ma y als o be pr o vi de d f or eac h st u d y i nter ve nti o n
b y  a ge strat u m ( 1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge ).
E x pl or at or y

H AI G M Ts a n d t he ass ociate d 2 -si de d 9 5 % CIs will be pr o vi de d 
f or eac h strai n, b y st u d y i nter ve nti o n, bef ore vacci nati o n a n d 
1 a n d 8 wee k s after recei pt of t he st u d y i nter ve nti o n, b y  a ge 
strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge).

H AI G M F Rs fr o m bef ore vacci nati o n t o 1 a n d 8 wee k s after 
vacci nati o n a n d t he ass ociate d 2- si de d 9 5 % C Is will be pr o vi de d 
f or eac h strai n, b y st u d y i nter ve nti o n, f or eac h a ge strat u m 
(1 8 t hr o u g h 6 4 a n d ≥6 5 years of a ge).

T he pr o p orti o n of partici pa nts ac hie vi n g H AI ser oc o n versi o n at
1 a n d 8 wee k s after vacci nati o n, a n d t he pr o p orti o n of partici pa nts 
wit h H AI titers ≥1: 4 0 bef ore vacci nati o n a n d at 1 a n d 8 wee k s
after vacci nati o n, a n d t he ass ociate d 2 -si de d Cl o p per-Pears o n
9 5 % CI s, will be pr o vi de d f or eac h strai n , b y st u d y i nter ve nti o n,
f or eac h a ge strat u m ( 1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge).

T he pr o p orti o n of partici pa nts ac hie vi n g H AI ser oc o n versi o n at
1 a n d 8 wee k s after vacci nati o n a n d t he pr o p orti o n of partici pa nts 
wit h H AI titers ≥1: 4 0 bef ore vacci nati o n a n d at 1 a n d 8 wee k s
after vacci nati o n, a n d t he ass ociate d 2-si de d Cl o p per-Pears o n
9 5 % CI s, will be pr o vi de d f or all strai ns, b y st u d y i nter ve nti o n, f or 
eac h a ge strat u m ( 1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge).

T he strai ns me nti o ne d a b o ve refer t o t he matc he d seas o nal strai ns
( 
) rec o m me n de d b y W H O.

G M Ts a n d t he ass ociate d 2-si de d 9 5 % CIs will be pr o vi de d f or 
eac h strai n-s pecific ne utralizi n g titer bef ore vacci nati o n a n d 1 a n d 
8 wee k s after vacci nati o n, b y  st u d y i nter ve nti o n, f or eac h a ge 
strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 ye ars of a ge) .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 3

G M F R fr o m bef ore vacci nati o n t o 1 a n d 8 wee k s after vacci nati o n 
a n d t he ass ociate d 2- si de d 9 5 % CIs will be pr o vi de d f or eac h 
strai n-s pecific ne utralizi n g titer, b y  st u d y i nter ve nti o n, f or eac h 
a ge strat u m ( 1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge).

Perce nta ges of partici pa nts wit h ser ores p o nse a n d t he ass ociate d 
2- si de d Cl o p per -Pears o n 9 5 % CI s will be pr o vi de d at 
1 a n d 8 wee k s after vacci nati o n f or eac h strai n titer, b y  st u d y 
i nter ve nti o n, f or eac h a ge strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of 
a ge).

T he strai n me nti o ne d a b o ve refers t o t he S A R S -C o V - 2 
O micr o n B A. 4/ B A. 5 or S A R S -C o V -2 refere nce strai n.
1 0. 1 1. 9. 3. 5. Ot her S afet y A n al yses f or S u bst u d y A
All safet y a nal ys es will be perf or me d o n t he safet y p o p ulati o n.
1 0. 1 1. 9. 3. 5. 1. Electr oc ar di o gr a m A n al yses f or S u bst u d y A
Partici pa nts wit h E C G a b n or malit ies will be liste d. T he n u m ber a n d pr o p orti o n of 
partici pa nts wit h a n y ne w E C G a b n or malit ies after vacci nati o n will be pr o vi de d b y  vacci ne 
gr o u p b y  a ge strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge ) a n d o verall (≥1 8 y ears of a ge ).
1 0. 1 1. 9. 3. 5. 2. Ot her A n al yses f or S u bst u d y A
T he data c ollecte d f or st u d y  partici pa nts w h o re p ort a n y sy m pt o m(s) t hat mi g ht be i n dicati ve 
of m y ocar ditis or pericar ditis wit hi n 4 wee ks after a st u d y  vacci nati o n ( E C G, tr o p o ni n le vel, 
car diac ec h ocar di o gra m, a n d/ or car diac ma g netic res o na nce st u d y ) will be s u m marize d a n d 
liste d b y vacci ne gr o u p b y  a ge strat u m (1 8 t hr o u g h 6 4 a n d ≥6 5 y ears of a ge ) a n d o verall 
(≥1 8 y ears of a ge ).
1 0. 1 1. 9. 4. I nteri m A n al yses f or S u bst u d y A
N o f or mal i nteri m a nal ys is will be c o n d ucte d f or t his st u d y p hase .  As t he s p o ns or is 
u n bli n de d wit h res pect t o partici pa nts’ st u d y i nter ve nti o n assi g n me nts (e xce pt f or staff 
r o uti nel y i nteracti n g wit h sites), t he s p o ns or ma y c o n d uct u n bli n de d re vie ws of t he data 
d uri n g t he c o urse of t he st u d y  f or t he p ur p ose of safety assess me nt, facilitati n g 
d ose -escalati o n decisi o ns a n d/ or s u p p orti n g cli nical de vel o p me nt.
1 0. 1 1. 9. 5. S a m ple Size Deter mi n ati o n f or S u bst u d y A
Si nce t he s u bst u d y is descri pti ve i n nat ure, t he pla n ne d sa m ple size f or t he st u d y is n ot base d 
o n a n y  statistical h y p ot hesis testi n g.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 4
A p pr o xi matel y  3 0 partici pa nts will be e nr olle d f or eac h vacci ne gr o u p i n eac h a ge strat u m
(1 8 t hr o u g h 6 4 a n d ≥6 5 years of a ge ); t heref ore, a t otal of ap pr o xi matel y 3 6 0 partici pa nts 
ma y  be e nr olle d i nt o t he st u d y acr oss 2 a ge strata.
F or safety o utc o mes i n t he st u d y, Ta ble 7 s h o ws t he pr o ba bilit y of o bser vi n g at least 1 A E f or 
a gi ve n tr ue e ve nt rate of a partic ular A E wit h 3 0 partici pa nts i n eac h vacci ne gr o u p.
T a ble 7.
Pr o b a bilit y of O bser vi n g at Le ast 1 A E b y Ass u me d Tr ue E ve nt R ate
S a m ple Size 
Ass u me d Tr ue R ate of a n A E
Pr o b a bilit y of O bser vi n g at 
Le ast 1 A E
3 0
0. 5 %
1 4. 0 %
1. 0 %
2 6. 0 %
2. 0 %
4 5. 5 %
5. 0 %
7 8. 5 %
7. 0 %
8 8. 7 %
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 5
1 0. 1 2. A p pe n di x 1 2: S u bst u d y B (P h ase 1/ 2 )
1 0. 1 2. 1. S o A – S u bst u d y B ( P h ase 1/ 2 )
Visit N u m ber
Scree ni n g
2 0 1
2 0 2
2 0 3
2 0 4
2 0 5
Visit Descri pti o n
Scree ni n g
V acci n ati o n
D a y 3 
F oll o w - U p 
Visit
1- Wee k
F oll o w -U p 
Visit
4- Wee k 
F oll o w -U p 
Visit
6- M o nt h 
Tele p h o ne 
C o nt act
Visit Wi n d o w ( D a ys)
0 t o 2 8 D a ys 
Bef ore 
Visit 2 0 1
D a y 1
2 t o 4
D a ys After 
Visit 2 0 1
6 t o 8
D a ys After 
Visit 2 0 1
2 6 t o 3 0
D a ys After
Visit 2 0 1
1 7 5 t o 1 8 9 D a ys 
After Visit 2 0 1
Visit T y pe/ L oc ati o n
Site
Site
Site or 
H o m e 
He alt h a
Site or 
H o m e 
He alt h a
Site or 
H o m e 
He alt h a
Tele he alt h b
O btai n i nf or me d c o nse nt
X
Assi g n partici pa nt n u m ber 
X
O btai n de m o gra p h y a n d me dical hist or y data (i ncl u di n g 
c o nfir me d C O VI D -1 9 dia g n osis or as y m pt o matic p ositi ve 
S A R S -C o V -2 test res ult [ N A A T or a nti ge n test])
X
O btai n details of me dicati o ns c urre ntl y ta ke n
X
Perf or m p h ysical e xa mi nati o n
X
Perf or m cli nical assess me nt c
X
Meas ure hei g ht a n d w ei g ht
X
Meas ure vital si g ns (i ncl u di n g oral te m perat ure)
X
X
X  
X
Perf or m 1 2 -lea d tri plicate E C G
X
X
X  
X
C ollect bl o o d sa m ple f or tr o p o ni n I la b orat or y testi n g
~ 2. 5 m L 
~ 2. 5 m L d
~ 2. 5 m L 
~ 2. 5 m L
Uri ne pre g na nc y test (if a p pr o priate)
X
X
C o nfir m use of c o ntrace pti ves (if a p pr o priate)
X
X
X  
X  
X
C ollect pri or C O VI D -1 9 a n d p ne u m oc occal vacci ne i nf or mati o n
X
C ollect details of a n y lice nse d i nfl ue nza vacci ne recei ve d i n t he 
pri or 1 2 m o nt hs 
X
C ollect n o nst u d y vacci ne i nf or mati o n 
X
X
X  
X  
X
X
C ollect pr o hi bite d me dicati o n use
X  
X  
X
X
Re vie w tr o p o ni n I a n d E C G res ults
X
X  
X  
X
C o nfir m eli gi bilit y
X
X
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 6
Visit N u m ber
Scree ni n g
2 0 1
2 0 2
2 0 3
2 0 4
2 0 5
Visit Descri pti o n
Scree ni n g
V acci n ati o n
D a y 3 
F oll o w - U p 
Visit
1- Wee k
F oll o w -U p 
Visit
4- Wee k 
F oll o w -U p 
Visit
6- M o nt h 
Tele p h o ne 
C o nt act
Visit Wi n d o w ( D a ys)
0 t o 2 8 D a ys 
Bef ore 
Visit 2 0 1
D a y 1
2 t o 4
D a ys After 
Visit 2 0 1
6 t o 8
D a ys After 
Visit 2 0 1
2 6 t o 3 0
D a ys After
Visit 2 0 1
1 7 5 t o 1 8 9 D a ys 
After Visit 2 0 1
Visit T y pe/ L oc ati o n
Site
Site
Site or 
H o m e 
He alt h a
Site or 
H o m e 
He alt h a
Site or 
H o m e 
He alt h a
Tele he alt h b
O btai n ra n d o mizati o n n u m ber a n d st u d y i nter ve nti o n all ocati o n
X
Re vie w t e mp or ar y  dela y criteria
X
C ollect bl o o d sa m ple f or i m m u n o ge nicit y assess me nt 
~ 1 5 or 
~ 5 0 m L d, e
~ 1 5 or 
~ 5 0 m L e
A d mi nister st u d y i nter ve nti o n
X
Assess ac ute reacti o ns f or at least 3 0 mi n utes after st u d y 
i nter ve nti o n a d mi nistrati o n
X
E x plai n t o t he partici pa nt e -diar y c o m pleti o n re q uire me nts a n d 
assist t he partici pa nt wit h d o w nl oa di n g t he a p p licati o n or iss ue 
pr o visi o ne d de vice if re q uire d
X
Pr o vi de t her m o meter a n d meas uri n g de vice
X
Re vie w react o ge nicit y e-diar y data ( dail y re vie w is o pti m al 
d uri n g t he acti ve diar y peri o d)
Re vie w o n g oi n g react o ge nicit y e -diar y s y m pt o ms a n d o btai n st o p 
dates 
X  
X
C ollect A Es a n d S A Es as a p pr o priate f, d
X
X
X  
X  
X
X
C ollect e -diar y or assist t he partici pa nt wit h deleti n g a p plicati o n
X  
X
a.
Visit ma y be c o m plete d as a h o me healt h visit (see Secti o n 1 0. 1 2. 8. 2 ).
b.
Visit will be c o m plete d as a tele healt h visit (see Secti o n 1 0. 1 2. 8. 1 ).
c.
I ncl u di n g, if i n dicate d, a p h ysical e xa mi nati o n.
d.
Pri or t o vacci nati o n at Visit 2 0 1.
e.
O nl y u p t o 2 0 partici pa nts i n G r o u ps 3, 4, a n d 5 will ha ve 5 0 m L dra w n (see Secti o n 1 0. 1 2. 4. 1 ).
f.  
A Es are c ollecte d fr o m t he c o m pleti o n of i nf or me d c o nse nt t hr o u g h Visit 2 0 4.  S A Es are c ollecte d fr o m t he c o m pleti o n of i nf or me d c o nse nt t hr o u g h t he 
e n d of st u d y partici pati o n. A d diti o nall y, a n y A E s occ urri n g u p t o 4 8 h o urs after bl o o d dra ws at Visit 2 0 4 m ust be rec or de d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 7
1 0. 1 2. 2. I ntr o d ucti o n f or S u bst u d y B
1 0. 1 2. 2. 1. S u bst u d y B R ati o n ale
T his P hase 1/ 2 s u bst u d y will descri be t he safety, t olera bilit y , a n d i m m u n o ge nicit y of I RV
(qI R V, t I RV , or bI R V) w he n a d mi nistere d i n c o m bi nati o n wit h bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5). Bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) will be use d 
d uri n g S u bst u d y  B, as detaile d i n Ta ble 2 .  S u bst u d y  B will be si n gle -bli n d 
(s p o nsor -u n bli n de d).
1 0. 1 2. 2. 2. B ac k gr o u n d f or S u bst u d y B
See Secti o n 2. 2 .
1 0. 1 2. 2. 3. Be nefit/ Ris k Assess me nt f or S u bst u d y B
See Secti o n 2. 3. 1 f or o verall st u d y ris ks.  N o u ni q ue ris ks are i de ntifie d f or S u bst u d y B.
Be nefits t o i n di vi d ual partici pa nts e nr olle d i n S u bst u d y  B ma y be:

Recei pt of a d ose of a n efficaci o us or p ote ntiall y efficaci o us C O VI D -1 9 vacci ne.

Recei pt of a p ote ntiall y efficaci o us i nfl ue nza vacci ne at n o c ost t o t he partici pa nt, a n d 
pr o visi o n of t he i m m u n o ge nicit y  res ults i n a s u bset of partici pa nts.

C o ntri b uti n g t o researc h t o hel p ot hers.

Please see Secti o n 2. 3 f or details of t he S R S Ds relati n g t o t he st u d y i nter ve nti o ns use d i n 
S u bst u d y  B.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 8
1 0. 1 2. 3. O bjecti ves, E n d p oi nts, a n d Esti m a n ds ( S u bst u d y B)
S u bst u d y B ( P h ase 1/ 2 )
O bjecti ves
Esti m a n ds
E n d p oi nts
Pri m ar y S afet y
Pri m ar y S afet y
Pri m ar y S afet y
T o descri be t he safet y a n d 
tolera bilit y of st u d y
i nter ve nti o ns i n partici pa nts 
1 8 thr o u g h 6 4 years of a ge 
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge, 
recei vi n g at least 1  d ose of st u d y i nter ve nti o n, 
t he perce nta ge of partici pa nts wit h:

A b n or mal tr o p o ni n I la b orat or y val ues 
2 da ys a n d 1 wee k after vacci nati o n

Tr o p o ni n I la b orat or y para meters 
detaile d i n Secti o n 1 0. 2
I n partici pa nts 1 8 t hr o u g h 6 4 years of a ge 
recei vi n g at least 1  d ose of st u d y i nter ve nti o n, 
t he perce nta ge of partici pa nts wit h:

Ne w E C G a b n or malities 2 da ys a n d 
1 wee k after vacci nati o n

E C G a b n or malities c o nsiste nt wit h 
pr o ba ble or p ossi ble m y ocar ditis or 
pericar ditis as defi ne d i n
Secti o n 1 0. 1 2. 8. 5. 1
I n partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge, 
recei vi n g at least 1  d ose of st u d y i nter ve nti o n, 
t he perce nta ge of partici pa nts re p orti n g:
L ocal reacti o ns f or u p t o 7 da ys f oll o wi n g 
vacci n ati o n i n t he ri g ht ar m o nl y
S yste mic e ve nts f or u p t o 7 da ys f oll o wi n g 
vacci nati o n
A E s fr o m vacci nati o n t hr o u g h 4  wee ks after 
vacci nati o n
S A Es fr o m vacci nati o n t hr o u g h 6 m o nt hs
after vacci nati o n

L ocal reacti o ns ( pai n at t he i njecti o n 
site, re d ness, a n d s welli n g) i n t he ri g ht 
ar m o nl y

S yste mic e ve nts (fe ver, fati g ue, 
hea dac he, c hills, v o miti n g, diarr hea, 
ne w or w orse ne d m uscle pai n, a n d ne w 
or w orse ne d j oi nt pai n)

A Es

S A Es
Sec o n d ar y I m m u n o ge nicit y a
Sec o n d ar y I m mu n o ge nicit y
Sec o n d ar y I m m u n o ge nicit y
T o descri be t he i m m u ne 
res p o nses t o S A R S -C o V -2 
a n d i nfl ue nza elicite d b y eac h 
st u d y i nter ve nti o n
I n partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge 
c o m pl yi n g wit h t he ke y pr ot oc ol criteria 
(e val ua ble partici pa nts):

G M Ts bef ore vacci nati o n a n d at eac h 
bl o o d sa m pli n g ti me p oi nt after i nfl ue nza 
vacci nati o n

G M F R fr o m bef ore vacci nati o n t o eac h 
bl o o d sa m pli n g ti me p oi nt after i nfl ue nza 
vacci nati o n

T he pr o p orti o n of partici pa nts ac hie vi n g 
H AI ser oc o n versi o n b f or eac h strai n at 
eac h bl o o d sa m pli n g ti me p oi nt af ter 
i nfl ue nza vacci nati o n

T he perce nta ge of partici pa nts wit h H AI 
titers ≥1: 4 0 f or eac h strai n bef ore 
vacci nati o n a n d at eac h bl o o d sa m pli n g 
ti me p oi nt after i nfl ue nza vacci nati o n

H AI titers f or t he matc he d seas o nal 
strai ns rec o m me n de d b y W H O
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 5 9
S u bst u d y B ( P h ase 1/ 2 )
O bjecti ves
Esti m a n ds
E n d p oi nts
I n partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge 
c o m pl yi n g wit h t he ke y pr ot oc ol criteria 
(e val ua ble partici pa nts):

G M Ts bef ore vacci nati o n a n d at eac h 
bl o o d sa m pli n g ti me p oi nt after 
vacci nati o n f or eac h strai n

G M F R fr o m bef ore S A R S -C o V - 2
v acci nati o n t o eac h bl o o d sa m pli n g ti me
p oi nt after S A R S -C o V - 2 vacci nati o n f or 
eac h strai n

Perce nta ges of partici pa nts wit h 
ser ores p o nsec at eac h bl o o d sa m pli n g ti me
p oi nt after S A R S -C o V - 2 vacci nati o n f or 
eac h strai n

S A R S -C o V - 2 ne utralizi n g titers b y 
strai n
Terti ar y/ E x pl or at or y
Terti ar y/ E x pl or at or y
Terti ar y/ E x pl or at or y
T o descri be t he i m m u ne 
res p o nse t o e mer gi n g varia nts 
( u n der m o nit ori n g, of i nterest, 
a n d/ or of c o ncer n) i n 
partici pa nts 1 8 t hr o u g h 
6 4 years of a ge
As detaile d i n t he S A P

S A R S -C o V -2 ne utralizi n g titers f or 
varia nts ( u n der m o nit ori n g, of 
i nterest, a n d/ or of c o ncer n) 
T o descri be t he tr o p o ni n a n d 
E C G a b n or malities detecte d 
i n partici pa nts w h o are 
e val uate d f or p ossi ble car diac 
s y m pt o ms  
As detaile d i n t he S A P

