A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Respiratory Combination Vaccine Candidates in Older Adults
Phase: PHASE1
Conditions: Healthy
Sponsor: Pfizer

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1
A 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 R E S PI R A T O R Y C O M BI N A TI O N V A C CI N E 
C A N DI D A T E S I N O L D E R A D U L T S 
St u d y I nter ve nti o n N u m ber :
P F -0 7 9 4 1 3 1 4
St u d y I nter ve nti o n N a me:
R S V S u b u nit a n d I nfl ue nza m o d R N A 
C o m bi nati o n Vacci ne
U S I N D N u m ber:
N ot a p plica ble
E u dr a C T N u m ber:
N ot a p plica ble
Cli nic al Tri als. g o v I D:  
N C T 0 5 7 8 8 2 3 7
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 4 0 1 0 0 1
P h ase:
1 b
Brief Title: A Safet y, T olera bilit y, an d I m m u n o ge nicit y  St u d y  of R es pirat or y
C o m bi nati o n V acci ne Ca n di dates in Ol der A d ults 
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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2
D oc u me nt Hist or y
D oc u me nt
Versi o n D ate
A me n d me nt 1
3 0 Ma y  2 0 2 3
Ori gi nal p r ot oc ol
2 0 Dec 2 0 2 2
T his a me n d me nt i nc or p orates all re visi o ns t o date, i ncl u di n g a me n d me nts ma de at t he 
re q uest of c o u ntr y healt h a ut h orities a n d I R Bs/ E Cs a n d a n y pr ot oc ol a d mi nistrati ve c ha n ge 
letter(s). 
P R O T O C O L A M E N D M E N T S U M M A R Y O F C H A N G E S T A B L E
A m e n d me nt 1 ( 3 0 M a y 2 0 2 3)
O ver all R ati o n ale f or t he A me n d me nt: 
S u bst u d y  B will i n vesti gate 2 f or m ulati o ns of R S V pre F + qI R V of differi n g v ol u mes a n d 
os m olarities . T hese f or m ulati o ns will be e val uate d f or safet y , t olera bilit y, a n d 
i m m u n o ge nicity , wit h t he g oal of selecti n g a f or m ul ati o n f or f urt her st u d y.
Secti o n # a n d N a m e or
P a ge N u m ber
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or
N o ns u bst a nti al
Secti o n 1. 1. 2
Secti o n 1. 3. 2
Secti o n 1 0. 1 0
A p pe n di x 1 0
A d de d i nf or mati o n 
s pecific t o S u bst u d y B.
S u bst u d y B will e val uate t he 
safet y a n d i m m u n o ge nicit y of 
c o m bi nati o n R S V pre F + qI R V i n 
a 1. 0 -m L v ol u me c o m pare d t o 
R S V pre F + qI R V i n a 0. 5 -m L 
v ol u me.
S u bsta ntial
Secti o n 1. 1. 1. 2 O verall 
Desi g n, 
Secti o n 1 0. 9. 4. 1 S u bst u d y 
A Rati o nale, a n d
Secti o n 1 0. 9. 6. 1 O verall 
Desi g n
C ha n ge d “ m ultice nter” t o 
“si n gle -ce nter.”
T he st u d y desi g n c ha n ge d fr o m 
m ultice nter t o si n gle ce nter after 
pr ot oc ol fi nalizati o n b ut pri or t o 
st u d y start. 
N o ns u bsta ntial
Secti o n 1. 1. 1. 3
Secti o n 1 0. 9. 6. 1
Defi niti o n of e nr olle d
m o difie d .
Ali g n me nt wit h t he S A P .
S u bsta ntial
Secti o n 2. 1
Re vise d t he st u d y 
rati o nale t o a d dress t he 
a d diti o n of S u bst u d y B .
S u bst u d y B a d de d t o pr ot oc ol.
S u bsta ntial
Secti o n 2. 2. 3. 1
U p date d t he Cli nical 
O ver vie w.
M o difie d
C 3 6 7 1 0 0 6 partici pa nt
n u m bers a n d a d de d t he 
i m m u n o ge nicit y res ults.
S u bsta ntial
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3
Secti o n # a n d N a m e or
P a ge N u m ber
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or
N o ns u bst a nti al
Secti o n 2. 2. 3. 2
A d de d t he res ults f or 
S t u d y C 4 7 8 1 0 0 1.
T he n u m ber of 
partici pa nts d ose d w it h 
qI R V i n t he C 4 7 8 1 0 0 4 
st u d y has bee n a d de d. 
Als o a d de d t hat a n 
i n de pe n de nt data re view 
c o m mittee has e n d orse d 
c o nti n uati o n of t he 
C 4 7 8 1 0 0 4 st u d y as of 
M a y  2 0 2 3.
Res ults a vaila bilit y f or 
C 4 7 8 1 0 0 1 .
St u d y stat us f or C 4 7 8 1 0 0 4 as of 
M a y  2 0 2 3.
S u bsta ntial
Secti o n 2. 3. 1
U p date d first a n d last 
ta ble r o ws t o reflect ne w 
i nf or mati o n i n qI R V 
e x p os ures .
C 4 7 8 1 0 0 4 qI R V safet y u p dates 
are a vaila ble .
S u bsta ntial
Secti o n 2. 3. 3
A d de d ris ks a n d be nefits 
a p plica ble t o S u bst u d y B .
Ma n dat or y safet y re q uire me nt.
S u bsta ntial
Secti o n 6. 1. 1
U p date d st u d y 
inter ve nt i o ns.
A d de d details a p plica ble t o 
S u bst u d y B a n d clarifie d t h ose 
i nter ve nti o ns o nl y a p plica ble t o 
S u bst u d y A .
S u bsta ntial
Secti o n 8. 1. 1
Re m o ve d first b ullet 
p oi nt .
N ot a p plica ble t o eit her s u bst u d y.
N o ns u bsta ntial
Secti o n 8. 3. 5
A d d e d pre g na nc y testi n g
re q uire me nts.
W o m e n of c hil d beari n g p ote ntial 
will be recr uite d i n S u bst u d y B .
S u bsta ntial
T hr o u g h o ut D oc u me nt
1.
“See S ectio n ” cr oss -
refere nces ha ve bee n 
a d ded.
2.
A p plie d ass ociati o ns 
b y s u bst u d y .
1.
T hese refer t he rea der t o t he 
l ocati o n of s pecific secti o ns 
of te xt a p plica ble b y
s u bst u dy.
2.
T he a d diti o n of S u bst u d y B 
re q uire d a re visi o n.
N o ns u bsta ntial f or 
b ot h
Secti o n 8. 3. 2. 1 Bl o o d 
Press ure a n d P ulse Rate
Re vise d t he secti o n t o 
i ncl u de t he st u d y ti me 
p oi nt t hat will re q uire 
meas ure me nt of 
partici pa nt p ulse rate a n d 
seate d bl o o d press ure. 
T he a d diti o n of S u bst u d y B 
re q uire d a re visi o n t o t his secti o n 
t o i nc or p orate rele va nt cr oss-
refere nce t o S u bst u d y A a n d
S u bst u d y B.
S u bsta ntial
Secti o n 8. 4. 8 , b ullet 3
M o difie d A E SI state me nt 
i n relati o n t o st u d y 
vacci nati o n.
T he a d diti o n of S u bst u d y  B 
re q uire d a re visi o n t o t his secti o n.
S u bsta ntial
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4
Secti o n # a n d N a m e or
P a ge N u m ber
Descri pti o n of C h a n ge
Brief R ati o n ale
S u bst a nti al or
N o ns u bst a nti al
Secti o n 9. 3. 1
A d de d state me nt t hat 
relate d e-diar y data ma y 
be i ncl u de d i n t he 
a nal ysis.
T o ali g n wit h t he S A P .
S u bsta ntial
Secti o n 1 0. 1. 6 - Data 
S hari n g
M o difie d state me nt t hat 
data s hari n g will bec o me 
a vaila ble i n 1 8 m o nt hs , 
rat her t ha n 2 4 m o nt hs. 
T e m plate u p date .
N o ns u bsta ntial
Secti o n 1 0. 1. 9
St u d y start date defi niti o n 
c ha n ge d.
T e m plate u p date .
N o ns u bsta ntial
Secti o n 1 0. 2
A p pe n di x 2: Cli nical 
La b orat or y Tests
A d de d a state me nt t o 
i n dicate t hat r o uti ne 
cli nical la b orat or y tests 
are n ot a p plica ble t o 
S u bst u d y B.
T he a d diti o n of S u bst u d y B 
re q uire d a re visi o n t o t his secti o n.
S u bsta ntial
Secti o n 1 0. 4. 2. 1 a n d 
Secti o n 1 0. 4. 2. 2
A d de d c o ntrace pti ve 
re q uire me nts f or wo m e n 
of c hil d beari n g p ote ntial .
W o m e n of c hil d beari n g p ote ntial 
will be recr uite d i n S u bst u d y B .
S u bsta ntial
Ta ble 7 , T a ble 8 , T a ble 9
A d de d S o A S u bst u d y B 
as Ta ble 7. U p date d ta ble 
n u m beri n g. 
F or m atti n g c orrecti o n.
N o ns u bsta ntial
Secti o n 1 0. 9. 5 a n d 
Secti o n 1 0. 9. 1 1. 3. 2
T w o e x pl orat or y 
esti ma n ds relate d t o 
S u bst u d y A H AI a nal yses 
ha ve bee n delete d.
M o dificati o ns t o t he S A P .
N o ns u bsta ntial
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5
T A B L E O F C O N T E N T S
P R O T O C O L  A M E N D M E N T SU M M A R Y O F C H A N G E S T A B L E ......................................2
LI S T O F T A B L E S ................................................................................................................... 1 3
1. P R O T O C O L  S U M M A R Y................................................................................................... 1 5
1. 1. S y n o psis .................................................................................................................. 1 5
1. 1. 1. S u bst u d y  A.................................................................................................. 1 6
1. 1. 1. 1. O bjecti ves, E n d p oi nts, a n d Esti ma n ds ...................................... 1 6
1. 1. 1. 2. O vera ll Desi g n........................................................................... 1 7
1. 1. 1. 3. N u m ber of Partici pa nts ..............................................................1 8
1. 1. 1. 4. St u d y  P o p ulati o n....................................................................... 1 8
1. 1. 1. 5. St u d y  Ar ms a n d D urati o n..........................................................2 0
1. 1. 1. 6. Statistical Met h o ds .................................................................... 2 2
1. 1. 2. S u bst u d y  B.................................................................................................. 2 3
1. 1. 2. 1. O bjecti ves, E n d p oi nts, a n d Esti ma n ds ...................................... 2 3
1. 1. 2. 2. O verall Desi g n ........................................................................... 2 4
1. 1. 2. 3. N u m ber of Partici pa nts ..............................................................2 6
1. 1. 2. 4. St u d y  P o p ulati o n....................................................................... 2 6
1. 1. 2. 5. St u d y  Ar ms a n d D urati o n.......................................................... 2 8
1. 2. Et hical C o nsi derati o ns ............................................................................................. 3 0
1. 3. Sc he ma .................................................................................................................... 3 1
1. 3. 1. S u bst u d y  A - C o m bi nati o n R S V pre F + qI R V vs Se q ue ntial 
A d mi nistrati o n ................................................................................................. 3 1
1. 3. 2. S u bst u d y  B – C o m bi nati o n R S V pre F + qI R V 1. 0 -m L  F or m ulati o n vs 
C o m bi nati o n R S V pre F + qI R V 0. 5 -m L  F or m ulati o n...................................... 3 2
1. 4. Sc he d ule of Acti vities ............................................................................................. 3 3
2. I N T R O D U C TI O N ............................................................................................................... 3 3
2. 1. St u d y  Rati o nale....................................................................................................... 3 3
2. 2. Bac k gr o u n d ............................................................................................................. 3 4
2. 2. 1. R S V ............................................................................................................. 3 4
2. 2. 1. 1. R S V pre F V acci nati o n ...............................................................3 5
2. 2. 2. I nfl ue nza ..................................................................................................... 3 5
2. 2. 2. 1. I nfl ue nza Vacci nati o n ...............................................................3 6
2. 2. 3. Cli nical O ver vie w ....................................................................................... 3 7
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6
2. 2. 3. 1. R S V pre F .................................................................................... 3 7
2. 2. 3. 2. qI R V .......................................................................................... 3 9
2. 3. Be nefit/ Ris k Assess me nt ......................................................................................... 4 0
2. 3. 1. Ris k Assess me nt ......................................................................................... 4 1
2. 3. 2. Be nefit Assess me nt ..................................................................................... 4 6
2. 3. 3. F or S u bst u d y  A a n d S u bst u d y B O verall Be nefit/ Ris k C o ncl usi o n........... 4 6
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 6
4. S T U D Y D E SI G N ................................................................................................................. 4 6
4. 1. O verall Desi g n ......................................................................................................... 4 6
4. 2. Sci e ntific Rati o nale f or St u d y Desi g n..................................................................... 4 6
4. 2. 1. Di versit y  of St u d y P o p ulati o n .................................................................... 4 6
4. 2. 2. C h oice of C o ntrace pti o n/ Barrier Re q uire me nts ......................................... 4 7
4. 3. J ustificati o n f or D ose ..............................................................................................4 7
4. 3. 1. R S V pre F ..................................................................................................... 4 7
4. 3. 2. qI R V ........................................................................................................... 4 7
4. 4. E n d of St u d y  Defi niti o n .......................................................................................... 4 7
5. S T U D Y P O P U L A T I ON ...................................................................................................... 4 8
5. 1. I ncl usi o n Criteria ..................................................................................................... 4 8
5. 2. E xcl usi o n Cri teria.................................................................................................... 4 8
5. 3. L ifest yle C o nsi derati o ns.......................................................................................... 4 8
5. 3. 1. C o ntrace pti o n ..............................................................................................4 8
5. 4. Scr ee n Fail ures ........................................................................................................ 4 9
5. 5. Criteria f or Te m p oraril y  Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/ A d mi nistrati o n of St u d y  Inter ve nti o n ( S u bst u d y  A 
an d S u bst u d y  B) ........................................................................................................ 4 9
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 ................................. 4 9
6. 1. St u d y  Inter ve nti o n(s) ...............................................................................................4 9
6. 1. 1. C o m bi nati o n R S V pre F + qI R V ( S u bst u d y A a n d S u bst u d y  B) ................. 4 9
6. 1. 2. R S V pre F ( S u bst u d y  A)...............................................................................5 0
6. 1. 3. qI R V ( S u bst u d y  A)..................................................................................... 5 0
6. 1. 4. Place b o ( S u bst u d y  A)................................................................................. 5 0
6. 2. St u d y  Inter ve nti o n(s) A d mi nistere d ........................................................................ 5 0
6. 2. 1. A d mi nistrati o n ............................................................................................ 5 0
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7
6. 2. 2. Me dical De vices ......................................................................................... 5 0
6. 3. Pre parati o n, Ha n dli n g, St ora ge, a n d Acc o u nta bilit y ............................................... 5 1
6. 3. 1. Pre parati o n a n d Dis pe nsi n g ........................................................................ 5 2
6. 4. Assi g n me nt t o St u d y I nter ve nti o n ........................................................................... 5 2
6. 5. Bli n di n g ................................................................................................................... 5 2
6. 5. 1. Bli n di n g of Partici pa nts .............................................................................. 5 2
6. 5. 2. Bli n di n g of Site Pers o n nel .......................................................................... 5 2
6. 5. 3. Bli n di n g of t he S p o ns or .............................................................................. 5 3
6. 5. 4. Brea ki n g t he Bli n d ...................................................................................... 5 3
6. 6. St u d y  Inter ve nti o n C o m plia nce ............................................................................... 5 3
6. 7. D ose M o dificati o n ................................................................................................... 5 3
6. 8. 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 ...................... 5 3
6. 9. Treat me nt of O ver d ose ............................................................................................ 5 4
6. 1 0. Pri or a n d C o nc o mita nt T hera p y ............................................................................ 5 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 ........................................................................... 5 4
7. 1. Disc o nti n uati o n of St u d y  Inter ve nti o n .................................................................... 5 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 ....................................... 5 4
7. 2. 1. Wit h dra wal of C o nse nt ............................................................................... 5 5
7. 3. L ost t o F oll o w -U p ................................................................................................... 5 5
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 ...............................................................5 6
8. 1. A d mi nistrati ve a n d Baseli ne Pr oce d ures ................................................................. 5 6
8. 1. 1. Tele healt h Visits ......................................................................................... 5 6
8. 2. Efficac y  a n d/ or I m m u n o ge nicit y Assess me nts....................................................... 5 7
8. 2. 1. Efficac y  Assess me nts ................................................................................. 5 7
8. 2. 2. I m m u n o ge nicit y Assess me nts .................................................................... 5 7
8. 2. 3. Bi ol o gical Sa m ples ..................................................................................... 5 7
8. 3. Safet y Assess me nts ................................................................................................. 5 8
8. 3. 1. P h y sical E xa mi nati o ns a n d Cli nical Assess me nts ...................................... 5 8
8. 3. 2. Vital Si g ns .................................................................................................. 5 9
8. 3. 2. 1. B l o o d Press ure a n d P ulse Rate.................................................. 5 9
8. 3. 2. 2. Te m perat ure .............................................................................. 5 9
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8
8. 3. 3. Cli nical Safet y La b orat or y Assess me nts ..................................................... 5 9
8. 3. 4. Electr o nic Diar y .......................................................................................... 5 9
8. 3. 4. 1. Gra di n g Scales ...........................................................................6 0
8. 3. 4. 2. L ocal Reacti o ns ......................................................................... 6 0
8. 3. 4. 3. S y ste mic E ve nts ........................................................................ 6 1
8. 3. 4. 4. Fe ver M o nit ori n g ....................................................................... 6 2
8. 3. 4. 5. A nti p y retic Me dicati o n ..............................................................6 3
8. 3. 5. Pre g na nc y  Testi n g ...................................................................................... 6 3
8. 3. 6. St o p pi n g R ules ............................................................................................ 6 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 ................. 6 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 Inf or mati o n ....... 6 4
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer Safet y ............................................... 6 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 ................... 6 5
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es .......................................................... 6 5
8. 4. 3. F oll o w -U p of A Es a n d S A Es ...................................................................... 6 5
8. 4. 4. Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es........................................... 6 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 ..................................................... 6 6
8. 4. 5. 1. E x p os ure D uri n g Pre g na nc y ...................................................... 6 6
8. 4. 5. 2. E x p os ure D uri n g Breastfee di n g ................................................ 6 8
8. 4. 5. 3. Occ u pati o nal E x p os ure ............................................................. 6 8
8. 4. 6. Car di o vasc ular a n d Deat h E ve nts ...............................................................6 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 .............................................................................. 6 8
8. 4. 8. A d verse E ve nts of S pecial I nterest ............................................................. 6 8
8. 4. 8. 1. Lac k of Efficac y ........................................................................ 6 9
8. 4. 9. Me dical De vice Deficie ncies ......................................................................6 9
8. 4. 9. 1. Ti me Peri o d f or Detecti n g Me dical De vice Deficie ncies .........6 9
8. 4. 9. 2. F oll o w - U p of Me dical De vice Deficie ncies.............................. 7 0
8. 4. 9. 3. Pr o m pt Re p orti n g of De vice Deficie ncies t o t he S p o ns or ........ 7 0
8. 4. 9. 4. Re g ulat or y  Re p orti n g Re q uire me nts f or De vice 
Deficie ncies ....................................................................................... 7 0
8. 4. 1 0. Vacci nati o n Err ors .................................................................................... 7 0
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9
8. 5. P har mac o ki netics .................................................................................................... 7 1
8. 6. G e netics ................................................................................................................... 7 1
8. 6. 1. S pecifie d Ge netics ...................................................................................... 7 1
8. 7. Bi o mar kers .............................................................................................................. 7 2
8. 8. I m m u n o ge nicit y Assess me nts ................................................................................. 7 2
8. 9. Healt h Ec o n o mics ................................................................................................... 7 2
9. S T A TI S TI C A L C O N SI D E R A TI O N S ................................................................................ 7 2
9. 1. Statistical H y p ot hesis ..............................................................................................7 2
9. 2. A nal y sis Sets ........................................................................................................... 7 2
9. 3. Statistical A nal y ses ................................................................................................. 7 2
9. 3. 1. Ge neral C o nsi derati o ns ...............................................................................7 2
9. 3. 1. 1. A nal y ses f or Bi nar y Data.......................................................... 7 3
9. 3. 1. 2. A nal y ses f or C o nti n u o us Data................................................... 7 3
9. 4. I nteri m A nal ys es ..................................................................................................... 7 4
9. 5. S a m ple Size Deter mi nati o n..................................................................................... 7 4
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 .......................................................................................................... 7 5
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............... 7 5
1 0. 1. 1. Re g ulat or y a n d Et hical C o nsi derati o ns .................................................... 7 5
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 ......................................................................... 7 5
1 0. 1. 2. Fi na ncial Discl o s ure ................................................................................. 7 6
1 0. 1. 3. I nf or me d C o nse nt Pr ocess ........................................................................ 7 6
1 0. 1. 4. Data Pr otecti o n ......................................................................................... 7 7
1 0. 1 . 5. C o m mittees Str uct ure ............................................................................... 7 7
1 0. 1. 5. 1. Data M o nit ori n g C o m mittee ................................................... 7 7
1 0. 1. 6. Disse mi nati o n of Cli nical St u d y  Data ...................................................... 7 8
1 0. 1. 7. Data Q ualit y Ass ura nce ............................................................................ 7 9
1 0. 1. 8. S o urce D oc u me nts .................................................................................... 8 0
1 0. 1. 9. St u d y  a n d Site Start a n d Cl os ure ..............................................................8 1
1 0. 1. 1 0. P u blicati o n P olic y ...................................................................................8 1
1 0. 1. 1 1. S p o ns or’s Me dicall y  Q ualifie d I n di vi d ual..............................................8 2
1 0. 2. A p pe n di x 2: Cli nical La b orat or y  Tests................................................................. 8 3
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0
1 0. 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 .....................................................................8 3
1 0. 3. 1. Defi niti o n of A E ....................................................................................... 8 3
1 0. 3. 2. Defi niti o n of a n S A E ................................................................................ 8 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............................................................................ 8 6
1 0. 3. 4. Re p orti n g of S A Es .................................................................................... 8 9
1 0. 4. A p pe n di x 4: C o ntrace pti ve a n d Barrier G ui da nce ................................................ 9 0
1 0. 4. 1. Male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria .................................... 9 0
1 0. 4. 1. 1. S u bst u d y  A a n d S u bst u d y B.................................................... 9 0
1 0. 4. 2. Fe male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria ................................. 9 0
1 0. 4. 2. 1. S u bst u d y  A.............................................................................. 9 0
1 0. 4. 2. 2. S u bst u d y  B .............................................................................. 9 0
1 0. 4. 3. W o ma n of C hil d beari n g P ote ntial
............................................................9 1
1 0. 4. 4. C o ntrace pti o n Met h o ds ............................................................................. 9 1
1 0. 4. 4. 1. S u bst u d y  A.............................................................................. 9 2
1 0. 4. 4. 2. S u bst u d y  B .............................................................................. 9 2
1 0. 5. A p pe n di x 5: 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 ....... 9 4
1 0. 6. A p pe n di x 6: Ki d ne y  Safet y M o nit ori n g G ui deli nes ............................................. 9 6
1 0. 6. 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 .............................................................................. 9 6
1 0. 6. 2. A ge -S pecific Ki d ne y  F u ncti o n Calc ulati o n Rec o m me n dati o ns............... 9 6
1 0. 6. 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........................................................................................... 9 6
1 0. 6. 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 ................................................................................................... 9 6
1 0. 7. A p pe n di x 7: E C G Fi n di n gs of P ote ntial Cli nical C o ncer n ................................... 9 7
1 0. 8. A p pe n di x 8: 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 ............................................. 9 9
1 0. 8. 1. Defi niti o n of A E a n d A D E ....................................................................... 9 9
1 0. 8. 2. Defi niti o n of S A E, S A D E, a n d U S A D E .................................................. 9 9
1 0. 8. 3. Defi niti o n of De vice Deficie nc y .............................................................1 0 0
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1
1 0. 8. 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 0 0
1 0. 8. 5. Re p orti n g of S A Es.................................................................................. 1 0 2
1 0. 8. 6. Re p orti n g of S A D Es ............................................................................... 1 0 2
1 0. 9. A p pe n di x 9: S u bst u d y  A..................................................................................... 1 0 2
1 0. 9. 1. S y n o psis – S u bst u d y  A........................................................................... 1 0 2
1 0. 9. 2. Sc he ma – S u bst u d y  A............................................................................. 1 0 2
1 0. 9. 3. S o A – S u bst u d y  A .................................................................................. 1 0 3
1 0. 9. 4. I ntr o d ucti o n – S u bst u d y  A...................................................................... 1 0 6
1 0. 9. 4. 1. S u bst u d y  A Rati o nale............................................................ 1 0 6
1 0. 9. 4. 2. Bac k gr o u n d ........................................................................... 1 0 6
1 0. 9. 4. 3. Be nefit/ Ris k Assess me nt....................................................... 1 0 6
1 0. 9. 5. O bjecti ves, E n d p oi nts, a n d Esti ma n ds ( S u bst u d y  A)............................. 1 0 7
1 0. 9. 6. S u bst u d y  A Desi g n................................................................................. 1 0 9
1 0. 9. 6. 1. O verall Desi g n ....................................................................... 1 0 9
1 0 . 9. 6. 2. Scie ntific Rati o nale f or St u dy Desi g n ................................... 1 1 0
1 0. 9. 6. 3. J ustificati o n f or D ose ............................................................ 1 1 1
1 0. 9. 6. 4. E n d of St u d y  Defi niti o n ........................................................ 1 1 1
1 0. 9. 7. S u bst u d y  A P o p ulati o n........................................................................... 1 1 1
1 0. 9. 7. 1. I ncl usi o n Criteria ................................................................... 1 1 1
1 0. 9. 7. 2. S u bst u d y  A E xcl usi o n Criteria.............................................. 1 1 2
1 0. 9. 8. S u bst u d y  A I nter ve nti o n a n d C o nc o mita nt T hera p y .............................. 1 1 3
1 0. 9. 8. 1. St u d y  Inter ve nti o n(s) A d mi nistere d ...................................... 1 1 3
1 0. 9. 8. 2. Bli n di n g ................................................................................. 1 1 6
1 0. 9. 8. 3. St u d y  Inter ve nti o n C o m plia nce ............................................. 1 1 7
1 0. 9. 8. 4. D ose M o dificati o n ................................................................. 1 1 7
1 0. 9. 8. 5. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d of 
t he St u d y.......................................................................................... 1 1 7
1 0. 9. 8. 6. Treat me nt of O ver d ose .......................................................... 1 1 7
1 0. 9. 8. 7. Pri or a n d C o nc o mita nt T hera p y............................................ 1 1 7
1 0. 9. 9. Disc o nti n uati o n of S u bst u d y  A I nter ve nti o n a n d Partici pa nt 
Disc o nti n uati o n/ Wit h dra wal ..........................................................................1 1 9
1 0. 9. 1 0. S u bst u d y  A Assess me nts a n d Pr oce d ures............................................. 1 1 9
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2
1 0. 9. 1 0. 1. I m m u n o ge nicit y  Assess me nts............................................. 1 1 9
1 0. 9. 1 0. 2. Bi ol o gical Sa m ples ..............................................................1 2 0
1 0. 9. 1 0. 3. Safet y Assess me nts .............................................................1 2 0
1 0. 9. 1 0. 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.............................................................................. 1 2 0
1 0. 9. 1 0. 5. St o p pi n g R ules .................................................................... 1 2 0
1 0 . 9. 1 0. 6. St u d y Pr oce d ures.................................................................1 2 2
1 0. 9. 1 1. Statistical C o nsi derati o ns – S u bst u d y  A............................................... 1 2 8
1 0. 9. 1 1. 1. Statistical H y p ot heses ......................................................... 1 2 8
1 0. 9. 1 1. 2. A nal y sis Sets ....................................................................... 1 2 8
1 0. 9. 1 1. 3. Statistical A nal y ses .............................................................1 2 9
1 0. 9. 1 1. 4. I nteri m A nal yses ................................................................. 1 3 1
1 0. 9. 1 1. 5. Sa m ple Size Deter mi nati o n ................................................. 1 3 2
1 0. 1 0. A p pe n di x 1 0: S u bst u d y  B ................................................................................. 1 3 2
1 0. 1 0. 1. S y n o psis – S u bst u d y  B......................................................................... 1 3 2
1 0. 1 0. 2. Sc he ma – S u bst u d y  B........................................................................... 1 3 2
1 0. 1 0. 3. Sc he d ule of Acti vities – S u bst u d y  B.................................................... 1 3 3
1 0. 1 0. 4. I ntr o d ucti o n – S u bst u d y  B.................................................................... 1 3 6
1 0. 1 0. 4. 1. S u bst u d y  B Rati o nale.......................................................... 1 3 6
1 0. 1 0. 4. 2. Bac k gr o u n d ......................................................................... 1 3 6
1 0. 1 0. 4. 3. Be nefit/ Ris k Assess me nt ..................................................... 1 3 7
1 0. 1 0. 5. O bjecti ves, E n d p oi nts, a n d Esti ma n ds ( S u bst u d y  B)........................... 1 3 8
1 0. 1 0. 6. S u bst u d y  B Desi g n ............................................................................... 1 4 0
1 0. 1 0. 6. 1. O verall Desi g n ..................................................................... 1 4 0
1 0. 1 0. 6. 2. Scie ntific Rati o nale f or St u d y Desi g n ................................. 1 4 1
1 0. 1 0. 6. 3. J ustificati o n f or D ose .......................................................... 1 4 1
1 0. 1 0. 6. 4. E n d of St u d y  Defi niti o n ...................................................... 1 4 1
1 0. 1 0. 7. S u bst u d y  B P o p ulati o n .........................................................................1 4 2
1 0. 1 0. 7. 1. I ncl usi o n Criteria ................................................................. 1 4 2
1 0. 1 0. 7. 2. E xcl usi o n Criteria ................................................................ 1 4 2
1 0. 1 0. 8. S u bst u d y  B I nter ve nti o n a n d C o nc o mita nt T hera p y ............................ 1 4 4
1 0. 1 0. 8. 1. St u d y  Inter ve nti o n(s) A d mi nistere d .................................... 1 4 4
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3
1 0. 1 0. 8. 2. Bli n di n g............................................................................... 1 4 6
1 0. 1 0. 8. 3. St u d y  Inter ve nti o n C o m plia nce ........................................... 1 4 7
1 0. 1 0. 8. 4. D ose M o dificati o n ...............................................................1 4 7
1 0. 1 0. 8. 5. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d 
of t he St u d y ...................................................................................... 1 4 7
1 0. 1 0. 8. 6. Treat me nt of O ver d ose ........................................................ 1 4 7
1 0. 1 0. 8. 7. Pri or a n d C o nc o mita nt T hera p y .......................................... 1 4 7
1 0. 1 0. 9. Disc o nti n uati o n of S u bst u d y  B I nter ve nti o n a n d Partici pa nt 
Disc o nti n uati o n/ Wit h dra wal .......................................................................... 1 4 8
1 0. 1 0. 1 0. S u bst u d y  B Assess me nts a n d Pr oce d ures........................................... 1 4 9
1 0. 1 0. 1 0. 1. I m m u n o ge nicit y  Assess me nts........................................... 1 4 9
1 0. 1 0. 1 0. 2. Bi ol o gical Sa m ples ............................................................ 1 5 0
1 0. 1 0. 1 0. 3. Safet y Assess me nts ........................................................... 1 5 0
1 0. 1 0. 1 0. 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.............................................................................. 1 5 0
1 0. 1 0. 1 0. 5. St o p pi n g R ules .................................................................. 1 5 0
1 0. 1 0. 1 0. 6. St u d y  Pr oce d ures...............................................................1 5 1
1 0. 1 0. 1 1. Statistical C o nsi derati o ns – S u bst u d y  B............................................. 1 5 6
1 0. 1 0. 1 1. 1. Statistical H y p ot heses ....................................................... 1 5 6
1 0. 1 0. 1 1. 2. A nal y sis Sets ..................................................................... 1 5 6
1 0. 1 0. 1 1. 3. Statistical A nal y ses ........................................................... 1 5 7
1 0. 1 0. 1 1. 4. I nteri m A nal y ses ...............................................................1 5 8
1 0. 1 0. 1 1. 5. Sa m ple Size Deter mi nati o n ............................................... 1 5 8
1 0. 1 1. A p pe n di x 1 1: 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 5 9
K n o w n HI V I nfecti o n ......................................................................................... 1 5 9
K n o w n H C V I nfecti o n ........................................................................................ 1 5 9
K n o w n H B V I nfecti o n ........................................................................................ 1 5 9
1 0. 1 2. A p pe n di x 1 2: A b bre viati o ns ............................................................................. 1 6 0
1 1. R E F E R E N C E S ................................................................................................................ 1 6 5
LI S T O F T A B L E S
Ta ble 1.
L ocal Reacti o n Gra di n g Scale ..................................................................6 1
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4
Ta ble 2.
S y ste mic E ve nt Gra di n g Scale .................................................................. 6 1
Ta ble 3.
Ra n ges f or Fe ver ....................................................................................... 6 3
Ta ble 4.
Sc he d ule of Acti vities – S u bst u d y  A...................................................... 1 0 3
Ta ble 5.
Pri mar y  E n d p oi nt A nalys es – S u bst u d y  A ............................................. 1 3 0
Ta ble 6.
E x pl orat or y  E n d p oi nt A nal yses – S u bst u d y  A....................................... 1 3 1
Ta ble 7.
Sc he d ule of Acti vities – S u bst u d y  B...................................................... 1 3 3
Ta ble 8.
Pri mar y  E n d p oi nt A nalys es – S u bst u d y  B.............................................. 1 5 7
Ta ble 9.
Sec o n dar y  a n d E x pl orat or y E n d p oi nt A nal yses – S u bst u d y  B............... 1 5 8
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5
1. P R O T O C O L S U M M A R Y 
1. 1. S y n o psis 
Pr ot oc ol Title 
A St u d y  to E val uate the Safet y , T olera bility, an d I m m u n o ge nicit y o f Res pirat or y  
C o m bi nati o n Vacci ne Ca n di date s i n Ol der A d ults
Brief Title
A Safet y, T olera bilit y, a n d I mm u n o ge nicit y St u d y of Res pirat or y C o m bi nati o n Vacci ne 
Ca n di dates i n Ol der A d ults
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:
N ot ap plica ble
E u dra C T N u m ber:
N ot a p plica ble
Cli nical Trials. g o v I D:  
N C T 0 5 7 8 8 2 3 7
Pe diatric I n vesti gati o nal Pla n N u m ber :
N ot ap plica ble
Pr ot oc ol N u m ber:
C 5 4 0 1 0 0 1
P hase:
1 b
R ati o n ale
T he c ocirc ulati o n of R S V a n d i nfl ue nza si g nifica ntl y  i m pacts t he ol der a d ult p o p ulati o n, 
w here t here is a hi g her i nci de nce of res pirat or y i nfecti o ns a n d i ncrease d m or bi dit y a n d 
m ortalit y  d uri n g t he wi nter m o nt hs. I n t he early 2 0 2 2 - 2 0 2 3 U S wi nter, t he i nci de nce s of 
infl ue nza a n d R S V- relate d disease were i ncreasi n g. As v acci nes a gai nst i nfl ue nza a n d 
C O VI D -1 9 ca n be a d m i nistere d at a si n gle healt hcare visit as i n di vi d ual vacci nati o ns, 
re q uiri n g m ulti ple i njecti o ns, s h o ul d a lice nse d R S V vacci ne bec o me a vaila ble, t he 
c oa d mi nistrati o n of t hese vacci nes w o ul d li kel y occ ur at t he sa me ti me of year . T he Pfizer 
R S V vacci ne , R SV pre F, was rece ntly f o u n d t o be efficaci o us a gai nst R S V-ass ociate d L R TI 
i n ol der a d ults. C o nc urre nt a d mi nistrati o n of vacci nes a gai nst t hese res pirat or y viral 
i nfecti o ns re d uces t he nee d f or m ulti ple healt hcare or p har mac y visits a n d ma y i m pr o ve 
vacci ne u p ta ke. A c o m bi nati o n vacci ne wit h R S V pre F a n d qI R V w o ul d re q uire 1 i njecti o n at 
a healt hcare pr o vi der visit. A st u d y  of c o m bi ne d vacci nati o n is re q uire d t o i n vesti gate 
p ote ntial i m m u n ol o gical i nterfere nce i n a d diti o n t o safet y a n d t olera bilit y. Pfizer is c u rre ntl y 
i n vesti gati n g t he efficac y of a q ua dri vale nt m o difie d R N A ( m o d R N A) i nfl ue nza vacci ne 
ca n di date ( qI RV) . T his st u d y series will i n vesti gate t he a d mi nistrati o n of c o m bi ne d R S V pre F 
wit h qI R V t o assess t he safet y, t olera bilit y, a n d p ote ntial f or i m m u n ol o gical i nterfere nce. 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6
1. 1. 1. S u bst u d y A
T he first of t he c o m bi nati o n R S V pre F + q I RV vacci ne st u dies will be c o n d ucte d as a P hase 
1 b s u bst u d y  i n healt hy partici pa nts ≥6 0 y ears of a ge.
 
 
1. 1. 1. 1. O bjecti ves, E n d p oi nts, a n d Esti m a n ds
Please refer t o t he a p pe n dices f or t he o bjecti ves, e n d p oi nts, a n d esti ma n ds f or eac h s u b st u d y.
S u bst u d y A
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y S afet y
Pri m ar y S afet y
Pri m ar y S afet y
T o e val uate t he safet y pr ofile 
of c o mbi nati o n R S V pre F + 
qI R V 

L ocal reacti o ns ( pai n at t he 
i njecti o n site, re d ness, a n d 
s welli n g)

S y ste mic e ve nts (fe ver, fati g ue, 
hea dac he, v o miti n g, na usea, 
diarr hea, 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 E s

S A Es
I n partici pa nts recei vi n g at least 
1 d ose of st u d y i nter ve nti o n, t he 
perce nta ge of partici pa nts 
re p orti n g:

L ocal reacti o ns wit hi n 7 d a y s 
f oll o wi n g eac h vacci nati o n

S y ste mic e ve nts wit hi n 7 d a y s 
f oll o wi n g eac h vacci nati o n

A E s wit hi n 1 m o nt h after 
eac h vacci nati o n

S A Es t hr o u g h o ut t he st u d y
Pri m ar y I m m u n o ge nicit y
Pri m ar y I m m u n o ge nicit y
Pri m ar y I m m u n o ge nicit y
T o descri be t he i m m u ne 
res p o nses elicite d b y 
c o m bi nati o n R S V pre F + 
qI R V i n c o m paris o n wit h 
t h ose elicite d b y R S V pre F 
al o ne

R S V A a n d R S V B N Ts
I n partici pa nts i n c o m plia nce wit h 
t he ke y pr ot oc ol criteria 
(e val ua ble partici pa nts): 

G M R of N Ts f or eac h R S V 
s u b gr o u p ( A or B) 1 m o nt h 
after vacci nati o n wit h 
c o m bi nati o n R S V pre F + 
qI R V t o t hat wit h 
R S V pre F al o ne 
(se q ue ntial-a d mi nistrati o n 
gr o u p , Visit A 1 0 3 )
T o descri be t he i m m u ne 
res p o nses elicite d b y 
c o m bi nati o n R S V pre F + 
qI R V i n c o m paris o n wit h 
t h ose elicite d b y qI R V al o ne

Strai n -s pecific H AI titers f or t he 
c urre nt seas o nal strai ns ( 2 × A, 
2 × B) rec o m me n de d b y W H O f or 
rec o m bi na nt or cell-base d 
i nfl ue nza vacci nes
I n partici pa nts i n c o m plia nce wit h 
t he ke y pr ot oc ol criteria 
(e val ua ble partici pa nts): 

G M R of strai n -s pecific H AI 
titers 1 m o nt h after 
vacci nati o n wit h c o mbi nati o n
R S V pre F + qI R V t o t hat wit h 
qI R V al o ne 
(se q ue ntial-a d mi nistrati o n 
gr o u p , Visit A 1 0 2 )
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 7
1. 1. 1. 2. O ver all Desi g n
S u bst u d y  A will be c o n d ucte d as a P hase 1 b , si n gle-site, parallel -gr o u p, ra n d o mize d, 
place b o -c o ntr olle d, o bser ver -bli n de d s u bst u d y of R S V pre F a n d a n ucle osi de -m o difie d R N A 
vacci ne ( qI R V) a gai nst R S V a n d i nfl ue nza w he n a d mi nistere d as a c o m bi ne d vacci ne a n d 
w he n a d mi nistere d al o ne .
H ealt h y a d ults ≥6 0 ye ars of a ge will be ra n d o mize d 1: 1 t o eit her Gr o u p 1: c o m bi nati o n
(R S V pre F + qI R V ) ( Visit A 1 0 1 ) f oll o we d by place b o ( Visit A 1 0 2 ); or Gr o u p 2: se q ue ntial
a d mi nistrati o n of qI R V ( Visit A 1 0 1 ) f oll o we d b y  R S V pre F ( Visit A 1 0 2 ) a d mi nistere d
1 m o nt h a part . Ra n d o mizati o n will be stratifie d b y 3 a ge gr o u ps ( 6 0-6 4, 6 5 -7 9, a n d 
≥8 0 ye ars) wit hi n t he st u d y site. St u d y  gr o u ps, bl o o d dra w s, a n d safet y assess me nt ti mi n gs 
are prese nte d bel o w.
S u bst u d y A Desi g n
Healt h y a d ults 
≥6 0 years of a ge
( 1 2 5 per gr o u p, 
ra n d o mize d 1: 1)
Visit A 1 0 1 ( D a y 1)
V acci n ati o n 1
Visit A 1 0 2 ( M o nt h 1)
2 8 -3 5 da ys
after Vacci nati o n 1
V acci n ati o n 2
Visit A 1 0 3 ( M o nt h 2) 
2 8 -3 5 da ys 
after Vacci nati o n 2
F oll o w -u p
S T U D Y G R O U P S
Gr o u p 1: C o m b i n ati o n
R S V pre F + qI R V / p lace b o
C o m b i nati o n
( R S V pre F + qI R V)
Place b o
B l o o d dra w
Gr o u p 2:
Se q ue nti al a d mi nistr ati o n
qI R V / R S V pre F
qI R V
R S V pre F
B l o o d dra w 
S A F E T Y
L ocal reacti o ns a n d syste mic 
eve nts 
A E s a n d A E SI s
S A Es
D a y s 1 t hr o u g h 7
D a y s 1 t hr o u g h 7 
4 8 h o urs
C o nse nt t hr o u g h st u d y c o m pleti o n
C o nse nt t hr o u g h st u d y c o m pleti o n
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 8
1. 1. 1. 3. N u m ber of P artici p a nts
A p pr o xi matel y  2 5 0 healt h y  partici pa nts ( n = 1 2 5 per gr o u p) will be e nr olle d i n S u bst u d y  A. 
N ote: " E nr olle d" mea ns a partici pa nt's a gree me nt t o partici pate i n a cli nical st u d y  f oll o wi n g 
c o m pleti o n of t he i nf or me d c o nse nt pr ocess .
1. 1. 1. 4. St u d y P o p ul at i o n
S u bst u d y A
I ncl usi o n Criteri a 
Partici pa nts m ust meet t he f oll o wi n g i ncl usi o n criteria t o be eli gi ble f or e nr oll me nt i nt o 
S u b st u d y A :
A ge a n d Se x:
1.
P artici pa nts ≥6 0 ye ars of a ge at st u d y e nr oll me nt.

