A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A COMBINED MODIFIED RNA VACCINE CANDIDATE AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
Phase: PHASE3
Conditions: Influenza, 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1
A P H A S E 3, R A N D O MI Z E D, O B S E R V E R -B LI N D E D S T U D Y 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 A 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 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 H Y I N DI VI D U A L S
St u d y S p o ns or:
Bi o N Tec h S E
St u d y C o n d ucte d b y:
Pfizer I nc.
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 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 6 1 7 8 9 9 1
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 2
P h ase:
3
S p o ns or ’s A ge nt’s Le g al A d dress:
Pfizer I nc.
6 6 H u ds o n B o ule var d East
Ne w Y or k, N Y 1 0 0 0 1
Brief Title: A St u d y  t o 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 
C o m bi ne d M o difie d R N A Vacci ne Ca n di date 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 nt s, yo 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
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 2
1 1 A pril 2 0 2 4
A me n d me nt 1
1 2 Ja n uar y 2 0 2 4
Ori gi nal pr ot oc ol
1 7 Oct o ber 2 0 2 3
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 pr ot oc ol a d mi nistrati ve c ha n ge 
letter(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 2 ( 1 1 A pril 2 0 2 4)
O ver all R ati o n ale f or t he A me n d me nt:
t o i ncl u de f urt her 
e val uat i o n of a c o m bi ne d m o difie d fl u a n d C o vi d - 1 9 vacci ne vers us sta n dal o ne vacci ne s t o 
deter mi ne w het her c o m bi ni n g t he vacci nes i nterferes wit h i m m u ne res p o nses.
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
S u bst a nti al M o dific ati o n(s)
A d d e d C o h ort 3 t o 
e na ble f urt her 
e val uati o n of 
c o m bi ne d 
m o difie d fl u a n d 
C o vi d - 1 9 vacci ne 
vers us sta n dal o ne 
vacci ne s t o 
deter mi ne w het her 
t he c o m bi ni n g t he 
vacci nes i nterferes 
wit h i m m u nes 
res p o nses.
t o i ncl u de 
C o h ort 3 f or f urt her e val uati o n of 
co m bi ne d m o difie d fl u a n d C o vi d - 1 9
vacci ne vers us sta n dal o ne vacci ne 
c o m p o ne nts t o deter mi ne w het her 
c o m bi ni n g t he vacci nes i nterferes wit h 
i m m u nes res p o nses.
1. 1 S y n o psis
1. 2 Sc he ma
1. 3 Sc he d ule of 
Acti vities
2. 1 St u d y  Rati o nale
2. 2. 3. 2 I nfl ue nza
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
2. 3 Be nefit/ Ris k 
Assess me nt
2. 3. 1 Ris k Assess me nt
2. 3. 3 O verall 
Be nefit/ Ris k C o ncl usi o n
3 O bjecti ves, E n d p oi nts ,
a n d Esti ma n ds
4. 1 Desi g n
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
4. 3. 2
B N T 1 6 2 b 2
( O mi X B B. 1. 5) a n d 
B N T 1 6 2 b 2 
( O mi X B B. 1. 5)
5 St u d y  P o p ulati o n
6. 1 St u d y  
Inter ve nti o n (s) 
A d mi nistere d
6. 1. 1 A d mi nistrati o n
6. 3 Assi g n me nt t o St u d y  
Inter ve nti o n
6. 9 Pri or a n d 
C o nc o mita nt T hera p y
6. 9. 1 Pr o hi bite d D uri n g 
t he St u d y
6. 9. 2 Per mitte d D uri n g 
t he St u d y
8. 2 I mm u n o ge nicit y 
Assess me nt s
8. 1 0 St u d y  Pr oce d ures
9. 1 Statistical 
H y p ot hes es
9. 1. 1 Esti ma n ds
9. 1. 2 M ulti plicit y  
A dj ust me nt
9. 3. 3 Sec o n dar y  
E n d p oi nts/ Esti ma n ds 
A nal y sis
9. 5. 1 I mm u n o ge nicit y
9. 5. 2 Safet y
1 1 Refere nces
U p date d t he
pr ot oc ol 
c o ncer ni n g 
C o h ort 1 
e nr ol lme nt a n d 
re m o ve d t he 
 1. 1 S y n o psis
1. 2 Sc he ma
1. 3 Sc he d ule of 
Acti vities
2. 1 St u d y  Rati o nale
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 7 ( G M T)
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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
c orres p o n di n g 
h y p ot hes es.
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
3 O bjecti ves, E n d p oi nts ,
a n d Esti ma n ds
4. 1 Desi g n
6. 1 St u d y  
I nter ve nti o n(s) 
A d mi nistere d
6. 3 Assi g n me nt t o St u d y  
Inter ve nti o n
9. 1 Statistical 
H y p ot hes es
9. 1. 2 M ulti plicit y  
A dj ust me nt
9. 3. 2 Pri mar y  
E n d p oi nts / Esti ma n ds 
A nal y sis
9. 5. 1 I mm u n o ge nicit y
N o ns u bst a nti al M o dific ati o n(s)
A dj uste d t he 
w or di n g t o all o w 
f or greater 
fle xi bilit y i n 
e val uati n g 
partici pa nts, 
e nc o m passi n g 
s ym pt o ms be y o n d 
t he 3 pre vi o usl y  
s pecifie d 
s ym pt o ms.
T h e u p date d w or di n g will all o w greater 
fle xi bilit y i n e val uati n g partici pa nts i n 
ti mel y ma n ner .
8. 1 0. 6 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
As reflecte d i n 
P A C L  3. 0 
( 2 9 Ja n 2 0 2 4) , t he 
pr ot oc ol has bee n 
u p date d t o i ncl u de
m y ocar ditis a n d 
pericar ditis 
w or di n g .
T he te xt has bee n u p date d t o ali g n wit h 
t he te xt use d i n t he sta n dal o ne B N T 1 6 2 b 2 
X B B. 1. 5 w or di n g ( whic h was u p date d ).
8. 1 0. 6 A d diti o nal 
Pr oce d ures f or 
M o nit ori n g of P ote ntial 
M y ocar dit is or
Pericar ditis
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
As reflecte d i n 
P A C L  3. 0
( 2 9 Ja n 2 0 2 4), t he 
pr ot oc ol ha s bee n
u p date d t o reflect
c ha n ges t o t he 
c o ntact pr oce d ure 
f or ur ge nt me dical 
q uesti o ns directe d 
t o t he s p o ns or. 
T he pr ocess f or c o ntacti n g a me dicall y 
q ualifie d i n di vi d ual has c ha n ge d fr o m a 
me dical escalati o n pr ocess via a Pfizer 
Call Ce nter t o direct cli nical tea m c o ntact 
usi n g a St u d y Tea m C o ntact L ist.  
1 0. 1. 1 2 S p o ns or’s 
Me dicall y  Q ualifie d 
I n di vi d ual
As reflecte d i n 
P A C L  3. 0 
( 2 9 Ja n 2 0 2 4) , t he 
pr ot oc ol has bee n 
u p date d t o reflect 
t he retire me nt of 
t he E mer ge nc y  
C o ntact C ar d.
T he E mer ge nc y  C o ntact Car d is bei n g 
re place d by a st u d y i nf or mati o n car d a n d 
will n o l o n ger be refere nce d .
1 0. 1. 1 2 S p o ns or’s 
Me dicall y  Q ualifie d 
I n di vi d ual
A d de d m i n or 
clarificati o n 
relate d t o left 
delt oi d 
react o ge nicit y a n d 
c o nfir m 
c o m plia nce wit h 
t her m o meter 
i nstr ucti o ns.
T o f urt her clarif y  t hat left delt oi d 
react o ge nicit y s h o ul d be c o nsi dere d a n 
A E .
8. 3. 4. 2 L o cal Reacti o ns
8. 3. 4. 4 Fe ver
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 
Inf or mati o n
8. 1 0. 5 U nsc he d ule d 
Visit f or a Gra de 3 or 
S us pecte d Gra de 4 
Reacti o n 
U p date d t he
pri mar y  esti ma n ds 
f or C o h ort 2.
U p date d t he pri mar y  esti ma n ds f or 
C o h ort 2 f or clarity.
1. 1 S y n o psis
3 O bjecti ves , E n d p oi nts, 
a n d Esti ma n ds
9. 3. 2 Pri mar y  
E n d p oi nts / Esti ma n ds 
A nal y sis
A d d e d a sec o n dar y 
i m m u n o ge nicity 
o bjecti ve f or 
C o h ort 2 .
T he a d diti o n of t his sec o n dar y  
i m m u n o ge nicity o bjecti ve will all o w
de m o nstrat i o n of t he s u peri orit y of H AI 
i m m u ne res p o nses.
1. 1 S y n o psis
3 O bjecti ves, E n d p oi n ts, 
a n d Esti ma n ds
9. 1 Statistical 
H y p ot heses
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
9. 1. 1 Esti ma n ds
9. 1. 2 M ulti plicit y  
A dj ust me nt
9. 3. 3 Sec o n dar y  
E n d p oi nts/ Esti ma n ds 
A nal y sis
A d d e d clarificati o n
f or t he e val ua ble 
i m m u n o ge nicity
a nal ys is sets.
T o f urt her clarif y  t he e val ua ble a n d mI T T 
i m m u n o ge nicity p o p ulati o ns .
9. 2 A nal y sis Sets
U p date d t he G M R 
calc ulati o n t o 
i ncl u de u na dj uste d 
G M R a n d 
m o del -base d 
G M R.
Ma de u p dates i n relati o n t o G M R 
statistics d ue t o t he a d diti o n of C o h ort 3 
a n d c ha n ges t o t he O bject i ves, E n d p oi nts, 
a n d Esti ma n ds.
9. 3. 1. 4 Ge o metric Mea n 
Rati o
Restr uct ur e d t he 
statistical a nal ysis 
met h o ds.
T o i m pr o ve clarit y of t he e x pl orat or y 
e n d p oi nts a nal ysis.
9. 3. 4 E x pl orat or y  
E n d p oi nts A nal y sis
Clarifi e d t hat t here 
is n o i nteri m 
a nal ys is a n d 
clarifie d t he ti mi n g 
of pla n ne d 
a nal ys is. 
F urt her clarit y re gar di n g t he ti mi n g of 
a nal ys is t o all o w f or h y p ot hesis 
assess me nt f or re g ulat or y p ur p oses.
9. 4 I nteri m A nalys es
9. 4. 1 A nal y sis Ti mi n g
R e m o ved t he 
i m m un o ge nicit y 
a nal ys is of 
C o h ort 1 a n d 
s pecifie d t he
a nal ys is of 
C o h ort 2 a n d 
C o h ort 3. Ma de 
cha n ges t o reflect 
t he u p date d sa m ple 
sizes a n d p o wer 
a nal ys is f or t he 
n o ni nferi orit y  
assess me nt s i n 
A dj ust me nt of i m m u n o ge nicit y  sa m ple 
sizes f or C o h ort 2 a n d C o h ort 3 a n d
re m o val of C o h ort 1 fr o m t he 
i m m u n o ge nicity p o p ulati o n.
9. 5. 1 I mm u n o ge nicit y
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
C o h ort 2 a n d 
C o h ort 3.
N ote a d de d t o 
clarif y t he 
pr oce d ure re q uire d 
if a partici pa nt has 
a c ha n ge i n healt h 
stat us re q uiri n g 
E ns ure it is clear to sites t he pr oce d ure if a 
partici pa nt has a c ha n ge i n healt h stat us 
re q uiri n g t he m t o recei ve a pr o hi bite d 
vacci ne
6. 9. 1 Pr o hi bite d D uri n g 
t he St u d y
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
t he m t o recei ve a 
pr o hi bite d vacci ne
Re m o val of 
N- bi n di n g 
a nti b o d y test t o 
esta blis h e x p os ure 
t o S A R S C o V 2 
N- bi n di n g a nti b o d y  test will n o l o n ger t o 
r u n t o esta blis h e x p os ure t o S A R S-C o V - 2
8. 2. 1 Testi n g f or 
S A R S -C o V -2 a n d 
I nfl ue nza E x p os ure
C ha n ges ma de t o 
t he bli n di n g of t he 
s p o ns or met h o d 
C ha n ges ha ve bee n ma de t o ma ke it m ore 
c o ncise
6. 4. 3 Bli n di n g of t he 
S p o ns or
A d diti o n of d ose 
le vels i nt o t he 
st u d y i nter ve nti o n 
a d mi nistrati o n 
ta ble
A d diti o n of t his i nf or mati o n will all o w 
better u n dersta n di n g of t he differe nces i n 
d oses of t he vacci nes use d i n t hi s st u d y
1. 1 S y n o psis
6. 1 St u d y  
I nter ve nti o n(s) 
A d mi nist ere d
A d diti o nal 
clarificati o n 
e ntere d t o e ns ure 
sites are re p orti n g 
A Es a n d S A Es 
a p pr o priatel y
Clarificati o n a d de d t o e ns ure sites re p ort 
A Es a n d S A Es a p pr o priatel y
1. 3 Sc he d ule of 
Acti vities
2. 3. 1 Ris k Assess me nt
3 O bjecti ves, E n d p oi nts ,
a n d Esti ma n ds
4. 1 Desi g 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
8. 1 0. 1 Visit 1 –
Vacci nati o n ( Da y  1)
8. 1 0. 2 Visit 1 A –
1- Wee k F oll o w -U p 
 
 
 
– 6 t o 8 da y s 
After Visit 1
8. 1 0. 3 Visit 2 – 4- W ee k 
F oll o w -U p V isit (A fter 
V acci nati o n) – 2 8 t o 
3 5 Da y s After Visit 1
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
8. 1 0. 4 Visit 3 – 6- M o nt h 
F oll o w - U p Visit ( After 
Vacci nati o n) – 1 6 8 t o 
1 9 6 Da y s After Visit 1
A d diti o n of ot her 
ke y  ris ks i de ntifie d 
f or B N T 1 6 2 b 2 
u n der 
B N T 1 6 2 b 2 
/ B N T 1 6 2 b 2 
Ot her ris k s i de ntifie d te xt a d de d t o t he 
ta ble secti o n f or t he c o m bi nati o n vacci ne
t o c o ver t he B N T 1 6 2 b 2 c o m p o ne nt of t he 
vacci ne
2. 3. 1 Ris k Assess me nt
M a de mi n or 
t yp o gra p h ical 
c ha n ges 
t hr o u g h o ut t he 
pr ot oc ol .
T o c orrect mi n or t y p o gra p hical err ors .
Title pa ge
1. 1 S y n o psis
1. 2 Sc he ma
2. 2. 1 S A R S- C o V - 2
2. 2. 3. 1 S A R S -C o V - 2
2. 3. 1 Ris k Assess me nt
2. 3. 2 Be nefit 
Assess me nt
2. 3. 3 O verall 
Be nefit/ Ris k C o ncl usi o n
6. 4. 3 Bli n di n g of t he 
S p o ns or
6. 9. 1 Pr o hi bite d D uri n g 
t he St u d y
7. 2 Partici pa nt 
Disc o nti n uati o n/ 
Wit h dra wal Fr o m t he 
S t u d y
8. 1 0. 1 Vi sit 1 –
Vacci nati o n ( Da y  1)
8. 1 0. 5 U nsc he d ule d 
Visit f or a Gra de 3 or 
S us pecte d Gra de 4 
Reacti o n
9. 3. 1. 1 A nal y sis f or 
Bi nar y  Data
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
M o ve d pr ot oc ol 
a me n d me nt 1 
hist or y  t o t he 
A p pe n di x a n d 
re n u m ber e d t he 
A p pe n di x secti o ns.
T o i ncl u de c ha n ges bet wee n t he ori gi nal 
pr ot oc ol a n d pr ot oc ol a me n d me nt 1.
1 0. 1 2 A p pe n di x 1 2 : 
Pr ot oc ol A me n d me nt 
Hist or y
1 0. 1 3 A p pe n di x 1 3: 
A b bre viati o ns
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1
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 7
1. P R O T O C O L  S U M M A R Y................................................................................................... 1 8
1. 1. S y n o psis .................................................................................................................. 1 8
1. 2. Sc he ma .................................................................................................................... 2 7
1. 3. Sc he d ule of Acti vities ............................................................................................. 2 8
2. I N T R O D U C TI O N ............................................................................................................... 3 1
2. 1. St u d y  Rati o nale....................................................................................................... 3 1
2. 2. Bac k gr o u n d ............................................................................................................. 3 2
2. 2. 1. S A R S -C o V -2.............................................................................................. 3 2
2. 2. 2. I nfl ue nza ..................................................................................................... 3 3
2. 2. 3. Cli nical O ver vie w ....................................................................................... 3 3
2. 2. 3. 1. S A R S -C o V -2................................ .............................................3 3
2. 2. 3. 2. I nfl ue nza .................................................................................... 3 6
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 ......................... 3 8
2. 3. Be nefit/ Ris k Assess me nt ......................................................................................... 3 9
2. 3. 1. Ris k Assess me nt ......................................................................................... 4 0
2. 3. 2. Be nefit Assess me nt ..................................................................................... 4 4
2. 3. 3. O verall Be nefit/ Ris k C o ncl usi o n ................................................................ 4 4
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 ........................................................... 4 5
4. S T U D Y D E SI G N ................................................................................................................. 4 9
4. 1. Desi g n ...................................................................................................................... 4 9
4. 2. Scie ntific Rati o nale f or St u d y  Desi g n..................................................................... 5 0
4. 2. 1. Di versit y  of St u d y P o p ulati o n ....................................................................5 0
4. 2. 2. C h oice of C o ntrace pti o n/ Barrier Re q uire me nts .........................................5 1
4. 3. J ustificati o n f or D ose ..............................................................................................5 1
4. 3. 1. M o n o vale nt B N T 1 6 2 b 2 ( O mi X B B. 1. 5) ....................................................5 1
4. 3. 2. 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d 
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) ................................................................................................. 5 1
...........................................................................................................5 1
4. 4. E n d of St u d y Defi niti o n .......................................................................................... 5 1
5. S T U D Y P O P U L A T I ON ......................................................................................................5 2
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2
5. 1. I ncl usi o n Criteria ..................................................................................................... 5 2
5. 2. E xcl usi o n Criteria .................................................................................................... 5 3
5. 3. Li fest yle C o nsi derati o ns.......................................................................................... 5 4
5. 3. 1. C o ntrace pti o n ..............................................................................................5 4
5. 4. 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 5
5. 5. Scree n Fail ures ........................................................................................................ 5 5
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 5
6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d ........................................................................ 5 6
6. 1. 1. A d mi nistrati o n ............................................................................................ 5 7
6. 1. 2. Me dical De vices ......................................................................................... 5 8
6. 2. Pre parati o n, Ha n dli n g, St ora ge, a n d Acc o u nta bilit y ............................................... 5 8
6. 2. 1. Pre parati o n a n d Dis pe nsi n g ........................................................................ 5 9
6. 3. Assi g n me nt t o St u d y I nter ve nti o n ........................................................................... 6 0
6. 4. Bli n di n g ................................................................................................................... 6 0
6. 4. 1. Bli n di n g of Partici pa nts .............................................................................. 6 0
6. 4. 2. Bli n di n g of Site Pers o n nel .......................................................................... 6 0
6. 4. 3. Bli n di n g of t he S p o ns or .............................................................................. 6 1
6. 4. 4. Brea ki n g t he Bli n d ...................................................................................... 6 1
6. 5. St u d y  Inter ve nti o n C o m plia nce ............................................................................... 6 2
6. 6. D ose M o dificati o n ................................................................................................... 6 2
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 2
6. 8. Treat me nt of O ver d ose ............................................................................................ 6 2
6. 9. Pri or a n d C o nc o mita nt T hera p y .............................................................................. 6 2
6. 9. 1. Pr o hi bite d D uri n g t he St u d y ....................................................................... 6 3
6. 9. 2. Per mitte d D uri n g t he St u d y ........................................................................ 6 4
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 4
7. 1. Disc o nti n uati o n of St u d y  Inter v e nti o n .................................................................... 6 4
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.......................................6 5
7. 2. 1. Wit h dra wal of C o nse nt ...............................................................................6 5
7. 3. L o st t o F oll o w-U p ................................................................................................... 6 6
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3
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 6
8. 1. A d mi nistrati ve Pr oce d ures ...................................................................................... 6 6
8. 1. 1. Tele healt h Visits ......................................................................................... 6 7
8. 2. I mm u n o ge nicit y Assess me nts ................................................................................. 6 7
................................... 6 8
8. 2. 2. Bi ol o gical Sa m ples ..................................................................................... 6 8
8. 3. Safet y Assess me nts ................................................................................................. 6 9
8. 3. 1. P h y sical E xa mi nati o ns ................................................................................ 6 9
8. 3. 2. Vital Si g ns .................................................................................................. 6 9
8. 3. 3. Cli nical Safet y  La b orat or y Assess me nts.................................................... 6 9
8. 3. 4. Electr o nic Diar y .......................................................................................... 6 9
8. 3. 4. 1. Gra di n g Scales ........................................................................... 7 0
8. 3. 4. 2. L ocal Reacti o ns .........................................................................7 0
8. 3. 4. 3. S y ste mic E ve nts ........................................................................ 7 1
8. 3. 4. 4. Fe ver .......................................................................................... 7 2
8. 3. 4. 5. A nti p y retic Me dicati o n ............................................................. 7 3
8. 3. 5. 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 uri 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 v asc ular a n d Deat h E ve nts ...............................................................7 8
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 Es or S A Es ..............................................................................7 9
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4
8. 4. 8. A d verse E ve nts of S pecial I nterest............................................................. 7 9
8. 4. 8. 1. Lac k of Efficac y ........................................................................ 7 9
8. 4. 9. Me dical De vice Deficie ncies ...................................................................... 7 9
8. 4. 9. 1. Ti me Peri o d f or Detecti n g Me dical De vice Deficie ncies ......... 8 0
8. 4. 9. 2. F oll o w -U p of Me dical De vice Deficie ncies.............................. 8 0
8. 4. 9. 3. Re g ulat or y  Re p orti n g Re q uire me nts f or De vice 
Deficie ncies ....................................................................................... 8 0
8. 4. 1 0. 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. 6. 1. 1. Use/ A nal ys is of D N A................................................................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
8. 1 0. St u d y  Pr oce d ures...................................................................................................8 2
8. 1 0. 1. Visit 1 – Vacci nati o n ( Da y 1) ................................................................... 8 2
8. 1 0. 2. Visit 1 A – 1- Wee k F oll o w -U p 
 