Tr o p o ni n I la b orat or y para meters 
detaile d i n Secti o n 1 0. 2

E C G a b n or malities c o nsiste nt wit h 
pr o ba ble or p ossi ble m y ocar ditis or 
pericar ditis as defi ne d i n
Secti o n 1 0. 1 2. 8. 5. 1
a.
T here are n o pri mar y i m m u n o ge nicit y o bjecti ves i n t his st u d y.
b. 
Ser oc o n versi o n is defi ne d as a n H AI titer < 1: 1 0 pri or t o vacci nati o n a n d ≥1: 4 0 at t he ti me p oi nt of i nterest, or a n H AI 
titer of ≥1: 1 0 pri or t o vacci nati o n wit h at least a 4 -f ol d rise at t he ti me p oi nt of i nterest.
c. 
Ser ores p o nse is defi ne d as ac hie vi n g a ≥4 -f ol d rise fr o m baseli ne ( bef ore t he st u d y vacci nati o n). If t he baseli ne 
meas ure me nt is bel o w t he L L O Q, t he p ost vacci n ati o n meas ure of ≥4 × L L O Q is c o nsi dere d ser ores p o nse.
1 0. 1 2. 4. S u bst u d y B Desi g n
1 0. 1 2. 4. 1. O ver all Desi g n f or S u bst u d y B
T his is a P hase 1/ 2 s u bst u d y t o descri be t he safet y, t olera bilit y , a n d i m m u n o ge nicit y of I RV 
( qIR V, tI R V, or bI R V) w he n a d mi nistere d i n c o m bi nati o n wit h bi vale nt B N T 1 6 2 b 2
( origi nal/ O mi B A. 4/ B A. 5) . Bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) will be use d 
d uri n g S u bst u d y  B, as detaile d i n Ta ble 2 . Bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) 
was rec o m me n de d b y A CI P i n 2 0 2 2 -2 0 2 3. 2 9 ,3 0 T his su bst u d y will be si n gle -bli n d 
(s p o ns or-u n bli n de d).
D uri n g S u bst u d y  B, u p t o a p pr o xi matel y  6 3 0 partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge will be 
e nr olle d.
Ra n d o mizati o n will be c o n d ucte d acr oss 3 e nr oll me nt c o h orts i n de pe n de ntl y d ue t o lice nse d 
QI V a vaila bilit y , wit h e nr oll me nt i n t hese c o h orts bei n g c o n d ucte d eit her c o nc urre ntl y or at 
differe nt ti mes as re q uire d base d o n o perati o nal c o nsi derati o ns as s h o w n i n Ta ble 8 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 0
T a ble 8.
S u bst u d y B E nr oll me nt C o h orts
E nr oll me nt 
C o h ort
T ot al N u m ber 
of 
P artici p a nts
N u m ber of 
P artici p a nts 
per V acci ne 
Gr o u p
V acci ne 
Gr o u p 
N u m ber
V acci ne Gr o u p Descri pti o ns
1
6 0
3 0
1
Lice nse d QI V (Fl ucel va x ) a d mi nistere d c o nc urre ntl y 
i n t he o p p osite ar m t o 
µ g bi vale nt B N T 1 6 2 b 2 
( ori gi nal* / O mi B A. 4/ B A. 5)
2
Lice nse d QI V (Fl ucel va x ) a d mi nistere d c o nc urre ntl y 
i n t he o p p osite ar m t o bI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5)
2
3 6 0
U p t o 1 2 0
3
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/
O m i B A. 4/ B A. 5) at d ose-le vel c o m bi nati o n 1a
4
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/
O m i B A. 4/ B A. 5) at d ose-le vel c o m bi nati o n 2a
5 
qI R V/ bi vale nt B N T 1 6 2 b 2
( ori gi nal/ O mi B A. 4/ B A. 5) at d ose-le vel 
c o m bi nati o n 3 a
3
2 1 0
3 0
6
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/
O m i B A. 4/ B A. 5) at d ose-le vel c o m bi nati o n 4a
7
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/
O m i B A. 4/ B A. 5) at d ose-le vel c o m bi nati o n 5a
8
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/
O m i B A. 4/ B A. 5) at d ose-le vel c o m bi nati o n 6a
9
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/
O m i B A. 4/ B A. 5) at d ose-le vel c o m bi nati o n 7a
1 0
qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/
O m i B A. 4/ B A. 5) at d ose-le vel c o m bi nati o n 8a
1 1
tI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi\B A . 4/ B A. 5)
1 2
qI R V
a.
C o m bi nati o ns as s h o w n i n Ta ble 2 . 
N ote: *  Ori gi nal refers t o t he a ncestral strai n ( W u ha n -H u -1; U S A -W A 1/ 2 0 2 0), als o referre d t o i n t his pr ot oc ol as t he 
refere nce strai n.
E nr oll me nt of partici pa nts 1 8 t hr o u g h 6 4 y ears of a ge will occ ur o nl y d uri n g S u bst u d y  B.
D uri n g S u bst u d y  B ( Gr o u ps 2, 6, 7, 8, 9, 1 0, 1 1, a n d 1 2), t he e nr oll me nt will be c o ntr olle d 
s uc h t hat n o m ore t ha n 1 0 partici pa nts (c o nsi dere d se nti nel partici pa nts) ca n be vacci nate d o n 
t he first da y; vacci nati o n of t he re mai ni n g partici pa nts will c o m me nce n o s o o ner t ha n 
2 4 h o urs after t his safety pa use .
St o p pi n g r ules will a p pl y t o t he gr o u ps recei vi n g t he n o vel-e x pl orat or y c o m bi nat i o ns of 
bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) wit h qI R V , tI R V, a n d bI R V, as detaile d i n 
Secti o n 1 0. 1 2. 8. 7 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 1
S afet y data acc u m ulate d at least 4 wee ks f oll o wi n g vacci nati o n of partici pa nts 1 8 t hr o u g h 
6 4 ye ars of a ge i n S u bst u d y  B will be re vie we d b y t he s p o ns or’s I R C , a n d if t hese data are
dee me d acce pta ble, t he I R C will e val uate w hic h gr o u ps (as detaile d i n Ta ble 2 ) are
acce pta ble f or f urt her st u d y. 
I m m u n o ge nicit y Bl o o d Dr a ws i n S u bst u d y B :
Bl o o d sa m ples of a p pr o xi matel y  1 5 m L  will be c ollecte d f or i m m u n o ge nicit y assess me nts 
pri or t o vacci nati o n a n d at 4 wee ks after vacci nati o n. U p t o 2 0 partici pa nts i n G r o u ps 3, 4, 
a n d 5 f or t he 1 8 - t hr o u g h 6 4- ye ar a ge strat u m will be as ke d t o c o nse nt t o alter nati vel y 
pr o vi di n g 5 0 -m L , rat her t ha n 1 5-m L , bl o o d sa m ples at t he sa me ti me p oi nts, w hic h will be 
use d f or i m m u n o ge nicit y assess me nts as well as assa y  de vel o p me nt/ mai nte na nce. 
F or S u bst u d y  B bl o o d dra ws (as detaile d a b o ve) , u p t o t he first 2 0 partici pa nts w h o are 
e nr olle d first, a n d w h o c o nse nt, will ha ve t he hi g her -v ol u me bl o o d dra ws of 5 0 m L . 
A ll partici pa nts will be as ke d t o c o m plete a react o ge nicit y e-diar y  f or 7 da ys f oll o wi n g eac h 
vacci nati o n.  
F oll o wi n g vacci nati o n, A Es will be c ollecte d fr o m i nf or me d c o nse nt si g ni n g t hr o u g h 
4 wee ks f oll o wi n g eac h vacci nati o n, a n d S A Es will be c ollecte d fr o m i nf or me d c o nse nt 
si g ni n g t hr o u g h 6 m o nt hs after t he first vacci nati o n. I n a d diti o n, A Es will be c ollecte d t hat
occ ur u p t o 4 8 h o urs after bl o o d dra ws.
1 0. 1 2. 4. 2. Scie ntific R ati o n ale f or St u d y Desi g n f or S u bst u d y B
See Secti o n 2. 1.
1 0. 1 2. 4. 3. J ustific ati o n f or D ose f or S u bst u d y B
See Secti o n 4. 3 .
1 0. 1 2. 4. 4. E n d of St u d y Defi niti o n f or S u bst u d y B
T he e n d of S u bst u d y  B is defi ne d as t he date of t he last visit of t he last partici pa nt i n t he 
s u bst u d y.
A partici pa nt is c o nsi dere d t o ha ve c o m plet e d t he s u bst u d y if he/s he has c o m plete d all 
peri o ds of t he s u bst u d y, i ncl u di n g t he last visit.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 2
1 0. 1 2. 5. S u bst u d y B P o p ul ati o n
1 0. 1 2. 5. 1. S u bst u d y B I ncl usi o n Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n S u bst u d y B o nl y if all of t he f oll o wi n g criteria 
a p pl y:
A ge a n d Se x:
1.
Male or fe male p artici pa nts 1 8 thr o u g h 6 4 ye ars of a ge ( or t he mi ni m u m a ge of c o nse nt 
i n acc or da nce wit h l ocal re g ulati o ns) at Visit 2 0 1 ( Da y  1).

Refer t o A p pe n di x 5 f or re pr o d ucti ve criteria f or male (Secti o n 1 0. 5. 1 ) a n d 
fe male (Secti o n 1 0. 5. 2 ) partici pa nts.
Dise ase C h ar acteristics:
N ot a p plica ble.
Ot her I ncl usi o n Criteri a:
2.
Partici pa nts w h o are willi n g a n d a ble t o c o m pl y wit h all sc he d ule d visits, i n vesti gati o nal 
pla n, la b orat or y  tests, lifest yle c o nsi derati o ns, a n d ot her st u d y pr oce d ures.
3.
Healt h y partici pa nts w h o are deter mi ne d b y me dical hist or y, p h ys ical e xa mi nati o n 
(if re q uire d), a n d cli nical j u d g me nt of t he i n vesti gat or t o be eli gi ble f or i ncl usi o n i n t he 
st u d y.
N ote: Healt h y partici pa nts wit h pree xisti n g sta ble disease, defi ne d as disease n o t 
re q uiri n g si g nifica nt c ha n ge i n t hera py or h os pitalizati o n f or w orse ni n g disease d uri n g 
t he 6 wee ks bef ore e nr oll me nt, ca n be i ncl u de d. S pecific criteria f or partici pa nts wit h 
k n o w n sta ble i nfecti o n wit h HI V, H C V, or H B V ca n be f o u n d i n Secti o n 1 0. 8 .
4.
Ca pa ble of gi vi n g si g ne d i nf or me d c o nse nt as descri be d i n t he pr ot oc ol , w hic h i ncl u des 
c o m plia nce wit h t he re q uire me nts a n d restricti o ns liste d i n t he IC D a n d i n t his pr ot oc ol.
5.
Partici pa nts w h o ha ve recei ve d at least 3 pri or U S -a ut h orize d m o dR N A C O VI D -1 9 
vacci ne s, wit h t he last d ose bei n g a n u p date d ( bi vale nt) vacci ne gi ve n at least 
1 5 0 da y s bef ore Visit 2 0 1. A n y  d ose of m o d R N A C O VI D - 1 9 vacci ne recei ve d after 
0 1 Se pte m ber 2 0 2 2 ma y  be c o nsi dere d t o be a bi vale nt vacci ne i n t he U S.
N ote: D oc u me nte d c o nfir mati o n of pri or d oses of S A R S -C o V -2 vacci ne recei ve d m ust be 
o btai ne d pri or t o ra n d o mizati o n .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 3
1 0. 1 2. 5. 2. S u bst u d y B E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m S u bst u d y  B if a ny of t he f oll o wi n g criteria a p pl y :
Me dic al C o n diti o ns:
1.
Me dical or ps yc hiatric c o n diti o n, i ncl u di n g rece nt ( wit hi n t he past year) or acti ve s uici dal 
i deati o n/ be ha vi or or la b orat or y a b n or malit y, t hat ma y i ncrease t he ris k of st u d y  
partici pati o n or, i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt i na p pr o priate f or t he 
st u d y.
2.
Hist or y  of se vere a d verse reacti o n ass ociate d wit h a n y vacci ne a n d/ or se vere aller gic 
reacti o n (e g, a na p hyl a xis) t o a n y c o m p o ne nt of t he st u d y i nter ve nti o n(s).
3. I m m u n oc o m pr o mise d i n di vi d uals wit h k n o w n or s us pecte d i m m u n o deficie nc y , as 
deter mi ne d b y hist or y  a n d/ or la b orat or y/ p h ysical e xa mi nati o n.
4.
Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d blee di n g t hat w o ul d, i n t he 
o pi ni o n of t he i n ves ti gat or, c o ntrai n dicate i ntra m usc ular i njecti o n.
5.
W o me n w h o are pre g na nt or breastfee di n g .
6.
Hist or y  of my o car ditis or pericar ditis .
Pri or/ C o nc o mit a nt T her a p y:
7.
Recei pt of c hr o nic me dicati o ns wit h k n o w n s yste mic i m m u n os u p pressa nt effects
(i ncl u di n g c yt ot o xic a ge nts or s yste mic c ortic oster oi ds), or ra di ot hera p y, wit hi n 6 0 da ys 
bef ore e nr oll me nt t hr o u g h c o ncl usi o n of t he st u d y.
N ote: S y ste mic c ortic oster oi ds are defi ne d as t h ose a d mi nistere d f or ≥1 4 da y s at a d ose 
of ≥2 0 m g/ da y  of pre d nis o ne or e q ui vale nt (e g, f or ca ncer or a n a ut oi m m u ne disease) or 
pla n ne d recei pt t hr o u g h o ut t he st u d y .  I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or 
t o pical (s ki n or e yes) c ortic oster oi ds are per mitte d.
8.
Recei pt of bl o o d/ plas ma pr o d ucts, i m m u n o gl o b uli n, or m o n ocl o nal a nti b o dies use d f or 
t he treat me nt or pre ve nti o n of C O VI D-1 9 or t h ose t hat are c o nsi dere d 
i m m u n os u p pressi ve, fr o m 6 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n, or pla n ne d 
recei pt t hr o u g h o ut t he st u d y.
9.
Vacci nati o n wit h a n y  i n vesti gati o nal or lice nse d i nfl ue nza vacci ne wit hi n 6 m o nt hs 
( 1 7 5 d a y s) bef ore st u dy i nter ve nti o n a d mi nistrati o n, or o n g oi n g recei pt of c hr o nic 
a nti viral t hera p y wit h acti vit y  a gai nst i nfl ue nza.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 4
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
1 0. Partici pati o n i n ot her st u dies i n v ol vi n g a d mi nistrati o n of a st u d y  i nter ve nti o n wit hi n 
2 8 da y s pri or t o, a n d/ or d uri n g, partici pati o n i n t his st u d y.
N ote: I n a d diti o n t o a d mi nistrati o n of i n vesti gati o nal pr o d ucts, st u d y  i nter ve nti o ns ma y 
i ncl u de a d diti o nal pr oce d ures, s uc h as c ollecti o n of bi ol o gical sa m ples. T heref ore, 
partici pa nts ma y  n ot be i n a n ot her st u d y w here by pr oce d ures, s uc h as res pirat or y ill ness 
visits, ma y  i nterfere wit h c o m plia nce wit h t his st u d y’s pr ot oc ol.
Di a g n ostic Assess me nts:
N ot a p plica ble.
Ot her E xcl usi o n Criteri a:
1 1. I n vesti gat or site staff directl y  i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site staff ot her wise s u per vise d b y t he i n vesti gat or, a n d s p o ns or a n d s p o ns or 
dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers.
A d diti o n al E xcl usi o n Criteri a:
1 2. Partici pati o n i n stre n u o us or e n d ura nce e xercise t hr o u g h Visit 2 0 3.
1 3. Pri or hist or y  of heart disease of c o ncer n: hist or y  of m yocar ditis, pericar ditis, 
car di o m y o pat h y, c or o nar y arter y disease (i ncl u di n g hist or y of m y ocar d ial i nfarcti o n, 
u nsta ble a n gi na), N Y H A Class III a n d a b o ve heart fail ure, or si g nifica nt arr h y t h mias
1 4. A n y  a b n or mal scree ni n g tr o p o ni n I la b orat or y val ue.
1 5. Scree ni n g 1 2 -lea d E C G t hat, as j u d ge d b y t he i n vesti gat or, is c o nsiste nt wit h pr o ba ble or 
p ossi ble m y oc ar ditis or pericar ditis, or de m o nstrates cli nicall y  rele va nt a b n or malities t hat 
ma y  affect partici pa nt safet y or i nter pretati o n of st u d y res ults.  Partici pa nts wit h a 
scree ni n g 1 2-lea d E C G t hat s h o ws a n a vera ge Q Tc F i nter val > 4 5 0 msec, c o m plete left 
b u n dle bra nc h bl oc k, si g ns of a n ac ute or i n deter mi nate -a ge m y ocar dial i nfarcti o n, S T -T 
i nter val c ha n ges s u g gesti ve of m yocar dial isc he mia, sec o n d - or t hir d -de gree A V bl oc k, or 
seri o us bra dya rr hyt h mias or tac h y arr h yt h mias s h o ul d be e xcl u de d fr o m st u d y 
partici pat i o n.
1 0. 1 2. 5. 3. Criteri a f or Te m p or aril y Del a yi n g 
E nr oll me nt/ R a n d o miz ati o n/ A d mi nistr ati o n of St u d y I nter ve nti o n f or S u bst u d y B
T he f oll o wi n g c o n diti o ns ma y  all o w a partici pa nt t o be ra n d o mize d o nce t he c o n diti o ns ha ve 
res ol ve d a n d t he partici pa nt is ot her wise eli gi ble.  Partici pa nts meeti n g t hese criteria at 
Visit 2 0 1 will be c o nsi dere d scree n fail ures if e nr oll me nt has cl ose d o nce t he c o n diti o n(s) 
has/ ha ve res ol ve d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 5
1.
A p ositi ve S A R S -C o V -2 test res ult ( N A A T or ra pi d a nti ge n test) wit hi n t he pre vi o us 
2 8 da y s.
2.
C ur re nt fe brile ill ness ( oral te m perat ure ≥3 8. 0° C [ ≥1 0 0. 4° F]) or ot her ac ute ill ness wit hi n 
4 8 h o urs bef ore st u d y i nter ve nti o n a d mi nistrati o n.  
3.
Recei pt of a n y n o nst u d y vacci ne wit hi n 1 4 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n 
at Visit 2 0 1.
4.
A ntici pate d recei pt of a n y n o nst u d y vacci ne wit hi n 1 4 da y s after st u d y i nter ve nti o n 
a d mi nistrati o n at Visit 2 0 1.
5.
Recei pt of s h ort -ter m (1 4 da y s) s yste mic c ortic oster oi ds.  St u d y i nter ve nti o n 
a d mi nistrati o n s h o ul d be dela y e d u ntil s yste mic c ortic oster oi d use has bee n disc o nti n ue d 
f or at least 2 8 da ys.  I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical (s ki n or 
e yes) c ortic oster oi ds are per mitte d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 6
1 0. 1 2. 6. S u bst u d y B I nter ve nti o n a n d C o nc o mit a nt T her a p y
1 0. 1 2. 6. 1. St u d y I nter ve nti o n(s) A d mi nistere d f or S u bst u d y B
St u d y  i nter ve nti o ns f or S u bst u d y B will i ncl u de:
I nter ve nti o n N a me
B N T 1 6 2 b 2 a
 
qI R V
qI R V b/ B N T 1 6 2 b 2a
tI R Vc/ B N T 1 6 2 b 2a
bI R V c/ B N T 1 6 2 b 2a
QI V
Ar m N a me
( gr o u p of p artici p a nts 
recei vi n g a s pecific 
st u d y i nter ve nti o n or 
n o st u d y i nter ve nti o n)
Lice nse d QI V +
B N T 1 6 2 b 2 a  
qI R V
qI R V/
B N T 1 6 2 b 2 a
tI R V/
B N T 1 6 2 b 2 a
bI R V/ B N T 1 6 2 b 2 a + 
lice nse d QI V
Lice nse d QI V + 
B N T 1 6 2 b 2 a
or
Lice nse d QI V + 
bI R V/ B N T 1 6 2 b 2 a
T ar gete d I nfl ue nz a 
Str ai ns
N/ A
Strai ns as 
rec o m me n de d b y 
W H O f or rec o m bi na nt 
or cell -base d i nfl ue nza 
vacci nes
Strai ns as 
rec o m me n de d b y 
W H O f or rec o m bi na nt 
or cell -base d i nfl ue nza 
vacci nes
Strai ns as 
rec o m me n de d b y 
W H O f or rec o m bi na nt 
or cell -base d i nfl ue nza 
vacci nes
Strai ns as 
rec o m me n de d b y 
W H O f or rec o m bi na nt 
or cell-base d i nfl ue nza 
vacci nes
F or eac h seas o nal strai n 
as rec o m me n de d b y 
W H O
T y pe
m o d R N A vacci ne
m o d R N A vacci ne
m o d R N A vacci ne
m o d R N A vacci ne
m o d R N A vacci ne
Vacci ne
D ose F or m ul ati o n
m o d R N A
m o d R N A
m o d R N A
m o d R N A
m o d R N A
U nit D ose Stre n gt h(s)
µ g
B N T 1 6 2 b 2 a
µ g qI R V f or 
partici pa nts 
1 8 t hr o u g h 6 4 years of 
a ge (as detaile d i n t he 
I P M)
µ g or 
µ g or
µ g i n d ose-le vel 
c o m bi nati o ns as 
descri be d i n t he ta bles 
title d S u bst u d y B: All 
Vacci ne Gr o u ps  
µ g tI R V/
µ g 
B N T 1 6 2 b 2 a
µ g bI R V
µ g 
B N T 1 6 2 b 2 a
µ g bI R V/
µ g
B N T 1 6 2 b 2 a
As detaile d i n t he I P M
R o ute of 
A d mi nistr ati o n
I ntra m usc ular i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular 
i njecti o n
I ntra m usc ular i njecti o n
Use
E x peri me ntal
E x peri me ntal 
E x peri me ntal 
E x peri me ntal 
E x peri me ntal 
E x peri me ntal
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 7
I M P or NI M P/ A x M P
I M P
I M P
I M P
I M P
I M P
I M P
P ac k a gi n g a n d 
L a beli n g
St u d y i nter ve nti o n will be 
pr o vi de d i n a glass vial as 
o pe n -la bel s u p pl y.  Eac h 
vial will be la bele d per 
c o u ntr y re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d i n a 
glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c ou ntr y 
re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d i n a 
glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d i n a 
glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c o u ntry 
re q uire me nt.
St u d y i nter ve nti o n 
will be pr o vi de d i n a 
glass vial as 
o pe n -la bel s u p pl y.  
Eac h vial will be 
la bele d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n will 
be pr o vi de d as eit her a 
P F S or a glass/ plastic 
vial as o pe n -la bel 
s u p pl y.  Eac h P F S or vial
will be la bele d per 
c o u ntr y re q uire me nt.
a.
Bi vale nt B N T 1 6 2 b 2 ( ori gi nal * / O mi B A. 4/ B A. 5) will be use d d uri n g S u bst u d y B . * O ri gi nal refers t o t he a ncestral strai n ( W u ha n-H u - 1; U S A-W A 1/ 2 0 2 0), als o referre d t o i n 
t his pr ot oc ol as t he refere nce strai n.
b.
Will ha ve f or m ulati o ns t hat are 
 per t he I P M a n d 
c.
F or m ulati o ns will be 
.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 8
1 0. 1 2. 6. 1. 1. A d mi nistr ati o n f or S u bst u d y B
See Secti o n 6. 1. 1 .
D uri n g S u bst u d y B, partici pa nts will recei ve st u d y i nter ve nti o n at Visit 2 0 1 as ra n d o mize d i n 
acc or da nce wit h t he S o A (Secti o n 1 0. 1 2. 1 ).  A ll st u d y i nter ve nti o n s h o ul d be a d mi nistere d 
i ntra m usc ularly i nt o t he delt oi d m uscle of t he ri g ht ar m , ot her t ha n lice nse d QI V, w hic h 
s h o ul d be a d mi nistere d i ntra m usc ularl y i nt o t he de lt oi d m uscle of t he left ar m.
1 0. 1 2. 6. 1. 2. Me dic al De vices
f or S u bst u d y B
See Secti o n 6. 1. 2.
1 0. 1 2. 6. 1. 3. Pre p ar ati o n, H a n dli n g, St or a ge, a n d Acc o u nt a bilit y f or S u bst u d y B
See Secti o n 6. 2 .
1 0. 1 2. 6. 1. 3. 1. Pre p ar ati o n a n d Dis pe nsi n g f or S u bst u d y B
See Secti o n 6. 2. 1 .
D uri n g S u bst u d y B , st u d y i nter ve nti o n will be pre pare d b y q ualifie d site pers o n nel acc or di n g 
t o t he IP M or pac ka ge i nsert, a n d t he st u d y  i nter ve nti o n will be a d mi nistere d i n s uc h a wa y as 
t o e ns ure t he partici pa nts re mai n bli n de d.
1 0. 1 2. 6. 1. 4. All oc ati o n t o St u d y I nter ve nti o n f or S u bst u d y B
See Secti o n 6. 3 .
All ocati o n of st u d y  i nter ve nti o n at Visit 2 0 1 i n S u bst u d y B will be c o n d ucte d via t he I R T.
1 0. 1 2. 6. 2. Bli n di n g f or S u bst u d y B
1 0. 1 2. 6. 2. 1. Bli n di n g of P artici p a nts f or S u bst u d y B
S u bst u d y  B p artici pa nts will be bli n de d t o t heir assi g ne d st u d y i nter ve nti o n.
1 0. 1 2. 6. 2. 2. Bli n di n g of Site Pers o n nel f or S u bst u d y B
S u bst u d y B is si n gle-bli n d, s uc h t hat all site pers o n nel, i ncl u di n g t he i n vesti gat or, 
i n vesti gat or staff, a n d st u d y staff recei vi n g, st ori n g, dis pe nsi n g, pre pari n g, a n d a d mi nisteri n g 
t he st u d y i nter ve nti o ns will be u n bli n de d.  
1 0. 1 2. 6. 2. 3. Bli n di n g of t he S p o ns or f or S u bst u d y B
T o facilitate ra pi d re vie w of data i n real ti me, a n d t o all o w a n assess me nt of safet y data b y 
st u d y i nter ve nti o n gr o u p, s p o ns or staff will be u n bli n de d t o st u d y i nter ve nti o n all ocati o n f or 
t he partici pa nts e nr olle d d uri n g S u bst u d y B.
1 0. 1 2. 6. 2. 4. Bre a ki n g t he Bli n d f or S u bst u d y B
N ot a p plica ble.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 6 9
1 0. 1 2. 6. 3. St u d y I nter ve nti o n C o m pli a nce f or S u bst u d y B
See Secti o n 6. 5 .
1 0. 1 2. 6. 4. D ose M o dific ati o n f or S u bst u d y B
N ot a p plica ble.
1 0. 1 2. 6. 5. C o nti n ue d Access t o St u d y I nter ve nti o n After t he E n d of t he St u d y f or 
S u bst u d y B
See Secti o n 6. 7 .
1 0. 1 2. 6. 6. Tre at me nt of O ver d ose f or S u bst u d y B
See Secti o n 6. 8 .
1 0. 1 2. 6. 7. Pri or a n d C o nc o mit a nt T her a p y f or S u bst u d y B
F or S u bst u d y  B, t he f oll o wi n g c o nc o mita nt me dicati o ns a n d vacci nati o ns will be rec or de d i n 
t he C R F:

Pri or recei pt of a n y C O VI D -1 9 vacci ne.

Pri or recei pt of a n y p ne u m oc occal vacci ne.

Lice nse d i nfl ue nza vacci ne, if recei ve d d uri n g t he 1 2 m o nt hs pri or t o e nr oll me nt.

A n y  vacci nati o ns recei ve d fr o m 2 8 da ys pri or t o enr oll me nt u ntil t he last visit ( Visit 2 0 4 ).

Pr o hi bite d me dicati o ns liste d i n Secti o n 1 0. 1 2. 6. 7. 1 , if ta ke n, will be rec or de d a n d 
i ncl u de start a n d st o p dates, na me of t he me dicati o n, d ose, u nit, r o ute, a n d fre q ue nc y.
1 0. 1 2. 6. 7. 1. Pr o hi bite d D uri n g t he St u d y f or S u bst u d y B

U nless c o nsi dere d me dicall y  necessar y, n o vacci nes ot her t ha n st u d y i nter ve nti o n s h o ul d 
be a d mi nistere d wit hi n 1 4 da y s bef ore a n d 1 4 d a y s after st u dy vacci nati o n at Visit 2 0 1.