Refer t o Secti o n 1 0. 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 ot a p plica ble .
Ot her I ncl usi o n Criteri a :
2.
Partici pa nts w h o are willi n g a n d a ble t o c o m pl y wit h all sc he d ule d visits, 
i n vesti gati o nal pla n, la b orat or y tests, 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 y sical e xa mi nati o n
(if re q uire d), a n d cli nical j u d g me nt of t he i n vesti gat or t o be eli gi ble f or i ncl usi o n i n t he 
st u d y.
N ot e: Healt h y partici pa nts wit h pree xisti n g sta ble disease, defi ne d as disease n ot re q uiri n g
si g nifica nt c ha n ge i n t hera p y or h os pitalizati o n f or w orse ni n g disease d uri n g t he 6 wee ks 
bef ore e nr oll me nt, ca n be i ncl u de d. S pecific criteria f or partici pa nts wit h k n o w n sta ble 
i nfecti o n wit h HI V, H C V, or H B V ca n be f o u n d i n Secti o n 1 0. 1 0 . 
4.
Ca pa ble of gi v i n g a n d ha vi n g si g ne d t he 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 ply in g wit h t he re q uire me nts a n d restricti o ns liste d i n t he I CD a n d i n
t his pr ot oc ol.
5.
Recei pt of lice nse d i nfl ue nza vacci nati o n f or t he 2 0 2 2- 2 0 2 3 n ort her n he mis p here seas o n 
or 2 0 2 2 s o ut her n he mis p here seas o n > 1 2 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 9
E xcl usi o n Criteri a 
Partici pa nts wit h a n y  of t he f oll o wi n g c haracteristics/c o n ditio ns will be e xcl u de d:
Me dic al C o n diti o ns
1.
A c o nfir me d dia g n osis of R S V i nfecti o n or i nfl ue nza ≤1 2 0 da y s bef ore st u d y i nter ve nti o n 
a d mi nistrati o n.
2.
Hist or y of se vere a d verse reacti o n ass ociate d wit h a n y vacci ne a n d/ or se vere aller gic 
reacti o n (e g, a na p h yla xis) t o a n y c o m p o ne nt of t he st u d y i nter ve nti o n(s).
3.
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 M i njecti o n.
4.
Seri o us c hr o nic dis or der, i ncl u di n g metastatic mali g na nc y , e n d-sta ge re nal disease wit h 
or wit h o ut dial y sis, cli nicall y u nsta ble car diac disease, or a ny ot her dis or der t hat, i n t he 
i n vesti gat or’s o pi ni o n, e xcl u des t he partici pa nt fr o m partici pati n g i n t he st u d y.
5.
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. Ot her me dical or 
ps y c hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he past year) or acti ve s uici dal 
i deati o n/ be ha vi or or la b orat or y a b n or malit y t hat ma y i ncrease t he ris k of st u d y 
partici pati o n or, i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt i na p pr o priate f or t he
st u d y. 
Pri or/ C o nc o mit a nt T her a p y
6.
Recei pt of c hr o nic s ys te mic treat me nt wit h k n o w n i m m u n os u p pressa nt me dicati o ns 
(i ncl u di n g c yt ot o xic a ge nts or s yste mic c ortic oster oi ds), or ra di ot hera py, wit hi n 6 0 da y s 
bef ore st u d y i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he st u d y.
N ote: S y ste mic c ortic oster oi ds are defi ne d as t h ose a d mi nistere d f or ≥1 4 da y s at a d ose of
≥2 0 m g/ da y of pre d nis o n e or e q ui vale nt (e g, f or ca ncer or a n a ut oi m m u ne disease) or 
pla n ne d recei pt t hr o u g h o ut t he st u d y . I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical 
(s ki n, e yes, or ears) c ortic oster oi ds are per mitte d.
7.
Recei pt of bl o o d/ plas ma pr o d ucts or i m m u n o gl o b uli n, fr o m 6 0 da y s bef ore st u d y
i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he st u d y.
8.
Recei pt of a n y lice nse d R S V vacci ne at a n y ti me pri or t o e nr oll me nt, or pla n ne d recei pt 
t hr o u g h o ut t he st u dy.
9.
Recei pt of a n y lice nse d i nfl ue nza vacci ne ≤1 2 0 da y s bef ore st u d y  e nr oll me nt, 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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 0
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce
1 0. Partici pati o n i n ot her st u dies i n v ol vi n g a n i n vesti gati o nal R S V vacci ne or m R N A 
i nfl ue nza vacci ne at a ny t i me pri or t o e nr oll me nt, a n d t hereafter u ntil st u dy c o m pleti o n, 
re gar dless of vacci ne assi g n me nt.
1 1. Partici pati o n i n a n y  ot her i nter ve nti o nal st u dies wit hi n 2 8 da ys bef ore st u d y e nr oll me nt 
t hr o u g h st u dy c o m pleti o n. Partici pa ti o n i n p urel y o bser vati o nal st u dies is acce pta ble.
Di a g n ostic Assess me nts
N ot 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 b y t he i n ve sti gat or, a n d s p o ns or a n d s p o ns or 
dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers .
1. 1. 1. 5. St u d y Ar ms a n d D ur ati o n
S u bst u d y A
F or i n di vi d ual partici pa nt s, t he d urati o n of S u bst u d y  A is a b o ut 2 m o nt hs. Base d o n a n 
esti mate d 2-m o nt h e nr oll me nt peri o d, t he d urati o n of S u bst u d y  A will be a p pr o xi matel y  
4 m o nt hs.
St u d y I nter ve nti o ns f or S u bst u d y A
S u bst u d y A
Gr o u p 1: C o m bi n ati o n ( R S V pre F + qI R V) / Pl ace b o
I nter ve nti o n N a me
V acci n ati o n 1 
C o m b i n ati o n
( R S V pre F + qI R V)
V acci n ati o n 2
Pl ace b o
Vacci ne C o m p o ne nt
R S V pre F
qI R V
Place b o
2 S ta bilize d R S V 
pref usi o n F a nti ge ns, i n 
e q ual a m o u nts fr o m 
vir us s u b gr o u ps A a n d B
E nc o di n g H A of 4 strai ns as 
rec o m me n de d f or t he 
i nfl ue nza seas o n ( 2 A strai ns 
a n d 2 B strai ns)
D ose F or m ulati o n
R S V vacci ne 1 2 0 µ g/ vial 
p o w der f or s ol uti o n f or 
i njecti o n
Q ua dri vale nt infl ue nza 
sus pe nsi o n f or injecti o n, 
m g/ m L ( qI R V)
0. 9 % N or mal sali ne
P r o d uct f or 
Rec o nstit uti o n
Sterile water as dil ue nt 
f or i njecti o n ( 0. 6 5 
m L/s yri n ge)
N/ A
N/ A
U nit D ose Stre n gt h(s)
1 2 0 µ g
µ g
0. 5 m L
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 1
S u bst u d y A
Gr o u p 1: C o m bi n ati o n ( R S V pre F + qI R V) / Pl ace b o
I nter ve nti o n N a me
V acci n ati o n 1 
C o m b i n ati o n
( R S V pre F + qI R V)
V acci n ati o n 2
Pl ace b o
R o ute of 
A d mi nistrati o n
A fter c o m bi ni n g b ot h vacci nes, a si n gle 1- m L IM 
i njecti o n is gi ve n i nt o t he delt oi d m uscle of t he 
n o n d o mi na nt ar m ( preferre d) . 
0. 5 -m L I M i njecti o n
i nt o t he delt oi d m uscle 
of t he n o n d o mi na nt ar m 
( preferre d)
Use
E x peri me ntal
Place b o 
I M P or NI M P/ A x M P
I M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y Pfizer
Pr o vi de d ce ntrall y b y 
Pfizer
Pac ka gi n g a n d 
La beli n g
R S V pre F is su p plie d as a l y o p hilize d w hite ca ke, 
pac ka ge d i n a clear glass 2 -m L vial wit h a r u b ber 
st o p per, al u mi n u m o verseal, a n d fli p -off ca p . It is 
rec o nstit ute d wit h a P F S of sterile w ater dil ue nt f or 
i njecti o n (s u p plie d).
qI R V is s u p plie d as
 
St u d y i nter ve nti o n(s) will be la bele d as per c o u ntr y 
re q uire me nts.
St u d y i nter ve nti o n will 
be s u p plie d i n a glass or 
plastic vial. Eac h vial 
will be la bele d as per 
c o u ntr y re q uire me nts.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 2
S u bst u d y A
Gr o u p 2: Se q ue nti al A d mi nistr ati o n qI R V / R S V pre F
I nter ve nti o n N a me
V acci n ati o n 1
qI R V
V acci n ati o n 2
R S V pre F
Vacci ne C o m p o ne nt
qI R V
R S V pre F
qI R V, ie, e nc o di n g H A of 4 strai ns as 
rec o m me n de d f or t he i nfl ue nza seas o n 
( 2 A strai ns a n d 2 B strai ns)
2 S ta bilize d R S V pref usi o n F a nti ge ns, 
i n e q ual a m o u nts fr o m vir us s u b gr o u ps 
A a n d B
Sterile water as dil ue nt f or i njecti o n
D ose F or m ulati o n
Q ua dri vale nt infl ue nza sus pe nsi o n f or 
injecti o n,  
m g/ m L ( qI R V)
R S V vacci ne 1 2 0 µ g/ vial p o w der f or 
s ol uti o n f or i njecti o n
Pr o d uct f or 
Rec o nstit uti o n
N/ A
Sterile water as dil ue nt f or i njecti o n 
( 0. 6 5 m L/s yri n ge)
U nit D ose Stre n gt h(s)
µ g
1 2 0 µ g
R o ute of 
A d mi nistrati o n
0. 5 -m L I M i njecti o n i nt o t he delt oi d 
m uscle of t he n o n d o mi na nt ar m 
( preferre d)
0. 5 -m L I M i njecti o n i nt o t he delt oi d 
m uscle of t he n o n d o mi na nt ar m 
( preferre d)
Use
E x peri me ntal
E x peri me ntal
I M P or NI M P/ A x M P
I M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y Pfizer
Pr o vi de d ce ntrall y b y Pfizer
Pac ka gi n g a n d 
La beli n g
q I R V is s u p plie d as
 
St u d y i nter ve nti o n(s) will be la bele d as 
per c o u ntr y re q uire me nts.
R S V pre F is s u p plie d as a l y o p hilize d 
w hite ca ke, pac ka ge d i n a clear glass 
2- m L vial. It is rec o nstit ute d wit h a P F S 
of sterile water dil ue nt f or i njecti o n 
(s u p plie d).
St u d y i nter ve nti o n(s) will be la bele d as 
per c o u ntr y re q uire me nts.
1. 1. 1. 6. St atistic al Met h o ds
Si nce S u bst u d y  A is descri pti ve i n nat ure, t he pla n ne d sa m ple size is n ot base d o n a n y 
statistical h yp ot hesis testi n g.
T he pri mar y  safety o bjecti ve f or t he st u d y will be e val uate d b y descri pti ve s u m mar y  statistics 
f or l ocal reacti o ns, sys te mic e ve nts, a n d A Es/ S A Es f or each vacci ne gr o u p after eac h 
vacci nati o n. 
T he pri mar y i m m u n o ge nicit y o bjecti ves will be e val uate d descri pti vel y  b y t he rati o of t he 
G M T f or t he c o m bi nati o n vacci ne t o t he G M T f or t he in di vi d ual vacci ne f or R S V 
s u b gr o u p A a n d s u b gr o u p B N T s a n d strai n-s pecific H AI N T s. 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 3
1. 1. 2. S u bst u d y B
T he de vel o p me nt of 
 is s o meti mes re q uire d f or i njecta ble pr o d ucts t o 
de m o nstrate efficac y , safet y, 
T he be nefits o btai ne d 
 
 nee d t o be bala nce d a gai nst t he p ote ntial ris ks t o t olera bilit y.
 
T he f or m ulati o n de vel o p me nt of c o m bi nati o n vacci nes re q uires c o nsi derati o n of 
 
 t o deter mi ne w het her t he ulti mate pr o d uct ac hie ves t he desire d 
effects i n a safe a n d t olera ble ma n ner. 
 
 
. A pri or st u d y of healt hy a d ults 
1 8 t o 4 0 ye ars of a ge w h o recei ve d a nter olateral t hi g h i njecti o n wit h 5 s us pe nsi o ns 
c o ntai ni n g t he sa me c o m p o ne nts as e xci pie nts of a c o m bi ne d p ert ussis– i nacti vate d 
p oli o m y elitis– H ae m o p hil us i nfl ue nz ae t ype b pe diatric vacci ne i n vesti gate d t he i nci de nce of 
l ocal pai n a n d b ur ni n g se nsati o n. 
 
 
T his is a P hase 1 b st u d y  i n healt h y partici pa nts ≥5 0 y ears of a ge. S u bst u d y B will i n vesti gate 
2 f or m ulati o ns of R S V pre F + qI RV of differi n g v ol u me s a n d os m olarit ies. T he first 
c o m bi nati o n is a be dsi de mi x of 
 
, yiel di n g a fi nal i njecti o n v ol u me of 1. 0 m L 
 
. T he sec o n d c o m bi nati o n is a be dsi de mi x of 
 
 t o yiel d a fi nal i njecti o n v ol u me of 0. 5 m L. T he 0. 5 -m L  
 
 c o m bi nati o n w o ul d res ult i n
wit h t he
p ote ntial t o i nfl ue nce react o ge nicit y at t he i njecti o n site. T hese c o m bi nati o ns will be 
e val uate d f or safet y, t olera bilit y , a n d i m m u n o ge nicit y, wit h t he g oal of selecti n g a 
f or m ulati o n f or f urt her st u d y.
1. 1. 2. 1. O bjecti ves, E n d p oi nts, a n d Esti m a n ds
S u bst u d y B
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y S afet y
Pri m ar y S afet y
Pri m ar y S afet y
T o e val uate t he safet y pr ofile 
of 2 f or m ulati o ns of
c o m bi nati o n R S V pre F + qI R V

L ocal reacti o ns ( pai n at t he i njecti o n 
site, re d ness, a n d s welli n g)

S y ste mic e ve nts (fe ver, fati g ue, 
hea dac he, v o miti n g, na usea, 
diarr hea, 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 E s

S A Es
I n partici pa nts recei vi n g th e st u d y 
i nter ve nti o n, t he perce nta ge of 
partici pa nts re p orti n g :

L ocal reacti o ns wit hi n 7 da ys 
f oll o wi n g vacci nati o n

S y ste mic e ve nts wit hi n 7 d a y s 
f oll o wi n g vacci nati o n

A E s t hr o u g h o ut t he st u d y

S A Es t hr o u g h o ut t he st u d y
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( 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 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 4
S u bst u d y B
O bjecti ves
E n d p oi nts
Esti m a n ds
Sec o n d ar y I m m u n o ge nicit y
Sec o n d ar y I m m u n o ge nicit y
Sec o n d ar y I m m u n o ge nicit y
T o descri be t he i m m u ne 
res p o nses elicite d b y 2
f or m ulati o ns of c o mbi nati o n 
R S V pre F + qI R V

R S V A a n d R S V B N Ts

Strai n -s pecific H AI titers f or t he 
c urre nt seas o nal strai ns ( 2 × A, 2 × B) 
rec o m me n de d b y W H O f or 
rec o m bi na nt or cell-base d i nfl ue nza 
vacci nes
I n partici pa nts i n c o m plia nce wit h 
t he ke y pr ot oc ol criteria 
(e val ua ble partici pa nts): 

G M T f or eac h R S V s u b gr o u p 
( A or B) 1 m o nt h after 
vacci nati o n wit h eac h 
f or m ulati o n

G M T of H AI titers f or eac h of  
t he i ncl u de d strai ns 1 m o nt h 
after vacci nati o n wit h eac h 
f or m ulati o n
1. 1. 2. 2. O ver all Desi g n
S u bst u d y B
S u bst u d y  B will be c o n d ucte d as a P hase 1 b, parallel-gr o u p, ra n d o mize d, o bser ver - bli n de d
s u bst u d y of R S V pre F a n d a n ucle osi de -m o difie d R N A vacci ne ( qI R V) a gai nst R S V a n d 
i nfl ue nza a d mi nistere d as a c o m bi ne d vacci ne i n a 1. 0- m L  f or m ulati o n a n d w he n 
a d mi nistere d i n a 0. 5-m L f or m ulati o n.
H ealt h y a d ults ≥5 0 ye ars of a ge will be ra n d o mize d 1: 1 t o eit her Gr o u p 1: c o m bi nati o n 
(R S V pre F + qI R V) 1. 0 -m L f or m ulati o n; or Gr o u p 2: c o m bi nati o n (R S V pre F + qI R V) 
0. 5- m L f or m ulati o n. Ra n d o mizati o n will be stratifie d b y 6 a ge/se x gr o u ps (fe male 5 0- 6 4, 
fe male 6 5- 7 9, a n d fe male ≥8 0 ye ars; male 5 0 -6 4, male 6 5 -7 9, a n d male ≥8 0 ye ars) wit hi n t he 
st u d y site. A p pr o xi matel y 1 0 0 partici pa nts will be ra n d o mize d wit hi n t he 5 0- t hr o u g h 
6 4- ye ar -ol d gr o u p , a n d 1 0 0 partici pa nts ≥6 5 y ears of a ge will be ra n d o mize d. St u d y  gr o u ps, 
bl o o d dra ws, a n d safet y assess me nt ti mi n gs are prese nte d bel o w.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 5
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 6
1. 1. 2. 3. N u m ber of P artici p a nts
A p pr o xi matel y  2 0 0 healt h y  partici pa nts ( n = 1 0 0 per gr o u p) will be e nr olle d i n S u bst u d y  B. 
N ote: " E nr olle d" mea ns a partici pa nt's a gree me nt t o partici pate i n a cli nical st u d y  f oll o wi n g 
c o m pleti o n of t he i nf or me d c o nse nt pr ocess .
1. 1. 2. 4. St u d y P o p ul ati o n 
I ncl usi o n Criteri a 
Partici pa nts m ust meet t he f oll o wi n g i ncl usi o n criteria t o be eli gi ble f or e nr oll me nt i nt o 
S u bst u d y  B:
A ge a n d Se x:
1.
P artici pa nts ≥5 0 ye ars of a ge at st u d y e nr oll me nt.
Refer t o Secti o n 1 0. 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 ot a p plica ble.
Ot her I ncl usi o n Criteri a:
2.
Partici pa nts w h o are willi n g a n d a ble t o c o m pl y wit h all sc he d ule d visits, 
i n vesti gati o nal pla n, la b orat or y tests, 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 y sical e xa mi nati o n
(if re q uire d), a n d cli nical j u d g me nt of t he i n vesti gat or t o be eli gi ble f or i ncl usi o n i n t he 
st u d y.
N ote: Healt h y partici pa nts wit h pree xisti n g sta ble disease, defi ne d as disease n ot re q uiri n g
si g nifica nt c ha n ge i n t hera p y or h os pitalizati o n f or w orse ni n g disease d uri n g t he 6 wee ks 
bef ore e nr oll me nt, ca n be i ncl u de d. S pecific criteria f or partici pa nts wit h k n o w n sta b le 
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 1 .
4.
Ca pa ble of gi vi n g a n d ha vi n g si g ne d t he 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 plyi n g wit h t he re q uire me nts a n d restricti o ns liste d i n t he I CD a n d i n
t his pr ot oc ol. 
5.
Recei pt of lice nse d i nfl ue nza vacci nati o n f or t he 2 0 2 2- 2 0 2 3 n ort her n he mis p here seas o n 
or 2 0 2 2 s o ut her n he mis p here seas o n > 1 8 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 7
E xcl usi o n Criteri a 
Partici pa nts wit h a n y  of t he f oll o wi n g c haracteristics/c o n diti o ns will be e xcl u de d:
Me dic al C o n diti o ns
1. A c o nfir me d dia g n osis of R S V i nfecti o n or i nfl ue nza ≤1 2 0 da y s bef ore st u d y i nter ve nti o n 
a d mi nistrati o n.
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. 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 M i njecti o n.
4. Seri o us c hr o nic dis or der, i ncl u di n g metastatic mali g na nc y , e n d-sta ge re nal disease wit h or 
wit h o ut dial y sis, cli nicall y u nsta ble car diac disease, or a n y ot her dis or der t hat, i n t he 
i n vesti gat or’s o pi ni o n, e xcl u des t he partici pa nt fr o m partici pati n g i n t he st u d y.
5. 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.
6. Ot her me dical or ps y c hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he past year) or acti ve 
s uici dal i deati o n/ be ha vi or or la b orat or y a b n or malit y t hat ma y i ncrease t he ris k of st u d y 
partici pati o n or, i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt i na p pr o priate f or t he
st u d y. 
Pri or/ C o nc o mit a nt T her a p y
7. Recei pt of c hr o nic s ys te mic treat me nt wit h k n o w n i m m u n os u p pressa nt me dicati o ns 
(i ncl u di n g c yt ot o xic a ge nts or s yste mic c ortic oster oi ds), or ra di ot hera py, wit hi n 6 0 da y s 
bef ore st u d y i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he st u d y.
N ote: S y ste mic c ortic oster oi ds are defi ne d as t h ose a d mi nistere d f or ≥1 4 da y s at a d ose of
≥2 0 m g/ da y of pre d nis o ne or e q ui vale nt (e g, f or ca ncer or a n a ut oi m m u ne disease) or 
pla n ne d recei pt t hr o u g h o ut t he st u d y . I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical 
(s ki n, e yes, or ears) c ortic oster oi ds are per mitte d.
8. Recei pt of bl o o d/ plas ma pr o d ucts or i m m u n o gl o b uli n, fr o m 6 0 da y s bef ore st u d y
i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he st u d y.
9. Recei pt of a n y R S V vacci ne at a n y ti me pri or t o e nr oll me nt, or pla n ne d recei pt t hr o u g h o ut 
t he st u d y.
1 0. Recei pt of a n y i nfl ue nza vacci ne ≤1 8 0 da y s bef ore st u d y  e nr oll me nt, or pla n ne d recei pt 
t hr o u g h o ut t he st u dy.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 8
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 n i n vesti gati o nal R S V vacci ne or m R N A 
i nfl ue nza vacci ne at a ny t i me pri or t o e nr oll me nt, a n d t hereafter u ntil st u dy c o m pleti o n, 
re gar dless of vacci ne assi g n me nt.
1 2. Partici pati o n i n a n y ot her i nter ve nti o nal st u dies wit hi n 2 8 da y s bef ore st u d y e nr oll me nt 
t hr o u g h st u dy c o m pleti o n. Partici pati o n i n p urel y  o bser vati o nal st u dies is acce pta ble.
Di a g n ostic Assess me nts
N ot a p plica ble.
Ot her E xcl usi o n Criteri a 
1 3. I n vesti gat or site staff directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site staff ot her wise s u per vise d b y t he i n vesti gat or, a n d s p o ns or a n d s p o ns or 
dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers.
1. 1. 2. 5. St u d y Ar ms a n d D ur ati o n
F or i n di vi d ual partici pa nts, t he d urat i o n of S u bst u d y B is a b o ut 1 m o nt h. Base d o n a n 
esti mate d 1- m o nt h e nr oll me nt peri o d, t he d urati o n of S u bst u d y  B will be a p pr o xi matel y  
2 m o nt hs.
St u d y I nter ve nti o ns f or S u bst u d y B
G R O U P 1
V acci ne Det ails
C O M BI N A TI O N
1. 0 m L
( R S V pre F + qI R V) 
Vacci ne 
C o m p o ne nt
R S V pre F
qI R V
2 Sta bilize d R S V pref usi o n 
F a nti ge ns, i n e q ual a m o u nts 
fr o m vir us s u b gr o u ps A a n d B 
E nc o di n g H A of 4 strai ns as 
rec o m me n de d f or t he i nfl ue nza 
seas o n ( 2 A strai ns a n d 2 B 
strai ns)
D ose 
F or m ulati o n
R S V vacci ne 1 2 0 µ g/ vial p o w der
f or s ol uti o n f or i njecti o n
Q ua dri vale nt i nfl ue nza 
s us pe nsi o n f or i njecti o n, 
m g/ m L ( qI R V)
P r o d uct f or 
Rec o nstit uti o n
Sterile water as dil ue nt f or 
i njecti o n ( 0. 6 5 m L/s yri n ge)
N/ A
U nit D ose 
Stre n gt h(s)
1 2 0 µ g 
µ g 
R o ute of 
A d mi nistrati o n
A fter c o m bi ni n g b ot h vacci nes, a si n gle 1- m L IM i njecti o n is gi ve n
i nt o t he delt oi d m uscle of t he n o n d o mi na nt ar m ( preferre d). 
Use
E x peri me ntal
I M P or 
NI M P/ A x M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y Pfizer
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 2 9
G R O U P 1
V acci ne Det ails
Pac ka gi n g a n d 
La beli n g
R S V pre F is s u p plie d as a l y o p hilize d w hite ca ke, pac ka ge d i n a 
clear glass 2 -m L vial wit h a r u b ber st o p per, al u mi n u m o verseal, a n d 
fli p-off ca p . F or t he 1. 0 -m L f or mulati o n , t he w hite ca ke is 
 
qI R V is s u p plie d as
 
 
St u d y i nter ve nti o n(s) will be la bele d as per c o u ntr y re q uire me nts.
G R O U P 2
V acci ne Det ails
C O M BI N A TI O N
0. 5 m L
( R S V pre F + qI R V)
Vacci ne 
C o m p o ne nt
R S V pre F
qI R V
2 Sta bilize d R S V pref usi o n 
F a nti ge ns, i n e q ual a m o u nts fr o m 
vir us s u b gr o u ps A a n d B 
E nc o di n g H A of 4 strai ns as 
rec o m me n de d f or t he i nfl ue nza 
seas o n ( 2 A strai ns a n d 2 B 
strai ns)
D ose 
F or m ulati o n
R S V vacci ne 1 2 0 µ g/ vial p o w der 
f or s ol uti o n f or i njecti o n
Q ua dri vale nt i nfl ue nza 
s us pe nsi o n f or i njecti o n, 
m g/ m L ( qI R V)
P r o d uct f or 
Rec o nstit uti o n
qI R V s us pe nsi o n
N/ A
U nit D ose 
Stre n gt h(s)
1 2 0 µ g 
µ g 
R o ute of 
A d mi nistrati o n
A fter c o m bi ni n g q I R V s us pe nsi o n wit h t he R S V pre F ca ke, a si n gle 
0. 5 -m L IM i njecti o n is gi ve n i nt o t he delt oi d m uscle of t he 
n o n d o mi na nt ar m ( preferre d). 
Use
E x peri me ntal
I M P or 
NI M P/ A x M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y Pfizer
Pac ka gi n g a n d 
La beli n g
R S V pre F is s u p plie d as a l y o p hilize d w hite ca ke, pac ka ge d i n a 
clear glass 2 -m L vial wit h a r u b ber st o p per, al u mi n u m o verseal, a n d 
fli p-off ca p . F or t he 0. 5-m L f or mulati o n , t he w hite ca ke is t o be 
qI R V is s u p plie d as
 
 
St u d y i nter ve nti o n(s) wi ll be la bele d as per c o u ntr y re q uire me nts.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 0
1. 2. Et hic al C o nsi der ati o ns
T he a vaila ble safet y, i m m u n o ge nicity, a n d effecti ve ness data fr o m o n g oi n g cli nical trials f or 
R S V pre F , as well as data fr o m n o ncli nical a n d cli nical trials wit h qI R V , s u p p ort a fa v ora ble 
be nefit/ris k pr ofile a n d s u p p ort cli nical de vel o p me nt of a vacci ne c o m bi ni n g t hese 
c o m p o ne nts. 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 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 hy partici pa nts.
As qI R V ha s t he sa me m o d R N A a n d L N P platf or m as t he C O VI D-1 9 vacci ne B N T 1 6 2 b 2, its
safety 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. Base d o n t he e x perie nce wit h 
B N T 1 6 2 b 2 a n d R S Vp re F, t he p ote ntial ris ks f or t he R S V p re F + qI R V c o m bi nati o n vacci ne
i ncl u de t he f oll o wi n g:

L ocal reacti o ns, s uc h as i njecti o n site re d ness, i njecti o n site s welli n g, 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, na usea, diarr hea, 
m uscle pai n, a n d j oi nt pai n .

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 R N A 
C O VI D -1 9 vacci nes (rate f or my ocar ditis : 2. 1 3 per 1 0 0, 0 0 0 pers o ns u p t o 4 2 da y s after 
at least 1 d ose of vacci ne ).

A na p h yl a xis has bee n re p orte d i n pe o ple after vacci nati o n wit h B N T 1 6 2 b 2 , at a rate of
1 1. 1 per milli o n d oses a d mi nistere d.
T he st u d y  pr oce d ure– relate d ris ks i ncl u de:

Partici pa nts will be re q uire d t o atte n d healt hcare facilities d uri n g seas o ns of hei g hte ne d 
res pirat or y vir us tra ns missi o n.

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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 1
1. 3. Sc he m a
1. 3. 1. S u bst u d y A - C o m b i n ati o n R S V pre F + qI R V vs Se q ue nti al A d mi nistr ati o n
Healt h y a d ults 
≥6 0 years of a ge
( 1 2 5 per gr o u p,
ra n d o mize d 1: 1)
Visit A 1 0 1
( D a y 1)
Visit A 1 0 2
( Mo nt h 1)
2 8 -3 5 da ys
after Vacci nati o n 1
Visit A 1 0 3
( Mo nt h 2)
2 8 -3 5 da ys
after Vacci nati o n 2
V acci n ati o n 1
V acci n ati o n 2
F oll o w -u p
Gr o u p 1: C o m b i n ati o n
R S V pre F + qI R V /
p lace b o
C o m bi nati o n
( R S V pre F + qI R V)
Place b o
B l o o d dra w
Gr o u p 2: Se q ue nti al 
a d mi nistr ati o n
qI R V / R S V pre F
qI R V
R S V pre F
B l o o d dra w
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 2
1. 3. 2. S u bst u d y B – C o m b i n ati o n R S V pre F + qI R V 1. 0 -m L F o r m ul ati o n vs C o m bi n ati o n R S V pre F + qI R V 0. 5 -m L
F or m ul ati o n
S u bst u d y B Desi g n
A ge Gr o u p
N = 2 0 0
St u d y Gr o u p
Ra n d o mizati o n 1: 1 
wit hi n eac h a ge c o h ort
P artici p a nt
s 
Se nti nel C o h ort
Visit B 1 0 1
( Vacci nati o n, Da y 1)
E x p a n de d E nr ol lme nt
Visit B 1 0 1
( Vacci nati o n, Da y 1)
Visit B 1 0 2
( F oll o w-u p,
Da y  2 8 – Da y 3 5)
5 0 -6 4 years 
n = 1 0 0
Gr o u p 1
R S V pre F + qI R V
1. 0 -m L f or m ulati o n *
1 0
R S V pre F + qI R V 1. 0 m L
bl o o d dra w
4 0
R S V pre F + qI R V 1. 0 m L
Gr o u p 2
R S V pre F + qI R V 
0. 5 -m L f or m ulati o n * *
1 0
R S V pre F + qI R V 0. 5 m L
bl o o d dra w
4 0
R S V pre F + qI R V 0. 5 m L
≥6 5 years
n = 1 0 0
Gr o u p 1
R S V pre F + qI R V 
1. 0 -m L f or m ulati o n *
5 0
R S V pre F + qI R V 1. 0 m L
bl o o d dra w
Gr o u p 2
R S V pre F + qI R V 
0. 5 -m L f or m ulati o n * *
5 0
R S V pre F + qI R V 0. 5 m L
bl o o d dra w
* Gr o u p 1: 1. 0 -m L f or m ulati o n: 
i njecti o n.
* * Gr o u p 2: 0. 5 -m L f or m ulati o n
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 3
1. 4. 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. Refer t o t he 
S T U D Y  AS S E S S M E N T S A N D P R O C E D U R E S secti o n of t he pr ot oc ol f or detaile d 
i nf or mati o n o n eac h pr oce d ure a n d assess me nt re q uire d f or c o m plia nce wit h t he pr ot oc ol. 
T he i n vesti gat or ma y  sc he d ule visits ( u n pla n ne d visits) i n a d diti o n t o t h ose liste d i n t he S o A 
ta ble, i n or der t o c o n d uct e val uati o ns or assess me nts re q uire d t o pr otect t he well-bei n g of t he 
partici pa nt.
Se e Secti o n 1 0. 9. 3 for t he S u bst u d y A S o A.
See Secti o n 1 0. 1 0. 3 f or t he S u bst u d y B S o A.
2. I N T R O D U C TI O N
2. 1. St u d y R ati o n ale 
T he c ocirc ulati o n of R S V a n d infl ue nza si g nifica ntl y  i m pacts t he ol der a d ult p o p ulati o n, 
w here t here is a hi g her i nci de nce of res pirat or y  i nfecti o ns a n d i ncrease d m or bi dit y a n d 
m ortalit y  d uri n g t he wi nter m o nt hs.1 ,2 I n t he early 2 0 2 2 -2 0 2 3 U S wi nter, t he i nci de nce s of 
infl ue nza a n d R S V- relate d disease were i ncreasi n g.3 As v acci nes a gai nst i nfl ue nza a n d 
C O VI D -1 9 ca n be a d mi nistere d at a si n gle healt hcare visit as i n di vi d ual vacci nati o ns,
re q uiri n g m ulti ple i njecti o ns ,4 s h o ul d a lice nse d R S V vacci ne bec o me a vaila ble, t he 
c oa d mi nistrati o n of t hese vacci nes w o ul d li kel y occ ur at t he sa me ti me o f year . T he Pfizer 
R S V vacci ne , R S V pre F, was rece ntly f o u n d t o be efficaci o us a gai nst R S V -ass ociate d L R TI 
i n ol der a d ults.5 C o nc urre nt a d mi nistrati o n of vacci nes a gai nst t hese res pirat or y  viral 
i nfecti o ns re d uces t he nee d f or m ulti ple healt hcare or p har mac y visits a n d ma y i m pr o ve 
vacci ne u pta ke . A c o m bi nati o n vacci ne wit h R S V pre F a n d qI R V w o ul d re q uire 1 i njecti o n at
a healt hcare pr o vi der visit. A st u d y of co m bi n e d vacci nati o n is re q uire d t o i n vesti gate
p ote ntial i m m u n ol o gical i nterfere nce i n a d diti on t o safety a n d t olera bilit y . Pfizer is c urre ntl y  
i n vesti gati n g t he efficac y of a q ua dri vale nt m o difie d R N A ( m o d R N A) i nfl ue nza vacci ne 
ca n di date ( qI RV) . T his st u d y series will i n vesti gate t he a d mi nistrati o n of res pirat or y 
c o m bi nati o n vacci ne ca n di dates t o assess t he safet y, t olera bilit y, a n d p ote ntial f or 
i m m u n ol o gical i nterfere nce. T his e val uati o n will i nitiall y be c o n d ucte d i n S u bst u d y A wit h 
R S V pre F a n d qI R V 1. 0 m L as a P hase 1 b s u bst u d y i n healt h y partici pa nts ≥6 0 ye ars of a ge. 
S u bst u d y  B will i n vesti gate 2 f or m ulati o ns of R S V pre F + qI R V of differi n g v ol u me a n d 
os m olalit y . T he first c o m bi nati o n is a be dsi de mi x of 
 
, yiel di n g a fi nal i njecti o n v ol u me of 1. 0 m L. T he sec o n d 
c o m bi nati o n is a be dsi de mi x of
t o yiel d a fi nal i njecti o n v ol u me of 0. 5 m L. T he 0. 5-m L
c o m bi nati o n 
w o ul d res ult i n 
 
 T hese c o m bi nati o ns will be e val uate d f or safety, t olera bilit y , a n d 
i m m u n o ge nicity , wit h t he g oal of selecti n g a f or m ulati o n f or f urt her st u d y . To better assess 
a n y relati o ns hi p bet wee n a ge/se x a n d t he t olera bilit y of t he st u d y inter ve nti o n ,6 ,7 t he st u d y 
p o p ulati o n will i ncl u de ol der a d ults 5 0 y ears of a ge a n d a b o ve w h o will be ra n d o mize d b y  
a ge/se x strata.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 4
2. 2. B ac k gr o u n d 
2. 2. 1. R S V
R S V is a maj or ca use of res pirat or y i nfecti o n i n all a ges, w hic h ca n res ult i n se vere ill ness i n 
b ot h i nfa nts a n d ol der a d ults. T here are 2 a nti ge nic varia nts of R S V: s u b gr o u ps A ( R S V A) 
a n d B ( R S V B), w hic h c ocirc ulate.8 Li ke i nfl ue nza, R S V i nfecti o n f oll o ws a seas o nal patter n, 
ca usi n g ye arl y wi nterti me e pi de mics i n te m perate cli mates, us uall y bet wee n late a ut u m n a n d 
earl y s pri n g. I n tr o pical cli mates, t he o ut brea ks are ge nerall y ass ociate d wi t h rai n y seas o ns 
b ut are m ore u n pre dicta ble a n d fre q ue ntl y c o nti n u o us. 9 Beca use of t he C O VI D -1 9 pa n de mic, 
w hic h s prea d w orl d wi de i n 2 0 2 0- 2 0 2 1, t he seas o nalit y  of se veral pat h o ge ns, i ncl u di n g R S V, 
has bee n disr u pte d a n d t he s hift of pea k i nci de nce has bee n o bser ve d i n a maj orit y  of 
ge o gra p hies. R S V n o w c ocirc ulates wit h i nfl ue nza a n d S A R S -C o V - 2 a n d i ncreases t he 
i nci de nce of res pirat or y i nfecti o n– relate d disease.1 0
A d ults ≥6 0 y ears of a ge are at i ncrease d ris k of R S V i nfecti o n, w hic h ca n tri g ger 
e xacer bati o n s of u n derlyi n g c o m or bi d c o n diti o ns s uc h as C O P D a n d C H F. R S V i nfecti o n has 
bee n ass ociate d wit h u p t o 2 2 % of ac ute C O P D e xacer bati o ns i n pr os pecti ve c o h ort st u dies 
a n d 1 1 % of wi nterti me h os pitalizati o ns f or C O P D e xacer bati o ns. 1 1 C urre nt e pi de mi ol o g y  
s h o ws t hat R S V is res p o nsi ble f or a p pr o xi matel y 1 7 7, 0 0 0 h os pitalizati o ns a n d 1 4, 0 0 0 deat hs 
a n n uall y i n U S a d ults 6 5 years of a ge a n d ol der. 1 2 M or bi dit y  is si g nifica nt a m o n g a d ults 
h os pitalize d wit h R S V disease, wit h 1 8 % re q uiri n g i nte nsi ve care, 3 1 % nee di n g h o me healt h 
ser vices at disc har ge, a n d 2 6 % d yi n g wit hi n 1 year of h os pitalizati o n. 1 3 I n t he U S, R S V 
disease i nci de nce rates i n ol der a d ults are a p pr o xi matel y half t h ose of i nfl ue nza, wit h 
variati o n y ear t o year. 1 4 I nci de nce rates a n d ris k f or se vere c o m plicati o ns fr o m R S V i nfecti o n 
are hi g her a m o n g i m m u n oc o m pr o mise d a d ults a n d t h ose wit h c hr o nic c o n diti o ns 
(e g, car di o p ul m o nar y or re nal disease, he mat ol o gical mali g na ncies, recei pt of c he m ot hera p y , 
or HI V i nfecti o n). 1 5 ,1 6 H o we ver, t he b ur de n of a d ult R S V disease c o ul d be u n deresti mate d 
si nce testi n g f or R S V is less c o m m o n i n ol der a d ults t ha n i n c hil dre n. R S V disease i n a d ults 
is als o diffic ult t o dia g n ose base d o n cli nical si g ns a n d s ym pt o ms al o ne, a n d, pri or t o t he 
br oa der use of m ore se nsiti ve detecti o n met h o ds, la b orat or y  c o nfir mati o n of R S V i n a d ults 
was c halle n gi n g beca use of l o w le vels of vir us s he d di n g. 9
R S V disease ma na ge me nt i n a d ults is li mite d t o s u p p orti ve meas ures, s uc h as h y drati o n a n d 
o x y ge nati o n. Aer os olize d ri ba viri n has li mite d e vi de nce of effecti ve ness a n d is 
pre d o mi na ntl y  restricte d t o se verely i m m u n oc o m pr o mise d h os pitalize d patie nts beca use of 
i nc o n ve nie nt a d mi nistrati o n, terat o ge nicity, a ne mia c o ncer ns, a n d hi g h c ost. Pre ve nti o n of 
R S V disease via acti ve i m m u nizati o n has t he p ote ntial t o ma ke a si g nifica nt i m pact i n t his 
p o p ulati o n, t h eref ore ma ki n g vacci ne de vel o p me nt a hi g h pri orit y. 1 6 ,1 7  
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 5
2. 2. 1. 1. R S V pre F V acci n ati o n
R S V pre F is a bi vale nt R S V pref usi o n F s u b u nit vacci ne de vel o pe d b y Pfizer. T he R S V 
F gl yc o pr otei n facilitates f usi o n of t he viri o n a n d h ost cell me m bra ne t hr o u g h a dra matic 
tra nsiti o n fr o m a n u nsta ble b ut hi g hly i m m u n o ge nic pref usi o n c o nf or mati o n t o t he m ore 
sta ble p ostf usi o n state. Precli nical st u dies s h o w t hat pref usi o n F elicits m uc h hig her 
ne utralizi n g a nti b o d y titers t ha n p ostf usi o n F a n d t hat t he m ost p ote nt ne utralizi n g a nti b o dies 
fr o m p osti nfecti o n h u ma n sera tar get t he pref usi o n f or m. R S V pre F is c o m p ose d of 
e n gi neere d, sta bilize d, tri meric, pref usi o n F gl yc o pr otei ns matc hi n g t he 2 s u b gr o u ps 
( A a n d B) t o hel p e ns ure t he br oa dest c o vera ge a gai nst R S V ill ness.
R S V pre F is bei n g de vel o pe d f or 2 i n dicati o ns:

Ol der A d ult: Pre ve nti o n of L R TI -R S V i n a d ults 6 0 y ears of a ge a n d ol der via acti ve 
i m m u nizati o n.