 – 6 t o 8 Da y s After Visit 1 ......... 8 5
8. 1 0. 3. Visit 2 – 4- Wee k F oll o w -U p Visit ( After Vacci nati o n) – 2 8 t o 
3 5 D a y s After Visit 1....................................................................................... 8 6
8. 1 0. 4. Visit 3 – 6- M o nt h F oll o w -U p Visit ( After Vacci nati o n) – 1 6 8 t o 
1 9 6 Da y s After Visit 1..................................................................................... 8 7
8. 1 0. 5. U nsc he d ule d Visit f or a Gra de 3 or S us pecte d Gra de 4 Reacti o n ............ 8 7
8. 1 0. 6. 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 ....................................................................................................... 8 8
8. 1 0. 7. 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 ..................................................................................................... 8 9
9. S T A TI S TI C A L C O N SI D E R A TI O N S ................................................................................8 9
9. 1. Statistical H y p ot heses ............................................................................................. 8 9
9. 1. 1. Esti ma n ds .................................................................................................... 9 1
9. 1. 2. M ulti plicit y  A dj ust me nt.............................................................................. 9 1
9. 2. A nal y sis Sets ........................................................................................................... 9 2
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 5
9. 3. Statistical A nal y ses ................................................................................................. 9 3
9. 3. 1. Ge neral C o nsi derati o ns ...............................................................................9 3
9. 3. 1. 1. A nal y sis f or Bi nar y Data........................................................... 9 3
9. 3. 1. 2. A nal y ses f or C o nti n u o us Data................................................... 9 4
9. 3. 1. 3. Ge o metric Mea n
Titers ..............................................................9 4
9. 3. 1. 4. Ge o metric Mea n Rati o ..............................................................9 4
9. 3. 1. 5. Ge o metric Mea n F ol d Rises ...................................................... 9 5
9. 3. 2. Pri mar y  E n d p oi nts/ Esti ma n ds A nal ysis ..................................................... 9 5
9. 3. 3. Sec o n dar y  E n d p oi nts/ Esti ma n ds A nal ysis ................................................. 9 6
9. 3. 4. E x pl orat or y  E n d p oi nts A nal ysis ................................................................. 9 7
9. 3. 5. Ot her Safet y A nal yses ................................................................................ 9 8
9. 4. I nteri m A nal ys es ..................................................................................................... 9 8
9. 4. 1. A nal y sis Ti mi n g .......................................................................................... 9 9
9. 5. Sa m ple Size Deter mi nati o n ..................................................................................... 9 9
9. 5. 1. I m m u n o ge nicit y.......................................................................................... 9 9
9. 5. 2. Safet y ........................................................................................................ 1 0 1
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 3
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............. 1 0 3
1 0. 1. 1. Re g ulat or y a n d Et hical C o nsi derati o ns .................................................. 1 0 3
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 ....................................................................... 1 0 3
1 0. 1. 2. Fi na ncial Discl os ure ............................................................................... 1 0 4
1 0. 1. 3. I nf or me d C o nse nt Pr ocess ...................................................................... 1 0 4
1 0. 1. 3. 1. Electr o nic C o nse nt ................................................................ 1 0 5
1 0. 1. 4. Data Pr otecti o n ....................................................................................... 1 0 5
1 0. 1. 5. C o m mittees Str uct ure .............................................................................1 0 6
1 0. 1. 5. 1. Data M o nit ori n g C o m mittee ................................................. 1 0 6
1 0. 1. 6. Disse mi nati o n of Cli nical St u d y  Data .................................................... 1 0 6
1 0. 1. 7. Data Q ualit y Ass ura nce .......................................................................... 1 0 7
1 0. 1. 8. S o urce D oc u me nts .................................................................................. 1 0 8
1 0. 1. 9. Use of Me dical Rec or ds .......................................................................... 1 0 9
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 6
1 0. 1. 1 0. St u d y  a n d Site Start a n d Cl os ure .......................................................... 1 0 9
1 0. 1. 1 1. P u blicati o n P olic y ................................................................................. 1 1 0
1 0. 1. 1 2. S p o ns or’s Me dicall y Q ualifie d I n di vi d ual ............................................ 1 1 1
1 0. 2. A p pe n di x 2: Cli nical La b orat or y  Tests...............................................................1 1 2
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 ................................................................... 1 1 3
1 0. 3. 1. Defi niti o n of A E ..................................................................................... 1 1 3
1 0. 3. 2. Defi ni ti o n of a n S A E .............................................................................. 1 1 4
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.......................................................................... 1 1 6
1 0. 3. 4. Re p orti n g of S A Es .................................................................................. 1 1 9
1 0. 4. A p pe n di x 4: C o ntrace pti ve a n d Barrier G ui da nce .............................................. 1 2 1
1 0. 4. 1. Male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria .................................. 1 2 1
1 0. 4. 2. Fe male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria ............................... 1 2 1
1 0. 4. 3. W o ma n of C hil d beari n g P ote ntial .......................................................... 1 2 2
1 0. 4. 4. C o ntrace pti o n Met h o ds ........................................................................... 1 2 3
1 0. 5. A p pe n di x 5: Ge netics .......................................................................................... 1 2 5
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 2 6
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 2 8
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 2 8
1 0. 7. 2. A g e-S pecific Ki d ne y  F u ncti o n Calc ulati o n Rec o m me n dati o ns............. 1 2 8
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 2 8
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 2 9
1 0. 8. A p pe n di x 8: E C G Fi n di n gs of P ote ntial Cli nical C o ncer n ................................. 1 3 0
1 0. 9. A p pe n di x 9: A Es, 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 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 3 2
1 0. 9. 1. Defi niti o n of A E a n d A D E ..................................................................... 1 3 2
1 0. 9. 2. Defi niti o n of S A E, S A D E, a n d U S A D E ................................................1 3 2
1 0. 9. 3. Defi niti o n of De vice Deficie nc y .............................................................1 3 3
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 7
1 0. 9. 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 3 3
1 0. 1 0. A p pe n di x 1 0: 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 3 6
1 0. 1 1. A p pe n di x 1 1: Strai n a n d D ose Selecti o n ........................................................... 1 3 7
1 0. 1 2. A p pe n di x 1 2: Pr ot oc ol A me n d me nt Hist or y ..................................................... 1 3 8
1 0. 1 3. A p pe n di x 1 3: A b bre viati o ns ............................................................................. 1 4 4
1 1. R E F E R E N C E S ................................................................................................................ 1 4 8
LI S T O F T A B L E S
Ta ble 1.
St u d y  Inter ve nti o n Sc he d ule: C o h ort 1 a n d C o h ort 2 ............................... 5 8
Ta ble 2.
St u d y  Inter ve nti o n Sc he d ule: C o h ort 3 ..................................................... 5 8
Ta ble 3. 
L ocal Reacti o n Gra di n g Scale.................................................................. 7 1
Ta ble 4.
S y ste mic E ve nt Gra di n g Scale.................................................................. 7 2
Ta ble 5.
Scale f or Fe ver .......................................................................................... 7 3
Ta bl e 6.
P o wer A nal ys is f or N o ni nferi ority Assess me nt ( C o h ort 2: 
I m m u n o ge nicity Pri mar y O bjecti ves) ..................................................... 1 0 0
Ta ble 7.
P o wer A nal ys is f or N oni nferi orit y Assess me nt ( C o h ort 3: 
I m m u n o ge nicity Sec o n dar y O bjecti ves) ................................................. 1 0 1
Ta ble 8.
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 0 1
Ta ble 9.
C 5 2 6 1 0 0 1: qI R V/ B N T 1 6 2 b 2 a n d tI R V/ B N T 1 6 2 b 2 C o m bi nati o ns .......1 3 7
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 8
1. P R O T O C O L S U M M A R Y
1. 1. S y n o psis
P r ot oc ol Title: A P hase 3, R a n d o mize d, O bser ver - Bli n de d St u d y  t o E val uate t he S afet y, 
T olera bilit y , a n d Im m u n o ge nicit y  of a C o m bi ne d M o difie d R N A V acci ne C a n di date A gai nst 
C O VI D -1 9 a n d Infl ue nza i n H ealt h y In di vi d uals
Brief Title: A St u d y  t o 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 
C o m bi ne d M o difie d R N A Vacci ne Ca n di date 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 6 1 7 8 9 9 1
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 2
P h ase:
3
R ati o n ale :
T he a n n ual vacci ne pr o gra ms i n t he U nite d States ( 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 or o na vir us disease 2 0 1 9 ( C O VI D - 1 9) m a y  be c o n d ucte d i n t he 
f ut ure at a si milar ti me of year; t heref ore, 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 gher vacci nati o n rates f or b ot h vir uses t ha n if t hese 
vacci nes were t o be a d mi nistere d se paratel y.
T he W orl d Healt h Or ga nizati o n ( W H O ) rec o m me n dati o n of t he c o m p ositi o n of i nfl ue nza 
vir us vacci nes i n t he 2 0 2 3 - 2 0 2 4 nort her n he mis p here i nfl ue nza seas o n i ncl u d es b ot h a 
q ua dri vale nt a n d a tri vale nt vacci ne differi n g b y  t he prese nce/a bse nce of 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. At t he 0 5 Octo ber 2 0 2 3 
Vacci nes a n d Relate d Bi ol o gical Pr o d ucts A d vis or y  C o m mittee (V R B P A C ) meeti n g , 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 i nitial st u d y desi g n t heref ore i ncl u de d t he 
fle xi bilit y t o i n de pe n de ntl y e val uate b ot h tri vale nt a n d q ua dri vale n t i nfl ue nza vacci nes 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 e nc o di n g t he se vere 
ac ute res pirat or y sy n dr o me [ S A R S -C o V - 2] s pi ke pr otei n ).
Wit h pr ot oc ol a me n d me nt 2, t he st u d y  desi g n has bee n u p date d base d o n 2 ke y  
de vel o p me nts. First, t he o n g oi n g s ur veilla nce of i nfl ue nza strai ns ca usi n g disease b ur de n has 
f urt her s oli difie d g ui da nce fr o m b ot h t he W H O a n d V R B P A C t hat i nfl ue nza vacci nes s h o ul d 
bec o me tri vale nt f or m ulati o ns rat her t ha n q ua dri vale nt f or m ulati o ns, effecti ve wit h t he 
2 0 2 4/ 5 n ort her n h e mis p here i nfl ue nza seas o n.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 9
 
. S ec o n d, t he st u d y 
desi g n has bee n a da pt e d t o i ncl u de t he e val uati o n of t he i m m u n o ge nicity res p o nses of 
/ B N T 1 6 2 b 2 as c o m pare d t o t he i m m u n o ge nicit y 
res p o nses elicite d by sta n dal o ne B N T 1 6 2 b 2, QI V ( q ua dri vale nt i nfl ue nza vacci ne ), a n d 
 C o h ort 3 will be e nr olle d a n d ra n d o mize d t o c o m pare t he c o m bi nati o n vacci ne vers us 
t hese sta n dal o ne vacci nes t o deter mi ne w het her t he c o m bi nati o n vacci ne s h o ws a ny 
mea ni n gf ul i nterfere nce i n i m m u ne res p o nses.  
C 5 2 6 1 0 0 1 wa s a st u d y e val uati n g m o d R N A e nc o di n g i nfl ue nza he ma g gl uti ni n ( H A), eit her 
as qI R V or tI R V , i n c o m bi nati o n wit h B N T 1 6 2 b 2 wit h a t otal m o d R N A vacci ne d ose le vel of 
9 0 µ g a n d 7 5 µ g, res pecti vel y.
T he data de m o nstrate d t hat t hese c o m bi nati o n vacci ne ca n di dates ha ve pri maril y  mil d or 
m o derate react o ge nicit y , c o nsiste nt wit h t he safety pr ofiles fr o m cli nical trials wit h 
B N T 1 6 2 b 2 a n d q I RV al o ne, a n d n o a d diti o nal safet y  c o ncer ns ha ve bee n i de ntifie d. T hese 
vacci nes elicite d i m m u ne res p o nses t o all vacci ne -e nc o de d a nti ge ns f or b ot h i nfl ue nza a n d 
S A R S -C o V -2. T he data gat here d t o date de m o nstrate t hat u p t o a t otal m o d R N A d ose of 
9 0 µ g f or t he c o m bi nati o n vacci ne ca n di dates is 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 a n d S A R S -C o V -2 vacci ne a nti ge ns i n partici pa nts 1 8 years of a ge a n d 
ol der. T h ese data s u p p ort pr o gressi o n t o P hase 3 cli nical de vel o p me nt of selecte d 
c o m bi nati o n vacci ne ca n di dates,
/ B NT 1 6 2 b 2 a n d/or
B N T 1 6 2 b 2 , u p t o 
 µ g t otal 
m o d R N A f or a d ults 1 8 t hr o u g h 6 4 ye ars of a ge.
T he P hase 3 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 selecte d 
m o d R N A vacci ne ca n di dates 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 (O micr o n 
[ O mi] X B B. 1. 5) , c o m pare d t o a lice nse d i nacti vate d QI V a d mi nistere d i n t he delt oi d
o p p osite t o t hat use d f or a d mi nistrati o n of B N T 1 6 2 b 2 ( O mi X B B. 1. 5) , i n healt h y a d ults 
1 8 t hr o u g h 6 4 ye ars of a ge i n C o h ort 1 a n d C o h ort 2 . A d diti o nall y , t he st u d y will e val uate 
t he
/ B N T 1 6 2 b 2 c o m bi nati o n vacci ne ca n di date i n c o m paris o n t o sta n dal o ne 
a d mi nistrati o n of 
, B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d QI V, t o deter mi ne w het her t he 
c o m bi nati o n vacci ne s h o ws a n y mea ni n gf ul i nterfere nce i n i m m u ne res p o nses i n C o h ort 3.
T he selecte d m o d R N A vacci ne d ose le vel a n d strai n t o be use d i n t his st u d y  are base d o n 
P hase 1/ 2 safet y a n d i m m u n o ge nicit y data , a n d t he d ose le vel a n d strai n i nf or mati o n f or eac h 
vacci ne ca n di date ca n be f o u n d i n t he st u d y i nter ve nti o n ta ble. F or t he c o m bi nati o n vacci ne 
ca n di dates, a t otal m o d R N A d ose of 
 µ g i n a c o m bi nati o n of 
a n d B N T 1 6 2 b 2 a n d a 
t otal m o d R N A d ose of 
µ g i n a c o m bi nati o n of 
a n d B N T 1 6 2 b 2 will be use d i n t his 
st u d y.
Mo d R N A i n vesti gati o nal vacci nes at d ose s of 
a n d 3 0 µ g B N T 1 6 2 b 2 
( O mi X B B. 1. 5), as well as QI V , will be use d as c o m parat or vacci nes i n t he e nr oll me nt of 
C o h ort 3 .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 0
O bjecti ves , E n d p oi nts , a n d Esti m a n ds :
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y :
Pri m ar 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 healt hy partici pa nts 1 8 t hr o u g h
6 4 years of a ge

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 delt oi d
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 d verse e ve nts ( A Es )

Seri o us a d verse e ve nts ( S A Es )
T he perce nta ge of 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 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 delt oi d 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 Es 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
I m m u n o ge nicit y
T o de m o nstrate t hat t he H AI
i m m u ne res p o nse elicite d b y 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) 
is n o ni nferi or t o t hat elicite d b y 
QI V a d mi nistere d c o nc o mita ntl y 
wit h B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
( C o h ort 2)

H AI titers (fr o m H AI base d 
o n
deri ve d vir us) f or t he 
matc he d seas o nal strai ns 
(
) rec o m me n de d b y 
W H O
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of H AI titers at 4 wee ks after vacci nati o n i n partici pa nts w h o recei ve d  
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5)  t o t h ose w h o recei ve d QI V a d ministere d c o nc o mita ntl y wit h B N T 1 6 2 b 2 
( O mi X B B. 1. 5)

T he differe nce i n perce nta ge of partici pa nts ac hie vi n g ser oc o n versi o n a at 4 wee ks after 
vacci nati o n i n partici pa nts w h o recei ve d 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d 
QI V a d mi nistere d c o nc o mita ntl y wit h B N T 1 6 2 b 2 ( O mi X B B. 1. 5).
T o de m o nstrate t hat t he S A R S -
C o V - 2 i m m u ne res p o nse elicite d 
b y
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) is n o ni nferi or t o 
t hat elicite d b y B N T 1 6 2 b 2 
( O mi X B B. 1. 5) a d mi nistere d 
c o nc o mita ntl y wit h QI V
( C o h ort 2)

S A R S -C o V -2 O micr o n 
( X B B. 1. 5)– ne utralizi n g titers
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of S A R S -C o V - 2 –ne utralizi n g titers at 4 wee ks after vacci nati o n i n partici pa nts w h o
recei ve d
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) c o m pare d t o partici pa nts w h o recei ve d B N T 1 6 2 b 2 
( O mi X B B. 1. 5) a d mi nistere d c o nc o mita ntl y wit h QI V

T he differe nce i n perce nta ges of partici pa nts wit h ser ores p o nse b t o t he S A R S -C o V -2 O micr o n 
( X B B. 1. 5) strai n at 4 wee ks after vacci nati o n c o m pare d t o partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d t o t h ose w h o recei ve d B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
a d mi nistere d c o nc o mita ntl y wit h QI V 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 1
O bjecti ves
E n d p oi nts
Esti m a n ds
Sec o n d ar y :
Sec o n d ar y :
Sec o n d ar y :
I m m u n o ge nicit y
T o de m o nstrate t hat t he H AI 
i m m u ne res p o nse elicite d b y 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) 
is n o ni nferi or t o t hat elicite d b y 
QI V al o ne ( C o h ort 3)

H AI titers (fr o m H AI base d 
o n
deri ve d vir us) f or t he 
matc he d seas o nal strai ns 
 rec o m me n de d b y 
W H O
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of H AI titers at 4 wee ks after vacci nati o n i n partici pa nts w h o recei ve d 
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) t o t h ose w h o recei ve d QI V al o ne
T o de m o nstrate t hat t he S A R S -
C o V - 2 i m m u ne res p o nse elicite d 
b y 
B N T 1 6 2 b 2 
( O mi X B B. 1. 5) is n o ni nferi or t o 
t hat elicite d b y B N T 1 6 2 b 2 
( O mi X B B. 1. 5) al o ne ( C o h ort 3)

S A R S -C o V -2 O micr o n 
( X B B. 1. 5)– ne utralizi n g titers
I n e val ua ble i m m u n o ge nicit y partici pa nts: 

G M R of S A R S -C o V - 2 – ne utralizi n g titers at 4 wee ks after vacci nati o n i n partici pa nts w h o
recei ve d 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
al o ne
T o de m o nstrate t hat t he H AI 
i m m u ne res p o nse elicite d b y 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) 
is n o ni nferi or t o t hat elicite d b y 
al o ne ( C o h ort 3)

H AI titers (fr o m H AI base d 
o n
deri ve d vir us) f or t he 
matc he d seas o nal strai ns 
) rec o m me n de d b y 
W H O
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of H AI titers at 4 wee ks after vacci nati o n i n partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 
( O mi X B B. 1. 5) t o t h ose w h o recei ve d
al o ne
T o de m o nstrate t hat t he H AI 
i m m u ne res p o nse elicite d b y 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) 
is s u peri or t o t hat elicite d b y QI V 
a d mi nistere d c o nc o mita ntl y wit h 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
( C o h ort 2)

H AI titers (fr o m H AI base d 
o n
deri ve d vir us) f or t he 
matc he d seas o nal strai ns 
 rec o m me n de d b y 
W H O
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of H AI titers at 4 wee ks after vacci nati o n i n partici pa nts w h o recei ve d 
B N T 1 6 2b 2 
( O mi X B B. 1. 5) t o t h ose w h o recei ve d QI V a d mi nistere d c o nc o mita ntl y wit h B N T 1 6 2 b 2 
( O mi X B B. 1. 5)

T he differe nce i n perce nta ge of partici pa nts wit h ser oc o n versi o n a t o t he seas o nal strai n 
 at 4 wee ks after vacci nati o n bet wee n partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 
( O mi X B B. 1. 5) a n d t h ose w h o recei ve d QI V a d mi nistere d c o nc o mita ntl y wit h B N T 1 6 2 b 2 
( O mi X B B. 1. 5)
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 p ost vacci nati o n 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 a mi ni m u m 4 -f ol d rise at t he p ost vacci nati o n 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 p ost vacci nati o n ≥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 o wer li mit of 
q ua ntitati o n ( 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 2
O ver all Desi g n:
T his is a P hase 3 o bser ver -bli n de d st u d y  t o e val uate t he safety, t olera bilit y , a n d 
i m m u n o ge nicity of c o m bi ne d m o difie d R N A ca n di date s. T he vacci ne ca n di dates are di vi de d 
i nt o 3 c o h orts, w hic h will be st u die d i n a sta g gere d ma n ner, as re q uire d b y t he cli nical pla n.
A ll t he d ose le vels use d i n t his st u d y are detaile d i n t he st u d y i nter ve nti o n ta ble.
C o h ort 1 : A p pr o xi matel y  4 5 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 a n d 
ra n d o mize d i n a 2: 1 rati o b y  site-base d ra n d o mizati o n t o 1 of t he f oll o wi n g:

Ar m A:
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d a n d 
place b o a d mi nistere d i n t he left delt oi d, c o nc urre ntl y.

Ar m B: 3 0 µ g  B N T 1 6 2 b 2 ( O mi X B B. 1 . 5) a d mi nistere d i n t he ri g ht delt oi d a n d 
lice nse d QI V ( 
) a d mi nistere d i n t he left delt oi d, c o nc urre ntl y.
E nr oll me nt of C o h ort 1 will be pa use d i n t he I R T after ra n d o mizati o n of a p pr o xi matel y  
4 5 0 partici pa nts i nt o C o h ort 1. Safet y data (i ncl u di n g electr o nic diar y [e-diar y ] react o ge nicity
data , S A Es, A Es, a n d A E SIs) of a p pr o xi matel y 4 5 0 vacci nate d partici pa nts will be e val uate d 
b y  t he e xter nal data m o nit ori n g c o m mittee (E D M C ) after 6 0 da ys,
 
 
 
 
 
 
C o h ort 2 : A p pr o xi matel y 4 5 0 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 a n d 
ra n d o mize d i n a 2 : 1 rati o b y  site-base d ra n d o mizati o n t o 1 of t he f oll o wi n g:

Ar m C:
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d a n d 
place b o a d mi nistere d i n t he left delt oi d, c o nc urre ntl y.

Ar m D: 3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d a n d 
lice nse d QI V
) a d mi nistere d i n t he left delt oi d , c o nc urre ntl y.
C o h ort 3: A p pr o xi matel y  3 6 0 0 partici pa nts will be e nr olle d a n d ra n d o mize d i n a 2 : 2: 1: 1
rati o b y  site-base d ra n d o mizati o n t o 1 of t he f oll o wi n g:

Ar m E:
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d.

Ar m F: 3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 7 ( G M T)
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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 3

Ar m G: lice nse d QI V
a d mi nistere d i n t he ri g ht delt oi d.

Ar m H:
a d mi nistere d i n t he ri g ht delt oi d .
P respecifie d l ocal reacti o n a n d s yste mic e ve nt data will be c ollecte d i n a n e-diar y  d uri n g t he 
7 da y s, or l o n ger f or o n g oi n g sy m pt o ms , after st u d y i nter ve nti o n (ie, fr o m Da y 1, t he da y of
vacci nati o n, u ntil s y m pt o m res ol uti o n), as well as a n y  me dicati o n ta ke n d uri n g t his peri o d t o 
treat a ny of t hese s y m pt o ms .
Bl o o d sa m ples of a p pr o xi matel y 2 0 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 a n d 6 m o n t hs after vacci nati o n i n all c o h orts. 
 
 
N u m ber of P artici p a nts:
C o h ort 1 : A p pr o xi matel y 4 5 0 partici pa nts will be e nr olle d.
C o h ort 2 : A p pr o xi matel y 4 5 0 0 partici pa nts will be e nr olle d.
C o h ort 3 : A p pr o xi matel y  3 60 0 partici pa nts will be e nr olle d.
St u d y P o p ul ati o n:
T he i ncl usi o n a n d e xcl usi o n criteria are liste d bel o w a n d are t he sa me f or a ll co h orts .
I ncl usi o n Criteri a: 
Partici pa nts m ust meet t he f oll o wi n g k e y  i ncl usi o n criteria t o be eli gi ble f or e nr oll me nt i nt o 
t he st u d y:

Partici pa nts 1 8 t hr o u g h 6 4 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 V isit 1.

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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 4
E xcl usi o n Criteri a:
Partici pa nts wit h a n y  of t he f oll o wi n g k e y  c haracteristics/c o n diti o ns will be e xcl u de d:

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 ys) 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 nflue nza.

Vacci nati o n wit h a n y  i n vesti gati o nal or lice nse d C O VI D-1 9 vacci ne wit hi n 6 m o nt hs 
( 1 7 5 da ys) bef ore st u dy i nter ve nti o n a d mi nistrati o n.
St u d y Ar ms a n d D ur ati o n :
T he st u d y d urati o n f or eac h partici pa nt will be a p pr o xi matel y 6 m o nt hs. T he 
d ose le vels w he n i n c o m bi nati o n wit h B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o be use d i n t his st u d y are
base d o n P hase 1/ 2 safet y  a n d i m m u n o ge nicity data a n d are detaile d i n t he st u d y i nter ve nti o n 
ta ble.
I nter ve nti o n 
N a me
B N T 1 6 2 b 2
( O mi X B B. 1. 5)
B N T 1 6 2 b 2
( O mi X B B. 1. 5)
QI V
(
B N T 1 6 2 b 2
( O mi X B B. 1. 5)
N or mal 
sali ne 
p lace b o
Use
E x peri me ntal 
E x peri me ntal
C o m parat or
E x peri me ntal
C o m parat or
Place b o
I n vesti g ati o n al 
M e dici n al 
P r o d uct (I M P) or 
N o ni n vesti g ati o n a
l M e dici n al 
P r o d uct 
(NI M P )/ Au x ili ar y 
M e dici n al 
P r o d uct (A x M P )
I M P
I M P 
I M P 
I M P
I M P 
I M P
D ose F or m ul ati o n
m o d R N A  
m o d R N A
S us pe nsi o n 
f or i njecti o n
m o d R N A  
m o d R N A
N or mal 
sali ne
( 0. 9 % 
s o di u m 
c hl ori de 
s ol uti o n f or 
i njecti o n)
U nit D ose 
Stre n gt h(s)
µ g
µ g
6 0 µ g H A 
per 0. 5 -m L 
d ose
µ g
3 0 µ g 
N/ A
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 5
D os a ge Le vel(s)
 
 
 
 µ g B N T 1 6 2 b 2 
( O mi X B B. 1. 5)
 
 
 
 
 
 µ g 
B N T 1 6 2 b 2 
( O mi X B B. 1. 5)
6 0 µ g
3 0 µ g 
B N T 1 6 2 b 2 
( O mi X B B. 1. 5)
N/ A
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 ula
r 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 ula
r i njecti o n
St atistic al Met h o ds :
T he pla n ne d sa m ple size f or t his st u d y  is base d o n t he re q uire me nt t o ge nerate a n a de q uate 
safety data base f or lice ns ure a n d t o de m o nstrate i m m u n ol o gical n o ni nferi orit y ( NI) 
o bjecti ves wit h s ufficie nt statistical p o wer. NI of i m m u ne res p o nse f or t he i m m u n oge nicit y 
pri mar y  o bjecti ves ( C o h ort 2) will be assesse d base d o n t he H AI a nti b o d y  G MR s, 
S A R S -C o V -2 G M R usi n g a 
 mar gi n, a n d b ot h H AI a nti b o dy ser oc o n versi o n rates 
a n d S A R S -C o V -2 ser ores p o nse rates usi n g a 
% mar gi n. After t he i m m u n o ge nicit y  
pri m ar y NI o bjecti ve ( C o h ort 2) is esta blis he d, s u peri orit y of H AI i m m u ne res p o nse 
o bjecti ve ( C o h ort 2) is esta blis he d, s u peri orit y of H AI i m m u ne o bjecti ve ( C o h ort 2) will be 
assesse d se q ue ntiall y. NI  of i m m u ne res p o nse f or t he i m m u n o ge nicity sec o n dar y o bjecti ves 
( C o h ort 3) will be assesse d base d o n t he H AI a nti b o d y G M Rs or S A R S -C o V -2 G M R usi n g a 
mar gi n . NI i m m u n o ge nicit y pri mar y  o bjecti ves i n C o h ort 2 a n d i m m u n o genicit y 
sec o n dar y o bjecti ves i n C o h ort 3 will be e val uate d i n de pe n de ntl y.
T he safet y pri mar y  o bjecti ve 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 f or eac h vacci ne gr o u p . A 3 -tier a p pr oac h will be 
use d t o s u m marize A Es.
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 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 a n d t he d ata fr o m n o ncli nical a n d cli nical trials wit h
sta n dal o ne a n d 
w he n i n c o m bi nati o n wit h B N T 1 6 2 b 2 , 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. C o nsi deri n g 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 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.
L ocal reacti o ns i n t he ri g ht ar m, 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, v o miti n g, 
diarr h ea m uscle pai n, a n d j oi nt pai n.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 6
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:

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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 7
1. 2. Sc he m a
Visit 1  
( Da y 1)
Vacci nati o n
Visit 1 A
1- Wee k 
F oll o w -U p 
 
Visit 2
4- Wee k 
F oll o w -U p
Visit
Visit 3
6- M o nt h 
F oll o w -U p
Visit
React o ge nicit y e -di ar y
S A E c ollecti o n * *
St u d y Vacci nati o n
Bl o o d Dra w 
I m m u n o ge nicit y
Bl o o d Dra w 
C o h ort 1
Ar m A a n d Ar m B
C o h ort 3
Ar m E, Ar m F, Ar m G a n d 
Ar m H
C o h ort 2
Ar m C a n d Ar m D
A E c ollecti o n *
* A d diti o n all y, a n y A Es occ urri n g u p t o 4 8 h o urs after a n y s u bse q ue nt bl o o d dr a ws t h at 
are rel ate d t o st u d y pr oce d ures m u st be rec or de d i n t he C R F.
* * Ple ase n ote t he s pecific ti me peri o ds f or A E SI re p orti n g; m y oc ar ditis/ p eric ar ditis will 
be c ollecte d t hr o u g h 6 wee k s.
a n d m e nstr u al d ist ur b a nces will be 
c ollecte d t hr o u g h 6 m o nt hs.
N ote: F or f urt her det ails o n e ac h c o h ort , refer t o Secti o n 6. 1 .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 8
1. 3. S c he d ule of Acti v ities
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 f or all c o h orts . 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 hed ule visits ( u n pla n ne d visits) i n a d diti on t o t h ose liste d in 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 .
Visit I de ntifier
1
1 A
2
3
N otes
Visit Wi n d o w
D a y 1
6 t o 8 D a ys 
After Visit 1
2 8 t o 3 5 D a ys 
After Visit 1
1 6 8 t o 19 6
D a ys After
Visit 1
Visit Descri pti o n
V acci n ati o n
1- Wee k 
F oll o w -U p 
Visit a
4- W ee k 
F oll o w - Up Visit
6- M o nt h 
F oll o w -U p 
Visit
Visit 2 a n d Visit 3 ma y be perf or me d as 
tele healt h visits if t he partici pa nt has bee n 
disc o nti n ue d fr o m f urt her st u d y 
pr oce d ures (see Secti o n 7. 1 a n d 
Secti o n 7. 2 f or f urt her details).
O btai n i nf or me d c o nse nt
X

I nf or me d c o nse nt s h o ul d be o btai ne d 
pri or t o u n der g oi n g a n y 
st u d y-s pecific pr oce d ures.