R ecei pt of a n y ot her ( n o nst u d y ) c or o na vir us vacci ne fr o m e nr oll me nt t hr o u g h o ut the 
e ntire st u d y is pr o hi bite d.

R ecei pt of a n y ot her ( n o nst u d y ) seas o nal i nfl ue nza vacci ne fr o m e nr oll me nt t hr o u g h o ut 
t he e ntire st u dy is pr o hi bite d.

Recei pt of c hr o nic me dicati o ns wit h k n o w n s yste mic i m m u n os u p pressa nt effects, or 
ra di ot hera py, wit hi n 6 0 da y s bef ore e nr oll me nt t hr o u g h c o ncl usi o n of t he st u d y is 
pr o hi bite d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 0

Recei pt of s ys te mic c ortic oster oi ds ( ≥2 0 m g/ da y  of pre d nis o ne or e q ui vale nt) f or 
≥1 4 da y s is pr o hi bite d fr o m 2 8 da ys pri or t o e nr oll me nt t hr o u g h 2 8 da ys after 
a d mi nistrati o n of t he st u d y i nter ve nti o n.

Recei pt of bl o o d/ plas ma pr o d ucts, i m m u n o gl o b uli ns, or m o n ocl o nal a nti b o dies, fr o m 
6 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n t hr o u g h c o ncl usi o n of t he st u d y.

Pr o p h y lactic a nti p yretics a n d ot her pai n me dicati o n t o pre ve nt sy m pt o ms ass oc iate d wit h 
st u d y i nter ve nti o n a d mi nistrati o n are n ot per mitte d.  H o we ver, if a partici pa nt is ta ki n g a 
me dicati o n f or a n ot her c o n diti o n, e ve n if it ma y  ha ve a nti p yretic or pai n-relie vi n g 
pr o perties, it s h o ul d n ot be wit h hel d pri or t o st u d y vacci nati o n.
1 0. 1 2. 6. 7. 2. Pe r mitte d D uri n g t he St u d y f or S u bst u d y B

Me dicati o n ot her t ha n t hat descri be d as pr o hi bite d i n
Secti o n 1 0. 1 2. 6. 7. 1 re q uire d f or 
treat me nt of pree xisti n g c o n diti o ns or ac ute ill ness is per mitte d.

I n hale d, t o pical, or l ocalize d i njecti o ns of c ortic oster oi ds (e g, i ntra-artic ular or i ntra b ursal 
a d mi nistrati o n) are per mitte d.
1 0. 1 2. 7. Disc o nti n u ati o n of S u bst u d y B I nter ve nti o n a n d P artici p a nt 
Disc o nti n u ati o n/ Wit h dr a w al
See Secti o n 7 .
1 0. 1 2. 8. S u bst u d y B Assess me nts a n d Pr oce d ures f or S u bst u d y B
F or partici pa nts i n S u bst u d y  B, t he mi ni mal bl o o d sa m pli n g v ol u me is a p pr o xi matel y 4 0 m L  
( 1 5 m L at Visits 2 0 1 a n d 2 0 4 a n d a p pr o xi matel y 2 . 5 m L  at scree ni n g a n d Visits 2 0 1, 2 0 2, 
a n d 2 0 3 ). U p t o 2 0 partici pa nts i n G r o u ps 3, 4, a n d 5 i n t he 1 8- t hr o u g h 6 4 -ye ar a ge strat u m
will be as ke d t o c o nse nt t o alter nati vel y pr o vi di n g 5 0 -m L , rat her t ha n 1 5-m L , bl o o d sa m ples 
at t he sa me ti me p oi nts, w hic h will be use d f or i m m u n o ge nicit y assess me nts as well as assa y 
de vel o p me nt .
F or all partici pa nts, ot her a d diti o nal bl o o d sa m ples ma y  be ta ke n f or safet y assess me nts, 
pr o vi de d t he t otal v ol u me ta ke n d uri n g t he st u d y d oes n ot e xcee d 5 5 0 m L  d uri n g a ny peri o d 
of 6 0 c o nsec uti ve da ys.
1 0. 1 2. 8. 1. Tele he alt h Visits f or S u bst u d y B
I n Su bst u d y  B, t he fi nal visit will c o nsist of a tele healt h visit t o assess partici pa nt safet y a n d 
c ollect data p oi nts. Tele healt h i ncl u des t he e xc ha n ge of healt hcare i nf or mati o n a n d ser vices 
via telec o m m u nicati o n tec h n ol o gies (e g, a u di o, vi de o, vi de oc o nfere nci n g s oft ware) re m otel y, 
all o wi n g t he partici pa nt a n d t he i n vesti gat or t o c o m m u nicate o n as pects of cli nical care, 
i ncl u di n g me dical a d vice, re mi n ders, e d ucati o n, a n d safety m o nit ori n g. T he f oll o wi n g 
assess me nts m ust be perf or me d d uri n g a tele healt h visit (see t he S o A ):
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 1

Re vie w a n d rec or d a n y A Es a n d S A Es si nce t he last c o ntact. Refer t o Secti o n 8. 4 .

Re vie w a n d rec or d a n y ne w c o nc o mita nt me dicati o ns or c ha n ges i n c o nc o mita nt 
me dicati o ns si nce t he last c o ntact.

Pr oce d ures as i n dicate d f or Visit 2 0 5 ( Secti o n 1 0. 1 2. 8. 9. 6 ).
St u d y  partici pa nts m ust be re mi n de d t o pr o m ptl y n otif y site staff a b o ut a ny c ha n ge i n t heir 
healt h stat us.
1 0. 1 2. 8. 2. H o me He alt h Visits f or S u bst u d y B
A h o me healt hcare ser vice ma y be utilize d t o facilitate sc he d ule d visits. H o me healt h visits 
i ncl u de a healt hcare pr o vi der c o n d ucti n g a n i n-pers o n st u d y  visit at t he partici pa nt’s l ocati o n, 
rat her t ha n a n i n-pers o n st u d y  visit at t he site. T he f oll o wi n g ma y  be perf or me d d uri n g a 
h o me healt h visit (see t he S o A ):

Pr oce d ures as i n dicate d f or Visits 2 0 2, 2 0 3, a n d 2 0 4 (see Secti o n 1 0. 1 2. 8. 9. 3 ,
Secti o n 1 0. 1 2. 8. 9. 4 , a n d Secti o n 1 0. 1 2. 8. 9. 5 , res pecti vely) .
1 0. 1 2. 8. 3. I m m u n o ge nicit y Assess me nts f or S u bst u d y B
Sa m ples will be c ollecte d at t he ti me p oi nts s pecifie d i n Secti o n 1 0. 1 2. 1 fr o m all partici pa nts, 
a n d t he f oll o wi n g assa ys will be perf or me d :

H AI titers a gai nst seas o nal strai ns (
), ( 
), a n d (
rec o m me n de d by W H O .

S A R S -C o V -2 ne utralizati o n assa y (refere nce strai n) .

S A R S -C o V -2 ne utralizati o n assa y s ( O micr o n B A. 4, O micr o n B A. 5, a n d ot her e mer gi n g 
varia nts [u n der m o nit ori n g, of i nterest , a n d/ or of c o ncer n ], i ncl u di n g ot her O micr o n 
s u bli nea ges, ma y als o be e val uate d).
1 0. 1 2. 8. 3. 1. N- Bi n di n g A nti b o d y Test f or S u bst u d y B
T he N -bi n di n g a nti b o d y  test will be perf or me d by t he ce ntral la b orat or y o n eac h bl o o d 
sa m ple t o esta blis h pri or e x p os ure t o S A R S-C o V -2 u p t o eac h ti me p oi nt.  T hese data will be 
use d f or st u d y a nal ys es.
1 0. 1 2. 8. 4. Bi ol o gic al S a m ples f or S u bst u d y B
See Secti o n 8. 2. 1 .
1 0. 1 2. 8. 5. S afet y Assess me nts f or S u bst u d y B
See Secti o n 8. 3 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 2
1 0. 1 2. 8. 5. 1. E C Gs f or S u bst u d y B
E C Gs will be c ollecte d at t he ti mes s pecifie d i n Secti o n 1 0. 1 2. 1 f or S u bst u d y  B.
All sc he d ule d 1 2 -lea d E C Gs s h o ul d be perf or me d after t he partici pa nt has reste d q uietly f or 
at least 1 0 mi n utes i n a s u pi ne p ositi o n.  T he E C Gs s h o ul d be o btai ne d pri or t o bl o o d 
c ollecti o n, meas ure me nt of bl o o d press ure, a n d meas ure me nt of p ulse rate.  E C Gs will be 
perf or me d i n tri plicate.
E C G data will be s u b mitte d t o a ce ntral la b orat or y f or e val uati o n.  T he fi nal E C G re p ort fr o m 
t he ce ntral la b orat or y s h o ul d be mai ntai ne d i n t he partici pa nt’s s o urce d oc u me ntati o n a n d be 
t he fi nal i nter pretati o n of t he E C G rec or di n g.  A n y cli nicall y si g nifica nt c ha n ges fr o m t he 
baseli ne/ Da y  1 E C G ma y p ote ntiall y be A Es (see Secti o n 1 0. 3 ) a n d s h o ul d be e val uate d 
f urt her, as cli nically warra nte d.
I n s o me cases, it ma y be a p pr o priate t o re peat a b n or mal E C Gs t o r ule o ut i m pr o per lea d 
place me nt as c o ntri b uti n g t o t he E C G a b n or malit y .  It is i m p orta nt t hat lea d place me nt be i n 
t he sa me p ositi o n eac h ti me d uri n g eac h assess me nt visit i n or der t o ac hie ve precise E C G 
rec or di n gs.
E C G a b n or malities c o nsiste nt wit h pr o ba ble or p ossi ble m y ocar ditis or pericar ditis are t h ose 
j u dge d as s uc h b y a car di ol o gist, i ncl u di n g :

S ustai ne d atrial or ve ntric ular arr h yt h mias

Sec o n d -de gree M o bitz T y pe II or w orse A V bl oc k, ne w b u n dle bra nc h bl oc k

Diff use S T -se g me nt ele vati o n or P R-se g me nt i n versi o n, c o m pati ble wit h pericar ditis
Ec h ocar di o gra ms ma y  be perf or me d as detaile d i n Secti o n 1 0. 1 2. 8. 1 0.
E C G val ues of p ote ntial cli nical c o ncer n are liste d i n Secti o n 1 0. 9 .
1 0. 1 2. 8. 6. Cli nic al S afet y L a b or at or y Assess me nts f or S u bst u d y B
Please see Secti o n 8. 3. 4 .  A d diti o nall y, see Secti o n 1 0. 2 f or t he list of cli nical safety 
la b orat or y tests t o be perf or me d a n d t he S o A f or t he ti mi n g a n d fre q ue nc y.
1 0. 1 2. 8. 7. St o p pi n g R ules f or S u bst u d y B Gr o u ps 2, 6, 7, 8, 9, 1 0, 1 1, a n d 1 2
T he f oll o wi n g st o p pi n g r ules are i n place f or partici pa nts recei vi n g o ne of t he f oll o wi n g 
c o m bi nati o ns, n ot pre vi o usl y  c o vere d i n S u bst u d y A: qI R V/ bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5), tI RV/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5), or 
b I RV/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5) c o nc urre ntl y wit h lice ns e d QI V i n
S u bst u d y  B, base d o n A E, E C G, a n d la b orat or y data re vie w. T hese data will be re vie we d o n 
a n o n g oi n g basis b y t he i n vesti gat or ( or me dicall y q ualifie d desi g nee) a n d s p o ns or i n or der t o 
pr o m ptl y  i de ntif y a n d fla g a ny e ve nt t hat p ote ntiall y c o ntri butes t o a st o p pi n g r ule.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 3
T he s p o ns or st u d y  tea m will be u n bli n de d, s o will be a ble t o assess w het her or n ot a st o p pi n g 
r ule has bee n met o n t he basis of a partici pa nt’s i n di vi d ual st u d y i nter ve nti o n all ocati o n.
I n t he e ve nt t hat s p o ns or pers o n nel c o nfir m that a st o p pi n g r ule is met, t he f oll o wi n g acti o ns 
will c o m me nce:

T he I R C will re vie w all a p pr o priate data.

T he st o p pi n g r ule will P A U S E ra n d o mizati o n a n d st u d y  i nter ve nti o n a d mi nistrati o n 
i n all vacci ne gr o u ps acr oss b ot h a ge strat a

F or all partici pa nts al rea d y vacci nate d, all ot her r o uti ne st u d y c o n d uct acti vities, 
i ncl u di n g o n g oi n g data e ntr y, re p orti n g of A Es, partici pa nt e-diar y  c o m pleti o n, bl o o d 
sa m ple c ollecti o n, a n d partici pa nt f oll o w- u p, will c o nti n ue d uri n g t he pa use.
A st o p pi n g r ule is met if a n y  of t he c o n diti o ns liste d i n t he st o p pi n g r ule criteria bel o w occ ur 
wit hi n 4 wee ks after st u d y i nter ven ti o n a d mi nistrati o n . Eac h vacci ne gr o u p will be e val uate d 
f or c o ntri b uti o n t o st o p pi n g r ules i n de pe n de ntly.
St o p pi n g R ule Criteri a:
1.
If a ny vacci nate d partici pa nt de vel o p s:

A ne w E C G a b n or malit y  t hat a car di ol o gist j u d ges c o nsiste nt wit h pr o ba ble or 
p ossi ble m y ocar ditis or pericar ditis, i ncl u di n g b ut n ot li mite d t o :

S ustai ne d atrial or ve ntric ular arr h yt h mias

Sec o n d -de gree M o bitz T y pe II or w orse A V bl oc k, ne w b u n dle bra nc h bl oc k

Diff use S T -se g me nt ele vati o n or P R-se g me nt i n versi o n, c o m pati ble wit h 
pericar ditis

A n a b n or mal tr o p o ni n I val ue t hat is c o nfir me d a b n or mal o n re peat testi n g, assesse d 
as relate d t o st u d y i nter ve nti o n b y t he i n vesti gat or.
2.
If ≥1 vacci nate d partici pa nt de vel o ps a c o nfir me d cli nical dia g n osis of m y ocar ditis or 
pericar ditis.
3.
If a ny vacci nate d partici pa nt dies.
4.
If ≥1 vacci nate d partici pa nt e x perie nces a Gra de 4 u ns olicite d A E, or S A E of a n y 
se verity, assesse d as relate d b y t he i n vesti gat or.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 4
5.
If ≥2 partici pa nts vacci nate d wit h qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5), 
tI RV/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5), or b I R V/bi vale nt B N T 1 6 2 b 2 
( ori gi nal/ O mi B A. 4/ B A. 5) gi ve n c o nc urre ntl y wit h lice nse d QI V , at t he sa me d ose le vel,
de v el o p t he sa me or si milar Gra de 3 or hi g her u ns olicite d A E, ot her t ha n 
m y ocar ditis/ pericar ditis, assesse d as relate d t o st u d y  i nter ve nti o n b y t he i n vesti gat or.  
N ote t hat t he l ocal reacti o ns, s y ste mic e ve nts, a n d fe ver s pecifie d i n Secti o n 8. 3. 5 , 
re p orte d wit hi n 7 da ys fr o m t he da y of a d mi nistrati o n of t he st u d y i nter ve nti o n, 
irres pecti ve of w het her t he y are rec or de d i n t he e-diar y  or as A Es, are e xcl u de d fr o m t his 
st o p pi n g r ule.
1 0. 1 2. 8. 8. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her S afet y Re p orti n g f or 
S u bst u d y B
See Secti o n 8. 4 .
1 0. 1 2. 8. 9. St u d y Pr oce d ures f or S u bst u d y B
1 0. 1 2. 8. 9. 1. Scree ni n g ( 0 t o 2 8 D a ys Bef ore Visit 2 0 1) f or S u bst u d y B
Bef ore e nr oll me nt a n d bef ore a n y st u d y -relate d pr oce d ures are perf or me d, v ol u ntar y, writte n, 
st u d y-s pecific i nf or me d c o nse nt will be o btai ne d fr o m t he partici pa nt.  Eac h si g nat ure o n t he 
I C D m ust be pers o nally date d b y t he si g nat or y.  T he i n vesti gat or or his or her desi g nee will 
als o si g n t he I C D.  A c o p y of t he si g ne d a n d date d IC D m ust be gi ve n t o t h e partici pa nt.  T he 
s o urce data m ust reflect t hat t he i nf or me d c o nse nt was o btai ne d bef ore partici pati o n i n t he 
st u d y.
It is a ntici pate d t hat t he pr oce d ures bel o w will be c o n d ucte d i n a ste p wise ma n ner

Assi g n a partici pa nt n u m ber usi n g t he I R T s ys te m.  

O b tai n t he partici pa nt’s de m o gra p hy (i ncl u di n g date of birt h, se x, race, a n d et h nicit y).  
T he f ull date of birt h will be c ollecte d t o criticall y e val uate t he i m m u ne res p o nse a n d 
safety pr ofile b y a ge.

O btai n me dical hist or y , i ncl u di n g c o nfir me d C O VI D-1 9 dia g n osis (see Secti o n 8. 4. 7 ) or 
as ym pt o matic p ositi ve S A R S -C o V -2 test res ult ( N A A T or a nti ge n test), a n d a n y  ot her 
me dical hist or y  of cli nical si g nifica nce.

O btai n t he details of a n y me dicati o ns c urre ntl y  ta ke n.

Perf or m 1 2 -lea d tri plicate E C G.

Perf or m p h ys ical e xa mi nati o n, i ncl u di n g vital si g ns ( wei g ht, hei g ht, oral te m perat ure, 
p ulse rate, a n d seate d bl o o d press ure), e val uati n g a n y  cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g b o d y  s yste ms: ge neral a p peara nce; s ki n; hea d, e yes, ears, n ose, a n d 
t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ne ur ol o gical; a n d l ym p h 
n o des.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 5

C ollect a bl o o d sa m ple of a p pr o xi matel y  2.5 m L as detaile d i n t he la b orat or y  ma n ual f or 
tr o p o ni n I la b orat or y testi n g as descri be d i n Secti o n 8. 3. 4.

Perf or m uri ne pre g na nc y test o n W O C B P as descri be d i n Secti o n 8. 3. 6 .

Disc uss c o ntrace pti ve use as descri be d i n Secti o n 5. 3. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 2. 6. 7 .

Re vie w d oc u me ntati o n of all pri or C O VI D -1 9 vacci nati o ns.  All vacci nes m ust be 
a ut h orize d f or use i n t he U S.  Rec or d pri or recei pt of a n y C O VI D -1 9 vacci ne as 
descri be d i n Secti o n 1 0. 1 2. 6. 7 .

Rec or d pri or recei pt of a n y  p ne u m oc occal vacci ne as descri be d i n 
Secti o n 1 0. 1 2. 6. 7 .

Rec or d details of a n y lice nse d i nfl ue nza vacci ne recei ve d i n t he pri or 1 2 m o nt hs, as 
descri be d i n Secti o n 1 0. 1 2. 6. 7 .

E ns ure a n d d oc u me nt t hat all of t he i ncl usi o n criteria a n d n o ne of t he e xcl usi o n criteria 
are met.

Rec or d A Es as descri be d i n Secti o n 8. 4. 1 .

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R F.
1 0. 1 2. 8. 9. 2. Visit 2 0 1 – V acci n ati o n ( D a y 1) f or S u bst u d y B

It is a ntici pate d t hat t he pr oce d ures bel o w will be c o n d ucte d i n a ste p wise ma n ner.

Disc uss c o ntrace pti ve use as descri be d i n Secti o n 5. 3. 1 .

Rec or d n o nst u d y vacci nati o ns as descr i be d i n Secti o n 1 0. 1 2. 6. 7 .

Re vie w scree ni n g ce ntral la b orat or y res ults (tr o p o ni n I) a n d ce ntral E C G re p orts .

Perf or m 1 2 -lea d tri plicate E C G.

Perf or m a cli nical assess me nt.  If t he cli nical assess me nt i n dicates t hat a p h y sical 
e xa mi nati o n is necessar y t o c o m pre he nsi vel y e val uate t he partici pa nt, perf or m a p h ys ical 
e xa mi nati o n a n d rec or d a n y fi n di n gs i n t he s o urce d oc u me nts a n d, if cli nicall y 
si g nifica nt, rec or d o n t he me dical hist or y C R F or o n t he A E C R F as per Secti o n 1 0. 3 .

Meas ure vital si g ns, i ncl u di n g or al te m perat ure, p ulse rate, a n d seate d bl o o d press ure.

Perf or m uri ne pre g na nc y test o n W O C B P as descri be d i n Secti o n 8. 3. 6 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 6

E ns ure t hat t he partici pa nt c o nti n ues t o meet all of t he i ncl usi o n criteria a n d n o ne of t he 
e xcl usi o n criteria.

E ns ure t hat t he partici pa nt meets n o ne of t he te m p orar y  dela y criteria as descri be d i n 
Secti o n 5. 5 .

O btai n t he partici pa nt’s ra n d o mizati o n n u m ber a n d st u d y  i nter ve nti o n all ocati o n usi n g 
t he IR T s ys te m.

C ollect a bl o o d sa m ple of a p pr o xi matel y  2. 5 m L as detaile d i n t he la b orat or y man ual f or 
tr o p o ni n I la b orat or y testi n g as descri be d i n Secti o n 8. 3. 4 .

C ollect a bl o o d sa m ple (a p pr o xi matel y  1 5 mL or 5 0 m L ), bef ore a d mi nistrati o n of st u d y 
i nter ve nti o n, f or i m m u n o ge nicit y assess me nt.

Site staff me m ber(s) will dis pe nse/a d mi nister 1 d ose of st u d y  i nter ve nti o n i nt o t he delt oi d 
m uscle per Secti o n 1 0. 1 2. 6. 1. 1 .

Site staff m ust o bser ve t he partici pa nt f or at least 3 0 mi n utes after st u d y  i nter ve nti o n 
a d mi nistrati o n f or a n y ac ute reacti o ns.  Rec or d a n y ac ute reacti o ns (i ncl u di n g ti me of 
o nset) i n t he partici pa nt’s s o urce d oc u me nts a n d o n t he A E pa ge of t he C R F, a n d o n a n 
S A E f or m as a p plica ble.

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns at t he i njecti o n site a n d a 
t her m o meter f or rec or di n g daily te m perat ures a n d pr o vi de i nstr ucti o ns o n t hei r use.

E x plai n t he e -diar y  c o m pleti o n re q uire me nt t o t he partici pa nt a n d assist t he partici pa nt 
wit h d o w nl oa di n g t he st u d y  a p plicati o n o nt o t he partici pa nt’s o w n de vice or iss ue a 
pr o visi o ne d de vice if re q uire d.  Pr o vi de i nstr ucti o ns o n e- diar y  c o m pleti o n a n d as k t he 
partici pa nt t o c o m plete t he react o ge nicit y e -diar y  fr o m Da y 1 t hr o u g h Da y  7, wit h Da y 1 
bei n g t he da y  of vacci nati o n.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if he or s he 
e x perie nces a n y of t he f oll o wi n g fr o m D a y 1 t hr o u g h Da y 7 after vacci nati o n 
( w here Da y 1 is t he da y  of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y 
visit is re q uire d:

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness or s welli n g at t he i njecti o n site meas uri n g greater t ha n 1 0 c m 
( > 2 0 meas uri n g d e vice u nits).

Se vere pai n at t he i njecti o n site.

A n y  se vere sys te mic e ve nt.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 7

Rec or d A Es as descri be d i n Secti o n 8. 4. 1 .

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dicall y atte n de d e ve nt 
(e g, d oct or’s visit, e mer ge nc y r o o m visit) or h os pitalizati o n occ urs.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if t he partici pa nt 
e x perie nces ac ute c hest pai n, s h ort ness of breat h, or pal pitati o ns (see Secti o n 1 0. 1 2. 8. 1 0 ).

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

Re mi n d t he partici pa nt t o bri n g t he e -diar y  t o t he ne xt visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti g at or or a n a ut h orize d desi g nee c o m pletes t he C R Fs a n d u p dates t he st u d y  
i nter ve nti o n acc o u nta bilit y rec or ds.