M ater n al:
Pre ve nti o n of L R TI -R S V i n i nfa nts b y acti ve i m m u nizati o n of pre g na nt 
w o me n.
As of Dec e m ber 2 0 2 2, R S V pre F has bee n st u die d i n 6 c o m plete d trials i n healt h y  a d ults a n d 
pre g na nt w o me n a n d 2 o n g oi n g P hase 3 cli nical trials i n ol der a d ults a n d i nfa nts b or n t o 
vacci nate d pre g na nt w o me n. R S V pre F was s h o w n t o be well t olerate d, wit h a n acce pta ble 
safety pr ofile, a n d hi g hl y efficaci o us i n ol der a d ults a n d i nfa nts of w o me n vacci nate d d uri n g 
pre g na nc y .
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 worl 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. 1 8 S y m pt o matic i nfl ue nza i nfecti o n 
ca uses a fe brile ill ness wit h res pirat or y  a n d sys te mic s ym pt o ms, 1 9 alt h o u g h it ma y ofte n be 
as ym pt o matic. 2 0 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 is 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 1 w hile t he a n n ual gl o bal n u m be r 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 2
I nfl ue nza vir uses are part of t he Ort h o myx oviri d ae fa mil y a n d are di vi de d i nt o 3 ge nera or 
t ypes ( A, B, a n d C) base d u p o n a nti ge nic differe nces i n t he n ucle o pr otei n a n d matri x pr otei n.
I nfl 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 3 T he R N A ge n o me is se g me nte d, w hic h all o ws ge netic 
reass ort me nt a m o n g vir uses of t he sa me ty pe. 2 3 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 1 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 1
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 6
2. 2. 2. 1. I nfl ue nz a V acci n ati o n
T he first i nfl ue nza vacci nes were lice nse d i n t he 1 9 4 0s, 2 4 a n d n o w a n u m ber of differe nt 
t ypes of vacci ne e xist: i nacti vate d, rec o m bi na nt, a n d L AI V. 2 5 T he vir uses t hat f or m t he basis 
f or i nacti vate d vacci nes are re plicate d i n eit her e m br yo nate d he ns’ e g gs or ma m malia n cell 
li nes,2 6 a n d s o me are c o m bi ne d wit h a n a dj u va nt, s uc h as M F 5 9, t o i m pr o ve t he i m m u ne 
res p o nse, partic ularly i m p orta nt i n ol der i n di vi d uals. 2 5
M ulti vale nt vacci nes are pr o d uce d f or r o uti ne seas o nal i m m u nizati o n, tar geti n g 3 or 4 
i nfl ue nza vir uses.2 5 Tri vale nt vacci nes tar get 2 A s u bt y pes a n d 1 B vir us, alt h o u g h t hese ha ve 
bee n re place d b y q ua dri vale nt vacci nes t hat tar get a n a d diti o nal B vir us (beca use of t he 
e mer ge nce of 2 a nti ge nicall y  disti nct li nea ges).2 7 Sta n dar d i nacti vate d vacci nes ge nerall y  
c o ntai n 1 5 μ g of eac h H A f or a d ult I M i njecti o n, alt h o u g h t he hi g h-d ose i nacti vate d vacci ne 
c o ntai ns 6 0 μ g of eac h H A. 2 8
A n n ual seas o nal i nfl ue nza vacci nati o n is rec o m me n de d i n a n u m ber of c o u ntries ar o u n d t he 
w orl d t o pre ve nt i nfl ue nza i n c hil dre n a n d a d ults. Ol der a d ults, partic ularl y t h ose wit h 
me dical c o m or bi dities, are at i ncrease d ris k of i nfl ue nza m or bi dit y  a n d m ortalit y a n d are 
rec o m me n de d t o recei ve hi g h-d ose or a dj u va nte d i nfl ue nza vacci ne f or m ulati o ns. 2 9 Beca use 
of t he o n g oi n g varia bilit y i n circ ulati n g i nfl ue nza vir uses, rec o m me n datio ns f or t he vir uses t o 
be tar gete d b y eac h i nfl ue nza seas o n’s vacci nes reflect t he gl o bal i nfl ue nza vir us s ur veilla nce 
t hat c o nti n ues t hr o u g h o ut t he year i n b ot h he mis p heres. 2 8 T his mea ns t hat t he sc he d ule f or 
vacci ne pr o d ucti o n, release, a n d a d mi nistrati o n is hi g hl y c o m presse d.
I n t he last se veral years, t he use of m R N A as t he basis f or p ote ntial vacci ne ca n di dates has 
s h o w n i ncreasi n g pr o mise. 3 0 Vari o us a p pr oac hes t o o pti mize t he res p o nse t o m R N A vacci nes 
ha ve bee n use d. T his i ncl u des m o d R N A i n w hic h s o me n ucle osi des are re place d b y nat urall y 
occ urri n g m o difie d n ucle osi des, s uc h as pse u d o uri di ne, w hic h decreases i n nate i m m u ne 
acti vati o n a n d i ncreases tra nslati o n. 3 0 T w o L N P -e nca ps ulate d m o d R N A vacci nes e nc o di n g 
t he S A R S-C o V -2 s pi ke pr otei n ha ve bee n de vel o pe d i n res p o nse t o t he p u blic healt h 
e mer ge nc y prese nte d by t he C O VI D- 1 9 pa n de mic: B N T 1 6 2 b 2 ( Pfizer/ Bi o N Tec h)3 1 a n d 
m R N A -1 2 7 3 ( M o der na) ,3 2 wit h b ot h vacci nes de m o nstrati n g hi g h effecti ve ness wit h n o 
si g nifica nt safety c o ncer ns d uri n g P hase 3 de vel o p me nt. 3 1 ,3 3 Si nce its first mar keti n g 
a ut h orizati o n i n Dece m ber 2 0 2 0, B N T 1 6 2 b 2 has bee n a d mi nistere d t o h u n dre ds of milli o ns 
of i n di vi d uals w orl d wi de. P osta ut h orizati o n safet y s ur veilla nce i n t he U S has c o nfir me d t he 
safety pr ofile o bser ve d i n cli nical trials a n d has als o i de ntifie d a d verse reacti o ns of 
a na p h yl a xis (esti mate d at 1 1. 1 per milli o n d oses a d mi nistere d) a n d a n i ncrease d ris k of 
m y ocar ditis a n d pericar ditis (rate f or m y ocar ditis : 2. 1 3 per 1 0 0, 0 0 0 pers o ns u p t o 4 2 da y s 
after at least 1 d ose of vacci ne) , pri maril y i n a d olesce nts a n d yo u n g a d ult males .3 4 ,3 5 ,3 6 ,3 7
E x perie nce wit h m o d R N A -base d C O VI D -1 9 vacci nes s u p p orts t he use of t he m o d R N A 
platf or m f or p ote ntial ra pi d de vel o p me nt of vacci nes e nc o di n g t he seas o nall y  a da pte d H 1, 
H 3, a n d 2 B H As f or t he pre ve nti o n of i nfl ue nza. P ote ntial a d va nta ges of t his platf or m 
i ncl u de accelerate d ma n ufact uri n g, t here by all o wi n g a later decisi o n as t o t he H A strai ns t o 
i ncl u de i n t he seas o nal vacci ne, a n d p ote ntiall y hi g her efficac y relati ve t o c urre ntly lice nse d 
i nfl ue nza vacci nes.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 7
A P hase 3, ra n d o mize d, 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 q ua dri vale nt m o d R N A -base d i nfl ue nza vacci ne is o n g oi n g ; at t he ti me of 
pr ot oc ol a ut h ors hi p , a p pr o xi matel y 2 5, 0 0 0 partici pa nt s 1 8 ye ars of a ge a n d ol der ha ve bee n 
e nr olle d i n t his st u d y a n d ra n d o mize d 1: 1 t o recei ve eit her qI R V or c o m parat or. 
m o d R N A -base d i nfl ue nza vacci ne e nc o des H A of 4 strai ns ( 2 A strai ns a n d 2 B strai ns) 
rec o m me n de d f or t he 2 0 2 2-2 0 2 3 n ort her n he mis p here i nfl ue nza seas o n.
2. 2. 3. Cli nic al O ver vie w
2. 2. 3. 1. R S V pre F
T he ol der a d ult pr o gra m i ncl u des 2 P hase 1/ 2 st u dies, 3 P hase 3 st u dies , a n d a P hase 2a 
h u ma n c halle n ge st u d y. 
I n t he P hase 1/ 2 st u d y C 36 7 1 0 0 1, 1 2 3 3 healt h y  a d ults 1 8 t hr o u g h 4 9 a n d 5 0 t hr o u g h 8 5 ye ars 
of a ge recei ve d 3 d ose le vels of R S V pre F ( 6 0 µ g, 1 2 0 µ g, a n d 2 4 0 µ g), wit h or wit h o ut 
Al( O H) 3, or place b o, a d mi nistere d wit h or wit h o ut c o nc o mita nt i nfl ue nza vacci ne. T he 
res ults ha ve s h o w n t hat t he vacci ne was well t olerate d a n d i m m u n o ge nic i n b ot h a ge gr o u ps. 
R S V pre F elicite d r o b ust ne utralizi n g res p o nses a gai nst R S V A a n d R S V B 1 m o nt h after 
vacci nati o n f or b ot h a ge gr o u ps acr oss all vacci ne d ose le vels a n d f or m ulati o ns ; t hese 
res p o nses re mai ne d hi g h t hr o u g h t he 1 2 m o nt hs after vacci nati o n. I n 6 1 6 vacci nate d 
partici pa nts i n t he 5 0- t hr o u g h 8 5-ye ar a ge gr o u p, R S V 5 0 % N T G M F Rs were hi g h acr oss all 
st u d y gr o u ps , ra n gi n g fr o m 9 t o 1 3 fr o m bef ore vacci nati o n t hr o u g h 1 m o nt h after 
vacci nati o n a n d fr o m 3 t o 4 fr o m bef ore vacci nati o n t hr o u g h 1 2 m o nt hs f or R S V A a n d R S V 
B . R S V pre F was safe a n d well t olerate d w he n a d mi nistere d al o ne or wit h SII V, wit h n o 
maj or differe nces o bser ve d acr oss all d ose le vels a n d f or m ulati o ns. M ost re p orte d l ocal 
reacti o ns or sys te mic e ve nts were mil d or m o derate i n se verity.
T he p r o p orti o ns of partici pa nts re p orti n g A Es were ge nerall y si milar acr oss R S V pre F gr o u ps, 
a n d n o S A Es were c o nsi dere d relate d t o t he i n vesti gati o nal vacci ne.
P hase 1/ 2 s t u d y C 3 6 7 1 0 0 2, i n 3 1 3 ol der a d ults 6 5 t hr o u g h 8 5 y ears of a ge, st u die d t he 3 d ose 
le vels of R S V pre F wit h Al( O H)3, or C p G/ Al( O H) 3 ( 6 0 µ g, 1 2 0 µ g, a n d 2 4 0 µ g), gi ve n as a 
si n gle d ose or o n a sc he d ule of 2 d oses a d mi nistere d 2 m o nt hs a part. All R S V pre F d oses a n d 
f or m ulati o ns elicite d hi g h R S V A– a n d R S V B– ne utralizi n g a nti b o d y G M Ts 1 m o nt h after 
vacci nati o n ( G M F Rs ra n gi n g fr o m 4. 8 t o 1 1. 6 a n d 4. 5 t o 1 4. 1, res pecti vel y) . C p G -c o ntai ni n g 
f or m ulati o ns di d n ot f urt her i ncrease ne utralizi n g G M Ts c o m pare d t o R S V pre F wit h or 
wit h o ut Al( O H) 3. G M Ts i n all gr o u ps decli ne d b ut re mai ne d hi g her t ha n baseli ne ( bef ore 
vacci nati o n) a n d place b o ( SII V o nl y) at 1 2 m o nt hs after vacci nati o n ( G M F Rs ra n gi n g fr o m 
2. 1 t o 3. 5 a n d 2. 2 t o 4. 3, res pecti vel y). N o i ncrease i n G M Ts was o bser ved 1 m o nt h after 
Vacci nati o n 2 ( G M F R of 0. 9). All d oses a n d f or m ulati o ns were safe a n d well t olerate d. 
St u d y  C 3 6 7 1 0 1 4 is a c o m plete d P hase 3, m ultice nter, parallel-gr o u p, place b o -c o ntr olle d, 
ra n d o mize d, d o u ble-bli n d l ot -c o nsiste nc y st u d y i n a p o p ulati o n of u p t o 1 0 0 0 healt h y  a d ults 
1 8 t o ≤4 9 y ears of a ge. T he st u d y e xa mi ne d t he i m m u ne res p o nse a n d t he safety a n d 
t olera bilit y pr ofiles acr oss 3 ma n ufact ure d l ots of R S V pre F w he n a d mi nistere d as a si n gle 
1 2 0- µ g d ose t o healt h y  a d ults. T he pri mar y a nalys es s h o wed t hat t he rati o s of ne utralizi n g 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 8
G M Ts f or eac h of t he 3 ma n ufact ure d R S V pre F l ots 1 m o nt h after vacci nati o n are 
e q ui vale nt, a n d t hat t he 1 2 0- μ g d ose of R S V pre F is well t olerate d a n d has a n acce pta ble 
safety pr ofile. 
A P hase 2a, Ra n d o mise d, D o u ble- Bli n d, Place b o -C o ntr olle d St u d y  t o E val uate t he Safety, 
I m m u n o ge nicity a n d Efficac y of a Res pirat or y  Sy nc ytial Vir us Vacci ne ( R S V pre F) i n a
Vir us C halle n ge M o del i n Healt h y  A d ults (N C T 0 4 7 8 5 6 1 2) was c o n d ucte d b y  h VI V O i n 
7 0 h ealt h y partici pa nts 1 8 t o 5 0 years of a ge . Partici pa nts recei ve d a si n gle d ose of eit her 
1 2 0 μ g R S V pre F or place b o a n d 4 wee ks later u n der we nt i ntra nasal c halle n ge wit h R S V A 
Me m p his 3 7 b vir us. T he i m m u n o ge nicit y a n d efficac y of R S V pre F vacci nati o n o n vir us 
re plicati o n, cli nical sy m pt o ms, a n d i nci de nce of s y m pt o matic R S V i nfecti o n f oll o wi n g t he 
i ntra nasal c halle n ge were e val uate d. T he pri mar y  a nalys is of t he h u ma n c halle n ge st u d y 
s h o we d t hat a 1 2 0- μ g  d ose of R S V pre F wa s well t olerate d a n d has a n acce pta ble safety 
pr ofile. T he st u d y de m o nstrate d 1 0 0 % efficac y of R S V pre F a gai nst R T -P C R – c o nfir me d 
s ym pt o matic i nfecti o n.
C 3 6 7 1 0 1 3 is a n o n g oi n g P hase 3, m ultice nter, ra n d o mize d, d o u ble -bli n d, 
place b o -c o ntr olle d st u d y t o assess t he safety, i m m u n o ge nicit y , a n d efficac y of Pfizer’s 
R S V pre F i n pre ve nti o n of R S V- ass ociate d L R TI i n a d ults 6 0 y ears of a ge a n d ol der. B ot h 
healt h y  a d ults a n d a d ults wit h sta ble c hr o nic car di o p ul m o nar y c o n diti o ns are i ncl u de d. 
A p pr o xi matel y  1 0 % of partici pa nts wit h sta ble c hr o nic car di o p ul m onar y  c o n diti o ns s uc h as 
C O P D, ast h ma, or C H F are bei n g e nr olle d. T he st u d y  e nr olle d o ver 37, 0 0 0 partici pa nts, 
ra n d o mize d t o recei ve R S V pre F or place b o i n a 1: 1 rati o. T his is a n e ve nt-dri ve n st u d y  wit h 
a tar get of 5 9 first e pis o des of e val ua ble R S V -ass ociate d L R TI cases. Interi m a nal y sis res ults 
i n A u gust 2 0 2 2 s h o we d pr otecti o n a gai nst L R TI -R S V defi ne d b y  2 or m ore s y m pt o ms 
de m o nstrate d vacci ne efficac y : 6 6. 7 %. Vacci ne efficac y  of 8 5. 7 % was o bser ve d i n 
partici pa nts wit h a m ore se vere disease pri mar y  e n d p oi nt of LR TI -R S V defi ne d b y  a nalys is 
of 3 or m ore R S V -ass ociate d s ym pt o ms. T he vacci ne was well t olerate d, wit h n o safet y 
c o ncer ns.
C 3 6 7 1 0 0 6 is a P hase 3 , m ultice nter, parallel -gr o u p, place b o -c o ntr olle d, ra n d o mize d, d o u ble -
bli n d st u d y . 1 4 0 3 healt h y a d ults ≥6 5 y ears of a ge were ra n d o mize d 1: 1 t o eit her a 
c oa d mi nistrati o n gr o u p or a se q ue ntial -a d mi nistrati o n gr o u p. T he i nte nti o n of t his st u d y  was 
t o de m o nstrate t hat t he i m m u ne res p o nses ge nerate d w he n a 1 2 0- μ g R S V pre F d ose was 
c oa d mi nistere d wit h SII V were n o ni nferi or t o t he i m m u ne res p o nses w he n t hese pr o d ucts
were a d mi nistere d 4 wee ks a part. T he safet y a n d t olera bilit y of R S V pre F were als o 
e xa mi ne d. R es ults de m o nstrat e d n o ni nferi orit y of t he R S V pre F a n d SII V i m m u ne res p o nses 
w he n R S V pre F was c oa d mi nistere d wit h SI I V. T he res ults of t his st u d y  s u p p ort t he 
acce pta bilit y of c oa d mi nistrati o n of R S V pre F a n d SII V i n a n ol der a d ult p o p ulati o n. 
R S V pre F is als o bei n g st u die d i n t he mater nal pr o gra m, w hic h i ncl u des P ha se 2 b a n d 
P hase 3 st u dies i n pre g na nt w o me n a n d a P hase 2 b st u d y i n n o n pre g na nt w o me n. Details of 
eac h of t hese st u dies are pr o vi de d i n t he R S V pre F I B.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 3 9
2. 2. 3. 2. qI R V
A P hase 1/ 2 st u d y  ( C 4 7 8 1 0 0 1) t o descri be t he safet y, t olera bilit y, a n d i m m u n o ge nicit y of a 
m o d R N A vacci ne a gai nst i nfl ue nza i n healt h y  i n di vi d uals was i nitiate d i n Se pte m ber 2 0 2 1 i n 
partici pa nts 6 5 t hr o u g h 8 5 y ears of a ge. T his st u d y  is bei n g c o n d ucte d acr oss 2 s u bst u dies –
S u bst u d y  A a n d S u bst ud y B. S u bst u d y  A is bei n g c o n d ucte d t o descri be t he safety a n d 
i m m u n o ge nicity of mI R V e nc o di n g s u b gr o u p A or B strai ns at 4 d ose le vels, bIR V e nc o di n g 
b ot h A a n d B strai ns i n 4 d ose -le vel c o m bi nati o ns, a n d qIR V e nc o di n g 2 A strai ns a n d 2 B 
strai ns at a d ose le vel of 
µ g per strai n. S u bst u d y  B will descri be t he safet y, t olera bilit y,
a n d i m m u n o ge nicit y of m o d R N A i nfl ue nza vacci nes w he n a d mi nistere d i n differi n g 
vacci nati o n sc he d ules.
Preli mi nar y  res ults fr o m St u d y C 4 7 8 1 0 0 1 fr o m partici pa nts 6 5 t hr o u g h 8 5 years of a ge 
i n dicate t hat qI R V at a
- or
-µ g  d ose le vel is well t olerate d, wit h mai nl y mil d t o 
m o derate l ocal reacti o ns a n d s y ste mic e ve nts c o nsiste nt wit h rates o bser ve d wit h B N T 1 6 2 b 2 
a n d s u p p orte d t he i nitiati o n of a gl o bal P hase 3 st u d y , C 4 7 8 1 0 0 4. I m m u n o ge nicit y  data fr o m 
C 4 7 8 1 0 0 1 a vaila ble t o date i n dicate d t hat:

F or A/ Wisc o nsi n a n d A/ Ca m b o dia, t he pr o p orti o n of partici pa nts ac hie vi n g 
ser oc o n versi o n 4 wee ks f oll o wi n g eit her 1 or 2 d oses of qI R V, at a t otal d ose le vel of 
µ g per d ose, was hi g her t h a n t he pr o p orti o n of partici pa nts ac hie vi n g ser oc o n versi o n 
f oll o wi n g eit her 1 or 2 d oses of QI V. A d diti o nall y, at 4 wee ks f oll o wi n g QI V 
a d mi nistere d wit h bIR V e nc o di n g 2 A strai ns at a t otal d ose of  
or  
µ g (
 or  
µ g 
per strai n), eit her c o nc urre ntl y or 2 1 da y s a part, t he pr o p orti o n of partici pa nts ac hie vi n g 
ser oc o n versi o n als o a p peare d t o be hi g her t ha n t he pr o p orti o n of partici pa nts ac hie vi n g 
ser oc o n versi o n f oll o wi n g eit her 1 or 2 d oses of QI V.

F or B / P h u ket a n d B/ Was hi n gt o n, t he pr o p orti o n of partici pa nts ac hie vi n g ser oc o n versi o n 
4 wee ks f oll o wi n g st u d y i nter ve nti o n i n all gr o u ps, i ncl u di n g 1- a n d 2 - d ose QI V 
reci pie nts, was l o wer c o m pare d t o t he pr o p orti o n of partici pa nts ac hie vi n g 
ser oc o n versi o n a gai nst A/ Wisc o nsi n a n d A/ Ca m b o dia. F or B/ P h u ket a n d B/ Was hi n gt o n, 
t he pr o p orti o n of partici pa nts ac hie vi n g ser oc o n versi o n 4 wee ks f oll o wi n g eit her 1 or 
2 d oses of qI R V, at a t otal d ose le vel of 
µ g per d ose, or f oll o wi n g QI V a d mi nistere d 
wit h bI R V e nc o di n g 2 A strai ns at a t otal d ose le vel of eit her 
or 
 µ g ( 
or 
 µ g 
per strai n), eit her c o nc urre ntl y  or 2 1 da ys a part, a p peare d t o be ge nerally less t ha n or 
e q ual t o t he pr o p orti o n of partici pa nts ac hie vi n g ser oc o n versi o n f oll o wi n g eit her 1 or 
2 d oses of QI V.
T he qI R V vacci ne has bee n a d mi nistere d t o a ppr o xi matel y  8 5 0 0 partici pa nts ≥6 5 y ears of 
a ge i n t he C 4 7 8 1 0 0 4 st u d y. O n g oi n g safet y re vie w fr o m t his bli n de d st u d y  has bee n o versee n 
b y  a n i n de pe n de nt data re vie w m o nit ori n g c o m mittee a n d c o nti n ue d st u d y d osi n g has bee n 
e n d orse d as of Ma y 2 0 2 3.
T he latest safet y a n d i m m u n o ge nicity res ults ca n be f o u n d i n t he I B f or q I R V. Base d o n t he 
safety a n d i m m u n o ge nicit y  data fr o m St u d y C 4 7 8 1 0 0 1, 1 d ose of qI R V e nc o di n g 2 A strai ns 
a n d 2 B strai ns has bee n selecte d f or st u d y  i n P hase 3,
µ g f or partici pa nts 1 8 t hr o u g h 
6 4 y ears of a ge a n d 
µ g f or partici pa nts ≥6 5 y ears of a ge.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 0
2. 3. Be nefit/ Ris k Assess me nt
R S V a n d i nfl ue nza are ty picall y seas o nal diseases, wit h pea ks d uri n g wi nter i n te m perate 
cli mates. 8 T heref ore , it is a reas o na ble p ossi bilit y  t hat R S V pre F ma y be gi ve n at t he sa me 
ti me as seas o nal i nfl ue nza vacci ne.
Gi ve n t hat a n n ual vacci ne pr o gra ms a gai nst b ot h i nfl ue nza a n d R S V ma y  be c o n d ucte d i n t he 
f ut ure at a si milar ti me of year, de vel o pi n g a c o m bi ne d vacci ne tar geti n g b ot h vir uses is 
li kel y t o ge nerate o verall hi g her vacci nati o n rates f or b ot h vir uses a n d all o w f or m ore 
c o n ve nie nt sc he d uli n g t ha n if t hese vacci nati o ns were t o be a d mi nistere d se par atel y.
T he a vaila ble safet y, i m m u n o ge nicity, a n d effecti ve ness data fr o m o n g oi n g cli nical trials f or 
R S V pre F , as well as data fr o m n o ncli nical a n d cli nical trials wit h qI R V , s u p p ort a fa v ora ble 
be nefit/ris k pr ofile a n d s u p p ort cli nical de vel o p me nt of a vacci ne c o m bi ni n g t hese 
c o m p o ne nts. As qI R V ha s t he sa me m o d R N A a n d LN P platf or m as t he C O VI D-1 9 vacci ne 
B N T 1 6 2 b 2, its 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.
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 bly 
e x pecte d A Es of R S V pre F a n d qI R V m a y  be f o u n d i n t he R S V pre F a n d qI R V I Bs, w hic h are
t he S R S Ds f or t his st u d y. 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 1
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): C o m b i n ati o n R S V pre F + qI R V 
F or R S V pre F : 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, v o miti n g, na usea, diarr hea, m uscle pai n, 
a n d j oi nt pai n) f oll o wi n g vacci nati o n.
F or qI R V : L ocal a n d s yste mic reacti o ns t o t he 
vacci ne ma y occ ur (i njecti o n site re d ness, i njecti o n 
site s welli n g, a n d i njecti o n site pai n; fe ver, fati g ue, 
hea dac he, c hills, m uscle pai n, a n d j oi nt pai n) 
f oll o wi n g vaccinati o n. 
T he m ost c o m m o n reacti o ns re p orte d w it h 
vacci nati o n i n ge neral 3 8 are als o re p orte d f or 
R S V pre F .
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 R S V pre F. T he m ost c o m m o n 
e ve nts re p orte d i n S t u dies C 3 6 7 1 0 0 8 a n d C 3 6 7 1 0 1 3
were m il d t o m o derate pai n at t he i njecti o n site, 
hea dac he, a n d m uscle pai n .
F or qI R V : 1-Wee k f oll o w -u p react o ge nicit y data of 
1 9 4 partici pa nts w h o recei ve d mI R V, bI R V, or 
qI R V i n C 4 7 8 1 0 0 1 S u bst u d y A a n d 1 2 0 partici pa nts 
fr o m C 4 7 8 1 0 0 1 S u bst u d y B s h o we d m ost e ve nts t o 
be mil d t o m o derate i n se verit y, wit h t he m ost 
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.
qI R V has bee n a d mi nistere d t o a p pr o xi matel y 
8 5 0 0 partici pa nts ≥6 5 years of a g e i n t he C 4 7 8 1 0 0 4 
st u d y. O n g oi n g safet y re vie w fr o m t his bli n de d 
st u d y has bee n o versee n b y a n i n de pe n de nt data 
re vie w m o nit ori n g c o m mittee a n d c o nti n ue d st u d y 
d osi n g has bee n e n d orse d as of Ma y 2 0 2 3 .
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 
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.
C ollecti o n of A Es a n d S A Es will be c o n d ucte d
fr o m si g ni n g of t he I C D t hr o u g h 4 wee ks after t he 
partici pa nt’s last st u d y vacci nati o n.
T he s afet y pr ofile of t he n o vel vacci ne is cl ose t o 
bei n g, b ut n ot yet f ull y, c haracterize d.
Alt h o u g h qI R Vs 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.
Assess me nts of A Es a n d S A Es will be c ollecte d 
a n d re vie we d t hr o u g h o ut t he st u d y.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 2
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
Alt h o u g h qI R Vs 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. Cases of a na p h yla xis, 
m y ocar 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.
A na p h yla xis has bee n re p orte d i n pe o ple after 
vacci nati o n wit h B N T 1 6 2 b 2, at a rate of 1 1. 1 per 
milli o n d oses a d mi nistere d. 3 5
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 R N A C O VI D-1 9 
vacci nes (rate for m y ocar ditis : 2. 1 3 per 
1 0 0, 0 0 0 pers o ns u p t o 4 2 da ys after at least 1 d ose 
of vacci ne ).3 6 T y picall y, t he cases ha ve occ urre d 
m o re 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, wit hi n se veral da ys after 
vacci nati o n. 3 9 T hese are ge nerall y mil d cases, a n d 
i n di vi d uals te n d t o rec o ver wit hi n a s h ort ti me 
f oll o wi n g sta n dar d treat me nt a n d rest. Healt hcare 
pr ofessi o nals s h o ul d be alert t o t he si g ns a n d 
s y m pt o ms of m y ocar ditis a n d pericar ditis i n vacci ne 
reci pie nts.
T he mec ha nis m b y w hic h m R N A C O VI D -1 9 
vacci nes c o ul d tri g ger cases of m y ocar ditis a n d 
pericar ditis has n ot bee n el uci date d. If it relates t o 
t he m o d R N A or L N P f or m ulati o n, rat her t ha n t he 
e nc o de d a nti ge n(s), it is pla usi ble t hat t he sa me ris k, 
ris k fact ors, a n d pr o g n osis ma y e xist f or i nfl ue nza 
m o d R N A vacci nes.
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.
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.
Recei pt of a n y m R N A -platf or m S A R S -C o V -2 
vacci ne wit hi n 1 4 da ys bef ore a n d 1 4 da ys after 
st u d y vacci nati o n is pr o hi bite d.
I nstr ucti o ns f or ha n dli n g s us pecte d cases of 
m y ocar ditis a n d pericar ditis are f o u n d i n
Secti o n 1 0. 9. 1 0. 6. 4. 2 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 3
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) : R S V pre F
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,
v o m iti n g, na usea, diarr hea, m uscle pai n, a n d j oi nt 
pai n) f oll o wi n g vacci nati o n.
T he m ost c o m m o n reacti o ns re p orte d w it h 
vacci nati o n i n ge neral 3 8 are als o re p orte d f or 
R S V pre F.
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 R S V pre F. T he m ost c o m m o n 
e ve nts re p orte d i n S t u dies C 3 6 7 1 0 0 8 a n d C 3 6 7 1 0 1 3
were mil d t o m o derate pai n at t he i njecti o n site, 
hea dac he, a n d m uscle pai n.
T h e 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 
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.
C ollecti o n of A E s a n d S A Es will be c o n d ucte d 
fr o m si g ni n g of t he I C D t hr o u g h st u d y c o m pleti o n.
T he s afet y pr ofile of t he n o vel vacci ne is cl ose t o 
bei n g, b ut n ot yet f ull y, c haracterize d.
Data a vaila ble fr o m c o m plete d a n d o n g oi n g 
R S V pre F st u dies s h o we d a 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. T he vacci ne a p pears t o be safe a n d 
well t olerate d 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, 
a n d race/et h nicit y.
C ollecti o n of A Es a n d S A Es will be c o n d ucte d 
t hr o u g h o ut t he st u d y. 
All 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) : qI R V
L ocal a n d s yste mic reacti o ns t o t he vacci ne ma y 
occ ur (i njecti o n site re d ness, i njecti o n site s welli n g, 
a n d i njecti o n site pai n; fe ver, fati g ue, hea dac he, 
c hills, m uscle pai n, a n d j oi nt pai n) f oll o wi n g 
vacci nati o n. N o safet y data are a vaila ble re gar di n g
t he use of qI R V i n pa rtici pa nts ≥6 5 years of a ge.
1- Wee k f oll o w -u p react o ge nicit y data of 1 9 4 
partici pa nts w h o recei ve d mI R V, bI R V, or qI R V i n 
C 4 7 8 1 0 0 1 S u bst u d y A a n d 1 2 0 partici pa nts fr o m 
C 4 7 8 1 0 0 1 S u bst u d y B s h o we d m ost e ve nts t o be 
mil d t o m o derate i n se verit y, wit h t he m ost 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 
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.
C ollecti o n of A Es a n d S A Es will be c o n d ucte d 
fr o m si g ni n g of t he I C D t hr o u g h st u d y c o m pleti o n.
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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 4
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 na p h yla xis has bee n re p orte d i n pe o ple after 
vacci nati o n wit h B N T 1 6 2 b 2, at a rate of 1 1. 1 per 
milli o n d oses a d mi nistere d. 3 5
T he s afet y pr ofile of t he n o vel vacci ne is cl ose t o 
bei n g, b ut n ot yet f ull y, c haracterize d.
Alt h o u g h qI R Vs 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 p r ofile.
Assess me nts of A Es a n d S A Es will be c ollecte d 
a n d re vie we d t hr o u g h o ut t he st u d y.
Alt h o u g h qI R Vs 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 . 
Cases of a na p h yla xis, m y ocar 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.
A na p h yla xis has bee n re p orte d i n pe o ple after 
vacci nati o n wit h B N T 1 6 2 b 2, at a rate of 1 1. 1 per 
milli o n d oses a d mi nistere d. 3 5
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 R N A C O VI D-1 9 
vacci nes (rate f or m y ocar ditis: 2. 1 3 per 
1 0 0, 0 0 0 pers o ns u p t o 4 2 da ys after at least 1 d ose 
of vacci n e). 3 6 T y picall y , t he cases ha ve occ urre d 
m o re 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, wit hi n se veral da ys after 
vacci nati o n .3 9 T hese are ge nerall y mil d cases, a n d 
i n di vi d uals te n d t o rec o ver wit hi n a s h ort ti me 
f oll o wi n g sta n dar d treat me nt a n d rest. Healt hcare 
pr ofessi o nals s h o ul d be alert t o t he si g ns a n d 
s y m pt o ms of m y ocar ditis a n d pericar ditis i n vacci ne 
reci pie nts.
T he mec ha nis m b y w hic h m R N A C O VI D -1 9 
vacci nes c o ul d tri g ger cases of m y ocar ditis a n d 
pericar ditis has n ot bee n el uci date d. If it relates t o 
t he m o d R N A or L N P f or m ulati o n, rat her t ha n t he 
e nc o de d a nti ge n(s), it is pla usi ble t hat t he sa me ris k, 
ris k fact ors, a n d pr o g n osis ma y e xist f or i nfl ue nza 
m o d R N A vacci nes.
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.
Recei pt o f a n y m R N A-platf or m S A R S -C o V -2 
vacci ne wit hi n 1 4 da ys bef ore a n d 1 4 da ys after 
st u d y vacci nati o n is pr o hi bite d.
F or a na p h yla xis, t here is a n o n -site 3 0-mi n ute 
o bser vati o n peri o d after vacci nati o n.
I nstr ucti o ns f or ha n dli n g s us pecte d cases of 
m y ocar ditis a n d pericar ditis are f o u n d i n 
Secti o n 1 0. 9. 1 0. 6. 4. 2 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 5
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 q ualifie d pers o n nel will o btai n 
t he bl o o d dra w.
Partici pa nts will be re q uire d t o atte n d healt hcare 
facilities d uri n g seas o ns of hei g hte ne d res pirat or y 
vir us tra ns missi o n .
T here is t he p ote ntial f or i ncrease d e x p os ure t o 
S A R S -C o V - 2, i nfl ue nza, a n d R S V.
Pfizer w ill w or k wit h sites t o e ns ure a p pr o priate 
tra nsmissi ble res pirat or y ill ness pre ve nti o n 
strate gies.
Cases of C O VI D -1 9 , i nfl ue nza, a n d R S V will be 
re p orte d as A Es or S A Es.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 6
2. 3. 2. Be nefit Assess me nt
Be nefits t o i n di vi d ual partici pa nts e nr olle d i n S u b st u d y A are gi ve n i n Secti o n 1 0. 9. 4. 3 .
Be nefits t o i n di vi d ual partici pa nts e nr olle d i n S u b st u d y B are gi ve n i n Secti o n 1 0. 1 0. 4. 3.
2. 3. 3. F or S u bst u d y A a n d S u bst u d y B 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 R S V pre F a n d qI R V 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 hy partici pa nts i n S u bst u d y 
A (Secti o n 1 0. 9. 4. 3 ) a n d S u bst u d y B (Secti o n 1 0. 1 0. 4. 3 ).
3. O B J E C TI V E S, E N D P OI N T S, A N D E S TI M A N D S
See Secti o n 1 0. 9. 5 f or t he S u bst u d y A o bjecti ves, e n d p oi nts, a n d esti ma n ds.
See Secti o n 1 0. 1 0. 5 f or t he S u bst u d y B o bjecti ves, e n d p oi nts, a n d esti ma n ds.
4. S T U D Y D E SI G N
4. 1. O ver all Desi g n
S ee Secti o n 1 0. 9. 6. 1 f or t he Su bst u d y  A desi g n.
S ee Secti o n 1 0. 1 0. 6. 1 f or t he Su bst u d y  B desi g n .
4. 2. Scie ntific R ati o n ale f or St u d y Desi g n
See Secti o n 2. 1 f or t he rati o nale f or t he desi g n of S u bst u d y  A a n d S u bst u d y  B.
4. 2. 1. Di versit y of St u d y P o p ul ati o n
W here s u p p orte d b y ge o gra p hical l ocati o n, 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 ocale.

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 o n cli nical trials a n d Pfizer 
c o m mit me nt.

I n vesti gat or site recr uit me nt pla ns t hat are c ocreate d wit h a n d i ncl u de di verse 
recr uit me nt t o ols a n d i nf or mati o n t o s u p p ort e nr oll me nt.  Real-w orl d data are use d t o 
tar get o utreac h a n d p ote ntial referri n g p h ysicia 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 pulati o ns.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 7
4. 2. 2. C h oice of C o ntr ace pti o n/ B arrier Re q uire me nts 
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 a vaila ble re pr o d ucti ve t o xicit y  
data; h o we ver, h u ma n re pr o d ucti ve safet y  data are li mite d, a n d a P hase 3 st u d y of R S V pre F 
i n m ore t ha n 7 0 0 0 p re g na nt w o me n is o n g oi n g . H u ma n re pr o d ucti ve safet y data are n ot 
a vaila ble f or t he m 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 heref ore, 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 ( Secti o n 1 0. 4. 4 ).
4. 3. J ustific ati o n f or D ose
4. 3. 1. R S V pre F
T he d ose a n d f or m ulati o n f or t his st u d y is 1 2 0 μ g R S V pre F wit h o ut a n y a dj u va nts.
T he FI H st u d y  i n a d ults 1 8 t hr o u g h 8 5 years of a ge e val uate d t he safet y, t olera bilit y, a n d 
i m m u n o ge nicity of 3 escalati n g R S V pre F d ose le vels of 6 0 μ g, 1 2 0 μ g, a n d 2 4 0 μ g, wit h or 
wit h o ut Al( O H) 3, w he n a d mi nistere d al o ne or c o nc o mita ntl y wit h SII V ( St u d y C 3 6 7 1 0 0 1).
A st u d y  i n ol der a d ults 6 5 t hr o u g h 8 5 ye ars of a ge e val uate d t he safet y, t olera bilit y , a n d 
i m m u n o ge nicity of 6 0 -μ g , 1 2 0-μ g , a n d 2 4 0-μ g R S V pre F d oses f or m ulate d wit h 
Al( O H) 3 or a C p G/ Al( O H) 3 a dj u va nt, or 2 4 0 µ g R S V pre F wit h R S V a nti ge ns al o ne, w he n 
a d mi nistere d c o nc o mita ntl y  wit h SII V ( St u d y C 3 6 7 1 0 0 2).
A P hase 3 st u d y i n a d ults 6 5 years of a ge a n d ol der e val uate d t he safet y , t olera bilit y, a n d 
i m m u n o ge nicity of 1 2 0 μ g R S V pre F w he n a d mi nistere d c o nc o mita ntl y wit h 
SI I V ( St u d y C 3 6 7 1 0 0 6).
A st u d y  i n healt h y a d ults 1 8 t hr o u g h 5 0 years of a ge e val uate d t he safet y, i m m u n o ge nicity, 
a n d efficac y of 1 2 0 µ g R S V pre F i n a vir us c halle n ge m o del ( N C T 0 4 7 8 5 6 1 2).
4. 3. 2. qI R V
Base d o n t he safet y  a n d i m m u n o ge nicity data fr o m P hase 1 of t he C 4 7 8 1 0 0 1 st u d y, 1 d ose of 
qI R V e nc o di n g 2 A strai ns a n d 2 B strai ns,
µ g  
µ g per strai n) , was selecte d f or 
partici pa nts 1 8 t hr o u g h 6 4 y ears of a ge i n t he P hase 2 C 4 7 8 1 0 0 1 s u bst u d y  a n d f or 
parti ci pa nts ≥6 5 y ears of a ge i n t he P hase 3 st u d y  ( C 4 7 8 1 0 0 4). T he sa me d ose will be 
a d mi nistere d i n t his pr ot oc ol. 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.
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  w he n s he/ he has c o m plete d all st u d y 
visits.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 8
5. S T U D Y P O P U L A TI O N
T his st u d y  ca n f ulfill its o bjecti ves o nl y if a p pr o priate partici pa nt s are e nr olle d, i ncl u di n g 
partici pa nts acr oss di verse a n d re prese ntati ve racial a n d et h nic bac k gr o u n ds. If a 
prescree n i n g t o ol is utilize d f or st u dy recr uit me nt p ur p oses , it will i ncl u de c ollecti o n of 
i nf or mati o n t hat reflects t he e nr oll me nt of a di verse partici pa nt p o pulati o n i ncl u di n g, w here 
per mitte d u n der l ocal re g ulati o ns, a ge, se x, race, a n d et h nicit y . T he f oll o wi n g eli gi bilit y  
criteria are desi g ne d t o select partici pa nt s f or w h o m partici pati o n i n t he st u d y  is c o nsi dere d 
a p pr o priate. All rele va nt me dical a n d n o n me d ical 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 n s, is n ot per mitte d.
5. 1. I ncl usi o n Criteri a
See Secti o n 1 0. 9. 7. 1 f or t he S u bst u d y A i ncl usi o n criteria.
See Secti o n 1 0. 1 0. 7. 1 f or t he S u bst u d y  B i ncl usi o n criteria.
5. 2. E xcl usi o n Criteri a 
See Secti o n 1 0. 9. 7. 2 f or t he S u bst u d y  A e xcl usi o n criteria.
See Secti o n 1 0. 1 0. 7. 2 f or t he S u bst u d y B e xcl usi o n criteria.
5. 3. Lifest yle C o nsi der ati o ns
5. 3. 1. C o ntr ace pti o n 
T he i n vesti gat or or t heir desi g nee, i n c o ns ultati o n wit h t he partici pa nt, will c o nfir m t hat t he 
partici pa nt is utilizi n g a n a p pr o priate met h o d of c o ntrace pti o n f or t he i n di vi d u al partici pa nt 
fr o m t he per mitte d list of c o ntrace pti o n met h o ds (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 hi g hl y 
eff ecti ve c o ntrace pti o n c o nsiste ntl y a n d c orrectl y a n d d oc u me nt t he c o n versati o n a n d t he 
partici pa nt ’s affir mati o n i n t he partici pa nt’s c hart. Partici pa nts nee d t o affir m t heir c o nsiste nt 
a n d c orrect use of at least 1 of t he selecte d met h o ds of c o ntrace pti o n, c o nsi deri n g t hat t heir 
ris k f or pre g na nc y ma y ha ve c ha n ge d si nce t he last visit.
I n a d diti o n, t he i n vesti gat or or desi g nee will i nstr uct t he partici pa nt t o call i m me diatel y if t he 
selecte d c o ntrace pti o n met h o d is disc o nti n ue d a n d d oc u me nt t he re q uire me nt t o use a n 
alter nate pr ot oc ol-s pecifie d met h o d, i ncl u di n g if t he partici pa nt will n o l o n ger use a bsti ne nce 
as t he selecte d c o ntrace pti o n met h o d, or if pre g na nc y is k n o w n or s us pecte d i n t he partici pa nt 
or part ner.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 4 9
5. 4. Scree n F ail ures
Scree n fail ures are defi ne d as partici pa nts w h o c o nse nt t o partici pate i n t he cli nical st u d y  b ut 
are n ot s u bse q ue ntl y e nr olle d i n t he st u d y. A mi ni mal set of scree n fail ure i nf or mati o n is 
re q uire d t o e ns ure tra ns pare nt re p orti n g of scree n fail ure partici pa nts t o meet t he C O N S O R T 
p u blis hi n g re q uire me nts a n d t o res p o n d t o q ueries fr o m re g ulat or y a ut h orities. Mi ni mal 
i nf or mati o n i ncl u des de m o gra p hy,  scree n fail ure details, a n d a ny S A 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 ures) m a y
be rescree ne d u n der a ne w partici pa nt n u m ber . 
5. 5. Criteri a f or Te m p or aril y Del a yi n g E nr oll me nt/ R a n d o miz ati o n/ A d mi nistr at i o n of 
St u d y I nter ve nti o n (S u bst u d y A a n d S u bst u d y B)
T he f oll o wi n g c o n diti o ns are te m p orar y  or self-li miti n g a n d a partici pa nt ma y be ra n d o mize d 
( Visit A 1 0 1 ) a n d vacci nate d ( Visit A 1 0 1 , Visit A 1 0 2 , a n d Visit B 1 0 1) o nce t he c o n diti o n(s) 
has/ ha ve res ol ve d .
1.
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.
2.
Recei pt of a n y i nacti vate d or rec o m bi na nt vacci ne, lice nse d C O VI D -1 9 vacci ne, or 
C O VI D -1 9 vacci ne a ut h orize d f or te m p orar y  or e mer ge nc y use wit hi n 1 4 da y s, or a n y  
li ve vacci ne wit hi n 2 8 da ys , bef ore st u dy i nter ve nti o n a d mi nistrati o n .
3.
Recei pt of s h ort -ter m (< 1 4 da y s) s yste mic c ortic oster oi ds (e q ui vale nt of ≥2 0 m g/ da y  of 
pre d nis o ne). 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 y s. I n hale d/ ne b ulize d, 
i ntra-artic ular, i ntra b ursal, or t o pical (s ki n, e yes, ears) c ortic oster oi ds are per mitte d.
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 (s ur gical a n d be ha vi oral) i nte n de d t o be a d mi nistere d t o t he st u d y partici pa nts 
d uri n g t he st u d y c o n d uct.
6. 1. St u d y I nter ve nti o n(s)
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 t he f oll o wi n g pr o d ucts :
6. 1. 1. C o m b i n ati o n R S V pre F + qI R V ( S u bst u d y A a n d S u bst u d y B)
R S V pre F + qI R V , w hic h is a c o m bi nati o n of t he f oll o wi n g vacci ne ca n di dates:

1 2 0 µ g R S V pre F c o ntai ni n g 2 sta bilize d R S V pref usi o n F a nti ge ns, i n e q ual a m o u nts fr o m 
vir us s u b gr o u ps A a n d B

µ g qI R V, ie, e nc o di n g H A of 4 strai ns as rec o m me n de d f or t he i nfl u e nza seas o n 
( 2 A strai ns a n d 2 B strai ns, at a d ose of 
µ g per strai n)
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 0
6. 1. 2. R S V pre F ( S u bst u d y A)

1 2 0 µ g R S V pre F c o ntai ni n g 2 sta bilize d R S V pref usi o n F a nti ge ns, i n e q ual a m o u nts fr o m 
vir us s u b gr o u ps A a n d B
6. 1. 3. qI R V ( S u bst u d y A)

µ g qI R V, e nc o di n g H A of 4 stra i ns as rec o m me n de d f or t he i nfl ue nza seas o n 
( 2 A strai ns a n d 2 B strai ns, at a d ose of  
µ g per strai n)
6. 1. 4. Pl ace b o ( S u bst u d y A)

T he place b o is 0. 9 % n or mal sali ne f or i njecti o n.
6. 2. St u d y I nter ve nti o n(s) A d mi nistere d
See Secti o n 1 0. 9. 8. 1 f or st u d y i nter ve nti o ns t o be a d mi nistere d d uri n g S u bst u d y  A.
See Secti o n 1 0. 1 0. 8. 1 f or st u d y i nter ve nti o ns t o be a d mi nistere d d uri n g S u bst u d y  B.
6. 2. 1. A d mi nistr ati o n
All st u d y i nter ve nti o ns are t o be a d mi nistere d as a n I M i njecti o n i nt o t he delt oi d m uscle,
prefera bl y of t he n o n d o mi na nt ar m.  
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 s h o ul d be a vaila ble i n acc or da nce wit h l ocal g ui deli nes f or sta n dar d 
i m m u nizati o n practices.
A d mi nistrati o n of st u d y i nter ve nti o ns s h o ul d be perf or me d by a n a p pr o priatel y q ualifie d, 
G C P -trai ne d, a n d vacci ne-e x perie nce d me m ber of t he st u d y staff ( p hys icia n, n urse, 
p h y sicia n’s assista nt, n urse practiti o ner, p har macist, or me dical assista nt) as all o we d b y l ocal, 
state, a n d i nstit uti o nal g ui da nce. 
St u d y  i nter ve nti o n a d mi nistrati o n details will be rec or de d o n t he C R F.
See Secti o n 1 0. 9. 8. 1 f or a d diti o nal a d mi nistrati o n details f or S u bst u d y  A.
See Secti o n 1 0. 1 0. 8. 1 f or a d diti o nal a d mi nistrati o n details f or S u bst u d y  B.
6. 2. 2. Me dic al De vices
I n t his st u dy, t he P F S a n d vial a da pter re q uire d f or t he pre parati o n of R S V pre F are
c o nsi dere d me dical de vices. F or S u bst u d y A a n d S u b st u d y B ( 1. 0-m L f or m ulati o n),
R S V pre F will be pr o vi de d i n a kit t hat c o ntai ns a vial of R S V pre F l y o p hilize d p o w der, a P F S 
c o ntai ni n g sterile water, a n d a vial a da pter. I nstr ucti o ns f or t heir use are pr o vi de d i n t he I PM.
All me dical de v ice deficie ncies (i ncl u di n g malf u ncti o n, use err or, a n d i na de q uate la beli n g) 
s hall be d oc u me nte d a n d re p orte d by t he i n vesti gat or t hr o u g h o ut t he 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 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 1
6. 3. Pre p ar ati o n , H a n dli n g , St or a ge , a n d Acc o u nt a bilit y

T he i n vesti gat or or desi g nee m ust c o nfir m t hat a p pr o priate c o n diti o ns (e g, te m perat ure) 
ha ve bee n mai ntai ne d d uri n g tra nsit f or all st u d y  i nter ve nti o ns recei ved 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. 

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 s t 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 y s m ust i n dicate t he 
mi ni m u m a n d ma xi m u m te m perat 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.

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 d y  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. 

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.

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.