See Secti o n 1 0. 1. 3 f or a d diti o nal 
i nf or mati o n.
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 
X
O btai n details of me dicati o ns c urre ntl y ta ke n
X
Perf or m cli nical assess me nt, i ncl u di n g oral 
t e mperat ure b
X
Meas ure hei g ht a n d w ei g ht
X
See Secti o n 8. 3. 1 f or a d diti o nal 
i nf or mati o n.
C ollect n o nst u d y vacci ne i nf or mati o n , i ncl u di n g 
C O VI D -1 9 a n d i nfl ue nza vacci ne i nf or mati o n
X
X
X
X
See Secti o n 6. 9. 1 f or a d diti o nal 
i nf or mati o n.
C ollect pr o hi bite d me dicati o n use
X
X
X
X 
See Secti o n 6. 9. 1 f or a d diti o nal 
i nf or mati o n.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 2 9
Visit I de ntifier
1
1 A
2
3
N otes
Visit Wi n d o w
D a y 1
6 t o 8 D a ys 
After Visit 1
2 8 t o 3 5 D a ys 
After Visit 1
1 6 8 t o 19 6
D a ys After
Visit 1
Visit Descri pti o n
V acci n ati o n
1- Wee k 
F oll o w -U p 
Visit a
4- W ee k 
F oll o w - Up Visit
6- M o nt h 
F oll o w -U p 
Visit
Visit 2 a n d Visit 3 ma y be perf or me d as 
tele healt h visits if t he partici pa nt has bee n 
disc o nti n ue d fr o m f urt her st u d y 
pr oce d ures (see Secti o n 7. 1 a n d 
Secti o n 7. 2 f or f urt her details).
Perf or m uri ne pre g na nc y test o n W O C B P
X
See Secti o n 8. 3. 5 f or a d diti o nal 
i nf or mati o n.
C o nfir m use of c o ntrace pti ves (if a p pr o priate)
X
X
X
See Secti o n 5. 3. 1 f or a d diti o nal 
i nf or mati o n.
C o nfir m eli gi bilit y
X
See Secti o n 5 f or a d diti o nal i nf or mati o n.
Re vie w t e mp or ar y  dela y criteria
X
See Secti o n 5. 4 f or a d diti o nal 
i nf or mati o n.
C ollect bl o o d sa m ple f or i m m u n o ge nic it y 
assess me nt
~ 2 0 m L
~ 2 0 m L
~ 2 0 m L
See Secti o n 8. 2 f or a d diti o nal 
i nf or mati o n.

See A p pe n di x 2 f or a list of cli nical 
la b orat or y tests t o be d o ne.

F or la b orat or y c ollecti o n v ol u mes, 
see t he la b orat or y ma n ual.
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
A d mi nister st u d y i nter ve nti o n
X
P ost vacci nati o n o bser vati o n (at least 3 0 mi n utes) 
a n d assess me nt of i m me diate e ve nts
X
E x plai n partici pa nt c o m m u nicati o n met h o ds 
(i ncl u di n g f or react o ge nicit y e-diar y c o m pleti o n), 
assist t he partici pa nt wit h d o w nl oa di n g t he 
a p plicati o n, or iss ue pr o visi o ne d de vice, if re q uire d
X
See Secti o n 8. 3. 4 f or a d diti o nal 
i nf or mati o n.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 0
Visit I de ntifier
1
1 A
2
3
N otes
Visit Wi n d o w
D a y 1
6 t o 8 D a ys 
After Visit 1
2 8 t o 3 5 D a ys 
After Visit 1
1 6 8 t o 19 6
D a ys After
Visit 1
Visit Descri pti o n
V acci n ati o n
1- Wee k 
F oll o w -U p 
Visit a
4- W ee k 
F oll o w - Up Visit
6- M o nt h 
F oll o w -U p 
Visit
Visit 2 a n d Visit 3 ma y be perf or me d as 
tele healt h visits if t he partici pa nt has bee n 
disc o nti n ue d fr o m f urt her st u d y 
pr oce d ures (see Secti o n 7. 1 a n d 
Secti o n 7. 2 f or f urt her details).
Pr o vi de/e ns ure t he partici pa nt has a 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 react o ge nicit y e -diar y 
peri o d 
[ Da ys 1 t hr o u g h 7])
Site re vie ws e -diar y data wit h partici pa nt f oll o w -
u p u ntil o n g oi n g s y m pt o m / me dicati o n res ol uti o n, 
if a p plica ble d
X
X
C ollect react o ge nicit y e -diar y me dicati o n use
X
X
C ollect A Es , S A Es , a n d A E SIs as a p pr o priate e
X
X
X 
X 
See Secti o n 8. 4 a n d Secti o n 8. 4. 8 f or 
a d diti o nal i nf or mati o n.
C ollect e -diar y or assist t he partici pa nt wit h 
deleti n g t he a p plicati o n


X 

a.
 
Refer t o Secti o n 8. 1 0. 2 f or f urt her details.
b.
I ncl u di n g, if cli nicall y i n dicate d, a p h ysical e xa mi nati o n.
c.
 
d.
Re vie w t he partici pa nt’s e-diar y data a n d rec or d assess me nt i n t he C R F. Assess c o m p lia nce, a n y me dicall y atte n de d e ve nts (i ncl u di n g h os pitalizati o ns). F or 
s y m pt o ms still o n g oi n g, c o nti n ue t o f oll o w u p u ntil res ol uti o n, a n d d oc u me nt a n d rec or d st o p dates i n t he C R F.
e.
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 2. 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 Es occ urri n g u p t o 4 8 h o urs after a bl o o d dra w a n d dee me d relate d t o st u d y pr oce d ures m ust be rec or de d i n t he 
C R F.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 1
2. I N T R O D U C TI O N
2. 1. St u d y R ati o n ale
T he 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 y ear; t heref ore,
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 t ha n if t hese vacci nes were t o be a d mi nistere d se paratel y.
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 vir us vacci nes i n t he 2 0 2 3- 2 0 2 4 
n ort her n h e mis p here i nfl ue nza seas o n 1 i ncl u des b ot h a q ua dri vale nt a n d a tri vale nt vacci ne 
differi n g b y t he prese nce/a bse nce of 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. 2 At t he 0 5 Oct o ber 2 0 2 3 V R B P A C meeti n g , 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. 3 T he i nitial st u d y desi g n t heref ore i ncl u de d t he fle xi bilit y t o 
i n de pe nde ntl y e val uate b ot h tri vale nt a n d q ua dri vale nt i nfl ue nza vacci nes w he n c o m bi ne d 
wit h B N T 1 6 2 b 2.
Wit h pr ot oc ol a me n d me nt 2, t he st u d y  desi g n has bee n u p date d base d o n 2 ke y  
de vel o p me nts. First, t he o n g oi n g s ur veilla nce of i nfl ue nza strai ns ca usi n g disease b ur de n has 
f urt her s oli difie d g ui da nce fr o m b ot h t he W H O a n d V R B P A C t hat i nfl ue nza vacci nes s h o ul d 
bec o me tri vale nt f or m ulati o ns rat her t ha n q ua dri vale nt f or m ulati o ns, effecti ve wit h t he 
2 0 2 4/ 5 n ort her n h e mis p here i nfl ue nza seas o n. 4 ,5
 
 
S ec o n d, t he st u d y desi g n has 
bee n a da pte d t o i ncl u de t he e val uati o n of t he i m m u n o ge nicit y res p o nses of 
/ B N T 1 6 2 b 2 
as c o m pare d t o t he i m m u n o ge nicit y  res p o nses elicite d b y sta n dal o ne B N T 1 6 2 b 2, QI V , a n d 
 C o h ort 3 will be e nr olle d a n d ra n d o mize d t o c o m pare t he c o m bi nati o n vacci ne vers us 
t hese sta n dal o ne vacci nes t o deter mi n e w het her t he c o m bi nati o n vacci ne s h o ws a n y 
mea ni n gf ul i nterfere nce i n i m m u ne res p o nses.  
C 5 2 6 1 0 0 1 wa s a st u d y e val uati n g m o d R N A e nc o di n g i nfl ue nza H A as a q ua dri vale nt 
vacci ne , qI R V , or a tri vale nt vacci ne , tIR V, i n c o m bi nati o n wit h B N T 1 6 2 b 2 wit h t otal 
m o d R N A vacci ne d ose le vels of u p t o 9 0 µ g. T he data de m o nstrate d t hat t hese c o m bi nati o n 
vacci ne ca n di dates ha ve pri maril y mil d or m o derate react o ge nicit y , c o nsiste nt wit h t he safety 
pr ofiles fr o m cli nical trials wit h B N T 1 6 2 b 2 a n d qI R V al o ne, a n d n o a d diti o nal safety 
c o ncer ns ha ve bee n i de ntifie d. T hese vacci nes elicite d i m m u ne res p o nses t o all 
vacci ne -e nc o de d a nti ge ns f or b ot h i nfl ue nza a n d S A R S -C o V - 2.
C 5 2 6 1 0 0 1 S u bst u d y  B is a P hase 1/ 2 s u bst u d y wit h safety a n d i m m u n o ge nicit y  data bei n g 
c ollecte d f or qI R V/ B N T 1 6 2 b 2 c o m bi nati o ns of u p t o 9 0 µ g t otal m o d R N A, as well as a 
tIR V/ B N T 1 6 2 b 2 c o m bi nati o n of 7 5 µ g t otal m o d R N A . T he data gat here d t o date 
de m o nstrate t hat u p t o a t otal m o d R N A d ose of 9 0 µ g f or t he c o m bi nati o n vacc i ne ca n di dates 
is 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 a n d S A R S -C o V -2 vacci ne 
a nti ge ns i n partici pa nts 1 8 years of a ge a n d ol der. T h ese data s u p p ort pr o gressi o n t o P hase 3 
cli nical de vel o p me nt of selecte d c o m bi nati o n vacci ne ca n di dates,
/B N T 1 6 2 b 2 a n d/or 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 7 ( G M T)
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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 2
B N T 1 6 2 b 2 , u p t o 
 µ g t otal m o d R N A d ose f or a d ults 1 8 t hr o u g h 6 4 years of a ge
(refer t o Secti o n 6. 1 ).
T he P hase 3 st u d y will e val uate t he safety, t olera bilit y , a n d i m m u n o ge nicit y of selecte d 
m o d R N A vacci ne ca n di dates 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 
( O mi X B B. 1. 5) c o m pare d t o a lice nse d i nacti vate d QI V a d mi nistere d i n t he delt oi d o p p osite 
t o t hat use d f or a d mi nistrati o n of B N T 1 6 2 b 2 ( O mi X B B. 1. 5) i n healt h y  a d ults 1 8 t hr o u g h 
6 4 ye ars of a ge i n C o h ort 1 a n d C o h ort 2. A d diti o nall y , t he st u d y will e val uate t he 
/ B N T 1 6 2 b 2 c o m bi nati o n vacci ne ca n di date i n c o m paris o n t o sta n dal o ne a d mi nistrati o n 
of
, B N T 1 6 2 b 2 ( O mi X B B. 1. 5), a n d QI V i n C o h ort 3 .
T he selecte d m o d R N A vacci ne d ose le vel s a n d strai n s f or t he c o m bi nati o n vacci nes t o be 
use d i n t his st u d y  are base d o n P hase 1/ 2 safet y  a n d i m m u n o ge nicity data (refer t o 
Secti o n 1 0. 1 1 ). For t he c o m bi nati o n vacci ne ca n di dates, a t otal m o d R N A d ose of 
 µ g i n a 
c o m bi nati o n of  
a n d B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d a t otal m o d R N A d ose of 
µ g i n 
a c o m bi nati o n of
 a n d B N T 1 6 2b 2 ( O mi X B B. 1. 5) will be use d i n t his st u d y (refer t o
Secti o n 6. 1 ).
Mo d R N A i n vesti gati o nal vacci nes at d ose s of  
 a n d 3 0 µ g 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) , as well as QI V, will be use d as c o m parat or vacci nes i n t he 
e nr oll me nt of C o h ort 3 .
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, 
d e 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. 6 ,7 T heref ore, vacci 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 f or 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 orize 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 ne wl y e mer gi n g varia nts .
B N T 1 6 2 b 2 ( C o mir nat y ® ) is a n m R N A-bas e d vacci ne t hat, as of Ja n uar y 2 0 2 3, has bee n 
a p pr o ve d i n 1 4 9 c o u ntries f or t he pre ve nti o n of C O VI D - 1 9 ca use d by S A R S -C o V - 2.8 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 2.9
Wit h hi g h bac k gr o u n d rates of p o p ulati o n ser o p ositi vit y , bi vale nt (o ri gi nal/ O mi B A. 4/ B A. 5) 
m R N A vacci nes c o nti n ue d t o pr o vi de effecti ve pr otecti o n a gai nst O micr o n -relate d 
C O VI D - 1 9,1 0 ,1 1 ,1 2 ,1 3 ,1 4 ,1 5 i ncl u di n g d uri n g peri o ds of early X B B s u bli nea ge d o mi na nce. 1 1
A d diti o nal bi vale nt ( o ri gi nal/ O mi B A. 4/ B A. 5) m R N A d oses ha ve bee n re p orte d t o ha ve 
hi g her V E a gai nst O micr o n t ha n t he ori gi nal vacci ne ,1 6 su p p orti n g t he hy p ot hesis t hat better 
strai n-matc he d vacci nes i m pr o ve pr otecti o n a gai nst C O VI D- 1 9. H o we ver , as of Ma y 2 0 2 3, 
t he desce n de nt s u bli nea ges of O micr o n X B B (e g, X B B. 1. 5, X B B. 1. 1 6, X B B.1. 9, X B B. 2. 3) 
ha ve s h o w n i m pr o ve d tra ns missi bilit y  a n d re d uce d s usce pti bilit y t o ne utralizati o n b y t he 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 3
c urre ntl y a vaila ble C O VI D -1 9 vacci nes ( bi vale nt ori gi nal / O mi B A. 4/B A. 5) c o m pare d t o 
earlier O micr o n strai ns (e g, B A. 1, B A. 4, B A. 5). 1 0 ,1 7 M ulti ple re p orts ha ve s u g geste d 
p ote ntial wa ni n g V E of bi vale nt B A. 4/ B A. 5 m R N A vacci nati o n a gai nst se vere ill ness, as 
well as less se vere e n d p oi nts (ie, ur ge nt/e me r ge nc y care), r o u g hly 2 t o 6 m o nt hs f oll o wi n g 
vacci nati o n. 1 5 ,1 8 ,1 9 T hese data s u g gest t hat c o nti n ual vir us e v ol uti o n t o war d i m pr o ve d viral 
fit ness, i m m u ne esca pe, a n d tra ns missi o n is i m pacti n g V E o ver ti me.2 0
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 nally i n gl o bal pa n de mics. 2 1 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, 2 2 alt h o u g h it ma y ofte n be 
as ym pt o matic. 2 3 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,2 4 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. 2 5
I nfl ue nza vir uses are part of t he Ort h o my x o viri dae fa mil y  a n d are di vi de d i nt o 4 ge nera 
( 3 of w hic h are k n o w n t o i nfect h u ma ns [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. Infl ue nza A vir uses are f urt her classifie 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. 2 6 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 t ype. 2 6 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 As a n d N As, 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. 2 4 T his ge netic i nsta bilit y  is w hat 
necessitates vacci nes t hat are tail ore d a n n uall y. 2 4
T here is a rec o m me n dati o n i n t he U S f or r o uti ne a n n ual i nfl ue nza vacci nati o n f or all pers o ns 
a ge d ≥6 m o nt hs w h o d o n ot ha ve c o ntrai n dicati o ns. 2 7 Si nce 2 0 1 2 , t he maj orit y of lice nse d 
i nfl ue nza vacci nati o ns i n t he U S ha ve c o ntai ne d 4 i nfl ue nza strai ns2 8; h o we ver,
W H O met i n 
Fe br uar y 2 0 2 3 1 t o re vie w t his, as B/ Ya ma gata strai ns ha ve n ot bee n i n circ ulati o n si nce 
Marc h
2 0 2 0. 2 Base d o n t he 0 5 Oct 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.3 T he st u d y  desi g n t heref ore i ncl u des t he fle xi bilit y t o e val uate b ot h tri vale nt 
a n d q ua dri vale nt i nfl ue nza vacci nes w he n c o m bi ne d wit h B N T 1 6 2 b 2 i n de pe n de ntl y .
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) was a 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 bilit y, i m m u n o ge nicit y, a n d efficac y data fr o m a n R N A - base d vacci ne 
ca n di date. 2 9 T he trial was 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 w h o are healt h y , 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 4
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-ske 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 d e nce of S A R S -C o V -2 i nfecti o n pri or t o 7 da y s after c o m 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. 3 0 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 nal y sis.
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 safety pr ofile. A vaila ble safet y data fr o m all partici 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 oll o 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. 2 9
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:
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 9.3 1
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 5
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. 3 2 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 orize 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 NT 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 fr 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 ofile of B N T 1 6 2 b 2 a n d pre vi o usl y re p orte d safety 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 ype B N T 1 6 2 b 2 vacci ne. I n t he ol der a ge gr o u p ( >5 5 y ears of a ge) 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 nic it 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 nicit y  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 nalys is of i m m u n o ge nicit y 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 years 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 ha nce 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 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 calle 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. 3 3
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). C 4 5 9 1 0 4 4 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 safety, t olera bilit y,
a n d i m m u n o ge nicit y of bi vale nt varia nt vacci nes at t he sta n dar d or hi g her d ose le vel. 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 nt s 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 years 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
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 6
gr o u p s, 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 after 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. NI 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, NI 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 e d 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.
Data o n S A R S -C o V - 2 e v ol uti o n i n dicate d t hat X B B s u bli nea ges acc o u nte d f or m ore t ha n 
9 5 % of t he circ ulati n g vir us varia nts i n t he U S as of late J u ne 2 0 2 3. 1 7 B y  se veral meas ures, 
i ncl u di n g esca pe fr o m a nti b o d y ne utralizati o n a n d wa nin g pr otecti o n, t he c urre ntl y a vaila ble 
bi vale nt C O VI D -1 9 ( ori gi nal pl us O micr o n B A. 4/ B A. 5) vacci nes a p pear less effecti ve 
a gai nst c urre ntl y circ ulati n g varia nts (e g, X B B-li nea ge vir uses, i ncl u di n g X B B. 1. 5) t ha n 
a gai nst pre vi o us strai ns of t he vir us. 1 1 ,1 2 T he t otalit y of a vaila ble e vi de nce s u p p orte d t hat a 
m o n o vale nt X B B-li nea ge vacci ne was warra nte d f or t he 2 0 2 3 -2 0 2 4 u p date. 9
T he E M A release d g ui da nce o n 0 6 J u ne 2 0 2 3 rec o m me n di n g t hat a m o n o vale nt vacci ne 
tar geti n g t he X B B. 1 desce n de nt li nea ges be a d mi nistere d be gi n ni n g i n a ut u m n 2 0 2 3.3 4 O n 
1 1 Se pte m ber 2 0 2 3, t he F D A a p pr o ve d a ut h orizati o n of a m o n o vale nt vacci ne tar geti n g t he 
X B B. 1. 5 O micr o n s u b varia nt. 3 5 ,3 6 O n 1 3 Dece m ber 2 0 2 3, t he W H O iss ue d a state me nt o n t he 
a nti ge n c o m p ositi o n of C O VI D -1 9 vacci nes , c o nti n ui n g t o rec o m me n d use of a m o n o vale nt
f or m ulati o n wit h X B B. 1. 5 as t he vacci ne a nti ge n. 1 0
St u d y  C 4 5 9 1 0 5 4 is c urre ntl y e val uati n g 3 0 µ g of m o n o vale nt varia nt -a da pte d B N T 1 6 2 b 2 
( O mi X B B. 1. 5) i n a p pr o xi matel y 7 0 0 partici pa nts ≥1 2 y ears of a ge. It is a P hase 2/ 3 st u d y 
i n vesti gati n g t he safety, t olera bilit y , a n d i m m u n o ge nicit y of B N T 1 6 2 b 2 ( O micr o n X B B. 1. 5) 
at 3 0 µ g i n healt h y partici pa nts ≥1 2 ye ars of a ge , a n d t his d ose le vel will als o be use d i n t his 
st u d y w he n B N T 1 6 2 b 2 ( O mi X B B. 1. 5) is a d mi nistere d al o ne a n d as part of t he 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) c o m bi nati o n vacci ne or t he 
B N T 1 6 2 b 2 
( O mi X B B. 1. 5) c o m bi nati o n vacci ne.
2. 2. 3. 2. I nfl ue nz a
I nfl ue nza m o d R N A vacci nes ha ve bee n e val uate d i n 2 Pfizer -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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 7
C 4 7 8 1 0 0 1 is a P hase 1/ 2 st u d y  c o n d ucte d fr o m first partici pa nt first v isit ( Se pte m ber 2 0 2 1) 
t o last partici pa nt last 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 m o d 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 m o d R N A e nc o di n g 2 i nfl ue nza strai ns i n d oses u p t o 
 µ g t otal 
m o d R N A d ose), q ua dri vale nt m o d 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 t otal m o d 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 
m o d 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.
T he data gat here d 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
t otal m o d R N A d ose) 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 efficac y  a n d i m m u n o genicit y 
t o deter mi ne effecti ve ness, al o n g wit h safety a nal yses 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 vels (
 µ g 
t otal m o d R N A d ose i n a d ults 1 8 t hr o u g h 6 4 y ears of a ge a n d 
 µ g t otal m o d R N A d ose i n 
a d ults ≥6 5 y ears of a ge ).
C 4 7 8 1 0 0 4 is 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 his 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 he mis p heres. T he st u d y 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 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 
9 0 0 0 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. S afet y data fr o m t his st u d y  are c o nti n ui n g t o be re vie we d b y  a n 
i n de pe n de nt data m o nit ori n g c o m mittee.
I n Oct o ber 2 0 2 3, Pfizer discl ose d res ults fr o m its pi v otal P hase 3 st u d y e val uati n g its 
first- ge nerati o n m o d R N A i nfl ue nza vacci ne ca n di date.3 7 B ot h pri mar y  efficac y e n d p oi nts 
were met i n t he 1 8 - thr o u g h 6 4- ye ar -ol d c o h ort , de m o nstrati n g NI t o t he lice nse d c o m parat or. 
B ot h pri mar y  a n d e n d - of-seas o n efficac y a nal yses c o nsi dere d b ot h i nfl ue nza A a n d B cases 
c ollecti vel y, t h o u g h t he maj orit y of cases i n t h e 1 8- thr o u g h 6 4- ye ar-ol d c o h ort a n d t he 
2 0 2 2/ 2 0 2 3 i nfl ue nza seas o n o verall were i nfl ue nza A cases. Sec o n dar y  i m m u n o ge nicit y 
e n d p oi nts were ac h ie ve d o nl y f or A strai ns, b ut n ot f or B strai ns . T he i n vesti gati o nal vacci ne 
t hat met its efficac y o bjecti ves f or a d ults 1 8 thr o u g h 6 4 y ears of a ge i n t his st u d y is 
.3 7
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 i m 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 8
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. 2 1 ,3 8 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 or bi dit y a n d m ortalit y.2 4
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 s i m plif yi 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 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.
C 5 2 6 1 0 0 1 is a n o n g oi n g P hase 1/ 2 st u d y e val uati n g bi vale nt, tri vale nt, a n d q ua dri vale nt 
i nfl ue nza vacci nes i n c o m bi nati o n wit h B N T 1 6 2 b 2.
T his st u d y  e val uate d m o d R N A e nc o di n g i nfl ue nza strai ns a n d B N T 1 6 2 b 2 i n c o m bi nati o n u p 
t o a t otal m o d R N A d ose of 9 0 µ g . T he data gat here d t o date i n t his st u d y de m o nstrate t hat u p 
t o a t otal m o d R N A d ose of 9 0 µ g i n a c o m bi nati o n of eit her q I R V or tIR V wit h B N T 1 6 2 b 2 is 
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 a n d S A R S -C o V -2 i n 
partici pa nts a ge d 1 8 ye ars a n d ol der. I n C 5 2 6 1 0 0 1 S u bst u d y  A, 6 0 partici pa nts 1 8 t hr o u g h 
6 4 ye ars of a ge ha ve recei ve d a qI R V/ B N T 1 6 2 b 2 c o m bi nati o n of 9 0 µ g t otal m o d R N A. 
T hirt y partici pa nts 1 8 t hr o u g h 6 4 y ears of a ge ha ve recei ve d a q I RV/ B N T 1 6 2 b 2 c o m bi nati o n 
of u p t o 6 0 µ g t otal m o d R N A d ose. C 5 2 6 1 0 0 1 S u bst u d y  B is a n o n g oi n g P hase 1/ 2 st u d y  
wit h a d diti o nal safet y a n d i m m u n o ge nicit y data bei n g c ollecte d f or b ot h qI R V a n d tI R V i n 
c o m bi nati o n wit h B N T 1 6 2 b 2 .
Usi n g t hese data s u p p orts pr o gressi o n t o P hase 3 cli nical de vel o p me nt of a selecte d 
c o m bi nati o n of
B N T 1 6 2 b 2 a n d/ or
/ B N T 1 6 2 b 2 f or a d ults 1 8 t hr o u g h 6 4 y ears of 
a ge u p t o 
µ g t otal m o d R N A.
Gi ve n t hat 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 vir us vacci nes i n t he 
2 0 2 3- 2 0 2 4 n ort her n h e mis p here i nfl ue nza seas o n 1 i ncl u des b ot h a q ua dri vale nt a n d a 
tri vale nt vacci ne 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 ,2 the i nitial st u d y desi g n i ncl u des b ot h a qI R V a n d a tIR V i n c o m bi nati o n 
wit h B N T 1 6 2 b 2 pre vi o usl y  teste d i n C 5 2 6 1 0 0 1 P hase 1/ 2 u p t o 
µ g t otal m o d R N A. I n 
Fe br uar y  2 0 2 4, after t he start of e nr oll me nt of t his st u d y, t he W H O rec o m me n de d t hat
i nfl ue nza vacci nes f or 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 be tri vale nt 
f or m ulati o ns wit h o ut a B/ Ya ma gata c o m p o ne nt.4
O n 0 5 Marc h 2 0 2 4 , t he V R B P A C pr o vi de d a rec o m me n dati o n f or tri vale nt i nfl ue nza vacci ne
f or m ulati o ns f or t he U S,5
 
 
. A t hir d c o h ort (C o h ort 3 ) will be a d de d t o e val uate t he c o m bi ne d
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) c o m pare d t o t he lice nse d i nacti vate d QI V
) w he n a d mi nistere d 
al o ne, t he lice nse d C O VI D- 1 9 vacci ne w he n a d mi nistere d al o ne , a n d t o  
w he n 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 3 9
a d mi nistere d al o ne. T his will all o w f or assess me nt of p ote ntial i m m u ne i nterfere nce bet wee n 
t he i n di vi d ual c o m p o ne nts of c o m bi ne d
B N T 1 6 2 b 2 ( O mi X B B. 1. 5).
 