T he i n vesti gat or or a p pr o priatel y  q ualifie d desi g nee re vie ws t he react o ge nicit y 
e-diar y  data o nli ne f oll o wi n g vacci nati o n t o e val uate partici pa nt c o m plia nce a n d as part 
of t he o n g oi n g safet y re vie w.  Dail y re vie w is o pti mal d uri n g t he acti ve diar y peri o d.
1 0. 1 2. 8. 9. 3. Visit 2 0 2 – D a y 3 F oll o w -U p Visit ( After V acci n ati o n) – 2 t o 4 D a ys After 
Visit 2 0 1 f or S u bst u d y B

Rec or d A Es as descri be d i n Secti o n 8. 4. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 2. 6. 7 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 1 0. 1 2. 6. 7. 1 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or c o ntrace pti o n as 
descri be d i n Secti o n 5. 3. 1 .

Re vie w scree ni n g ce ntral la b orat or y res ults (tr o p o ni n I) a n d ce ntral E C G re p orts .  A n y 
a b n or mal tr o p o ni n I le vel m ust res ult i n f urt her assess me nts as o utli ne d i n 
Secti o n 1 0. 1 2. 8. 1 0 .

Perf or m 1 2 -lea d tri plicate E C G.  A n y ne w E C G a b n or malit y (c o m pare d t o baseli ne) 
c o nsiste nt wit h pr o ba ble or p ossi ble m y ocar ditis or pericar ditis (as liste d i n 
Secti o n 1 0. 1 2. 8. 5. 1 ) m ust res ult i n f urt her assess me nts as o utli ne d i n 
Secti o n 1 0. 1 2. 8. 1 0 .

Meas ure vital si g ns, i ncl u di n g oral te m perat ure, p ulse rate, a n d seate d bl o o d press ure.

C ollect a bl o o d sa m ple of a p pr o xi matel y  2. 5 m L as detaile d i n t he la b orat or y ma n ual f or 
tr o p o ni n I la b orat or y testi n g as descri be d i n Secti o n 8. 3. 4 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 8

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y i f he or s he 
e x perie nces a n y of t he f oll o wi n g fr o m Da y  1 t hr o u g h Da y 7 after vacci nati o n 
( w here Da y 1 is t he d a y  of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y 
visit is re q uire d:

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness or s welli n g at t he i njecti o n site meas uri n g greater t ha n 1 0 c m 
( > 2 0 meas uri n g de vice u nits).

Se vere pai n at t he i njecti o n site.

A n y  se vere s yste mic e ve nt.

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dicall y atte n de d 
e ve nt (e g, d oct or’s visit, e mer ge nc y r o o m visit) or h os pitalizati o n occ urs.

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me dia tely i f t he 
partici pa nt e x perie nces ac ute c hest pai n, s h ort ness of breat h, or pal pitati o ns 
(see Secti o n 1 0. 1 2. 8. 1 0 ).

Re mi n d t he par tici pa nt t o c o m plete t he e-diar y , w hic h s h o ul d be re vie we d dail y  b y t he 
site.

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
1 0. 1 2. 8. 9. 4. Visit 2 0 3 – 1- Wee k F oll o w- U p Visit ( After V acci n ati o n) – 6 t o 8 D a ys After 
Visit 2 0 1 f or S u bst u d y B

Rec or d A Es as descri be d i n Secti o n 8. 4. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 2. 6. 7 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 1 0. 1 2. 6. 7. 1 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or c o ntrace pti o n as 
descri be d i n Secti o n 5. 3. 1 .

Re vie w scree ni n g ce ntral la b orat or y res ults (tr o p o ni n I) a n d ce ntral E C G re p orts .  A n y 
a b n or mal tr o p o ni n I le vel m ust res ult i n f urt her assess me nts as o utli ne d i n 
Secti o n 1 0. 1 2. 8. 1 0 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 7 9

Perf or m 1 2 -lea d tri plicate E C G.  A n y ne w E C G a b n or malit y (c o m pare d t o baseli ne) 
c o nsiste nt wit h pr o ba ble or p ossi ble m y ocar ditis or pericar ditis (as liste d i n 
Secti o n 1 0. 1 2. 8. 5. 1 ) m ust res ult i n f urt her assess me nts as o utli ne d i n Secti o n 1 0. 1 2. 8. 1 0 .

Meas ure vital si g ns, i ncl u di n g oral te m perat ure, p ulse rate, a n d seate d bl o o d press ure.

C ollect a bl o o d sa m ple of a p pr o xi matel y  2. 5 m L as detaile d i n t he la b orat or y ma n ual f or 
tr o p o ni n I la b orat or y testi n g as descri be d i n Secti o n 8. 3. 4 .

Re vie w t he partici pa nt’s react o ge nicit y  e-diar y  data.  If t he e- diar y c ollecti o n peri o d is 
c o m plete:

C ollect st o p dates of a n y react o ge nicit y e-diar y  e ve nts o n g oi n g o n t he last da y t hat t he 
react o ge nicit y e-diar y  was c o m plete d a n d rec or d st o p dates i n t he C R F if re q uire d.

C ollect t he partici pa nt’s e- diar y  or assist t he partici pa nt wit h re m o vi n g t he st u d y  
a p plicati o n fr o m his or her o w n pers o nal de vice (if t he visit is c o n d ucte d after Da y  7).

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y i f he or s he 
e x perie nces a n y of t he f oll o wi n g fr o m Da y 1 t hr o u g h Da y  7 after vacci nati o n 
( w here Da y 1 is t he da y  of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y 
visit is re q uire d:

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness or s welli n g at t he i njecti o n site meas uri n g greater t ha n 1 0 c m 
( > 2 0 meas uri n g de v ice u nits).

Se vere pai n at t he i njecti o n site.

A n y  se vere sys te mic e ve nt.

Re mi n d t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dicall y atte n de d 
e ve nt (e g, d oct or’s visit, e mer ge nc y  r o o m visit) or h os pitalizati o n occ urs.

Re mi n d t he partic i pa nt t o c o ntact t he site staff or i n vesti gat or i m me diately i f t he 
partici pa nt e x perie nces ac ute c hest pai n, s h ort ness of breat h, or pal pitati o ns 
(see Secti o n 1 0. 1 2. 8. 1 0 ).

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 0
1 0. 1 2. 8. 9. 5. Visit 2 0 4 – 4- Wee k F oll o w- U p Visit ( After V acci n ati o n) – 2 6 t o 3 0 D a ys 
After Visit 2 0 1 f or S u bst u d y B

Rec or d A Es as descri be d i n Secti o n 8. 4. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 2. 6. 7 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 1 0. 1 2. 6. 7. 1 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or c o ntrace pti o n as 
descri be d i n Secti o n 5. 3. 1 .

Re vie w scree ni n g ce ntral la b orat or y res ults (tr o p o ni n I) a n d ce ntral E C G re p orts .  A n y 
a b n or mal tr o p o ni n I le vel m ust res ult i n f urt her assess me nts as o utli ne d i n 
Secti o n 1 0. 1 2. 8. 1 0 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 5 m L or 5 0 m L f or i m m u n o ge nicit y testi n g.

Re vie w t he partici pa nt’s react o ge nicit y  e-diar y  data.  C ollect st o p dates of a n y 
react o ge nicit y e-diar y  e ve nts o n g oi n g o n t he last da y t hat t he react o ge nicit y e-diar y  was 
c o m plete d a n d rec or d st o p dates i n t he C R F if re q uire d.

If n ot alrea dy c o m plete d, c ollect t he partici pa nt’s e -diar y  or assist t he partici pa nt wit h
re m o vi n g t he st u dy a p plicati o n fr o m his or her o w n pers o nal de vice.

Rec or d a n y A Es t hat occ ur wit hi n t he 4 8 h o urs after t he bl o o d dra w as descri be d i n 
Secti o n 8. 4. 1 .
1 0. 1 2. 8. 9. 6. Visit 2 0 5 – 6- M o nt h Tele p h o ne C o nt act – 1 7 5 t o 1 8 9 D a ys After L ast St u d y 
V acci n ati o n f or S u bst u d y B

C o ntact t he partici pa nt b y  tele p h o ne.

Rec or d S A Es as descri be d i n Secti o n 8. 4. 1 .

Rec or d n o nst u d y vacci nati o ns as descri be d i n Secti o n 1 0. 1 2. 6. 7 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 1 0. 1 2. 6. 7. 1 .

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 1
1 0. 1 2. 8. 9. 7. U nsc he d ule d Visit f or a Gr a de 3 or S us pecte d Gr a de 4 Re acti o n f or 
S u bst u d y B
If a Gra de 3 l ocal reacti o n (Secti o n 8. 3. 5. 2 ), sys te mic e ve nt (Secti o n 8. 3. 5. 3 ), or fe ver 
(Secti o n 8. 3. 5. 4 ) is re p orte d i n t he react o ge nicity e -diar y , a tele p h o ne c o ntact s h o ul d occ ur t o 
ascertai n f urt her d etails a n d deter mi ne w het her a site visit is cli nicall y  i n dicate d.  If a 
s us pecte d Gra de 4 l ocal reacti o n (Secti o n 8. 3. 5. 2 ), s yste mic e ve nt (Secti o n 8. 3. 5. 3 ), or fe ver 
(Secti o n 8. 3. 5. 4 ) is re p orte d i n t he react o ge nicity e -diar y , a tele p h o ne c o ntact or site visit 
s h o ul d occ ur t o c o nfir m w het her t he e ve nt meets Gra de 4 criteria.
A site visit m ust be sc he d ule d as s o o n as p ossi ble t o assess t he pa rtici pa nt u nless a n y of t he 
f oll o wi n g is tr ue:

T he partici pa nt is u na ble t o atte n d t he u nsc he d ule d visit.

T he l ocal reacti o n/s ys te mic e ve nt is n o l o n ger prese nt at t he ti me of t he tele p h o ne 
c o ntact.

T he partici pa nt rec or de d a n i nc orrect val ue i n t he react o ge nicit y  e-diar y  (c o nfir mati o n of 
a react o ge nicit y e -diar y  data e ntr y err or).

T he PI  or a ut h orize d desi g nee deter mi ne d it was n ot nee de d.
T his tele p h o ne c o ntact will be rec or de d i n t he partici pa nt’s s o urce d oc u me ntati o n a n d t he 
C R F.
If t he partici pa nt is una ble t o atte n d t he u nsc he d ule d visit, or t he PI  or a ut h orize d desi g nee 
deter mi ne d it was n ot nee de d, a n y o n g oi n g l ocal reacti o ns/s y ste mic e ve nts m ust be assesse d 
at t he ne xt st u d y visit.
D uri n g t he u nsc he d ule d visit, t he reacti o ns s h o ul d be assesse d b y t h e i n vesti gat or or a 
me dicall y  q ualifie d me m ber of t he st u d y staff, s uc h as a st u d y p h ysicia n or a st u d y n urse, as 
a p plica ble t o t he i n vesti gat or’s l ocal practice, w h o will:

Meas ure b o d y t e m perat ure ( °F/ ° C).

Meas ure mi ni m u m a n d ma xi m u m dia meters of re d ness (if prese nt).

Meas ure mi ni m u m a n d ma xi m u m dia meters of s welli n g (if prese nt).

Assess i njecti o n site pai n (if prese nt) i n acc or da nce wit h t he gra des pr o vi de d i n 
Secti o n 8. 3. 5. 2 .

Assess s y ste mic e ve nts (if prese nt) i n acc or da nce wit h t he gra des pr o vi de d i n 
Secti o n 8. 3. 5. 3 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 2

Assess ot her fi n di n gs ass ociate d wit h t he reacti o n a n d rec or d t his o n t he A E pa ge of t he 
C R F if a p pr o priate.

T he i n vesti gat or or a n a ut h orize d desi g nee will c o m plete t he u nsc he d ule d visit 
assess me nt pa ge of t he C R F.
1 0. 1 2. 8. 1 0. A d dit i o n al Pr oce d ures f or M o nit ori n g of P ote nti al M y oc ar ditis or 
Peric ar ditis f or S u bst u d y B
A n y  st u d y partici pa nt w h o re p orts ac ute c hest pai n, s h ort ness of breat h, pal pitati o ns, or a n y 
ot her s y m pt o m(s) t hat mi g ht be i n dicati ve of m y ocar ditis or pericar ditis w it hi n 6 wee ks after 
st u d y vacci nati o n m ust be s pecificall y e val uate d i n cli nic b y  a car di ol o gist f or p ossi ble 
m y ocar ditis or pericar ditis.  T he sa me a p plies f or a n y  partici pa nt i n w h o m a ne w E C G 
a b n or malit y (c o m pare d t o baseli ne) c o nsiste nt wit h pr o ba ble or p ossi ble m yocar ditis or 
pericar ditis (as liste d i n Secti o n 1 0. 1 2. 8. 5. 1 ) or a b n or mal tr o p o ni n I le vel is o bser ve d at 
Visit 2 0 2 or Visit 2 0 3.
I n a d diti o n t o a cli nical e val uati o n, t he f oll o wi n g s h o ul d be perfor me d:

E C G a n d

Meas ure me nt of t he tr o p o ni n le vel
F or a n y partici pa nt i n w h o m a ne w E C G a b n or malit y  (c o m pare d t o baseli ne) c o nsiste nt wit h 
pr o ba ble or p ossi ble m y o car ditis or pericar ditis (as liste d i n Secti o n 1 0. 1 2. 8. 5. 1 ) or a b n or mal 
tr o p o ni n I le vel is o bser ve d at Visit 20 2 or Visit 2 0 3, t his s h o ul d be ac hie ve d b y  re peati n g t he 
assess me nts wit h t he ce ntral ve n d or(s).
If m yocar ditis o r pericar ditis is s us pecte d base d u p o n t he i nitial e val uati o n, t he f oll o wi n g 
s h o ul d als o be perf or me d:

Car diac ec h ocar di o gra m a n d/ or

Car diac ma g netic res o na nce st u d y
Details of t he s y m pt o ms re p orte d, a n d res ults of t he i n vesti gati o ns perf or me d, will be 
recor de d i n t he C R F.
A n y  dia g n osis of my o car ditis or pericar ditis is c o nsi dere d a n i m p orta nt me dical e ve nt a n d 
m ust be re p orte d as a n S A E (refer t o Secti o ns 8. 4. 1. 1 a n d 8. 4. 3 ). Ot her dia g n oses s h o ul d be 
rec or de d as A Es or S A Es, as a p pr o priate. Ref er als o t o Secti o n 8. 4. 7 .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 3
1 0. 1 2. 8. 1 1. A d diti o n al Pr oce d ures f or M o nit ori n g of P ote nti al Me nstr u al C ycle 
Dist ur b a nces f or S u bst u d y B
A n y  fe male st u d y partici pa nt w h o re p orts a n y s y m pt o ms t hat ma y  i n dicate a dist ur ba nce of 
t heir n or mal me nstr ual c ycle (i ncl u di n g, b ut n ot e xcl usi vel y, hea v y me nstr ual blee di n g, 
a me n orr hea, a n d irre g ular peri o ds) f oll o wi n g recei pt of st u d y i nter ve nti o n u ntil 6 m o nt hs 
after t he first vacci nati o n s h o ul d be s pecifically e val uate d b y t he i n vesti gat or. Details of t he 
s ym pt o ms, me nstr ual hist or y , a n d res ults of a n y i n vesti gati o ns perf or me d will be rec or de d i n 
t he C R F.
1 0. 1 2. 8. 1 1. 1. U nsc he d ule d Visit f or a Gr a de 3 or S us pecte d Gr a de 4 Re acti o n f or 
S u bs t u d y B
If a Gra de 3 l ocal reacti o n (Secti o n 8. 3. 5. 2 ), sys te mic e ve nt (Secti o n 8. 3. 5. 3 ), or fe ver 
(Secti o n 8. 3. 5. 4 ) is re p orte d i n t he react o ge nicity e -diar y , a tele p h o ne c o ntact s h o ul d occ ur t o 
ascertai n f urt her details a n d deter mi ne w het her a site visit is cli nicall y  i n dicate d. If a 
s us pecte d Gra de 4 l ocal reacti o n (Secti o n 8. 3. 5. 2 ), s yste mic e ve nt (Secti o n 8. 3. 5. 3 ), or fe ver
(Secti o n 8. 3. 5. 4 ) is re p orte d i n t he react o ge nicity e -diar y , a tele p h o ne c o ntact or site visit 
s h o ul d occ ur t o c o nfir m w het her t he e ve nt meets Gra de 4 criteria.
A site visit m ust be sc he d ule d as s o o n as p os si ble t o assess t he partici pa nt u nless a n y of t he 
f oll o wi n g is tr ue:

T he partici pa nt is u na ble t o atte n d t he u nsc he d ule d visit.

T he l ocal reacti o n/s ys te mic e ve nt is n o l o n ger prese nt at t he ti me of t he tele p h o ne 
c o ntact.

T he partici pa nt rec or de d a n i nc orre ct val ue i n t he react o ge nicit y e-diar y  (c o nfir mati o n of 
a react o ge nicit y e -diar y  data e ntr y err or).

T he PI  or a ut h orize d desi g nee deter mi ne d it was n ot nee de d.

T his tele p h o ne c o ntact will be rec or de d i n t he partici pa nt’s s o urce d oc u me ntati o n a n d t he 
C R F.
If t he partici pa nt is u na ble t o atte n d t he u nsc he d ule d visit, or t he PI or a ut h orize d desi g nee 
deter mi ne d it was n ot nee de d, a n y o n g oi n g l ocal reacti o ns/s y ste mic e ve nts m ust be assesse d 
at t he ne xt st u d y visit.
D uri n g t he u nsc he d ule d visit, t he reacti o ns s h o ul d be assesse d b y t he i n vesti gat or or a 
me dicall y  q ualifie d me m ber of t he st u d y staff, s uc h as a st u d y p h ysicia n or a st u d y n urse, as 
a p plica ble t o t he i n vesti gat or’s l ocal practice, w h o will:

Meas ure oral te m perat ure ( °F/ ° C).

Meas ure mi ni m u m a n d ma xi m u m dia meters of re d ness (if prese nt).
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 4

Meas ure mi ni m u m a n d ma xi m u m dia meters of s welli n g (if prese nt).

Assess i njecti o n site pai n (if prese nt) i n acc or da nce wit h t he gra des pr o vi de d i n
Secti o n 8. 3. 5. 2 .

Assess s y ste mic e ve nts (if prese nt) i n acc or da nce wit h t he gra des pr o vi de d i n
Secti o n 8. 3. 5. 3 .

Assess f or ot her fi n di n gs ass ociate d wit h t he reacti o n a n d rec or d t hese o n t he A E pa ge of 
t he C R F if a p pr o priate.

T he i n vesti gat or or a n a ut h orize d desi g nee will c o m plete t he u nsc he d ule d visit 
assess me nt pa ge of t he C R F.
1 0. 1 2. 8. 1 2. A d diti o n al Pr oce d ures f or M o nit ori n g of P ote nti al M y oc ar ditis or 
Peric ar ditis f or S u bst u d y B
D uri n g S u bst u d y  B, partici pa nt s 1 8 t hr o u g h 6 4 ye ars of a ge will be cl osel y m o nit ore d f or 
p ote ntial as y m pt o matic a n d s y m pt o matic m y ocar ditis/ pericar ditis , i ncl u di n g t he use of 
r o uti ne E C Gs a n d tr o p o ni n testi n g. 
A n y  st u d y partici pa nt w h o re p orts ac ute c hest pai n, s h ort ness of breat h, pal pitati o ns, or a n y 
ot her s y m pt o m(s) t hat mi g ht be i n dicati ve of m y ocar ditis or pericar ditis wit hi n 6 wee ks after 
st u d y vacci nati o n m ust be s pecificall y e val uate d i n cli nic b y  a car di ol o gist f or p ossi ble 
m y ocar ditis or pericar ditis : 

Ac ute c hest pai n, 

S h or t ness of breat h, 

Pal pitati o ns, or 

A n y  ot her sy m pt o m(s) t hat mi g ht be i n dicati ve of m y ocar ditis or pericar ditis .

I n a d diti o n t o a cli nical e val uati o n, t he f oll o wi n g s h o ul d be perf or me d:

E C G a n d

Meas ure me nt of t he tr o p o ni n le vel.
If m yocar ditis or pericar ditis is s us pecte d base d u p o n t he i nitial e val uati o n, t he f oll o wi n g 
s h o ul d als o be perf or me d:

Car diac ec h ocar di o gra m a n d/ or

Car diac ma g netic res o na nce st u d y .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 5
Details of t he s y m pt o ms re p orte d, a n d res ults of t he i n vesti gati o ns perf or me d, will be 
rec or de d i n t he C R F. A n y  dia g n osis ma de (e g, m yocar ditis, pericar ditis, or ot her) s h o ul d be 
rec or de d as a n A E or S A E, as a p pr o priate . Refer als o t o Secti o n 8. 4. 7 .
1 0. 1 2. 8. 1 3. A d diti o n al Pr oce d ures f or M o nit ori n g of P ote nti al Me nstr u al C ycle 
Dist ur b a nces f or S u bst u d y B
A n y  fe male st u d y partici pa nt w h o re p orts a n y s y m pt o ms t hat ma y i n dicate a dist ur ba nce of 
t heir n or mal me nstr ual c ycle (i ncl u di n g, b ut n ot e xcl usi vel y, hea v y me nstr ual blee di n g, 
a me n orr hea, a n d irre g ular peri o ds) f oll o wi n g recei pt of st u d y i nter ve nti o n u ntil 6 m o nt hs 
after t he first vacci nati o n s h o ul d be s pecificall y e val uate d b y t he i n vesti gat or at t he ne xt 
pla n ne d visit . Details of t he s y m pt o ms, me nstr ual hist or y , a n d res ults of a n y i n vesti gati o ns 
perf or me d will be rec or de d i n t he C R F.
1 0. 1 2. 9. St atistic al C o nsi de r ati o ns – S u bst u d y B
Met h o d ol o g y  f or s u m mar y a n d statistical a nalys es of t he data c ollecte d i n t his s u bst u d y is 
descri be d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or.  T he 
S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc ol w h ere a p pr o priate; h o we ver, a n y maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
1 0. 1 2. 9. 1. St atistic al H y p ot heses f or S u bst u d y B
T here are n o statistical h y p ot heses f or S u bs t u d y B .
1 0. 1 2. 9. 1. 1. Esti m a n ds f or S u bst u d y B
1 0. 1 2. 9. 1. 1. 1. Pri m ar y Esti m a n ds/ C o pri m ar y Esti m a n ds f or S u bst u d y B
T he esti ma n ds t o e val uate t he safet y o bjecti ve are base d o n t he safet y p o p ulati o n. T hese 
esti ma n ds esti mate vacci ne safet y after st u d y i nter ve nti o n. C o m pletel y  missi n g e-diar y  data 
will n ot be i m p ute d; missi n g A E dates a n d missi n g A E i nte nsit y  will be ha n dle d acc or di n g t o 
Pfizer safet y r ules. Missi n g e -diar y  data n ot rec or de d i n t he e-diar y will be rec or de d o n t he 
A E C R F.
T heref ore, t he pri mar y  a nalys is will use react o ge nicit y rec or de d as AEs i n t he
C R F t o i m p ute t he missi n g e-diar y  data.
1 0. 1 2. 9. 1. 1. 2. Sec o n d ar y Esti m a n ds f or S u bst u d y B
T he sec o n dar y  esti ma n ds c orres p o n di n g t o eac h sec o n dar y o bjecti ve are descri be d i n t he 
ta ble i n Secti o n 1 0. 1 2. 3.
T he esti ma n ds t o e val uate t he i m m u n o ge nicit y  o bjecti ves are base d o n t he e val ua ble 
i m m u n o ge nicity p o p ulati o n. T hese esti ma n ds esti mate t he i m m u ne res p o nse after st u d y 
i nter ve nti o n a d mi nistrati o n i n t he h yp ot hetical setti n g w here partici pa nts f oll o w t he st u d y  
sc he d ules a n d pr ot oc ol re q uire me nts as directe d. Missi n g i m m u n o ge nicit y res ults will n ot be 
i m p ute d, as M C A R is ass u me d. F or partici pa nts w h o disc o nti n ue fr o m t he st u d y  or ha ve 
maj or pr ot oc ol vi olati o ns, all p ost disc o nti n uati o n or p ost vi olati o n o bser vati o ns will be 
ce ns ore d.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 6
I m m u n o ge nicity res ults t hat are bel o w t he L L O Q will be set t o 0. 5 × L L O Q i n t he a nal ys es.
1 0. 1 2. 9. 1. 2. M ulti plicit y A dj ust me nt
f or S u bst u d y B
T here is n o m ulti plicit y adj ust me nt f or t he st u d y as t he st u d y is descri pti ve i n nat ure.
1 0. 1 2. 9. 2. A n al ysis Sets f or S u bst u d y B
F or p ur p oses of a nal y sis, t he f oll o wi n g a nalys is sets are defi ne d i n S u bst u d y B:
P o p ul ati o n
Descri pti o n
Scree ne d
All partici pa nts w h o si g n t he I C D.
Ra n d o mize d
All partici pa nts w h o are assi g ne d a ra n d o mizati o n n u m ber i n 
t he IR T s ys te m.
E val ua ble i m m u n o ge nicit y
All partici pa nts w h o are eli gi ble, recei ve t he st u d y 
i nter ve nti o n(s) t o w hic h t he y were ra n d o mize d, ha ve bl o o d 
dra w n f or assa y testi n g wit hi n t he s pecifie d ti me fra me after 
vacci nati o n (s), ha ve at least 1 vali d a n d deter mi nate assa y 
res ult at t he 4-wee k p ost vacci nati o n visit, a n d ha ve n o maj or 
pr ot oc ol vi olati o ns.
mI T T i m m u n o ge nicit y  
All ra n d o mize d partici pa nts w h o recei ve t he st u d y 
i nter ve nti o n a n d ha ve at least 1 vali d a n d deter mi nate assa y 
res ult after vacci nati o n.
Safet y
All partici pa nts w h o recei ve t he st u d y  i nter ve nti o n.
I n di vi d uals wit h o nset of i nfl ue nza or C O VI D- 1 9 d uri n g t he st u d y  peri o d (starti n g fr o m t he 
ti me of vacci nati o n/ Da y  1) ma y  be re m o ve d fr o m t he e val ua ble i m m u n o ge nicit y p o p ulati o n 
f or i nfl ue nza or C O VI D-1 9, res pecti vel y. 
1 0. 1 2. 9. 3. St atistic al A n al yses f or S u bst u d y B
T he S A P f or S u bst u d y B will be de vel o pe d a n d fi nalize d bef ore a n y a nal ys es are perf or me d 
a n d will descri be t he a nal ys es a n d pr oce d ures f or acc o u nti n g f or missi n g, u n use d, a n d 
s p uri o us data. T his secti o n is a s u m mar y  of t he pla n ne d statistical a nalys es of t he pri mar y, 
sec o n dar y, a n d tertiar y/e x pl orat or y e n d p oi nts.
1 0. 1 2. 9. 3. 1. Ge ner al C o nsi der ati o ns f or S u bst u d y B
Refer t o Secti o n 9 f or ge neral c o nsi derati o ns of statistical a nalys es.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 7
1 0. 1 2. 9. 3. 2. Pri m ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis f or S u bst u d y B
E n d p oi nt
St atistic al A n al ysis Met h o ds
Pri mar y  safet y 

P oi nt esti mates a n d t he ass ociate d e xact 2 -si de d 9 5 % CI s will 
be calc ulate d usi n g t he Cl o p per -Pears o n met h o d f or t he 
pr o p orti o n of partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge re p orti n g 
a b n or mal tr o p o ni n I la b orat or y  val uesf or eac h st u d y
i nter ve nti o n at 2 da ys a n d 1 wee k after vacci nati o n, f or all 
partici pa nts .