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.
F ur t her g ui da nce a n d i nf or mati o n f or t he fi nal dis p ositi o n of u n use d st u d y i nter ve nti o ns are 
pr o vi de d i n t he I P M. All destr ucti o n m ust be a de q uatel y  d oc u me nte d. If destr ucti o n is 
a ut h orize d t o ta ke place at t he i n vesti gat or site, t he i n vesti gat or m ust e ns ure t hat t he materials 
are destr o ye d i n c o m plia nce wit h a p plica ble e n vir o n me ntal re g ulati o ns, i nstit uti o nal p olic y , 
a n d a n y s pecial i nstr ucti o ns pr o vi de d b y Pfizer.
U p o n i de ntificati o n of a pr o d uct c o m plai nt, n otif y t he s p o ns or w it hi n 1 b usi ness da y  of 
disc o ver y  as descri be d i n t he IP M.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 2
6. 3. 1. Pre p ar ati o n a n d Dis pe nsi n g
See t he I PM 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 perience d me m ber of t he st u d y  staff (e g, p h ysicia n, n urse, p h ysicia n’s assista nt, n urse 
practiti o ner, p har mac y  assista nt/tec h nicia n, or p har macist) as all o we d b y l ocal, state, a n d 
i nstit uti o nal g ui da nce. A sec o n d u n bli n de d staff me m ber will verif y t he dis pe nsi ng.
6. 4. Assi g n me nt t o St u d y I nter ve nti o n
All ocati o n (ra n d o mizati o n) of partici pa nts t o vacci ne gr o u ps will pr ocee d usi n g a n I R T 
s yste m. T he 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 o t 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 vacci ne gr o u p , a n d D U or c o ntai ner 
n u m ber (s) w he n st u d y i nter ve nti on is bei n g s u p plie d via t he I R T s ys te m. T he IR T s ys te 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 D U or c o ntai ner n u m ber assi g ne d. T his re p ort will be pr o vi de d t o bli n de d or u n bli n de d
site staff as a p pr o priate o n t he r ole/ per missi o n t he user is gra nte d a n d m ust be st ore d i n t he 
site’s bli n de d or u n bli n de d files as a p pr o priate.
St u d y  i nter ve nti o n will be dis pe nse d at t he st u d y visits s u m marize d i n t he S o A – S u bst u d y  A
or Sc he d ule of Acti vities – S u bst u d y  B.
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. Bli n di n g
See Secti o n 1 0. 9. 8. 2 f or S u bst u d y A bli n di n g arra n ge me nts.
See Secti o n 1 0. 1 0. 8. 2 f or S u bst u d y B bli n di n g arra n ge me nts.
6. 5. 1. Bli n di n g of P artici p a nts
S u bst u d y  A bli n di n g arra n ge me nts f or partici pa nts are detaile d i n Secti o n 1 0. 9. 8. 2. 1 .
S u bst u d y  B bli n di n g arra n ge me nts f or partici pa nts are detaile d i n S ecti o n 1 0. 1 0. 8. 2. 1 .
6. 5. 2. Bli n di n g of Site Pers o n nel
S u bst u d y  A bli n di n g arra n ge me nts f or site pers o n nel are detaile d i n Secti o n 1 0. 9. 8. 2. 2 .
S u bst u d y  B bli n di n g arra n ge me nts f or site pers o n nel are detaile d i n Secti o n 1 0. 1 0. 8. 2. 2 . 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 3
6. 5. 3. Bli n di n g of t he S p o ns or
S u bst u d y  A bli n di n g arra n ge me nts f or t he s p o ns or are detaile d i n Secti o n 1 0. 9. 8. 2. 3 .
S u bst u d y  B bli n di n g arra n ge me nts f or t he s p o ns or are detaile d i n Secti o n 1 0. 1 0. 8. 2. 3 .
6. 5. 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 uc 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 
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. 6. St u d y I nter ve nti o n C o m pli a nce
W he n partici pa nts are d ose d at t he site, t he y  will recei ve st u d y i nter ve nti o n directl y fr o m t he 
i n vesti gat or or desi g nee, u n der me dical s u per visi o n. T he date a n d ti me of eac h d ose 
a d mi nistere d i n t he cli nic will be rec or de d i n t he s o urce d oc u m e 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.
F or S u bst u d y  A a n d S u b st u d y B, t he pre parati o n a n d a d mi nistrati o n of st u d y i nter ve nti o n 
will be d o ne b y  u n bli n de d st u d y  staff. A d diti o nal i nf or mati o n is pr o vi de d i n t he IP M .
6. 7. D ose M o dific ati o n
D ose m o difica ti o n is n ot a p plica ble t o t his pr ot oc ol.
6. 8. 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 .
It is e x pecte d t hat partici pa nts will be treate d as re q uire d wit h sta n dar d -of -care treat me nts, as 
a d vise d b y t heir us ual care p h ysicia n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 4
6. 9. Tre at me nt of O ver d ose
A n y m ore t ha n 1 d ose of t he sa me 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:

C o ntact t he st u d y me dical m o nit or wit hi n 2 4 h o urs.

Cl osel y  m o nit or t he partici pa nt f or a ny A Es/ S A Es a n d la b orat or y  a b n or malities as 
me dicall y  a p pr o priate a n d at least u ntil t he ne xt sc he d ule d f oll o w - u p.

D oc u me nt t he q ua ntit y of t he e x cess 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.

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. 1 0. Pri or a n d C o nc o mit a nt T her a p y
See Secti o n 1 0. 9. 8. 7 f or S u bst u d y A pri or a n d c o nc o mita nt t hera p y.
See Secti o n 1 0. 1 0. 8. 7 f or S u bst u d y B pri or a n d c o nc o mita nt t hera p y .
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L
7. 1. Disc o nti n u ati o n of St u d y I nter ve nti o n
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 uati o 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; a n d 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).
N ote t hat disc o nti n uati o n of st u d y  i nter ve nti 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 d y i nter ve nti o n is per ma ne ntly disc o n ti 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 safety a n d w here a p plica ble, i m m u n o ge nicit y. See t he S o A – S u bst u d y  A
or Sc he d ule of Acti vities – S u bst u d y  B 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.
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 nti 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, p ostvacci nati o n 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 F r o m t he St u d y
A partici pa nt ma y  wit h dra w fr o m t he st u d y at a ny ti me at their o w n re q uest . Reas o ns f or 
disc o nti n uati o n fr o m t he st u d y  i ncl u de t he f oll o wi n g:

Re f use d f urt her st u dy pr oce d ures;

L ost t o f oll o w - u p;
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 5

Deat h;

St u d y  ter mi nate d b y s p o ns or;

A Es;

Partici pa nt re q uest; 

I n vesti gat or re q uest;

Selecte d p r 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 (s e e Secti o n 7. 2. 1 )
f or discl os ure of f ut ure i nf or mati o n, n o f urt her e val uati o ns will be perf or me d, a n d n o 
a d diti o nal data will be c ollecte d. T he s p o ns or ma y retai n a n d c o nti n ue t o use a n y  data 
c ollecte d bef ore s uc h wit h dra wal of c o nse nt.
7. 2. 1. Wit h dr a w al of C o nse nt
Partici pa nt s 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 pecifically wit h dra ws c o nse nt f or a n y f urt her c o ntact 
wit h t he m or pers o ns pre vi o usl y  a ut h orize d b y t he partici pa nt t o pr o vi de t his i nf or mati o n. 
Partici pa nt s s h o ul d n otif y t he i n vesti gat or i n writi n g of t he decisi o n t o wit h dra w c o nse nt 
fr o m f ut ure f oll o w-u p, w he ne ver p ossi ble. T he wit h dra wal of c o nse nt s h o ul d be e x plai ne d i n 
detail i n t he me dical rec or ds b y  t he i n vesti gat or, as t o w het her t he wit h dra wal is o nly fr o m 
f urt her recei pt of st u d y i nter ve nti o n or als o fr o m st u d y  pr oce d ures a n d/ or p ostvacci nati o n
st u d y f oll o w-u p, a n d e ntere d o n t he a p pr o priate C R F pa ge. I n t he e ve nt t hat vital stat us 
( w het her t he partici pa nt is ali ve or dea d) is bei n g meas ure d, p u blicly a vaila ble i nf or mati o n 
s h o ul d be use d t o deter mi ne vital stat us o nl y as a p pr o priately directe d i n acc or da nce wit h 
l ocal la w.
7. 3. L ost t o F ol l o w- Up 
A partici pa nt will be c o nsi dere d l ost t o f oll o w- u p if t he partici pa nt re peate dl y fails t o ret ur n 
f or sc he d ule d visits a n d is u na ble t o be c o ntacte d b y  t he st u d y site.
T he f oll o wi n g acti o ns m ust be ta ke n if a partici pa nt fails t o ret ur n t o t he cli nic f or a re q uire d 
st u d y visit:

T he site m ust atte m pt t o c o ntact t he partici pa nt a n d resc he d ule t he misse d visit as s o o n as 
p ossi ble . Co u nsel t he partici pa nt o n t he i m p orta nce of mai ntai ni n g t he assi g ne d visit 
sc he d ule, a n d ascertai n w het her t he partici pa nt wis hes t o a n d/ or s h o ul d c o nti n ue i n t he 
st u d y;
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 6

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 de si 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 a n d B aseli ne Pr oce d ures
T he i n vesti gat or ( or a n a p pr o priate dele gate at t he i n vesti gat or site) m ust o btai n a si g ne d a n d 
date d I C D bef ore perf or mi n g a n y  st u d y-s pecific pr oce d ures.
T he date of birt h will be c ollecte d t o criticall y  e val uate t he i m m u ne res p o nse a n d safet y 
pr ofile b y a ge.
St u d y  pr oce d ures a n d t heir ti mi n g are s u m marize d i n t he S o 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 – S u bst u d y  A, is esse ntial a n d re q uire d f or st u d y 
c o n d uct. All scree ni n g e val uati o ns m ust be c o m plete d a n d re vie we d t o c o nfir m t hat p ote ntial 
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  eff 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 a s descri be d. H o we ver, it is a ntici pate d t hat fr o m ti me t o ti me t here ma y be 
circ u msta nces o utsi de t he c o ntr ol of t he i n vesti gat or t hat ma ke it u nfeasi ble t o perf or m t he 
test. 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 safet y 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.
8. 1. 1. Tele he alt h Visits 
I n t he e ve nt t hat i n-cli nic st u d y visits ca n n ot be c o n d ucte d, e ver y eff ort s h o ul d be ma de t o 
f oll o w u p o n t he safet y of st u d y partici pa nts as s pecifie d i n t he S o A – S u bst u d y  A or
Sc he d ule of Acti vities – S u bst u d y  B.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 7
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 otely, 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. 
T he f oll o wi n g assess me nts m ust be perf or me d d uri n g a tele healt h visit (see t he 
S o A – S u bst u d y  A or Sc he d ule of Acti vities – S u bst u d y  B ):

Re vie w a n d rec or d a n y A Es a n d S A Es si nce t he last c o ntact. Refer t o Secti o n 1 0. 3. 3 .

Re vie w a n d rec or d a n y ne w c o nc o mita nt me dicati o ns or c ha n ges i n c o nc o mita nt 
me dicati o ns si nce t he last c o ntact .

Re vie w a n d rec or d c o ntrace pti ve met h o d a n d res ults of pre g na nc y testi n g. C o nfir m t hat 
t he partici pa nt is a d heri n g t o t he c o ntrace pti o n met h o d(s) re q uire d i n t he pr ot oc ol. Refer 
t o A p pe n di x 4 .

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.

O btai n st o p dates f or pre vi o usl y  re p orte d A Es a n d S A Es. 

O btai n st o p dates f or a n y react o ge nicit y e ve nts re p orte d as prese nt o n t he last da y  of 
e-diar y  c o m pleti o n.

Rec or d t he use of p r o hi bite d medicati o ns i n t he C R F as n ote d i n Secti o n 1 0. 9. 8. 7. 1
( S u bst u d y A) a n d Secti o n 1 0. 1 0. 8. 7. 1 ( S u bst u d y B).

Rec or d t he u se of a n y ne w n o nst u d y vacci nes i n t he C R F.
8. 2. Effic ac y a n d/ or I m m u n o ge nicit y Assess me nts
8. 2. 1. Effic ac y Assess me nts 
N ot a p plica ble.
8. 2. 2. I m m u n o ge nicit y Assess me nts
See Secti o n 1 0. 9. 1 0. 1 f or S u bst u d y A i m m u n o ge nicit y assess me nts.
See Secti o n 1 0. 1 0. 1 0. 1 f or S u bst u d y  B i m m u n o ge nicit y assess me nts. 
8. 2. 3. 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 ulati o ns or et hical re q uire me nts, t he sa m ples will be st ore d f or u p t o 
1 5 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 by 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 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 8
vacci ne -relate d pr o d ucts, a n d/ or f or vacci ne-relate d assa y w or k s u p p orti n g vacci ne pr o gra ms.
N o testi n g of t he partici pa nt’s D N A will be perf or me d.
T he partici pa nt ma y  re q uest t hat t heir sa m ples, if still i de ntifia ble, be destr o ye d at a n y ti me; 
h o we ver, a n y data alrea d y c ollecte d fr o m t h ose sa m ples wi ll 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 ge netic material/ D N A is perf or me d.
8. 3. S afet y Assess me nts
S u bst u d y  A pla n ne d ti me p oi nts f or all safety assess me nts are pr o vi de d i n t he S o A –
S u bst u d y  A.
S u bst u d y  B pla n ne d ti me p oi nts f or all safety assess me nts are pr o vi de d i n t he S c he d ule of 
Acti vities – S u bst u d y  B.
U nsc he d ule d safety meas ure me nts m a y  be o btai ne d at a n y ti me d uri n g t he st u d y t o assess 
a n y percei ve d safety iss ues.
A cli nical assess me nt a n d me dical hist or y will be perf or me d o n all partici pa nts at t heir first 
visit t o esta blis h a baseli ne. Si g nifica nt me dical hist or y  a n d o bser vati o ns fr o m a n y p h ysical 
e xa mi nati o n, if perf or me d, will be d oc u me nte d i n t he C R F.
A Es a n d S A Es are c ollecte d, rec or de d, a n d re p orte d as defi ne d i n Secti o n 8. 4.
Ac ute reacti o ns wit hi n t he first 3 0 mi n utes after a d mi nistrati o n of eac h st u d y i nter ve nti o n 
will be assesse d a n d d oc u me nte d i n t he A E C R F.
Safet y  para meters als o i ncl u de react o ge nicity e -diar y  re p orts of l ocal reacti o ns, s yste mic 
e ve nts (i ncl u di n g fe ver), a n d use of a nti p yr etic me dicati o n t hat occ ur i n t he 7 da y s after 
a d mi nistrati o n of t he st u d y i nter ve nti o n. T hese pr os pecti vel y self-c ollecte d occ urre nces of 
l ocal reacti o ns a n d s ys te mic e ve nts are gra de d as descri be d i n Ta ble 1 , Ta ble 2 , a n d Ta ble 3 .
8. 3. 1. P h ysic al E x a mi n ati o ns a n d Cli nic al Assess me nts
A c li nical assess me nt is t o be perf or me d prior t o a n y st u d y vacci nati o n . ( Please refer t o t he
S o A – S u bst u d y  A a n d Sc he d ule of Acti vities – S u bst u d y  B f or t he st u dy ti me p oi nt [s]
re q uiri n g cli nical assess me nt.)
If t he cli nical assess me nt i n dicates t hat a p hys ical e xa mi nati o n is necessar y t o 
c o m pre he nsi vel y e val uate t he partici pa nt, perf or m a p h y sical 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 nically si g nifica nt, rec or d o n t he me dical hist or y
C R F or A E C R F as a p plica ble.
A p h y sical e xa mi nati o n will i ncl u de vital si g ns ( oral or t y m pa nic te m perat ure, p ulse rate, a n d 
seate d bl o o d press ure) a n d e val uatio n of a n y cli nicall y si g nifica nt a b n or malities wit hi n t he 
f oll o wi n g b o dy s ys te ms: ge neral a p peara nce; s ki n; hea d, e yes, ears, n ose, a n d t hr oat; heart; 
l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ne ur ol o gical; a n d l ym p h n o des .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 5 9
P h y sical e xa mi nati o n fi n di n gs c ollecte d d uri n g t he st u d y will be c o nsi dere d s o urce data a n d 
will n ot be re q uire d t o b e re p orte d, u nless ot her wise n ote d. A n y u nt o war d p h y sical 
e xa mi nati o n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d meet t he 
defi niti o n of a n A E or S A E (Secti o n 1 0. 3 ) must be re p orte d acc or di n g t o t he pr ocesses i n 
Secti o n 8. 4 .
8. 3. 2. Vit al Si g ns
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 ( Secti o n 1 0. 3 ) m ust be re p orte d acc or di n g t o t he 
pr ocesses i n Secti o n 1 0. 3. 3 .
8. 3. 2. 1. Bl o o d Press ure a n d P ulse R ate
F or S u bst u d y  A, t he partici pa nt’s p ulse rate a n d seate d bl o o d press ure will be meas ure d pri or 
t o vacci nati o n at Visit A 1 0 1 .
F or S u bst u d y  B, t he partici pa nt’s p ulse rate a n d seate d bl o o d press ure will be meas ure d pri or 
t o vacci nati o n at Visit B 1 0 1.
8. 3. 2. 2. Te m per at ure 
T he partici pa nt’s oral or t y m pa nic te m perat ure will be meas ure d pri or t o eac h vacci nati o n
a n d, if cli nicall y i n dicate d, at a n y u nsc he d ule d react o ge nicit y visits.
8. 3. 3. Cli nic al S afet y L a b or at or y Assess me nts
F or S u bst u d y  A, cli nical safet y la b orat or y assess me nts will n ot be c ollecte d. Meas ure me nt of 
tr o p o ni n will be perf or me d l ocally f or p ote ntial m y ocar ditis/ pericar ditis e val uati o n. Refer t o 
Secti o n 1 0. 9. 1 0. 6. 4. 2.
F or S u bst u d y  B, cli nical safet y la b orat or y assess me nts will n ot be c ollecte d . Meas ure me nt of 
tr o p o ni n will be perf or me d l ocally f or p ote ntial m y ocar ditis/ pericar ditis e val uati o n. Refer t o 
Secti o n 1 0. 1 0. 1 0. 6. 3. 2 .
8. 3. 4. Electr o nic D i ar y
Partici pa nts will be re q uire d t o c o m plete a react o ge nicit y  e-diar y  after eac h vacci nati o n 
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, s yste mic e ve nts, 
a n d use of a nti p yr etic me dicati o n use d t o treat p ost vacci nati o n s y m pt o ms, f or 7 da ys fr o m 
t he da y of a d mi nistrati o n of eac h st u d y i nter ve nti o n. T he react o ge nicit y e- diar y all o ws 
rec or di n g of t hese assessme nts o nl y wit hi n a fi xe d ti me wi n d o w, t h us pr o vi di n g t he acc urate
re prese ntati o n of t he partici pa nt’s e x perie nce at t hat ti me. Data o n l ocal reacti o ns a n d 
s yste mic e ve nts re p orte d i n t he react o ge 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 al wa ys 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 via a n i nter net - base d p ortal.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 0
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 bas e f or a nal ys is a n d re p orti n g. T o a v oi d d u plicate re p orti n g, e -diar y  data
are n ot re p orte d i n t he C R F as A E s.
I n vesti gat ors ( or desi g nee) will be re q uire d t o re vie w t he react o ge nicit y e-diar y data o nli ne at 
fre q ue nt i nter vals as part of t he o n g oi n g safety re vie w. 
T he i n vesti gat or or desi g nee m ust o btai n st o p dates fr o m t he partici pa nt f or a n y  o n g oi n g 
l ocal reacti o ns, s yste mic e ve nts, or use of a nti p yretic me dicati o n o n t he last da y t hat t he 
react o ge nicit y e-diar y was c o m plete d. T he st o p dates s h o ul d be d oc u me nte d i n t he s o urce 
d oc u me nts a n d t he i nf or mati o n e ntere d i n t he C R F.
8. 3. 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 f or 
healt h y  a d ult v ol u nteers e nr olle d i n pre ve nti ve vacci ne cli nical trials .3 8
8. 3. 4. 2. L oc al Re acti 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 .
If a l ocal reacti o n persists be y o n d t he e n d of t he react o ge nicit y  e-diar y  peri o d f oll o wi n g 
vacci nati o n, t he i n vesti gat or will e nter t his i nf or mati o n i nt o t he C R F a n d f oll o w u p at t he 
ne xt st u d y  visit t o o btai n st o p dates f or l ocal reacti o ns t hat ha ve res ol ve d.
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 r ec or de d i n meas uri n g de vice u nits (ra n ge: 1 t o 2 1) a n d t he n cate g orize d 
d uri n g a nal ys is as a bse nt, mil d, m o derate, or se vere base d o n t he gra di n g scale i n Ta ble 1 . 
Meas uri n g
de vice u nits ca n be c o n verte d t o ce nti meters acc or di n g t o t he f oll o wi n g f or m ula: 
1 meas uri n g de vice u nit = 0. 5 c m. Pai n at t he i njecti o n site will be assesse d b y  t he partici pa nt 
as a bse nt, mil d, m o derate, or se vere acc or di n g t o t he gra di n g scale i n Ta ble 1 .
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 nl y a n i n vesti gat or or me dicall y q ualifie d pers o n ca n 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 m me diatel y n otif y t he s p o ns or a n d, if it is deter mi ne d t o be relate d t o t he 
a d mi nistrati o n of t he st u d y i nter ve n ti o n, f urt her vacci nati o ns will be disc o nti n ue d i n t hat 
partici pa nt.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 1
T a ble 1. 
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
Gr a de 4 a
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
a.
O nl y a n i n vesti gat or or q ualifie d desi g nee ca n classif y a partici pa nt’s l ocal reacti o n as Gra de 4, after 
cli nical e val uati o n of t he partici pa nt or d oc u me ntati o n fr o m a n ot her me dicall y q ualifie d s o urce 
(e g, e mer ge nc y r o o m or h os pital rec or d) or c o ntact wit h t he partici pa nt. Gra de 4 l ocal reacti o ns will be 
c ollecte d o n t he A E C R F a n d assesse d b y t he i n vesti gat or usi n g t he A E i nte nsit y gra di n g scale as detaile d 
i n Secti o n 1 0. 3. 3 . 
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, na usea, 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 ym pt o ms i n t he react o ge nicit y e- di ar y. T he
s ym 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 2.
If a s yste mic e ve nt persists be y o n d t he e n d of t he react o ge nicit y  e-diar y  peri o d f oll o wi n g 
vacci nati o n, t he i n vesti gat or will e nter t his i nf or mati o n i nt o t he C R F a n d f oll o w u p at t he 
ne xt st u d y  visit t o o btai n st o p dates f or t he e ve nts t hat ha ve res ol ve d. 
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 nl y a n i n vesti gat or or me dicall y q ualifie d pers o n ca n 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 n d, if it is deter mi ne d t o be relate d t o 
t he a d mi nistrati o n of t he st u d y i nter ve nti o n, f urt her vacci nati o ns will be disc o ntin ue d i n t hat 
partici pa nt.
T a ble 2.
S yste mic E ve nt Gr a di n g Sc ale
Mil d
Gr a de 1
M o der ate
Gr a de 2
Se vere
Gr a de 3
Gr a de 4 a
Fati g ue
( = tire d ness)
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y 
r o uti ne acti vit y
E m er ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
fati g ue
Hea dac he
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y 
r o uti ne acti vit y
E m er ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
hea dac he
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 2
T a ble 2.
S yste mic E ve nt Gr a di n g Sc ale
Mil d
Gr a de 1
M o der ate
Gr a de 2
Se vere
Gr a de 3
Gr a de 4 a
V o m iti n g
1 t o 2 ti mes i n 
2 4 h o urs
> 2 ti mes i n 
2 4 h o urs
Re q uires i ntra ve n o us 
h y drati o n
E m er ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
v o m iti n g
Na usea
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y 
r o uti ne acti vit y
E m er ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
na usea
Diarr hea
2 t o 3 l o ose st o ols i n 
2 4 h o urs
4 t o 5 l o ose st o ols 
i n 2 4 h o urs
6 or m ore l o ose 
st o ols i n 2 4 h o urs
E m er ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
diarr hea
C hills
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Prece nts dail y 
r o uti ne acti vit y
E m er ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
c hills
N e w  or 
w orse ne d 
m uscle pai n
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y 
r o uti ne acti vit y
E m er ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
m uscle pai n
N e w  or 
w orse ne d j oi nt 
pai n
D oes n ot i nterfere 
wit h acti vit y
S o m e i nterfere nce 
wit h acti vit y
Pre ve nts dail y 
r o uti ne acti vit y
E m er ge nc y r o o m visit or 
h os pitalizati o n f or se vere 
j oi nt pai n
a.
O nl y a n i n vesti gat or or q ualifie d desi g nee ca n classif y a partici pa nt’s s yste mic e ve nt as Gra de 4, after 
cli nical e val uati o n of t he partici pa nt or d oc u me ntati o n fr o m a n ot her me dicall y q ualifie d s o urce 
(e g, e mer ge nc y r o o m or h os pital rec or d) or c o ntact wit h t he partici pa nt. Gra de 4 s yste mic e ve nts will be 
c ollecte d o n t he A E C R F a n d assesse d b y t he i n vesti gat or usi n g t he A E i nte nsit y gra di n g scale as detaile d 
i n Secti o n 1 0. 3. 3 . 
8. 3. 4. 4. Fe ver M o nit ori n g 
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 nicit y e-diar y  i n t he e ve ni n g daily d uri n g t he 7- d a y react o ge nicit y e-diar y re p orti n g 
peri o d s. It will als o be c ollecte d at a n y ti me d uri n g t he react o ge nicity e- diar y data c ollecti o n 
peri o ds w he n fe ver is s us pecte d. Fe ver is defi ne d as a n oral te m perat ure of ≥3 8. 0° C 
(≥1 0 0. 4° F). T he hi g hest te m perat ure f or eac h da y  will be rec or de d i n t he e-diar y , w here 
p ossi ble. 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 ra n ges s h o w n i n Ta ble 3 d uri n g a nal ysis.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 3
If a fe ver of ≥3 9. 0° C ( ≥1 0 2. 1° F) is re p orte d i n t he e -diar y , a tele p h o ne c o ntact wit h t he 
partici pa nt 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 ca n 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. Gra de 4 fe vers 
will be c ollecte d o n t he A E C R F a n d assesse d b y t he i n vesti gat or usi n g t he A E i nte nsit y 
g ra di n g scale as detaile d i n Secti o n 1 0. 3. 3 .
T a ble 3.
R a n ges f or Fe ver
Mil d
Gr a de 1
M o der ate
Gr a de 2
Se vere
Gr a de 3
Gr a de 4 a
Fe ver
≥3 8. 0 °C t o 3 8. 4° C
( 1 0 0. 4-1 0 1. 1° F)
> 3 8. 4 °C t o 3 8. 9 ° C
( 1 0 1. 2-1 0 2. 0 °F)
> 3 8. 9 °C t o 4 0. 0 ° C
( 1 0 2. 1-1 0 4. 0 °F)
> 4 0. 0 ° C
(> 1 0 4. 0 °F)
a.
O nl y a n i n vesti gat or or q ualifie d desi g nee c a n classif y a partici pa nt’s fe ver as Gra de 4, after cli nical 
e val uati o n of t he partici pa nt, d o c u m e ntati o n fr o m a n ot her me dicall y q ualifie d s o urce (e g, e mer ge nc y 
r o o m or h os pital rec or d), or c o ntact wit h t he partici pa nt. Gra de 4 fe vers will be c ollecte d o n t he A E C R F
a n d assesse d b y t he i n vesti gat or usi n g t he A E i nte nsit y gra di n g scale as detaile d i n Secti o n 1 0. 3. 3 .
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 b ot h
p ost vacci nati o n re p orti n g peri o ds ( Da y 1 t hr o u g h Da y 7).
8. 3. 5. Pre g n a nc y Testi n g
Uri ne pre g na nc y tests 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 Visit B 1 0 1 , bef ore t he a d mi nistrati o n of t he 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 t he partici pa nt’s 
receivi n g t he st u d y  i nter ve nti o n. Pre g na nc y tests ma y als o be re peate d if re q ueste d b y 
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 n ot be a d mi nistere d t he st u dy i nter ve nti o n a n d will be wit h dra w n fr o m 
t he st u d y.
8. 3. 6. St o p pi n g R ules
S t o p pi n g r ules will be e m pl o y e d i n S u bst u d y A ; see Secti o n 1 0. 9. 1 0. 5 .
St o p pi n g r ules will be e m pl o y e d i n S u bst u d y B; see Secti o n 1 0. 1 0. 1 0. 5 .
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 Secti o n 1 0. 3 .
T he defi niti o ns of de vice -relate d safety e ve nts ( A D Es a n d S A D Es) ca n be f o u n d i n 
Secti o n s 1 0. 8. 1 a n d 1 0. 8. 2 . De vice deficie ncies are co vere d i n Secti o n 1 0. 8. 3 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 4
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 gall y 
a ut h orize d re prese ntati ve), or t he y  ma y arise fr o m cli nical fi n di n gs of t he in vesti gat or or 
ot her healt hcare pr o vi ders (cli nical si g ns, test res ults, etc).
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detec ti 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 i nter ve nti o n (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 pa nt 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 .
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 t he 
last st u d y visit. 
F oll o w -u p b y  t he i n vesti gat or c o nti n ues t hr o u g h o ut t he acti ve c ollecti o n peri o d a n d u ntil t he 
A E or S A E or its se q uelae res ol ve or sta bilize at a le vel acce pta ble t o t he i n vesti gat or .
W he n a cli nicall y  i m p orta nt A E re mai ns o n g oi n g at t he e n d of t he acti ve c ollecti o n peri o d, 
f oll o w-u p b y  t he i n vesti gat or c o nti n ues u ntil t he A E or S A E or its se q uelae res ol ve or 
sta bilize at a le vel acce pta ble t o t he i n vesti gat or a n d Pfizer c o nc urs wit h t hat assess me nt.
F or partici pa nts w h o are scree n fail ures, t he 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 st u d y i nter ve nti o n 
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 orti n g F or m .
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 ny 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 m plete d t he st u d y, a n d t he y c o nsi der 
t he e ve nt t o be reas o na bl y relate d t o t he st u dy i nter ve nti o n, t he i n vesti gat or m ust pr o m ptl y  
re p ort t he S A E t o Pfizer usi n g t he Va cci ne S A E Re p orti n g F or m .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 5
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer S afet y
All S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d as descri be d i n
Secti o n 8. 4. 1 are re p orte d t o Pfizer Safet y o n t he Vacci ne S A E Re p orti n g F or m i m me diately 
u p o n a ware ness a n d u n der n o circ u msta nce s h o ul d t his e xcee d 2 4 h o urs, as i n dicate d i n
Secti o n 1 0. 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 , w ill 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 Es a n d S A Es re p orte d b y  t he partici pa nt.
As part of o n g oi n g safet y re vie ws c o n d ucte d b y t he s p o ns or, a n y n o nseri o us A E t hat is 
deter mi ne d b y t he s p o ns or t o be seri o us will be re p orte d b y t he s p o ns or as a n S A E. T o assist 
i n t he deter mi nati o n of case seri o us ness, f urt her i nf or mati o n ma y be re q ueste d fr o m t he 
i n vesti gat or t o pr o vi de clarit y a n d u n dersta n di n g of t he e ve nt i n t he c o nte xt of t he cli nical 
st u d y.
8. 4. 2. Met h o d of Detecti n g A Es 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 E s 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 Secti o n 1 0. 3 .
Care will be ta ke n n ot t o i ntr o d uce bias w he n detecti n g A Es 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 -U p of A Es a n d S A Es
A fter t he i nitial A E or S A E re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y  f oll o w eac h 
partici pa nt at s u bse q ue nt visits/c o ntacts. F or eac h e ve nt, t he i n vesti gat or m ust p urs ue a n d 
o btai n a de q uate i nf or mati o n u ntil res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, 
or t he partici pa nt is l ost t o f oll o w- u p (as defi ne d i n Secti o n 7. 3 ).
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 os si 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 Secti o n 1 0. 3 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 6
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 l e gal res p o nsi bilit y t o n otif y b ot h t he l ocal re g ulat or y a ut h orit y a n d ot her 
re g ulat or y a ge ncies a b o ut t he safety of a st u d y i nter ve nti o n u n der cli nical i n vesti gati o n. T he 
s p o ns or will c o m pl y wit h c o u ntr y-s pecific re g ulat or y re q uire me nts relati n g t o safety 
re p orti n g t o t he re g ulat or y a ut h ority,  IR B s/ E Cs, 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 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 njecti o n or s ki n c o ntact.

A male fa mil y me m ber or healt hcare pr o vi der w h o has bee n e x p ose d t o t he st u d y  
i nter ve nti o n b y i njecti 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 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 7
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’s part ner, t he i n vesti gat or m ust re p ort t his i nf or mati o n t o 
Pfizer Safet y  o n t he Vacci ne S A E Re p orti n g F or m a n d a n E D P S u p ple me ntal F or m, 
re gar dless of w het her a n S A E has occ urre d. Details of t he pre g na nc y will be c ollecte d 
after t he start of st u d y i nter ve 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 i n g F or m a n d E D P 
S u p ple me ntal F or m. Si nce t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he partici pa nt 
e nr olle d i n t he st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; h o we ver, a c o p y  of t he 
c o m plete d Vacci ne S A E Re p ort i n g F or m is mai ntai ne d i n t he i n vesti gat or site file.
F oll o w -u p is c o n d ucte d t o o btai n ge neral i nf or mati o n o n t he pre g na nc y  a n d its o utc o me f or 
all E D P re p orts wit h a n u n k n o w n o utc o me. T he i n vesti gat or will f oll o w t he pre g nan c 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 E D P  Su p ple me ntal F or m. I n t he case of a li ve birt h, t he str uct ural 
i nte grity of t he ne o nate ca n be assesse d at t he ti me of birt h. I n t he e ve nt of a ter mi nati o n, t he 
reas o n(s) f or ter mi nati o n s h o ul d be s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural 
i nte grity of t he ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual i ns pecti o n ( u nless 
pre pr oce d ure test fi n di n gs are c o ncl usi ve f or a c o n ge nital a n o mal y a n d t he fi n di n gs are 
re p orte d).
A b n or mal pre g na nc y  o utc o mes are c o nsi dere d S A Es. If t he o utc o me of t he pre g na nc y meets 
t he criteria f or a n S A E (ie, ect o pic pre g na nc y, s p o nta ne o us a b orti o n, i ntra uteri ne fetal 
de mise, ne o natal deat h, or c o n ge nital a n o mal y) , t he i n vesti gat or s h o ul d f oll o w the 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 A Es 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 w it 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. 
A d diti o nal i nf or mati o n re gar di n g t he E D P  ma y be re q ueste d b y t he s p o ns or. F urt her 
f oll o w-u p of birt h o utc o mes will be ha n dle d o n a case- b y -case basis (e g, f oll o w- u p o n 
preter m i nfa nts t o i de ntif y de vel o p me ntal dela y s). I n t he case of pater nal e x p os ure, t he 
i n vesti gat or will pr o vi de t he partici pa nt wit h t he Pre g na nt Part ner Release of I nf or mati o n 
F or m t o deli ver t o his part ner. T he i n vesti gat or m ust d oc u me nt i n t he s o urce d oc u me nts t hat 
t he partici pa nt was gi ve n t he Pre g na nt Part ner Release of I nf or mati o n F or m t o pr o vi de t o his 
part ner.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 8
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 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 njecti 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 the 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 orti n g F or m . W he n E D B occ urs i n t he setti n g of e n vir o n me ntal 
e x p os ure, t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he part ici 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 Vacci ne S A E 
Re p orti n g F or m is mai ntai ne d i n t he i n vesti gat or site file.
A n E D B re p ort is n ot create d w he n a Pfizer dr u g s pecifically a p pr o ve d f or use i n 
breastfee di n g w o me n (e g, vita mi ns) is a d mi nistere d i n acc or d a nce wit h a ut h orize d use. 
H o we ver , if t he i nfa nt 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 orti n g F or m , re gar dless of 
w het her t here is a n ass ociate d S A E. Si nce t he i nf or mati o n a b o ut t he occ u pati o nal e x p os ure
d oes n ot pertai n t o a partici pa nt e nr olle d i n t he st u d y, t he i nf or mati o n is n ot rec or de d o n a 
C R F; h o we ver , a c o p y of t he c o m plete d Vacci ne S A E Re p orti n g F or m m ust be 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
N ot a p plica ble .
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 Es 
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 c o nsi dere d A E SI s:

C o nfir me d dia g n osis of i nfl ue nza ;

C o nfir me d dia g n osis of R S V i nfecti o n;
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 6 9

C o nfir me d dia g n osis of m y ocar ditis or pericar ditis wit hi n 4 wee ks after a d mi nistrati o n of 
t he first st u d y vacci nati on. See Secti o n 1 0. 9. 1 0. 6. 4. 2 ( S u bst u d y A) a n d 
Secti o n 1 0. 1 0. 1 0. 6. 3. 2 ( S u bst u d y B) f or 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.
A E SI s are e xa mi ne d as part of r o uti ne safet y data re vie w pr oce d ures t hr o u g h o ut t he cli nical 
trial a n d as part of si g nal detecti o n pr ocesses. S h o ul d a n a g gre gate a nal y sis i n dicate t hat 
t hese pres pecifie d e ve nts occ ur m ore fre q ue ntly t ha n e x pecte d, e g, base d o n e pi de mi ol o gical 
data, literat ure, or ot her data, t he n t his will be s u b mitte d a n d re p orte d i n acc or da nce wit h 
Pfizer’s safet y re p orti n g re q uire me nts. A g gre gate a nal ys es of safet y data will be perf or me d 
o n a re g ular basis per i nter nal S O Ps . 
All A E SI s m ust be re p orte d as a n A E or S A E f oll o wi n g t he pr oce d ures descri be d i n 
S ecti o ns 8. 4. 1 t o 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 usi n g t he Vacci ne S A E Re p orti n g F or m .
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 ncie s
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. 2. 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 ume 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 Secti o n 1 0. 8. 3 .
N ote: A Es 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 Es or S A Es, as o utli ne d i n Secti o ns 8. 4. 1 t o 8. 4. 4 a n d Secti o n 1 0. 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 detecte d, d oc u me nte d, a n d 
re p orte d d uri n g all peri o ds of t he st u d y  i n w hic h t he me dical de vice is use d.
I m p orta ntl y, re p orta ble de vice deficie ncies are n ot li mite d t o pr o ble ms wit h t he de vice itself 
b ut als o i ncl u de i nc orrect or i m pr o per use of t he de vice a n d e ve n i nte nti o nal mis use, etc. 
If t he u n bli n de d si te 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.
T he met h o d of d oc u me nti n g m e dical d e vice deficie ncies is pr o vi de d i n Secti o n 1 0. 8. 4 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 0
8. 4. 9. 2. F oll o w - Up 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. Pr o m pt Re p orti n g of De vice Deficie ncies t o t he S p o ns or
W he n a de vice deficie nc y  occ urs: 
1.
T he u n bli n de d site staff n otifies t he s p o ns or b y  tele p h o ne or e mail wit hi n 1 b usi ness da y  
of deter mi ni n g t hat t he i nci de nt meets t he pr ot oc ol defi niti o n of a me dical d e vice 
deficie nc y .
2.
T he de vice deficie nc y  m ust be rec or de d o n t he Me dical De vice C o m plai nt f or m.
3. 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.
4.
If a n S A E ass ociate d wit h t he de vice deficie nc y is br o u g ht t o t he atte nti o n of t he 
u n bli n de d site staff , t he u n bli n de d site staff m ust i m me diatel y  n otif y Pfizer Safet y  of t he 
S A E (see Secti o n 8. 4. 1. 1 ). All rele va nt details relate d t o t he r ole of t he de vice i n t he 
e ve nt m ust be i ncl u de d i n t he Vacci ne S A E Re p orti n g F or m as o ut li ne d i n 
Secti o ns 8. 4. 1. 1 a n d 8. 4. 1. 2 . T he s p o ns or will be t he c o ntact f or t he recei pt of de vice 
deficie nc y  i nf or mati o n.
8. 4. 9. 4. 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 onsi bilit y  t o n otif y a p pr o priate re g ulat or y a ut h orities a n d ot her e ntities a b o ut certai n 
safety i nf or mati o n relati n g t o me dical de vices bei n g use d i n cli nical st u dies.
T he u n bli n de d site staff , or res p o nsi ble pers o n acc or di n g t o l ocal re q uire me nts (e g, t he hea d 
of t he me dical i nstit uti o n), will c o m pl y  wit h t he a p plica ble l ocal re g ulat or y re q uire me nts 
relati n g t o t he re p orti n g of de vice deficie ncies t o t he IR B/ E C.
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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 1
Va cci nati o n err ors are rec or de d a n d re p orte d as f oll o ws:
Rec or de d o n t he 
V acci n ati o n Err or P a ge 
of t he C R F
Rec or de d o n t he 
A d verse E ve nt P a ge 
of t he C R F
Re p orte d o n t he V acci ne 
S A E Re p orti n g F or m t o 
Pfizer S afet y Wit hi n 
2 4 H o urs of A w are ness
All (re gar dless of w het her 
ass ociate d wit h a n A E)
A n y  A E or S A E ass ociate d 
wit h t he vacci nati o n err or
O nl y  if ass ociate d wit h a n 
S A E
Va cci nati o n err ors i ncl u de:

Va cci 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.
S uc h vacci nati o n err ors occ urri n g t o a st u d y partici pa nt are t o be ca pt ure d o n t he vacci nati o n
err or pa ge of t he C R F, w hic h is a s pecific versi o n of t he A E pa ge.
W het her or n ot t he vacci nati o n err or is acc o m pa nie d b y a n A E, as deter mi ne d b y  t he 
i n vesti gat or, t he vacci nati o n err or is rec or de d o n t he vacci nati o n err or pa ge of t he C R F a n d, 
if a p plica ble, a ny ass ociate d A E(s), seri o us a n d n o nseri o us, are rec or de d o n t he A E pa ge of 
t he C R F.
I n t he e ve nt of a vacci nati o n d osi n g err or , t he s p o ns or s h o ul d be n otifie d wit hi n 2 4 h o urs .
Va cci nati o n err ors s h o ul d be re p orte d t o Pfizer Safet y  wit hi n 2 4 h o urs o n a Vacci ne S A E 
Re p orti n g F or m o nl y w he n ass oci ate d wit h a n S A E.
8. 5. P h ar m ac o ki netics 
P har mac o ki netic para meters are n ot e val uate d i n t his st u d y . 
8. 6. Ge netics
8. 6. 1. S pecifie d Ge netics
S pecifie d g e netic a nal ys es are n ot e val uate d i n t his st u d y .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 2
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 1 0. 9. 1 0. 1 f or i m m u n o ge nicit y assess me nts f or S u bst u d y A.
Refer t o Secti o n 1 0. 1 0. 1 0. 1 f or i m m u n o ge nicit y assess me nts f or S u bst u d y B.  
8. 9. He alt h Ec o n o mics
Healt h ec o n o mics/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.
9. S T A TI S TI C A L C O N SI D E R A TI O N S
M et h o d ol o g y f or s u m mar y a n d statistical a nalys es of t he data c ollecte d i n t his st u d y is 
descri be d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or. 
T he S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc ol w here a p pr o priate; h o we ver, a ny maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
9. 1. St atistic al H y p ot hesis
Refer t o Secti o n 1 0. 9. 1 1. 1 f or statistical h yp ot heses f or S u bst u d y  A.
Refer t o Secti o n 1 0. 1 0. 1 1. 1 f or statistical h y p ot heses f or S u bst u d y  B.
9. 2. A n al ysis Sets
Refer t o Secti o n 1 0. 9. 1 1. 2 fo r a nal ys is sets f or S u bst u d y A.
Refer t o Secti o n 1 0. 1 0. 1 1. 2 f or a nal ys is sets f or S u bst u d y B.
9. 3. St atistic al A n al yses
T he S A P will be de vel o pe d a n d fi nalize d bef ore a n y a nalys es are p erf or me d a n d will 
descri be t he a nal ys es a n d pr oce d ures f or acc o u nti n g f or missi n g, u n use d, a n d s p uri o us data.
T his secti o n is a s u m mar y of t he pla n ne d statistical a nal y ses of t he pri mar y a n d sec o n dar y 
e n d p oi nts.
Statistical a nal y ses f or S u bst u d y A are detaile d i n Secti o n 1 0. 9. 1 1. 3 .
Statistical a nal y ses f or S u bst u d y B are detaile d i n Secti o n 0 .
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 nalys is will be prese nte d as 2-si de d at t he 9 5 % le vel 
u nless s pecifie d ot her wise.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 3
T he safet y a nal ys es are base d o n t he saf et y p o p ulati o n. Partici pa nts will be s u m marize d b y
vacci ne gr o u p acc or di n g t o t he st u d y  i nter ve nti o ns t he y act ually recei ve d. Missi n g A E dates
will be i m p ute d acc or di n g t o Pfizer safet y  r ules. 
C o m pletel y  missi n g e-diar y  data (ie, all 7 d a y s of e-diar y  c ollecti o n were missi n g) will n ot be 
i m p ute d. F or partially c o m plete e -diar y data (ie, 1- 6 da y s of react o ge nicit y data are 
a vaila ble), it is ass u me d t hat n o reacti o ns or e ve nts were e x perie nce d o n missi n g da y s base d 
o n t he e -diar y  data s o urce. F or partici pa nt s wit h e-diar y  data tra ns mitte d, relate d 
react o ge nicit y data re p orte d wit hi n 7 da y s after vacci nati o n ma y be i ncl u de d i n t he a nalys is. 
F or all t he i m m u n o ge nicit y  e n d p oi nts, t he a nal ysis will be base d o n t he e val ua ble 
i m m u n o ge nicity p o p ulati o n (s). A n a d diti o nal a nal ysis m a y be perf or me d base d o n t he mI T T 
p o p ulati o n. Partici pa nts will be s u m marize d acc or di n g t o t he gr o u p t o w hic h t he y  were 
ra n d o mize d. 
9. 3. 1. 1. A n al yses f or Bi n ar y D at a
Descri pti ve statistics f or cate g orical varia bles (e g, pr o p orti o ns) are t he perce nta ge ( %) a n d
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. T he 9 5 % CI 
f or perce nta ge, a n d f or differe nce i n perce nta ges, ma y als o be prese nte d w here a p pr o priate.
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). 4 0
T he 9 5 % CI f or t he differe nce i n t he pr o p orti o ns will be c o m p ute d usi n g t he Mietti ne n a n d 
N ur mi ne n met h o d. 4 0 T he 9 5 % CI  will be prese nte d i n ter ms of perce nta ge.
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, 
S D, mi ni m u m, a n d ma xi m u m.
9. 3. 1. 2. 1. Ge o metric Me a ns
C o nti n u o us i m m u n o ge nicit y  e n d p oi nts will be l o garit h micall y tra nsf or me d f or a nalys is. 
Ge o metric mea ns a n d ass ociate d 2 -si de d 9 5 % CIs will be deri ve d by calc ulati n g gr o u p 
mea ns a n d CIs o n t he nat ural l o g scale base d o n t he t distr i b uti o n, a n d t he n e x p o ne ntiati n g 
t he res ults.
9. 3. 1. 2. 2. Ge o metric Me a n F ol d Rises
G M F Rs will be calc ulate d as t he gr o u p mea n of t he differe nce of l o garit h micall y  tra 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. G M F Rs
are li mite d t o partici pa nts wit h n o n missi n g val ues at b ot h ti me p oi nts. T he ass ociate d 2 -si de d 
9 5 % CI s will be o btai ne d b y 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 l i mits.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 4
9. 3. 1. 2. 3. Ge o metric Me a n R ati os
T he G M Rs will be calc ulate d as t he mea n of t he differe nce 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 mea n. T w o -si de d CIs will be 
o btai ne d b y  calc ulati 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 of t he 
l o garit h mically tra nsf or me d assa y  res ults a n d e x p o ne ntiati n g t he c o nfi de nce li mits.
9. 3. 1. 2. 4. Re verse C u m ul ati ve Distri b uti o n C ur ves
E m pirical R C D Cs will pl ot pr o p orti o ns of partici pa nts wit h val ues e q ual t o or e xcee di n g a
s pecifie d assa y val ue vers us t he i n dicate d assa y val ue, f or all o bser ve d assa y val ues. Data 
p oi nts will be j oi ne d b y  a ste p f u ncti o n wit h t he li ne first g oi n g d o w n a n d t he n t o t he ri g ht t o 
t he ne xt assa y val ue.
9. 4. I nteri m A n al yses
N ot a p plica ble .
9. 5. S a m ple Size Deter mi n ati o n
Refer t o Secti o n 1 0. 9. 1 1. 5 f or sa m ple size d eter mi nati o n f or S u bst u d y A.
Refer t o Secti o n 1 0. 1 0. 1 1. 5 f or sa m ple size deter mi nati o n f or S u bst u d y B.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 5
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 CIO 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 h e 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 ntly 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 IR 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 RB/ 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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 6
I n 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 bi n vesti gat ors will pr o vi de t he s p o ns or wit h s ufficie nt, acc urate fi na ncial 
i nf or mati o n as re q ueste d t o all o w t he s p o ns or t o s u b mit c o m plete a n d acc urate fi na ncial 
certificati o n or discl os ure state me nts t o t he a p pr o priate re g ulat or y  a ut h orities. I nvesti gat ors 
are res p o nsi ble f or pr o vi di n g i nf or mati o n o n fi na ncial i nterests d uri n g t he c o urse of t he st u d y 
a n d f or 1 ye ar after c o m pleti o n of t he st u d y .
1 0. 1. 3. I nf or me d C o nse nt Pr ocess
T he i n vesti gat or or t he i n vesti gat or’s re prese ntati ve will e x plai n t he nat ure of t he st u d y, 
i ncl u di n g t he ris ks a n d be nefits, t o t he partici pa nt a n d a ns wer all q uesti o ns re gar di n g t he 
st u d y. T he partici pa nt s h o ul d be gi ve n s uf ficie nt ti me a n d o p p ort u nit y t o as k q uesti o ns a n d t o 
deci de w het her or n ot t o partici pate i n t he trial.
Partici pa nts m ust be i nf or me d t hat t heir partici pati o n is v ol u ntar y . Partici pa nts will be 
re q uire d t o si g n a state me nt of i nf or me d c o nse nt t hat meets t he re q uire me nts of 2 1 C F R 5 0, 
l ocal re g ulati o ns, I C H g ui deli nes, pri vac y  a n d data pr otecti o n re q uire me nts, w here 
a p plica ble, a n d t he I R B/ E C or st u d y  ce nter.
T he i n vesti gat or m ust e ns ure t hat eac h partici pa nt is f ull y i nf or me d a b o ut t he nat ure a n d 
o bjecti ves of t he st u d y, t he s hari n g of data relate d t o t he st u d y, a n d p ossi ble ris ks ass ociate d 
wit h partici pati o n, i ncl u di n g t he ris ks ass ociate d wit h t he pr ocessi n g of t he partici pa nt ’s 
pers o nal data. 
T he partici pa nt m ust be i nf or me d t hat t heir pers o na l 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 pers o n o btai ni n g t he i nf or me d c o nse nt m ust als o si g n t he I C D .
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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 7
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 h e 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 ntifia ble data tra nsferre d t o t he 
s p o ns or will be i de ntifie d b y t his si n gle, partici pa nt -s pecific c o de. T he st u d y site will 
mai ntai n a c o nfi de ntial list of partici pa nt s w h o partici pate d i n t he st u d y, li n ki n g eac h 
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.
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 I R C . T he I RC 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  
i nter nal me m bers. T he I R C c harter descri bes t he r ole of t he I R C i n m ore detail.
T he I RC will be res p o nsi ble f or o n g oi n g m o nit ori n g of t he safet y of partici pa nts i n t he st u d y  
acc or di n g t o t he c harter. T he rec o m me n dati o ns ma de b y t he I R C will be f or war de d t o t he 
a p pr o priate a ut h orize d Pfizer pers o n nel f or re view a n d fi nal decisi o n. Pfizer will 
c o m m u nicate s uc h decisi o ns, w hic h ma y i ncl u de s u m maries of a g gre gate a nal yses of safety 
data t o re g ulat or y a ut h orities a n d i n vesti gat ors, as a p pr o priate. 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 8
T he res p o nsi bilities of t he I R C will i ncl u de at a mi ni m u m:

Re vie w of safety data i n t he case of a st o p pi n g r ule bei n g met.
T his st u d y  will n ot use an E D M C.
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 dy 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 nic altri als. g o v
Pfizer p osts cli nical trial res ults o n w w w.cli nicaltrials. g o v f or Pfizer-s p o ns ore d i nter ve nti o nal 
st u dies (c o n d ucte d i n patie nts) t hat e val uate t he safet y a n d/ or efficac y of a pr o d uct, 
re gar dless of t he ge o gra p hical l ocati o n i n w hic h t he st u d y is c o n d ucte d. T hese r es ults are 
s u b mitte d f or p osti n g i n acc or da nce wit h t he f or mat an d ti meli nes set f ort h b y  U S la w.
E u dr a C T / C TI S
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 sy 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 an o n y mize d.
D oc u me nts wit hi n m ar keti n g a p plic ati 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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 7 9
D at a sh ari 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 f or m a n d are pass w or d pr otecte d 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 that 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 ufficie nt ti me is de v ote d t o t he pr ocess.
M o nit ori n g details descri bi n g strate g y , i ncl u di n g defi niti o n of st u d y-critical data ite ms a n d 
pr ocesses (e g, ris k-base d i nitiati ves i n o perati o ns a n d q ualit y  s uc h as ris k m a na ge me nt a n d 
m iti gati o n strate gies a n d anal yt ical ris k- base d m o nit ori n g), met h o ds, res p o nsi bilities , a n d 
re q uire me nts, i ncl u di n g ha n dli n g of n o nc o m plia nce iss ues a n d m o nit ori n g tec h ni q ues 
(ce ntral, virt ual , or o n-site m o nit ori n g), are pr o vi de d i n t he data ma na ge me nt pla n a n d 
m o nit ori n g p la n mai ntai ne d a n d utilize d b y  t he s p o ns or or desi g nee.
T he s p o ns or or desi g nee is res p o nsi ble f or t he data ma na ge me nt of t his st u d y , i ncl u di n g 
q ualit y  c hec ki n g of t he data.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 0
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 od 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 n tai 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 relati o n t o t he st u d y. F urt her m ore, t he i n vesti gat or will c o o perate 
wit h t he s p o ns or or its a ge nts t o pre pare t he i n vesti gat or site f or t he i ns pecti o n a n d will all o w 
t he s p o ns or or its a ge nt, w he ne ver feasi ble, t o be prese nt d uri n g t he i ns pecti o n. T he 
i n vesti gat or site a n d i n vesti gat or will pr o m ptl y res ol ve a n y discre pa ncies t hat are i de ntifie d 
bet wee n t he st u d y data a n d t he partici pa nt ’s me dical rec or ds. T he i n vesti gat or will pr o m ptl y  
pr o vi de c o pies of t he i ns pecti o n fi n di n gs t o t he s po 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 s o urce data a n d its ori gi n ca n be f o u n d i n t he S o urce 
D oc u me nt L ocat or , w hic h is mai ntai ne d b y t he s p o ns or.
Descri pti o n of t he use of t he c o m p uterize d s yste m is d oc u me nte d i n t he d ata m a na ge me nt 
p la n, w hic h is mai ntai ne d b y t he s p o ns or.
T he i n vesti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce data) t hat s u p p orts t he 
i nf or mati o n e ntere d i n t he C R F.
T he s p o ns or or desi g nee will perf or m m o nit ori n g t o c o nfir m t hat data e ntere d i nt o t he C R F 
b y  a ut h orize d site pers o n nel are acc urate, c o m plete, a n d verifia ble fro 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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 1
1 0. 1. 9. St u d y a n d Site St art a n d Cl os ure
T he st u d y  start date is t he date of t he first partici pa nt’s first visit.
T he s p o ns or desi g nee reser ves t he ri g 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 
assess me nt . St u d y  sites will be cl ose d u p o n st u d y c o m pleti o n. A st u d y site is c o nsi dere d 
cl ose d w he n all re q uire d d oc u me nts a n d st u d y  s u p plies ha ve bee n c ollecte d a n d a st u d y-site 
cl os ure visit has bee n perf or me d.
T he i n vesti gat or ma y  i nitiate st u d y-site cl os ure at 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.
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 IR B/ 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 IC H 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 ment.
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 de d 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 0. P u blic ati o n P olic y
F or m ultice nter trials, t he pri mar y  p u blicati o n will be a j oi nt p u blicati o n de vel o pe d by t he 
i n vesti gat or a n d Pfizer re p orti n g t he pri mar y e n d p oi nt(s) of t he st u d y  c o veri n g all st u d y sites. 
T he i n vesti gat or a grees t o refer t o t he pri mar y  p u blicati o n i n a n y s u bse q ue nt p u blicati o ns. 
Pfizer will n ot pr o vi de a n y fi na ncial c o m pe nsati o n f or t he i n vesti gat or’s partici pati o n i n t he 
pre parati o n of t he pri mar y c o n gress a bstract, p oster, prese ntati o n, or pri mar y  ma n uscri pt f or 
t he st u d y.
I n vesti gat ors are free t o p u blis h i n di vi d ual ce nter res ults t hat t he y dee m t o be cli nicall y 
mea ni n gf ul after p u blicati o n of t he o verall res ults of t he st u d y  or 1 2 m o nt hs after pri mar y 
c o m pleti o n date or st u d y c o m pleti o n at all sites, w hic he ver occ urs first, s u bject t o t he ot her 
re q uire me nts descri be d i n t his secti o n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 2
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 ur e of t he st u d y res ults (c ollecti vel y, “ p u blicati o n”) bef ore it is 
s u b mitte d or ot her wise discl ose d a n d will s u b mit all p u blicati o ns t o Pfizer 3 0 da y s bef ore 
s u b missi o n. If a ny pate nt acti o n is re q uire d t o pr otect i ntellect ual pr o pert y ri g hts, t he 
i n vesti gat or a grees t o dela y t he discl os ure f or a peri o d n ot t o e xcee d a n a d diti o nal 6 0 da ys 
u p o n re q uest fr o m Pfizer. T his all o ws Pfizer t o pr otect pr o prietar y  i nf or mati o n a n d t o pr o vi de 
c o m me nts, a n d t he i n vesti gat or will, o n re q uest, re m o ve a n y pre vi o usl y u n disc l ose d 
c o nfi de ntial i nf or mati o n bef ore discl os ure, e xce pt f or a n y st u d y- i nter ve nti o n or 
Pfizer -relate d i nf or mati o n necessar y f or t he a p pr o priate scie ntific prese ntati o n or 
u n dersta n di n g of t he st u d y  res ults. F or j oi nt p u blicati o ns, s h o ul d t here be disa gree me nt 
re gar di n g i nter pretati o n a n d/ or prese ntati o n of s pecific a nalys is res ults, res ol uti o n of, a n d 
res p o nsi bilit y f or, s uc h disa gree me nts will be t he c ollecti ve res p o nsi bilit y of all a ut h ors of 
t he p u blicati o n.
F or all p u blicati o ns relati n g t o t he st u d y, t h e 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 Pfiz er 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 1. S p o ns or’s Me dic all y Q u alifie d I n di vi d u al 
T he c o ntact i nf or mati o n f or t he s p o ns or ’s M QI
f or t he st u d y is d oc u me nte d i n t he st u d y 
c o ntact list l ocate d i n t he s u p p orti n g st u dy d oc u me ntati o n/st u d y  p ortal or ot her electr o nic 
s yste m.
To  facilitate access t o t heir i n vesti gat or a n d t he s p o ns or’s M QI f or st u d y-relate d me dical 
q uesti o ns or pr o ble ms fr o m n o nst u d y healt hcare pr ofessi o nals, partici pa nts are pr o vi de d wit h 
a n E C C at t he ti me of i nf or me d c o nse nt. T he E C C c o ntai ns, at a mi ni m u m, (a) pr ot oc ol a n d 
st u d y i nter ve nti o n i de ntifiers, ( b) partici pa nt’s st u d y i de ntificati o n n u m ber, (c) site 
e mer ge nc y p h o ne n u m ber acti ve 2 4 h o urs/ da y, 7 d a y s per wee k, a n d ( d) Pfizer C all C e nter 
n u m ber.
T he E C C is i nte n de d t o a u g me nt, n ot re place, t he esta blis he d c o m m u nicati o n pat h wa y s 
bet wee n t he partici pa nt a n d t heir i n vesti gat or a n d site staff, a n d bet wee n t he i n vesti gat or a n d 
s p o ns or st u d y tea m. T he EC C is o nl y  t o be use d b y healt hcare pr ofessi o nals n ot i n v ol ve d i n 
t he researc h st u d y, as a mea ns of reac hi n g t he i n vesti gat or or site staff relate d t o t he care of a 
partici pa nt. T he Pfizer Call Ce nter n u m ber is t o be use d w he n t he i n vesti gat or a n d site sta ff 
are u na vaila ble. T he Pfizer Call Ce nter n u m ber is n ot f or use b y  t he partici pa nt directly;  if a 
partici pa nt calls t hat n u m ber directl y , t he y will be directe d bac k t o t he i n vesti gat or site.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 3
1 0. 2. A p pe n di x 2 : Cli nic al L a b or at or y Tests
R o uti ne cli nical la b orat or y tests are n ot a p plica ble t o S u bst u d y A.
R o uti ne cli nical la b orat or y tests are n ot a p plica ble t o S u bst u d y  B.
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 -U p, 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 nically si g nifica nt i n t he 
me dical a n d scie ntific j u d g me nt of t he i n vesti gat or . A n y a b n or mal la b orat or y  test 
res ults t hat meet a ny of t he c o n diti o ns bel o w m ust be rec or de d as a n A E:

Is ass ociate d wit h acc o m pa n yi n g 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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 4
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 
t o 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 oci al 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 o s 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 ys icia 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.
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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 5
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 u s. T hese cases are 
c o nsi dere d u ne x pecte d a n d ha n dle d as seri o us e x pe dite d cases b y p har mac o vi gila nce 
pers o n nel. S uc h cases are als o c o nsi dere d f or re p orti n g as pr o d uct defects, if 
a p pr o priate.
g.
Ot her sit u ati o ns:

Me dical or scie ntific j u d g me nt s h o ul d be e xercise d b y  t he i n vesti gat or i n deci di n g 
w het her S A E re p orti n g is a p pr o priate i n ot her sit uati o ns, s uc h as si g nifica nt me dical 
e ve nts t hat ma y je o par dize t he partici pa nt or ma y re q uire me dical or s ur gical 
i nter ve nti o n t o pre ve nt o ne of t he ot her o utc o mes liste d i n t he a b o ve defi niti o n. T hese 
e ve nts s h o ul d us uall y be c o nsi dere d seri o us.

E xa m ples of s uc h e ve nts i ncl u de i n vasi ve or mali g na nt ca ncers, i nte nsi ve treat me nt i n 
a n e mer 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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 6
1 0. 3. 3. Rec or di n g / Re p orti n g a n d F oll o w - Up of A Es a n d/ or S A E s D uri n g t he Acti ve 
C olle cti o n Peri o d 
A E a n d S A E Rec or di n g/ Re p orti n g
T he ta ble bel o w s u m marizes t he re q uire me nts f or rec or di n g A Es o n t he C R F a n d f or 
re p orti n g S A E s o n t he Vacci ne S A E Re p orti n g F or m t o Pfizer Safet y t hr o u g h o ut t he acti ve 
c ollecti o n peri o d. T hese re q uire me nts are deli neate d f or 3 t 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 orti n g F or m f or re p orti n g of S A E i nf or mati o n 
is n ot t he sa me as t he A E pa ge of t he C R F. W he n t he sa me data are c ollecte d, t he f or ms 
m ust be c o m plete d i n a c o nsiste nt ma n ner. A Es s h o ul d be rec or de d usi n g c o ncise me dical 
ter mi n ol o g y a n d t he sa me A E ter m s h o ul d be use d o n b ot h t he C R F a n d t he Vacci ne S A E 
Re p orti n g F or m f or re p orti n g of S A E i nf or mati o n.

S afet y E ve nt
Rec or de d o n t he C R F
Re p orte d o n t he V acci ne S A E 
Re p orti n g F or m  t o Pfizer 
S afet y Wit hi n 2 4 H o urs of 
A w are ness
S A E
All
All
N o nseri o us A E
All
N o ne
E x p os ure t o t he st u d y 
i nter ve nti o n u n der st u d y d uri n g 
pre g na nc y or breastfee di n g
All A Es or S A Es ass ociate d 
wit h E D P or E D B
N ote: I nsta nces of E D P or E D B 
n ot ass ociate d wit h a n A E or 
S A E are n ot ca pt ure d i n t he 
C R F
All i nsta nces of E D P are 
re p orte d ( w het her or n ot t here is 
a n ass ociate d S A E) *
All i nsta nces of E D B are 
re p orte d ( w het her or n ot t here is 
a n ass ociate d S A E) * *
E n vir o n me ntal or occ u pati o nal 
e x p os ure t o t he pr o d uct u n der 
st u 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 ( whet 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 ( w it h or wit h o ut a n ass ociate d A E or S A E): a n y pre g na nc y i nf or mati o n is re p orte d t o Pfizer 
Safet y usi n g t he Vacci ne S A E Re p ort i n g F or m  a n d E D P S u p ple me ntal F or m; if t he E D P is ass ociate d 
wit h a n S A E, t he n t he S A E is re p orte d t o Pfizer Safet y usi n g t he Vacci ne S A E Re p ort i n g F or m . 
* * E D B is re p orte d t o Pfizer Safet y usi n g t he Vacci ne S A E Re p ort i n g F or m , w hic h w o ul d als o i ncl u de 
detai ls 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 ntal or occ u pati o nal e x p os ure: A Es or S A Es ass ociate d wit h occ u pati o nal e x p os ure are 
re p orte d t o Pfizer Safet y usi n g t he Vacci ne S A E Re p ort i n g F or m .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 7

W he n a n A E or S A E occ urs, it is t he res p o nsi bilit y of t he i n vesti gat or t o re vie w all 
d oc u me ntati o n (e g, h os pital pr o gress n otes, la b orat or y  re p orts, a n d dia g n ostic re p orts) 
relate d t o t he e ve nt.

T he i n vesti gat or will t he n rec or d all rele va nt A E or S A E i nf or mati o n i n t he C R F.

It is n ot acce pta ble f or t he i n vesti gat or t o se n d p h ot oc o pies of t he partici pa nt’s 
me dical rec or ds t o Pfizer Safet y  i n lie u of c o m pleti o n of t he Vacci ne S A E Re p orti n g 
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 
b y  Pfizer Safety. I n t his case, all partici pa nt i de ntifiers, wit h t he e xce pti o n of t he 
partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he me dical rec or ds bef ore 
s u b missi o n t o Pfizer Safet y.

T he i n vesti gat or will atte m pt t o esta blis h a dia g n osi s 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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 8
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 out.

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 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 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 d efi 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 ne S A E Re p orti n g F or m a n d i n acc or da nce wit h t he S A E 
re p orti n g re q uire me nts.
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. 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 8 9

Ne w or u p date d i nf or mat i o n will be rec or de d i n t he ori gi nall y s u b mitte d d oc u me nts.

T he i n vesti gat or will s u b mit a n y  u p date d S A E data t o t he s p o ns or wit hi n 2 4 h o urs of 
recei pt of t he i nf or mati o n.
1 0. 3. 4. Re p orti n g of S A Es
S A E Re p orti n g t o Pfizer S afet y vi a a n Electr o nic D C T

T he pri mar y  mec ha nis m f or re p orti n g a n S A E t o Pfizer Safet y will be t he electr o nic 
D C T .

If t he electr o nic sys te m is u na vaila ble, t he n t he site will use t he pa per S A E D C T
(see ne xt secti o n) t o re p ort t he e ve nt wit hi n 2 4 h o urs.

T he site will e nter t he S A E 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.
S A E Re p orti n g t o Pfizer S afet y vi a t he V acci ne S A E Re p orti n g F or m

Facsi mile tra ns missi o n of t he Vacci ne S A E Re p orti n g F or m is t he preferre d met h o d t o 
tra ns mit t his i nf or mati o n t o Pfizer Safet y .

I n circ u msta nces w he n t he facsi mile is n ot w or ki n g, a n alter nati ve met h o d s h o ul d be 
use d, e g, sec ure d ( Tra ns p ort La y er Sec urit y) or pass w or d -pr otecte d e mail. If n o ne of 
t hese met h o ds ca n be use d, n otificati o n b y  tele p h o ne is acce pta ble wit h a c o p y of t he 
Vacci ne S A E Re p orti n g F or m se nt by 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 orti n g 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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9 0
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
1 0. 4. 1. 1. S u bst u d y A a n d S u bst u d y B
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 da y s after t he last d ose of st u dy 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.

Be v asect o mize d a n d t he a bse nce of s per m has bee n c o nfir me d.
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 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.
1 0. 4. 2. Fe m ale P artici p a nt Re pr o d ucti ve I ncl usi o n Criteri a
1 0. 4. 2. 1. S u bst u d y A
A fe male partici pa nt is eli gi ble t o partici pate if s he 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) .
1 0. 4. 2. 2. S u bst u d y B
T he criteria bel o w are part of i ncl usi o n criteri o n 1 ( A ge a n d Se x; Secti o n 1 0. 1 0. 7. 1 ) a n d 
s pecif y t he repr o d ucti ve re q uire me n ts f or i ncl u di ng fe male partici pa nts. Refer t o 
Secti o n 1 0. 4. 4. 2 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 inter ve nti o n.
T he i n vesti gat or is res p o nsi ble f or re vie w of me dical hist or y , me nstr ual hist or y, a n d rece nt 
se x ual acti vit y t o decrease t he ris k f or i ncl usi o n of a w o ma n wit h a n early u n detecte d 
pre g na nc y .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9 1
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 i n a d olesce nts or at hletes) a n d a me nstr ual c ycle ca n n ot 
be c o nfir me d bef ore t he first d ose of st u d y i nter ve nti o n, a d diti o nal e val uati o n s h o ul d be 
c o nsi dere d.
Wo me n i n t he f oll o wi n g cate g ories are n ot c o nsi dere d W O C B P:
1.
Pre me n o pa usal fe male wit h 1 of t he f oll o wi n g:

D oc u me nte d h ys terect o m y;

D oc u me nte d bilateral sal pi n gect o m y ;

D oc u me nte d bilateral o o p h orect o m y.
F or i n di vi d uals wit h per ma ne nt i 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.
2.
P ost me n o pa usal fe male :

A p os t me n o pa usal state is defi ne d as n o me nses f or 1 2 m o nt hs wit h o ut a n alter nati ve 
me dical ca use. I n a d diti o n:

A hi g h F S H le vel i n t he p ost me n o pa usal ra n ge m ust be use d t o c o nfir m a 
p ost me n o pa usal state i n w o me n u n der 6 0 ye ars of a ge a n d n ot usi n g h or m o nal 
c o ntrace pti o n or H R T. 

A f e male o n H R T a n d w h ose me n o pa usal stat us is i n d o u bt will be re q uire d t o use o ne 
of t he hi g hl y effecti ve n o nestr o ge n h or m o nal c o ntrace pti o n met h o ds if s he wis h es t o 
c o nti n ue her H R T d uri n g t he st u d y . Ot her wise, s he m ust disc o nti n ue H R T t o all o w 
c o nfir mati o n of p ost me n o pa usal stat us bef ore st u d y  e nr oll me nt.
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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9 2
1 0. 4. 4. 1. S u bst u d y A
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 S u bst u d y  A:

As all fe male partici pa nts i n S u bst u d y  A are at least 6 0 years of a ge, c o ntrace pti ve use is 
n ot re q uire d f or fe males.

Refer t o Secti o n 1 0. 4. 1 f or male partici pa nts.
1 0. 4. 4. 2. S u bst u d y B
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 W O C B P
partici pati n g i n S u bst u d y  
B:
Hi g hl y Effecti ve Met h o ds T hat Ha 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 occ l 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 ontrace 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 Are 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 ginal

Tra ns der mal
7.
Pr o gest o ge n - o nly h or m o ne c o ntrace pti o n ass ociate d wit h i n hi biti o n of o v ulati o n:

Oral

I njecta ble
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9 3
8.
Se x ual a bsti 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 
i n relati o n t o t he d urati o n of t he st u d y a n d t he preferre d a n d us ual lifestyl e of t he 
partici pa nt.
Ot her Effecti ve Met h o ds
9.
Pr o gest o ge n - o nly oral h or m o nal c o ntrace pti o n w here i n hi biti o n of o v ulati o n is n ot t he 
pri mar y  m o de of acti o n.
1 0.
Male or fe male c o n d o m, wit h or wit h o ut s per mici de.
1 1. Cer vical ca p, dia p hra g m, or s p o n ge wit h s per 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 c a 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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9 4
1 0. 5. A p pe n di x 5 : Li ver S afet y: S u g geste d Acti o ns a n d F oll o w-U p Assess me nts
P ote nti al C ases of Dr u g -I n d uce d Li ver I nj ur y
H u ma ns e x p ose d t o a dr u g w h o s h o w n o si g n of li ver i nj ur y  (as deter mi ne d b y ele vati o ns i n 
tra nsa mi nases) are ter me d “t olerat ors,” w hile t h ose w h o s h o w tra nsie nt li ver i nj ur y  b ut a da pt 
are ter me d “a da pt ors.” I n s o me partici pa nt s, tra nsa mi nase ele vati o ns are a har bi n ger of a 
m ore seri o us p ote ntial o utc o me. T hese partici pa nt s fail t o a da pt a n d t heref ore are 
“s usce pti ble” t o pr o gressi ve a n d seri o us li ver i nj ur y, c o m m o nl y referre d t o as DI LI. 
Partici pa nt s w h o e x perie nce a tra nsa mi nase ele vati o n a b o ve 3 × U L N s h o ul d be m o nit ore d 
m ore fre q ue ntl y  t o deter mi ne if t he y are “a da pt or s” or are “s usce pti ble.”
L F T s are n ot re q uire d as a r o uti ne safet y m o nit ori n g pr oce d ure i n t his st u d y. H o we ver, s h o ul d 
a n i n vesti gat or dee m it necessar y  t o assess L F Ts beca use a partici pa nt prese nts wit h cli nical 
si g ns/s 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 hiche ver is s maller).
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9 5
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 the 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, t otal bile aci ds, a n d al kali ne p h os p hatase. C o nsi derati o n s h o ul d als o be gi ve n 
t o dra wi n g a se parate t u be of cl otte d bl o o d a n d a n a ntic oa g ulate d t u be of bl o o d f or f urt her 
testi n g, as nee de d, f or f urt her c o nte m p ora ne o us a nal yses at t he ti me of t he rec o g nize d i nitial 
a b n or malities t o deter mi ne eti ol o g y.  A detaile d hist or y, i ncl u di n g rele va nt i nf or mati o n, s uc h 
as re vie w of et ha n ol, aceta mi n o p he n / paraceta m ol (eit her b y itself or as a c of or m ulate d 
pr o d uct i n prescri pti o n or o ver -t he-c o u nter me dicati o ns), recreati o nal dr u g, or s u p ple me nt 
( her bal) use a n d co ns u m pti o n, fa mil y  hist or y, se x ual hist or y, tra vel hist or y, hist or y of c o ntact 
wit h a ja u n dice d pers o n, s ur ger y, bl o o d tra nsf usi o n, hist or y of li ver or aller gic disease, a n d 
p ote ntial occ u pati o nal e x p os ure t o c he micals, s h o ul d be c ollecte d. F urt her testi n g f or ac ute 
he patitis A, B, C, D, a n d E i nfecti o n , li ver i ma gi n g (e g, biliar y tract), a n d c ollecti o n of ser u m 
sa m ples f or aceta mi n o p he n/ paraceta m ol dr u g a n d/ or pr otei n a d d uct le vels ma y  be warra nte d. 
All cases de m o nstrate d o n re peat testi n g as meeti n g t 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 pe cti 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 have e xcl u de d a n alter nati ve eti ol o g y.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

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

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9 7
1 0. 7. A p pe n di x 7: 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 bra d yc 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 -o nset atrial fl utter or fi brillati o n, wit h c o ntr olle d ve ntric ular res p o nse rate: 
ie, rate < 1 2 0 b p m.

Ne w -o nset t y pe I sec o n d-de gree ( We nc ke bac h) A V bl oc k of > 3 0 sec o n ds’ d urati o n.

Fre q ue nt P V Cs, tri plets, or s h ort i nter vals ( < 3 0 sec o n ds) of c o nsec uti ve ve ntric ular 
c o m ple xes.
E C G Fi n di n gs T h at M a y
Q u alif y as S A Es

Q Tc F pr ol o n gati o n > 5 0 0 ms.

Ne w S T -T c ha n ges s u g gesti ve of m y ocar dial isc he mia.

Ne w -o nset 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 bra nc h bl oc k ( Q R S c o m ple x > 1 2 0 ms).

S y m pt o matic bra d y car dia.

As y st ole:

I n a wa ke, sy m pt o m -free partici pa nts i n si n us r h yt h m, wit h d oc u me nte d peri o ds 
of as ys t ole ≥3. 0 sec o n ds or a n y esca pe rate < 4 0 b p m, or wit h a n esca pe r h yt h m 
t hat is bel o w t he A V n o de; 

I n a wa ke, sy m pt o m -free partici pa nts wit h atrial fi brillati o n a n d bra d ycar dia wit h 
1 or m ore pa uses of at least 5 sec o n ds or l o n ger; 

Atrial fl utter or fi brillati 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.

S ustai ne d s u 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 r h yt h ms > 3 0 sec o n ds’ d urati o n, i ncl u di n g i di o ve ntric ular r h y t 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 y car dia ( H R > 1 0 0 b p m [s uc h as t orsa des 
de p oi ntes]).

T y pe II sec o n d- de gree ( M o bitz II) A V bl oc k.

C o m plete (t hir d- de gree) heart bl oc k.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9 8
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 ve ntric ular tac h y arr h yt h mias ( > 3 0 sec o n ds’ d urati o n).

Sec o n d - or t hir d -de gree A V bl oc k re q uiri n g pace ma ker place me nt.

As y st olic pa uses re q uiri n g pace ma ker place me nt.

Atrial fl utter or fi brillati o n wit h ra pi d ve ntric ular res p o nse re q uiri n g car di o versi o n.

Ve ntric ular fi brillati o n/fl utter.

At t he discreti o n of t he i n vesti gat or, a n y arr h yt h mia classifie d as a n a d verse 
e x perie nce.
T he e n u merate d list of maj or e ve nts of p ote ntial cli nical c o ncer n are rec o m me n de d as “alerts” or n otificati o ns 
fr o m t he c ore E C G la b orat or y t o t he i n vesti gat or a n d Pfizer st u d y tea m, a n d n ot t o be c o nsi dere d as all-
i ncl usi ve of w hat t o be re p orte d as A Es/ S A Es.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 9 9
1 0. 8. A p pe n di x 8 : 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 - Up, 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. 2. 2 ) f or t he list of s p o ns or 
me dical de v ices).
1 0. 8. 1. Defi niti o n of A E a n d A D E
A E a n d A D E Defi niti o n

A n A E is defi ne d i n A p pe n di x 3 ( Secti o n 1 0. 3. 1 ).

A n A D E is defi ne d as a n A E relate d t o t he use of a n i n vesti gati o nal me dical de vice. 
T his defi niti o n i ncl u des a n y  AEs res ulti n g fr o m i ns ufficie nt or i na de q uate i nstr ucti o ns 
f or use, de pl oy m e nt, i m pla ntati o n, i nstallati o n, or o perati o n, or a n y  malf u ncti o n of t he 
i n vesti gati o nal me dical de vice as well as a 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. 8. 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.
U S A D E Defi niti o n

A U S A D E (als o i de ntifie d as U A D E i n U S Re g ulati o ns 2 1 C F R 8 1 3. 3) is a S A D E t hat
b y  its nat ure, i nci de nce, se verity, 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 y sis ma na ge me nt file.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 0
1 0. 8. 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. 8. 4. Rec or di n g / Re p orti n g a n d F oll o w - U p of Me dic al De vice Deficie ncies
De vice Deficie nc y Rec or di n g

W he n a de vice deficie nc y  occ urs, it is t he res p o nsi bilit y of t he u n bli n de d site staff t o 
re vie w all d oc u me ntati o n (e g, h os pital pr o gress n otes, la b orat or y re p orts, a n d 
dia g n ostic re p orts) relate d t o t he e ve nt.

T he u n bli n de d site staff will t he n rec or d all rele va nt de vice deficie nc y i nf or mati o n i n 
t he partici pa nt’s me dical rec or ds, i n acc or da nce wit h t he i n vesti gat or’s n or mal cli nical 
practice , a n d will als o 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 .

It is n ot acce pta ble f or t he u n bli n de d site staff t o se n d p h ot oc o pies of t he partici pa nt’s 
me dical rec or ds t o Pfizer Safet y i n lie u of f oll o wi n g t he re p orti n g pr ocess descri be d i n 
t he Me dical De vice C o m plai nt f or m.

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 . In 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 .

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. Re q uire me nts f or rec or di n g a n d 
re p orti n g a n A E or S A E are pr o vi de d i n A p pe n di x 3 (Secti o n 1 0. 3. 3 ).

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 here s uc h acti o n is necessar y  t o pre ve nt rec urre nce of a de vice 
deficie nc y . T his i ncl u des a n y a me n d me nt t o t he de vice desi g n t o pre ve nt rec urre nce.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 1
Assess me nt of C a us alit y 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 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 hip 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 i n t heir assess me nt.

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 hav e pr o vi de d a n assess me nt of 
ca usalit y.

T here ma y  be sit uati o ns i n w hic h a n S A E has occ urre d a n d t he i n vesti gat or has 
mi ni mal i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o t he s p o ns or. H o we ver, it is ver y 
i m p orta nt t hat t he i nvesti 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 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.
F oll o w - Up of Me dic al De vice
D eficie nc y

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 .

Ne w or u p date d i nf or mati o n re g ar 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 orti n g 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 Secti o n 1 0. 3 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 2
1 0. 8. 5. Re p orti n g of S A Es
Re p orti n g of a n S A E t o Pfizer Safet y  m ust be perf or me d acc or di n g t o t he pr ocesses 
descri be d i n A p pe n di x 3 (Secti o n 1 0. 3. 4 ). 
1 0. 8. 6. Re p orti n g of S A D Es
S A D E Re p orti n g t o Pfizer S afet y
N ote : T here are a d diti o nal re p orti n g o bli gati o ns f or me dical de vice deficie ncies t hat are 
p ote ntiall y  relate d t o S A Es (ie, a n S A D E) t hat m ust f ulfill t he le gal res p o nsi bilit y t o n otif y 
a p pr o priate re g ulat or y a ut h orities a n d ot her e ntities a b o ut certai n safety i nf or mati o n 
relati n g t o me dical de vices bei n g use d i n cli nical st u dies.

A n y  de vice deficie nc y t hat is ass ociate d wit h a n S A E m ust be re p orte d t o t he s p o ns or 
wit hi n 2 4 h o urs after t he i n vesti gat or deter mi nes t hat t he e ve nt meets t he defi niti o n of a 
de vice deficie nc y .

T he s p o ns or s hall re vie w all de vice deficie ncies a n d deter mi ne a n d d oc u me nt i n 
writi n g w het her t he y  c o ul d ha ve le d t o a n S A E. T hese s hall be re p orte d t o t he 
re g ulat or y a ut h orities a n d IR Bs/ E Cs as re q uire d b y nati o nal re g ulati o ns.
1 0. 9. A p pe n di x 9 : S u bst u d y A
1 0. 9. 1. S y n o psis – S u bst u d y A
See Secti o n 1. 1. 1 .
1 0. 9. 2. Sc he m a – S u bst u d y A
See Secti o n 1. 3. 1 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 3
1 0. 9. 3. S o A – S u bst u d y A
T a ble 4.
Sc he d ule of Acti vities – S u bst u d y A
Visit I de ntifier
A 1 0 1
A 1 0 2
A 1 0 3
E arl y 
Wit h dr a w al
N otes
Visit Descri pti o n
V acci n ati o n 1
V acci n ati o n 2
F oll o w -U p 
Visit
S afet y
F oll o w -U p *
* M a y be c o n d ucte d as a tele he alt h visit O R
site visit if a bl o o d dr a w is re q uire d.
Visit Wi n d o w ( D a ys)
D a y 1
2 8 -3 5 D a ys 
After 
V acci n ati o n 1
2 8 -3 5 D a ys 
After 
V acci n ati o n 2
2 8 -3 5 D a ys 
After L ast 
V acci n ati o n
D a y 1 = d a y of V acci n ati o n 1 .
O btai n inf or me d c o nse nt
X
See Secti o n 1 0. 1. 3 .
Assi g n partici pa nt n u m ber 
X
See Secti o n 6. 4 .
O btai n d e m o gra p h y a n d me dical hist or y † data
X
† I ncl u de date of o nset a n d res ol uti o n 
(if a p plica ble).
Perf or m cli nical assess me nt
X
X
I ncl u di n g, if i n dicate d, a p h ysical e xa mi nati o n. 
E xa mi nati o ns a n d assess me nts m ust occ ur pri or 
t o vacci nati o n. 
See Secti o n 8. 3. 1 .
Meas ure vital si g ns 
X
Bl o o d press ure a n d p ulse rate; see Secti o n 8. 3. 2 .
Meas ure pre vacci nati o n te m perat ure ( oral or 
t y m pa nic)
X
X
If ≥3 8° C ( 1 0 0. 4 °F), vacci nati o n dela y criteria 
a p pl y. See Secti o n 5. 5 .
Disc uss/re vie w c o ntrace pti ve e x pectati o ns 
( where a p pr o priate)
X
X
See Secti o n 1 0. 4 .
C ollect details of a n y lice nse d i nfl ue nza 
vacci ne recei ve d i n t he pri or 1 2 m o nt hs
X
I ncl u de pr o d uct na me a n d date of 
a d mi nistrati o n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 4
T a ble 4.
Sc he d ule of Acti vities – S u bst u d y A
Visit I de ntifier
A 1 0 1
A 1 0 2
A 1 0 3
E arl y 
Wit h dr a w al
N otes
Visit Descri pti o n
V acci n ati o n 1
V acci n ati o n 2
F oll o w -U p 
Visit
S afet y
F oll o w -U p *
* M a y be c o n d ucte d as a tele he alt h visit O R
site visit if a bl o o d dr a w is re q uire d.
Visit Wi n d o w ( D a ys)
D a y 1
2 8 -3 5 D a ys 
After 
V acci n ati o n 1
2 8 -3 5 D a ys 
After 
V acci n ati o n 2
2 8 -3 5 D a ys 
After L ast 
V acci n ati o n
D a y 1 = d a y of V acci n ati o n 1 .
C ollect a n d rec or d n o nst u d y vacci ne use
X ‡
X ¶
X ¶
‡ I n t he pre vi o us 2 8 da ys; ¶ si nce t he last st u d y 
visit. 
See Secti o n 1 0. 9. 8. 7 . 
C ollect a n d rec or d pr o hi bite d me dicati o n use
X §
X * *
X * *
§ I n t he pre vi o us 6 0 da ys; * * si nce t he last st u d y 
visit. See Secti o n 1 0. 9. 8. 7. 1 .
C o nfir m eli gi bilit y
X
X
See Secti o n 5.
C o nfir m t hat vacci nati o n dela y criteria ha ve 
n ot bee n met
X
X
See Secti o n 5. 5 .
C ollect bl o o d sa m ple f or i m m u n o ge nicit y 
assess me nt
~ 5 0 m L
~ 5 0 m L
~ 5 0 m L
~ 5 0 m L † †
See Secti o n 1 0. 9. 1 0. 1 . † † C ollecti o n of 
i m m u n o ge nicit y sa m ples s h o ul d occ ur if t he 
visit bef ore earl y wit h dra w al i ncl u de d t he st u d y 
i nter ve nti o n a d mi nistrati o n.
O btai n ra n d o mizati o n n u m ber 
X
D o n ot ra n d o mize u ntil eli gi bilit y is c o nfir me d 
a n d t he partici pa nt is prese nt at t he site.
See Secti o n 6. 4 .
O btai n st u d y i nter ve nti o n all ocati o n
X
X
See Secti o n 6. 4 .
A d mi nister st u d y i nter ve nti o n
X
X
See Secti o n 1 0. 9. 8. 1 .
Assess ac ute reacti o ns f or at least 3 0 mi n utes 
after st u d y i nter ve nti o n a d mi nistrati o n
X
X
M ust i ncl u de ti me of o nset .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 5
T a ble 4.
Sc he d ule of Acti vities – S u bst u d y A
Visit I de ntifier
A 1 0 1
A 1 0 2
A 1 0 3
E arl y 
Wit h dr a w al
N otes
Visit Descri pti o n
V acci n ati o n 1
V acci n ati o n 2
F oll o w -U p 
Visit
S afet y
F oll o w -U p *
* M a y be c o n d ucte d as a tele he alt h visit O R
site visit if a bl o o d dr a w is re q uire d.
Visit Wi n d o w ( D a ys)
D a y 1
2 8 -3 5 D a ys 
After 
V acci n ati o n 1
2 8 -3 5 D a ys 
After 
V acci n ati o n 2
2 8 -3 5 D a ys 
After L ast 
V acci n ati o n
D a y 1 = d a y of V acci n ati o n 1 .
E x plai n e -diar y c o m pleti o n re q uire me nts, 
pr o vi de trai ni n g, assist wit h d o w nl oa di n g t he 
a p p , or iss ue pr o visi o ne d de vice as nee de d
X
X
See Secti o n 8. 3. 4 .
Pr o vi de t her m o meter a n d meas uri n g de vice
X
X ‡ ‡
‡ ‡ Reiss ue if nee de d .
Re vie w react o ge nicit y e-diar y data ( dail y 
re vie w is o pti mal d uri n g t he acti ve diar y 
peri o d)
Da y s 1 t hr o u g h
7
Da y s 1 t hr o u g h
7
See Secti o n 8. 3. 4 .
C o ntact t he partici pa nt re p orti n g a se vere 
reacti o n or fe ver i n t heir e-diar y ; arra n ge a n 
u nsc he d ule d visit if re q uire d
Da y s 1 t hr o u g h
7
Da y s 1 t hr o u g h
7
See Secti o n 8. 3. 4 .
Re vie w t he e-diar y f or reacti o ns re p orte d as 
prese nt o n t he last da y of e -diar y c o m pleti o n 
a n d rec or d t heir st o p d ates
X
X
X
See Secti o n 8. 3. 4 .
C ollect t he s p o ns or -pr o visi o ne d e -diar y or 
assist t he partici pa nt wit h re m o vi n g t he st u d y 
a p plicati o n fr o m his or her o w n pers o nal 
de vice
X
X
E ns ure all e-diar y data ha ve bee n tra nsferre d 
pri or t o e-diar y deacti vati o n or re m o val of t he 
a p p.
Rec or d A Es/ S A Es a n d o btai n st o p dates f or 
pre vi o usl y re p orte d e ve nts
X
X
X
X
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 6
1 0. 9. 4. I ntr o d ucti o n – S u bst u d y A
1 0. 9. 4. 1. S u bst u d y A R ati o n ale
T his is a P hase 1 b , si n gle-site, parallel-gr o u p, ra n d o mize d, place b o -c o ntr olle d, 
o bser ver - bli n de d s u bst 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
R S V pre F a n d a m o difie d R N A vacci ne w he n a d mi nistere d as c o m bi ne d R S V pre F + qI R V 
a n d w he n a d mi nistere d al o ne.
1 0. 9. 4. 2. B ac k gr o u n d
See Secti o n 2. 2 .
1 0. 9. 4. 3. Be nefit / Ris k Assess me nt
T he ris k assess me nt s f or S u bst u d y A are a d dresse d i n Secti o n 2. 3 .
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  ma y be:

Recei pt of a safe a n d efficaci o us R S V vacci ne at n o c ost t o t he partici pa nt, a n d pr o visi o n 
of t he i m m u n o ge nicit y res ults.