 
 
 
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, a n d t he data fr o m n o ncli nical a n d cli nical trials wit h 
sta n dal o ne a n d
w he n i n c o m bi nati o n wit h B N T 1 6 2 b 2 , 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 pote 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.
Cli 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 n e 
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 .3 9
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 Es of
/ B N T 1 6 2b 2 ( O mi X B B. 1. 5),
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5),
B N T 1 6 2 b 2 ( O mi X B B. 1. 5), a n d
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 D s f or t his st u d y. T he S R S D f or QI V  is t he
 U S PI. Refer t o t he 
St u d y  Inter ve nti o n(s) ta ble i n Secti o n 6. 1 f or a c o m plete descri pti o n of S R S Ds.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 0
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) : Selecte d 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
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,
dia rr hea, m uscle pai n, a n d j oi nt 
pai n) f oll o wi n g vacci nati o n.
Ot her ke y ris ks i de ntifie d f or 
B N T 1 6 2 b 2, a n d t heref ore f or t he 
c o m bi nati o n vacci ne ca n di dates, 
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. 4 0
T hese are c o m m o n a d verse 
reacti o ns see n wit h ot her 
vacci nes ,4 1 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 ost 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 mil 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. 2 9
1- w ee 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 s h o we d 
m o st 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.
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.
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 a n d efficac 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
are 
n o vel vacci nes, t he y are base d o n 
t he sa me platf or m ( m o 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 wee ks a n d 6 
m o nt hs, res pecti vel y , after vacci nati o n.
 
w hile t he A E SIs of 
m y ocar ditis/ pericar ditis will be c ollecte d fr o m vacci nati o n t hr o u g h 6 wee ks after 
vacci nati o n .
All partici pa nts will be o bser ve d f or at least 3 0 mi n utes after vacci nati o n.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 7 ( G M T)
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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 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
St u d y I nter ve nti o n(s) : B N T 1 6 2 b 2 ( O m i XB B. 1. 5)
T his vacci ne has t he sa me 
m o d R N A platf or m a n d L N P 
f or m ulati o n as t he ori gi nal 
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 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, 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. 4 0
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 use d i n t his 
st u d y.
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 w e 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. 2 9
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 
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.
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 wee ks a n d 6 
m o nt hs, res pecti vel y , after vacci nati o n.
 
 w hile t he A E SIs of 
m y ocar ditis/ pericar ditis will be c ollecte d fr o m vacci nati o n t hr o u g h 6 wee ks after 
vacci nati o n .
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 8. 1 0. 6 .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 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
a s h ort ti me 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 nd 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 ur veilla 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 (
L ocal a n d s yste mic reacti o ns t o t he 
vacci ne s 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 worse ne d m uscle 
pai n, a n d ne w or w orse ne d j oi nt 
pai n) f oll o wi n g vacci nati o n.
T hese are c o m m o n a d verse 
reacti ons see n wit h ot her 
vacci nes .4 2
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 wee ks a n d 
6 m o nt hs, res pecti vel y , after vacci nati o n.
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 I nter ve nti o n(s): 
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, m uscle pai n, a n d 
j oi nt pai n) 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 as well as B N T 1 6 2 b 2 
( O mi X B B. 1. 5) use d i n t his 
st u d y.
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, m uscle pai n, a n d 
j oi nt pai n) f oll o wi n g vacci nati o n.  
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 3
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 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 trai ne d pers o n nel will o btai n t he bl o o d dra w .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 4
2. 3. 2. Be nefit Assess me nt
See Secti o n 2. 3 f or o verall st u d y ris ks. Be nefits t o i n di vi d ual partici pa nts e nr olle d i n t his 
st u d y m a 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 at n o 
c ost t o t h e partici pa nts .

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 s.

C o ntri b uti n g t o researc h t o hel p ot hers .
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 Ar m A , Ar m C, Ar m E , 
Ar m G, a n d Ar m H 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 5
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
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y :
Pri m ar 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 healt hy
partici pa nts 1 8 t hr o u gh 6 4 years 
of a ge

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 delt oi d 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
T he perce nta ge of 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 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 delt oi d 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 Es 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
I m m u n o ge nicit y
T o de m o nstrate t hat t he H AI 
i m m u ne res p o nse elicite d b y 
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) is n o ni nferi or t o 
t hat elicite d b y QI V 
a d mi nistere d c o nc o mita ntl y 
wit h B N T 1 6 2 b 2 
( O mi X B B. 1. 5) ( C o h ort 2)

H AI titers (fr o m H AI base d o n 
deri ve d 
vir us) f or t he matc he d seas o nal strai ns ( 
 
) rec o m me n de d b y W H O
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of H AI titers at 4 wee ks after vacci nati o n i n partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 ( O mi X B B. 1 . 5) t o t h ose w h o recei ve d QI V a d mi nistere d 
c o nc o mi ta ntl y wit h B N T 1 6 2 b 2 ( O mi X B B. 1. 5)

T he differe nce i n perce nta ge of partici pa nts wit h ser oc o n versi o na t o t he seas o nal 
strai n
) at 4 wee ks after vacci nati o n bet wee n partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d t h ose w h o recei ve d QI V a d mi nistere d 
c o nc o mita ntl y wit h B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
T o de m o nstrate t hat t he S A R S -
C o V - 2 i m m u ne res p o nse 
elicite d b y 
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) is n o ni nferi or t o 
t hat elicite d b y B N T 1 6 2 b 2 
( O mi X B B. 1. 5) a d mi nistere d 
c o nc o mita ntl y wit h QI V
( C o h ort 2)

S A R S -C o V -2 O micr o n ( X B B. 1. 5) –
ne utralizi n g titers
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of S A R S -C o V - 2 –ne utralizi n g titers at 4 wee ks after vacci nati o n i n 
partici pa nts w h o recei ve d
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) c o m pare d t o 
partici pa nts w h o recei ve d B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d c o nc o mita ntl y 
wit h QI V

T he differe nce i n perce nta ges of partici pa nts wit h ser ores p o nse b t o t he
S A R S -C o V -2 O micr o n ( X B B. 1. 5) strai n at 4 wee ks after vacci nati o n c o m pare d t o
partici pa nts w h o recei ve d  
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d t o t h ose w h o 
recei ve d B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d c o nc o mita ntl y wit h QI V
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 6
O bjecti ves
E n d p oi nts
Esti m a n ds
S ec o n d ar y:
Sec o n d ar y:
Sec o n d ar y:
I m m u n o ge nicit y
T o de m o nstrate t hat t he H AI 
i m m u ne res p o nse elicite d b y 
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) is n o ni nferi or t o 
t hat elicite d b y QI V al o ne
( C o h ort 3)

H AI titers (fr o m H AI base d o n 
deri ve d 
vir us) f or t he matc he d seas o nal strai ns 
 rec o m me n de d b y W H O
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of H AI titers at 4 wee ks after vacci nati o n i n partici pa nts w h o recei ve d
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d QI V al o ne
T o de m o nstrate t hat t he 
S A R S -C o V - 2 i m m u ne res p o nse 
elicite d b y
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) is n o ni nferi or t o 
t hat elicite d b y B N T 1 6 2 b 2 
( O mi X B B. 1. 5) al o ne
( C o h ort 3)

S A R S -C o V -2 O micr o n ( X B B. 1. 5)–
ne utralizi n g titers
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of S A R S -C o V - 2 –ne utralizi n g titers at 4 wee ks after vacci nati o n i n
partic i pa nts w h o recei ve d
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ved 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) al o ne
T o de m o nstrate t hat t he H AI 
i m m u ne res p o nse elicite d b y 
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) is n o ni nferi or t o 
t hat elicite d b y
al o ne
( C o h ort 3)

H AI titers (fr o m H AI base d o n
deri ve d 
vir us) f or t he matc he d seas o nal strai ns 
 rec o m me n de d b y W H O
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of H AI titers at 4 wee ks after vacci nati o n i n partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d
al o ne
T o de m o nstrate t hat t he H AI 
i m m u ne res p o nse elicite d b y 
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) is s u peri or t o 
t hat elicite d b y QI V 
a d mi nistere d c o nc o mita ntl y 
wit h B N T 1 6 2 b 2 
( O mi X B B. 1. 5) ( C o h ort 2)

H AI titers (fr o m H AI base d o n 
deri ve d 
vir us) f or t he matc he d seas o nal strai ns 
( 
) rec o m me n de d b y W H O
I n e val ua ble i m m u n o ge nicit y partici pa nts:

G M R of H AI titers at 4 wee ks after vacci nati o n i n partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d QI V a d mi nistere d 
c o nc o mita ntl y wit h B N T 1 6 2 b 2 ( O mi X B B. 1. 5)

T he differe nce i n perce nta ge of partici pa nts wit h ser oc o n versi o n a t o t he seas o nal 
strai n  
) at 4 wee ks after vacci nati o n bet wee n partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 ( O m i X B B. 1. 5) a n d t h ose w h o recei ve d QI V a d mi nistere d 
c o nc o mita ntl y wit h B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
E x pl or at or y :
E x pl or at or y :
E x pl or at or y :
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 7
O bjecti ves
E n d p oi nts
Esti m a n ds
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 8
O bjecti ves
E n d p oi nts
Esti m a n ds
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 p ost vacci nati o n 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 a mi ni m u m 4 -f ol d rise at t he p ost vacci nati o n 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 p ost vacci nati o n ≥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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 4 9
4. S T U D Y D E SI G N
4. 1. Desi g n
T his is a P hase 3 o bser ver- bli n de d st u d y t o e val uate t he safety, t olera bilit y , a n d 
i m m u n o ge nicity of selecte d
w he n a d mi nistere d i n c o m bi nati o n wit h 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) c o m pare d t o a lice nse d i nacti vate d QI V a d mi nistere d i n t he 
delt oi d o p p osite t o t hat use d f or a d mi nistrati o n of B N T 1 6 2 b 2 ( O mi X B B. 1. 5) i n healt h y  
a d ults 1 8 t hr o u g h 6 4 ye ars of a ge. A d diti o nall y, t he st u d y will e val uate
a d mi nistere d i n 
c o m bi nati o n wit h B N T 1 6 2 b 2 ( O mi X B B. 1. 5) i n c o m paris o n t o sta n dal o ne a d mi nistrati o n of 
QI V, 
, or B N T 1 6 2 b 2 ( O mi X B B. 1. 5). T he vacci ne ca n di dates are di vi de d i nt o c o h orts, 
w hic h will be st u d ie d i n a sta g gere d ma n ner, as re q uire d b y  t he cli nical pla n. T his st u d y  will 
be o bser ver - bli n de d (s po ns or - bli n de d), w here u p t o a p pr o xi matel y 8 5 5 0 t otal partici pa nts 
1 8 t hr o u g h 6 4 ye ars of a ge will be e nr olle d i nt o 1 of 3 c o h orts :
C o h ort 1 : A p pr o xi matel y  4 5 0 partici pa nts e nr olle d a n d ra n d o mize d i n a 2: 1 rati o b y  
site-base d ra n d o mizati o n t o 1 of t he f oll o wi n g:

Ar m A:
/ B N T 1 6 2 b 2 (O mi X B B. 1. 5 ) a d mi nistere d i n t he ri g ht delt oi d a n d 
place b o a d mi nistere d i n t he left delt oi d, c o nc urre ntl y.

Ar m B: 3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d a n d lice nse d 
QI V 
) a d mi nistered i n t he left delt oi d, c o nc urre ntl y.
E nr oll me nt of C o h ort 1 will be pa use d i n t he I R T after t he ra n d o mizati o n of a p pr o xi matel y 
4 5 0 partici pa nts i nt o C o h ort 1. Safet y data (i ncl u di n g e-diar y react o ge nicity data , S A Es, A Es, 
a n d A E SIs) of a p pr o xi matel y 4 5 0 vacci nate d partici pa nts will be e val uate d b y t he E D M C 
after 6 0 da ys 
 
 
C o h ort 2 : A p pr o xi matel y  4 5 0 0 partici pa nts e nr olle d a n d ra n d o mize d i n a 2: 1 rati o b y  
site-base d ra n d o mizati o n t o 1 of t he f oll o wi n g:

Ar m C:
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d a n d 
place b o a d mi nistere d i n t he left delt oi d, c o nc urre ntl y.

Ar m D: 3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d a n d lice nse d 
QI V ( 
) a d mi nistere d i n t he left delt oi d, c o nc urre ntl y.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 0
C o h ort 3: A p pr o xi matel y  3 6 0 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 a n d 
ra n d o mize d i n a 2: 2: 1: 1 rati o b y  site-base d ra n d o mizati o n t o 1 of t he f oll o wi n g:

Ar m E:
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d.

Ar m F: 3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d i n t he ri g ht delt oi d .

Ar m G: lice nse d QI V ( 
) a d mi nistere d i n t he ri g ht delt oi d.

Ar m H:
 a d mi nistere d i n t he ri g ht delt oi d.
See Secti o n 6. 1. 1 f or a d diti o nal detail s o n st u d y i nter ve nti o n a d mi nistrati o n i n all c o h orts .
T he
 d ose le vels t o be use d i n c o m bi nati o n wit h B N T 1 6 2 b 2 ( O mi X B B. 1. 5) 
t his st u d y are base d o n P hase 1/ 2 safet y a n d i m m u n o ge nicit y data a n d are detaile d i n
Secti o n 6. 1 . 
 
.
P res pecifie d l ocal reacti o n a n d s yste mic e ve nt data will be c ollecte d i n a n e-diar y  d uri n g t he 
7 da y s, or l o n ger f or o n g oi n g s y m pt o ms , after st u d y i nter ve nti o n (ie, fr o m Da y 1, t he da y of 
vacci nati o n, u ntil s y m pt o m res ol uti o n), as well as a n y  me dicati o n ta ke n d uri n g t his peri o d t o 
treat a ny of t hese s y m pt o ms . Bl o o d sa m ples of a p pr o xi matel y 2 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 a n d at 4 wee ks a n d 6 m o nt hs after 
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 Visit 2, 
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 Visit 3. I n a d diti o n, A Es 
occ urri n g u p t o 4 8 h o urs after bl o o d dra ws t hat are relate d t o st u d y pr oce d ures will als o be 
c ollecte d. For t he c ollecti o n of A E SIs, refer t o Secti o n 8. 4. 8 f or f urt her details . T his st u d y  
will use a n E D M C ; refer t o Secti o n 1 0. 1. 5. 1 f or f urt her details.
4. 2. Scie ntific R ati o n ale f or St u d y Desi g n
T he o verall scie ntific rati o nale f or t he st u d y desi g n is prese nte d i n Secti o n 2. 1 .
4. 2. 1. Di versit y of St u d y P o p ul ati 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 nts 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. T he di versit y 
strate g y f or t his st u d y will i ncl u de t he f oll o wi n g:

Selecti n g sites t hat ha ve access t o di verse partici pa nts wit hi n t heir l ocales.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 1

E d ucati n g sites a b o ut t he i m p orta nce of i ncreasi n g di versit y  i n cli nical trials a n d Pfizer’s 
c o m mit me nt t o di versit y a n d i ncl usi o n.

Use of real -w orl d data t o tar get o utreac h a n d p ote ntial referri n g p h y sicia ns.
C o nti n ual m o nit ori n g of di verse e nr oll me nt t o i de ntif y  a d diti o nal o p p ort u nities t o i ncl u de 
di verse p o p ulati o ns.
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 hl y  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. 4 ).
4. 3. J ustific ati o n f or D ose
4. 3. 1. M o n o v ale nt B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
T he 3 0 - μ g d ose le vel of B N T 1 6 2 b 2 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 b ot h t he ori gi nal a n d bi vale nt f or m ulati o ns.
4. 3. 2. 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
Base d o n t he safet y  data i n St u d y C 5 2 6 1 0 0 1 S u bst u d y A f or partici pa nts e x p ose d t o u p t o 
9 0 µ g t otal m o d R N A d ose, all c o m bi nati o ns of qI R V/ B N T 1 6 2 b 2 are well t olerate d, wit h 
mai nl y  mil d t o m o derate l ocal reacti o ns a n d sys te mic e ve nts, co nsiste nt wit h t he safet y data 
f or B N T 1 6 2 b 2 a n d qI R V a d mi nistere d al o ne. Base d o n C 5 2 6 1 0 0 1 i m m u n o ge nicit y data fr o m 
b ot h S u bst u d y  A a n d S u bst u d y B, u p t o 9 0 µ g t otal m o d R N A d oses pr o d uce d a n i m m u ne 
res p o nse, a n d d ose le vels of t he c o m bi nati o n
B N T 1 6 2 b 2 a n d t he c o m bi nati o n 
/ B N T 1 6 2 b 2 were selecte d t o be e val uate d i n t his st u d y. Refer t o Secti o n 6. 1 a n d 
t he IP M f or f urt her details.
I n C 4 7 8 1 0 0 4, the 
 µ g q I RV 
 met its st u d y 
o bjecti ves f or t he de m o nstrati o n of efficac y  i n t he pre ve nti o n of la b orat or y-c o nfir me d 
i nfl ue nza.3 7
 
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 t he st u d y.
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 t he y ha ve c o m plete d t he last visit
of t he st u d y .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 2
5. S T U D Y P O P U L A TI O N
T his secti o n is a p plica ble t o all co h orts .
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 p artici 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.
5. 1. I ncl usi o n Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n t h is st u d y o nl y if all of t he f oll o wi n g criteria a p ply:
A ge a n d Se x :
1.
P artici 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 V isit 1.

Refer t o A p pe n di x 4 f or re pr o d ucti ve criteria f or male ( Secti o n 1 0. 4. 1 ) a n d fe male 
(Secti o n 1 0. 4. 2 ) partici pa nts.
Dise ase C h ar acteristics:
N o 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, lifestyl e 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 cli nicall y 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 o te: Healt hy 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 
Secti o n 1 0. 1 0.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 3
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. 2. E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m t he st u d y  if a n y of t he f oll o wi n g criteria a p pl y:
Me dic al C o n diti o ns:
1.
A n y  me dical or ps yc hi atric c o n diti o n , i ncl u di n g rece nt ( wit hi n t he past ye ar) 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 the 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 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 .
Pri or/ C o nc o mit a nt T her a p y:
7.
Recei pt of s yste 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, e g, f or ca ncer or a n 
a ut oi m m u ne disease), or ra di ot hera py, wit hi n 6 0 da ys bef ore e nr oll me nt or pla n ne d 
recei pt t hr o u g h c o ncl usi o n of t he st u d y.
N ote: A p plies t o l o n g-ter m, hi g h -d ose s yste mic c ortic oster oi ds a d mi nistere d at a d ose 
of ≥2 0 m g/ da y  of pre d nis o ne   ore q ui vale nt f or ≥1 4   da ys. L o w- d ose sys te mic 
c ortic oster oi ds a d mi nistere d at a d ose of < 2 0 m g/ da y  of pre d nis o ne or e q ui vale nt are 
per mitte d. 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 y es) 
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 u li 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 ys 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 .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 4
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 da ys) 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.
1 0. Vacci nati o n wit h a n y  i n vesti gati o nal or lice nse d C O VI D - 1 9 vacci ne wit hi n 6 m o nt hs 
( 1 7 5 da ys) bef ore st u dy 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 1. 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 b y 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 o a p plica ble.
Ot her E xcl usi o n Criteri a :
1 2. 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 by 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.
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 Secti o n 1 0. 4. 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 dicate d i n t he S o A , 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 effecti 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. Partici pa nts nee d 
t o affir m t heir c o nsiste nt an 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 no l o n ger use a bsti ne nce 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 5
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. 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
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 1 
will n ot be ra n d o mize d 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 osi ti ve i nfl ue nza or 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 ys.
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.
3.
Recei pt of a n y n o nst u d y  vacci ne wit hi n 2 8 da ys 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 ys 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, hi g h-d ose s y ste mic c ortic oster oi ds (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). 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.
N ote: L o w -d ose s ys te mic c ortic oster oi ds (a d mi nistere d at a d ose of 2 0 m g/ da y  of 
pre d nis o ne or e q ui vale nt) are per mitte d. 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 y es) c ortic oster oi ds are per mitte d.
5. 5. 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 f r 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 E s.
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 ure) ma y be 
rescree ne d u n der a differe nt partici pa nt n u m ber, o nce eli gi bilit y  criteria are met .
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 nten 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 i n vesti gati o nal pr o d uct.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 6
6. 1. St u d y I nter ve nti o n(s) A d mi nistere d
C o h ort 1

Ar m A:
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d n or mal sali ne p lace b o

Ar m B: QI V ( 
) a n d 3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
C o h ort 2

Ar m C:
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a n d n or mal sali ne p lace b o

Ar m D: QI V 
) a n d 3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
C o h ort 3

Ar m E:
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5)

Ar m F: 3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5)

Ar m G: QI V (
)

Ar m H:
St u d y I nter ve nti o n(s)
I nter ve nti o n 
N a me
/ B N T 1 6 2 b
2
( O mi X B B. 1. 5)
B N T 1 6 2 b
2
( O mi X B B. 1. 5)
QI V 
B N T 1 6 2 b 2
( O mi X B B. 1. 5)
N or mal sali ne 
place b o
T y pe
m R N A vacci ne
m R N A vacci ne
Vacci ne  
Vacci ne
m R N A vacci ne
Place b o
Use
E x peri me ntal 
E x peri me ntal
C o m parat or
E x peri me ntal
(all c o h orts)
C o m parat or 
(C o h ort 3 o nl y)
C o m parat or
Place b o
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
D ose 
F or m ul ati o n
m o d R N A  
m o d R N A
S us pe nsi o n f or 
i njecti o n
m o d R N A  
m o d R N A
N or mal sali ne
( 0. 9 % s o di u m 
c hl ori de s ol uti o n 
f or i njecti o n)
U nit D ose 
Stre n gt h(s)
 µ g
µ g
6 0 µ g H A per 
0. 5 -m L d ose
µ g
3 0 µ g
N/ A
D os a ge 
Le vel(s)
 
 
 
 µ g 
B N T 1 6 2 b 2 
( O mi X B B. 1. 5)
6 0 µ g
3 0 µ g B N T 1 6 2 b 2 
( O mi X B B. 1. 5)
N/ A
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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

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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 7
St u d y I nter ve nti o n(s)
 µ g 
B N T 1 6 2 b 2 
( O mi X B B. 1. 5)
T ar gete d 
I nfl ue nz a 
Str ai ns
As rec o m me n de d b y W H O f or cell c ult ure – or rec o m bi na nt -base d 
vacci nes ( 2 0 2 3 -2 0 2 4 n ort her n he mis p here i nfl ue nza seas o n) a
N/ A
N/ A
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
S o urci n g
Pr o vi de d 
ce ntrall y b y t he 
s p o ns or
Pr o vi de d 
ce ntrall y b y t he 
s p o ns or
Pr o vi de d ce ntrall y 
b y t he s p o ns or
Pr o vi de d 
ce ntrall y b y t he 
s p o ns or
Pr o vi de d ce ntrall y 
b y t he s p o ns or
Pr o vi de d 
ce ntrall y b y t he 
s p o ns or
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 b e 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. 
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.
a.
F or 
 
.1
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 m ust n ot be i njecte d i nt o bl o o d 
vessels. A p pr o priate 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 m ust 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 will be perf or me d b y  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.
Partici pa nts will recei ve 2 i njecti o ns at Vi sit 1 i n C o h ort 1 a n d C o h ort 2 a n d will recei ve
1 i njecti o n at Visit 1 i n C o h ort 3 as ra n d o mize d i n acc or da nce wit h t he S o A . 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 ularl y i nt o t he delt oi d m uscle of t he 
a p pr o priate ar m as detaile d i n Ta ble 1 a n d Ta ble 2 . St u d y  i nter ve nti o n will be a d mi nistere d 
o nl y  b y a n u n bli n de d a d mi nistrat or.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 8
T a ble 1.
St u d y I nter ve nti o n Sc he d ule : C o h ort 1 a n d C o h ort 2
C o h ort
St u d y Ar m
Ri g ht Delt oi d a
Left Delt oi d
1
A
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
Place b o
B
3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
6 0 µ g QI V ( 
)
2
C
B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
Place b o
D
3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5) 
6 0 µ g QI V
)
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 delt oi d.
T a ble 2 .
St u d y I nter ve nti o n Sc he d ule: C o h ort 3
C o h ort
St u d y Ar m
Ri g ht Delt oi d a
3
E
B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
F
3 0 µ g B N T 1 6 2 b 2 ( O mi X B B. 1. 5)
G
6 0 µ g QI V ( 
)
H
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 delt oi d.
6. 1. 2. Me dic al De vices 
QI V ( 
) a n d n or mal sali ne place b o m a y  be pr o vi de d as a P F S, i n w hic h case t he P F S 
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) 
f or t he a b o ve-liste d me dical de vices 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 cli nical i n vesti gati o n (see Secti o n 8. 4. 9 ) 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 be e 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 5 9
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.
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 ual 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. D ata f or n o n w or ki n g da ys m ust i n dicate t he 
mi ni m u m a n d ma xi m u m te m perat ures 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.
3.
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 ons 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 mis si 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 I PM.
4.
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.
5.
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.
6.
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 st 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.
7.
F urt h er 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 h at 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 a n d dis pe nse d b y a n u n bli n de d 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, p har macist, or ot her trai ne d staff me m ber ) 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 u n bli n de d staff me m ber will 
verif y  t he dis pe nsi n g.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 0
T he 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 I P 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.
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 st u d y ar ms will pr ocee d t hr o u g h t he use of a n 
I R T sys te m (IW R) . T he u n bli n de d site pers o n nel (st u d y 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 site 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 c orres p o n di n g t o t he assi g ne d st u d y i nter ve nti o n. *
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. C o nfir mati o n re p ort m ust 
be st ore d i n t he site’s files.
* D o n ot ra n d o mize u ntil eli gi bilit y  is c o nfir med a n d t he partici pa nt is prese nt.
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 A .
T he st u d y -s pecific IR T refere nce ma n ual a n d I P M will pr o vi de t he c o ntact i nf or mati o n a n d 
f urt her details o n t he use of t he IR T s y ste m.
E nr oll me nt of C o h ort 1 will be c o ntr olle d i n t he f oll o wi n g fas hi o n: R a n d o mizati o n i n t he IR T 
will be pa use d after e nr oll me nt of a p pr o xi matel y  4 5 0 partici pa nts i nt o C o h ort 1. After t he 
E D M C has re vie we d t he safet y data fr o m t hese partici pa nts a n d a gree d t o c o nti n ue t he st u d y, 
t he IR T will be release d t o all o w t he e nr oll me nt of t he re mai ni n g partici pa nts i nt o C o h ort 1.
T he 
e nr oll me nt of C o h ort 2 a n d C o h ort 3 will n ot i n v ol ve a n e nr oll me nt pa use i n t he I RT.
6. 4. Bli n di n g
T his is a n o bser ver - bli n de d st u d y.
6. 4. 1. Bli n di n g of P artici p a nts
Partici 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.
6. 4. 2. Bli n di n g of Site Pers o n nel
T he 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. All ot her st u d y a n d site pers o n nel, i ncl u di n g t he i n vesti gat or 
a n d i n vesti gat or staff, will be bli n de d t o assi g n me nt of st u d y  i nter ve nti o n. I n partic ular, t he 
i n di vi d uals w h o e val uate partici pa nt safet y will be bli n de d. Beca use t here are differe nces i n 
p h y sical a p peara nce of t he st u d y i nter ve nti o ns, t hese will be a d mi nistere d i n a ma n ner t hat 
pre ve nts t he st u d y partici pa nts fr o m i de ntif yi n g t he st u d y i nter ve nti o n gr o u p base d o n its 
a p peara nce.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 1
T he PI  will assi g n t he res p o nsi bilit y of t he u n bli n de d dis pe nsers/a d mi nistrat ors t o pers o ns 
w h o will n ot partici pate i n t he e val uati o n of a n y st u d y  partici pa nt. T o e ns ure a de q uate 
c o vera ge, at least 2 u n bli n de d dis pe nsers/a d mi nistrat ors will be assi g ne d per site. Me m bers 
of t he st u d y  site staff or cli nic p har mac y s h o ul d f ulfill t hese r oles. C o ntact bet wee n t he 
u n bli n de d dis pe nsers a n d st u d y  partici pa nts s h o ul d be ke pt t o a mi ni m u m. T he i n vesti gat or, 
st u d y c o or di nat or, a n d a n y site staff ot her t ha n t he u n bli n de d dis pe nsers/a d mi nistrat ors m ust 
n ot be all o we d t o k n o w t he st u d y  i nter ve nti o n assi g ne d t o a n y st u d y partici pa nt a n d m ust n ot 
be all o we d t o see t he st u d y  i nter ve nti o n c o ntai ner c o nte nts.
I n t he e ve nt of a Q uality Ass ura nce a u dit, t he a u dit or(s) will be all o we d access t o u n bli n de d 
st u d y i nter ve nti o n rec or ds at t he site(s) t o verif y t hat ra n d o mizati o n/ dis pe nsi n g has bee n d o ne 
acc uratel y.
6. 4. 3. Bli n di n g of t he S p o ns or
T he maj orit y of s p o ns or staff will be bli n de d t o st u d y  i nter ve nti o n all ocati o n d uri n g t he 
e nr oll me nt. All la b orat or y testi n g pers o n nel perf or mi n g ser ol o g y  assa ys will re mai n bli n de d 
t o st u d y i nter ve nti o n assi g ne d/recei ve d t hr o u g h o ut t he st u d y. T he f oll o wi ng s p o ns or/ Pfizer 
staff, w h o will ha ve n o part i n t he bli n de d c o n d uct of t he st u d y, will be u n bli n de d (f urt her 
details will be pr o vi de d i n a data bli n di n g pla n):

T h ose st u d y tea m me m bers w h o are i n v ol ve d i n e ns uri n g t hat pr ot oc ol re q uire me nts f or 
st u d y i nter ve nti o n pre parati o n, ha n dli n g, all ocati o n, a n d a d mi nistrati o n are f ulfille d at t he 
site will be u n bli n de d f or t he d urati o n of t he st u dy (e g, u n bli n de d st u d y ma na ger, 
u n bli n de d cli nical researc h ass ociate).