P oi nt esti mates a n d t he ass ociate d e xact 2 -si de d 9 5 % CI s will 
be calc ulate d usi n g t he Cl o p per -Pears o n met h o d f or t he 
pr o p orti o n of partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge wit h ne w 
E C G a b n or malities f or eac h st u d y i nter ve nti o n at 2 wee ks a n d
1 wee k after vacci nati o n, f or all partici pa nts .

P oi nt esti mates a n d t he ass ociate d e xact 2 -si de d 9 5 % CI s will 
be calc ulate d usi n g t he Cl o p per -Pears o n met h o d f or t he 
pr o p orti o n of partici pa nts re p orti n g eac h e ve nt (l ocal reacti o ns
a n d s yste mic e ve nts) f or eac h vacci ne gr o u p, in partici pa nts 
1 8 t hr o u g h 6 4 ye ars of a ge.

P oi nt esti mates a n d t he ass ociate d e xact 2 -si de d 9 5 % CI s will 
be calc ulate d usi n g t he Cl o p per -Pears o n met h o d f or t he 
pr o p orti o n of partici pa nts re p orti n g eac h e ve nt (A Es a n d 
S A Es) f or eac h vacci ne gr o u p , in partici pa nts 1 8 t hr o u g h 
6 4 y ears of a ge .

A Es a n d S A Es will be cate g orize d acc or di n g t o Me d D R A 
ter ms.
1 0. 1 2. 9. 3. 3. Sec o n d ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis f or S u bst u d y B
E n d p oi nt
St atistic al A n al ysis Met h o ds
Sec o n dar y  
i m m u n o ge nicity 
( partici pa nts 
1 8 t hr o u g h 
6 4 ye ars of a ge)
I nfl ue nz a:

H AI G M Ts, a n d t he ass ociate d 2 -si de d 9 5 % CI s, will be pr o vi de d 
f or eac h strai n, b y st u d y i nter ve nti o n, bef ore vacci nati o n a n d at 
4 wee ks after vacci nati o n ( pri mar y) a n d at ot her p ost vacci nati o n 
ti me p oi nts (sec o n dar y ), f or all partici pa nts.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 8
E n d p oi nt
St atistic al A n al ysis Met h o ds

H AI G M F Rs fr o m bef ore vacci nati o n t o 4 wee ks after vacci nati o n 
( pri mar y) a n d t o ot her p ost vacci nati o n ti me p oi nts (sec o n dar y ), 
a n d t he ass ociate d 2 -si de d 9 5 % CI s, will be pr o vi de d f or eac h 
strai n, b y st u d y i nter ve nti o n, f or all partici pa nts .

T he pr o p orti o n of partici pa nts ac hie vi n g H AI ser oc o n versi o n at 
4 wee ks after vacci nati o n ( primar y ) a n d at ot her p ost vacci nati o n 
ti me p oi nts (sec o n dar y ) a n d t he pr o p orti o n of partici pa nts wit h 
H AI titers ≥1: 4 0 bef ore vacci nati o n a n d at 4 wee ks a n d 6 m o nt hs 
after vacci nati o n, a n d t he ass ociate d 2 -si de d Cl o p per-Pears o n 
9 5 % CI s, will be pr o vi de d f or eac h strai n, b y  st u d y i nter ve nti o n,
f or all partici pa nts .

T he strai ns me nti o ne d a b o ve f or qI R V or QI V-relate d st u d y 
i nter ve nti o ns refer t o t he matc he d seas o nal strai ns rec o m me n de d 
b y  W H O.
S A R S -C o V - 2:

G M Ts , a n d t he ass ociate d 2-si de d 9 5 % CI s, will be pr o vi de d b y
st u d y i nter ve nti o n f or eac h strai n-s pecific ne utralizi n g titer bef ore 
vacci nati o n a n d at 4 wee ks after vacci nati o n ( pri mar y) a n d at ot her 
p ost vacci nati o n ti me p oi nts (sec o n dar y ), f or all partici pa nts .

G M F R fr o m bef ore vacci nati o n t o 4 wee ks after vacci nati o n 
( pri mar y) a n d t o ot her p ost vacci nati o n ti me p oi nts (sec o n dar y ),
a n d t he ass ociate d 2- si de d 9 5 % CI s, will be pr o vi de d b y st u d y
i nter ve nti o n f or eac h strai n-s pecific ne utralizi n g titer, f or all 
partic i pa nts.

Perce nta ges of partici pa nts wit h ser ores p o nse, a n d t he ass ociate d 
2- si de d Cl o p per -Pears o n 9 5 % CI s, will be pr o vi de d b y st u d y
i nter ve nti o n at 4 wee ks after vacci nati o n ( pri mar y) a n d at ot her 
p ost vacci nati o n ti me p oi nts (sec o n dar y ) f or eac h strai n, f or all 
partici pa nts .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 8 9
1 0. 1 2. 9. 3. 4. Terti ar y/ E x pl or at or y E n d p oi nt(s) f or S u bst u d y B
Pla n ne d a nal ys es of e x pl orat or y  e n d p oi nts are i n dicate d bel o w. 
I m m u ne res p o nse 
t o e mer gi n g 
varia nts ( u n der 
m o nit ori n g, of 
i nterest, a n d/ or of 
c o ncer n)

G M Ts of S A R S- C o V - 2 varia nt ( u n der m o nit ori n g, of i nterest,
a n d/ or of c o ncer n) ne utralizi n g titers f or varia nts ( u n der 
m o nit ori n g , of i nterest, a n d/ or of c o ncer n) n ot alrea d y  s pecifie d, 
al o n g wit h t he ass ociate d 2 -si de d 9 5 % CIs, will be pr o vi de d at 
s pecific ti me p oi nts f or eac h st u d y i nter ve nti o n. 

G M F Rs fr o m baseli ne ( bef ore t he st u d y  vacci nati o n) t o eac h 
s u bse q ue nt ti me p oi nt, a n d t he perce nta ge of partici pa nts wit h 
ser ores p o nse at eac h ti me p oi nt after vacci nati o n, al o n g wit h t he 
ass ociate d 2 -si de d 9 5 % CI s, ma y als o be pr o vi de d f or eac h st u d y 
i nter ve nti o n.
T o descri be t he 
tr o p o ni n a n d E C G 
a b n or malities 
detecte d i n 
partici pa nts w h o 
are e val uate d f or 
p ossi ble car diac 
s ym pt o ms  