Recei pt of a p ote ntiall y safe a n d efficaci o us i nfl ue nza vacci ne at n o c ost t o t he 
partici pa nt, a n d pr o visi o n of t he i m m u n o ge nicit y res ults.

C o ntri b uti n g t o researc h t o hel p ot hers.
T he o verall be nefit /ris k assess me nt f or S u bst u d y A is a d dresse d i n Secti o n 2. 3. 3 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 7
1 0. 9. 5. O bjecti ves, E n d p oi nts, a n d Esti m a n ds ( S u bst u d y A)
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y S afet y
Pri m ar y S afet y
Pri m ar y S afet y
T o e val uate t he safet y pr ofile of c o mbi nati o n
R S V pre F + qI R V 

L ocal reacti o ns ( pai n at t he i njecti o n site, 
re d ness, a n d s welli n g)

S y ste mic e ve nts (fe ver, fati g ue, hea dac he, 
v o m iti n g, na usea, diarr hea, 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 E s

S A Es
I n partici pa nts recei vi n g at least 1 d ose of st u d y 
i nter ve nti o n, t he perce nta ge of partici pa nts re p orti n g:

L ocal reacti o ns wit hi n 7 d a y s f oll o wi n g eac h 
vacci nat i o n

S y ste mic e ve nts wit hi n 7 d a y s f oll o wi n g eac h 
vacci nati o n

A E s wit hi n 1 m o nt h after eac h vacci nati o n

S A Es t hr o u g h o ut t he st u d y
Pri m ar y I m m u n o ge nicit y
Pri m ar y I m m u n o ge nicit y
Pri m ar y I m m u n o ge nicit y
T o descri be t he i m m u ne res p o nses elicite d b y 
c o m bi nati o n R S V pre F + qI R V i n c o m paris o n wit h 
t h ose elicite d b y R S V pre F al o ne

R S V A a n d R S V B N Ts
I n partici pa nts i n c o m plia nce wit h t he ke y pr ot oc ol 
criteria (e val ua ble partici pa nts): 

G M R of N Ts f or eac h R S V s u b gr o u p ( A or B) 
1 m o nt h after vacci nati o n wit h c o m bi nati o n
R S V pre F + qI R V t o t hat wit h R S V pre F al o ne 
(se q ue ntial-a d mi nistrati o n gr o u p , Visit A 1 0 3 )
T o descri be t he i m m u ne res p o nses elicite d b y 
c o m bi nati o n R S V pre F + qI R V i n c o m paris o n wit h 
t h ose elicite d b y qI R V al o ne

Strai n -s pecific H AI titers f or t he c urre nt
seas o nal strai ns ( 2 × A, 2 × B) rec o m me n de d b y 
W H O f or rec o m bi na nt or cell -base d i nfl ue nza 
vacci nes
I n partici pa nts i n c o m plia nce wit h t he ke y pr ot oc ol 
criteria (e val ua ble partici pa nts): 

G M R of strai n -s pecific H AI titers 1 m o nt h after 
vacci nati o n wit h c o mbi nati o n R S V pre F + qI R V t o 
t hat wit h qI R V al o ne (se q ue ntial-a d mi nistrati o n 
gr o u p , Visit A 1 0 2 )
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 8
O bjecti ves
E n d p oi nts
Esti m a n ds
E x pl or at or y
E x pl or at or y
E x pl or at or y
T o f urt her descri be t he i m m u ne res p o nses elicite d 
b y c o mbi nati o n R S V pre F + qI R V, b y R S V pre F 
al o ne, a n d b y qI R V al o ne

R S V A a n d R S V B N Ts

Strai n -s pecific H AI titers 
I n partici pa nts i n c o m plia nce wit h t he ke y pr ot oc ol 
criteria (e val ua ble partici pa nts): 

G M Ts of N Ts f or eac h R S V s u b gr o u p ( A or B) at 
eac h a p plica ble ti me p oi nt

G M F Rs of N Ts f or eac h R S V s u b gr o u p ( A or B) 
fr o m bef ore vacci nati o n t o eac h a p plica ble 
p ost vacci nati o n ti me p oi nt 

G M Ts of strai n -s pecific H AI at eac h a p plica ble 
ti me p oi nt

G M F Rs of strai n -s pecific H AI fr o m bef ore 
vacci nati o n t o eac h a p plica ble p ost vacci nati o n 
ti me p oi nt 

T he perce nta ge of partici pa nts w it h strai n-s pecific 
H AI titers ≥1: 4 0 at eac h a p plica ble ti me p oi nt

T he perce nta ge of partici pa nts ac hie vi n g 
strai n-s pecific H AI ser oc o n versi o na at eac h 
a p plica ble p ost vacci nati o n ti me p oi nt
a.
Ser oc o n versi o n is defi ne d as a n H AI titer < 1: 1 0 pri or t o vacci nati o n a n d ≥1: 4 0 at t he ti me p oi nt of i nterest, or a n H AI titer of ≥1: 1 0 pri or t o vacci nati o n 
wit h a 4 -f ol d rise at t he ti me p oi nt of i nterest.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 0 9
1 0. 9. 6. S u bst u d y A Desi g n
1 0. 9. 6. 1. O ver all Desi g n
T his st u d y  is desi g ne d 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 R S V pre F
a n d a m o difie d R N A vacci ne ( qI R V) a gai nst R S V a n d i nfl ue nza w he n a d mi nistere d as a 
c o m bi ne d vacci ne a n d w he n a d mi nistere d al o ne. T h is 3- visit st u d y will i nitiall y be c o n d ucte d 
as a P hase 1 b, si n gle-site, parallel-gr o u p, ra n d o mize d, place b o -c o ntr olle d, o bs er ver - bli n de d
s u bst u d y.
A p pr o xi matel y  2 5 0 healt h y  partici pa nts ( n = 1 2 5 per gr o u p) will be e nr olle d i n S u bst u d y  A. 
N ote: " E nr olle d" mea ns a partici pa nt's a gree me nt t o partici pate i n a cli nical st u d y  f oll o wi n g 
c o m pleti o n of t he i nf or me d c o nse nt pr ocess .
H ealth y  a d ults ≥6 0 ye ars of a ge will be ra n d o mize d 1: 1 t o eit her:

Gr o u p 1: co m b i nati o n (R S V pre F + qI R V) ( Visit A 1 0 1) f oll o we d b y place b o ( Visit A 1 0 2 ) 
or 

Gr o u p 2: se q ue ntial a d mi nistrati o n of qI R V ( Visit A 1 0 1) f oll o we d b y R S V pre F
( Visit A 1 0 2 ) a d mi nistere d 1 m o nt h a part.  
Ra n d o mizati o n will be stratifie d b y 3 a ge gr o u ps ( 6 0 - 6 4, 6 5-7 9, a n d ≥8 0 y ears) wit hi n eac h 
st u d y site. T o e ns ure a br oa d re prese ntati o n of a ge gr o u p s (partici pa nts at least 6 5 years of 
a ge) f or t he c urre nt rec o m me n dati o n o n seas o n al i nfl ue nza vacci nati o n , n o m ore t ha n 
4 0 partici pa nts 6 0 t hr o u g h 6 4 y ears of a ge will be vacci nate d .
Bl o o d will be c ollecte d pri or t o eac h vacci nati o n a n d at t he fi nal st u d y visit.
L ocal reacti o ns a n d s ys te mic e ve nts occ urri n g wit hi n 7 da ys after eac h vacci nati o n will be 
rec or de d i n a n e-diar y  de vice or s mart p h o ne a p p.
A Es a n d S A Es will be c ollecte d fr o m t he si g ni n g of i nf or me d c o nse nt t hr o u g h st u d y 
c o m pleti o n.
T his st u d y  will ha ve st o p pi n g r ules t hat will a p ply t o partici pa nts as s pecifie d i n Secti o n 8. 3. 6
wit h m o nit ori n g b y  desi g nate d u n bli n de d s p o ns or site staff o n a n o n g oi n g basis. If a st o p pi n g 
r ule is c o nfir me d as ha vi n g be e n met, f urt her ra n d o mizati o n a n d a d mi nistrati o n of 
Vacci nati o n 1 will be pa use d w hile a d diti o nal i nf or mati o n is gat here d, a n d c u m ulati ve 
u n bli n de d safet y data will be re vie we d b y t he I R C. Partici pa nts w h o ha ve recei ve d 
Vacci nati o n 1 will c o nti n ue f urt her st u d y visits a n d pr oce d ures as sc he d ule d. A c harter f or 
t he IR C will be pre pare d a n d fi nalize d bef ore t he first partici pa nt pr o vi des i nf or me d c o nse nt .
T he I RC will re vie w c u m ulati ve safet y data fr o m at least 1 0 partici pa nts w h o ha ve recei ve d
R S V pre F + q I RV. C o nc urre ntl y, e nr ol lme nt will pa use u ntil t he IR C c o nfir m s a satisfact or y 
safety assess me nt, w here u p o n e nr ollme nt will rec o m me nce. 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 0
Safet y  data acc u m ulate d at least 1 wee k f oll o wi n g V acci nati o n 1 i n eac h gr o u p will be 
re vie we d by t he s p o ns or’s I R C t o i nf or m f urt her de vel o p me nt. Base d o n re vie w of safet y  or 
i m m u n o ge nicity data of a n y st u d y i nter ve nti o n gr o u p, at Pfizer’s discreti o n, s u bse q ue nt 
c ollecti o n of bl o o d sa m ples fr o m partici pa nts i n t hat gr o u p ma y  be halte d a n d/ or n ot a nal yze d 
a n d st u d y visits or ot her pr oce d ures ma y  be disc o nti n ue d.
I n t he e ve nt t hat S u bst u d y  A is c o n d ucte d i m me diatel y pri or t o or wit hi n t he i nfl ue nza 
seas o n, SII V will be offere d t o partici pa nts at t he e n d of t heir st u d y partici pati o n .
T he t otal d urati o n of S u bst u d y  A f or eac h partici pa nt will be u p t o a p pr o xi matel y 2 m o nt hs. 
T he t otal d urati o n of S u bst u d y  A base d o n t he a p pr o xi mate 2-m o nt h e nr oll me nt peri o d will 
be a p pr o xi matel y  4 m o nt hs.
S u bst u d y A Desi g n
Healt h y a d ults 
≥6 0 years of a ge
( 1 2 5 per gr o u p, ra n d o mize d 
1: 1)
Visit A 1 0 1 ( D a y 1)
V acci n ati o n 1
Visit A 1 0 2 ( M o nt h 1)
2 8 -3 5 da ys        
after Vacci nati o n 1
V acci n ati o n 2
Visit A 1 0 3 ( M o nt h 2) 
2 8 -3 5 da ys 
after Vacci nati o n 2
F oll o w -u p
S T U D Y G R O U P S
Gr o u p 1: C o m bi n ati o n 
R S V pre F + qI R V / place b o
C o m bi nati o n
( R S V pre F + qI R V) 
Place b o
Bl o o d dra w
Gr o u p 2:
Se q ue nti al a d mi nistr ati o n
qI R V / R S V pre F
qI R V
R S V pre F
Bl o o d dra w  
S A F E T Y
L ocal reacti o ns a n d s yste mic 
e ve nts 
A E s a n d A E SIs
S A Es
D a y s 1 t hr o u g h 7    
  D a y s 1 t hr o u g h 7 
1 0. 9. 6. 2. Scie ntific R ati o n ale f or St u d y Desi g n
See Secti o n 2. 1 .
4 8 h o urs
C o nse nt t hr o u g h st u d y c o m pleti o n
C o nse nt t hr o u g h st u d y c o m pleti o n
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 1
1 0. 9. 6. 3. J ustific ati o n f or D ose
See Secti o n 4. 3 .
1 0. 9. 6. 4. E n d of St u d y Defi niti o n
See Secti o n 4. 4.
1 0. 9. 7. S u bst u d y A P o p ul ati o n
1 0. 9. 7. 1. I ncl usi o n Criteri a
Partici pa nts m ust meet t he f oll o wi n g 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:
A ge a n d Se x:
1.
P artici pa nts ≥6 0 ye ars of a ge at st u d y e nr oll me nt.
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 ot a p plica ble.
Ot her I ncl usi o n Criteri a :
2.
Partici pa nts w h o are willi n g a n d a ble t o c o m pl y wit h all sc he d ule d visits, i n vesti gati o nal 
pla n, la b orat or y  tests, lifest yle c o nsi derati o ns, a n d ot her st u d y pr oce d ures.
3.
Healt h y partici pa nts w h o are deter mi ne d b y me dical hist or y , p h y sical e xa mi nati o n
(if re q uire d), a n d cli nical j u d g me nt of t he i n vesti gat or t o be eli gi ble f or i ncl usi o n i n t he 
st u d y.
N ote: Healt h y partici pa nts wit h pree xisti n g sta ble disease, defi ne d as disease n ot 
re q uiri n g si g nifica nt c ha n ge i n t hera p y or h os pitalizati o n f or w orse ni n g disease d uri n g 
t he 6 wee ks bef ore e nr oll me nt, ca n be i ncl u de d. S pecific criteria f or partici pa nts wit h 
k n o w n sta ble i nfecti o n wit h HI V, H C V, or H B V ca n be f o u n d i n Secti o n 1 0. 1 1 .
4.
Ca pa ble of gi vi n g a n d ha vi n g si g ne d t he 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 plyi n g wit h t he re q uire me nts a n d restricti o ns liste d i n t he I CD a n d i n
t his pr ot oc ol.
5.
Recei pt of lice nse d i nfl ue nza vacci nati o n f or t he 2 0 2 2- 2 0 2 3 n ort her n he mis p here seas o n 
or 2 0 2 2 s o ut her n he mis p here seas o n 1 2 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 2
1 0. 9. 7. 2. S u bst u d y A E xcl usi o n Criteri a
Partici pa nts wit h a n y  of t he f oll o wi n g c haracteristics/c o n diti o ns will be e xcl u de d:
Me dic al C o n diti o ns :
1.
A c o nfir me d dia g n osis of R S V i nfecti o n or i nfl ue nza ≤1 2 0 da y s bef ore st u d y  i nter ve nti o n 
a d mi nistrati o n.
2.
Hist or y of se vere a d verse reacti o n ass ociate d wit h a n y vacci ne a n d/ or se vere aller gic 
reacti o n (e g, a na p h yl 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.
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 M i njecti o n.
4.
Seri o us c hr o nic dis or der, i ncl u di n g metastatic mali g na nc y , e n d-sta ge re nal disease wit h 
or wit h o ut dial y sis, cli nicall y u nsta ble car diac disease, or a ny ot her dis or der t hat, i n t he 
i n vesti gat or’s o pi ni o n, e xcl u des t he partici pa nt fr o m partici pati n g i n t he st u d y.
5.
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.
6.
Ot her me dical or ps y c hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he past year) or acti ve 
s uici dal i deati o n/ be ha vi or or la b orat or y a b n or malit y t hat ma y i ncrease t he ris k of st u d y 
partici pati o n or, i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt i na p pr o priate f or t he
st u d y. 
Pri or/ C o nc o mit a nt T her a p y :
7.
Recei pt of c hr o nic s ys te mic treat me nt wit h k n o w n i m m u n os u p pressa nt me dicati o ns 
(i ncl u di n g c yt ot o xic a ge nts or s yste mic c ortic oster oi ds), or ra di ot hera py, wit hi n 6 0 da y s 
bef ore st u d y i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he st u d y.
N ote: S y ste mic c ortic oster oi ds are defi ne d as t h ose ad mi nistere d f or ≥1 4 da y s at a d ose of
≥2 0 m g/ da y of pre d nis o ne or e q ui vale nt (e g, f or ca ncer or a n a ut oi m m u ne disease) or 
pla n ne d recei pt t hr o u g h o ut t he st u d y . I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or 
t o pical (s ki n, e yes, or ears) c ortic oster oi ds are per mitte d.
8.
Recei pt of bl o o d/ plas ma pr o d ucts or i m m u n o gl o b uli n, fr o m 6 0 d a y s bef ore st u d y
i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he st u d y.
9.
Recei pt of a n y lice nse d R S V vacci ne at a n y ti me pri or t o e nr oll me nt, or pla n n e d recei pt 
t hr o u g h o ut t he st u dy.
1 0. Recei pt of a n y lice nse d i nfl ue nza vacci ne ≤1 2 0 da ys bef ore st u d y e nr oll me nt, or pla n ne d 
recei pt t hr o u g h o ut t he st u d y.
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 n i n vesti gati o nal R S V or m R N A i nfl ue nza 
vacci ne at a n y ti me pri or t o e nr oll me nt , a n d t hereafter u ntil st u d y  c o m pleti o n, re gar dless
of vacci ne assi g n me nt .
1 2. Partici pati o n i n a n y ot her i nter ve nti o nal st u dies wit hi n 2 8 da y s bef ore st u d y e nr oll me nt
t hr o u g h st u dy c o m pleti o n . Partici pati o n i n p urel y o bser vati o nal st u dies is acce pta ble.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 3
Di a g n ostic Assess me nts:
N ot a p plica ble .
Ot her E xcl usi o n Criteri a :
1 3. I n vesti gat or site staff directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site staff ot her wise s u per vise d b y t he i n vesti gat or, a n d s p o ns or a n d s p o ns or 
dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers.
1 0. 9. 8. S u bst u d y A I nter ve nti o n a n d C o nc o mit a nt T her a p y
1 0. 9. 8. 1. St u d y I nter ve nti o n(s) A d mi nistere d
St u d y  i nter ve nti o ns f or S u bst u d y A will i ncl u de:
1 0. 9. 8. 1. 1. Gr o u p 1: C o m b i n ati o n R S V pre F + qI R V a n d Pl ace b o
Gr o u p 1: C o m bi n ati o n ( R S V pre F + qI R V) / Pl ace b o
I nter ve nti o n N a me
V acci n ati o n 1 
C o m b i n ati o n
( R S V pre F + qI R V)
V acci n ati o n 2
Pl ace b o
Vacci ne C o m p o ne nt
R S V pre F
qI R V
Place b o
2 S ta bilize d R S V 
pref usi o n F a nti ge ns, i n 
e q ual a m o u nts fr o m 
vir us s u b gr o u ps A a n d B 
E nc o di n g H A of 4 
strai ns as 
rec o m me n de d f or t he 
i nfl ue nza seas o n ( 2 A 
strai ns a n d 2 B strai ns)
D ose F or m ulati o n
R S V vacci ne 1 2 0 µ g/ vial 
p o w der f or s ol uti o n f or 
i njecti o n
Q ua dri vale nt infl ue nza 
sus pe nsi o n f or 
injecti o n,  
m g/ m L 
( qI R V)
0. 9 % N or mal sali ne
P r o d uct f or 
Rec o nstit uti o n
Sterile water as dil ue nt 
f or i njecti o n ( 0. 6 5 
m L/s yri n ge)
N/ A
N/ A
U nit D ose Stre n gt h(s)
1 2 0 µ g
µ g
0. 5 m L
R o ute of 
A d mi nistrati o n
A fter c o m bi ni n g b ot h vacci nes, a si n gle 1- m L IM 
i njecti o n is gi ve n i nt o t he delt oi d m uscle of t he 
n o n d o mi na nt ar m ( preferre d). 
0. 5 -m L I M i njecti o n i nt o t he 
delt oi d m uscle of t he 
n o n d o mi na nt ar m ( preferre d)
Use
E x peri me ntal
Place b o 
I M P or NI M P/ A x M P
I M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y Pfizer
Pr o vi de d ce ntrall y b y Pfizer
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 4
Gr o u p 1: C o m bi n ati o n ( R S V pre F + qI R V) / Pl ace b o
I nter ve nti o n N a me
V acci n ati o n 1 
C o m b i n ati o n
( R S V pre F + qI R V)
V acci n ati o n 2
Pl ace b o
Pac ka gi n g a n d 
La beli n g
R S V pre F is su p plie d as a l y o p hilize d w hite ca ke, 
pac ka ge d i n a clear glass 2 -m L vial wit h a r u b ber 
st o p per, al u mi n u m o verseal, a n d fli p -off ca p . It is 
rec o nstit ute d wit h a P F S of sterile water dil ue nt f or 
i njecti o n (s u p plie d).
qI R V is s u p plie d as
 
 
 
S t u d y i nter ve nti o n(s) will be la bele d as per c o u ntr y 
re q uire me nts.
St u d y i nter ve nti o n will be 
s u p plie d i n a glass or plastic 
vial. Eac h vial will be la bele d 
as per c o u ntr y re q uire me nts.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 5
1 0. 9. 8. 1. 2. Gr o u p 2: Se q ue nti al A d mi nistr ati o n of qI R V / R S V pre F
Gr o u p 2: Se q ue nt i al A d mi nistr ati o n of qI R V / R S V pre F
I nter ve nti o n N a me
V acci n ati o n 1
qI R V
V acci n ati o n 2
R S V pre F
Vacci ne C o m p o ne nt
qI R V
R S V pre F
qI R V, ie, e nc o di n g H A of 4 strai ns as 
rec o m me n de d f or t he i nfl ue nza seas o n 
( 2 A strai ns a n d 2 B strai ns)
2 S ta bilize d R S V pref usi o n F a nti ge ns, 
i n e q ual a m o u nts fr o m vir us s u b gr o u ps 
A a n d B
Sterile water as dil ue nt f or i njecti o n
D ose F or m ulati o n
Q ua dri vale nt infl ue nza sus pe nsi o n f or 
injecti o n,  
m g/ m L ( qI R V)
R S V vacci ne 1 2 0 µ g/ vial p o w der f or 
s ol uti o n f or i njecti o n
Pr o d uct f or 
Rec o nstit uti o n
N/ A
Sterile water as dil ue nt f or i njecti o n 
( 0. 6 5 m L/s yri n ge)
U nit D ose Stre n gt h(s)
µ g
1 2 0 µ g
R o ute of 
A d mi nistrati o n
0. 5 -m L I M i njecti o n i nt o t he delt oi d 
m uscle of t he n o n d o mi na nt ar m 
( preferre d)
0. 5 -m L I M i njecti o n i nt o t he delt oi d 
m uscle of t he n o n d o mi na nt ar m 
( preferre d)
Use
E x peri me ntal
E x peri me ntal
I M P or NI M P/ A x M P
I M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y Pfizer
Pr o vi de d ce ntrall y b y Pfizer
Pac ka gi n g a n d 
La beli n g
q I R V is s u p plie d as
 
St u d y i nter ve nti o n (s) will be la bele d as 
per c o u ntr y re q uire me nts.
R S V pre F is s u p plie d as a l y o p hilize d 
w hite ca ke, pac ka ge d i n a clear glass 
2- m L vial. It is rec o nstit ute d wit h a P F S 
of sterile water dil ue nt f or i njecti o n 
(s u pplie d).
St u d y i nter ve nti o n(s) will be la bele d as 
per c o u ntr y re q uire me nts.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 6
1 0. 9. 8. 1. 3. A d mi nistr ati o n
See Secti o n 6. 2. 1 .
1 0. 9. 8. 1. 4. Me dic al De vices
See Secti o n 6. 2. 2.
1 0. 9. 8. 1. 5. 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
See Secti o n 6. 3.
1 0. 9. 8. 1. 5. 1. Pre p ar ati o n a n d Dis pe nsi n g
See Secti o n 6. 3. 1 .
1 0. 9. 8. 1. 6. All oc ati o n t o S t u d y I nter ve nti o n
See Secti o n 6. 4.
All ocati o n of st u d y  i nter ve nti o n i n S u bst u d y A will be c o n d ucte d via t he I R T:

Visit A 1 0 1 : Ra n d o mize t he partici pa nt a n d t he n o btai n t he Visit A 1 0 1 kit /c o ntai ner
n u m ber assi g n me nt .

Visit A 1 0 2 : O btai n t he partici pa nt’s Visit A 1 0 2 kit /c o ntai ner n u m ber assi g n me nt .
1 0. 9. 8. 2. Bli n di n g
T his is a n o bser ver - bli n de d st u d y. 
1 0. 9. 8. 2. 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.
1 0. 9. 8. 2. 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 bet wee n st u d y  i nter ve nti o ns, st u d y i nter ve nti o n s will be a d mi nistere d i n 
a ma n ner t hat pre ve nts t he partici pa nts fr o m i de ntif y i n g t he st u d y i nter ve nti o n base d o n its 
a p peara nce.
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 ny 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 n ursi n g/ me dical staff or cli nic p har mac y will 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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 7
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 ud 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.
1 0. 9. 8. 2. 3. Bli n di n g of t he S p o ns or
T o facilitate ra pi d re vie w of data i n real ti me, s p o ns or staff will be u n bli n de d t o st u d y
i nter ve nti o n all ocati o n f or t he partici pa nts i n S u bst u d y A. H o we ver, s p o ns or staff w h o
r o uti nel y ha ve c o ntact wit h bli n de d site pers o n nel, a n d w h o are n ot 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 als o re mai n bli n de d. F urt her, details will be
pr o v i de d i n a data bli n di n g pla n.
1 0. 9. 8. 2. 4. Bre a ki n g t he Bli n d
See Secti o n 6. 5. 4 .
1 0. 9. 8. 3. St u d y I nter ve nti o n C o m pli a nce
See Secti o n 6. 6.
1 0. 9. 8. 4. D ose M o dific ati o n
N ot a p plica ble t o S u bst u d y A.
1 0. 9. 8. 5. C o nti n ue d Access t o St u d y I nter ve nti o n After t he E n d of t he St u d y
See Secti o n 6. 8.
1 0. 9. 8. 6. Tre at me nt of O ver d ose
See Secti o n 6. 9.
1 0. 9. 8. 7. Pri or a n d C o nc o mit a nt T her a p y
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 :

Lice nse d i nfl ue nza vacci ne, if recei ve d wit hi n t he 1 2 m o nt hs pri or t o e nr oll me nt.

A n y n o nst u d y  vacci nati o ns recei ve d fr o m 2 8 d a y s pri or t o st u d y e nr oll me nt u ntil t he last
st u d y visit .
Pr o hi bite d me dicati o ns liste d bel o w , if ta ke n, will be rec or de d i n t he C R F 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 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 8
1 0. 9. 8. 7. 1. Pr o hi bite d D uri n g t he St u d y
Recei pt of t he f oll o wi n g vacci nes a n d me dicati o ns d uri n g t he ti me peri o ds liste d bel o w ma y  
e xcl u de a partici pa nt fr o m t he per- pr ot oc ol a nal ysis fr o m t hat p oi nt o n war d; h o we ver, it is 
a ntici pate d t hat t he partici pa nt w o ul d n ot be wit h dra w n fr o m t he st u d y (Secti o n 7 ). 
Me dicati o ns a n d vacci nati o ns s h o ul d n ot be wit h hel d if re q uire d f or a partici pa nt’s me dical 
care.

I n vesti gati o nal vacci nes a n d i n vesti gati o nal dr u gs are pro hi bite d wit hi n 2 8 da y s pri or t o
e nr oll me nt a n d t hereafter d uri n g t he c o urse of t he st u d y .

Lice nse d or n o nst u d y i n vesti gati o nal R S V vacci nes are pr o hi bite d at a n y ti me pri or t o 
st u d y e nr oll me nt a n d t hereafter d uri n g t he c o urse of t he st u d y .

N o nst u d y  i n vesti gati o nal i nfl ue nza vacci nes are pr o hi bite d at a n y ti me pri or t o st u d y  
e nr oll me nt a n d t hereafter d uri n g t he c o urse of t he st u d y .

L ice nse d i nfl ue nza vacci ne s are pr o hi bite d ≤1 2 0 da y s bef ore st u d y i nter ve nti o n 
a d mi nistrati o n a n d t hereafter d uri n g t he c o urse of t he st u d y .

N o nst u d y  i nacti vate d or rec o m bi na nt vacci nes , lice nse d C O VI D-1 9 vacci ne s, or 
C O VI D -1 9 vacci nes a ut h orize d f or te m p orar y or e mer ge nc y use are pr o hi bite d wit hi n 
1 4 da y s after st u d y i nter ve nti o n a d mi nistrati o n.

N o nst u d y  li ve vacci nes s h o ul d n ot be gi ve n wit hi n 2 8 da y s pri or t o e nr oll me nt a n d 
t hereafter d uri n g t he c o urse of t he st u d y.

C hr o nic s y ste mic treat me nt wit h k n o w n i m m u n os u p pressa nt me dicati o ns, or 
ra di ot hera py, is pr o hi bite d wit hi n 6 0 da y s pri or t o e nr oll me nt t hereafter d uri n g t he c o urse 
of t he st u d y .

S y ste mic c ortic oster oi ds (≥2 0 m g/ da y  of pre d nis o ne or e q ui vale nt) f or ≥1 4 da y s are 
pr o hi bite d wit hi n 2 8 da ys pri or t o e nr oll me nt a n d t hereafter d uri n g t he c o urse of t he 
st u d y.

Bl o o d/ plas ma pr o d ucts or i m m u n o gl o b uli ns are pr o hi bite d wit hi n 6 0 da y s pri or t o 
e nr oll me nt a n d t hereafter d uri n g t he c o urse 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 s ym pt o ms ass ociate d wit h 
st u d y i nter ve nti o n a d mi nistrati o n are n ot per mitte d. H o we ver, if a partici pa nt is ta ki n g a 
me dicati o n f or a n ot her c o n diti o n, e ve n if it ma y  ha ve a nti p yretic or pai n-relie vi n g 
pr o perties, it s h o ul d n ot be wit h hel d pri or t o st u d y va cci nati o n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 1 9
1 0. 9. 8. 7. 2. Per mitte d D uri n g t he St u d y

Me dicati o n ot her t ha n t hat descri be d as pr o hi bite d i n Secti o n 1 0. 9. 8. 7. 1 re q uire d f or 
treat ment of pree xisti n g c o n diti o ns or ac ute ill ness is per mitte d.

I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical (e g, s ki n, e y es, ears) 
c ortic oster oi ds are per mitte d. 
T he use of a nti p yr etics a n d ot her pai n me dicati o n t o treat s ym pt o ms ass ociate d wi t h st u d y 
i nter ve nti o n a d mi nistrati o n is per mitte d.
1 0. 9. 9. Disc o nti n u ati o n of S u bst u d y A I nter ve nti o n a n d P artici p a nt 
Disc o nti n u ati o n/ Wit h dr a w al
See Secti o n 7 .
1 0. 9. 1 0. S u bst u d y A Assess me nts a n d Pr oce d ures
1 0. 9. 1 0. 1. I m m u n o ge nicit y Assess me nts
1 0. 9. 1 0. 1. 1. Bl o o d C ollecti o n
Bl o o d sa m ples (a p pr o xi matel y  50 m L per sa m ple) f or i m m u n o ge nicit y  assess me nts will be 
c ollecte d fr o m all e nr olle d partici pa nts j ust pri or t o eac h st u d y vacci nati o n at Visit A 1 0 1 a n d 
Visit A 1 0 2 , a n d at Visit A 1 0 3 . 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 1 50 m L acr oss 2 m o nt hs.
I nstr ucti o ns f or t he c ollecti o n a n d ha n dli n g of bl o o d a n d ser u m sa m ples will be pr o vi de d i n 
t he la b orat or y ma n ual. T he date a n d ti me of eac h sa m ple will be rec or de d.
T he i m m u n o ge nicit y sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns 
pr o vi de d t o t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y . A ny de viati o ns fr o m t he 
i m m u n o ge nicity sa m ple ha n dli n g pr oce d ure (e g , sa m ple c ollecti o n a n d pr ocessi n g ste ps,
i nteri m st ora ge, or s hi p pi n g c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d, 
a n d re p orte d t o t he s p o ns or. O n a case -b y -case basis, t he s p o ns or ma y  ma ke a deter mi nati o n 
as t o w het her sa m ple i nte grit y has bee n c o m pr o mise d.
1 0. 9. 1 0. 1. 2. R S V V acci ne A nti b o d y Testi n g
Ser u m sa m ples c ollecte d at all 3 visits will be assa ye d f or R S V A a n d R S V B ser u m N Ts.
R S V A a n d R S V B ser u m N Ts will be deter mi ne d a n d re p orte d as t he N T at eac h bl o o d 
sa m pli n g visit. 
Sa m ple c ollecti o n, pr ocessi n g, st ora ge, a n d s hi p pi n g i nf or mat i o n ca n be f o u n d i n t he 
la b orat or y ma n ual. All assa ys will be perf or me d b y Pfizer a n d/ or at a facilit y desi g nate d b y 
Pfizer.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 0
1 0. 9. 1 0. 1. 3. qI R V I m m u ne Res p o nse Testi n g
Ser u m sa m ples c ollecte d at Visit A 1 0 1 a n d Visit A 1 0 2 will be assa ye d f or seas o nal i nfl ue nza 
strai ns ( 2× A, 2 × B) as rec o m me n de d b y W H O f or rec o m bi na nt or cell-base d i nfl ue nza 
assa ys.
I m m u ne res p o nse testi n g f or seas o nal strai ns ( 2 × A, 2 × B) will be assesse d b y  strai n-s pecific 
H AI a nti b o d y titers t o e val uate vacci ne res p o nses.
Sa m ple c ollecti o n, pr ocessi n g, st ora ge, a n d s hi p pi n g i nf or mati o n ca n be f o u n d i n t he 
la b orat or y ma n ual. All assa ys will be perf or me d b y Pfizer a n d/ or at a facilit y desi g nate d b y 
Pfizer.
1 0. 9. 1 0. 1. 4. E x pl or at or y Ass a ys, I ncl u di n g I m m u n o ge nicit y Assess me nts a n d Ass a y 
De vel o p me nt
Sa m ples re mai ni n g afte r c o m pleti o n of t he pla n ne d assa ys fr o m bl o o d dra ws ma y be use d f or 
a d diti o nal vacci ne a n d i nfecti o us disease -relate d researc h. Sa m ples ma y als o be use d f or 
assa y de vel o p me nt, sta n dar dizati o n, q ualificati o n, a n d vali dati o n. T his w or k is critical i n t he 
de v el o p me nt, q ualificati o n, a n d vali dati o n of ser ol o gical assa y s a n d is re q uire d by re g ulat or y 
a ut h orities f or t heir use i n t he lice ns ure of a vacci ne.
1 0. 9. 1 0. 2. Bi ol o gic al S a m ples
See Secti o n 8. 2. 3 .
1 0. 9. 1 0. 3. S afet y Assess me nts
See Secti o n 8. 3 .
1 0. 9. 1 0. 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
See Secti o n 8. 4.
1 0. 9. 1 0. 5. St o p pi n g R ules
T he f oll o wi n g st o p pi n g r ules are i n place f or S u bst u d y  A partici pa nts, base d o n re vie w of 
A Es , E C G, a n d la b orat or y data, a n d a p pl y t o Vacci nati o n 1, Da y 1 t hr o u g h Da y 2 8. T hese 
data will be m o nit ore d o n a n o n g oi n g basis b y  t he i n vesti gat or ( or me dicall y q ualifie d 
desi g nee) a n d s p o ns or i n or der t o pr o m ptl y  i de ntif y a n d fla g a n y e ve nt t hat p ote ntiall y 
c o ntri b utes t o a st o p pi n g r ule. I n t he e ve nt t hat s p o ns or pers o n nel c o nfir m t hat a st o p pi n g r ule 
is met, t he f oll o wi n g acti o ns will c o m me nce:

T he I R C will re vie w all a p pr o priate data.

T he st o p pi n g r ule will P A U S E ra n d o mizati o n a n d a n y  f urt her a d mi nistrati o n of 
Vacci nati o n 1 ( R S V pre F + qIR V or qI R V) . T he P A U S E will n ot a p pl y t o t h ose 
partici pa nts w h o recei ve d Vacci nati o n 1 pri or t o t he st o p pi n g r ule bei n g met.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 1

F or t h ose partici pa nts alrea d y vacci nate d, all r o uti ne st u d y c o n d uct acti vities, i ncl u di n g 
o n g oi n g data e ntr y , re p orti n g of A Es, partici pa nt e-diar y  c o m pleti o n, bl o o d sa m ple 
c ollecti o n, a n d partici pa nt f oll o w -u p, will c o nti n ue d uri n g t he pa use.
A st o p pi n g r ule is met if a n y of t he f oll o wi n g criteria occ ur wit hi n 2 8 da y s after recei vi n g 
Vacci nati o n 1 (R S V pre F + qI R V or qI R V ).
1 0. 9. 1 0. 5. 1. St o p pi n g R ule Criteri a
If a ny partici pa nt vacci nate d wit h q I RV or R S V pre F + q I RV de vel o ps:
1.
A ne w E C G a b n or malit y  t hat a car di ol o gist j u d ges c o nsiste nt wit h pr o ba ble or p ossi ble 
m y ocar ditis or pericar ditis, i ncl u di n g:

S ustai ne d atrial or ve ntric ular arr h yt h mias .

Sec o n d -de gree M o bitz T y pe II or w orse A V bl oc k or ne w b u n dle bra nc h bl oc k.

Diff use S T -se g me nt ele vati o n or P R -se g me nt i n versi o n, c o m pati ble wit h pericar ditis.
2.
A n a b n or mal tr o p o ni n I val ue t hat is c o nfir me d t o be a b n or mal o n re peat testi n g, assesse d 
as relate d t o st u d y i nter ve nti o n b y  t he i n vesti gat or.
3.
If ≥1 partici pa nt vacci nate d wit h q I RV o r R S Vpre F + qI R V de vel o ps c o nfir me d 
m y ocar ditis or pericar ditis.
4.
If a ny partici pa nt vacci nate d wit h q I RV or R S V pre F + q I RV dies.
5.
If ≥1 partici pa nt vacci nate d wit h q I RV or R S V pre F + qI R V e x perie nces a Gra de 4 
u ns olicite d A E, or S A E of a n y se verit y, assesse d as relate d b y t he i n vesti gat or.
6.
If ≥2 partici pa nts vacci nate d wit h q I RV or R S V pre F + q I RV de vel o p t he sa me or si milar 
Gra de 3 or hi g her (see Secti o n 1 0. 3. 3, Assess me nt of I nte nsit y ) u ns olicite d A E (i ncl u di n g 
la b orat or y a b n or malities, e xce pt l ym p h oc y te c o u nt a n d C-reacti ve pr otei n), ot her t ha n 
m y ocar ditis/ pericar ditis, assesse d as relate d t o st u d y  i nter ve nti o n b y t he i n vesti gat or.
N ote t hat t he l ocal reacti o ns, s y ste mic e ve nts, a n d fe ver (S ecti o n 8. 3. 4 ) re p orte d wit hi n 
7 da y s fr o m t he da y of a d mi nistrati o n of Vacci nati o n 1 , irres pecti ve w het her t he y are 
rec or de d i n t he e-diar y  or as A Es, are e xcl u de d fr o m t his st o p pi n g r ule.
A c harter f or t he I R C will be pre pare d a n d fi nalize d bef ore t he first partici pa nt is c o nse nte d.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 2
1 0. 9. 1 0. 6. St u d y Pr oce d ures
1 0. 9. 1 0. 6. 1. Visit A 1 0 1 – V acci n ati o n 1 ( 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, vol 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 a n d date t he I C D. A c o p y of t he si g ne d a n d date d I C 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 .
St u d y  pr oce d ures s h o ul d be c o n d ucte d i n a ste p wise ma n ner as s h o w n bel o w: 

O btai n writte n i nf or me d c o nse nt eit her i n electr o nic or har d -c o p y f or mat fr o m t he 
partici pa nt bef ore perf or mi n g a n y st u d y- s pecific pr oce d ures.

Assi g n a si n gle partici pa nt i de ntifier usi n g t he I RT s y ste m. 

O btai n a n d rec or d t he partici pa nt de m o gra p h y (i ncl u di n g c o m plete date of birt h 
[ d d-M m m -Y Y Y Y], se x, race, racial desi g nati o n, a n d et h nicit y ). T he f ull date of birt h will 
be c ollecte d t o criticall y e val uate t he i m m u ne res p o nse a n d safet y pr ofile b y a ge.

O btai n a n d rec or d a n y m e dical hist or y of cli nical si g nifica nce. I ncl u de date of o nset a n d 
res ol uti o n (if a p plica ble). Use best esti mate if u n k n o w 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 y sical 
e xa mi nati o n is necessar y t o c o m pre he nsi vel y e val uate t he partici pa nt, perf or m a p h ys ical 
e xa mi nati o n a n d rec ord a n y  fi n di n gs i n t he s o urce d oc u me nts a n d, if cli nicall y 
si g nifica nt, rec or d o n t he me dical hist or y C R F (Secti o n 8. 3. 1 ). 

Meas ure
t he partici pa nt’s vital si g ns, i ncl u di n g bl o o d press ure (seate d) a n d p ulse rate.

Meas ure t he partici pa nt ’s pre vacci nati o n b o d y te m perat ure ( oral or t y m pa nic) t o e ns ure
t hat t he te m perat ure is n ot ≥3 8° C .

Disc uss c o ntrace pti ve use w here a p plica ble a n d as de scri be d i n Secti o n 5. 3. 1 .

C ollect details ( w he n a vaila ble) of a n y lice nse d i nfl ue nza vacci ne recei ve d i n t he last 
1 2 m o nt hs pri or t o e nr oll me nt i n t he st u d y . I ncl u de pr o d uct na me a n d date of 
a d mi nistrati o n.

Rec or d a n y n o nst u d y  vacci nati o ns recei ve d pri or t o Visit A 1 0 1 as descri be d i n
Secti o n 1 0. 9. 8. 7. I ncl u de pr o d uct na me a n d date of a d mi nistrati o n.

Re vie w c o nc o mita nt me dicati o n use a n d rec or d a n y me dicati o ns t hat are pr o hi bite d, as 
descri be d i n Secti o n 1 0. 9. 8. 7. 1 .

E ns ure a n d d oc u me nt t hat all 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.

E ns ure t hat t he partici pa nt d oes n ot meet a n y te m p orar y dela y criteria as descri be d i n 
Secti o n 5. 5 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 3
N ote: If dela y criteria are met, resc he d ule Vacci nati o n 1 f or a later date whe n t he 
reas o n(s) f or t he te m p orar y dela y ha ve res ol ve d. Ra n d o mizati o n , Visit A 1 0 1 st u d y 
i nter ve nti o n assi g n me nt i n t he I RT, a n d bl o o d c ollecti o n are t o be deferre d u ntil t he 
partici pa nt ret ur ns f or Vacci nati o n 1. 

Pri or t o vacci nati o n, c ollect a bl o o d sa m ple of a p pr o xi matel y 5 0 m L f or i m m u n o ge nicity 
testi n g.

O btai n t he partici pa nt’s ra n d o mizati o n n u m ber a n d Visit A 1 0 1 st u d y i nter ve nti o n
assi g n me nt usi n g t he I R T s y ste m.

U n bli n de d site staff me m ber(s) will dis pe nse/a d mi nister t he assi g ne d st u d y i nter ve nti o n 
i nt o t he delt oi d m uscle as detaile d i n Secti o n 6. 2. 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 a n d o n t he A E pa ge of t he C R F, a n d 
o n a n S A E f or m, if a p plica ble.

E x plai n t he e -diar y  tec h n ol o g y a n d c o m pleti o n re q uire me nts. Assist wit h i nstalli n g t he 
e-diar y  a p plicati o n o nt o t he partici pa nt’s o w n de vice or , if re q uire d, iss ue a s p o ns or-
pr o visi o ne d e -diar y . 

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns at t he i njecti o n site a n d a 
t her m o meter f or rec or di n g oral te m perat ure.

E ns ure t hat t he partici pa nt is c o mf orta ble wit h t he c h ose n e -diar y  platf or m, c o nfir m 
i nstr ucti o ns o n e-diar y  c o m pleti o n, a n d as k t he partici pa nt t o c o m plete t he e-diar y  fr o m 
D a y  1 t hr o u g h Da y 7, w here Da y 1 is t he da y of Vacci nati o n 1.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if he or s he 
e x perie nces a n y of t he f oll o wi n g fr o m Da y  1 t hr o u g h Da y 7 after vacci nati o n ( w here Da y 
1 is t he da y  of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y visit is 
re q uire d:

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness or s welli n g at t he i njecti o n site meas uri n g greater t ha n 1 0 c m ( > 2 0 meas uri n g 
de vice u nits).

Se ver e pai n at t he i njecti o n site.

A n y  se vere sys te mic e ve nt.

If t he partici pa nt d oes n’t call, t he site s h o ul d c o ntact t he partici pa nt 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.

Re q uest t hat t he partici pa nt bri n g t heir c o m plete d e- diar y  de vice t o t he ne xt visit.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if t he partici pa nt 
e x perie nces ac ute c hest pai n, s h ort ness of breat h, or pal pitati o ns 
(see Secti o n 1 0. 9. 1 0. 6. 4. 2 ).
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 4

Rec or d A Es a n d S A Es as descri be d i n Secti o n 1 0. 3. 3 a n d o btai n a n d rec or d st o p dates f or 
pre vi o usl y  re p orte d e ve nts. 