U n bli n de d cli nicia n(s) w h o are n ot direct me m bers of t he st u d y  tea m a n d will n ot 
partici pate i n a n y ot her st u d y -relate d acti vities will re vie w u n bli n de d pr ot oc ol de viati o ns.

A tea m s u p p orti n g i nteracti o ns wit h, a n d a nal ys es f or, t he E D M C (see Secti o n 1 0. 1. 5. 1 ) 
will be u n bli n de d.

A n u n bli n de d s u b missi o ns tea m ma y be res p o nsi ble f or pre pari n g u n bli n de d a nal ys es a n d 
d oc u me nts t o s u p p ort re g ulat or y  acti vities t hat ma y be re q uire d w hile t he st u d y is 
o n g oi n g. A se parate gr o u p of tea m me m bers will re mai n bli n de d a n d c o nti n ue s u p p orti n g 
t he bli n de d c o n d uct of t he st u d y after s uc h a n a nal ysis.
6. 4. 4. Bre a ki n g t he Bli n d
T he I R T will be pr o gra m me d wit h bli n d -brea ki n g i nstr ucti o ns. I n case of a n e mer ge nc y , t he 
i n vesti gat or has t he s ole res p o nsi bilit y f or deter mi ni n g if u n bli n di n g of a partici pa nt’s st u d y 
i nter ve nti o n assi g n me nt is warra nte d. Partici pa nt safet y m ust al wa ys be t he first 
c o nsi derati o n i n ma ki n g s u c h a deter mi nati o n. If t he i n vesti gat or deci des t hat u n bli n di n g is 
warra nte d, t he i n vesti gat or s h o ul d ma ke e ver y  eff ort t o c o ntact t he st u d y me dical m o nit or 
pri or t o u n bli n di n g a partici pa nt’s st u d y i nter ve nti o n assi g n me nt u nless t his c o ul d dela y  
f urt her ma na ge me nt of t he partici pa nt. If a partici pa nt’s st u d y i nter ve nti o n assi g n me nt is 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 2
u n bli n de d, t he s p o ns or m ust be n otifie d wit hi n 2 4 h o urs after brea ki n g t he bli n d. T he date 
a n d reas o n t hat t he bli n d was br o ke n m ust be rec or de d i n t he s o urce d oc u me ntati o n a n d C R F.
T he st u d y -s pecific IR T refere nce ma n ual a n d I P M will pr o vi de t he c o ntact i nf or mati o n a n d 
f urt her details o n t he use of t he IR T s y ste m.
6. 5. S t 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 rec 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.
2.
Cl osel y m o nit or t he partici pa nt f or a n y A Es/ S A Es a n d la b orat or y  a b n or malities as 
me dicall y  a p pro priate a n d f oll o w u p 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 ).
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
T his secti o n is a p plica ble t o all c o h orts. 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:
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 3

O n g oi n g me dicati o ns if ta ke n, will be rec or de d a n d i ncl u de start date, na me of t he 
me dicati o n, d ose, u nit, r o ute, a n d fre q ue nc y  at Visit 1.

All p ri or recei pt of a ny C O VI D -1 9 vacci ne s.

Date of l ice nse d or i n vesti gati o nal i nfl ue nza vacci ne wit hi n t he 3 y ears 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 Visit 1 u ntil t he last visit ( Visit 3).

Pr o hi bite d me dicati o ns liste d i n Secti o n 6. 9. 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 .

Details of a n y c o nc o mita nt me dicati o n ta ke n t o treat a n y pres pecifie d l ocal or s yste mic 
react o ge nicit y sy m pt o ms re p orte d i n t he e-diar y  will be c ollecte d.
6. 9. 1. Pr o hi bite d D uri n g t he St u d y
T his secti o n is a p plica ble t o b ot h all c o h orts.
U nless c o nsi dere d me dicall y  necessar y, t he f oll owi n g i nter ve nti o ns are pr o hi bite d d uri n g t he 
st u d y, a n d recei pt of t hese i nter ve nti o ns will res ult i n e x cl usi o n fr o m t he rele va nt a nal ys is
( de pe n di n g o n ti mi n g of pr o hi bite d vacci nati o n or me dicati o n use) of i m m u n o ge nicit y data i n 
t he per - pr ot oc ol a nalys is:

Vacci nes ot her t ha n st u d y  i nter ve nti o n a d mi nistere d wit hi n 2 8 da y s bef ore a n d 2 8 d a y s 
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 O VI D - 1 9 vacci ne fr o m e nr oll me nt t hr o u g h o ut t he 
e ntire st u d y.

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 o ut 
t he e ntire st u dy .
N ote: S h o ul d a partici pa nt e x perie nce a c ha n ge i n healt h stat us t hat places t hat partici pa nt at 
i ncrease d ris k of se vere i nfl ue nza or C O VI D-1 9 c o m plicati o ns , a n d t heref ore re q uest t o 
recei ve lice nse d i nfl ue nza a n d/ or C O VI D- 1 9 vacci ne d uri n g st u dy partici pati o n, t he 
f oll o wi n g ste ps sh o ul d be ta ke n . The healt h stat us c ha n ge will be d oc u me nte d as a n A E , t he 
recei pt of t he lice nse d vacci nes will be d oc u me nte d as a c o nc o mita nt vacci ne, t he ori gi nal 
vacci ne assi g n me nt will n ot be u n bli n de d f or t he p ur p oses of decisi o n ma ki n g as t o w hic h 
lice nse d vacci ne(s) t o recei ve, a n d t he partici pa nt will be as ke d t o c o nti n ue all st u d y 
assess me nts t hr o u g h t he fi nal visit wit h t he e xce pti o n of f urt her bl o o d sa m pli n g f or 
i m m u n o ge nicity testi n g. T he recei pt of t he lice nse d i nfl ue nza a n d/ or C O VI D -1 9 vacci ne will 
be rec or de d as a pr ot oc ol de viati o n.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 4

Recei pt of c hr o nic s yste 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 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.
* A p plies t o l o n g-ter m, hi g h -d ose s yste mic c ortic oster oi ds a d mi nistere d at a d ose of 
≥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.

Recei pt of s h ort-ter m, hi g h -d ose c ortic oster oi ds a d mi nistere d at a d ose of ≥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 fr o m 2 8 da ys pri or t o e nr oll me nt t hr o u g h 2 8 d a y s 
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 ociate d wit h 
st u d y i nter ve nti o n a d mi nistrati o n pri or t o 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 m e 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.
6. 9. 2. Per mitte d D uri n g t he St u d y
T his secti o n is a p plica ble t o all c o h orts.

H or m o nal c o ntrace pti ves t hat meet t he re q uire me nts of t his st u d y are all o we d t o be use d 
i n partici pa nts w h o are W O C B P (see A p pe n di x 4 ).

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 6. 9. 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.
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
It ma y be necessar y f or a partici pa nt t o per ma ne ntl y disc o nti n ue st u d y i nter ve nti o n. Reas o ns 
f or per ma ne nt disc o nti n uatio n of st u d y  i nter ve nti o n i ncl u de t he f oll o wi n g: A Es; partici pa nt 
re q uest; i n vesti gat or re q uest; pre g na nc y; pr ot oc ol de viati o n (i ncl u di n g n o l o n ger meeti n g all 
t he i ncl usi o n criteria or meeti n g 1 or m ore e xcl usi o n criteria).
Disc o nti n uati o n of st u d y  i nter venti o n d oes n ot re prese nt wit h dra wal fr o m t he st u d y . If st u dy 
i nter ve nti o n is per ma ne ntl y disc o nti n ue d, t he partici pa nt s h o ul d re mai n i n t he st u d y t o be 
e val uate d f or safet y. See t he S o A f or data t o be c ollecte d at t he ti me of disc o nti n uati o n of 
st u d y i nter ve nti o n a n d f oll o w-u p f or a n y f urt her e val uati o ns t hat nee d t o be c o m plete d.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 5
I n t he e ve nt of disc o nti n uati o n of st u d y i nter ve nti o n, it m ust be d oc u me nte d o n t he 
a p pr o priate C R F/i n t he me dical rec or ds w het her t he partici pa nt is disc o n ti n ui n g f urt her 
recei pt of st u dy i nter ve nti o n or als o fr o m st u d y  pr oce d ures, f urt her st u d y f oll o w-u p, a n d/ or 
f ut ure c ollecti o n of a d diti o nal i nf or mati o n.
7. 2. P artici p a nt Disc o nti n u ati o n / Wit h dr a w al Fr 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 mi nate d b y s p o ns or;

React o ge nicit y e ve nt;

A Es;

Partici pa nt re q uest; 

I n vesti gat or re q uest;

Select pr ot oc ol de viati o ns
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.
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. 1)
f or discl os ure of fut 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 nts w h 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 pecificall y wit h dra ws c o nse nt f or a n y f urt her c o ntact 
wit h t h e 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 nse nt s h o ul d be e x p lai 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
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 6
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 the 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 wi ll 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 he s 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 .
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.
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 A . Pr ot oc ol wai vers or 
e xe m pti o ns are 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 A , is esse ntial 
a n d req 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 
partici 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 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 7
test. In 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 me nt 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.
T he t otal bl o o d sa m pli n g v ol u me f or 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 
6 0 m L , or
 
 T he act ual c ollecti o n ti mes of bl o o d sa m pli n g ma y 
c ha n ge. A d diti o nal bl o o d sa m ples ma y  be ta ke n f or safety assess me nts at ti mes s pecifie d b y 
Pfizer , 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 5 6 c o nsec uti ve da y s.
8. 1. 1. Tele he alt h Visits
A n y  partici pa nts w h o ha ve sc he d ule d bl o o d dra ws disc o nti n ue d * ma y be f oll o we d f or safety 
at Visit 2 ( Wee k 4) a n d Visit 3 ( M o nt h 6) via tele healt h visits. N ote: Visit 1 ( Da y  1) m ust 
re mai n as a n i n-pers o n visit t o t he site .
* F or e xa m ple, bl o o d dra ws disc o nti n ue d beca use t he partici pa nt n o l o n ger meet s t he 
eli gi bilit y criteria.
Ge neral Re q uire me nts:
Tele healt h visits ma y  be use d t o assess partici pa nt safety 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 safet y m o nit ori n g. Assess me nts t hat ma y  be perf or me d 
d uri n g a tele healt h visit are descri be d i n t he S o A .
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.
8. 2. I m m u n o ge nicit y Assess me nts
Sa m ples will be c ollecte d at t he ti me p oi nts s pecifie d i n t he S o A 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:
C o h ort 1

H AI titers (fr o m H AI base d o n
deri ve d vir us) 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 8

S A R S -C o V - 2 ne utralizati o n assa y s (O mi X B B. 1. 5 ).
C o h ort 2

H AI titers (fr o m H AI base d o n 
deri ve d vir us) 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 s ( O mi X B B. 1. 5).
C o h ort 3

H AI titers (fr o m H AI base d o n
deri ve d vir us) 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 s ( O mi X B B. 1. 5).
8. 2. 2. Bi ol o gic al S a m ples
Bl o o d 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 n al yst testi n g t he sa m ples will n ot k n o w t he partici pa nt’s 
i de ntit y, 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 oc ol ma y be st ore d b y  Pfizer. U nless a ti me li mitati o n 
is re q uire d by l ocal re g u lati 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 y ears 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 b y t he 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 d y 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 6 9
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 p les will still be use d f or t his researc h. 
T he bi ol o gical 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 A . 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 ng t he st u d y  t o assess a n y percei ve d safet y 
iss ues.
8. 3. 1. P h ysic al E x a mi n ati o ns
I n t his st u dy, a p h ys ical e xa mi nati o n ma y be perf or me d pri or t o vacci nati o n, if cli nicall y 
i n dicate d.
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 rec or d 
a n d will n ot be re q uire d t o be re p orte d, u nless ot her wise n ote d. A n y u nt o war d p h ys ical 
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 t he 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 t his st u d y , t he partici pa nt’s oral te m perat ure will be meas ure d pri or t o vacci nati o n. 
A d diti o nall y , wei g ht a n d hei g ht will be meas ure d pri or t o vacci nati o n.
Vital si g 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 rec or d a n d will n ot 
be re q uire d t o be re p orte d, u nless ot her wise n ote d .
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. 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 n ot be c ollecte d i n t his st u d y.
8. 3. 4. Electr o nic Di ar y
All partici pa nts will be re q uire d t o c o m plete a react o ge ni cit y e -diar y  after vacci nati o n gi ve n 
at Visit 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, 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 0
s yste mic e ve nts, a n d use of a nti p yretic me dicati o n f or 7 da y s, or l o n ger f or o n g oi n g 
s ym pt o ms , 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 isit 1. T he 
react o ge nicit y e-diar y  all o ws rec or di n g of t hese assess me nts eac h da y, 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. 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 nicit y  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 nalys is a n d re p orti n g. Ge nerall y , t hese data d o n ot nee d t o be 
re p orte d by t he i n vesti gat or i n t he C R F as A Es. H o we ver, if a partici pa nt wit h dra ws beca use 
of e ve nts re p orte d i n t he e- diar y , t he e ve nt(s) s h o ul d be rec or de d o n t he C R F, re gar dless of 
w het her t he i n vesti gat or c o nsi ders t he e ve nt(s) t o be cli nicall y  si g nifica nt. If a partici pa nt 
misse d re p orti n g a n e ve nt i n t he e -diar y  a n d re p orts it t o t he st u d y site i nstea d, t he e ve nt 
s h o ul d als o be rec or de d o n t he 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 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.
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 s ym pt o ms
o n g oi n g o n t he last da y fr o m Da y 7 o n war ds u ntil res ol uti o n. 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. 4. 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 for 
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.4 1
8. 3. 4. 2. L oc al R eacti o ns
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 
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 . L ocal reacti o ns will be assesse d at t he i njecti o n site o n t he ri g ht 
delt oi d o nl y  after vacci nati o ns gi ve n at V isit 1.
N ote: A n y l ocal reacti o n occ urri n g at t he i njecti o n site o n t he left delt oi d will be c ollecte d i n 
t he C R F as a n A E.
If a l ocal reacti o n persists be yo n d t he e n d of t he 7- d a y  e-diar y  c ollecti o n 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 a n d/ or a n y ne w
react o ge nicit y reacti o ns t hat de vel o p t o t he i n vesti gat or or t he st u d y staff. 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.
Partici pa nts will be pr o vi de d wit h a meas 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 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 1
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 3.
M eas 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 3.
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 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 
l ocal reacti o n as Gra de 4. If a partici pa nt e x perie nces a c o nfir me d Gra de 4 l ocal reacti o n, t he 
i n vesti gat or m ust i mme diatel y  n otif y t he s p o ns or.
T a ble 3.
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. 4. 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 s y 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 4 .
If a sys te mic e ve nt persists be yo n d t he e n d of t he 7 -d a y  e-diar y  c ollecti o n 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 a n d/ or a n y  ne w 
react o ge nicit y e ve nts t hat de vel o p t o t he i n vesti gat or or t he st u d y staff. T he i n vesti gat or will 
enter t his a d diti o nal i nf or mati o n i n t he C R F.
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 yste 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. A Gra de 4 s ys te mic e ve nt will be 
c ollecte d o n t he C R F.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 2
T a ble 4.
S yste mic E ve nt Gr a di n g Sc ale
Mi l 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 mer 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 mer 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 me i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E mer 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 me i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E mer 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 me i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E mer ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
c hills
Ne w or w orse ne d 
m uscle p ai n
D oes n ot i nterfere 
wit h acti vit y
S o me i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E mer ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
ne w or w orse ne d m uscle 
pai n
Ne w or w orse ne d 
j oi nt pai n
D oes n ot i nterfere 
wit h acti vit y
S o me i nterfere nce 
wit h acti vit y
Pre ve nts dail y r o uti ne 
acti vit y
E mer ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
ne w or w orse ne d j oi nt pai n
8. 3. 4. 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 dail y  f or 7 da ys or l o n ger 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 nicit y 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 d a y will be rec or de d i n t he 
react o ge nicit y 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 5 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 , t o c o nfir m c o m plia nce wit h t he t her m o meter 
i nstr ucti o ns gi ve n, a n d t o deter mi ne w het her a site visit is cli nicall y  i n dicate d. O nl y a n 
i n vesti gat or or me dically 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 3
Fe vers 4 0. 0° C ( 1 0 4. 0° F) will be c ollecte d o n t he C R F .
T a ble 5.
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. 4. 5. A nti p yretic Me dic ati o n
T he use of a nti p yr etic me dicati o n t o treat s y 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  daily d uri n g t he 7- d a y re p orti n g 
peri o d or l o n ger f or o n g oi n g s y m pt o ms . Me dicati o n use i n dicate d i n t he e -diar y  s h o ul d b e
f oll o we d u p b y  t he site t o tra nscri be details of t he me dicati o n (as per Secti o n 6. 9 ) i nt o t he 
C R F.
8. 3. 5. 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 A , 
i m me diatel y bef ore t he a d mi nistrati o n of eac h d ose of st u d y i nter ve nti o n. A ne gati ve 
pre g na nc y  test res ult will be re q uire d pri or t o recei vi n g t he st u d y i nter ve nti o n. Pre g na n c y  
tests ma y als o be re peate d if re q ueste d by I RBs/ E Cs 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 Es 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 gally 
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 ves ti 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 partici 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 Secti o n 8. 4. 1 , eac h partici pant will be 
q uesti o ne d a b o ut t he occ urre nce of A Es i n a n o nlea di n g ma n ner .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 4
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.
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
T he ti me peri o d f or acti vel y  eliciti n g a n d c ollecti n g A Es 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 2 f or A Es a n d Vi sit 3 f or S A Es.
Please r efer t o Secti o n 8. 4. 8 f or t he ti me peri o d f or re p orti n g A E SIs.
A d diti o nall y :

A n y  A E occ urri n g u p t o 4 8 h o urs after a n y s u bse q ue nt bl o o d dra ws a n d dee me d 
relate d t o st u dy pr oce d ures m ust be rec or de d i n t he C R F.

A n y  l ocal react o ge nicity e ve nt t hat occ ur s i n t he left delt oi d is t o be re p orte d as a n 
A E i 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 hr o u g h a n d 
i ncl u di n g Visit 3 . Deat hs, p ne u m o nia, a n d h os pitalizati o ns will be rec or de d f or t he e ntire 
st u d y d urati o n, as A Es/ S A Es as a p pr o priate.
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 bili ze 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 acti 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 fr o m t he 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 or via P S S A .
I n vesti gat ors are n ot o bli gate d t o acti vely see k i nf or mati o n o n A E s 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 ny ti me after a partici pa nt has c o ncl u de d st u d y partici pati o n , 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 Vacci ne S A E Re p ort F or m or via P S S A .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 5
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 ort e d t o Pfizer Safet y o n t he Vacci ne S A E Re p ort F or m / P S S A
i m me diatel y up o n a ware ness a n d u n der  n o circ u mst a 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 the 
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 of 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 ves ti 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 ).
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 uf ficie 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 o ssi 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 u rt 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 .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 6
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 ulator 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.

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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 7

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 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 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 or t t his 
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 a n E D P 
S u p ple me ntal F or m or via P S S A , 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 nti o 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 a n E D P 
S u p ple me ntal F or m or via P S S A . 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 re p ort 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 -u p t o t he i nitial re p ort. 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 or 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 AEs f oll o ws:

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 ut 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 8
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 w ill 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 os 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 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.
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 Vacci ne S A E Re p ort F or m or via P S S A . 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
re p ort 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 e x 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 Vacci ne S A E Re p ort F or m or via P S S A , 
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 re p ort is mai ntai ne d i n t he 
i n vesti gat or site file.
8. 4. 6. C ar di o v asc ul ar a n d De at h E ve nts
Deat hs a n d 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 .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 7 9
8. 4. 7. Dise ase -Rel ate d E ve nts a n d/ or Dise ase -Rel ate d O utc o mes N ot Q u alif yi n g as A E s 
or S A Es
N ot a p plica ble .
8. 4. 8. A d verse E ve nts of S peci al I nterest
T he f oll o wi n g e ve nts are pr ot oc ol -s pecifie d A E SIs a n d are c ollecte d fr o m vacci nati o n 
t hr o u g h 6 m o nt hs after vacci nati o n u nless ot her wise s pecifie d :

C o nfir me d dia g n osis of m y ocar ditis or pericar ditis occ urri n g after Visit 1 t hr o u g h
6 wee ks after vacci nati o n. See Secti o n 8. 1 0. 6.

P ote ntial me nstr ual c y cle dist ur ba nces occ urri n g after Visit 1 t hr o u g h 6 m o nt hs after 
vacci nati o n . See Secti o n 8. 1 0. 7.
Pr ot oc ol -s pecifie d A E SIs are e xa mi ne d as part of r o uti ne safet y data re vie w a n d si g nal 
detecti o n pr ocesses a n d pr oce d ures t hr o u g h o ut t he cli nical trial. S h o ul d a n a g gre gate a nal ys is 
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 w ill 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 pr ot oc ol -s pecifie d 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 p r oce d ures 
descri be d i n Secti o ns 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 . In 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 o n t he Vacci ne S A E Re p ort 
F or m or via P S S A .
8. 4. 8. 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 efficac 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 ate d wit h a n S A E .
8. 4. 9. 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 m e dical d e vice deficie nc y ca n be f o u n d i n A p pe n di x 9 .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 0
N ote: A E s a n d/ or S A Es t hat are ass ociate d wit h a me dical de vice deficie nc y will f oll o w t he 
sa me pr ocesses as ot her A E s 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
A p pe n di x 3 of t he pr ot oc ol.
8. 4. 9. 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 det ecte 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. 9. 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. 9. 2. F oll o w - U p of Me dic al De vice Deficie ncies
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 u n bli n de d site staff is res p o nsi ble f or e ns uri n g t hat f oll o w -u p i ncl u des a n y  s u p ple me ntal 
i n vesti gati o ns as i n dicate d t o el uci date t he nat ure a n d/ or ca usalit y of t he deficie nc y.
Ne w or u p date d i nf or mati o n will be rec or de d o n a f oll o w -u p f or m wit h all c ha n ges si g ne d 
a n d date d b y t he u n bli n de d site staff.
8. 4. 9. 3. Re g ul at or y Re p orti n g Re q uire me nts 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 ory 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.
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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 1

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 SA 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 Cs as re q uire d b y  nati o nal re g ulati o ns.
8. 4. 1 0. 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 partici 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 Me dic 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 / P S S A t o Pfiz er 
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 w it 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.
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 deter mi ne d b y  t he 
i n vesti gat or, suc h vacci nati o n err ors occ urri n g t o a st u d y partici pa nt are rec or de d o n t he 
me dicati 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 a n d, if 
a p plica ble, a n y ass ociate d seri o us a n d n o nseri o us A E(s) are rec or de d o n t he A E pa ge of 
t he C R F .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 2
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 o n a Vacci ne S A E Re p ort 
F or m or via P S S A 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. 5 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. 6. 1. 1. Use/ A n al ysis of D N A
Refer t o Secti o n 1 0. 5.
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
Refer t o Secti o n 8. 2 .
8. 9. He alt h Ec o n o mics
Healt h ec o n o mics/m e dical res o urce u tilizati o n a n d h ealt h ec o n o mics para meters are n ot 
e val uate d i n t his st u d y.
8. 1 0. St u d y Pr oce d ures
T his secti o n is a p plica ble t o all c o h orts.
8. 1 0. 1. Visit 1 – V acci n ati o n ( D a y 1)
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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 3
It is a nticipate 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 si n gle partici pa nt n u m ber usi n g t he I R T s y ste m.

O btai n t he partici pa nt’s de m o gra p h y (i ncl u di n g a ge i n years, se x, race, a n d et h nicit y).

O btai n a n y 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 as descri be d i n Secti o n 6 .

O n t he da y  of a n d pri or t o st u d y i nter ve nti o n a d mi nistrati o n, 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 ys ical e xa mi nati o n is necessar y 
t o c o m pre he nsi vely e val uate t he partici pa nt, perf or m a p h ysical 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 fi n di n gs o n t he 
me dical hist or y  C R F.

Meas ure t he partici pa nt’s hei g ht a n d wei g ht.

O n t he da y  of a n d pri or t o st ud y  i nter ve nti o n a d mi nistrati o n, meas ure t he partici pa nt’s 
oral te m perat ure.

Rec or d n o nst u d y vacci nati o ns a n d pri or recei pt of a n y lice nse d or i n vesti gati o nal 
C O VI D -1 9 or i nfl ue nza vacci ne as descri be d i n Secti o n 6. 9 .

O n t he da y  of a n d pri or t o st u d y i nter ve nti o n a d mi nistrati o n, 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. 5 .

If a p plica ble, disc uss c o ntrace pti ve use as descri be d i n Secti o n 1 0. 4. 4 .

O n t he da y  of a n d pri or t o st u d y i nter ve nti o n a d mi nistrati o n, 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.

O n t he da y  of a n d pri or t o st u d y i nter ve nti o n a d mi nistrati o n, 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. 4 .

C ollect a bl o o d sa m ple (a p pr o xi matel y  2 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.

O n t he da y  of a n d pri or t o st u d y i nter ve nti o n a d mi nistrati o n, 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 I RT s ys te m.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 4

U n bli n de d 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 of t he a p pr o priate ar m as detaile d i n Secti o n 6. 1. 1 . 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.

Bli n de d 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 ny 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, o n t he A E C R F, a n d o n a n S A E 
f or m as a p plica ble.

E x plai n t he e -diar y  tec h n ol o gies a vaila ble f or t his st u d y (see Secti o n 8. 3. 4 ), a n d assist t he 
partici pa nt i n 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 react o ge nicit y 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 or l o n ger u ntil a n y 
s ym pt o ms t hat are o n g oi n g are res ol ve d, wit h Da y  1 bei n g t he da y of vacci nati o n.

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns at t he ri g ht ar m 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; pr o vi de i nstr ucti o ns o n t heir use.

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 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 
D a 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 ri g ht ar m 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 ri g ht ar m i njecti o n site.

A n y  se vere sys te mic e ve nt.

Rec or d A Es , S A Es, a n d A E SIs as descri be d in Secti o n 8. 4 .