A d diti o nal s u m maries a n d/ or listi n gs of tr o p o ni n a n d E C G 
a b n or malities relate d t o pri mar y safet y e n d p oi nts f or partici pa nts 
1 8 t hr o u g h 6 4 y ears of a ge ma y be pr o vi de d, as detaile d f urt her i n 
t he S A P.
1 0. 1 2. 9. 3. 5. Ot her S afet y A n al yses f or S u bst u d y B
T he data c ollecte d f or st u d y  partici pa nts w h o re p ort a n y sy m pt o m(s) t hat mi g ht be i n dicati ve 
of m y ocar ditis or pericar ditis wit hi n 4 wee ks after a st u d y  vacci nati o n ( E C G, tr o p o ni n le vel, 
car diac ec h ocar di o gra m, a n d/ or car diac ma g netic res o na nce st u d y)  will be s u m marize d a n d 
liste d b y st u d y i nter ve nti o n.
1 0. 1 2. 9. 4. I nteri m A n al yses f or S u bst u d y B
T here are n o f or mal i nteri m a nal y ses pla n ne d f or t his st u d y.
1 0. 1 2. 9. 5. A n al ysis Ti mi n g f or S u bst u d y B
A nal y ses (i m m u n o ge nicit y or safety) ma y be perf or me d at a n y ti me (e g, safet y data t hr o u g h 
a p pr o xi matel y 1 wee k after vacci nati o n) f or all partici pa nts .  
C o m plete sa fety a n d i m m u n o ge nicity a nal ys is will be perf or me d at t he e n d of t his su bst u d y .
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 0
1 0. 1 2. 9. 6. S a m ple Size Deter mi n ati o n f or S u bst u d y B
1 0. 1 2. 9. 6. 1. I m m u n o ge nicit y f or S u bst u d y B
Si nce t he s u bst u d y  is descri pti ve i n nat ure, t he pla n ne d sa m ple size f or t he st u d y is n ot base d 
o n a n y  statistical h yp ot hesis testi n g.
A p pr o xi matel y  3 0 partici pa nts/ u p t o 1 2 0 partici pa nts will be e nr olle d f or eac h vacci ne 
gr o u p f or partici pa nts of 1 8 t hr o u g h 6 4 ye ars of a ge. A t otal of u p t o a p pr o xi matel y
6 3 0 partici pa nts ma y  be e nr olle d.
1 0. 1 2. 9. 6. 2. S afet y f or S u bst u d y B
F or safet y o utc o mes i n t he st u d y, Ta ble 9 s h o ws t he pr o ba bilit y of o bser vi n g at least 1 A E f or 
a gi ve n tr ue e ve nt rate of a partic ular A E wit h vari o us sa m ple sizes.
T a ble 9.
Pr o b a bilit y of O bser vi n g at Le ast 1 A E b y Ass u me d Tr ue E ve nt R ate
S a m ple Size 
Ass u me d Tr ue R ate of a n A E
Pr o b a bilit y of O bser vi n g at 
Le ast 1 A E
3 0
0. 5 %
1 4. 0 %
1. 0 %
2 6. 0 %
2. 0 %
4 5. 5 %
5. 0 %
7 8. 5 %
7. 0 %
8 8. 7 %
1 2 0
0. 5 %
4 5. 2 %
1. 0 %
7 0. 1 %
2. 0 %
9 1. 1 %
5. 0 %
9 9. 8 %
7. 0 %
> 9 9. 9 9 %
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 1
1 0. 1 3. A p pe n di x 1 3 : Pr ot oc ol A me n d me nt Hist or y
T he Pr ot oc ol A me n d me nt S u m mar y  of C ha n ges Ta ble f or t he c urre nt a me n d me nt is l ocate d 
directl y  bef ore t he T O C.  T he pr ot oc ol a me n d me nt s u m mar y of c ha n ges ta bles f or past 
a me n d me nt(s) ca n be f o u n d bel o w:
A m e n d me nt 5 (1 5 A u g ust 2 0 2 3)
O ver all R ati o n ale f or t he A me n d me nt:  
Pr ot oc ol re visi o ns i n res p o nse t o partial cli nical h ol d.
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
T hr o u g h o ut
A d de d m o n o vale nt B N T 1 6 2 b 2 ( O mi
X B B. 1. 5)
A d diti o n of ne w 
m o n o vale nt 
B N T 1 6 2 b 2 X B B. 1. 5 
i n t he vacci ne gr o u ps 
S u bsta ntial
Secti o n 1. 1 : S y n o psis
Rati o nale was u p date d
T o ali g n wit h 
X B B. 1. 5 a d diti o n
S u bsta ntial
Secti o n 1. 1 : S y n o psis
O bjecti ves w ere u p date d
T o c o nsi der t he 
m o n o vale nt 
B N T 1 6 2 b 2 ( O mi 
X B B. 1. 5) a n d t he 
se parati o n of t he 2 
a ge gr o u ps i n 
S u bst u d y B
S u bsta ntial
Secti o n 1. 1 S y n o psis
T he o verall desi g n was s u m marize d 
as a para gra p h; t he b ullet p oi nts were 
r e mo ve d
T o bri n g clarit y i n t he 
desi g n
N o ns u bsta ntial
Secti o n 1. 1 : S y n o psis
T he ta ble title d “ S u bst u d y B: All
V acci ne Gr o u ps” was u p date d t o 
“ S u bst u d y B: All I nitial-E nr oll me nt 
V acci ne Gr o u ps f or Partici pa nts 
1 8 T hr o u g h 6 4 Years of A ge”
T o ali g n wit h t he 
desi g n
S u bsta ntial
Secti o n 1. 1 : S y n o psis
A d de d a ne w ta ble title d “ S u bst u d y 
B: All E x pa n de d -E nr oll me nt Vacci ne 
Gr o u ps f or Partici pa nts ≥6 5 Years of 
A ge” t o r e place 3 ta bles titled 
“S u bst u d y B: qI R V/ Bi vale nt 
B N T 1 6 2 b 2 ( Ori gi nal/ O mi 
B A. 4/ B A. 5) D ose -Le vel 
C o m bi nati o n s,” “ S u bst u d y B: 
tI R V/ Bi vale nt B N T 1 6 2 b 2 
( Ori gi nal/ O mi B A. 4/ B A. 5),” a n d 
“ S u bst u d y B: b I R V/ Bi vale nt 
B N T 1 6 2 b 2 ( Ori gi nal/ O mi 
B A. 4/ B A. 5) ”
T o ali g n wit h t he ne w 
desi g n a n d bri n g 
clarit y i n t he na mi n g 
of t he vari o us vacci ne 
gr o u ps
S u bsta ntial
Secti o n 1. 1 : S y n o psis
Vacci ne pre parati o n ta ble w as 
r e mo ve d
T o i m pr o ve 
rea da bilit y of t he 
s y n o psis
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 2
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1. 1 : S y n o psis
Ta ble title d “I nitial -E nr oll me nt Sta ge 
C o h orts i n Partici pa nts 1 8 T hr o u g h 
6 4 Years of A ge” was u p date d
T o bri n g detail o n 
lice nse d QI V
N o ns u bsta ntial
Secti o n 1. 1 : S y n o psis
U p date d I R C re vie w t o 4 w ee ks after
vacci nati o n i n S u bst u d y A
Safet y a n d 
i m m u n o ge nicit y 
re vie w was c o n d ucte d 
at least 4 wee ks after
vacci nati o n i n 
S u bst u d y A
S u bsta ntial
Secti o n 1. 1 : S y n o psis
Secti o n was re vise d t o al i g n wit h 
c ha n ges t o t he st u d y desi g n
T o ali g n wit h st u d y 
desi g n
S u bsta ntial
Secti o n 1. 1 : S y n o psis
Clarificati o n o n t he S u bst u d y B 
e nr oll me nt strate g y f or b ot h i nitial 
a n d e x pa n de d p hases
E nr oll me nt of t he
partici pa nts 1 8
t hr o u g h 6 4 y ears of 
a ge a n d safet y re vie w 
pri or t o e nr olli n g t he
partici pa nts ≥6 5 years 
o f a ge
S u bsta ntial
Secti o n 1. 1 : S y n o psis
U p date d t he n u m ber of partici pa nts
T o ali g n wit h t he 
u p date d e nr oll me nt 
strate g y
S u bsta ntial
Secti o n 1. 1 : S y n o psis
E xcl usi o n criteria were a d de d t o 
S u bst u d y B
T o bri n g clarit y
S u bsta ntial
Secti o n 1. 1 : S y n o psis
S u bst u d y B st u d y ar m ta ble was 
u p date d
T o reflect X B B. 1. 5, 
place b o, a n d 
c o m parat or
S u bsta ntial
Secti o n 1. 2 : Sc he ma 
Sc he ma was u p date d
T o reflect t he ne w 
e nr oll me nt strate g y 
a n d safet y re vie w
S u bsta ntial
Secti o n 2. 1 : St u d y 
Rati o nale
Te xt w as e dite d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 2. 2 : 
Bac k gr o u n d
Te xt a n d refere nces were re vise d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 2. 2. 3 : Cli nical 
O ver vie w
Te xt w as e dite d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 2. 3 : 
Be nefit/ Ris k 
Assess me nt
Te xt w as e dite d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 4. 3 : 
J ustificati o n f or D ose 
Te xt w as e dite d; a d diti o n of 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
T o ali g n wit h t he 
st u d y desi g n
S u bsta nti al
Secti o n 6 : St u d y 
I nter ve nti o n(s) a n d 
C o nc o mita nt T hera p y
Te xt w as e dite d; m ore details were 
a d de d
T o bri n g clarit y o n t he 
vacci ne gr o u ps
S u bsta ntial
Secti o n 6 : St u d y 
I nter ve nti o n(s) a n d 
C o nc o mita nt T hera p y
Te xt w as e dite d; Ta ble 2 was e dite d 
a n d s plit i nt o 2 ta bles ( n o w Ta bles 2 
a n d 3); pre vi o us Ta bles 3 a n d 4 were 
r e mo ve d 
T o bri n g clarit y o n t he 
vacci ne gr o u ps
S u bsta ntial
Secti o n 7. 1 : 
Disc o nti n uati o n of 
St u d y I nter ve nti o n
Details were a d de d f or partici pa nts i n 
Gr o u p 1 4 or 1 5 w h o ma y disc o nti n ue 
st u d y i nter ve nti o n a d mi nistrati o n
T o ali g n wit h t he 
a d diti o n of 2 -d ose 
gr o u ps
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 3
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 8. 3. 5 : Electr o nic 
Diar y
A d de d i nstr ucti o n t hat misse d e -diar y 
e ntries s h o ul d be i ncl u de d i n t he A E 
C R F
T o ali g n wit h 
re g ulat or y 
e x pectati o ns
N o ns u bsta ntial
Secti o n 8. 4. 1 : Ti me 
Peri o d a n d Fre q ue nc y 
f or C ollecti n g A E a n d 
S A E I nf or mati o n
Te xt a d de d t o details of A E 
c ollecti o n re q uire me nts f or 
partici pa nts recei vi n g 2 d oses of 
st u d y i nter ve nti o n
T o e ns ure a de q uate 
safet y f oll o w-u p f or 
t h ose w h o recei ve 
2 d oses
S u bsta ntial
Secti o n 8. 4. 7 : A d verse 
E ve nts of S pecial 
I nterest
M y ocar ditis a n d pericar ditis are n o w  
c o nsi dere d A E SIs f or u p t o 6 wee ks 
( pre vi o usl y 4 wee ks) after 
vacci nati o n
T o ali g n wit h 
re g ulat or y 
re q uir e me nts f or 
C O VI D -1 9 vacci nes
S u bsta ntial
Secti o n 9. 3. 1 : Ge neral 
C o nsi derati o ns
Te xt w as e dite d
T o ali g n wit h t he 
o bjecti ves
N o ns u bsta ntial
Secti o n 1 0. 1. 5. 1 : Data 
M o nit ori n g C o m mittee
D M C will r e vie w safet y data a n d 
i m m u n o ge nicit y acc u m ulate d f or at 
least 4 wee ks f oll o wi n g vacci nati o n 
i n S u bst u d y A a n d t he i nitial -
e nr oll me nt sta ge of S u bst u d y B , was 
pre vi o usl y 1 we e k
T o ali g n wit h 
re g ulat or y 
e x pectati o ns
S u bsta ntial
Secti o n 1 0. 2 : 
A p pe n di x 2: Cli nical 
La b orat or y Tests
Te xt w as e dite d
T o ali g n wit h t he
st u d y desi g n
N o ns u bsta ntial
Secti o n 1 0. 1 1. 4 : 
S u bst u d y A Desi g n
Te xt w as e dite d
T o bri n g clarit y
N o ns u bsta ntial
Secti o n 1 0. 1 2. 1 : S o A –
S u bst u d y B ( P hase 1/ 2)
Sc he d ule of acti vities was e dite d
A visit was a d de d 
S u bsta ntial
Secti o n 1 0. 1 2. 2. 1 : 
S u bst u d y B Rati o nale
Te xt w as e dite d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 2. 3 : 
O bjecti ves, E n d p oi nts, 
a n d Esti ma n ds 
( S u bst u d y B)
O bjecti ves w ere u p date d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 4. 1 : 
O verall Desi g n 
( S u bst u d y B)
Te xt a n d Ta ble 9 w ere e dite d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 5. 2 : 
S u bst u d y B E xcl usi o n 
Criteria
E xcl usi o n criteria were a d de d; 
pri or/c o nc o mita nt t hera p y was e dite d
T o bri n g clarit y 
S u bsta ntial
Secti o n 1 0. 1 2. 6. 1 : 
St u d y I nter ve nt i o n(s) 
A d mi nistere d 
(S u bst u d y B 
I nter ve nti o n a n d 
C o nc o mita nt T hera p y )
S u bst u d y B st u d y i nter ve nti o n ta ble 
wa s e dite d; pre vi o us Ta ble 1 0 was 
r e mo ve d
T o ali g n wit h t he 
st u d y desi g n;
Ta bles 1 0 a n d 2 w ere 
c o m bi ne d i nt o 1 ta ble 
( Ta ble 2)
S u bsta ntial
Secti o n 1 0. 1 2. 6. 1. 1 : 
A d mi nistrati o n
Te xt w as e dite d a n d pre vi o us 
T a ble 1 1 wa s re place d b y te xt
T o a d d clarit y o n
a d mi nistrati o n of t he 
vacci nes
S u bsta ntial
Secti o n 1 0. 1 2. 6. 7. 1 : 
Pr o hi bite d D uri n g t he 
St u d y
W or di n g has bee n c ha n ge d
T o bri n g clarit y o n t he 
pr o hi bite d me dicati o n 
d uri n g t he st u d y
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 4
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1 2. 6. 7. 2 : 
Per m itte d D uri n g t he 
St u d y
A d de d n o nst u d y c or o na vir us a n d 
n o nst u d y i nfl ue nza vacci ne 
all o wa nce at t he 4- wee k f oll o w-u p
visit
All o wi n g partici pa nts 
t o recei ve c or o na vir us 
a n d/ or i nfl ue nza 
vacci nes 4 w e e ks after
a d mi nistrati o n of 
st u d y i nter ve nti o n
S u bsta ntial
Secti o n 1 0. 1 2. 8 : 
S u bst u d y B 
Assess me nts a n d 
Pr oce d ures
Te xt w as re vise d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 1 : 
Tele healt h Visits
Te xt w as e dite d
T o clarif y t he visits
N o ns u bsta ntial
Secti o n 1 0. 1 2. 8. 7 : 
St o p pi n g R ules
Re vise d st o p pi n g r ules te xt a n d 
a d diti o n of st o p pi n g r ules criteria
T o all o w  a better 
safet y s ur veilla nce 
after st u d y 
i nter ve nti o n 
a d mi nistrati o n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 1 0 : 
A d diti o nal Pr oce d ures 
f or M o nit ori n g of 
P ote ntial M y ocar ditis or 
Pericar ditis
Te xt w as u p date d
T o bri n g clarit y
N o ns u bsta ntial
Secti o n 1. 1. 1. 1. 1 : 
Visit 3 0 2 – 4- Wee k 
F oll o w -U p Visit ( After 
Vacci nati o n)
Te xt w as re m o ve d
T here is n o P B M C
N o ns u bsta ntial
Sec ti o n 1. 1. 1. 1. 1 : 
Visit 3 0 2 – 4- Wee k 
F oll o w -U p Visit ( After 
Vacci nati o n)
A d diti o nal st u d y i nter ve nti o n f or 
selecte d gr o u ps. Re mi n der a d de d t o 
alert partici pa nt t o o pti o n f or 
a d mi nistrati o n of n o nst u d y vacci nes
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 1. 1. 1. 1. 1 : 
Visit 3 0 3 – 8- Wee k 
F oll o w -U p Visit ( After 
Vacci nati o n)
Te xt w as re m o ve d
T here is n o P B M C
N o ns u bsta ntial
Secti o n 1. 1. 1. 1. 1 : 
Visit 3 0 3 – 8- Wee k 
F oll o w -U p Visit ( After 
Vacci nati o n)
A d diti o n of Visit 3 0 3
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 1. 1. 1. 1. 1 : 
Visit 3 0 4 – 6- M o nt h 
F oll o w -U p Visit ( After 
Vacci nati o n)
Visit 3 0 4 is re placi n g Visit 3 0 3 
A d diti o n of a visit t o 
ali g n wit h t he st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 1 0 : 
A d diti o nal Pr oce d ures 
f or M o nit ori n g of 
P ote ntial M y ocar ditis or 
Pericar ditis
Te xt w as e dite d
T o bri n g clarit y
N o ns u bsta ntial
Secti o n 1 0. 1 2. 9. 1. 1. 1
Pri mar y 
Esti ma n ds/ C o pri mar y 
Esti ma n ds
I ncl u de d i nf or mati o n o n t he a nal ysis 
of m issi n g e-diar y data rec or de d o n 
t he A E C R F. 
T o clarif y a nal ysis 
pla n
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 5
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1 2. 9. 3. 2 : 
Pri mar y 
E n d p oi nt(s)/ Esti ma n d(s) 
A nal ysis
Te xt w as e dite d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 9. 6. 1 : 
I m m u n o ge nicit y 
( Sa mple Size 
Deter mi nati o n)
Te xt w as a d de d
T o ali g n wit h t he 
st u d y desi g n
S u bsta ntial
A m e n d me nt 4 ( 1 6 A pril 2 0 2 3)
O ver all R ati o n ale f or t he A me n d me nt:
T o reflect c ha n ges t o t he st u d y  desi g n of S u bst u d y B f oll o wi n g s p o ns or re vie w of S u bst u d y 
A data fr o m partici pa nts 1 8 t hr o u g h 6 4 ye ars of a ge, a n d t o re m o ve refere nces t o P hase 3.
Pr ot oc ol A me n d me nt S u m m ar y of C h a n ges T a ble:
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
T hr o u g h o ut
Re m o ve d refere nces t o 
P hase 3
Desi g n c ha n ge
N o ns u bsta ntial
T hr o u g h o ut
Secti o n n u m ber c ha n ges d ue 
t o re m o val of secti o ns n o 
l o n ger rele va nt t o t he ne w 
S u bst u d y B desi g n
D ue t o t he st u d y desi g n 
c ha n ge, pre vi o us secti o ns n o 
l o n ger nee de d
N o ns u bsta ntial
Secti o n 1 Pr ot oc ol 
S u m mar y
Re visi o ns were ma de t o 
matc h u p dates t hr o u g h o ut 
t he b o d y of t he pr ot oc ol
T o acc o m m o dat e t he st u d y 
desi g n c ha n ge of S u bst u d y B 
a n d re m o val of P hase 3
S u bsta ntial
Secti o n 2. 1 St u d y 
Rati o nale
Re vise d wit h u p date d 
i nf or mati o n
T o acc o m m o date st u d y desi g n 
c ha n ges
N o ns u bsta ntial
Secti o n 2. 2. 3. 3 C o m bi ne d 
I nfl ue nza a n d S A R S -C o v - 2
Vacci nes
A d de d secti o n f or clarit y 
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 2. 3 Be nefit/ Ris k 
Assess me nt
U p date d QI V fr o m Fl uz o ne 
t o Fl ucel va x
T o u p date per t he st u d y desi g n
S u bsta ntial
Secti o n 2. 3. 1 Ris k 
Assess me nt
U p date d QI V st u d y 
i nter ve nti o n i nf or mati o n a n d
r e mo ve d st u d y pr oce d ure 
ris ks f or t he c urre nt st u d y 
desi g n
T o acc o m m o date st u d y desi g n 
c ha n ges
S u bsta ntial
Secti o n 4. 3. 2 qI R V
U p date d per t he ne w st u d y 
desi g n
T o acc o m m o date st u d y desi g n 
c ha n ges
N o ns u bsta ntial
Secti o n 4. 3. 3
qI R V/ Bi vale nt B N T 1 6 2 b 2 
( Ori gi nal/ O mi B A. 4/ B A. 5)
Re vise d per t he u p date d 
S u bst u d y B st u d y desi g n
T o acc o m m o date st u d y desi g n 
c ha n ges
N o ns u bsta ntial
Secti o n 4. 3. 4
tI R V/ Bi vale nt B N T 1 6 2 b 2 
( Ori gi nal/ O mi B A. 4/ B A. 5)
A d de d a secti o n f or 
j ustificati o n f or t he a d diti o n 
of st u d y i nter ve nti o ns
T o acc o m m o date st u d y desi g n 
c ha n ges
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 6
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 4. 3. 5
bI R V/ Bi vale nt B N T 1 6 2 b 2 
( Ori gi nal/ O mi B A. 4/ B A. 5)
A d de d a secti o n f or 
j ustificati o n f or t he a d diti o n 
of st u d y i nter ve nti o ns
T o acc o m m o date st u d y desi g n 
c ha n ges
N o ns u bsta ntial
Secti o n 6 St u d y 
I nter ve nti o n(s) a n d 
C o nc o mita nt T hera p y
U p date d wit h ne w st u d y 
i nter ve nti o ns a n d ta bles; 
u p date d ta ble hea ders
T o u p date per t he ne w  st u d y 
desi g n
S u bsta ntial
Secti o n 7. 2 Partici pa nt 
Disc o nti n uati o n/ Wit h dra w
al Fr o m t he St u d y
U p date d t o refere nce 
S u bst u d y B i nf or mati o n
U p date d f or t he ne w st u d y 
desi g n
N o ns u bsta ntial
Secti o n 8. 2. 1 Bi ol o gical 
Sa m ples
Re m o ve d refere nces t o D N A 
testi n g
P B M Cs n o l o n ger bei n g 
perf or me d
S u bsta ntial
Secti o n 8. 3. 1 P h ysical 
E xa mi nati o ns
U p date d wit h S u bst u d y B –
s pecific i nf or mati o n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 8. 3. 2 Vital Si g ns
U p date d wit h S u bst u d y B –
s pecific i nf or mati o n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 8. 3. 3
Electr ocar di o gra ms
A d de d ne w h y perli n k
U p date d f or t he ne w st u d y 
desi g n
N o ns u bsta ntial
Secti o n 8. 3. 4 Cli nical 
Safet y La b orat or y 
Assess me nts
U p date d wit h refere nces f or 
S u bst u d y B
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 8. 3. 5 Electr o nic 
Diar y
Re m o ve d refere nce t o t he 
A RI e -diar y
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 8. 4. 1 Ti m e Peri o d 
a n d Fre q ue nc y f or 
C ollecti n g A E a n d S A E 
I nf or mati o n
S u bst u d y A
U p date d f or t he ne w 
S u bst u d y B desi g n, t o 
r e mo ve refere nces t o 
pr oce d ures n o l o n ger 
rele va nt, a n d u p date d t he 
S A E c ollecti o n peri o d w it h 
ne w visit n u m bers
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 8. 4. 6
Car di o vasc ular a n d Deat h 
E ve nts
U p date d secti o n f or clarit y 
a n d t he ne w st u d y desi g n
U p date d f or clarit y
S u bsta ntial
Secti o n title d Disease -
Relate d E ve nts a n d/ or 
Disease -Relate d O utc o mes 
N ot Q ualif yi n g as A Es or 
S A Es ( S u bst u d y B)
Secti o n re m o ve d as it n o 
l o n ger fits wit h t he new 
st u d y desi g n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 8. 4. 7 A d verse 
E ve nts of S pecial I nterest
Secti o n u p date d wit h ne w 
A E SIs
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 8. 6. 1 S pecifie d 
Ge netics
Re m o ve d refere nce t o L CI 
cases
N o l o n ger rele va nt t o t he 
S u bst u d y B desi g n
S u bsta ntial
Secti o n 8. 9 Healt h 
Ec o n o mics
A d de d refere nce t o S u bst u d y 
B a n d re m o ve d o bs olete 
i nf or mati o n d ue t o t he new 
st u d y desi g n
U p date d per ne w  st u d y desi g n 
i nf or mati o n
N o ns u bsta ntial
Secti o n 1 0. 1. 3. 1 Electr o nic 
C o nse nt
Secti o n a d de d per ne w  
pr ot oc ol te m plate 
i nf or mati o n
U p date d i n a d va nce of t he ne w 
pr ot oc ol te m plate
S u bsta ntial
Secti o n 1 0. 1. 5. 1 Data 
M o nit ori n g C o m mittee
Re m o ve d t he refere nce t o 
E D M C a n d u p date d t he I R C 
i nf or mati o n f or S u bst u d y B
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 7
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1. 7 Data 
Q ualit y Ass ura nce
U p date d la n g ua ge t o ali g n 
wit h t he ne w pr ot oc ol 
t e mplate
U p date d t o ali g n wit h t he 
u pc o mi n g pr ot oc ol te m plate
N o ns u bsta ntial
Secti o n 1 0. 1. 9 St u d y a n d 
Site Start a n d Cl os ure
U p date d la n g ua ge t o ali g n 
wit h t he ne w pr ot oc ol 
t e mplate
U p date d t o ali g n wit h t he 
u pc o mi n g te m plate
N o ns u bsta ntial
Secti o n 1 0. 2 A p pe n di x 2: 
Cli nical La b orat or y Tests
U p date d refere nce S u bst u d y 
B a n d i ncl u de d ne w 
h y perli n k
U p date d f or t he ne w st u d y 
desi g n
N o ns u bsta ntial
Secti o n 1 0. 1 1. 4. 1 O verall 
Desi g n
U p date d t o reflect c ha n ges i n 
t he S u bst u d y B desi g n a n d 
a d d ne w ta bles
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 1. 6. 1 St u d y 
I nter ve nti o n(s) 
A d mi nistere d
U p date d wit h ta bles wit h 
ne w li n ks f or clarit y
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 1 0. 1 1. 8. 8. 1
Scree ni n g ( 0 t o 2 8 Da ys 
Bef ore Visit 1)
U p date d t o re m o ve refere nce 
t o c ollecti o n of pre vi o us 
st u d y partici pa nt n u m bers
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 1 0. 1 2. 1. 1 S o A —
I nitial-E nr oll me nt ( P hase 
1/ 2)
A d de d a ne w secti o n a n d 
S o A ta ble d ue t o t he ne w 
S u bst u d y B desi g n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n
Secti o n 1 0. 1 2. 1. 2 S o A —
E x pa n de d -E nr oll me nt 
( P hase 2)
A d de d a ne w secti o n a n d 
u p date d t he pre vi o us S o A 
ta ble d ue t o t he ne w 
S u bst u d y B desi g n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 2. 1 S u bst u d y 
B Rati o nale
U p date d t o pr o vi de t he
rati o nale f or t he c urre nt 
st u d y desi g n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 2. 3
Be nefit/ Ris k Assess me nt
U p date d t o ali g n wit h t he 
ne w st u d y desi g n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 3 O bjecti ves, 
E n d p oi nts, a n d Esti ma n ds 
( S u bst u d y B)
A d de d ne w o bjecti ves, 
esti ma n ds, a n d e n d p oi nts t o 
reflect t he ne w S u bst u d y B 
desi g n a n d re m o ve o bs olete 
i nf or mati o n; re m o ve d 
pre vi o us defi niti o ns of L CI, 
C CI, I LI, c o nfir me d 
C O VI D -1 9, a n d c o nfir me d 
se vere C O VI D -1 9 
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 4. 1 O verall 
Desi g n
Re vise d a n d u p date d t he 
e ntire secti o n t o u p date te xt 
t o t he c urre nt desi g n, re m o ve 
t he o bs olete desi g n, a n d a d d 
ne w ta bles f or t he c urre nt 
desi g n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 5. 1
S u bst u d y B I ncl usi o n 
Criteria
U p date d i ncl usi o n criteria 1 
a n d 5 t o reflect t he st u d y 
desi g n c ha n ge
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 8
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1 2. 5. 2
S u bst u d y B E xcl usi o n 
Criteria
Re m o ve d pre vi o us e xcl usi o n 
criteria 5 a n d 8; a d de d ne w 
e xcl usi o n criteria 1 0 t hr o u g h 
1 3
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 5. 3 Criteria 
f or Te m p oraril y Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n
/ A d mi nistrati o n of St u d y 
I nter ve nti o n
U p date d wit h ne w visit 
i nf or mati o n d ue t o t he new 
st u d y desi g n
U p date d f or t he ne w st u d y 
desi g n
N o ns u bsta ntial
Secti o n 1 0. 1 2. 6. 1 St u d y 
I nter ve nti o n(s) 
A d mi nistere d
U p date d t he ta ble w it h ne w 
i nter ve nti o ns a n d a d de d t he 
S u bst u d y B: All Vacci ne 
Gr o u ps ta ble
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 6. 1. 1
A d mi nistrati o n
U p date d wit h a ne w 
S u bst u d y B i nter ve nti o n 
sc he d ule a n d i nter ve nti o n 
ar ms
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 6. 1. 3. 1
Pre parati o n a n d Dis pe nsi n g
Re m o ve d o bs olete 
i nf or matio n d ue t o t he ne w 
st u d y desi g n
U p date d f or t he ne w st u d y 
desi g n
N o ns u bsta ntial
Secti o n 1 0. 1 2. 6. 1. 4
All ocati o n t o St u d y 
I nter ve nti o n
U p date d t o reflect t he 
a d diti o n of t he e x pa n de d -
e nr oll me nt sta ge
U p date d f or t he ne w st u d y 
desi g n
N o ns u bsta ntial
Secti o n 1 0. 1 2. 6. 2. 2
Bli n di n g of Site Pers o n nel
U p date d t o reflect t he ne w 
bli n di n g desi g n a n d re m o ve 
o bs olete desi g n i nf or mati o n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 6. 2. 3
Bli n di n g of t he S p o ns or
U p date d t o reflect t he ne w 
bli n di n g desi g n a n d re m o ve 
o bs olete desi g n i nf or mati o n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 6. 2. 4
Brea ki n g t he Bli n d
Re m o ve d o bs olete st u d y 
desi g n i nf or mati o n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 6. 7 Pri or a n d 
C o nc o mita nt T hera p y
U p date d t o ali g n wit h t he 
ne w st u d y visits
U p date d f or t he ne w st u d y 
desi g n
N o ns u bsta ntial
Secti o n 1 0. 1 2. 8
S u bst u d y B Assess me nts 
a n d Pr oce d ures
U p date d t o i ncl u de S u bst u d y 
B st u d y visits
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 1
Tele healt h Visits
U p date d as a res ult of t he 
ne w st u d y desi g n
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 2 H o me 
Healt h Visits
U p date d t o i ncl u de S u bst u d y 
B st u d y visits
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 3 
S ur veilla nce f or 
C O VI D -1 9 a n d I nfl ue nza
Re m o ve d t he secti o n as it is 
n o l o n ger rele va nt t o t he ne w 
st u d y desi g n
Re m o ve d as u n nee de d
S u bsta ntial
Secti o n 1 0. 1 2. 8. 3. 1 
A nti ge nic C haracterizati o n 
of I nfl ue nza Vir uses
Re m o ve d t he secti o n as it is 
n o l o n ger rele va nt t o t he ne w 
st u d y desi g n
Re m o ve d as u n nee de d
S u bsta ntial
Secti o n 1 0. 1 2. 8. 3
I m m u n o ge nicit y 
Assess me nts
U p date d d ue t o ne w  
o bjecti ves f or S u bst u d y B
U p date d f or t he ne w st u d y 
desi g n
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 1 9 9
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1 2. 8. 6 A RI 
M e m or y  Ai d
Re m o ve d t he secti o n as it is 
n o l o n ger rele va nt t o t he ne w 
st u d y desi g n
Re m o ve d as u n nee de d
S u bsta ntial
Secti o n 1 0. 1 2. 8. 5. 1 E C Gs
A d de d a ne w secti o n t o ali g n 
wit h t he ne w st u d y desi g n 
a n d m o nit ori n g pr oce d ures
A d de d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 6 Cli nical 
Safet y La b orat or y 
Assess me nts
A d de d a ne w secti o n t o ali g n 
wit h t he ne w st u d y desi g n 
a n d m o nit ori n g pr oce d ures
A d de d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 7 St o p pi n g 
R ules f or I nitial-
E nr oll me nt Sta ge i n All 
N e w  E x pl orat or y Gr o u ps: 
2, 6, 7, 8, 9, 1 0, 1 1, a n d 1 2
A d de d a ne w secti o n t o ali g n 
wit h t he ne w st u d y desi g n 
a n d m o nit ori n g pr oce d ures
A d de d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 9 St u d y 
Pr oce d ures – I nitial-
E nr oll me nt Gr o u p
A d de d a ne w secti o n a n d 
s u bsecti o ns t o ali g n wit h t he 
ne w st u d y desi g n a n d ne w 
pr oce d ures
A d de d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 1 2 St u d y 
Pr oce d ures – E x pa n de d -
E nr oll me nt Gr o u p
A d de d a ne w secti o n a n d 
s u bsecti o ns t o ali g n wit h t he 
ne w st u d y desi g n a n d ne w 
pr oce d ures
A d de d f or t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 8. 1 1 
C o m m u nicati o n a n d Use of 
Tec h n ol o g y
Re m o ve d t he secti o n as it is 
n o l o n ger rele va nt t o t he ne w 
st u d y desi g n
Re m o ve d as u n nee de d
S u bsta ntial
Secti o n 1 0. 1 2. 9. 1
Statistical H y p ot heses
U p date d t he secti o n per t he 
ne w st u d y desi g n
U p date d per t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 9. 2 A nal ysis 
Sets
Re m o ve d i nf or mati o n n o 
l o n ger rele va nt t o t he ne w 
st u d y desi g n
U p date d per t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 9. 3. 2
Pri mar y 
E n d p oi nt(s)/ Esti ma n d(s) 
A nal ysis
U p date d t he secti o n per t he 
ne w st u d y desi g n
U p date d per t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 9. 3. 3
Sec o n dar y 
E n d p oi nt(s)/ Esti ma n d(s) 
A nal ysis
U p date d t he secti o n per t he 
ne w st u d y des i g n
U p date d t he secti o n per t he 
ne w st u d y desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 9. 3. 4
Tertiar y/ E x pl orat or y 
E n d p oi nt(s)
U p date d t he secti o n per t he 
ne w st u d y desi g n
U p date d t he secti o n per t he 
ne w st u d y desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 9. 5 A nal ysis 
Ti m i n g
Secti o n u p date d wit h t he 
ne w a nal ysis ti mi n g 
i nf or mati o n as a res ult of t he 
ne w st u d y desi g n
U p date d per t he ne w st u d y 
desi g n
S u bsta ntial
Secti o n 1 0. 1 2. 9. 6 Sa m ple 
Size Deter mi nati o n
U p date d t he secti o n a n d 
s u bsecti o ns t o reflect t he 
ne w st u d y desi g n a n d 
re mo ve o bs olete desi g n 
i nf or mati o n
U p date d per t he ne w st u d y 
desi g n
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 0
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1 2. 9. 6. 2 Safet y
U p date d t he secti o n per t he 
ne w st u d y desi g n
U p date d t he secti o n per t he 
ne w st u d y desi g n
S u bsta ntial
A m e n d me nt 3 ( 1 5 Fe br u ar y 2 0 2 3) 
O ver all R ati o n ale f or t he A me n d me nt:
I ncl usi o n of S u bst u d y B: A Phase 2/ 3 st u d y  t o descri be t he safety, t olera bilit y , a n d 
i m m u n o ge nicity of qI R V/ bi vale nt B N T 1 6 2 b 2 ( ori gi nal/ O mi B A. 4/ B A. 5).
Pr ot oc ol A me n d me nt S u m m ar y of C h a n ges T a ble:
Secti o n # a n d N a m e
Descri pti o n of C h a n ge 
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 Pr ot oc ol S u m mar y
Re visi o ns were ma de t o 
matc h u p dates 
t hr o u g h o ut t he b o d y of 
t he pr ot oc ol 
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 2. 1 St u d y Rati o nale
Re vise d wit h u p date d 
i nf or mati o n
A vaila bilit y of m ore 
c urre nt i nf or mati o n
S u bsta ntial
Secti o n 2. 2. 1 S A R S -C o V - 2
Re vise d wit h u p date d 
i nf or mati o n
A vaila bilit y of m ore 
c urre nt i nf or mati o n
S u bsta ntial
Secti o n 2. 2. 3 Cli nical 
O ver vie w
Re vise d wit h u p date d 
i nf or mati o n
A vaila bilit y of m ore 
c urre nt i nf or mati o n
S u bsta ntial
Secti o n 2. 3 Be nefit/ Ris k 
Assess me nt
S pecifie d S R S D f or 
QI V is Fl uz o ne 
Q ua dri vale nt
T o pr o vi de 
clarificati o n
N o ns u bsta ntial
Secti o n 2. 3. 1 Ris k Assess me nt
A d de d a ris k assess me nt 
f or QI V a n d
mi dt ur bi nate s wa bs, a n d 
u p date d t he 
B N T 1 6 2 b 2 O micr o n 
( B A. 4/ B A. 5 s u bli nea ge) 
ris ks
T o a d d a d diti o nal 
i nf or mati o n a n d 
clarif y p ote ntial 
ris ks
S u bsta ntial
Secti o n 2. 3. 1 Ris k Assess me nt
A d de d A RI visits t o 
p ote ntial visits f or 
c ollecti o n of 
mi dt ur bi nate s wa bs
Ne w  A RI visits will 
e ntail s wa bs liste d 
as a ris k i n ta ble
N o ns u bsta ntial
Secti o n 2. 3. 2 Be nefit 
Assess me nt
A d de d li n k t o 
S u bst u d y B 
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
N o ns u bsta ntial
Secti o n 3 O bjecti ves, 
E n d p oi nts, a n d Esti ma n ds
A d de d li n k t o 
S u bst u d y B
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 1
Secti o n # a n d N a m e
Descri pti o n of C h a n ge 
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 4. 3 J ustificati o n f or 
D ose
Re m o ve d i nf or mati o n 
u n der t his hea der a n d 
u p date d t he 
c orres p o n di n g 
s u bsecti o ns
A vaila bilit y of m ore 
c urre nt i nf or mati o n
S u bs ta ntial
Secti o n 4. 3. 1 Bi vale nt 
B N T 1 6 2 b 2 
( Ori gi nal/ O mi B A. 4/ B A. 5)
Re vise d j ustificati o n t o 
n ote t he F D A’s E U A as 
t he reas o n f or t he 
c h ose n d ose
A vaila bilit y of m ore 
c urre nt i nf or mati o n
S u bsta ntial
Secti o n 4. 3. 2 qI R V
Re vise d j ustificati o n of 
d ose base d o n P hase 3 
data i n differe nt a ge 
gr o u ps ( 1 8 t hr o u g h 6 4 
a n d ≥6 5 years of a ge)
A vaila bilit y of m ore 
c urre nt i nf or mati o n
S u bsta ntial
Secti o n 5 St u d y P o p ulati o n
A d de d li n ks t hr o u g h o ut 
t he secti o n t o ne w 
c orres p o n di n g S u bst u d y 
B secti o ns
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 5. 5 Criteria f or 
T e m p oraril y Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/
A d mi nistrati o n of St u d y 
I nter ve nti o n
A d de d t he S u bst u d y 
A a n d B li n ks
M o ve d t he secti o n 
c o nte nt t o t he 
S u bst u d y A a p pe n di x 
T o better ali g n t o 
t he master pr ot oc ol 
f or mat
N o ns u bsta ntial
Secti o n 6 St u d y 
I nter ve nti o n(s) a n d 
C o nc o mita nt T hera p y
A d de d li n ks t hr o u g h o ut 
t he secti o n t o ne w 
c orres p o n di n g S u bst u d y 
B secti o ns
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 6 St u d y 
I nter ve nti o n(s) a n d 
C o nc o mita nt T hera p y
Clarifie d i nter ve nti o ns 
acr oss b ot h s u bst u dies
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 8. 2. 1 Bi ol o gical 
Sa m ples
A d de d ver bia ge 
re gar di n g partici pa nts 
w h o pr o vi de c o nse nt f or 
ge netic testi n g
T o a d d e xce pti o ns 
f or t h ose t hat a gree 
t o ge netic testi n g of 
P B M C sa m ples
S u bsta ntial
Secti o n 8. 2 Efficac y a n d/ or 
I m m u n o ge nicit y Assess me nts
A d de d li n k t o t h e 
c orres p o n di n g S u bst u d y 
B secti o n
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 8. 3. 1 P h ysical 
E xa mi nati o ns
A d de d la n g ua ge s pecific 
t o S u bst u dies A a n d B, 
res pecti vel y
P h y sical e xa ms are 
re q uire d i n 
S u bst u d y A a n d 
ma y be perf or me d 
i n S u bst u d y B
S u bsta ntial
Secti o n 8. 3. 2 Vital Si g ns
A d de d la n g ua ge s pecific 
t o S u bst u d y B
Details t he vital 
si g ns t hat are ta ke n 
f or S u bst u d y B
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 2
Secti o n # a n d N a m e
Descri pti o n of C h a n ge 
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 8. 3. 4 Cli nical Safet y 
La b orat or y Assess me nts
A d de d la n g ua ge n oti n g 
t hat t he cli nical safet y 
la b orat or y assess me nts 
are o nl y c o n d ucte d i n 
S u bst u d y A
Details t hat t he 
assess me nts are 
nee de d o nl y f or 
S u bst u d y A
S u bsta ntial
Secti o n 8. 4. 1 Ti m e Peri o d a n d 
Fre q ue nc y f or C ollecti n g A E 
a n d S A E I nf or mati o n
A d de d la n g ua ge s pecific 
t o t he c ollecti o n ti mes 
f or S u bst u d y B
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 8. 4. 6 Car di o vasc ular 
a n d Deat h E ve nts
A d de d detail o n w he n 
deat hs are rec or de d 
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 8. 4. 7 Disease -Relate d 
E ve nts a n d/ or Disease -Relate d 
O utc o mes N ot Q ualif yi n g as 
A E s or S A Es ( S u bst u d y B)
A d de d i nf or mati o n 
detaili n g A RI visits
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 8. 4. 7 A d verse E ve nts 
of S pecia l I nterest
A d de d u p date d 
i nf or mati o n nee de d t o 
i ncl u de S u bst u d y B
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 8. 4. 7 A d verse E ve nts 
of S pecial I nterest
Clarifie d t hat a 
c o nfir me d C O VI D -1 9 
dia g n osis is a n A E SI 
after Visit 2 0 1
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 8. 6. 1 S pecifie d 
Ge netics
A d de d i n i nf or mati o n 
re gar di n g ge netic testi n g 
t hat was n ot necessar y 
pri or t o t he a me n d me nt
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 8. 9 Healt h Ec o n o mics
A d de d la n g ua ge 
re gar di n g t he p ossi ble 
e val uati o n of me dical 
res o urce utilizati o n i n 
S u bst u d y B o nl y
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 9 Statistical 
C o nsi derati o ns 
A d de d li n ks t hr o u g h o ut 
t he secti o n t o t he ne w 
c orr es p o n di n g 
S u bst u d y B secti o ns
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 9. 3. 1 Ge neral 
C o nsi derati o ns
A d de d la n g ua ge t hat f or 
all efficac y e n d p oi nts, 
t he a nal yses will be 
perf or me d o n b ot h t he 
e val ua ble efficac y 
p o p ulati o n a n d t he 
mI T T efficac y 
p o p ulati o n
T o clarif y c urre nt 
la n g ua ge
S u bsta ntial
Secti o n 1 0. 1. 5. 1 Data 
M o nit ori n g C o m mittee
A d de d S u bst u d y B t o 
t he I R C la n g ua ge as 
well as n ote d t hat 
S u bst u d y B will als o use 
a n E D M C
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 3
Secti o n # a n d N a m e
Descri pti o n of C h a n ge 
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1. 6 Disse mi nati o n 
of Cli nical St u d y Data
A d de d li n ks t o 
Cli nical Trials. g o v a n d 
Pfizer.c o m
T o pr o vi de li n ks t o 
areas of accessi n g 
data
N o ns u bsta ntial
Secti o n 1 0. 4 A p pe n di x 4: 
Ge netics
A d de d secti o n as it is 
a p plica ble wit h t he 
a d diti o n of S u bst u d y B
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 1 0. 5. 1
Male
Partici pa nt Re pr o d ucti ve 
I ncl usi o n Criteria
U p date d a n d s pecifie d 
c o ntrace pti o n use
T o ali g n wit h 
c urre nt 
rec o m me n dati o ns
S u bsta ntial
Secti o n 1 0. 5. 2 Fe male 
Partici pa nt Re pr o d ucti ve 
I ncl usi o n Criteria
U p date d li n k t o re vise d 
secti o n n u m ber
Secti o n n u m bers 
ha ve c ha n ge d
N o ns u bsta ntial
Secti o n 1 0. 8 A p pe n di x 8 : 
Criteria f or All o wi n g 
I ncl usi o n of Partici pa nts Wit h 
C hr o nic Sta ble HI V, H C V, or 
H B V I nfecti o n
A d de d a secti o n t o 
clarif y t he all o wa nce of 
partici pa nts wit h c hr o nic 
sta ble HI V, H C V, or 
H B V i nfecti o ns
T o pr o vi de clarit y
S u bsta ntial
Secti o n 1 0. 1 1. 1 S o A –
S u bst u d y A ( P hase 1)
U p date d t he or der of 
bl o o d dra ws
T o pr o vi de clarit y
N o ns u bsta n tial
Secti o n 1 0. 1 1. 3 O bjecti ves, 
E n d p oi nts, a n d Esti ma n ds 
( S u bst u d y A)
U p date d t he o bjecti ves 
a n d esti ma n ds t o i ncl u de 
t he ne w a ge strat u m
T o acc o m m o date 
t he ne w a ge strat u m
S u bsta ntial
Secti o n 1 0. 1 1. 4. 1 O verall 
Desi g n
U p date d t he desi g n 
secti o n t o i ncl u de t he 
≥6 5 years of a ge strat u m 
a n d i ncl u de h o w t he 
I R C ma y all o w t he 
st u d y t o pr o gress t o 
P hase 2
T o acc o m m o date 
t he ne w a ge strat u m
S u bsta ntial
Secti o n 1 0. 1 1. 5. 1 S u bst u d y A 
I ncl usi o n Criteria
U p date d t he i ncl usi o n 
criteria t o re m o ve t he 
1 8 t hr o u g h 6 4 years 
of a ge ra n ge a n d als o 
clarifie d t he a d diti o n 
of partici pa nts wit h 
c hr o nic sta ble HI V, 
H C V, a n d H B V 
i nfecti o ns
U p date d i ncl usi o n 
criteri o n 5 t o detail 
t he 2 a ge strata
A d de d i ncl usi o n 
criteri o n 6
T o pr o vi de clarit y
a n d all o w 
e nr oll me nt of ot her 
m o d R N A 
S A R S -C o V -2 
reci pie nts a n d t o 
a d d t he i nfl ue nza 
vacci ne criteri o n
S u bsta ntial
Secti o n 1 0. 1 1. 5. 2 S u bst u d y A 
E xcl usi o n Criteria
U p date d e xcl usi o n 
criteri o n 9
T o acc o m m o date 
t he ne w a ge strat u m
S u bsta ntial
Secti o n 1 0. 1 1. 5. 3 Criteria f or 
T e m p oraril y Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/
A d mi nistrati o n of St u d y 
I nter ve nti o n 
M o ve d t he c o nte nt 
pre vi o usl y i n 
Secti o n 5. 5 here t o ali g n 
wit h t he master pr ot oc ol 
f or mat
T o ali g n secti o ns t o 
t he master pr ot oc ol 
f or mat
N o ns u bsta n tial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 4
Secti o n # a n d N a m e
Descri pti o n of C h a n ge 
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1 1. 6. 1
St u d y I nter ve nti o n(s) 
A d mi nistere d
A d de d a r o w  f or 
tar gete d i nfl ue nza 
strai ns
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 1 0. 1 1. 8. 8. 2 Visit 1 –
Vacci nati o n ( Da y 1)
U p date d t he or der of 
bl o o d dra ws
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 1 0. 1 1. 8. 8. 2 Visit 1 –
Vacci nati o n ( Da y 1)
U p date d t he i njecti o n 
site i n t he delt oi d 
m uscle b y re m o vi n g 
refere nce t o t he 
n o n d o mi na nt ar m
T o u p date per t he 
P A C L
N o ns u bsta ntial
Secti o n 1 0. 1 1. 8. 8. 6 Visit 5 –
8- Wee k F oll o w -U p Visit 
( After Vacci nati o n) – 5 2 t o 
6 0 Da ys After Visit 1
U p date d visit t o all o w  
f or partici pa nts w h o ha d 
n ot recei ve d lice nse d 
QI V at Visit 1 t o recei ve 
it at Visit 5, if dee me d 
as re q uire d b y t he 
i n vesti gat or
T o acc o m m o date 
t he ne w a ge strat u m
S u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 2 Pri ma r y 
E n d p oi nt(s)/ Esti ma n d(s) 
A nal ysis
U p date d t he secti o n t o 
i ncl u de a ge 
stratificati o ns
T o acc o m m o date 
t he ne w a ge strat u m
S u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 3 Sec o n dar y 
E n d p oi nt(s)/ Esti ma n d(s) 
A nal ysis
U p date d t he o bjecti ves 
a n d esti ma n ds t o i ncl u de 
t he ne w a ge strat u m a n d 
matc h t he u p date d 
la n g ua ge t hr o u g h o ut t he 
pr ot oc ol
T o acc o m m o date 
t he ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 4
E x pl orat or y 
E n d p oi nt(s)/ Esti ma n d(s) 
A nal ysis
U p date d t he o bjecti ves 
a n d esti ma n ds t o i ncl u de 
t he ne w a ge strat u m a n d 
m atc h t he u p date d 
la n g ua ge t hr o u g h o ut t he 
pr ot oc ol
T o acc o m m o date 
t he ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 5. 1
Electr ocar di o gra m A nal yses
U p date d t he secti o n t o 
i ncl u de a ge 
stratificati o ns
T o acc o m m o date 
t he ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 5. 2 Ot her 
A nal yses
U p date d t he secti o n t o 
i ncl u de a ge 
stratificati o ns
T o acc o m m o date 
t he ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 1. 9. 5 Sa m ple Size 
Deter mi nati o n
U p date d t he secti o n t o 
i ncl u de a ge 
stratificati o ns
T o acc o m m o date 
t he ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 2 A p pe n di x 1 2: 
S u bst u d y B ( P hase 2/ 3)
Secti o n (a n d all 
s u bsecti o ns) create d t o 
a d d P hase 2/ 3 
S u bst u d y B t o e xisti n g 
pr ot oc ol
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 1 0. 1 2. 8. 1 Tele healt h 
Visits
A d de d t he a bilit y t o 
perf or m a tele healt h 
visit, w he n a p plica ble
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 5
Secti o n # a n d N a m e
Descri pti o n of C h a n ge 
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1 2. 8. 2 H o me 
Healt h Visits
A d de d t he a bilit y t o 
perf or m a h o me healt h 
visit, w he n a p plica ble
T o acc o m m o date 
t he a d diti o n of 
S u bst u d y B 
( P hase 2/ 3)
S u bsta ntial
Secti o n 1 0. 1 2. 8. 1 0. 4. 2
A d diti o nal Pr oce d ures f or 
M o nit ori n g of P ote ntial 
Me nstr ual C ycle Dist ur ba nces
A d de d secti o n per ne w 
A E SI
T o acc o m m o date 
ne w A E SI
S u bsta ntial
Secti o n 1 0 . 13 A p pe n di x 1 3 : 
Pr ot oc ol A me n d me nt Hist or y
A d de d t he a p pe n di x o n 
t he pr ot oc ol a me n d me nt 
hist or y
T o u p date per t he 
pr ot oc ol te m plate
N o ns u bsta ntial
T hr o u g h o ut
Re m o ve d ( 2 2/ 2 3) after 
qI R V
T o all o w  f or 
u p dates as t his 
pr ot oc ol ma y later 
i ncl u de s u bst u dies 
wit hi n ot her 
i nflue nza seas o ns
N o ns u bsta ntial
T hr o u g h o ut
U p date d a ge ra n ges 
t hr o u g h o ut t he pr ot oc ol
T o acc o m m o date 
t he ne w a ge strat u m
N o ns u bsta ntial
A m e n d me nt 2 ( 0 9 Dece m ber 2 0 2 2)
O ver all R ati o n ale f or t he A me n d me nt:
P artici pa nts ≥6 5 y ears of a ge were a d de d t o S u bst u d y A.
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1. 1 S y n o psis, 
S u bst u d y A
Re visi o ns were ma de t o matc h u p dates 
t hr o u g h o ut t he b o d y of t he pr ot oc ol
T o acc o m m o date t he 
ne w a ge strat u m
S u bsta ntial
Secti o n 2. 3. 1
Ris k Assess me nt
A d de d a ris k assess me nt f or QI V, 
mi dt ur bi nate s wa bs, a n d u p date d 
B N T 1 6 2 b 2 O micr o n ( B A. 4/ B A. 5 
s u bli nea ge) ris ks
T o a d d a d diti o nal 
i nf or mati o n a n d clarif y 
p ote ntial ris ks
S u bsta ntial
Secti o n 2. 2. 3
Cli nical O ver vie w
U p date d t he secti o n wit h ne w 
i nf or mati o n
T o a d d a d diti o nal 
i nf or mati o n
S u bsta ntial
Secti o n 1 0. 5. 1
Male
Partici pa nt 
Re pr o d ucti ve I ncl usi o n 
Criteria
U p date d a n d s pecifie d c o ntrace pti o n 
use
T o ali g n wit h c urre nt 
rec o m me n dati o ns
S u bsta ntial
Secti o n 1 0. 8
A p pe n di x 7: Criteria f or 
All o wi n g I ncl usi o n of 
Partici pa nts Wit h 
C hr o nic Sta ble HI V, 
H C V, or H B V I nfecti o n
A d de d a secti o n t o clarif y t he 
all o wa nce of partici pa nts wit h c hr o nic 
sta ble HI V, H C V, or H B V i nfecti o ns
T o pr o vi de clarit y
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 6
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1 1. 3
O bjecti ves, E n d p oi nts, 
a n d Esti ma n ds 
( S u bst u d y A)
U p date d t he o bjecti ves a n d esti ma n ds 
t o i ncl u de t he ne w a ge strat u m
T o acc o m m o date t he 
ne w a ge strat u m
S u bsta ntial
Secti o n 1 0. 1 1. 4. 1
O verall Desi g n
U p date d t he desi g n secti o n t o i ncl u de 
t he ≥6 5 years of  a ge strat u m a n d 
i ncl u de h o w t he I R C ma y all o w t he 
st u d y t o pr o gress t o P hase 2
T o acc o m m o date t he 
ne w a ge strat u m
S u bsta ntial
Secti o n 1 0. 1 1. 5. 1
S u bst u d y A I ncl usi o n 
Criteria

U p date d t he i ncl usi o n criteria t o 
r e mo ve t he 1 8 t hr o u g h 6 4 years of 
a ge ra n ge a n d als o clarifie d t he 
a d diti o n of partici pa nts wit h 
c hr o nic sta ble HI V, H C V, a n d 
H B V i nfecti o ns

U p date d i ncl usi o n criteri o n 5 t o 
detail t he t w o a ge strata

A d de d i ncl usi o n criteri o n 6
T o pr o vi de clarit y a n d 
all o w e nr oll me nt of 
ot her m o d R N A 
S A R S -C o V -2 
reci pie nts a n d a d d 
i nfl ue nza vacci ne 
criteri o n
S u bsta ntial
Secti o n 1 0. 1 1. 5. 2
S u bst u d y A E xcl usi o n 
Criteria

U p date d e xcl usi o n criteri o n 9
T o acc o m m o date t he 
ne w a ge strat u m
S u bsta ntial
Secti o n 1 0. 1 1. 8. 8. 6
Visit 5 – 8- Wee k 
F oll o w -U p Visit ( After 
Vacci nati o n) – 5 2 t o 
6 0 Da ys After Visit 1
U p date d visit t o all o w  f or partici pa nts 
w h o ha d n ot recei ve d lice nse d QI V at 
Visit 1 t o recei ve it at Visit 5, if 
dee me d as re q uire d b y t he i n vesti gat or
T o acc o m m o date t he 
ne w a ge strat u m
S u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 2
Pri mar y E n d p oi nt(s)/ 
Esti ma n d(s) A nal ysis
U p date d t he secti o n t o i ncl u de a ge 
stratificati o ns
T o acc o m m o date t he 
ne w a ge strat u m
S u bsta ntial
Secti o n 2. 3 Be nefit/ Ris k 
Assess me nt
S pecifie d S R S D f or QI V is Fl uz o ne 
Q ua dri vale nt
T o pr o vi de 
clarificati o n
N o ns u b sta ntial
T hr o u g h o ut
Re m o ve d ( 2 2/ 2 3) after qI R V
T o all o w  f or u p dates 
as t his pr ot oc ol ma y 
later i ncl u de 
s u bst u dies wit hi n ot her 
i nfl ue nza seas o ns
N o ns u bsta ntial
T hr o u g h o ut
U p date d a ge ra n ges t hr o u g h o ut t he 
pr ot oc ol
T o acc o m m o date t he 
ne w a ge strat u m
N o ns u bsta ntial
Secti o n 5. 5 Criteria f or 
T e m p oraril y Dela yi n g 
E nr oll me nt/ 
Ra n d o mizati o n/ 
A d mi nistrati o n of St u d y 
I nter ve nti o n

A d de d S u bst u d y A li n k

M o ve d t he secti o n c o nte nt t o t he 
S u bst u d y A a p pe n di x 
T o better ali g n t o t he 
master pr ot oc ol f or mat
N o ns u bst a ntial
Secti o n 7. 2 Partici pa nt 
Disc o nti n uati o n/ Wit h dra
wal Fr o m t he St u d y
A d de d ne w la n g ua ge f or w he n 
partici pa nts w o ul d be disc o nti n ue d i n 
S u bst u d y A
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 8. 4. 8
A d verse E ve nts of 
S pecial I nterest
Clarifie d t hat a c o nfir me d C O VI D -1 9 
dia g n osis is a n A E SI after Visit 1
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 1 0. 1 1. 1
U p date d or der of bl o o d dra ws
T o pr o vi de clarit y
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 7
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1 0. 1 1. 8. 8. 2
Visit 1 – Vacci nati o n 
( Da y 1)
U p date d or der of bl o o d dra ws
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 1 0. 1 1. 5. 3
Criteria f or Te m p oraril y 
Dela yi n g E nr oll me nt/ 
Ra n d o mizati o n/ A d mi nist
rati o n of St u d y 
I nter ve nti o n 
M o ve d t he c o nte nt pre vi o usl y i n 
Secti o n 5. 5 here t o ali g n wit h t he 
master pr ot oc ol f or mat
T o ali g n secti o ns t o 
t he master pr ot oc ol 
f or mat
N o ns u bsta ntial
Secti o n 1 0. 1 1. 6. 1
St u d y I nter ve nti o n(s) 
A d mi nistere d
A d de d a r o w  f or tar gete d i nfl ue nza 
strai ns
T o pr o vi de clarit y
N o ns u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 3
Sec o n dar y E n d p oi nt(s)/ 
Esti ma n d(s) A nal ysis
U p date d t he o bjecti ves a n d esti ma n ds 
t o i ncl u de t he ne w a ge strat u m a n d 
matc h t he u p date d la n g ua ge 
t hr o u g h o ut t he pr ot oc ol
T o acc o m m o date t he 
ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 4
E x pl orat or y E n d p oi nt(s)/ 
Esti ma n d(s) A nal ysis
U p date d t he o bjecti ves a n d esti ma n ds 
t o i ncl u de t he ne w a ge strat u m a n d 
matc h t he u p date d la n g ua ge 
t hr o u g h o ut t he pr ot oc ol
T o acc o m m o date t he 
ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 5. 1
Electr ocar di o gra m 
A nal yses
U p date d t he secti o n t o i ncl u de a ge 
stratificati o ns
T o acc o m m o date t he 
ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 1. 9. 3. 5. 2
Ot her A nal yses
U p date d t he secti o n t o i ncl u de a ge 
stratificati o ns
T o acc o m m o date t he 
ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 1. 9. 5
Sa m ple Size 
Deter mi nati o n
U p date d t he secti o n t o i ncl u de a ge 
stratificati o ns
T o acc o m m o date t he 
ne w a ge strat u m
N o ns u bsta ntial
Secti o n 1 0. 1 1. 8. 8. 2
Visit 1 – Vacci nati o n 
( Da y 1)
U p date d t he i njecti o n site i n t he 
delt oi d m uscle b y re m o vi n g refere nce 
t o t he n o n d o mi na nt ar m
T o u p date per t he 
P A C L
N o ns u bsta ntial
Secti o n 1 0. 1 2
A p pe n di x 1 1: Pr ot oc ol 
A me n d me nt Hist or y
A d de d t he a p pe n di x o n t he pr ot oc ol 
a me n d me nt hist or y
T o u p date per t he 
pr ot oc ol te m plate
N o ns u bsta ntial
A m e n d me nt 1 ( 1 8 Oct o ber 2 0 2 2)
O ver all R ati o n ale f or t he A me n d me nt:
T he st o p pi n g r ules f or t he bi vale nt B N T 1 6 2 b 2 ( o ri gi nal/ O mi B A. 4/ B A. 5)/ qIR V ar ms ha ve 
bee n u p date d t o i ncl u de t he 
µ g d ose le vels. T his c ha n ge was i n res p o nse t o a C B E R 
re q uest.
Secti o n # a n d 
N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1. 1
S y n o psis, 
S u bst u d y A 
( P hase 1)
U p date d la n g ua ge re gar di n g st o p pi n g r ules t o 
be i ncl usi ve of 
µ g d ose le vels
T o ali g n wit h c urre nt 
rec o m me n dati o ns
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 8
Secti o n # a n d 
N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 
1 0. 1 0. 8. 6
St o p pi n g R ules
A d de d la n g ua ge t o i ncl u de t he 
µ g 
c o m bi nati o n ar ms. U p date d st o p pi n g r ules f or 
clarit y beca use of t he a d diti o nal ar ms bei n g 
i ncl u de d
T o ali g n wit h c urre nt 
rec o m me n dati o ns 
S u bsta ntial
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
C CI