Re mi n d partici pa nts t o i nf or m t he st u d y  staff of a n y A Es a n d S A Es t hat occ ur f or t he 
d urati o n of t he trial as descri be d i n Secti o n 8. 4

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 dically 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 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 8. 1 0. 6 ).

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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 5

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 a n u n bli n de d 
dis pe nser/a d mi nistrat or u p dates t he st u d y  i nterve 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 a n d rec or d s t he assess me nt i n t he C R F 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.
8. 1 0. 2. Visit 1 A – 1- Wee k F oll o w -U p 
 
 – 6 t o 8 D a ys After Visit 1
 
T his visi t m ust be 
c o m plete d a t a site.

Rec or d A Es , S A Es , a n d A E SI s as descri be d i n Secti o n 8. 4 .

Rec or d n o nst u d y  vacci nati o ns as descri be d i n Secti o n 6. 9 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 6. 9. 1 .

If a p plica ble, disc uss c o ntrace pti ve use as descri be d i n Secti o n 1 0. 4. 4

Re vie w t he partici pa nt’s react o ge nicit y  e-diar y  data a n d rec or d t he assess me nt i n t he 
C R F. Assess c o m plia nce , a n y me dically atte n de d e ve nts (i ncl u di n g h os pitalizati o ns), a n d 
c ollect st o p dates f or a n y s ym pt o ms /me dicati o ns o n g oi n g o n t he last da y  of t he e-diar y  
c ollecti o n peri o d i n t he C R F. F or s y m pt o ms still o n g oi n g, c o nti n ue t o f oll o w u p u ntil 
res ol uti o n, a n d d oc u me nt a n d rec or d st o p dates i n t he C R F.

Rec or d react o ge nicit y  me dicati o n use d as descr i be d i n Secti o n 6. 9 .

Re mi n d partici pa nts t o i nf or m t he st u d y  staff of a n y A Es a n d S A Es t hat occ ur f or t he 
d urati o n of t he trial as descri be d i n Secti o n 8. 4

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 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 8. 1 0. 6 ).
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 6

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.
8. 1 0. 3. Visit 2 – 4- Wee k F oll o w- U p Visit ( After V acci n ati o n) – 2 8 t o 3 5 D a ys After 
Visit 1
N ote: Visit 2 ma y  be perf or me d as a tele healt h visit if t he partici pa nt ha d bl o o d dra ws 
disc o nti n ue d.

Rec or d A Es , S A Es , a n d A E SIs as descri be d i n Secti o n 8. 4 .

Rec or d n o nst u d y  vacci nati o ns as descri be d i n Secti o n 6. 9 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 6. 9. 1 .

If a p plica ble, disc uss c o ntrace pti ve use as descri be d i n Secti o n 1 0. 4. 4 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  2 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 a n d rec or d assess me nt i n t he C R F. 
Assess c o m plia nce , a n y me dicall y atte n de d e ve nts (i ncl u di n g h os pitalizati o ns), a n d 
c ollect st o p dates f or a n y s y m pt o ms / me dicati o ns o n g oi n g o n t he last da y  of t he e-diar y  
c ollecti o n peri o d i n t he C R F. F or s y m pt o ms still o n g oi n g, c o nti n ue t o f oll o w u p u ntil 
res ol uti o n, a n d d oc u me nt a n d rec or d st o p dates i n t he C R F.

Rec or d react o ge nicit y  me dicati o n use d as descri be d i n Secti o n 6. 9 .

Re mi n d partici pa nts t o i nf or m t he st u d y  staff of a n y A Es a n d S A Es t hat occ ur f or t he 
d urati o n of t he trial as descri be d i n Secti o n 8. 4

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.

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 .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 7
8. 1 0. 4. Visit 3 – 6- M o nt h F oll o w -U p Visit ( After V acci n ati o n) – 1 6 8 t o 19 6 D a ys After 
Visit 1
N ote: Visit 3 ma y  be perf or me d as a tele healt h visit if t he partici pa nt ha d bl o o d dra ws 
disc o nti n ue d.

Rec or d S A Es a n d A E SIs as descri be d i n Secti o n 8. 4 .

Rec or d n o nst u d y  vacci nati o ns as descri be d i n Secti o n 6. 9 .

Rec or d pr o hi bite d me dicati o n use as descri be d i n Secti o n 6. 9. 1 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  2 0 m L  f or i m m u n o ge nicity testi n g.

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 .
8. 1 0. 5. 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
If a Gra de 3 l ocal reacti o n i n t he ri g ht ar m (Secti o n 8. 3. 4. 2 ), s yste mic e ve nt (Secti o n 8. 3. 4. 3 ), 
or fe ver ( Secti o n 8. 3. 4. 4 ) 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 deta ils 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 i n t he ri g ht ar m (Secti o n 8. 3. 4. 2 ), s yste mic e ve nt 
(Secti o n 8. 3. 4. 3 ), or fe ver (Secti o n 8. 3. 4. 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 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 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 8
T his tele p h o ne c o ntact will be re c 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
i n t he ri g ht arm (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 i n t he ri g ht ar m (if prese nt).

Assess i njecti o n site pai n i n t he ri g ht ar m (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. 4. 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. 4. 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 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.
N ote: A n y  left ar m react o ge nicit y e ve nt s h o ul d be c ollecte d i n t he C R F o n t he A E l o g pa ge.
8. 1 0. 6. 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
A n y  st u d y partici pa nt w h o re p orts s ym pt o ms (i ncl u di n g, b ut n ot li mite d t o, ac ute c hest pai n, 
s h ort ness of breat h, a n d pal pitati o ns) will be e val uate d at t he site prefer a bl y wit hi n 
4 8 h o urs b ut n o m ore t h a n 7 2 h o urs of o nset (if t he partici pa nt is me dicall y  sta ble a n d n ot 
ot her wise see ki n g me dical atte nti o n ). 
As part of t he i nitial site cli nical e val uati o n, t he f oll o wi n g m ust 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.
A n y  st u d y partici pa nt wit h cli nical fi n di n gs n ote d wit hi n 6 wee ks after st u d y vacci nati o n a n d 
w h o m t he i n vesti gat or assesses as cli nicall y s us pici o us f or m y ocar ditis or pericar ditis m ust 
be e val uate d b y a car di ol o gist.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 8 9
As part of t he c ar di ol o gist 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 i n a d diti o n t o 
ot her a p pr o priate cli nical tests t o el uci date if t he partici pa nt has e x perie nce d m y ocar ditis or 
pericar ditis :

C ar 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 
rec or de d i n t he C R F. A n y dia g n osis ma de ( m y ocar ditis, pericar ditis, or ot her) s h o ul d be 
rec or de d as a n A E. Refer als o t o Secti o n 8. 4. 8 .
8. 1 0. 7. 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
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, 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 
last 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. 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.
9. S T A TI S TI C A L C O N SI D E R A TI O N S
Met h o d ol o g y f or s u m mar y  a n d statistical a nal ys 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 a 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 o f 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 w o i m m u n o ge nicity pri mar y  o bjecti ves a n d4 i m m u n o ge nicity sec o n dar y o bjecti ves ha ve 
bee n defi ne d f or t his st u d y. T he i m m u n o ge nicity pri mar y  ( C o h ort 2) a n d se c o n dar y
( C o h ort 3) o bje cti ves i n v ol ve a de m o nstrati o n of NI of t he i m m u ne res p o nses meas ure d 
4 wee ks after st u d y i nter ve nti o n a d mi nistrati o n, a n d t he i m m u n o ge nicit y sec o n dar y 
( C o h ort 2) o bjecti ve i n v ol ve s a de m o nstrati o n of s u peri orit y of t he i m m u ne res p o nses 
meas ure d 4 wee ks after st u d y i nter ve nti o n a d mi nistrati o n, as detaile d bel o w.
T he i m m u n o ge nicit ypri mary o bjecti ves ( C o h ort 2) are t o de m o nstrate NI of t he i m m u ne 
res p o nse t o
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) at 4 wee ks after vacci nati o n c o m pare d t o
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d c o nc o mita ntl y wit h QI V f or all tar gete d strai ns 
(seas o nal strai ns 
] rec o m me n de d by W H O) a n d t he S A R S -C o V -2 O micr o n 
X B B. 1. 5 strai n .
T he first i m m u n o ge nicit y sec o n dar y o bjecti ve ( C o h ort 3) is t o de m o nstrate NI of t he H AI  
i m m u ne res p o nse f or t he matc he d seas o nal i nfl ue nza strai ns rec o m me n de d b y W H O 
([ 
] elicite d by
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) at 4 wee ks after vacci nati o n 
c o m pare d t o QI V al o ne.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 7 ( G M T)
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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 0
T he sec o n d i m m u n o ge nicit y sec o n dar y o bjecti ve ( C o h ort 3) is t o de m o nstrate NI of t he 
S A R S -C o V - 2 i m m u ne res p o nse elicite d b y
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) at 4 wee ks after 
vacci nati o n c o m pare d t o B N T 1 6 2 b 2 ( O mi X B B. 1. 5) al o ne.
T he t hir d i m m u n o ge nicit y sec o n dar y o bjecti ve ( C o h ort 3) is t o de m o nstrate NI of t he H AI 
i m m u ne res p o nse f or t he matc he d seas o nal i nfl ue nza strai ns rec o m me n de d b y W H O 
(
elicite d b y 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) at 4 wee ks after vacci nati o n 
c o m pare d t o
al o ne.
T he f o urt h i m m u n o ge nicit y sec o n dar y o bjecti ve ( C o h ort 2) is t o de m o nstrate s u peri orit y of 
t he i m m u ne res p o nse t o 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) at 4 wee ks after vacci nati o n 
c o m pare d t o B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d c o nc o mita ntl y  wit h QI V f or all 
tar gete d strai ns (seas o nal strai ns  
 rec o m me n de d b y W H O).
F or e val uati o n of t he i m m u n o ge nicity pri mar y  o bjecti ve s (C o h ort 2 ), 2 statistical h yp ot heses 
f or eac h tar gete d strai n will be defi ne d as descri be d bel o w:
   :l n(  ) −l n(  ) ≤l n
),
w here l n( 
) c orres p o n ds t o a 
mar gi n f or NI , a n d   a n d   are t he G M Ts fr o m
Ar m C a n d Ar m D,
res pecti vely, meas ure d at 4 wee ks after vacci nati o n.
   :  −  ≤
% ,
w here   a n d   are t he pr o p orti o ns of partici pa nts ac hie vi n g ser oc o n versi o n or ser ores p o nse 
at 4 wee ks after vacci nati o n f or Ar m C a n d Ar m D , res pecti vely.
F or e val uati o n of i m m u n o ge nicit y  sec o n dar y o bjecti ves ( C o h ort 3), 1 statistical h yp ot h esis 
f or eac h tar get strai n will be defi ne d as descri be d bel o w:
   :l n(  ) −l n(  ) ≤l n(
,
w here l n( 
) c orres p o n ds t o a 
 mar gi n f or NI, a n d   a n d   are t he G M Ts i n Ar m 
E a n d t he c orres p o n di n g c o m parati ve ( Ar m F a n d Ar m G) a n d e x peri me ntal ( Arm H) vacci ne 
gr o u p s, res pecti vel y, meas ure d 4 wee ks after vacci nati o n.
F or e val uati o n of t he i m m u n o ge nicity sec o n dar y o bjecti ve ( C o h ort 2), 2 statistical 
h y p ot heses f or eac h tar gete d seas o nal strai n ([ 
] rec o m me n de d b y W H O) will be 
defi ne d as descri be d bel o w:
   :l n(  ) −l n(  ) ≤l n(
,
w here l n(
c orres p o n ds t o a
mar gi n f or s u periorit y , a n d   a n d   are t he G M Ts
fr o m Ar m C a n d Ar m D,
res pecti vely, meas ure d at 4 wee ks after vacci nati o n.
   :  −  ≤
% ,
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 1
w here   a n d   are t he pr o p orti o ns of partici pa nts ac hie vi n g ser oc o n versi o n at 4 wee ks after 
vacci nati o n f or Ar m C a n d Ar m D, res pecti vel y.
F or eac h strai n, NI base d o n G M T will be declare d if t he l o wer li mit of t he 2 -si de d 9 5 % CI 
f or t he G M R is
; NI base d o n ser oc o n versi o n or ser ores p o nse ( C o h ort 2 o nl y ) will be 
declare d if t he l o wer li mit of t he 2- si de d 9 5 % CI f or t he differe nce i n perce nta ges of 
partici pa nts ac hie vi n g ser oc o n versi o n or ser ores p o nse is greater t ha n
% ; s u peri orit y
( C o h ort 2 o nl y ) base d o n G M T will be declare d if t he l o wer li mit of t he 2 si de d 9 5 % CI f or 
t he G M R is
 s u peri orit y base d o n ser oc o n versi o n ( C o h ort 2 o nl y ) will be declare d if t he 
l o wer li mit of t he 2-si de d 9 5 % CI f or t he differe nce i n perce nta ges of partici pa nts ac hie vi n g 
ser oc o n versi o n is
 
 
 
9. 1. 1. Esti m a n ds
T he esti ma n ds c orres p o n d i n g t o t he pri mar y a n d sec o n dar y o bjecti ve s are descri be d i n t he 
ta ble i n Secti o n 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. T he esti ma n ds a d dresses t he o bjecti ve of 
esti mati n g t he ma xi m u m p ote ntial differe nce bet wee n 2 st u d y ar ms of t he tar get p o p ulati o n, 
si nce t he i m pact of n o nc o m plia nce is li kel y t o di mi nis h t he o bser ve d differe nce bet wee n t he 
2 c o m pare d st u d y ar ms. Missi n g i m m u n o ge nicit y res ults will n ot be i m p ute d .
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.
Data ha n dli n g f or i m m u n o ge nicit y  f oll o wi n g o nset of i nfecti o n f or partici pa nts w h o ha ve 
i nfl ue nza or C O VI D-1 9 will be o utli ne d i n t he S A P.
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.
9. 1. 2. M ulti plicit y A dj ust me nt
H y p ot hesis testi n g of t he o bjecti ves f or C o h ort 2 ( 2 i m m u n o ge nicity pri mar y  o bjecti ve s a n d 
t he f o urt h sec o n dar y o bjecti ve) will be e val uate d i n de pe n de ntl y fr o m t hat of C o h ort 3 
( 3 i m m u n o ge nicity sec o n dar y  o bjecti ves) wit h o ut a p pl y i n g a ny m ulti plicit y a dj ust me nt .
 
 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 2
Wit hi n C o h ort 2, t he i m m u n o ge nicit y pri mar y  o bj ecti ves a n d t he f o urt h sec o n dar y o bjecti ve
will be e val uate d se q ue ntiall y . The i m m u n o ge nicit y  pri mar y e n d p oi nts/esti ma n ds are 
c o nsi dere d c o pri mar y. T here are
h y p ot hesis tests (
) f or t he 
i m m u n o ge nicity pri mar y  NI o bjecti ve s ( 
B N T 1 6 2 b 2 [ O mi X B B. 1. 5] vs B N T 1 6 2 b 2 
( O mi X B B. 1. 5) a d mi nistere d c o nc o mita ntl y wit h QI V ), wit h 2 statistical h yp ot heses f or eac h 
of t he
tar gete d i nfl ue nza a n d S A R S -C o V -2 strai ns . Eac h h y p ot hesis will be teste d at a 
1 -si de d al p ha le vel of 0. 0 2 5. T he i m m u n o ge nicity pri mar y o bjecti ve s will be ac hie ve d if NI
is met f or all
statistical h yp ot heses. After t he i m m u n oge nicit y pri mar y  NI o bjecti ves
( C o h ort 2) are esta blis he d, the
statistical h y p ot heses f or t he f o urt h sec o n dar y o bjecti ve 
( C o h ort 2) will be teste d se q ue ntiall y i n t he f oll o wi n g or der of
seas o nal i nfl uenza strai ns : 
a n d t he hy p ot hesis will be teste d first base d o n G M R a n d 
t he n base d o n t he ser oc o n versi o n rate f or eac h strai n. T heref ore, t he o verall t y pe I err or rate 
wit hi n C o h ort 2 is f ull y  c o ntr olle d.
Wit hi n C o h ort 3, t he 3 i m m u n o ge nicity sec o n dar y o bjecti ves will be e val uate d se q ue ntiall y 
i n t he f oll o wi n g or der: c o m pari n g 
/ B N T 1 6 2 b 2 [ O mi X B B. 1. 5] wit h QI V f or
tar gete d 
i nfl ue nza strai ns,
/ B N T 1 6 2 b 2 [ O mi X B B. 1. 5] wit h B N T 1 6 2 b 2 [ O mi X B B. 1. 5] f or t he 
S A R S -C o V - 2 O micr o n X B B. 1. 5 strai n, a n d
/ B N T 1 6 2 b 2 [ O mi X B B. 1.5] wit h 
f or 
tar gete d i nfl ue nza strai ns. T here are
h y p ot hesis tests f or t he i m m u n o ge nicit y sec o n dar y
NI o bjecti ves 
/ B N T 1 6 2 b 2 [ O mi X B B. 1. 5] vs QI V f or
tar gete d i nfl ue nza strai ns,
1 f or
/ B N T 1 6 2 b 2 [ O mi X B B. 1. 5] vs B N T 1 6 2 b 2 [ O mi X B B. 1. 5] f or t he S A R S -C o V - 2
O micr o n X B B. 1. 5 strai n, a n d 
/ B N T 1 6 2 b 2 [ O mi X B B. 1. 5] vs
f or
tar gete d 
i nfl ue nza strai ns). Eac h h y p ot hesis will be teste d at a 1 -si de d al p ha le vel of 0.0 2 5. F or 
o bjecti ves i n v ol vi n g h y p ot heses f or
i nfl ue nza strains, all
h y p ot heses wit hi n t he o bjecti ve 
m ust be esta blis he d bef ore assessi n g t he ne xt o bjecti ve i n t he se q ue nce. T heref ore, t he 
o verall t y pe I err or wit hi n C o h ort 3 is f ull y  c o ntr olle d.
9. 2. A n al ysis Sets
F or p ur p oses of a nal y sis, t he f oll o wi n g a nal ys is sets are defi ne d:
P artici p a nt A n al ysis Set
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 I R T 
s yste m.
E val ua ble i m m u n o ge nicit y 
All ra n d o mize d 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 nat i o n visit, a n d 
ha ve n o maj or pr ot oc ol vi olati o ns. Partici pa nts will be gr o u pe d acc or di n g 
t o t he vacci ne as ra n d o mize d i n t he a nal ysis base d o n t he e val ua ble 
i m m u n o ge nicit y p o p ulati o n.
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.
Partici pa nts will be gr o u pe d acc or di n g t o t he vacci ne as ra n d o mize d i n t he 
a nal ysis base d o n t he mI T T i m m u n o ge nicit y p o p ulati o n.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 3
P artici p a nt A n al ysis Set
Descri pti 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.
Partici pa nts will be gr o u pe d acc or di n g t o t he vacci ne as a d mi nistere d i n 
t he a nal ysis base d o n t he safet y p o p ulati o n.
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 nalys 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 e x pl orat or y 
e n d p oi nts.
9. 3. 1. Ge ner al C o nsi der ati o ns
CI s f or all e n d p oi nts i n t he statistical a nal ys 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.
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 pri maril y 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 n a d diti o nal a nal ys is will be perf or me d base d o n t he mI T T 
i m m u n o ge nicity p o p ulati o n if t here is a lar ge e n o u g h differe nce i n t he n u m ber of partici pa nts 
i ncl u de d bet wee n t he mI T T a n d t he e val ua ble i m m u n o ge nicity p o p ulati o ns.
9. 3. 1. 1. A n al ysis 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 % CIs 
w here a p plica ble.
T he e xact 9 5 % CI 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 met h o d ).
F or t he bet wee n -gr o u p differe nce, t he 2 -si de d 95 % CI  will be calc ulate d usi n g t he Mietti ne n 
a n d N ur mi ne n met h o d.
T hree - Tier A p pr o ac h f or A E S u m m ar y
A 3 -tier a p pr oac h will be use d t o s u m marize A Es. U n der t his a p pr oac h, A Es are classifie d 
i nt o 1 of 3 tiers:
1.
Tier 1 e ve nts are pres pecifie d e ve nts of cli nical i m p orta nce a n d are i de ntifie d i n a list i n 
t he pr o d uct’s safety re vie w pla n; there is n o Tier 1 e ve nt i de ntifie d f or t he st u d y 
i nter ve nti o ns at t his sta ge.
2.
Tier 2 e ve nts are t h ose t hat are n ot Tier 1 b ut are c o nsi dere d “relati vel y c o m m o n”; 
a
Me d D R A preferre d ter m is defi ne d as a Tier 2 e ve nt if t here are at least 1 % of 
partici pa nts i n at least 1 st u d y ar m re p orti n g t he e ve nt.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 4
3.
Tier 3 e ve nts are t h ose t hat are neit her Tier 1 n or Tier 2 e ve nts.

F or b ot h Tier 1 (if a n y are i de ntifie d later) a n d Tier 2 e ve nts, t he 9 5 % CIs f or t he 
differe nce i n perce nta ge of partici pa nts re p orti n g t he e ve nts bet wee n Ar m A a n d
Ar m B a n d bet wee n Ar m C a n d Ar m D will be calc ulate d usi n g t he Mietti ne n a n d 
N ur mi ne n met h o d.

I n a d diti o n, f or Tier 1 e ve nts (if a ny are i de ntifie d later), t he as ym pt otic p - val ues will 
als o be prese nte d f or t he differe nce i n perce nta ge of partici pa nts re p orti n g t he e ve nts 
bet wee n Ar m A a n d Ar m B a n d bet wee n Ar m C a n d Ar m D , base d o n t he sa me test 
statistic a n d u n der t he ass u m pti o n t hat t he test statistic is as ym pt oticall y  n or mall y 
distri b ute d.

Descri pti ve s u m mar y  statistics will be pr o vi de d f or Tier 3 e ve nts f or eac h st u d y ar m.
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. 3. 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. 4. Ge o metric Me a n R ati o
U na dj uste d G M R
T he u na dj uste d G M R will be calc ulate d as t he differe nce i n t he mea ns of l o garit h micall y  
tra nsf or me d assa y res ults bet wee n 2 vacci ne gr o u ps a n d e x p o ne ntiati n g t he differe nce. T he 
2 -si de d 9 5 % C I will be o btai ne d b y e x p o ne ntiati n g t he li mits of t he CI f or t he mea n 
differe nce of t he l o garit h micall y  tra nsf or me d assa y res ults base d o n t he t distri b uti o n.
M o del -base d G M R
T he m o del - base d G M R a n d ass ociate d 9 5 % CI will be calc ulate d by e x p o ne ntiati n g t he 
differe nce i n L S mea ns a n d t he c orres p o n di n g CIs base d o n t he a nal y sis of l o garit h mically 
tra nsf or me d assa y res ults usi n g a li near re gressi o n m o del t hat i ncl u des t he baseli ne 
ne utralizi n g titer, a ge, a n d vacci ne gr o u p as c o variates.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 5
9. 3. 1. 5. 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 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 d iffere nce of l o garit h mically 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 CIs 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. 5. 1. Re verse C u m ul ati ve Distri b uti o n C ur ves
E m pirical R C D Cs will be pl otte d as a ste p f u ncti o n of t he pr o p orti o n of partici pa nts wit h t he 
assa y res ults e q ual t o or e xcee di n g a s pecifie d val ue o ver t he f ull ra n ge of t he o bser ve d assa y  
res ults.
9. 3. 2. Pri m ar y E n d p oi nt s/ Esti m a n ds A n al ysis
E n d p oi nt
St atistic al A n al ysis Met h o d s
Saf et y

Descri pti ve statistics will be pr o vi de d f or eac h react o ge nicit y 
e n d p oi nt f or eac h vacci ne gr o u p wit hi n eac h c o h ort. L o cal reacti o ns 
a n d s yste mic e ve nts fr o m Da y 1 t hr ou g h Da y  7 after eac h 
vacci nati o n ( w here Da y  1 is t he da y of vacci nati o n) will be 
prese nte d b y se verity a n d c u m ulati vel y across se verit y  le vels. 
Descri pti ve s u m mar y  statistics will i ncl u de c o u nts a n d perce nta ge of 
partici pa nts wit h t he i n dicate d e n d p oi nt a n d t he ass ociate d 2-si de d 
9 5 % C Is base d o n Cl o p per-Pears o n met h o d.

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. 
C o u nts, perce nta ge, a n d ass ociate d 2 -si de d 9 5 % CI s base d o n 
Cl o p per -Pears o n met h o d of A Es fr o m vacci nati o n ( Da y 1) t hr o u g h 
4 wee ks after vacci nati o n , a n d S A Es fr o m vacci nati o n ( Da y 1) 
t hr o u g h 6 m o nt hs after vacci nati o n will be pr o vi de d f or eac h 
vacci ne gr o u p wit hi n eac h c o h ort.

T he safet y data are s u m marize d wit hi n eac h c o h ort b ut ma y  als o be 
s u m marize d descri pti vel y acr oss c o h orts as s pecifie d i n t he S A P.
I m m u n o ge nicity
( C o h ort 2)

G M R of H AI titers f or eac h matc he d seas o nal strai n 
) at 
4 wee ks after st u d y vacci nati o n i n partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d B N T 1 6 2 b 2 
( O mi X B B. 1. 5) a d mi nistere d c o nc o mita ntl y wit h QI V. 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 6
E n d p oi nt
St atistic al A n al ysis Met h o d s

T he differe nce i n perce nta ges of partici pa nts wit h ser oc o n versi o n t o 
t he seas o nal strai n ( 
 at 4 wee ks after st u d y vacci nati o n 
bet wee n partici pa nts w h o recei ve d 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) 
a n d t h ose w h o recei ve d B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d 
c o nc o mita ntl y wit h QI V. 

G M R of S A R S -C o V -2 O micr o n ( X B B. 1. 5) – ne utralizi n g titers at 
4 wee ks after st u d y vacci nati o n i n partici pa nts w h o recei ve d 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d B N T 1 6 2 b 2 
( O mi X B B. 1. 5) a d mi nistere d c o nc o mita ntl y wit h QI V. 

T he differe nce i n perce nta ges of partici pa nts wit h ser ores p o nse t o 
S A R S -C o V - 2 O micr o n ( X B B. 1. 5) strai n at 4 wee ks after st u dy 
vacci nati o n bet wee n partici pa nts w h o recei ve d  
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) a n d t h ose w h o recei ve d B N T 1 6 2 b 2 ( O mi X B B. 1. 5) 
a d mi nistere d c o nc o mita ntl y  wit h QI V.

G M R s a n d t he ass ociate d 2 -si de d 9 5 % CIs will be calc ulate d usi n g 
t he met h o d descri be d i n Secti o n 9. 3. 1. 4 U na dj uste d G M R s will be 
t he pri mar y a p pr oac h. A dj uste d G M Rs will als o be s u m marize d as 
s u p p orti ve.

T he differe nce s i n perce nta ge of partici pa nts wit h 
ser oc o n versi o n/ser ores p o nse a n d t he ass ociate d 2-si de d 9 5 % CIs 
will be calc ulate d usi n g t he Mietti ne n a n d N ur mi ne n met h o d i n 
Secti o n 9. 3. 1. 1 .
9. 3. 3. Sec o n d ar y E n d p oi nts / Esti m a n ds A n al ysis
E n d p oi nt
St atistic al A n al ysis Met h o ds
I m m u n o ge nicity
( C o h ort 3)

G M R of H AI titers f or eac h matc he d seas o nal strai n ( 
) at 
4 wee ks after vacci nati o n f or partici pa nts w h o recei ve d 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d QI V al o ne. 

G M R of S A R S -C o V -2 O micr o n ( X B B. 1. 5) – ne utralizi n g titers at 
4 wee ks after vacci nati o n f or partici pa nts w h o recei ve d 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d B N T 1 6 2 b 2 
( O mi X B B. 1. 5) al o ne. 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 7 ( G M T)
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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 7
E n d p oi nt
St atistic al A n al ysis Met h o ds

G M R of H AI titers f or eac h matc he d seas o nal strai n ( 
 at 
4 wee ks after vacci nati o n f or partici pa nts w h o recei ve d 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d 
al o ne. 

G M R s a n d t he ass ociate d 2 -si de d 9 5 % CIs will be calc ulate d usi n g 
t he met h o d descri be d i n Secti o n 9. 3. 1. 4 U na dj uste d G M R will be 
t he pri mar y a p pr oac h. A dj uste d G M Rs will als o be s u m marize d as 
s u p p orti ve.
I m m u n o ge nicity
( C o h ort 2)

G M R of H AI titers f or eac h matc he d seas o nal strai n ( 
 at 
4 wee ks after st u d y vacci nati o n i n partici pa nts w h o recei ve d 
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) t o t h ose w h o recei ve d B N T 1 6 2 b 2 
( O mi X B B. 1. 5) a d mi nistere d c o nc o mita ntl y wit h QI V. 

T he differe nce i n perce nta ges of partici pa nts wit h ser oc o n versi o n t o 
t he seas o nal strai n ( 
) at 4 wee ks after st u d y vacci nati o n 
bet wee n partici pa nts w h o recei ve d
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) 
a n d t h ose w h o recei ve d B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d 
c o nc o mita ntl y wit h QI V. 

T he sa me a nal ys es a n d esti ma n ds as t he i m m u n o ge nicit y  pri mar y 
o bjecti ve f or H AI res p o nse.
9. 3. 4. E x pl or at or y E n d p oi nts A n al ysis
E n d p oi nt
St atistic al A n al ysis Met h o ds
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 8
E n d p oi nt
St atistic al A n al ysis Met h o ds
9. 3. 5. Ot her S afet y A n al yses
All safety a nal ys es (i ncl u di n g react o ge nicit y a n d u ns olicite d A Es) are perf or me d o n t he 
safety p o p ulati o n .
9. 4. I nteri m A n al yses
N o f or mal i nteri m a nalys is will be c o n d ucte d f or t his st u d y. Statistical a nal y ses will be 
carrie d o ut w he n t he fi nal data f or s pecifie d o bjecti ves are a vaila ble w hile t he st u d y  is 
o n g oi n g. T he ti mi n g of t hese pla n ne d a nal ys is a n d re p orti n g e ve nts is descri bed i n t he secti o n 
bel o w .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 9 9
9. 4. 1. A n al ysis Ti mi n g
Statistical a nal y ses will be carrie d o ut w he n data are a vaila ble f or eac h c o h ort as s pecifie d 
bel o w :

S afet y a n d i m m u n o ge nicit y data t hr o u g h 4 wee ks after vacci nati o n after all partici pa nts 
c o m plete 4 wee ks after vacci nati o n (f or t he res pecti ve c o h ort).

S afet y, i m m u n o ge nicity, a n d ot her data t hr o u g h 6 m o nt hs after vacci nati o n (f or t he 
res pecti ve c o h ort).
A d diti o nal a nal y ses ma y be c o n d ucte d if re q uire d f or re g ulat or y p ur p oses after t he 
i m m u n o ge nicity pri mar y or sec o n dar y h yp ot he ses f or t he res pecti ve c o h ort ha ve bee n 
e val uate d. T he st u d y  tea m will re mai n bli n de d t hr o u g h e n d of t he st u dy as per Secti o n 6. 4 , as 
t he a nal ys is pri or t o t he fi nal a nal ys is at e n d of t he st u d y will be perf or me d b y a se parate 
u n bli n de d statistical tea m. T he i n vesti gat or site staff will re mai n bli n de d t o partici pa nt st u d y
ar m u ntil t he last partici pa nt c o m pletes t he fi nal visit. L a b orat or y pers o n nel perf or mi n g t he 
assa ys will re mai n bli n de d u ntil all assa ys are c o m plete d.
9. 5. S a m ple Size Deter mi n ati o n
9. 5. 1. I m m u n o ge nicit y
T he sa m ple size of u p t o 8 5 5 0 partici pa nts was deter mi ne d t o ge nerate a n a de q uate safet y 
data base f or lice ns ure a n d wit h s ufficie nt statistical p o wer f or ac hie vi n g i m m u n o ge nicit y 
pri mar y  ( C o h ort 2) a n d sec o n dar y ( C o h ort 3) o bjecti ves. I n C o h ort 2 , a p pr o xi matel y 
4 5 0 0 partici pa nts will be ra n d o mize d i n a 2: 1 rati o t o recei ve eit her
B N T 1 6 2 b 2
( O mi X B B. 1. 5) or c oa d mi nistere d QI V a n d B N T 1 6 2 b 2 ( O mi X B B. 1. 5 ). I n C o h ort 3, 
a p pr o xi matel y 3 6 0 0 partici pa nts will be ra n d o mize d i n a 2: 2: 1: 1 rati o t o recei ve eit her 
B N T 1 6 2 b 2 ( O mi X B B. 1. 5) , B N T 1 6 2 b 2 ( O mi X B B. 1. 5), QI V , or
I n C o h ort 2, NI of t he i m m u ne res p o nse elicite d b y t he c o m bi nati o n vacci ne
(
B N T 1 6 2 b 2 [ O mi X B B. 1. 5 ]) t o c oa d mi nistrati o n of QI V a n d B N T 1 6 2 b 2 
( O mi X B B. 1. 5) will be assesse d base d o n H AI a nti b o d y  G M Rs a n d/ or S A R S -C o V -2 G M R
usi n g a 
mar gi n a n d differe nce of H AI a nti b o d y  ser oc o n versi o n rates a n d/ or 
S A R S -C o V -2 ser ores p o nse rates usi n g a
% mar gi n.
I n C o h ort 3, NI of t he i m m u ne res p o nse elicite d b y  t he c o m bi nati o n vacci ne 
B N T 1 6 2 b 2 [ O mi X B B. 1. 5]) t o B N T 1 6 2 b 2 ( O m i X B B. 1. 5) al o ne will be assesse d 
base d o n S A R S -C o V - 2 O micr o n ( X B B. 1. 5 ) a nti b o d y G MR usi n g 
mar gi n; NI  of t he 
i m m u ne res p o nse elicite d b y t he c o m bi nati o n vacci ne 
/ B N T 1 6 2 b 2 [ O mi X B B. 1. 5]) t o 
QI V or 
al o ne will be assesse d base d o n H AI a nti b o d y G MR s usi n g 
mar gi n .
F or t he i m m u n o ge nicity pri mar y  o bjecti ves relate d t o t he de m o nstrati o n of NI of t he i m m u ne 
res p o nses elicite d b y
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) at 4 wee ks after vacci nati o n c o m pare d 
t o B N T 1 6 2 b 2 ( O mi X B B. 1. 5) a d mi nistere d c o nc urre ntl y wit h QI V , all e nr olle d partici pa nts 
will be teste d f or S A R S -C o V -2 O micr o n X B B. 1. 5 – ne utralizi n g titers a n d a ra n d o m s u bset of 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 0
a p pr o xi matel y 3 0 0 0 partici pa nts ( 2 0 0 0 fr o m 
/ B N T 1 6 2 b 2[ O mi X B B. 1. 5] gr o u p a n d 
1 0 0 0 fr o m B N T 1 6 2 b 2 [O mi X B B. 1. 5 ] a n d QI V c oa d mi nistrati o n gr o u p) will be teste d f or
H AI titers. T he o verall p o wer t o de m o nstrate NI acr oss t h e e n d p oi nts u n der vari o us 
ass u m pti o ns f or G M Rs a n d differe nces i n perce nta ge of partici pa nts ac hie vi n g 
ser oc o n versi o n or ser ores p o nse is prese nte d i n Ta ble 6.
 
 
 
 
Si milarl y , t he p o wer relate d t o t he de m o nstrati o n of NI of t he i m m u ne res p o nse elicite d b y
/ B N T 1 6 2 b 2 ( O mi X B B. 1. 5) at 4 wee ks after vacci nati o n c o m pare d t o B N T 1 6 2 b 2 
( O mi X B B. 1. 5),
, a n d QI V al o ne f or gi ve n ass u m pti o ns is prese nte d i n Ta ble 7 .
T a ble 6.
P o wer A n al ysis f or N o ni nferi orit y Assess me nt ( C o h ort 2: I m m u n o ge nicit y 
Pri m ar y O bjecti ves)
Ass u me d G M R 
/ B N T 1 6 2 b 2 t o 
QI V + B N T 1 6 2 b 2)
Ass u me d Differe nce of 
Ser ores p o nse/ Ser oc o n ver
si o n R ates 
/ B N T 1 6 2 b 2 Mi n us 
QI V + B N T 1 6 2 b 2)
E v al u a ble P artici p a nts/ St u d y Ar m
P o w er a
S A R S -C o V -2 
O m icr o n 
X B B. 1. 5 –
ne utr alizi n g 
titers
H AI titers 
f or 
se as o n al 
i nfl ue nz a 
str ai ns
S A R S -C o V -
2 O m icr o n 
X B B. 1. 5 –
ne utr alizi n g 
titers
H AI titers 
f or 
se as o n al 
i nfl ue nz a 
str ai ns
S A R S -C o V -2 O m icr o n 
X B B. 1. 5 – ne utr alizi n g 
titers
H AI titers f or se as o n al 
i nfl ue nz a str ai ns
B N T 1 6
2 b 2 
( O mi X B B. 1.
5)
QI V + B N T 1 6
2 b 2
B N T 1
6 2 b 2 
( O mi X B B.
1. 5)
QI V + B N T 1
6 2 b 2
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 1
T a ble 7.
P o wer A n al ysis f or N o ni nferi orit y Assess me nt ( C o h ort 3: I m m u n o ge n icit y 
Sec o n d ar y O bjecti ves)
Ass u me d G M R
E v al u a ble P artici p a nts / St u d y Ar m
P o wer
S A R S -C o V -2 
O m icr o n 
X B B. 1. 5 –
ne utr alizi n g titers
H AI titers f or 
se as o n al i nfl ue nz a 
str ai ns
/ B N T 1 6 2 b 2 t o 
B N T 1 6 2 b 2
B N T 1 6 2 b 2
( Ar m E)
B N T 1 6 2 b 2
( Ar m F)
P o w er a
/ B N T 1 6 2 b 2 t o 
B N T 1 6 2 b 2
( Ar m E)
( Ar m H)
P o w er b
B N T 1 6 2 b 2 t o
QI V
B N T 1 6 2 b 2
( Ar m E)
QI V
( Ar m G)
P o w er b
9. 5. 2. S afet y
F or safet y o utc o mes i n t he st u d y, Ta ble 8 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 a sa m ple size of 1 5 0, 3 0 0, 6 0 0, 1 2 0 0, 1 5 0 0, 
3 0 0 0, a n d 4 5 0 0 partici pa nts .
T a ble 8.
Pr o b a bilit y of O bser vi n g at L e ast 1 A E , b y Ass u me d Tr ue E ve nt R ate
S a m ple S ize
Ass u me d Tr ue R ate
of a n A E
Pr o b a bilit y of H a v i n g at L e ast 1 
A E
1 5 0
0. 0 1 %
1. 5 %
1 5 0
0. 0 5 %
7. 2 %
1 5 0
0. 1 %
1 3. 9 %
3 0 0
0. 0 1 %
3. 0 %
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 2
T a ble 8.
Pr o b a bilit y of O bser vi n g at L e ast 1 A E , b y Ass u me d Tr ue E ve nt R ate
S a m ple S ize
Ass u me d Tr ue R ate
of a n A E
Pr o b a bilit y of H a v i n g at L e ast 1 
A E
3 0 0
0. 0 5 %
1 3. 9 %
3 0 0
0. 1 %
2 5. 9 %
6 0 0
0. 0 1 %
5. 8 %
6 0 0
0. 0 5 %
2 5. 9 %
6 0 0
0. 1 %
4 5 . 1%
1 2 0 0
0. 0 1 %
1 1 . 3%
1 2 0 0
0. 0 5 %
4 5 . 1%
1 2 0 0
0. 1 %
6 9. 9 %
1 5 0 0
0. 0 1 %
1 3. 9 %
1 5 0 0
0. 0 5 %
5 2. 8 %
1 5 0 0
0. 1 %
7 7. 7 %
3 0 0 0
0. 0 1 %
2 5. 9 %
3 0 0 0
0. 0 5 %
7 7. 7 %
3 0 0 0
0. 1 %
9 5. 0 %
4 5 0 0
0. 0 1 %
3 6. 2 %
4 5 0 0
0. 0 5 %
8 9. 5 %
4 5 0 0
0. 1 %
9 8. 9 %
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 3
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 deli 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 otif y i 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 re 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 4
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 deli 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 b-i 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 n vesti 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 year 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 
d eci 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, t he s hari n g of data relate d t o t he st u dy, 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 ot her 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 per s 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 CD.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 5
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 nf or me d 
c o nse nt d oc u me nt (eI C 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 or 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 dy 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 t he 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 partici 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 nt ifia 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 
partici 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 access.
T he s p o ns or mai ntai ns S O P s 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 6
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
T his st u d y  will use a n E D M C. T he E D M C is i n de pe n de nt of t he st u d y tea m a n d i ncl u des
o nl y  e xter nal me m bers. T he E D M C c harter descri bes t he r ole of t he E D M C i n m ore detail.
T he E D M C 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 he rec o m me n dati o ns ma de b y t he E D M 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 vie w 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
e n d p oi nt e ve nts a n d of safet y data t hat are n ot e n d p oi nts, 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.
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 he 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 the 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
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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 7
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 pers 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 derstan 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 
1 8 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 electr 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 .
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 n nel 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 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 8
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 part y 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 m ust e ns ure t hat t he rec or ds c o nti n ue t o be st ore d sec urely 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 vesti 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 rel ati 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.
Data 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.
Defi niti o n of w hat c o nstit utes a s o urce d oc u me nt , 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 data ma na ge me nt 
pla 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 rec or d) 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 9
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. Use of Me dic al Rec or ds
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 b y 
Pfizer Safet y , w here et hicall y  a n d scie ntificall y j ustifie d a n d per mitte d b y l ocal re g ulati o ns, 
t o e ns ure partici pa nt safet y.
D ue t o t he p ote ntial f or a partici pa nt t o be re -i de ntifie d fr o m t heir me dical rec or ds, t he 
f oll o wi n g acti o ns 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:

T he i n vesti gat or or site staff m ust re dact pers o nal i nf or mati o n fr o m t he me dical rec or d. 
T he pers o nal i nf or mati o n i ncl u des, b ut is n ot li mite d t o, t he f oll o wi n g: partici pa nt na mes 
or i nitials , partici pa nt dates (e g, birt h date, date of h os pital a d missi o n/ disc har ge, date of 
deat h), partici pa nt i de ntificati o n n u m bers (e g, S ocial Sec urit y n u m ber, healt h i ns ura nce 
n u m ber, me dical rec or d n u m ber, h os pital/i nstit uti o n i de ntifier), partici pa nt l ocati o n 
i nf or mati o n (e g, street a d dress, city, c o u ntr y, p ostal c o de, I P a d dress), partici pa nt 
c o ntact i nf or mati o n (e g, tele p h o ne/fa x n u m ber, e mail a d dress).

Eac h me dical rec or d m ust be tra ns mitte d t o t he s p o ns or or s p o ns or desi g nee usi n g 
s yste ms wit h tec h nical a n d or ga nizati o nal sec urit y  meas ures t o e ns ure t he pr otecti o n of 
pers o nal data (e g, Fl ore nce is t he preferre d sys te m if a vaila ble).

T here m a y  be u n pla n ne d sit uati o ns w here t he s p o ns or ma y re q uest me dical rec or ds 
(e g, s hari n g me dical rec or ds s o t hat t he s p o ns or ca n pr o vi de st u d y-relate d a d vice t o t he 
i n vesti gat or). T he me dical rec or ds s h o ul d be s u b mitte d acc or di n g t o t he pr oce d ure 
descri be d a b o ve.
1 0. 1. 1 0. 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 re ser ves t he ri g ht 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 
asses s 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 a n 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 0
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 de 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 f or 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.
St u d y  ter mi nati o n is als o pr o vi ded f or i n t he cli nical st u d y  a gree me nt. If t here is a n y 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 1. 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 aft er 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 gat 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 , “ pu 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 prietar y  i nf or mati o n a n d t o pr o vi de 
c o mme 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 usly 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 din 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 1
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 I nter 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 ors 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 2. S p o ns or’s Me dic all y Q u alifie d I n di vi d u al
T he s p o ns or will desi g nate a me dicall y q ualifie d i n di vi d ual ( M QI ), als o k n o w n as t he 
me dical m o nit or , t o a d vise t he i n vesti gat or o n st u d y-relate d me dical q uesti o ns. T he c o ntact 
i nf or mati o n f or t he st u dy me dical m o nit or is d oc u me nte d i n t he St u d y Tea m C o ntact L ist 
l ocate d i n t he site bi n der/i n vesti gat or site file.
Partici pa nts are pr o vi de d wit h a Pfizer st u d y  i nf or mati o n car d at t he ti me of i nf or me d c o nse nt 
w hic h i ncl u des c o ntact i nf or mati o n f or t heir i n vesti gat or i n case of st u d y-relate d me dical 
q uesti o ns. T he st u d y  i nf or mati o n car d c o ntai ns, at a mi ni m u m, (a) st u dy n u m ber, ( b) 
partici pa nt’s st u d y i de ntificati o n n u m ber, a n d (c) pri nci pal i n vesti gat or c o ntact i nf or mati o n.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 2
1 0. 2. A p pe n di x 2: Cli nic al L a b or at or y Tests
If a p pr o priate, a pre g na nc y test will be perf or me d at ti mes defi ne d i n t he S o A .

Pre g na n c y  test ( β- h C G): L ocal uri ne testi n g will be sta n dar d f or t he pr ot oc ol u nless 
ser u m testi n g is re q uire d b y l ocal re g ulati o n or I R B/ E C f or partici pa nts w h o are 
W O C B P.
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 ny 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 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 3
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 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 test res ults t hat 
meet a n y 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 sy m 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 ver 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 4
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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 5
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 nific 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 r e 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 n si ve treat me nt 
i n a n e mer ge nc 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 6
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 usi n g t he Vacci ne S A E Re p ort F or m or via P S S A 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 ypes 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 / P S S A 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. AEs s h o ul d be rec or de d usi n g c o ncise 
me dical te r 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 / P S S A 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 / P S S A 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 
( whet 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 
( whet 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 d y 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 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 a n d 
E D P S u p ple me ntal F or m or via P S S A .
* *
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 or via P S S A , 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 wit h t he E D B.
* * * E n vir o n me nt al or occ 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 
Pf izer Safet y usi n g t he Vacci ne S A E Re p ort F or m or via P S S A .

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 o s 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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 7

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 vesti gat or t o se n d p h ot oc o pies of t he partici pa nt’s 
me d ical 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. Refer t o Secti o n 1 0. 1. 9 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.

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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 8
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.

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 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 bef 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 secti o n of t he Vacci n e S A E Re p ort F or m / P S S A 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 9
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 h er 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 mati 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 (e g, e S A E or P S S A).

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 re p ort 
f or m (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 data 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 n g 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 o n) or t o 
Pfizer Safet y  b y tele p h o ne.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 0
S A E Re p orti n g t o Pfizer S afet y vi a t he Vacci 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 o ne of t he preferre d 
met h o ds 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 se nt 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 1
1 0. 4. A p pe n di x 4: C o ntr ace pti ve a n d B arrier G ui d a nce 
1 0. 4. 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 preferre 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 hl y 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 C B P
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. 4. 2. Fe m ale P artici p a nt Re pr o d ucti ve I ncl usi o n Cri teri 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 
re pr o d ucti ve re q uire me nts f or i ncl u di n g fe male partici pa nts. Refer t o Secti o n 1 0. 4. 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. 4. 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 2
T he i n vesti gat or is res p o nsi ble f or re vie w of me dical his t 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. 4. 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 or oli g o me n orr hea ) 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 narc hal .
2.
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 nfertilit 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.
3.
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 a lter 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 3
1 0. 4. 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 hose 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 ociate 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.
8.
Se x ual absti ne nce

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 defi ne 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 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 4
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 nl y 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 o r 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 mici 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 5
1 0. 5. A p pe n di x 5: 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, s usce pti bilit y 
t o, a n d se verity 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 RB s/ 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/o r R N A a nal ysis.

T he res ults of ge netic a nal y ses 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 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 ntialit y .

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 ) will 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 6
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 - Up 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 ym 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 b ili val ues will be ele vate d wit hi n 
t he sa me la borat or y sa m ple). I n rare i nsta nces, b y t he ti me T b ili ele vati o ns are detecte d, 
A S T/ A L T val ues mi g ht ha ve decrease d. T his oc c 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 baseli ne val ues a n d u n derl yi 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 y sis 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 mal 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).

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).
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 7
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 hys ical 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, e osi n o p hils ( %), a n d al k ali 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 nalys es at t he ti me of t he rec o g nize d 
i nitial a b n or malities to 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 by 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 ollect e d. F urt her testi n g f or ac ute 
he patitis A, B, C, D, a n d E i nfecti o n , t otal bile aci ds, 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 nstrat e d o n re peat testi n g as meeti n g t he 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, irres 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 8
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 Screat 
meas ure me nt t o esti mate ki d ne y f u ncti o n [ Screat -base d e G F R] or creati ni ne cleara nce 
[e Cr Cl]). Baseli ne a n d p ost baseli ne Sc ys ma kes it feasi ble t o disti n g uis h A KI fr o m ot her 
ca uses of Screat i ncrease. If Screat 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.
A D U L T S: C urre ntl y, 2 0 2 1 C K D -E PI  e G F R e q uati o ns ( Screat- o nl y base d a n d c o m bi ne d 
Screat pl us Sc y s-base d) are vali d f or use i n a d ults o nl y . At baseli ne Screat a n d Sc ys val ues 
are nee de d t o calc ulate 2 0 2 1 C K D -E PI  e G F R b y Screat- o nl y base d e q uati o n (see t he ta ble i n 
Secti o n 1 0. 7. 2. 1 ) a n d by c o m bi ne d Screat pl us Sc ys -base d e q uati o n. W he n p ost baseli ne 
Screat i ncrease ≥0. 3 m g/ d L  is c o nfir me d, t he n refle x Sc ys meas ure me nt is nee de d t o e na ble 
p ost baseli ne c o m paris o n of e G F R c ha n ges ( Screat -o nl y base d e G F R a n d c o m bi ne d Screat 
pl us Sc y s e G F R).
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
e G F R ( m L/ mi n/ 1. 7 3 m²)
2 0 2 1 
C K D -E PI 
Scr e at O nl y
Scr e at
( m g/ d L)
Sc ys
( m g/ 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 eat/ 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 eat/ 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 eat/ 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 eat/ 0. 9)-1. 2 0 0 × ( 0. 9 9 3 8) A ge
2 0 2 1 
C K D -E PI 
Scr e at-Sc ys 
C o m bi ne d
Scr e at
( m g/ d L)
Sc ys
( m g/ 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 eat/ 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 eat/ 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 eat/ 0. 7)-0. 5 4 4 × ( Sc ys/ 0. 8)-0. 3 2 3 ×
( 0. 9 9 6 1)A ge
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 9
Fe male
if 0. 7
if 0. 8
e G F R = 1 3 0 × ( Scr eat/ 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 eat/ 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 eat/ 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 eat/ 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 eat/ 0. 9)-0. 5 4 4 × ( Sc ys/ 0. 8)-0. 7 7 8 ×
( 0. 9 9 6 1)A ge
I nker L A et al. N E n gl J Me d. 2 0 2 1; 3 8 5( 1 9): 1 7 3 7 - 4 94 3
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 K DI G O
criteri a.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 0
1 0. 8. A p pe n di x 8: 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).

Ne w pr ol o n gati o n of Q Tc F b y > 6 0 ms fr o m baseli ne.

Ne w - onset 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 d 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 .

A bs ol ute val ue of Q Tc F > 4 5 0 ms A N D Q Tc F c ha n ge fr o m baseli ne > 6 0 ms.

Ne w S T -T c ha n ges s u g gesti ve of m y ocar 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 as yst olic
pa uses ≥3 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 as ys t olic pa uses of at least 5 sec o n ds or l o n ger .

Atrial fl utter or fi brillati o n, wit h ra pi d ve ntric ular res p o nse rate: ra pi d = rate 
> 1 2 0 b p m.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 1

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) .

Ve ntric ular rh y t h ms > 3 0 sec o n d d urati o n, i ncl u di n g i di o ve ntric ular r h yt 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 d 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 ula r 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 maj or e ve nts of p ote ntial cli nical c o ncer n liste d a b o ve 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 is t o be re p orte d as AEs / S A Es.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 2
1 0. 9. A p pe n di x 9 : A Es , 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 n s 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. 9. 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  A Es 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 yme 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 ves ti gati o nal me dical de vice as well as a ny 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. 9. 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 3
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 n 2 1 C F R 8 1 3. 3) is a 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. 9. 3. Defi niti o n of De vice Deficie nc y
De vice Deficie nc y D efi 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. 9. 4. Rec or d i n g/ Re p orti n g a n d F oll o w - Up 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 orda nce wit h t he i n vesti gat or’s n or mal 
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  c o ntact met h o d, 
e g, tele p h o ne, 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 for 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.

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 A E 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 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 4
De vice Deficie nc y Rec or di n g
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 an d 8. 4. 1. 2 .

T here m a 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. Refer t o Secti o n 1 0. 1. 9 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 n y 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 her e 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 u rri 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 de vice 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 y s 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 p r o d uct inf or mati o n, f or mar kete d 
pr o d ucts i n t heir assess ment.