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 0 9
1 0. 1 4. A p pe n di x 1 4 : A b bre vi ati o ns
T he f oll o wi n g is a list of a b bre viati o ns t hat ma y  be use d i n t he pr ot oc ol.
A b bre vi ati o n
Ter m
A CI P
A d vis or y  C o m mittee o n I m m u nizati o n Practices ( U nite d States)
A D E
a d verse de vice effect
A E
a d verse e ve nt
A E SI
a d verse e ve nt of s pecial i nterest
A KI
ac ute ki d ne y i nj ur y
A L T
ala ni ne a mi n otra nsferase
A RI
ac ute res pirat or y ill ness
A S T
as partate a mi n otra nsferase
A V
atri o ve ntric ular
A x M P
a u xiliar y me dici nal pr o d uct
B C R
B- cell rece pt or
bI R V
bi vale nt i nfl ue nza m o d R N A vacci ne
B L Q
bel o w t he li mit of q ua ntitati o n
B N T 1 6 2 b 2
Pfizer / Bi o N Tec h C O VI D - 1 9 vacci ne
C B E R
Ce nter f or Bi ol o gics E val uati o n a n d Researc h ( U nite d States)
C CI
c ult ure-c o nfir me d i nfl ue nza
C D C
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n ( U nite d States)
C F R
C o de of Fe deral Re g ulati o ns
C h A d O x 1 - S
C h A d O x 1 -S (rec o m bi na nt) S A R S -C o V -2 vacci ne ( Astra Ze neca)
CI
c o nfi de nce i nter val
CI O M S
C o u ncil f or I nter nati o nal Or ga nizati o ns of Me dical Scie nces
C K
creati ne ki nase
C K D -E PI
chr o nic k i d ne y disease epi de mi ol o g y
C O N S O R T
C o ns oli date d Sta n dar ds of Re p orti n g Trials
C O VI D - 1 9
c or o na vir us disease 2 0 1 9
C R F
case re p ort f or m
C R O
c o ntract researc h or ga nizati o n
C S R
cli nical st u d y re p ort
C T
cli nical trial
C T C A E
C o m m o n Ter mi n ol o g y  Criteria f or A d verse E ve nts
C TI S
Cli nical Trial I nf or mati o n S y ste m
D B P
diast olic bl o o d press ure
D C T
d ata c ollecti o n t o ol
DI LI
dr u g -i n d uce d li ver i nj ur y
D M C
data m o nit ori n g c o m mittee
D N A
de o x yri b o n ucleic aci d
E C
et hics c o m mittee
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 1 0
A b bre vi ati o n
Ter m
E C C
e mer ge nc y c o ntact car d
E C G
electr ocar di o gra m
E C M O
e xtrac or p oreal me m bra ne o x y ge nati o n
e Cr Cl
esti mate d creati ni ne cleara nce
e C R F
electr o nic case re p ort f or m
E D B
e x p os ure d uri n g breastfee di n g
e-diar y
electr o nic diar y
E D M C
e xter nal data m o nit ori n g c o m mittee
E D P
e x p os ure d uri n g pre g na nc y
e G F R
esti mate d gl o mer ular filtrati o n rate
eIC D
electr o nic i nf or me d c o nse nt d oc u me nt
e S A E
electr o nic safet y a d verse e ve nt
E U
E ur o pea n U ni o n
E U A
e mer ge nc y use a ut h orizati o n
E u dra C T
E ur o pea n U ni o n Dr u g Re g ulati n g A ut h orities Cli nical Trials 
(E ur o pea n Cli nical Trials Data base )
F D A
F o o d a n d Dr u g A d mi nistrati o n ( U nite d States)
Fi O 2
fracti o n of i ns pire d o xy g e n
F S H
f ollicle-sti m ulati n g h or m o ne
G C P
G o o d Cli nical Practice
G G T
ga m ma -gl uta m y l tra nsferase
G M F R
ge o metric mea n f ol d rise
G M R
ge o metric mea n rati o
G M T
ge o metric mea n titer
H A
he ma g gl uti ni n
H AI
he ma g gl uti nati o n i n hi biti o n assa y
H b e
he patitis B e
H b e A g
he patitis B e a nti ge n
H b s A g
he patitis B s urface a nti ge n
H B V
he patitis B vir us
H C V
he patitis C vir us
HI V
h u ma n i m m u n o deficie nc y vir us
H R
heart rate
H R T
h or m o ne re place me nt t hera p y
I B
i n vesti gat or’s br oc h ure
I C D
i nf or me d c o nse nt d oc u me nt
I C H
I nter nati o nal C o u ncil f or Har m o nisati o n of Tec h nical 
Re q uire me nts f or P har mace uticals f or H u ma n Use
I C U
i nte nsi ve care u nit
I D
i de ntificati o n
I g G
i m m u n o gl o b uli n G
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 1 1
A b bre vi ati o n
Ter m
I LI
i nfl ue nza-li ke ill ness
I M P
i n vesti gati o nal me dici nal pr o d uct
I ND
i n vesti gati o nal ne w dr u g
I N R
i nter nati o nal n or malize d rati o
I P A L
I n vesti gati o nal Pr o d uct Acc o u nta bilit y L o g
I P M
i n vesti gati o nal pr o d uct ma n ual
I RB
i nstit uti o nal re vie w b oar d
I R C
i nter nal re vie w c o m mittee
I R T
i nteracti ve res p o nse tec h n ol o g y
IR V
i nfl ue nza m o d R N A vacci ne ( bI R V, mI R V, or tI R V)
I S O
I nter nati o nal Or ga nizati o n f or Sta n dar dizati o n
I V
i ntra ve n o us(ly)
I W R
i nteracti ve We b-base d res p o nse
K DI G O
Ki d ne y  Disease I m pr o vi n g Gl o bal O utc o mes
L B B B
left b u n dle bra nc h bl oc k
L C I
la b orat or y-c o nfir me d i nfl ue nza
L F T
li ver f u ncti o n test
L L O Q
l o wer li mit of q ua ntitati o n
L N P
li pi d na n o particle
M C A R
missi n g c o m pletel y at ra n d o m
M D R
m e dical d e vice re g ulati o n
Me d D R A
Me dical Dicti o nar y  f or Re g ulat or y Acti vities
mI R V
m o n o vale nt i nfl ue nza m o d R N A vacci ne
mI T T
m o difie d i nte nt-t o-treat
m o d R N A
n ucle osi de -m o difie d messe n ger ri b o n ucleic aci d
M QI
me dicall y  q ualifie d i n di vi d ual
m R N A
messe n ger ri b o n ucleic aci d
m R N A - 1 2 7 3
m R N A -1 2 7 3 S A R S -C o V -2 vacci ne ( M o der na)
N A
ne ura mi ni dase
N/ A
n ot a p plica ble
N A A T
n ucleic aci d a m plificati o n test
N- bi n di n g
S A R S -C o V -2 n ucle o pr otei n – bi n di n g
NI
n o ni nferi orit y
NI M P
n o ni n vesti gati o nal me dici nal pr o d uct
N Y H A
N e w Y or k Heart Ass ociati o n
O mi
O micr o n
P A C L
pr ot oc ol a d mi nistrati ve c ha n ge letter
Pa O 2
partial press ure of o x y ge n, arterial
P B M C
peri p heral bl o o d m o n o n uclear cell
P C R
p ol y merase c hai n reacti o n
P F S
prefille d s yri n ge(s)
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 1 2
A b bre vi ati o n
Ter m
PI
pri nci pal i n vesti gat or
P P E
pers o nal pr otecti ve e q ui p me nt
P S S A
Pfizer’ s Se ri o us A d verse E v e nt S u b missi o n Assista nt
P T
pr ot hr o m bi n ti me
P V C
pre mat ure ve ntric ular c o ntracti o n
qI R V
q ua dri vale nt i nfl ue nza m o d R N A vacci ne
QI V
q ua dri vale nt i nfl ue nza vacci ne
Q Tc F
Q T i nter val c orrecte d usi n g Fri dericia ’s f or m ula
Q T L
q ualit y  t olera nce li mit
R C D C
re verse c u m ulati ve distri b uti o n c ur ve
R N A
ri b o n ucleic aci d
R R
res pirat or y rate
R S V
res pirat or y sy n c ytial vir us
R T -P C R
re verse tra nscri pti o n –p ol y merase c hai n reacti o n
S A E
seri o us a d verse e ve nt
S A D E
seri o us a d verse de vice effect
S A P
statistical a nal ysis pla n
S A R S
se vere ac ute res pirat or y s yn dr o me
S A R S -C o V
se vere ac ute res pirat or y s yn dr o me c or o na vir us 
S A R S -C o V - 2
se vere ac ute res pirat or y s yn dr o me c or o na vir us 2
S B P
s yst olic bl o o d press ure
Scr
ser u m creati ni ne
Sc y s
ser u m c ystati n C
S D
sta n dar d-d ose
S o A
sc he d ule of acti vities
S O P
sta n dar d o perati n g pr oce d ure
S p O 2
o x y ge n sat urati o n as meas ure d b y p ulse o xi metr y
S R S D
si n gle refere nce safety d oc u me nt
S T - T
S T se g me nt a n d T wa ve
S U S A R
s us pecte d u ne x pecte d seri o us a d verse reacti o n
T bili
t otal bilir u bi n
T C R
T- cell rece pt or
T h 1
T- hel per t y pe 1
tI RV
tri vale nt i nfl ue nza m o d R N A vacci ne
T O C
ta ble of c o nte nts
U A D E
u na ntici pate d a d verse de vice effect
U K
U nite d Ki n g d o m
U L N
u p per li mit of n or mal
U S
U nite d States
U S A D E
u na ntici pate d seri o us a d verse de vice effect
U S PI
U nite d States pac ka ge i nsert
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 1 3
A b bre vi ati o n
Ter m
V E
vacci ne efficac y
V O C
varia nt of c o ncer n
V R B P A C
Vacci nes a n d Relate d Bi ol o gical Pr o d ucts A d vis or y  C o m mittee
W H O
W orl d Healt h Or ga nizati o n
W O C B P
w o ma n/ w o me n of c hil d beari n g p ote ntial
W T
w il d t ype
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 1 4
1 1. R E F E R E N C E S
1
Vi per Gr o u p C O VI D -1 9 Vacci ne Trac ker Tea m. C O VI D -1 9 vacci ne trac ker: 
Pfizer/ Bi o N Tec h: C o mir nat y.  A vaila ble fr o m:
htt ps://c o vi d 1 9.trac k vacci nes. or g/ vacci nes/ 6/ .  Accesse d: 0 2 J u n 2 0 2 2.
2
U S F o o d a n d Dr u g A d mi nistrati o n. F D A ro u n d u p: J ul y  8, 2 0 2 2. A vaila ble fr o m: 
htt ps:// w w w.f da. g o v/ ne ws -e ve nts/ press -a n n o u nce me nts/f da -r o u n d u p-j uly- 8- 2 0 2 2. 
Accesse d: 1 1 Fe b 2 0 2 3 .
3
U S F o o d a n d Dr u g A d mi nistrati o n. Pfizer -Bi o N Tec h C O VI D - 1 9 v acci nes. A vaila ble 
fr o m: htt ps:// w w w.f da. g o v/ vacci nes -bl o o d -bi ol o gics/c or o na vir us -c o vi d- 1 9-c ber-
re g ulate d-bi ol o gics/ pfizer -bi o ntec h -c o vi d- 1 9-vacci nes . Accesse d: 2 5 J ul 2 0 2 3.
4
U S F o o d a n d Dr u g A d mi nistrati o n. Re vie w me m ora n d u m, 2 8 Mar 2 0 2 2: C B E R 
assess me nt of a sec o n d b o oster d ose of t he Pfizer Bi o N Tec h C O VI D -1 9 vacci ne 
( 0. 3 m L) a d mi nistere d f oll o wi n g a first b o oster d ose of a ny F D A a ut h orize d or a p pr o ve d 
C O VI D -1 9 vacci ne i n certai n i n di vi d uals. A vaila ble fr o m: 
htt ps:// w w w.f da. g o v / me dia/ 1 5 7 3 6 4/ d o w nl oa d. Accesse d: 0 2 J u n 2 0 2 2.
5
Pfizer a n d Bi o N Tec h. B N T 1 6 2 b 2 [ C O MI R N A T Y ( C O VI D -1 9 vacci ne, m R N A)] 
e val uati o n of a b o oster d ose (t hir d d ose). Vacci nes a n d Relate d Bi ol o gical Pr o d ucts 
A d vis or y  C o m mittee meeti n g briefi n g d oc u me nt, 1 7 Se p 2 0 21. A vaila ble fr o m: 
htt ps:// w w w.f da. g o v/ me dia/ 1 5 2 1 6 1/ d o w nl oa d. Accesse d : 0 2 J u n 2 0 2 2.
6
Pfizer. Real -w orl d e vi de nce c o nfir ms hi g h effecti ve ness of Pfizer -Bi o N Tec h C O VI D - 1 9 
vacci ne a n d pr of o u n d p u blic healt h i m pact of vacci nati o n o ne year after pa n de mic 
decl are d [ press release]. A vaila ble fr o m: htt ps:// w w w. pfizer.c o m/ ne ws/ press -
release/ press-release-detail/real -w orl d -e vi de nce -c o nfir ms-hi g h -effecti ve ness -pfizer.  
P u blis he d: 1 1 Mar 2 0 2 1. Accesse d: 0 2 J u n 2 0 2 2.
7
W orl d Healt h Or ga nizati o n. Wee kl y  e pi de mi ol o gical u p date o n C O VI D- 1 9 -
2 9 Mar 2 0 2 2. A vaila ble fr o m: htt ps:// w w w. w h o.i nt/ p u blicati o ns/ m/ite m/ wee kl y -
e pi de mi ol o gical-u p date - o n-c o vi d- 1 9---2 9 -marc h - 2 0 2 2. Accesse d: 0 5 A pr 2 0 2 2.
8
W orl d Healt h Or ga nizati o n. Rec o m me n dati o ns an n o u nce d f or infl ue nza v acci ne 
co m p ositi o n f or t he 2 0 2 3- 2 0 2 4 n ort her n h e mis p here infl ue nza seas o n. A vaila ble fr o m: 
htt ps:// w w w. w h o.i nt/ ne ws/ite m/ 2 4 - 0 2- 2 0 2 3-rec o m me n dati o ns-a n n o u nce d-f or-i nfl ue nza-
vacci ne -c o m p ositi o n -f or-t he- 2 0 2 3- 2 0 2 4-n ort her n -he mis p here -i nfl ue nza-seas o n. 
Accesse d : 0 6 Fe b 2 0 2 4.
9
Vacci nes a n d Relate d Bi ol o gical Pr o d ucts A d vis or y  C o m mittee Oct o ber 5, 2 0 2 3 
m eeti n g su m mar y  mi n utes. A vaila ble fr o m: 
htt ps:// w w w.f da. g o v/ me dia/ 1 7 3 6 5 4/ d o w nl oa d . Accesse d: 0 6 Fe b 2 0 2 4.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 1 5
1 0
C o he n K W, L i n der ma n S L, M o o die Z, et al. L o n git u di nal a nal ysis s h o ws d ura ble a n d 
br oa d i m m u ne me m or y  after S A R S-C o V -2 i nfecti o n wit h persisti n g a nti b o d y  res p o nses 
a n d me m or y B a n d T cells. Cell Re p Me d. 2 0 2 1; 2( 7): 1 0 0 3 5 4.
1 1
D u L , He Y, Z h o u Y, et al. T he s pi ke pr otei n of S A R S-C o V --a tar get f or vacci ne a n d 
t hera pe utic de vel o p me nt. Nat Re v Micr o bi ol. 2 0 0 9; 7( 3): 2 2 6 - 3 6.
1 2
C u n ha B A. I nfl ue nza: hist orical as pects of e pi de mics a n d pa n de mics. I nfect Dis Cli n 
N ort h A m. 2 0 0 4; 1 8( 1): 1 4 1 - 5 5.
1 3
M o nt o A S, Gra ve nstei n S, Elli ott M, et al. Cli nical si g ns a n d s y m pt o ms pre dicti n g 
i nfl ue nza i nfecti o n. Arc h I nter n Me d. 2 0 0 0; 1 6 0( 2 1): 3 2 4 3 - 7.
1 4
C o wli n g BJ, C ha n K H, Fa n g VJ, et al. C o m parati ve e pi de mi ol o g y  of pa n de mic a n d 
seas o nal i nfl ue nza A i n h o use h ol ds. N E n gl J Me d. 2 0 1 0; 3 6 2( 2 3): 2 1 7 5 - 8 4.
1 5
Hall E. I nfl ue nza. C ha pter 1 2. I n: Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. Hall E, 
W o di A P, Ha m b ors k y  J, et al, e ds. E pi de mi ol o g y a n d pre ve nti o n of vacci ne-pre ve nta ble 
diseases. 1 4t h e d. Was hi n gt o n, D C: P u blic Hea lt h F o u n dati o n; 2 0 2 1: 1 7 9-9 2.
1 6
I ulia n o A D, R o g us ki K M, C ha n g H H, et al. Esti mates of gl o bal seas o nal i nfl ue nza-
ass ociate d res pirat or y m ortalit y: a m o delli n g st u d y. La n cet. 2 0 1 8; 3 9 1( 1 0 1 2 7): 1 2 8 5 - 3 0 0.
1 7
C o x NJ, S u b bara o K. I nfl ue nza. La ncet. 1 9 9 9; 3 5 4( 9 1 8 6): 1 2 7 7- 8 2.
1 8
P olac k F P, T h o mas SJ, Kitc hi n N, et al. Safet y a n d efficac y of t he B N T 1 6 2 b 2 m R N A 
C o vi d -1 9 vacci ne. N E n gl J Me d. 2 0 2 0; 3 8 3( 2 7): 2 6 0 3 -1 5.
1 9
Pfizer. Pfizer a n d Bi o N Tec h c o nfir m hi g h efficac y  a n d n o seri o us safety c o ncer ns 
t hr o u g h u p t o si x m o nt hs f ollo wi n g sec o n d d ose i n u p date d t o pli ne a nal ys is of la n d mar k 
C O VI D -1 9 vacci ne st u d y [ press release]. A vaila ble fr o m: 
htt ps:// w w w. pfizer.c o m/ ne ws/ press -release/ press-release-detail/ pfizer -a n d-bi o ntec h -
c o nfir m-hi g h -efficac y-a n d- n o-seri o us. P u blis he d: 0 1 A pr 2 0 21. Accesse d: 2 5 Fe b 2 0 2 2.
2 0
U S F o o d a n d Dr u g A d mi nistrati o n. E mer ge nc y  use a ut h orizati o n ( E U A) f or a n 
u na p pr o ve d pr o d uct: re vie w me m ora n d u m. Pfizer -Bi o N Tec h C O VI D -1 9 vacci ne 
B N T 1 6 2 b 2 as a si n gle b o oster d ose. A vaila ble fr o m: 
htt ps:// w w w.f da. g o v/ me dia/ 1 5 2 4 3 2/ d o w nl oa d. Accesse d: 0 2 J u n 2 0 2 2.
2 1
Pfizer. Pfizer a n d Bi o N Tec h recei ve e x pa n de d U. S. F D A e mer ge nc y  use a ut h orizati o n 
of C O VI D -1 9 vacci ne b o oster t o i ncl u de i n di vi d uals 1 8 a n d ol der [ press release]. 
A vaila ble fr o m: htt ps:// w w w. pfizer.c o m/ ne ws/ press -release/ press-release-detail/ pfizer -
a n d-bi o ntec h -recei ve-e x pa n de d- us-f da-e mer ge nc y- use. P u blis he d: 1 9 N o v 2 0 2 1. 
Accesse d: 0 2 J u n 2 0 2 2.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

P F -0 7 9 2 6 3 0 7 ( C o m bi nati o n C O VI D -1 9 a n d I nfl ue nza m o d R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 6, 0 9 Fe br uar y 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2)
Pa ge 2 1 6
2 2
U S F o o d a n d Dr u g A d mi nistrati o n. C or o na vir us ( C O VI D -1 9) u p date: F D A rec o m me n ds 
incl usi o n of O micr o n B A. 4/ 5 co m p o ne nt f or C O VI D -1 9 v acci ne b o oster d oses . 
A vaila ble fr o m :
htt ps:// pr o of p oi ntis olati o n.c o m/ br o wser? url = htt p % 3 A % 2 F % 2 F we b.arc hi ve. or g % 2 F we b
% 2 F 2 0 2 4 0 1 2 4 0 3 2 0 2 0 % 2 F htt ps % 3 A % 2 F % 2 F w w w.f da. g o v % 2 F ne ws -e ve nts % 2 F press -
a n n o u nce me nts % 2 Fc or o na vir us -c o vi d- 1 9-u p date -f da-rec o m me n ds -i ncl usi o n-o micr o n -
ba 4 5 -c o m p o ne nt -c o vi d-1 9 -vacci ne . Accesse d: 1 0 A u g 2 0 2 3.
2 3
U S F o o d a n d Dr u g A d mi nistrati o n. G ui da nce f or i n d ustr y: t o xicit y gra di n g scale f or
healt h y a d ult a n d a d olesce nt v ol u nteers e nr olle d i n pre ve nti ve vacci ne cli nical trials.
R oc k ville, M D: Ce nter f or Bi ol o gics E val uati o n a n d Researc h; Se pte m ber 2 0 0 7.
A vaila ble fr o m: htt ps:// w w w.f da. g o v/ me dia/ 7 3 6 7 9/ d o w nl oa d. Accesse d: 1 0 A u g 2 0 2 3.
2 4
Fl uz o ne Q ua dri vale nt (infl ue nza v acci ne). U S prescri bi n g i nf or mati o n: Marc h 2 0 2 3. 
A vaila ble fr o m: htt ps:// w w w.f da. g o v/ me dia/ 1 7 0 0 1 9/ d o w nl oa d . Accesse d: 0 6 N o v 2 0 2 3.
2 5
Fl ucel va x Q ua dri vale nt (i nfl ue nza vacci ne). U S prescri bi n g i nf or mati o n; Octo ber 2 0 2 1. 
A vaila ble fr o m: htt ps:// w w w.f da. g o v/ me dia/ 1 1 5 8 6 2/ d o w nl oa d. Accesse d: 2 9 Mar 2 0 2 3.
2 6
Fl uz o ne Hi g h -D ose Q ua dri vale nt. U S prescri bi n g i nf or mati o n: Marc h 2 0 2 3. A vaila ble 
fr o m: htt ps:// w w w.f da. g o v/ me dia/ 1 3 9 7 3 1/ d o w nl oa d?attac h me nt . Accesse d: 
0 1 N o v 2 0 2 3.
2 7
Pfizer. Pfizer a n d Bi o N Tec h gra nte d F D A e mer ge nc y  use a ut h orizati o n of O micr o n 
B A. 4/ B A. 5 -a da pte d bi vale nt C O VI D -1 9 vacci ne b o oster f or a ges 1 2 y ears a n d ol der 
[ press release]. A vaila ble fr o m: htt ps:// w w w. pfizer.c o m/ ne ws/ press-release/ press-
release-detai l/ pfizer-a n d-bi o ntec h -gra nte d -f da-e mer ge nc y-use -a ut h orizati o n. P u blis he d: 
3 1 A u g 2 0 2 2. Accesse d: 1 6 Se p 2 0 2 2.
2 8
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. S y m pt o ms of C O VI D- 1 9. A vaila ble fr o m: 
htt ps:// w w w.c dc. g o v/c or o na vir us/ 2 0 1 9- nc o v/s y m pt o ms -testi n g/s ym pt o ms. ht ml. 
Accesse d: 0 9 Fe b 2 0 2 3 .
2 9
Becer ra X. Secretarial d irecti ve o n b i vale nt C O VI D-1 9 v acci ne b o oster d oses f or 
in di vi d uals a ges 5 y ears a n d o l der. 1 3 Oct 2 0 2 2 . A vaila ble fr o m: 
htt ps:// w w w. h hs. g o v/sites/ defa ult/files/secretarial -directi ve -c o vi d- 1 9-bi vale nt -vacci ne -
b o osters -y o u n ger -pe ds. p df . Accesse d: 2 2 Ja n 2 0 2 4.
3 0
U S De part me nt of Healt h a n d H u ma n Ser vices. C O VI D - 1 9 vacci nes . 1 5 Dec 2 0 2 3. 
A vaila ble fr o m: htt ps:// w w w. h hs. g o v/c or o na vir us/c o vi d - 1 9-vacci nes/i n de x. ht ml . 
Accesse d: 2 2 Ja n 2 0 2 4.
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)

D o c u m e nt A p pr o v al R e c or d
D o c u m e nt N a m e:
D o c u m e nt Titl e:
Si g n e d B y:
D at e( G M T)
Si g ni n g C a p a cit y
0 9 0 1 7 7 e 1 9f e 5ff 1 b\ A p pr o v e d\ A p pr o v e d O n: 1 2- F e b- 2 0 2 4 1 2: 2 7 ( G M T)
P P D
P P D