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 have pr o vi de d a n assess me nt of 
ca usalit y.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 5
Assess me nt of C a us alit y Occ u rri n g i n C o nj u ncti o n Wit h a Me dic al De vice Deficie nc 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 ca usalit 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 m a 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.
F oll o w - Up of Me dic al De vice
D eficie 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 De vice C o m plai nt for 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 .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 6
1 0. 1 0. A p pe n di x 1 0 : 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 HI 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 p y 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 Be 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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 7
1 0. 1 1. A p pe n di x 1 1: Str ai n a n d D ose Selecti o n
T he selecte d m o d R N A vacci ne d ose le vel a n d strai n t o be use d i n t his st u d y  will be base d o n 
P hase 1/ 2 safet y a n d i m m u n o ge nicit y data a n d will be detaile d i n t he I P M. T he strai ns a n d 
d oses t hat are selecte d ca n be f o u n d i n Ta ble 9.
T a ble 9.  
C 5 2 6 1 0 0 1: qI R V/ B N T 1 6 2 b 2 a n d tI R V/ B N T 1 6 2 b 2 C o m bi n ati o ns
V acci ne
Gr o u p a
m o d R N A V acci ne
B N T 1 6 2 b 2
T ot al 
m o d R N A
D ose
3
3 0 µ g
9 0 µ g
1 1
3 0 µ g
7 5 µ g
a.
T he vacci ne gr o u p is fr o m C 5 2 6 1 0 0 1 , A P hase 1/ 2 St u d y t o E val uate t he Safet y, T olera bilit y, 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 i n 
Healt h I n di vi d uals, S u bst u d y B .
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 8
1 0. 1 2. A p pe n di x 1 2 : 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 1 (1 2 J a n u ar y 2 0 2 4 )
O ver all R ati o n ale f or t he A me n d me nt:
 
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
S u bst a nti al M o dific ati o n(s)
I ncrease i n t he t otal 
n u m ber of 
partici pa nts i n 
C o h ort 2 t o 4 5 0 0 b y  
i ncreasi n g t he 
/ B N T 1 6 2 b 2 
( O mi X B B. 1. 5) st u dy 
ar m t o 3 0 0 0 
partici pa nts a n d 
e nr olli n g i n a 2: 1 
rati o.
 
 f or a safety 
data base of 3 0 0 0 
partici pa nts t o 
s u p p ort lice ns ure of 
t his c o m bi nati o n.
1. 1 . S yn o psis
4. 1 . Desi g n
9. 5. 1. I mm u n o ge nicit y
N o ns u bst a nti al M o dific ati o n(s)
Descri pti o n of 
sit uati o ns w here 
tele healt h visits are 
per missi ble i n t he 
st u d y.
T o clarif y  t hat 
tele healt h visits ma y 
be use d f or safet y 
visits w here bl o o d 
dra ws are 
disc o nti n ue d.
8. 1. 1 . Tele healt h Visits
8. 1 0. 3 . Visit 2
8. 1 0. 4 . Visit 3
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 7 ( G M T)
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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 9
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
F urt her clari ficati o n 
of per missi ble 
c ortic oster oi ds b y 
clarif yi n g hi g h- a n d 
l o w-d ose a n d 
l o n g- a n d s h ort -ter m 
a d mi nistrati o n.
T o pr o vi de a d diti o nal 
clarit y t o t he ti me 
fra mes a n d d oses 
me nti o ne d i n 
P A C L  2. 0.
5. 2 . E xcl usi o n Criteria
5. 4 . Criteria f or Te m p oraril y Delayi 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
6. 9. 1 . Pr o hi bite d D uri n g t he St u d y
A d diti o n of 
Cli nical Trials. g o v 
I D.
T he I D beca me 
a vaila ble after t he 
i nitial pr ot oc ol was 
writte n.
Title pa ge
1. 1 . S yn o psis
Clarifie d t hat all 
pri or C O VI D - 1 9 
vacci nati o n hist or y  
a n d 3 years ( pri or t o 
e nr oll me nt) of 
lice nse d or 
i n vesti gati o nal 
i nfl ue nza vacci ne 
hist or y  was t o be 
c ollecte d. 
T o pr o vi de a 
mi ni m u m 
re q uire me nt t o sites 
o n t he c ollecti o n of 
i nfl ue nza vacci nati o n 
hist or y . 
6. 9 . Pri or a n d C o nc o mita nt T hera py
Mi n or e diti n g of t he 
rati o nale secti o ns t o 
f oc us o n C 5 2 6 1 0 0 1 
S u bst u d y  B.
T o e ns ure t hat t he 
rati o nale secti o ns are 
a p pr o priate f or t his 
st u d y.
1. 1 . S yn o psis
2. 1 . St u d y Rati o nale
Mi n or clarificati o ns 
of t he c o h ort ar ms, 
i ncl u di n g s pecif yi n g 
t he delt oi d t hat was 
use d f or st u d y 
i nter ve nti o n 
a d mi nistrati o n earl y 
i n t he st u d y. 
T o f urt her clarif y  
w hic h delt oi d t he 
vacci nes are 
a d mi nistere d i nt o.
4. 1 . Desi g n
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 0
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
Mi n or clarificati o n of 
t he i nter ve nti o ns 
pr o hi bite d d uri n g t he 
st u d y res ulti n g i n 
e xcl usi o n fr o m 
a nal ys is of 
i m m u n o ge nicity data, 
a n d mi n or 
t yp o gra p hical 
c ha n ges.
T o pr o vi de a d diti o nal 
clarit y t hat me dical 
i nter ve nti o ns 
c o nsi dere d necessar y 
s h o ul d n ot be 
wit h hel d, b ut t he y
s h o ul d res ult i n 
e xcl usi o n fr o m 
i m m u n o ge nicity 
a nal ys is.
6. 9. 1 . Pr o hi bite d D uri n g t he St u d y
E diti n g of te xt i n 
A E SI  ti meli nes t o 
f urt her clarif y t hat 
A E SI s, u nless 
s pecifie d ot her wise, 
s h o ul d be c ollecte d 
after vacci nati o n 
t hr o u g h 6 m o nt hs. 
Secti o n n o w 
co nsiste nt i n 
descri pti o n wit h 
ot her pr ot oc ol 
secti o ns.
T o pr o vi de f urt her 
clarit y o n t he A E SI 
c ollecti o n ti meli nes.
8. 4. 8 . Pr ot oc ol- S pecifie d A d verse E ve nts 
of S pecial I nterest
Mi n or clarificati o n 
t hat me dicati o n use 
i n dicate d i n t he 
e-diar y  s h o ul d be 
tra nscri be d i nt o t he 
C R F.
T o pr o vi de a d diti o nal 
clarificati o n of h o w 
me dicati o n use 
s h o ul d be 
tra nscri be d.
8. 3. 4. 5 . A nti p yretic Me dicati o n
U p date t o t he W H O 
a nti ge n c o m p ositi o n 
state me nt t o i n dicate 
n o c ha n ge i n strai n 
c o m p ositi o n 
rec o m me n dati o n.
T o reflect t he latest 
g ui da nce i n t he W H O 
a nti ge n c o m p ositi o n 
state me nt f or t he 
C O VI D -1 9 vacci nes.
2. 2. 3. 1 . S A R S-C o V -2
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 1
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
Descri pti o n of 
preli mi nar y  data 
fr o m St u d y 
C 4 7 8 1 0 0 4.
T o pr o vi de f urt her 
e vi de nce of i nfl ue nza 
vacci ne efficac y .
2. 2. 3. 2 . Infl ue nza
F o ot n ote a d de d t o 
Ta ble 9 t o i n dicate 
w hic h st u d y  t he 
vacci ne gr o u ps are 
fr o m.
T o clarif y  t hat t he 
vacci ne gr o u ps i n t his 
ta ble are relate d t o a 
se parate st u d y.
1 0. 1 1 . A p pe n di x 1 1: Strai n a n d D ose 
Selecti o n
Mi n or t y p o gra p hical 
c ha n ges t hr o u g h o ut.
T o c orre ct mi n or 
t yp o gra p hical err ors.
1. 1 . S yn o psis
2. 1 . St u d y Rati o nale
2. 2. 3. 1 . S A R S-C o V -2 
2. 2. 3. 3 . C o m bi ne d Infl ue nza a n d 
C O VI D -1 9 Vacci nes
3 . O bjecti ves, E n d p oi nts, a n d Esti ma n ds
4. 1 . Desi g n
6. 1 . St u d y Inter ve nti o n(s) A d mi nistere d
6. 9. 1 . Pr o hi bite d D uri n g t he St u d y
8. 2 . Im m u n o ge nicit y Assess me nts
8. 2. 1. Testi n g f or S A R S- C o V -2 a n d 
I nfl ue nza E x p os ure
8. 3. 5 . Pre g na nc y Testi n g 
8. 4. 8 . Pr ot oc ol- S pecifie d A d verse E ve nts 
of S pecial I nterest
9. 3. 2 . Pri mar y E n d p oi nt(s)/ Esti ma n d(s) 
A nal y sis
9. 3. 4 . E x pl orat or y E n d p oi nt(s)
9. 4. 1 . A nal ysis Ti mi n g
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 2
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
P A C L  2. 0 
( 2 0 Dec 2 3): After 
e nr oll me nt of 
~ 4 5 0 partici pa nts 
i nt o C o h ort 1, t he 
I R T sys te m will 
i m ple me nt a pa use 
o n e nr oll me nt, 
all o wi n g f or 
o bser vati o n of safet y 
data f oll o wi n g 
vacci nati o n 
(i ncl u di n g e-diar y  
data, S A Es, A Es, a n d 
A E SI s) f or 6 0 da ys 
after vacci nati o n. 
T he E D M C will 
re vie w t he safety 
data pri or t o t he 
c o nti n uati o n of 
e nr oll me nt of t he 
re mai ni n g 
partici pa nts i n 
C o h ort 1.
 
 
m o dificati o ns t o 
f urt her s u p p ort t he 
safety a nal ysis of t he 
c o m bi ne d 
a n d 
B N T 1 6 2 b 2 ( O mi 
X B B 1. 5) vacci ne 
(
/ B N T 1 6 2 b 2 
[ O mi X B B. 1. 5]).
4. 1 . Desi g n
6. 3 . Assi g n me nt t o St u d y Inter ve nti o n
9. 5. 2 . Safety
P A C L  2. 0 
( 2 0 Dec 2 3): T he 
ti me fra mes d uri n g 
w hic h c hr o nic 
s yste mic treat me nt 
wit h c ortic oster oi ds 
is pr o hi bite d d uri n g 
t he st u d y were 
u p date d t o 6 0 da ys 
bef ore a n d after 
e nr oll me nt f or 
s yste mic 
c ortic oster oi ds at 
≥2 0 m g/ da y  
pre d nis o ne or 
e q ui vale nt f or 
≥1 4 da y s, a n d 
T o clarif y t he 
differe nt ti me fra mes 
wit hi n w hic h c hr o nic 
a n d s h ort -ter m 
s yste mic 
c ortic oster oi ds are 
pr o hi bite d d uri n g t he 
st u d y.
6. 9. 1 . Pr o hi bite d D uri n g t he St u d y
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 3
Descri pti o n of 
C h a n ge
Brief R ati o n ale
Secti o n # a n d N a me
u p date d t o 2 8 da ys 
bef ore a n d after
e nr oll me nt f or 
s yste mic 
c ortic oster oi ds at 
≥2 0 m g/ da y  
pre d nis o ne or 
e q ui vale nt f or 
1 4 da y s.
P A C L  1. 0 
( 0 1 Dec 2 3): 
A d diti o n t hat A Es 
are c ollecte d u p t o 
Visit 2, w hile S A Es 
are c ollecte d u p t o 
Visit 3.
T o clarif y  t he “acti ve 
c ollecti o n peri o d” f or 
c ollecti n g A E, S A E, 
a n d A E SI 
i nf or mati 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
1. 2 . Sc he ma
2. 3. 1 . Ris k Assess me nt
P A C L  1. 0 
( 0 1 Dec 2 3): U p date 
of t he wi n d o w f or 
n o nst u d y  
vacci nati o ns t o 
2 8 da y s bef ore a n d 
2 8 da y s after st u d y 
vacci nati o n.
T o u p date t he date 
w here n o nst u d y 
vacci nes are 
pr o hi bite d, t o c orrect 
a t yp o gra p hical err or.
6. 9. 1 . Pr o hi bite d D uri n g t he St u d y
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 4
1 0. 1 3. A p pe n di x 1 3 : A b brevi 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 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 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
-h C G
beta -h u ma n c h ori o nic g o na d otr o pi n
bI R V
bi vale nt i nfl ue nza m o d R N A vacci ne
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 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 ( U nite d States)
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
c hr o nic ki d ne y disease e pi 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 C T
data c ollecti o n t o ol
DI LI
dr u g -i n d uce d li ver i nj ur y
D N A
de o x yri b o n ucleic aci d
E C
et hics c o m mittee
E C G
electr ocar di o gra m
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
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 5
A b bre vi ati o n
Ter m
eIC D
electr o nic i nf or me d c o nse nt d oc u me nt
E M A
E ur o pea n Me dici nes A ge nc y
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)
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 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 D
i de ntificati o n
I g G
i m m u n o gl o b uli n G
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
I nter net Pr ot oc ol
I P A L
in vesti gati o nal p r o d uct acc o u nta bilit y lo 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 T
i nteracti ve res p o nse tec h n ol o g y
I R V
i nfl ue nza m o d R N A vacci ne
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)
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 6
A b bre vi ati o n
Ter m
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
nat ural l o g
L N P
li pi d na n o particle
M D R
me dical de 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
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
O mi
O micr o n
P A C L
pr ot oc ol a d mi nistrati ve c ha n ge letter
P C R
p ol y merase c hai n reacti o n
P F S
prefille d s yri n ge(s)
PI
pri nci pal i n vesti gat or
P S S A
Pfizer’s Seri o us A d verse E ve 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 b y  t he Fri dericia 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
S 1
s pi ke pr otei n S 1 s u b u nit
S A D E
seri o us a d verse de vice effect
S A E
seri o us a d verse e ve nt
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 
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 7
A b bre vi ati o n
Ter m
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
Screat
ser u m creati ni ne
Sc y s
ser u m c ystati n C
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 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 h 1
T -hel per t y pe 1
tIR V
tri vale nt i nfl ue nza m o d R N A vacci ne
U A D E
u na ntici pate d a d verse de vice effect
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
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
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 8
1 1. R E F E R E N C E S
1
W H O. 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. 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. 
P u blis he d: 2 4 Fe b 2 0 2 3. Accesse d: 0 2 Oct 2 0 2 3.
2
Pa get J, Cai ni S, Del Ricci o M, et al. Has i nfl ue n za B/ Ya ma gata bec o me e xti nct a n d 
w hat i m plicati o ns mi g ht t his ha ve f or q ua dri vale nt i nfl ue nza vacci nes? E ur o S ur veill. 
2 0 2 2; 2 7( 3 9): 2 2 0 0 7 5 3. D OI : 1 0. 2 8 0 7/ 1 5 6 0-7 9 1 7. E S. 2 0 2 2. 2 7. 3 9. 2 2 0 0 7 5 3.
3
F D A. Vacci nes a n d Relate d Bi ol o gical Pr o d ucts A d vis or y  C o m mittee Octo ber 5, 2 0 2 3 
meeti n g a n n o u nce me nt. A vaila ble fr o m: htt ps:// w w w.f da. g o v/a d vis or y -
c o m mittees/a d vis or y-c o m mittee-cale n dar/ 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-meeti n g -a n n o u nce me nt #e ve nt- materials. 
P u blis he d: 0 5 Oct 2 0 2 3. Accesse d: 1 1 Oct 2 0 2 3.
4
W H O. 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 4 
2 0 2 5 n ort her n he mis p here i nfl 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 3 - 0 2- 2 0 2 4-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 4- 2 0 2 5- n ort her n -he mis p here -i nfl ue nza-seas o n. 
P u blis he d: 2 3 Fe b 2 0 2 4. Accesse d: 1 7 Mar 2 0 2 4.
5
F D A. Use of tri vale nt i nfl ue nza vacci nes f or t he 20 2 4- 2 0 2 5 U. S. i nfl ue nza seas o n.
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/l ot -release/ use-tri vale nt-
i nfl ue nza-vacci nes - 2 0 2 4- 2 0 2 5- us-i nfl ue nza-seas o n. P u blis he d: 0 5 Mar 2 0 2 4. Accesse d: 
1 7 Mar 2 0 2 4.
6
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.
7
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.
8
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 3.
9
F D A. F D A r o 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 ul y-8- 2 0 2 2. Accesse d: 1 1 Fe b 2 0 2 3.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 9
1 0
W H O. State me nt o n t he a nti ge n c o m p ositi o n of C O VI D -1 9 vacci nes. A vaila ble fr o m: 
htt ps:// w w w. w h o.i n t/ ne ws/ite m/ 1 3- 1 2- 2 0 2 3-state me nt- o n-t he-a nti ge n -c o m p ositi o n -of-
c o vi d- 1 9-vacci nes . P u blis he d: 1 1 Dec 2 0 2 3. Accesse d: 2 3 Dec 2 0 2 3.
1 1
Li n k -Gelles R, Ciesla A A, R o per L E, et al. Earl y esti mates of bi vale nt m R N A b o oster 
d ose vacci ne effecti ve ness i n pre ve nti n g s ym pt o matic S A R S -C o V -2 i nfecti o n 
attri b uta ble t o O micr o n B A. 5 - a n d X B B/ X B B. 1. 5 -relate d s u bli nea ges a m o n g 
i m m u n oc o m pete nt a d ults - i ncreasi n g c o m m u nit y access t o testi n g pr o gra m, U nite d 
States, Dece m ber 2 0 2 2 -Ja n uar y 2 0 2 3. M M W R M or b M ortal W kl y Re p. 
2 0 2 3; 7 2( 5): 1 1 9 - 2 4.
1 2
S urie D, De C uir J, Z h u Y, et al. Earl y esti mates of bi vale nt m R N A vacci ne effecti ve ness 
i n pre ve nti n g C O VI D- 1 9 –ass ociate d h os pitalizati o n a m o n g i m m u n oc o m pete nt a d ults 
a ge d ≥6 5 y ears — I V Y Net w or k, 1 8 states, Se pte m ber 8– N o ve m ber 3 0, 2 0 2 2. M M W R
M or b M ortal W kl y  Re p. 2 0 2 2; 7 1( 5 1 5 2): 1 6 2 5- 3 0.
1 3
Te nf or de M W, We ber Z A, Nataraja n K, et al. Earl y  esti mates of bi vale nt m R N A 
vacci ne effecti ve ness i n pre ve nti n g C O VI D - 1 9 –ass ociate d e mer ge nc y de part me nt or 
ur ge nt care e nc o u nters a n d h os pitalizati o ns a m o n g i m m u n oc o m pete nt a d ults —
VI SI O N 
Net w or k, ni ne states, Se pte m ber – N o ve m ber 2 0 2 2. M M W R M or b M ortal W kl y  Re p. 
2 0 2 3; 7 1( 5 3): 1 6 3 7 -4 6.
1 4
Fa bia ni M, Mate o - Ur diales A, Sacc o C, et al. Pr otecti o n a gai nst se vere C O VI D-1 9 after 
sec o n d b o oster d ose of a da pte d bi vale nt ( ori gi nal/ O micr o n B A. 4-5) m R N A vacci ne i n 
pers o ns ≥  6 0 years, b y ti me si nce i nfecti o n, Ital y, 1 2 Se pte m ber t o 1 1 Dece m ber 2 0 2 2. 
E ur o S ur veill. 2 0 2 3; 2 8( 8): 2 3 0 0 1 0 5. D OI : 1 0. 2 8 0 7/ 1 5 6 0-7 9 1 7. E S. 2 0 2 3. 2 8. 8. 2 3 0 0 1 0 5.
1 5
Li n k -Gelles R. C D C. Data prese nte d at t he A CI P me eti n g ( 1 9 A pril 2 0 2 3). A vaila ble 
fr o m: htt ps:// w w w.c dc. g o v/ vacci nes/aci p/ meeti n gs/ d o w nl oa ds/sli des- 2 0 2 3- 0 4-1 9/ 0 5 -
C O VI D -Li n k -Gelles -5 0 8. p df. Accesse d: 3 0 J u n 2 0 2 3.
1 6
Li n D Y, X u Y, G u Y, et al. Effecti ve ness of bi vale nt b o osters a gai nst se vere O micr o n 
i nfecti o n. N E n gl J Me d. 2 0 2 3; 3 8 8( 8): 7 6 4- 6.
1 7
C D C. C O VI D d ata trac ker. Atla nta, G A: U S De part me nt of Healt h a n d H u ma n 
Ser vices, C D C. A vaila ble fr o m: htt ps://c o vi d.c dc. g o v/c o vi d -data -trac ker. P u blis he d: 
0 3 J u n 2 0 2 3. Accesse d: 0 3 J u n 2 0 2 3.
1 8
Li n k -Gelles R, We ber Z A, Reese S E, et al. Esti mates of bi vale nt m R N A vacci ne 
d ura bilit y  i n pre ve nti n g C O VI D- 1 9 –ass ociate d h os pitalizati o n a n d critical ill ness a m o n g 
a d ults wit h a n d wit h o ut i m m u n oc o m pr o misi n g c o n diti o ns —
VI SI O N Net w or k, 
Se pte m ber 2 0 2 2 – A pril 2 0 2 3. M M W R M o r b M ortal W kl y Re p. 2 0 2 3; 7 2( 2 1): 5 7 9- 8 8.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 5 0
1 9
P o u k ka E, N o h y ne k H, G oe beler S, et al. Bi vale nt b o oster effecti ve ness a gai nst se vere 
C O VI D -1 9 o utc o mes i n Fi nla n d, Se pte m ber 2 0 2 2 —
Marc h 2 0 2 3. me d R xi v 2 0 2 3. D OI : 
htt ps:// d oi. or g/ 1 0. 1 1 0 1/ 2 0 2 3. 0 3. 0 2. 2 3 2 8 6 5 6 1. A vail a ble fr o m: 
htt ps:// w w w. me dr xi v. or g/c o nte nt/ 1 0. 1 1 0 1/ 2 0 2 3. 0 3. 0 2. 2 3 2 8 6 5 6 1 v 3. Accesse d: 
3 0 J u n 2 0 2 3 .
2 0
Cara belli A M, Peac oc k T P, T h or ne L G, et al. S A R S -C o V -2 varia nt bi ol o g y : i m m u ne 
esca pe, tra ns missi o n a n d fit ness. Nat Re v Micr o bi ol. 2 0 2 3; 2 1: 1 6 2 - 7 7. D OI : 
htt ps:// d oi. or g/ 1 0. 1 0 3 8/s 4 1 5 7 9 -0 2 2- 0 0 8 4 1- 7.
2 1
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.
2 2
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.
2 3
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.
2 4
Hall E. I nfl ue nz a. C ha pter 1 2. I n: 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. C D C. Hall E, W o di A P, Ha m b ors k y  J, et al, e ds. Was hi n gt o n, D C: 
P u blic Healt h F o u n dati o n; 2 0 2 1: 1 7 9 - 9 2.
2 5
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 ncet. 2 0 1 8; 3 9 1( 1 0 1 2 7): 1 2 8 5 - 3 0 0.
2 6
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.
2 7
C D C . S u m mar y : ‘ Pre ve nti o n a n d co ntr ol of seas o nal i nfl ue nza wit h vacci nes: 
rec o m me n dat i o ns of t he A d vis or y C o m mittee o n I m m u nizati o n Practices ( A CIP) —
U nite d States, 2 0 2 3- 2 4. ’ A vaila ble fr o m: 
htt ps:// w w w.c dc. g o v/fl u/ pr ofessi o nals/aci p/s u m mar y /s u m mar y-rec o m me n dati o ns. ht m. 
P u blis he d : 2 3 A u g 2 0 2 3. Accesse d: 0 5 Oct 2 0 2 3 .
2 8
C D C. Pre ve nti o n a n d co ntr ol of i nfl ue nza wit h vacci nes: rec o m me n dati o ns of t he 
A d vis or y  C o m mittee o n I m m u nizati o n Practices ( A CIP) —
U nite d States, 2 0 1 2 - 1 3 
infl ue nza seas o n. M or bi d M ortal W kl y Re p. 2 0 1 2; 6 1( 3 2): 6 1 3 - 8. A vaila ble fr o m: 
htt ps:// w w w.c dc. g o v/ m m wr/ pre vie w/ m m wr ht ml/ m m 6 1 3 2a 3. ht m #: ~:te xt =I n % 2 0 Fe br uar
y % 2 0 2 0 1 2 % 2 C % 2 0 F D A % 2 0a p pr o ve d,tri vale nt % 2 0 Fl u Mist % 2 0f or m ulati o n % 2 0
( Ta ble). P u blis he d: 1 7 A u g 2 0 1 2. Accesse d: 0 5 Oct 2 0 2 3.
2 9
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.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 5 1
3 0
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 oll o wi n g sec o n d d ose i n u p date d t o pli ne a nalys 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 2 1. Accesse d: 2 5 Fe b 2 0 2 2.
3 1
F D A. 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.
3 2
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 pan 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.
3 3
F D A. C or o na vir us ( C O VI D -1 9) u p date: F D A rec o m me n ds i ncl usi o n of O micr o n 
B A. 4/ 5 c o m p o ne nt f or C O VI D -1 9 vacci ne b o oster d oses. A vaila ble fr o m: 
htt ps:// w w w.f da. g o v/ ne ws -e ve nts/ press -an n o u nce me nts/c 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 -b o oster. 
Accesse d: 1 0 A u g 2 0 2 3.
3 4
E C D C, E M A. E C D C- E M A state me nt o n u p dati n g C O VI D -1 9 vacci nes c o m p ositi o n f or 
ne w S A R S -C o V -2 vir us varia nts. A vaila ble fr o m:
htt ps:// w w w.e ma.e ur o pa.e u/e n/ d oc u me nts/ ot her/ec dc -e ma-state me nt-u p dati n g -c o vi d - 1 9-
vacci nes -c o m p ositi o n -ne w -sars-c o v-2- vir us -varia nts _e n. p df. P u blis he d: 0 6 J u n 2 0 2 3. 
Accesse d: 2 2 J u n 2 0 2 3.
3 5
F D A. U p date d C O VI D -1 9 vacci nes f or use i n t he U nite d States be gi n ni n g i n fall 2 0 2 3 
[ press release]. 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/ u p date d -
c o vi d- 1 9-vacci nes -use -u nite d -states-be gi n ni n g -fall- 2 0 2 3. P u blis he d: 1 6 J u n 2 0 2 3. 
Accesse d: 2 2 J u n 2 0 2 3.
3 6
F D A . Pfizer -Bi o N Tec h C O VI D- 1 9 v acci ne, 11 Se p 2 0 2 3. 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 ne . Accesse d: 1 4 Se p 2 0 2 3.
3 7
Pfizer I nc. Pfizer re p orts thir d - quarter 2 0 2 3 res ults, 3 1 Oct 2 0 2 3 . A vaila ble fr o m:
htt ps://s 2 8. q 4c d n.c o m/ 7 8 1 5 7 6 0 3 5/files/ d oc _fi na ncials/ 2 0 2 3/ q 3/ Q 3- 2 0 2 3- P F E -Ear ni n gs -
Release. p df . Accesse d: 2 3 Dec 2 0 2 3.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 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 R N A Vacci ne)
Pr ot oc ol C 5 2 6 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 2 , 1 1 A pril 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 ( 1 4 A pril 2 0 2 3)
Pa ge 1 5 2
3 8
F D A. 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 n y 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 .
3 9
F D A. Rec o m me n dati o n f or t he 2 0 2 3- 2 0 2 4 f or m ula of C O VI D - 19 vacci nes i n t he U. S. 
A vaila ble fr o m: htt ps:// w w w.f da. g o v/ me dia/ 1 6 9 5 9 1/ d o w nl oa d?attac h me nt. Accesse d: 
0 2 Oct 2 0 2 3 .
4 0
F D A. C O MI R N A T Y prescri bi n g i nf or mati o n. A vaila ble fr o m: 
htt ps:// w w w.f da. g o v/ me dia/ 1 5 1 7 0 7/ d o w nl oa d?attac h me nt . Accesse d: 0 3 A pr 2 0 2 4
4 1
F D A. 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 di a/ 7 3 6 7 9/ d o w nl oa d. Accesse d: 1 0 A u g 2 0 2 3.
4 3
I n ker L A, E nea nya  N D, C ores h J, et al. Ne w creati ni ne- a n d c ys tati n C-b ase d eq uati o ns 
t o esti mate G F R wit h o ut race. N E n gl J Me d. 2 0 2 1; 3 8 5( 1 9): 1 7 3 7 - 4 9.
0 9 0 1 7 7 e 1 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 7 ( G M T)
C CI

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 a 0 6 9 d 7 d 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- A pr- 2 0 2 4 1 5: 0 7 ( G M T)
P P D
P P D