Sc he d ule a n a p p oi nt me nt f or t he ne xt st u d y  visit.

C o m plete t he s o urce n otes a n d C R F.

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 nter ve nti o n acc o u nta bilit y rec or ds.

T he i n vesti gat or or a p pr o priatel y  q ualifie d desi g nee re vie ws t he react o ge nicit y e-diar y  
data o nli ne f oll o wi n g vacci nati o n t o e val uate partici pa nt c o m plia nce a n d as part of t he 
o n g oi n g safet y re vie w.  Dail y re vie w is o pti mal d uri n g t he acti ve diar y  peri o d.
1 0. 9. 1 0. 6. 2. Visit A 1 0 2 – V acci n ati o n 2 ( 2 8 - 3 5 D a ys After V acci n ati o n 1)

Perf or m a cli nical assess me nt. If t he cli nical assess me nt i n dicates t hat a p h y sical 
e xa mi nati o n is necessar y t o c o m pr e he nsi vel y e val uate t he partici pa nt, perf or m a p h ys ical 
e xa mi nati o n a n d rec or d a n y fi n di n gs i n t he s o urce d oc u me nts a n d, if cli nicall y 
si g nifica nt, rec or d as a n A E (Secti o n 8. 3. 1 ). 

Meas ure t he partici pa nt ’s pre vacci nati o n b o d y te m perat ure ( oral or t y m pa nic) t o e ns ure
t hat t he te m perat ure is n ot ≥3 8° C .

Disc uss c o ntrace pti ve use w here a p plica ble a n d as descri be d i n Secti o n 5. 3. 1 . 

Rec or d a n y n o nst u d y vacci nati o ns recei ve d pri or t o Visit A 1 0 2 as descri be d i n 
Secti o n 1 0. 9. 8. 7. I ncl u de pr o d uct na me a n d date of a d mi nistrati o n.

Re vie w c o nc o mita nt me dicati o n use a n d rec or d a n y  me dicati o ns t hat are pr o hi bite d, as 
descri be d i n Secti o n 1 0. 9. 8. 7. 1 .

E ns ure a n d d oc u me nt t hat all 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 . If t he partici pa nt is n o l o n ger eli gi ble , f oll o w- u p acti o ns are descri be d i n
Secti o n 7. 1.

E ns ure t hat t he partici pa nt d oes n ot meet a n y te m p orar y  dela y criteria as descri be d i n 
Secti o n 5. 5 . 
N ote: If dela y criteria are met, resc he d ule Vacci nati o n 2 f or a later date w he n t he 
reas o n(s) f or t he te m p orar y dela y ha ve res ol ved. Ra n d o mizati o n, Visit A 1 0 2 st u d y 
i nter ve nti o n assi g n me nt i n t he I RT , a n d bl o o d c ollecti o n are t o be deferre d u ntil t he 
partici pa nt ret ur ns f or Vacci nati o n 2. 

Pri or t o vacci nati o n, c ollect a bl o o d sa m ple of a p pr o xi matel y  5 0 m L f or i m m u n o ge nicity 
testi n g. 

O btai n t he partici pa nt’s Visit A 1 0 2 st u d y i nter ve nti o n assi g n me nt usi n g t he I R T s ys te m.

U n bli n de d site staff me m ber(s) will dis pe nse/a d mi nister t he assi g ne d st u d y i nter ve nti o n 
i nt o t he delt oi d m uscle as detaile d i n Secti o n 6. 2. 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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 5

Bli n de d s ite 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 a n d o n t he A E pa ge of 
t he C R F, a n d o n a n S A E f or m as a p plica ble.

Re vie w t he e-diar y  tec h n ol o g y a n d c o m pleti o n re q uire me nts. Assist wit h i nstalli n g t he 
e-diar y  a p plicati o n o nt o t he partici pa nt’s o w n de vice or , if re q uire d, iss ue a 
s p o ns or-pr o visi o ne d e - di ar y. 

If re q uire d, reiss ue a meas uri n g de vice t o meas ure l ocal reacti o ns at t he i njecti o n site a n d 
a t her m o meter f or rec or di n g oral te m perat ure.

E ns ure t hat t he partici pa nt re mai ns c o mf orta ble wit h t he c h ose n e -diar y  platf or m, 
c o nfir m i nstr ucti o ns o n e -di ar 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 
e-diar y  fr o m Da y 1 t hr o u g h Da y 7, w here Da y 1 is t he da y of Vacci nati o n 2.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if he or s he 
e x perie nces a n y of t he f oll o wi n g fr o m D a y  1 t hr o u g h Da y 7 after vacci nati o n t o 
deter mi ne if a n u nsc he d ule d react o ge nicit y visit is re q uire d:

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness or s welli n g at t he i njecti o n site meas uri n g greater t ha n 1 0 c m 
( > 2 0 meas uri n g de vice u nits).

Se vere pai n at t he i njecti o n site.

A n y  se vere sys te mic e ve nt.

If t he partici pa nt d oes n’t call, t he site s h o ul d c o ntact t he partici pa nt 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.

Re q uest t hat t he partici pa nt bri n g t heir c o m plete d e- diar y  de vice t o t he ne xt visit.

O btai n st o p dates f or a n y o n g oi n g e ve nts rec or de d o n t he last da y of e -diar y c o m pleti o n 
f or t he pre vi o us peri o d.

Rec or d A Es a n d S A Es as descri be d i n Secti o n 1 0. 3. 3 a n d o btai n a n d rec or d st o p dates 
f or pre vi o usly re p orte d e ve nts. 

Sc he d ule a n a p p oi nt me nt f or t he ne xt st u d y  visit.

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 b li n de d 
dis pe nser/a d mi nistrat or u p dates t he st u d y  i nter ve nti o n acc o u nta bilit y rec or ds.

T he i n vesti gat or or a p pr o priatel y  q ualifie d desi g nee re vie ws t he react o ge nicit y e-diar y  
data o nli ne f oll o wi n g vacci nati o n t o e val uate partici pa nt c o m plia nce a n d as part o f t he 
o n g oi n g safet y re vie w. Dail y re vie w is o pti mal d uri n g t he acti ve diar y peri o d .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 6
1 0. 9. 1 0. 6. 3. Visit A 1 0 3 - F oll o w -U p Visit ( 2 8- 3 5 D a ys After V acci n ati o n 2)

Rec or d a n y n o nst u d y vacci nati o ns recei ve d si nce t he last st u d y visit as descri be d i n 
Secti o n 1 0. 9. 8. 7 .

Re vie w c o nc o mita nt me dicati o n use a n d rec or d a n y  me dicati o ns t hat are pr o hi bite d, as 
descri be d i n Secti o n 1 0. 9. 8. 7. 1 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  5 0 m L f or i m m u n o ge nicity. 

Re vie w t he e-diar y  data a n d o btai n st o p dates f or a n y  o n g oi n g e ve nts rec or de d o n t he last 
da y  of e-diar y  c o m pleti o n f or t he pre vi o us peri o d.

Rec or d A Es a n d S A Es as descri be d i n Secti o n 1 0. 3. 3 a n d o btai n a n d rec or d st o p dates f or 
pre vi o usl y  re p orte d e ve nts. 

C ollect t he s p o ns or -pr o visi o ne d e -diar y or assist t he partici pa nt wit h re m o vi n g t he st u d y 
a p plicati o n fr o m his or her o w n pers o nal de vice . E ns ure t hat all data ha ve bee n 
tra nsferre d bef ore deacti vati n g t he e-diar y  or deleti n g t he a p p.

C o m plete t he C R F a n d s o urce d oc u me nts.
1 0. 9. 1 0. 6. 4. E arl y Wit h dr a w als – S afet y F oll o w -U p ( 2 8 - 3 5 Da ys A fter L ast V acci n ati o n 
R ecei ve d) 

Safet y  f oll o w-u p ma y  be c o n d ucte d via a p h o ne call, or a site visit if a bl o o d dra w is 
re q uire d.

F or partici pa nts w h o recei ve d st u d y i nter ve nti o n at t he visit pri or t o wit h dra wal , c ollect 
t he i m m u n o ge nicity 5 0- m L  bl o o d sa m ple a n d pr ocess it as i n dicate d i n t he la b orat or y 
m a n ual. 

Re vie w t he e -diar y  data a n d o btai n a n d rec or d st o p dates f or a ny o n g oi n g e ve nts rec or de d 
o n t he last da y  of e-diar y  c o m pleti o n f or t he pre vi o us peri o d(s).

Rec or d A Es a n d S A Es as descri be d i n Secti o n 1 0. 3. 3 a n d o btai n a n d rec or d st o p dates f or 
pre vi o usl y  re p orte d e ve nts. 

C ollect t he s p o ns or -pr o visi o ne d e -diar y or assist t he partici pa nt wit h re m o vi n g t he st u d y 
a p plicati o n fr o m his or her o w n pers o nal de vice .

C o m plete t he C R F a n d s o urce d oc u me nts.
1 0. 9. 1 0. 6. 4. 1. U nsc he d ule d Re act o ge nicit y Visits f or a Gr a de 3 or S us pecte d Gr a de 4 
Re acti o n
If a se vere l ocal reacti o n (Secti o n 8. 3. 4. 2 ), se vere s yste mic e ve nt (Secti o n 8. 3. 4. 3 ), or fe ver 
≥3 9. 0 °C ( ≥1 0 2. 1 °F) ( Secti o n 8. 3. 4. 4 ) is re p orte d i n t he e-diar y , a tele p h o ne c o ntact wit h t he 
partici pa nt s h o ul d occ ur t o ascertai n f urt her details a n d deter mi ne w het her a site visit is 
cli nicall y i n dicate d. If a s us pecte d Gra de 4 l ocal reacti o n, s yste mic e ve nt, or fe ver 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 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 t he criteria f or Gra de 4.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 7
A site visit or referral t o a healt hcare facilit y  s h o ul d be sc he d ule d as s o o n as p ossi ble t o 
assess t he e xte nt of t he reacti o n, u nless:

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 reacti o n is n o l o n ger prese nt at t he ti me of t he c o ntact, or

T he partici pa nt rec or de d a n i nc orrect val ue i n t he e- diar y  (c o nfir mati o n of a n e-diar y  data 
e ntr y err or), or

T he i n ves ti gat or or a p pr o priate desi g nee deter mi nes t hat a n u nsc he d ule d visit is n ot 
re q uire d.
T his c o ntact will be rec or de d i n t he partici pa nt’s s o urce n otes a n d i n 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 i n vesti gat or or a ut h orize d 
desi g nee deter mi n es it is 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.
T he react o ge nicit y e ve nts 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 site staff, s u c h as a st u d y p h ys icia 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 or healt hcare facilit y, w h o will:

Meas ure b o d y t e m perat ure (° C/°F) .

If prese nt, meas ure t he mi ni m u m a n d ma xi m u m dia meters of re d ness at t he i njecti o n site.

If prese nt, meas ure t he mi ni m u m a n d ma xi m u m dia meters of s welli n g at t he i njecti o n 
site.

Assess t he i njecti o n site pai n i n acc or da nce wit h t he react o ge nicit y gra di n g scale 
pr o vi de d i n Secti o n 8. 3. 4. 2.

Assess a n y s ys te mic e ve nts (fati g ue, hea dac he, v o miti n g, na usea, diarr hea, c hills, ne w or 
w orse ne d m uscle pai n, or ne w or w orse ne d j oi nt pai n) t hat are prese nt i n acc or da nce wit h 
t he react o ge nicity gra di n g scale 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 o n t he A E C R F, if 
a p pr o priate.

Rec or d A Es a n d S A Es as descri be d i n Secti o n 8. 4 .

C o m plete t he partici pa nt’s 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 u nsc he d ule d visit assess me nt 
C R F.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 8
1 0. 9. 1 0. 6. 4. 2. A d diti o n al Pr oce d ures f or M o nit ori n g of P ote nti al M y oc ar ditis or 
Peric ar ditis
A n y  st u d y partici pa nt w h o re p orts ac ute c hest pai n, s h ort ness of breat h, pal pitati o ns, or a n y  
ot her s y m pt o m(s) t hat mi g ht be i n dicati ve of m y ocar ditis or pericar ditis wit hi n 2 8 da y s after
V acci nati o n 1 m ust be s pecificall y e val uate d f or p ossi ble m y ocar ditis or pericar ditis.
I n a d diti o n t o a cli nical e val uati o n, t he f oll o wi n g s h o ul d be perf or me d:

E C G a n d

Meas ure me nt of t he tr o p o ni n le vel
If m yocar ditis or pericar ditis is s us pecte d base d u p o n t he i nitial e val uati o n, t he f oll o wi n g 
s h o ul d als o be perf or me d:

E val uati o n b y  a car di ol o gist,

Car diac ec h ocar di o gra m , a n d/ or

Car diac ma g netic res o na nce st u d y
Details of t he s y m pt o ms re p orte d, a n d res ults of t he i n vesti gati o ns perf or me d, will be 
rec or de d i n t he C R F.
1 0. 9. 1 1. St atistic al C o nsi der ati o ns – S u bst u d y A   
M et h o d ol o g y f or s u m mar y a n d statistical a nalys es of t he data c ollecte d i n t his s u bst u d y is 
descri be d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or. T he 
S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc ol w here a p pr o priate; h o we ver, a n y maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
1 0. 9. 1 1. 1. St a tistic al H y p ot heses
T here is n o statistical h y p ot hesis i n S u bst u d y  A.
T he esti ma n ds c orres p o n di n g t o eac h pri mar y , sec o n dar y, or e x pl orat or y o bjecti ve are 
descri be d i n Secti o n 1 0. 9. 5 .
1 0. 9. 1 1. 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
E nr olle d p o p ulati o n
All partici pa nts w h o ha ve a si g ne d I C D.
Ra n d o mize d 
p o p ulati o n
All e nr olle d 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.
Safet y p o p ulati o n
All e nr olle d partici pa nts w h o recei ve t he st u d y i nter ve nti o n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 2 9
Defi ne d A n al ysis 
Set
Descri pti o n
E val ua ble H AI 
i m m u n o ge nicit y 
p o p ulati o n 
All partici pa nts w h o meet t he f oll o wi n g criteria:

Are eli gi ble f or t he st u d y;

Recei ve t he st u d y i nter ve nti o n(s) t o w hic h t he y were ra n d o mize d at Visit A 1 0 1
( R S V pre F + qI R V i n t he c o m bi nati o n gr o u p vs qI R V i n t he 
se q ue ntial-vacci nati o n gr o u p);

Ha ve t he 1- m o nt h p ost vacci nati o n bl o o d c ollecti o n f or H AI assa y wit hi n a n 
a p pr o priate wi n d o w;

Ha ve at least 1 vali d a n d deter mi nate H AI res ult at t he 1- m o nt h p ost vacci nati o n 
bl o o d c ollecti o n ;

Ha ve n o maj or pr ot oc ol vi olati o ns fr o m ra n d o mizati o n t hr o u g h t he 1 -m o nt h 
p ost vacc i nati o n bl o o d c ollecti o n (t hr o u g h Visit A 1 0 2 ).
E val ua ble R S V 
i m m u n o ge nicit y 
p o p ulati o n 
All partici pa nts w h o meet t he f oll o wi n g criteria:

Are eli gi ble f or t he st u d y;

Recei ve t he st u d y i nter ve nti o n(s) t o w hic h t he y were ra n d o mize d ( R S V pre F + 
qI R V at Visit A 1 0 1 f or t he c o m bi nati o n gr o u p, a n d R S V pre F at Visit A 1 0 2 f or 
t he se q ue ntial-a d mi nistrati o n gr o u p);

Ha ve t he 1- m o nt h p ost vacci nati o n bl o o d c ollecti o n w it hi n a n a p pr o priate 
wi n d o w  ( Visit A 1 0 2 f or t he c o mbi nati o n gr o u p a n d Visit A 1 0 3 f or t he 
se q ue ntial-a d mi nistrati o n gr o u p);

Ha ve at least 1 vali d a n d deter mi nate R S V N T res ult at t he 1- m o nt h 
p ost vacci nati o n bl o o d c ollecti o n ;

Ha ve n o maj or pr ot oc ol vi olati o ns fr o m ra n d o mizati o n t hr o u g h t he 1 -m o nt h 
p ost vacci nati o n bl o o d c ollecti o n.
mI T T 
i m m u n o ge nicit y 
p o p ulati o n 
All partici pa nts w h o are ra n d o mize d a n d have at least 1 vali d a n d deter mi nate assa y 
res ult at a n y ti me p oi nt after recei vi n g st u d y i nter ve nti o n.
1 0. 9. 1 1. 3. St atistic al A n al yses
U nless state d ot her wise, “ vacci ne gr o u p” i n t his secti o n refers t o partici pa nts recei vi n g 
co m b i n ati o n R S V pre F + qI R V a n d partici pa nts recei vi n g se q ue ntial a d mi nistrati o n of 
qI R V a n d R S V pre F .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 0
1 0. 9. 1 1. 3. 1. Pri m ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis
Ta ble 5 descri bes t he pri mar y  e n d p oi nt statistical a nalys is met h o ds. 
T a ble 5 .
Pri m ar y E n d p oi nt A n al yses – S u bst u d y A
E n d p oi nt
St atistic al A n al ysis Met h o ds
Safet 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 after eac h vacci nati o n f or eac h vacci ne gr o u p. L ocal 
reacti o ns (re d ness, s welli n g, a n d pai n at t he i njecti o n site) a n d 
s yste mic e ve nts (fati g ue, hea dac he, v o miti n g, na usea, diarr hea, 
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) fr o m Da y 1 t hr o u g h Da y 7 after eac h vacci nati o n will be 
prese nte d b y ma xi m u m se verit y a n d a n y se verity. Descri pti ve 
s u m mar y statistics will i ncl u de c o u nts a n d perce nta ges 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 
Cl o p per -Pears o n 9 5 % CI ( Secti o n 9. 3. 1. 1 ).

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. 
All of t he A Es wit hi n 1 m o nt h after eac h vacci nati o n a n d S A Es
t hr o u g h o ut t he st u dy will be descri pti vel y s u m marize d wit h c o u nt s, 
perce nta ges, a n d ass ociate d Cl o p per- Pears o n 9 5 % CI  f or eac h 
vacci ne gr o u p ( Secti o n 9. 3. 1. 1 ).
I m m u n o ge nicity

I nfl ue nza strai n-s pecific G M Rs of H AI titers 1 m o nt h after 
vacci nati o n ( Visit A 1 0 2 i n t he c o m bi n ati o n R S V pre F + qI R V
gr o u p t o Visit A 1 0 3 i n t he se q ue ntial-a d mi nistrati o n gr o u p ) a n d 
G M Rs of R S V N Ts 1 m o nt h after vacci nati o n ( Visit A 1 0 2 i n t he
c o m bi n ati o n R S V pre F + qI R V gr o u p t o Visit A 1 0 3 i n t he
se q ue ntial-a d mi nistrati o n gr o u p) will be pr o vi de d al o n g wit h t he 
ass ociate d 2 -si de d 9 5 % CIs (Secti o n 9. 3. 1. 2. 3 ).
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 1
1 0. 9. 1 1. 3. 2. E x pl or at or y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis
Ta ble 6 descri bes t he e x pl orat or y  e n d p oi nt statistical a nalys is met h o ds. 
T a ble 6.
E x pl or at or y E n d p oi nt A n al yses – S u bst u d y A
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

G M Ts of N Ts f or eac h R S V s u b gr o u p ( A or B) a n d G M Ts of 
i nfl ue nza strai n-s pecific H AI titers at eac h a p plica ble ti me p oi nt will 
be descri pti vel y s u m marize d wit h 2 -si de d 9 5 % CIs f or eac h vacci ne 
gr o u p ( Secti o n 9. 3. 1. 2. 1 ).

G M F Rs of N Ts f or eac h R S V s u b gr o u p ( A or B) fr o m bef ore 
vacci nati o n t o eac h a p plica ble p ost vacci nati o n ti me p oi nt a n d 
G M F Rs of i nfl ue nza strai n- s pecific H AI titers fr o m bef ore 
vacci nati o n t o eac h a p plica ble p ost vacci nati o n ti me p oi nt will be 
descri pti vel y s u m marize d wit h 2 -si de d 9 5 % CIs f or eac h vacci ne 
gr o u p (Secti o n 9. 3. 1. 2. 2 ).

T he n u m ber a n d perce nta ge of partici pa nts wit h strai n -s pecific H AI 
titers ≥1: 4 0 at eac h a p plica ble ti me p oi nt a n d t he n u m ber a n d 
perce nta ge of partici pa nts ac hie vi n g strai n-s pecific H AI 
ser oc o n versi o n at eac h a p plica ble p ost vacci nati o n ti me p oi nt will be 
s u m marize d wit h 2-si de d Cl o p per-Pears o n 9 5 % CI s f or eac h vacci ne 
gr o u p ( Secti o n 9. 3. 1. 1 ).

T he differe nce i n t he perce nta ge of partici pa nts ac hie vi n g i nfl ue nza 
strai n-s pecific ser oc o n versi o n a n d strai n-s pecific H AI titers ≥1: 4 0
1 m o nt h after Vacci nati o n 1 bet wee n t he 2 vacci ne gr o u ps will be 
s u m marize d wit h 2-si de d Mietti ne n a n d N ur mi ne n 9 5 % CI 
(Secti o n 9. 3. 1. 1 ).

I m m u n o ge nicity data ma y be s u m marize d f or eac h a ge strat u m.
1 0. 9. 1 1. 4. I nteri m A n al yses
N o i nteri m a nal ys is is pla n ne d.
1 0. 9. 1 1. 4. 1. A n al ysis Ti mi n g
As t his is a P hase 1 b st u d y, data ma y be s u m marize d w he n data are a vaila ble f or a n y s pecific 
o bjecti ve.
O ne fi nal a nal y sis re p ort will be perf or me d after t he last visit of t he last partici pa nt w he n all 
pri mar y  a n d sec o n dar y e n d p oi nt data are a vaila ble.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 2
1 0. 9. 1 1. 5. S a m ple Size Deter mi n ati o n
As t his s u bst u d y  is n ot a h y p ot hesis -testi n g st u d y, t he sa m ple size was n ot base d o n st u d y 
p o wer f or s uccess . 
Wit h
a p pr o xi matel y 2 5 0 partici pa nts wit h a 1: 1 ra n d o mizati o n rati o, ass u mi n g a 
1 0 % n o ne val ua ble rate, a p pr o xi mate l y 1 1 0 partici pa nts will be i ncl u de d i n t he e val ua ble 
p o p ulati o n. Wit h 1 1 0 e val ua ble partici pa nts i n eac h gr o u p, ass u mi n g t here is n o differe nce i n
i m m u ne res p o nse bet wee n t he c o m bi nati o n vacci ne a n d t he i n di vi d ual vacci ne, t he 
pr o ba bilit y  of o bser vi n g a n L B of 9 5 % CI of G M R < 0. 5 is pr o vi de d i n t he ta ble bel o w. F or 
a n y gi ve n strai n/a nti ge n, t here is a < 5 % pr o ba bilit y  of o bser v i n g t hat t he c o m bi nati o n
vacci ne is i nferi or t o t he i n di vi d ual vacci ne wit h a 2- f ol d mar gi n.
A nti ge n / 
Str ai n
C o m m o n S D 
( Lo g e Sc ale) a
Pr o b a bilit y of O bser vi n g L B of 9 5 % G M R < 0. 5 
( C o mb i n ati o n t o I n di vi d u al V acci ne)
R S V A
1. 3
2. 4 %
R S V B
1. 4
4. 5 %
H 1 N 1
1. 2 4
1. 5 %
H 3 N 2
1. 2 4
1. 5 %
B strai n 1
1. 2 4
1. 5 %
B strai n 2
1. 2 4
1. 5 %
a.
T he ma xi m u m S D acr oss all a ge/ vacci ne gr o u ps fr o m St u d y C 3 6 7 1 0 0 1 w as use d f or R S V A a n d R S V B. 
St u d y C 4 7 8 1 0 0 4 ass u m pti o ns were use d f or t he S D f or i nfl ue nza strai ns.
1 0. 1 0. A p pe n di x 1 0: S u bst u d y B
1 0. 1 0. 1. S y n o psis – S u bst u d y B
See Secti o n 1. 1. 2 .
1 0. 1 0. 2. Sc he m a – S u bst u d y B
See Secti o n 1. 3. 2 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 3
1 0. 1 0. 3. Sc he d ule of Acti vities – S u bst u d y B
T a ble 7 .
Sc he d ule of Acti vities – S u bst u d y B
Visit I de ntifier
B 1 0 1
B 1 0 2
E arl y 
Wit h dr a w al
N otes
Visit Descri pti o n
V acci n ati o n 
F oll o w -U p Visit
S afet y
F oll o w -U p *
* Ma y be c o n d ucte d as a tele healt h visit .
Visit Wi n d o w ( D a ys)
D a y 1
2 8 -3 5 D a ys After 
V acci n ati o n 
Da y  1 = da y of v acci nati o n.
O btai n i nf or me d c o nse nt
X
See Secti o n 1 0. 1. 3 .
Assi g n partici pa nt n u m ber 
X
D o n ot re gister t he partici pa nt i n I m pala u ntil t he 
partici pa nt is prese nt at t he site . See Secti o n 6. 4 .
O btai n de m o gra p h y a n d me dical hist or y † data
X
† I ncl u de t he date of o nset a n d date of res ol uti o n 
(if a p plica ble).
Perf or m cli nical assess me nt
X
I ncl u di n g, if i n dicate d, a p h ysical e xa mi nati o n. 
E xa mi nati o ns a n d assess me nts m ust occ ur pri or t o 
vacci nati o n. See Secti o n 8. 3. 1 .
Meas ure vital si g ns 
X
Bl o o d press ure a n d p ulse rate; see Secti o n 8. 3. 2 .
Meas ure pre vacci nati o n te m perat ure 
( oral or t y m pa nic)
X
If ≥3 8° C ( ≥1 0 0. 4 °F), vacci nati o n dela y criteria 
a p pl y. See Secti o n 5. 5 .
Perf or m uri ne pre g na nc y test o n W O C B P
X
See Secti o n s 8. 3. 5 a n d 1 0 . 4. 2. 2.
Disc uss/re vie w c o ntrace pti ve e x pectati o ns 
X
See Secti o n 1 0. 4 .
C ollect details of a n y lice nse d i nfl ue nza vacci ne 
recei ve d i n t he pri or 18 m o nt hs
X
I ncl u de pr o d uct na me (if k n o w n) a n d date of 
a d mi nistrati o n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 4
T a ble 7 .
Sc he d ule of Acti vities – S u bst u d y B
Visit I de ntifier
B 1 0 1
B 1 0 2
E arl y 
Wit h dr a w al
N otes
Visit Descri pti o n
V acci n ati o n 
F oll o w -U p Visit
S afet y
F oll o w -U p *
* Ma y be c o n d ucte d as a tele healt h visit .
Visit Wi n d o w ( D a ys)
D a y 1
2 8 -3 5 D a ys After 
V acci n ati o n 
Da y  1 = da y of v acci nati o n.
C ollect a n d rec or d n o nst u d y vacci ne use
X ‡
X ¶
‡ I n t he pre vi o us 2 8 da ys; ¶ si nce t he last st u d y visit. 
See Secti o n 1 0. 1 0. 8. 7 .
C ollect a n d rec or d pr o hi bite d me dicati o n use
X §
X * *
§ I n t he pre vi o us 6 0 da ys; * * si nce t he last st u d y 
visit. See Secti o n 1 0. 1 0. 8. 7. 1 .
C o nfir m eli gi bilit y
X
See Secti o n 5.
C o nfir m t hat vacci nati o n dela y criteria ha ve n ot 
bee n met
X
See Secti o n 5. 5 .
C ollect bl o o d sa m ple f or i m m u n o ge nicit y 
assess me nt
~ 5 0 m L
~ 5 0 m L
O btai n ra n d o mizati o n n u m ber 
X
D o n ot ra n d o mize u ntil eli gi bilit y is c o nfir me d a n d 
t he partici pa nt is prese nt at t he site . See Secti o n 6. 4 .
O btai n st u d y i nter ve nti o n all ocati o n
X
See Secti o n 6. 4 .
A d mi nister st u d y i nter ve nti o n
X
See Secti o n 1 0. 1 0. 8. 1 .
Assess ac ute reacti o ns f or at least 3 0 mi n utes after 
st u d y i nter ve nti o n a d mi nistrati o n
X
M ust i ncl u de ti me of o nset.
E x plai n e -diar y c o m pleti o n re q uire me nts, pr o vi de 
trai ni n g, assist wit h d o w nl oa di n g t he a p p, or iss ue 
pr o visi o ne d de vice as nee de d
X
See Secti o n 8. 3. 4 .
Pr o vi de t her m o meter a n d meas uri n g de vice
X
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 5
T a ble 7 .
Sc he d ule of Acti vities – S u bst u d y B
Visit I de ntifier
B 1 0 1
B 1 0 2
E arl y 
Wit h dr a w al
N otes
Visit Descri pti o n
V acci n ati o n 
F oll o w -U p Visit
S afet y
F oll o w -U p *
* Ma y be c o n d ucte d as a tele healt h visit .
Visit Wi n d o w ( D a ys)
D a y 1
2 8 -3 5 D a ys After 
V acci n ati o n 
Da y  1 = da y of v acci nati o n.
Re vie w react o ge nicit y e-diar y data ( dail y re vie w 
is o pti mal d uri n g t he acti ve diar y peri o d)
Da y s 1 t hr o u g h 7
See Secti o n 8. 3. 4 .
C o ntact t he partici pa nt re p orti n g a se vere reacti o n 
or fe ver i n t heir e -diar y; arra n ge a n u nsc he d ule d 
visit if re q uire d
Da y s 1 t hr o u g h 7
See Secti o n 8. 3. 4 .
Re vie w t he e-diar y f or reacti o ns re p orte d as 
prese nt o n t he last da y of e -diar y c o m pleti o n a n d 
rec or d t heir st o p dates
X
X
See Secti o n 8. 3. 4 .
C ollect t he s p o ns or -pr o visi o ne d e -diar y or assist 
t he partici pa nt wit h re m o vi n g t he st u d y 
a p plicati o n fr o m his or her o w n pers o nal de vice
X
X
E ns ure t hat all e -diar y data ha ve bee n tra ns mitte d
pri or t o e -diar y deacti vati o n or re m o val of t he 
a p p licati o n.
Rec or d A Es/ S A Es a n d o btai n st o p dates f or 
pre vi o usl y re p orte d e ve nts
X
X
X
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 6
1 0. 1 0. 4. I ntr o d ucti o n – S u bst u d y B
1 0. 1 0. 4. 1. S u bst u d y B R ati o n ale
T he de vel o p me nt of 
is s o meti mes re q uire d f or i njecta ble pr o d ucts t o 
de m o nstrate efficac y , safet y,
T he be nefits o btai ne d 
 
 nee d t o be bala nce d a gai nst t he p ote ntial ris ks t o t olera bilit y.6
 
 
 
T he f or m ulati o n de vel o p me nt of c o m bi nati o n vacci nes re q uires c o nsi derati o n of 
 
 t o deter mi ne w het her t he ulti mate pr o d uct ac hie ves t he desire d 
effects i n a safe a n d t olera ble ma n ner. 7
 
 
. A pri or st u d y of healt hy a d ults 
1 8 t o 4 0 y ears of a ge w h o recei ve d a nter olateral t hi g h i njecti o n wit h 5 s us pe nsi o ns 
c o ntai ni n g t he sa me c o m p o ne nts as e xci pie nts of a c o m bi ne d p ert ussis– i nacti vate d 
p oli o m y elitis– H ae m o p hil us i nfl ue nz ae t ype b pe diatric vacci ne i n vesti gate d t he i nci de nce of 
l ocal pai n a n d b ur ni n g se nsati o n.7
 
 
T his is a P hase 1 b st u d y  i n healt h y partici pa nts ≥5 0 y ears of a ge. S u bst u d y B will i n vesti gate 
2 f or m ulati o ns of R S V pre F + qI RV o f differi n g v ol u mes a n d os m olarit ies. T he first 
c o m bi nati o n is a be dsi de mi x of 
 
, yiel di n g a fi nal i njecti o n v ol u me of 1. 0 m L, 
 
. T he sec o n d c o m bi nati o n is a be dsi de mi x of 
 
 t o yiel d a fi nal i njecti o n v ol u me of 0. 5 m L. T he 0. 5-m L  
c o m bi nati o n w o ul d res ult i n
wit h t he p ote ntial t o i nfl ue nce react o ge nicity at t he i njecti o n site . T hese c o m bi nati o ns will be 
e val uate d f or safet y, t olera bilit y , a n d i m m u n o ge nicit y, wit h t he g oal of selecti n g a 
f or m ulati o n f or f urt her st u d y.
1 0. 1 0. 4. 2. B ac k gr o u n d
See Secti o n 2. 2 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( 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 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 7
1 0. 1 0. 4. 3. Be nefit/ Ris k Assess me nt
T he ris k assess me nts f or S u bst u d y  B are a d dresse d i n Secti o n 2. 3 .
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  ma y be:

Recei pt of a safe a n d efficaci o us R S V vacci ne at n o c ost t o t he partici pa nt, a n d pr o visi o n 
of t he i m m u n o ge nicit y res ults .

Recei pt of a p ote ntiall y s afe a n d efficaci o us i nfl ue nza vacci ne at n o c ost t o t he 
partici pa nt, a n d pr o visi o n of t he i m m u n o ge nicit y res ults.

C o ntri b uti n g t o researc h t o hel p ot hers. 
T he o verall be nefit/ ris k assess me nt f or S u bst u d y B is a d dresse d i n Secti o n 2. 3. 3 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 8
1 0. 1 0. 5. O bjecti ves, E n d p oi nts, a n d Esti m a n ds ( S u bst u d y B)
S u bst u d y B
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y S afet y
Pri m ar y S afet y
Pri m ar y S afet y
T o e val uate t he safet y pr ofile of 
2 f or m ulati o ns of c o mbi nati o n 
R S V pre F + qI R V

L ocal reacti o ns ( pai n at t he i njecti o n site, 
re d ness, a n d s welli n g)

S y ste mic e ve nts (fe ver, fati g ue, hea dac he, 
v o m iti n g, na usea, diarr hea, 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 E s

S A Es
I n partici pa nts recei vi n g the st u d y i nter ve nti o n, t he perce nta ge 
of partici pa nts re p orti n g :

L ocal reacti o ns wit hi n 7 da ys f oll o wi n g vacci nati o n

S y ste mic e ve nts wit hi n 7 d a y s f oll o wi n g vacci nati o n

A E s t hr o u g h o ut t he st u d y

S A Es t hr o u g h o ut t he st u d y
Sec o n d ar y I m m u n o ge nicit y
Sec o n d ar y I m m u n o ge nicit y
Sec o n d ar y I m m u n o ge nicit y
T o descri be t he i m m u ne res p o nses 
elicite d b y 2 f or m ulati o ns of 
c o m bi nati o n R S V pre F + qI R V

R S V A a n d R S V B N Ts

Strai n -s pecific H AI titers f or t he c urre nt seas o nal 
strai ns ( 2 × A, 2 × B) rec o m me n de d b y W H O f or 
rec o m bi na nt or cell-base d i nfl ue nza vacci nes
I n partici pa nts i n c o m plia nce wit h t he ke y pr ot oc ol criteria 
(e val ua ble partici pa nts): 

G M T f or eac h R S V s u b gr o u p ( A or B) 1 m o nt h after 
vacci nati o n wit h eac h f or m ulati o n

G M T of H AI titers f or eac h strai n i ncl u de d 1 m o nt h after 
vacci nati o n wit h eac h f or m ulati o n
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 3 9
S u bst u d y B
O bjecti ves
E n d p oi nts
Esti m a n ds
E x pl or at or y
E x pl or at or y
E x pl or at or y
T o f urt her descri be t he i m m u ne 
res p o nses elicite d b y 2 f or m ulati o ns 
of c o mbi nati o n R S V pre F + qI R V

R S V A a n d R S V B N Ts

Strai n -s pecific H AI titers 
I n partici pa nts i n c o m plia nce wit h t he ke y pr ot oc ol criteria 
(e val ua ble partici pa nts): 

G M T s of N Ts f or eac h R S V s u b gr o u p ( A or B) bef ore 
vacci nati o n 

G M F Rs of N Ts f or eac h R S V s u b gr o u p ( A or B) fr o m 
bef ore vacci nati o n t o 1 m o nt h after vacci nati o n

G M T s of strai n-s pecific H AI titers bef ore vacci nati o n 

G M F Rs of strai n -s pecific H AI titers fr o m bef ore vacci nati o n 
t o 1 m o nt h after vacci nati o n

T he perce nta ge of partici pa nts wit h strai n -s pecific H AI titers 
≥1: 4 0 at eac h ti me p oi nt

T he perce nta ge of partici pa nts ac hie vi n g strai n -s pecific H AI 
ser oc o n versi o na 1 m o nt h after vacci nati o n
a.
Ser oc o n versi o n is defi ne d as a n H AI titer < 1: 1 0 pri or t o vacci nati o n a n d ≥1: 4 0 at t he ti me p oi nt of i nterest, or a n H AI titer ≥1: 1 0 pri or t o vacci nati o n wit h 
a 4 -f ol d rise at t he ti me p oi nt of i nterest.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 0
1 0. 1 0. 6. S u bst u d y B Desi g n
1 0. 1 0. 6. 1. O ver all Desi g n
S u bst u d y  B is desi g ne d 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 R S V pre F 
a n d a m o difie d R N A vacci ne ( qI R V) a gai nst R S V a n d i nfl ue nza w he n a d mi nistere d as a 
c o m bi ne d vacci ne i n a 1. 0- m L  f or m ulati o n a n d a 0. 5 -m L  f or m ulati o n. F or m ulati o ns differ by 
os m olalit y  a n d v ol u me as descri be d i n Secti o n 1 0. 1 0. 8. 1 .
T his 2 -visit st u d y  will be c o n d ucte d as a P hase 1 b, parallel-gr o u p, ra n d o mize d, 
place b o -c o ntr olle d, o bser ver- bli n de d s u bst u d y.
A p pr o xi matel y  2 0 0 healt h y  partici pa nts ( n = 1 0 0 per gr o u p) will be e nr olle d i n S u bst u d y  B. 
N ote: " E nr olle d" mea ns a partici pa nt's a gree me nt t o partici pate i n a cli nical st u d y  f oll o wi n g 
c o m pleti o n of t he i nf or me d c o nse nt pr ocess .
H ealt h y a d ults ≥5 0 ye ars of a ge will be ra n d o mize d 1: 1 t o eit her:

Gr o u p 1: c o m bi nati o n ( R S V pre F + qI R V) 1. 0 -m L  f or m ulati o n or 

Gr o u p 2: c o m bi nati o n ( R S V pre F + qI R V) 0. 5 -m L  f or m ulati o n.  
P artici pa nts will be ra n d o mize d b y a ge/se x strata. Ra n d o mizati o n will be stratifie d at t he 
st u d y site b y 6 a ge/se x gr o u ps s o t hat a p pr o xi matel y 1 0 0 partici pa nts will be 5 0 t hr o u g h 
6 4 y ears of a ge a n d 1 0 0 will be ≥6 5 y ears of a ge , i n a d diti o n t o ha vi n g bala nce d se x 
distri b uti o n bet wee n vacci ne gr o u p s. T hese gr o u ps are as f oll o ws:

Fe male s 5 0 t hr o u g h 6 4 years of a ge

Fe male s 6 5 t hr o u g h 7 9 years of a ge

Fe male s ≥8 0 y e ars of a ge

Male s 5 0 t hr o u g h 6 4 y ears of a ge

Male s 6 5 t hr o u g h 7 9 y ears of a ge

Male s ≥8 0 y ears of a ge
T he se nti nel c o h ort will i ncl u de a p pr o xi matel y 2 0 male a n d fe male partici pa nts i n t he 
5 0- t hr o u g h 6 4 -ye ar a ge strata o nl y. E nr oll me nt will be c o ntr olle d s uc h t hat n o m ore t ha n 
2 0 partici pa nts ma y  be vacci nate d o n t he first da y. E-diar y  data will be re vie we d b y t he 
u n bli n de d cli nical st u d y  tea m me m bers o n a n o n g oi n g basis. If a n i m bala nce of l ocal 
reacti o ns or sys te mic e ve nts bet wee n t he se nti nel-c o h ort gr o u ps is detecte d, t he u n bli n de d 
st u d y tea m cli nicia n will n otif y t he I R C me m bers, w h o will t he n deter mi ne if a n I R C meeti n g 
is re q uire d t o re vie w c u m ulati ve safety data. 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 1
Vacci nati o n of t he e x pa n de d c o h ort will c o m me nce n o s o o ner t ha n 4 8 h o urs after t he 2 0 t h
partici pa nt i n t he se nti nel c o h ort has recei ve d his or her vacci nati o n a n d f oll o wi n g re vie w of 
t he a vaila ble safety data b y t he u n bli n de d cli nical st u d y tea m. If n o i m bala nce is detecte d i n 
t he se nti nel c o h ort after 4 8 h o urs ha ve passe d fr o m vacci nati o n of t he 2 0 t h partici pa nt, t he 
site will be n otifie d t o pr ocee d wit h f ull e nr oll me nt of t he e x pa n de d c o h ort. 
Bl o o d will be c ollecte d pri or t o vacci nati o n a n d at t he fi nal st u d y  visit.
L ocal reacti o ns a n d s ys te mic e ve nts occ urri n g wit hi n 7 da ys after vacci nati o n will be 
rec or de d i n a n e-diar y  de vice or s mart p h o ne a p plicati o n.
A Es a n d S A Es will be c ollecte d fr o m t he si g ni n g of i nf or me d c o nse nt t hr o u g h st u d y 
c o m pleti o n.
T his st u d y  will ha ve st o p pi n g r ules t hat will a p ply t o partici pa nts as s pecifie d i n
Secti o n 1 0. 1 0. 1 0. 5 wit h m o nit ori n g b y  desi g nate d u n bli n de d s p o ns or site staff o n a n o n g oi n g 
basis. If a st o p pi n g r ule is c o nfir med, f urt her ra n d o mizati o n a n d a d mi nistrati o n of st u d y  
i nter ve nti o n will be pa use d w hile a d diti o nal i nf or mati o n is gat here d, a n d c u m ulati ve 
u n bli n de d safet y data will be re vie we d b y t he I R C.  Partici pa nts w h o ha ve recei ve d st u d y 
vacci nati o n will c o nti n ue f ur t her st u dy visits a n d pr oce d ures as sc he d ule d. A c harter f or t he 
I R C will be pre pare d a n d fi nalize d bef ore t he first partici pa nt pr o vi des i nf or me d c o nse nt.
Safet y  data acc u m ulate d at least 1 wee k f oll o wi n g vacci nati o n i n eac h gr o u p will be 
re vie we d by t he s p o ns or’s IR C t o i nf or m f urt her de vel o p me nt. Base d o n re vie w of safet y  or 
i m m u n o ge nicity data of a n y st u d y i nter ve nti o n gr o u p, at Pfizer’s discreti o n, s u bse q ue nt 
c ollecti o n of bl o o d sa m ples fr o m partici pa nts i n t hat gr o u p ma y  be halte d a n d/ or n ot a nal yze d 
a n d st u d y visits or ot her pr oce d ures ma y be disc o nti n ue d.
I n t he e ve nt t hat S u bst u d y  B is c o n d ucte d i m me diatel y pri or t o or wit hi n t he i nfl ue nza 
seas o n, SII V will be offere d t o partici pa nts at t he e n d of t heir st u dy partici pati o n .
T he t otal d urati o n of S u bst u d y B f or eac h partici pa nt will be u p t o a p pr o xi matel y  1 m o nt h. 
T he t otal d urati o n of S u bst u d y  B base d o n t he a p pr o xi mate 1- m o nt h e nr oll me nt peri o d will 
be a p pr o xi matel y  2 m o nt hs.
1 0. 1 0. 6. 2. Scie ntific R ati o n ale f or St u d y Desi g n
See Secti o n 2. 1 .
1 0. 1 0. 6. 3. J ustific ati o n f or D ose
See Secti o n 4. 3 .
1 0. 1 0. 6. 4. E n d of St u d y Defi niti o n
See Secti o n 4. 4 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 2
1 0. 1 0. 7. S u bst u d y B P o p ul ati o n
1 0. 1 0. 7. 1. I ncl usi o n Criteri a
Partici pa nts m ust meet t he f oll o wi n g i ncl usi o n criteria t o be eli gi ble f or e nr oll me nt i nt o 
S u bst u d y  B:
A ge a n d Se x:
1.
P artici pa nts ≥5 0 ye ars of a ge at st u d y e nr oll me nt.
Refer t o Secti o n 1 0. 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 ot a p plica ble.
Ot her I ncl usi o n Criteri a:
2.
Partici pa nts w h o are willi n g a n d a ble t o c o m ply 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 y sical e xa mi nati o n
(if re q uire d), a n d cli nical j u d g me nt of t he i n vesti gat or t o be eli gi ble f or i ncl usi o n i n t he 
st u d y.
N ote: Healt h y partici pa nts wit h pree xisti n g sta ble disease, defi ne d as disease n ot 
re q uiri n g si g nifica nt c ha n ge i n t hera p y or h os pitalizati o n f or w orse ni n g disease d uri n g 
t he 6 wee ks bef ore e nr oll me nt, ca n be i ncl u de d. S pecific criteria f or partici pa nts wit h 
k n o w n sta ble i nfecti o n wit h HI V, H C V, or H B V ca n be f o u n d i n Secti o n 1 0. 1 1 . 
4.
Ca pa ble of gi vi n g a n d ha vi n g si g ne d t he 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 plyi n g wit h t he re q uire me nts a n d restricti o ns liste d i n t he I CD a n d i n
t his pr ot oc ol. 
5.
Recei pt of lice nse d i nfl ue nza vacci nati o n f or t he 2 0 2 2- 2 0 2 3 n ort her n he mis p here seas o n 
or 2 0 2 2 s o ut her n he mis p here seas o n 1 8 0 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n.
1 0. 1 0. 7. 2. E xcl usi o n Criteri a
Partici pa nts wit h a n y  of t he f oll o wi n g c haracteristics/c o n diti ons will be e xcl u de d:
Me dic al C o n diti o ns
1.
A c o nfir me d dia g n osis of R S V i nfecti o n or i nfl ue nza ≤1 2 0 da y s bef ore st u d y i nter ve nti o n 
a d mi nistrati o n.
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).
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 3
3.
Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d blee di n g t hat w o ul d, i n t he 
o pi ni o n of t he i n vesti gat or, c o ntrai n dicate I M i njecti o n.
4.
Seri o us c hr o nic dis or der, i ncl u di n g metastatic mali g na nc y , e n d-sta ge re nal disease wit h 
or wit h o ut dial y sis, cli nicall y u nsta ble car diac disease, or a ny ot her dis or der t hat, i n t he 
i n vesti gat or’s o pi ni o n, e xcl u des t he partici pa nt fr o m partici pati n g i n t he st u d y.
5.
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 mu 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.
6.
Ot her me dical or ps y c hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he past year) or acti ve 
s uici dal i deati o n/ be ha vi or or la b orat or y a b n or malit y t hat ma y i ncrease t he ris k of st u dy 
partici pati o n or, i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt i na p pr o priate f or t he
st u d y. 
Pri or/ C o nc o mit a nt T her a p y
7.
Recei pt of c hr o nic s ys te mic treat me nt wit h k n o w n i m m u n os u p pressa nt me dicati o ns 
(i ncl u di n g c yt ot o xic a ge nts or s yste mic c ortic oster oi ds), or ra di ot hera py, wit hi n 6 0 da y s 
bef ore st u d y i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he st u d y.
N ote: S y ste mic c ortic oster oi ds are defi ne d as t h ose a d mi nistere d f or ≥1 4 da y s at a d ose of 
≥2 0 m g/ da y  of pre d nis o ne or e q uivale nt (e g, f or ca ncer or a n a ut oi m m u ne disease) or 
pla n ne d recei pt t hr o u g h o ut t he st u d y . I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or 
t o pical (s ki n, e yes, or ears) c ortic oster oi ds are per mitte d.
8.
Recei pt of bl o o d/ plas ma pr o d ucts or i m m u n o gl o b uli n, fr o m 6 0 da y s bef ore st u d y
i nter ve nti o n a d mi nistrati o n, or pla n ne d recei pt t hr o u g h o ut t he st u d y.
9.
Recei pt of a n y R S V vacci ne at a n y ti me pri or t o e nr oll me nt, or pla n ne d recei pt 
t hr o u g h o ut t he st u dy.
1 0. Recei pt of a n y i nfl ue nza vacci ne ≤1 8 0 da y s bef ore st u d y  e nr oll me nt, or pla n ne d recei pt 
t hr o u g h o ut t he st u dy.
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 n i n vesti gati o nal R S V vacci ne or m R N A 
i nfl ue nza vacci ne at a ny t i me pri or t o e nr oll me nt, a n d t hereafter u ntil st u dy c o m pleti o n, 
re gar dless of vacci ne assi g n me nt.
1 2. Partici pati o n i n a n y ot her i nter ve nti o nal st u dies wit hi n 2 8 da y s bef ore st u d y e nr oll me nt 
t hr o u g h st u dy c o m pleti o n. Partici pati o n i n p urel y  o bser vati o nal st u dies is acce pta ble.
Di a g n ostic Assess me nts
N ot a p plica ble.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 4
Ot her E xcl usi o n Criteri a 
1 3. I n vesti gat or site staff directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site staff ot her wise s u per vise d b y t he i n vesti gat or, a n d s p o ns or a n d s p o ns or 
dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers .
1 0. 1 0. 8. S u bst u d y B I nter ve nti o n a n d C o nc o mit a nt T her a p y
1 0. 1 0. 8. 1. St u d y I nt er ve nti o n(s) A d mi nistere d
St u d y  i nter ve nti o ns f or S u bst u d y B will i ncl u de:
1 0. 1 0. 8. 1. 1. Gr o u p 1: C o m bi n ati o n R S V pre F + qI R V 1. 0- m L F or m ul ati o n
G R O U P 1
V acci ne Det ails
C O M BI N A TI O N
1. 0 m L
( R S V pre F + qI R V) 
Vacci ne 
C o m p o ne nt
R S V pre F
qI R V
2 Sta bilize d R S V pref usi o n 
F a nti ge ns, i n e q ual a m o u nts 
fr o m vir us s u b gr o u ps A a n d B 
E nc o di n g H A of 4 strai ns as 
rec o m me n de d f or t he i nfl ue nza 
seas o n ( 2 A strai ns a n d 2 B 
strai ns)
D ose 
F or m ulati o n
R S V vacci ne 1 2 0 µ g/ vial p o w der 
f or s ol uti o n f or i njecti o n
Q ua dri vale nt i nfl ue nza 
s us pe nsi o n f or i njecti o n, 
m g/ m L ( qI R V)
P r o d uct f or 
Rec o nstit uti o n
Sterile water as dil ue nt f or 
i njecti o n ( 0. 6 5 m L/s yri n ge)
N/ A
U nit D ose 
Stre n gt h(s)
1 2 0 µ g 
µ g 
R o ute of 
A d mi nistrati o n
A fter c o m bi ni n g b ot h vacci nes, a si n gle 1- m L IM i njecti o n is gi ve n
i nt o t he delt oi d m uscle of t he n o n d o mi na nt ar m ( preferre d). 
Use
E x peri me ntal
I M P or 
NI M P/ A x M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y Pfizer
Pac ka gi n g a n d 
La beli n g
R S V pre F is s u p plie d as a l y o p hilize d w hite ca ke, pac ka ge d i n a 
clear glass 2 -m L vial wit h a r u b ber st o p per, al u mi n u m o verseal, a n d 
fli p-off ca p . F or t he 1. 0 -m L f or mulati o n , t he w hite ca ke is 
 
qI R V is s u p plie d as
 
St u d y i nter ve nti o n(s) will be la bele d as per c o u ntr y re q uire me nts.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 5
1 0. 1 0. 8. 1. 2. Gr o u p 2: C o m bi n ati o n R S V pre F + qI R V 0. 5- m L F or m ul ati o n
G R O U P 2
V acci ne Det ails
C O M BI N A TI O N
0. 5 m L
( R S V pre F + qI R V)
Vacci ne 
C o m p o ne nt
R S V pre F
qI R V
2 Sta bilize d R S V pref usi o n 
F a nti ge ns, i n e q ual a m o u nts 
fr o m vir us s u b gr o u ps A a n d B 
E nc o di n g H A of 4 strai ns as 
rec o m me n de d f or t he i nfl ue nza 
seas o n ( 2 A strai ns a n d 2 B 
strai ns)
D ose 
F or m ulati o n
R S V vacci ne 1 2 0 µ g/ vial p o w der 
f or s ol uti o n f or i njecti o n
Q ua dri vale nt i nfl ue nza 
s us pe nsi o n f or i njecti o n, 
m g/ m L ( qI R V)
P r o d uct f or 
Rec o nstit uti o n
qI R V s us pe nsi o n
N/ A
U nit D ose 
Stre n gt h(s)
1 2 0 µ g 
µ g 
R o ute of 
A d mi nistrati o n
A fter c o m bi ni n g q I R V s us pe nsi o n wit h t he R S V pre F ca ke, a si n gle 
0. 5 -m L IM i njecti o n is gi ve n i nt o t he delt oi d m uscle of t he 
n o n d o mi na nt ar m ( preferre d). 
Use
E x peri me ntal
I M P or 
NI M P/ A x M P
I M P
S o urci n g
Pr o vi de d ce ntrall y b y Pfizer
Pac ka gi n g a n d 
La beli n g
R S V pre F is s u p plie d as a l y o p hilize d w hite ca ke, pac ka ge d i n a 
clear glass 2 -m L vial wit h a r u b ber st o p per, al u mi n u m o verseal, a n d 
fli p-off ca p . F or t he 0. 5-m L f or mulati o n , t he w hite ca ke is t o be 
qI R V is s u p plie d as
 
St u d y i nter ve nti o n(s) will be la bele d as per c o u ntr y re q uire me nts.
1 0. 1 0. 8. 1. 3. A d mi nistr ati o n
See Secti o n 6. 2. 1 .
1 0. 1 0. 8. 1. 4. Me dic al De vices
See Secti o n 6. 2. 2.
1 0. 1 0. 8. 1. 5. 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
See Secti o n 6. 3 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI
C CI
C CI
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 6
1 0. 1 0. 8. 1. 5. 1. Pre p ar ati o n a n d Dis pe nsi n g
See Secti o n 6. 3. 1 .
1 0. 1 0. 8. 1. 6. All oc ati o n t o St u d y I nter ve nti o n
See Secti o n 6. 4.
All ocati o n of st u d y  i nter ve nti o n i n S u bst u d y B will be c o n d ucte d via t he I R T:

Visit B 1 0 1 : Ra n d o mize t he partici pa nt a n d t he n o btai n t he kit/c o ntai ner n u m ber 
assi g n me nt.
1 0. 1 0. 8. 2. Bli n di n g
T his is a n o bser ver - bli n de d st u d y. 
1 0. 1 0. 8. 2. 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.
1 0. 1 0. 8. 2. 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 he a d mi nistere d v ol u me 
a n d a p peara nce differ bet wee n st u d y  i nter ve nti o ns, st u d y i nter ve nti o ns wil l be a d mi nistere d 
i n a ma n ner t hat pre ve nts t he partici pa nts fr o m i de ntif yi n g t he st u d y i nter ve nti o n base d o n 
t hese fact ors.
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 uat i o n of a ny 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 n ursi n g/ me dical staff or cli nic p har mac y will 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.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 7
1 0. 1 0. 8. 2. 3. Bli n di n g of t he S p o ns or
T o facilitate ra pi d re vie w of data i n real ti me, s p o ns or staff will be u n bli n de d t o st u d y
i nter ve nti o n all ocati o n f or t he partici pa nts i n S u bst u d y B. H o we ver, s p o ns or staff w h o
r o uti nel y ha ve c o ntact wit h bli n ded site pers o n nel, a n d w h o are n ot 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 als o re mai 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.
1 0. 1 0. 8. 2. 4. Bre a ki n g t he Bli n d
See Secti o n 6. 5. 4 .
1 0. 1 0. 8. 3. St u d y I nter ve nti o n C o m pli a nce
See Secti o n 6. 6.
1 0. 1 0. 8. 4. D ose M o dific ati o n
N ot a p plica ble t o S u bst u d y  B.
1 0. 1 0. 8. 5. C o nti n ue d Access t o St u d y I nter ve nti o n After t he E n d of t he St u d y
See Secti o n 6. 8.
1 0. 1 0. 8. 6. Tre at me nt of O ver d ose
See Secti o n 6. 9.
1 0. 1 0. 8. 7. Pri or a n d C o nc o mit a nt T her a p y
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:

Lice nse d i nfl ue nza vacci ne recei ve d wit hi n t he 1 8 m o nt hs pri or t o e nr oll m e nt. 

A n y n o nst u d y  vacci nati o ns recei ve d fr o m 2 8 d a y s pri or t o st u d y e nr oll me nt u ntil t he last
st u d y visit.
Pr o hi bite d me dicati o ns liste d bel o w, if ta ke n, will be rec or de d i n t he C R F 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 u te, a n d fre q ue nc y.
1 0. 1 0. 8. 7. 1. Pr o hi bite d D uri n g t he St u d y
Recei pt of t he f oll o wi n g vacci nes a n d me dicati o ns d uri n g t he ti me peri o ds liste d bel o w ma y  
e xcl u de a partici pa nt fr o m t he per- pr ot oc ol a nal ysis fr o m t hat p oi nt o n war d; h o we ver, it is 
a ntici pate d t hat t he parti ci pa nt w o ul d n ot be wit h dra w n fr o m t he st u d y  (Secti o n 7 ). 
Me dicati o ns a n d vacci nati o ns s h o ul d n ot be wit h hel d if re q uire d f or a partici pa nt’s me dical 
care.

I n vesti gati o nal vacci nes a n d i n vesti gati o nal dr u gs are pr o hi bite d wit hi n 2 8 da ys pri or t o
e nr oll me nt a n d t hereafter d uri n g t he c o urse of t he st u d y .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 8

Lice nse d or n o nst u d y i n vesti gati o nal R S V vacci nes are pr o hi bite d at a n y ti me pri or t o 
st u d y e nr oll me nt a n d t hereafter d uri n g t he c o urse of t he st u d y .

N o nst u d y  i n vesti gati o nal i nfl ue nza vacci nes are pr o hi bite d at a n y ti me pri or t o st u d y  
e nr oll me nt a n d t hereafter d uri n g t he c o urse of t he st u d y .

Lice nse d i nfl ue nza vacci nes are pr o hi bite d ≤1 8 0 da y s bef ore st u d y i nter ve nti o n 
a d mi nistrati o n a n d t hereafter d uri n g t he c o urse of t he st u d y .

N o nst u d y  i nacti vate d or rec o m bi na nt vacci nes , lice nse d C O VI D-1 9 vacci ne s, or 
C O VI D - 1 9 vacci nes a ut h orize d f or te m p orar y or e mer ge nc y use are pr o hi bite d wit hi n 
1 4 da y s after st u d y i nter ve nti o n a d mi nistrati o n.

N o nst u d y  li ve vacci nes s h o ul d n ot be gi ve n wit hi n 2 8 da y s pri or t o e nr oll me nt a n d 
t hereafter d uri n g t he c o urse of t he st u d y.

C hr o nic s y ste mic treat me nt wit h k n o w n i m m u n os u p pressa nt me dicati o ns, or 
ra di ot hera py, is pr o hi bite d wit hi n 6 0 da y s pri or t o e nr oll me nt a n d t hereafter d uri n g t he 
c o urse of t he st u d y.

S y ste mic c ortic oster oi ds ( ≥2 0 m g/ da y  of pre d nis o ne or e q ui vale nt) f or ≥1 4 da y s are 
pr o hi bite d wit hi n 2 8 da ys pri or t o e nr oll me nt a n d t hereafter d uri n g t he c o urse of t he 
st u d y.

Bl o o d/ plas ma pr o d ucts or i m m u n o gl o b uli ns are pr o hi bite d wit hi n 6 0 da y s pri or t o 
e nr oll me nt a n d t hereafter d uri n g t he c o urse 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 s ym pt o ms ass ociate d wit h 
st u d y i nter ve nti o n a d mi nistrati o n are n ot per mitte d. H o we ver, if a partici pa nt is ta ki n g a 
me dicati o n f or a n ot her c o n diti o n, e ve n if it ma y  ha ve a nti p yretic or pai n-relie vi n g 
pr o perties, it s h o ul d n ot be wit h hel d pri or t o st u d y vacci nati o n.
1 0. 1 0. 8. 7. 2. Per mitte d D uri n g t he St u d y

Me dicati o n ot her t ha n t hat descri be d as pr o hi bite d i n Secti o n 1 0. 1 0. 8. 7. 1 re q uire d f or t he 
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/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical (e g, s ki n, e y es, ears) 
c ortic oster oi ds are per mitte d. 
1 0. 1 0. 9. Disc o nti n u ati o n of S u bst u d y B I nter ve nti o n a n d P artici p a nt 
Disc o nti n u ati o n/ Wit h dr a w al
See Secti o n 7 .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 4 9
1 0. 1 0. 1 0. S u bst u d y B Assess me nts a n d Pr oce d ures
1 0. 1 0. 1 0. 1. I m m u n o ge nicit y Assess me nts
1 0. 1 0. 1 0. 1. 1. Bl o o d C ollecti o n
Bl o o d sa m ples (a p pr o xi matel y  50 m L per sa m ple) f or i m m u n o ge nicit y  assess me nts will be 
c ollecte d fr o m all e nr olle d partici pa nts j ust pri or t o st u d y  vacci nati o n at Visit B 1 0 1, a n d at 
Visit B 1 0 2 . 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 is a p pr o xi matel y 
1 0 0 m L  acr oss 1 m o nt h.
I nstr ucti o ns f or t he c ollecti o n a n d ha n dli n g of bl o o d a n d ser u m sa mples will be pr o vi de d i n 
t he la b orat or y ma n ual. T he date a n d ti me of eac h sa m ple will be rec or de d.
T he i m m u n o ge nicit y sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns 
pr o vi de d t o t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y . A ny de viati o ns fr o m t he 
i m m u n o ge nicit y sa m ple ha n dli n g pr oce d ure (e g, sa m ple c ollecti o n a n d pr ocessi n g ste ps, 
i nteri m st ora ge, or s hi p pi n g c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d 
a n d re p orte d t o t he s p o ns or. O n a case -b y -case basis, t he s p o ns or ma y ma ke a deter mi nati o n 
as t o w het her sa m ple i nte grit y has bee n c o m pr o mise d.
1 0. 1 0. 1 0. 1. 2. R S V A nti ge n I m m u n o ge nicit y Testi n g
Ser u m sa m ples c ollecte d at b ot h visits will be assa y e d f or R S V A a n d R S V B ser u m N Ts.
R S V A a n d R S V B ser u m N Ts will be deter mi ne d a n d re p orte d as t he N T at eac h bl o o d 
sa m pli n g visit. 
Sa m ple c ollecti o n, pr ocessi n g, st ora ge, a n d s hi p pi n g i nf or mati o n ca n be f o u n d i n t he 
la b orat or y ma n ual. All assa ys will be perf or me d b y Pfizer a n d/ or at a facilit y desi g nate d b y 
Pfizer.
1 0. 1 0. 1 0. 1. 3. qI R V Str ai n -S pecific H AI Testi n g
Ser u m sa m ples c ollecte d at Visit B 1 0 1 a n d Visit B 1 0 2 will be assa y e d f or seas o nal i nfl ue nza 
strai ns ( 2 × A, 2 × B) as rec o m me n de d b y W H O f or rec o m bi na nt or cell-base d i nfl ue nza 
assa ys.
I m m u ne res p o nse testi n g f or seas o nal strai ns ( 2 × A, 2 × B) will b e assesse d b y  strai n-s pecific 
H AI a nti b o d y titers t o e val uate vacci ne res p o nses.
Sa m ple c ollecti o n, pr ocessi n g, st ora ge, a n d s hi p pi n g i nf or mati o n ca n be f o u n d i n t he 
la b orat or y ma n ual. All assa ys will be perf or me d b y Pfizer a n d/ or at a facilit y desi g nate d b y  
Pfizer.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 0
1 0. 1 0. 1 0. 1. 4. E x pl or at or y Ass a ys, I ncl u di n g I m m u n o ge nicit y Assess me nts a n d Ass a y 
De vel o p me nt
Sa m ples re mai ni n g after c o m pleti o n of t he pla n ne d assa y s fr o m bl o o d dra ws ma y be use d f or 
a d diti o nal vacci ne a n d i nfecti o us disease – relate d researc h. Sa m ples ma y also be use d f or 
assa y de vel o p me nt, sta n dar dizati o n, q ualificati o n, a n d vali dati o n. T his w or k is critical i n t he 
de vel o p me nt, q ualificati o n, a n d vali dati o n of ser ol o gical assa y s a n d is re q uire d by re g ulat or y 
a ut h orities f or t heir use i n t he lice ns ure of a vac ci ne.
1 0. 1 0. 1 0. 2. Bi ol o gic al S a m ples
See Secti o n 8. 2. 3 .
1 0. 1 0. 1 0. 3. S afet y Assess me nts
See Secti o n 8. 3 .
1 0. 1 0. 1 0. 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
See Secti o n 8. 4.
1 0. 1 0. 1 0. 5. St o p pi n g R ules
T he f oll o wi n g st o p pi n g r ules are i n place f or S u bst u d y  B partici pa nts, base d o n re vie w of 
A Es , E C G, a n d la b orat or y data, a n d a p pl y t o t he 2 8 -d a y peri o d i m me diatel y  f oll o wi n g 
a d mi nistrati o n of st u d y vacci nati o n at Visit B 1 0 1, Da y  1 t hr o u g h Da y 2 8. T hese data will be 
m o nit ore d o n a n o n g oi n g basis b y  t he i n vesti gat or ( or me dically q ualifie d desi g nee) a n d 
s p o ns or i n or der t o pr o m ptl y i de ntif y a n d fla g a n y e ve nt t hat p ote ntiall y c o ntri b utes t o a 
st o p pi n g r ule. I n t he e ve nt t hat s p o ns or pers o n nel c o nfir m t hat a st o p pi n g r ule is met, t he 
f oll o wi n g acti o ns will c o m me nce:
1.
T he I R C will re vie w all a p pr o priate data.
2.
T he st o p pi n g r ule will P A U S E ra n d o mizati o n a n d a n y  f urt her a d mi nistrati o n of st u d y 
vacci nati o n ( Visit B 1 0 1). 
3.
F or t h ose partici pa nts alrea d y vacci nate d, all r o uti ne st u d y c o n d uct acti vities, i ncl u di n g 
o n g oi n g dat a e ntr y, re p orti n g of A Es, partici pa nt e-diar y  c o m pleti o n, bl o o d sa m ple 
c ollecti o n, a n d partici pa nt f oll o w -u p, will c o nti n ue d uri n g t he pa use.
1 0. 1 0. 1 0. 5. 1. St o p pi n g R ule Criteri a
A st o p pi n g r ule is met if a n y of t he f oll o wi n g criteria occ ur wit hi n 2 8 da y s after recei vi n g 
st u d y vacci nati o n ( Visit B 1 0 1).
If a ny partici pa nt vacci nate d wit h R S V pre F + q I RV de vel o ps:
1.
A ne w E C G a b n or malit y  t hat a car di ol o gist j u d ges c o nsiste nt wit h pr o ba ble or p ossi ble 
m y ocar ditis or pericar ditis, i ncl u di n g:
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 1

S ustai ne d atrial or ve ntric u lar arr hyt h mias .

Sec o n d -de gree M o bitz T y pe II or w orse A V bl oc k or ne w b u n dle bra nc h bl oc k.

Diff use S T -se g me nt ele vati o n or P R-se g me nt i n versi o n, c o m pati ble wit h pericar ditis.
2.
A n a b n or mal tr o p o ni n I val ue t hat is c o nfir me d t o be a b n or mal o n re peat testi n g, assesse d 
as relate d t o st u d y i nter ve nti o n b y  t he i n vesti gat or.
3.
If ≥1 partici pa nt vacci nate d wit h R S V pre F + q I RV de vel o ps c o nfir me d m y ocar ditis or 
pericar ditis.
4.
If a ny partici pa nt vacci nate d wit h R S V pre F + q I RV dies.
5.
If ≥1 partici pa nt vacci nate d wit h R S V pr e F + q I RV e x perie nces a Gra de 4 u ns olicite d A E, 
or S A E of a n y se verit y, assesse d as relate d t o st u d y i nter ve nti o n b y  t he i n vesti gat or.
6.
If ≥2 partici pa nts vacci nate d wit h R S V pre F + q I RV de vel o p t he sa me or si milar Gra de 3 
or hi g her (see Secti o n 1 0. 3. 3 , Assess me nt of I nte nsit y ) u ns olicite d A E (i ncl u di n g 
la b orat or y a b n or malities, e xce pt l ym p h oc y te c o u nt a n d C-reacti ve pr otei n), ot her t ha n 
m y ocar ditis/ pericar ditis, assesse d as relate d t o st u d y  i nter ve nti o n b y t he i n vesti gat or.
N ote t hat t he l ocal reacti o ns, s y ste mic e ve nts, a n d fe ver (Secti o n 8. 3. 4 ) re p orte d wit hi n 
7 da y s fr o m t he da y of a d mi nistrati o n of st u d y vacci nati o n, irres pecti ve of w het her t he y  
are rec or de d i n t he e -diar y  or as A Es, are e xcl u de d fr o m t his st o p pi n g r ule.
A c ha rter f or t he I R C will be pre pare d a n d fi nalize d bef ore t he first partici pa nt is c o nse nte d.
1 0. 1 0. 1 0. 6. St u d y Pr oce d ures
1 0. 1 0. 1 0. 6. 1. Visit B 1 0 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 a n d date t he I C D. A c o p y of t he si g ne d a n d date d I C D m ust be gi ve n t o t he 
partici pa n t. 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 .
St u d y  pr oce d ures s h o ul d be c o n d ucte d i n a ste p wise ma n ner as s h o w n bel o w: 

O btai n writte n i nf or me d c o nse nt eit her i n electr o nic or har d -c o p y f or mat fr o m t he 
partici pa nt bef ore perf or mi n g a n y st u d y- s pecific pr oce d ures.

Assi g n a si n gle partici pa nt i de ntifier usi n g t he I RT s y ste m. 
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 2

O btai n a n d rec or d t he partici pa nt de m o gra p h y (i ncl u di n g c o m plete date of birt h 
[ d d-M m m -Y Y Y Y], se x, race, racial desi g nati o n, a n d et h nicit y). T he f ull date of birt h will 
be c ollecte d t o criticall y e val uate t he i m m u ne res p o nse a n d safet y pr ofile b y a ge.

O btai n a n d rec or d a n y m e dical hist or y of cli nical si g nifica nce. I ncl u de date of o nset a n d 
res ol uti o n (if a p plica ble). Use best esti mate if u n k n o w 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 y sical 
e xa mi nati o n is necessar y t o c o m pre he nsi vel y e val uate t he partici pa nt, perf or m a p h ys ical 
e xa mi nati o n a n d rec or d a n y fi n di n gs i n t he s o urce d oc u me nts a n d, if cli nicall y 
si g nifica nt, rec or d o n t he me dical hist or y C R F (Secti o n 8. 3. 1 ). 

Meas ure t he partici pa nt’s vital si g ns, i ncl u di n g bl o o d press ure (seate d) a n d p ulse rate.

Meas ure t he partici pa nt ’s pre vacci nati o n b o d y te m perat ure ( oral or t y m pa nic) t o e ns ure
t hat t he te m perat ure is n ot ≥3 8° C .

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 .

Disc uss c o ntrace pti ve use w here a p plica ble a n d as descri be d i n Secti o n 5. 3. 1 .

C ollect details of a n y lice nse d i nfl ue nza vacci ne recei ve d i n t he last 1 8 m o nt hs pri or t o 
e nr oll me nt i n t he st u d y. I ncl u de pr o d uct na me (if k n o w n) a n d date of a d mi nistrati o n.

Rec or d a n y n o nst u d y vacci nati o ns recei ve d pri or t o Visit B 1 0 1 as descri be d i n
Secti o n 1 0. 1 0. 8. 7 . Incl u de pr o d uct na me a n d date of a d mi nistrati o n.

Re vie w c o nc o mita nt me dicati o n use a n d rec or d a n y me dicati o ns t hat are pr o hi bite d, as 
descri be d i n Secti o n 1 0. 1 0. 8. 7. 1 .

E ns ure a n d d oc u me nt t hat all 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.

E ns ure t hat t he partici pa nt d oes n ot meet a n y te m p o rary dela y  criteria as descri be d i n 
Secti o n 5. 5 . 
N ote: If dela y criteria are met, resc he d ule t he st u d y vacci nati o n  f or a later date w he n 
t he reas o n(s) f or t he te m p orar y dela y ha ve res ol ve d. Ra n d o mizati o n, Visit B 1 0 1 st u d y 
i nter ve nti o n assi g n me nt i n t he I RT, a n d bl o o d c ollecti o n are t o be deferre d u ntil t he 
partici pa nt ret ur ns f or v acci nati o n. 

O n t he da y  of a n d pri or t o st u d y vacci nati o n, c ollect a bl o o d sa m ple of a p pr o xi matel y  5 0 
m L  f or i m m u n o ge nicity t esti n g.

O n t he da y  of a n d pri or t o st u d y vacci nati 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 Visit B 1 0 1 st u d y i nter ve nti o n assi g n me nt usi n g t he I R T s ys te m.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 3

S uita bl y  q ualifie d a n d a ut h orize d u n bli n de d site staff me m ber(s) will dis pe nse t he 
assi g ne d kit n u m ber , pre pare t he st u d y i nter ve nti o n, a n d a d mi nister t he assi g ne d st u d y 
vacci nati o n i nt o t he partici pa nt’s delt oi d m uscle as a n I M i njecti o n as detaile d i n
Secti o n 6. 2. 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 s ite 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 
t he ti me of o nset) i n t he partici pa nt’s s o urce d oc u me nts a n d o n t he A E pa ge of t he C R F, 
a n d o n a n S A E f or m, if a p plica b le.

E x plai n t he e -diar y  tec h n ol o g y a n d c o m pleti o n re q uire me nts. Assist wit h i nstalli n g t he 
e-diar y  a p plicati o n o nt o t he partici pa nt’s o w n de vice or , if re q uire d, iss ue a 
s p o ns or-pr o visi o ne d e -diar y . 

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns at t he i njecti o n site a n d a 
t her m o meter f or rec or di n g oral te m perat ure.

E ns ure t hat t he partici pa nt is c o mf orta ble wit h usi n g t he c h ose n e-diar y  platf or m, c o nfir m 
i nstr ucti o ns o n e-diar y  c o m pleti o n, a n d as k t he partici pa nt t o c o m plete t he e-diar y  fr o m 
D a y  1 thr o u g h Da y  7, w here Da y 1 is t he da y of v acci nati o n.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if he or s he 
e x perie nces a n y of t he f oll o wi n g l ocal reacti o ns or s yste mic e ve nts fr o m Da y 1 t hr o u g h 
D a y  7 after vacci nati o n ( w here Da y 1 is t he da y of vacci nati o n) t o deter mi ne if a n 
u nsc he d ule d react o ge nicit y  visit is re q uire d:

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness or s welli n g at t he i njecti o n site meas uri n g greater t ha n 1 0 c m 
( > 2 0 meas uri n g de vice u nits).

Se vere pai n at t he i njec ti o n site.

A n y  se vere sys te mic e ve nt.
If t he partici pa nt d oes n ot call, t he site s h o ul d c o ntact t he partici pa nt 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.

Re q uest t hat t he partici pa nt bri n g t heir c o m plete d e -diar y  de vice t o t he ne xt visit.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if t he partici pa nt 
e x perie nces ac ute c hest pai n, s h ort ness of breat h, or pal pitati o ns 
(see Secti o n 1 0. 1 0. 1 0. 6. 3. 2 ).

Rec or d A Es a n d S A Es as descri be d i n Secti o n 1 0. 3. 3 .

Sc he d ule a n a p p oi nt me nt f or t he ne xt st u d y  visit.

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 nter ve nti o n acco u nta bilit y  rec or ds.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 4

T he i n vesti gat or or a p pr o priatel y  q ualifie d desi g nee re vie ws t he react o ge nicit y e-diar y  
data o nli ne f oll o wi n g vacci nati o n t o e val uate partici pa nt c o m plia nce a n d as part of t he 
o n g oi n g safet y re vie w. Dail y re vie w is o pti mal d uri n g t he a cti ve diar y peri o d.
1 0. 1 0. 1 0. 6. 2. Visit B 1 0 2 - F oll o w -U p Visit ( 2 8-3 5 D a ys After St u d y V acci n ati o n)

Rec or d a n y n o nst u d y vacci nati o ns recei ve d si nce t he last st u d y  visit as descri be d i n 
Secti o n 1 0. 1 0. 8. 7 .

Re vie w c o nc o mita nt me dicati o n use a n d rec or d a n y  me dicati o ns t hat are pr o hi bite d, 
as descri be d i n Secti o n 1 0. 1 0. 8. 7. 1 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  5 0 m L f or i m m u n o ge nicity assess me nts . 

Re vie w t he e-diar y  data a n d o btai n st o p dates f or a n y  o n g oi n g e ve nts rec or de d o n t he last 
da y  of e-diar y  c o mpleti o n f or t he pre vi o us peri o d .

Rec or d A Es a n d S A Es as descri be d i n Secti o n 1 0. 3. 3 a n d o btai n a n d rec or d st o p dates f or 
pre vi o usl y  re p orte d e ve nts. 

C ollect t he s p o ns or -pr o visi o ne d e -diar y or assist t he partici pa nt wit h re m o vi n g t he st u d y  
a p plicati o n fr o m his or her o w n pers o nal de vice . E ns ure t hat all data ha ve bee n 
tra nsmitte d bef ore deacti vati n g t he e -diar y  or deleti n g t he a p plicati o n.

C o m plete t he C R F a n d s o urce d oc u me nts.
1 0. 1 0. 1 0. 6. 3. E arl y Wit h dr a w als – S afet y F oll o w -U p 

Safet y  f oll o w-u p ma y  be c o n d ucte d eit her via a p h o ne call or at a site visit. 

Re vie w t he e -diar y  data a n d o btai n a n d rec or d st o p dates f or a ny o n g oi n g e ve nts rec or de d 
o n t he last da y  of e-diar y  c o m pleti o n f or t he pre vi o us peri o d(s).

E ns ure t hat all e-diar y  data have bee n tra ns mitte d t o t he trial m a na ger pri or t o 
deacti vati o n . C ollect t he s p o ns or -pr o visi o ne d e -diar y a n d, if nee de d, assist t he partici pa nt 
wit h re m o vi n g t he st u d y a p plicati o n fr o m his or her o w n pers o nal de vice.

Rec or d A Es a n d S A Es as descri be d i n Secti o n 1 0. 3. 3 a n d o btai n a n d rec or d st o p dates f or 
pre vi o usl y  re p orte d e ve nts. 

C o m plete t he C R F a n d s o urce d oc u me nts.
1 0. 1 0. 1 0. 6. 3. 1. U nsc he d ule d Re act o ge nicit y Visits f or a Gr a de 3 or S us pecte d Gr a de 4 
Re acti o n
If a se vere l ocal reacti o n (Secti o n 8. 3. 4. 2 ), se vere s yste mic e ve nt (Secti o n 8. 3. 4. 3 ), or fe ver 
≥3 9. 0 °C ( ≥1 0 2. 1 °F) ( Secti o n 8. 3. 4. 4 ) is re p orte d i n t he e-diar y , a tele p h o ne c o ntact wit h t he 
partici pa nt s h o ul d occ ur t o ascertai n f urt her details a n d deter mi ne w het her a site visit is 
cli nicall y i n dicate d. If a s us pecte d Gra de 4 l ocal reacti o n, s yste mic e ve nt, or fe ver 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 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 t he criteria f or Gra de 4.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 5
A site visit or referral t o a healt hcare facilit y  s h o ul d be sc he d ule d as s o o n as p ossi ble t o 
assess t he e xte nt of t he reacti o n, u nless:

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 reacti o n is n o l o n ger prese nt at t he ti me of t he c o ntact, or

T he partici pa nt rec or de d a n i nc orrect val ue i n t he e- diar y  (c o nfir mati o n of a n e-diar y  data 
e ntr y err or), or

T he i n vesti gat or or a p pr o priate desi g nee deter mi nes t hat a n u nsc he d ule d visit is n ot 
re q uire d.
T his c o ntact will be rec or de d i n t he partici pa nt’s s o urce n otes a n d i n 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 i n vesti gat or or a ut h orize d 
desi g nee deter mi n es it is 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.
T he react o ge nicit y e ve nts 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 site staff, s uc h as a st u d y p h ys icia 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 or healt hcare facilit y, w h o will:

Meas ure b o d y t e m perat ure (° C/°F) (if cli nically i n dicate d ).

If prese nt, meas ure t he mi ni m u m a n d ma xi m u m dia meters of re d ness at t he i njecti o n site.

If prese nt, meas ure t he mi ni m u m a n d ma xi m u m dia meters of s welli n g at t he i njecti o n 
site.

Assess t he i njecti o n site pai n i n acc or da nce wit h t he react o ge nicit y gra di n g scale 
pr o vi de d i n Secti o n 8. 3. 4. 2.

Asses s a ny s ys te mic e ve nts (fati g ue, hea dac he, v o miti n g, na usea, diarr hea, c hills, ne w or 
w orse ne d m uscle pai n, or ne w or w orse ne d j oi nt pai n) t hat are prese nt i n acc or da nce wit h 
t he react o ge nicity gra di n g scale 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 o n t he A E C R F, if 
a p pr o priate.

Rec or d A Es a n d S A Es as descri be d i n Secti o n 8. 4 .

C o m plete t he partici pa nt’s 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 u nsc he d ule d vis it assess me nt 
C R F.
1 0. 1 0. 1 0. 6. 3. 2. A d diti o n al Pr oce d ures f or M o nit ori n g of P ote nti al M y oc ar ditis or 
Peric ar ditis
A n y  st u d y partici pa nt w h o re p orts ac ute c hest pai n, s h ort ness of breat h, pal pitati o ns, or a n y 
ot her s y m pt o m(s) t hat mi g ht be i n dicati ve of m y ocar ditis or peric ar ditis wit hi n 2 8 da y s after 
Vacci nati o n 1 m ust be s pecificall y e val uate d f or p ossi ble m y ocar ditis or pericar ditis.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 6
I n a d diti o n t o a cli nical e val uati o n, t he f oll o wi n g s h o ul d be perf or me d:

E C G 

Meas ure me nt of t he tr o p o ni n le vel
If m yocar ditis or pericar dit is is s us pecte d base d u p o n t he i nitial e val uati o n, t he f oll o wi n g 
s h o ul d als o be perf or me d:

E val uati o n b y  a car di ol o gist,

Car diac ec h ocar di o gra m, a n d/ or

Car diac ma g netic res o na nce st u d y
Details of t he s y m pt o ms re p orte d, a n d res ults of t he i n vesti gati o ns per f or me d, will be 
rec or de d i n t he C R F.
1 0. 1 0. 1 1. St atistic al C o nsi der ati o ns – S u bst u d y B
M et h o d ol o g y f or s u m mar y a n d statistical a nalys es of t he data c ollecte d i n t his s u bst u d y is 
descri be d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or. 
T he S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc ol w here a p pr o priate; h o we ver, a n y maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
1 0. 1 0. 1 1. 1. St atistic al H y p ot heses
T here is n o statistical h y p ot hesis i n S u bst u d y  B.
T he esti ma n ds c orres p o n di n g t o eac h pri mar y , sec o n dar y, or e x pl orat or y o bjecti ve are 
descri be d i n Secti o n 1 0. 1 0. 5 .
1 0. 1 0. 1 1. 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
E nr olle d p o p ulati o n
All partici pa nts w h o ha ve a si g ne d I C D.
Ra n d o mize d 
p o p ulati o n
All e nr olle d 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.
Safet y p o p ulati o n
All e nr olle d partici pa nts w h o recei ve t he st u d y i nter ve nti o n.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 7
Defi ne d A n al ysis 
Set
Descri pti o n
E val ua ble 
i m m u n o ge nicit y 
p o p ulati o n 
All partici pa nts w h o meet t he f oll o wi n g criteria:

Are eli gi ble f or t he st u d y;

Recei ve t he st u d y i nter ve nti o n t o w hic h t he y we re ra n d o mize d at Visit B 1 0 1 ;

Ha ve t he 1- m o nt h p ost vacci nati o n bl o o d c ollecti o n f or ser ol o g y assa y testi n g 
wit hi n a n a p pr o priate w i n d o w;

Ha ve at least 1 vali d a n d deter mi nate assa y res ult at t he 1-m o nt h p ost vacci nati o n 
bl o o d c ollecti o n;

Ha ve n o maj or pr ot oc ol vi olati o ns fr o m ra n d o mizati o n t hr o u g h t he 1 -m o nt h 
p ost vacci nati o n bl o o d c ollecti o n (t hr o u g h Visit B 1 0 2).
mI T T 
i m m u n o ge nicit y 
p o p ulati o n 
All partici pa nts w h o are ra n d o mize d a n d ha ve at least 1 vali d a n d deter mi nate assa y 
res ult after recei vi n g st u d y i nter ve nti o n.
1 0. 1 0. 1 1. 3. St atistic al A n al yses
U nless state d ot her wise, “ vacci ne gr o u p” i n t his secti o n refers t o partici pa nts recei vi n g 
s pecific f or m ulati o n of c o m bi n ati o n R S V pre F + qI R V vacci ne .
1 0. 1 0. 1 1. 3. 1. Pri m ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis
Ta ble 8 descri bes t he pri mar y  e n d p oi nt statistical a nalys is met h o ds. 
T a ble 8.
Pri m ar y E n d p oi nt A n al yses – S u bst u d y B
E n d p oi nt
St atistic al A n al ysis Met h o ds
Safet 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 after 
vacci nati o n f or eac h vacci ne gr o u p. L ocal reacti o ns (re d ness, s w elli n g, a n d pai n at 
t he i njecti o n site) a n d s yste mic e ve nts (fati g ue, hea dac he, v o miti n g, na usea, diarr hea, 
c hills, 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) fr o m Da y 1 
t hr o u g h Da y 7 after vacci nati o n will be prese nte d b y ma xi m u m se verit y a n d a n y
se verit y. Descri pti ve s u m mar y statistics will i ncl u de c o u nts a n d perce nta ges 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 Cl o p per -Pears o n 9 5 % CI 
(Secti o n 9. 3. 1. 1 ).

A E s 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. All of t he 
A E s/ S A Es wit hi n 1 m o nt h after vacci nati o n will be descri pti vel y s u m marize d wit h 
c o u nts, perce nta ges, a n d ass ociate d Cl o p per -Pears o n 9 5 % CI f or eac h vacci ne gr o u p 
( Secti o n 9. 3. 1. 1 ).

Data w ill be s u m marize d f or o verall as well as b y a ge gr o u p ( 5 0-6 4 years a n d 
6 5 years a n d ol der) .
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 8
1 0. 1 0. 1 1. 3. 2. Sec o n d ar y a n d E x pl or at or y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis
Ta ble 9 descri bes t he sec o n dar y a n d e x pl orat or y e n d p oi nt statistical a nal ysis met h o ds. 
T a ble 9 .
Sec o n d ar y a n d E x pl or at or y E n d p oi nt A n al yses – S u bst u d y B
E n d p oi nt
St atistic al A n al ysis Met h o ds
I m m u n o ge nicit y

G M Ts of N Ts f or eac h R S V s u b gr o u p ( A or B) a n d G M Ts of i nfl ue nza strai n -s pecific 
H AI titers at eac h ti me p oi nt will be descri pti vel y s u m marize d w it h 2-si de d 9 5 % CIs 
f or eac h vacci ne gr o u p ( Secti o n 9. 3. 1. 2. 1 ).

G M F Rs of N Ts f or eac h R S V s u b gr o u p ( A or B) a n d G M F Rs of i nfl ue nza strai n-
s pecific H AI titers fr o m bef ore vacci nati o n t o after vacci nati o n will be descri pti vel y 
s u m marize d with 2 -si de d 9 5 % CIs f or eac h vacci ne gr o u p (Secti o n 9. 3. 1. 2. 2 ).

T he n u m ber a n d perce nta ge of partici pa nts wit h strai n -specific H AI titers ≥1: 4 0 at 
eac h ti me p oi nt, a n d t he n u m ber a n d perce nta ge of partici pa nts ac hie vi n g strai n -
s pecific H AI ser oc o n versi o n, will be s u m marize d wit h 2-si de d Cl o p per-Pears o n 9 5 % 
CIs f or eac h vacci ne gr o u p ( Secti o n 9. 3. 1. 1 ).

Data w ill be s u m marize d f or o verall as well as b y a ge gr o u p ( 5 0-6 4 years a n d 6 5 
years a n d ol der).
1 0. 1 0. 1 1. 4. I nteri m A n al yses
N o i nteri m a nal ys is is pla n ne d.
1 0. 1 0. 1 1. 4. 1. A n al ysis Ti mi n g
As t his is a P hase 1 b st u d y , data ma y be s u m marize d w he n data are a vaila ble f or a ny s pecific 
o bjecti ve.
O ne fi nal a nal y sis re p ort will be perf or me d after t he last visit of t he last partici pa nt w he n all 
pri mar y  a n d sec o ndar y  e n d p oi nt data are a vaila ble.
1 0. 1 0. 1 1. 5. S a m ple Size Deter mi n ati o n
As t his s u bst u d y  is n ot a h yp ot hesis -testi n g st u d y, t he sa m ple size was n ot base d o n st u d y 
p o wer f or s uccess. 
Ass u mi n g t hat 6 5 % of partici pa nts w h o recei ve t he 1. 0- m L f or m ulati o n w o ul d re p ort at least 
1 l ocal reacti o n, 5 0 partici pa nts per gr o u p will pr o vi de 8 2 % p o wer t o detect a statistical 
i ncrease of 2 5 % (ie, 9 0 %) fr o m t he 0. 5 -m L rec o nstit ute d f or m ulati o n ( Fis her e xact test).
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 5 9
1 0. 1 1. A p pe n di x 1 1 : 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 Infecti o n

C o nfir me d sta ble HI V disease , defi ne d as d oc u me nte d viral l oa d < 5 0 c o pies/ m L  a n d C D 4 
c o u nt > 2 0 0 cells/ m m 3 wit hi n 6 m o nt hs bef ore e nr oll me nt, a n d o n sta ble a ntiretr o viral 
t hera py f or at least 6 m o nt hs.

If C D 4 cell c o u nt is 3 0 0- 5 0 0/ m m 3 a n d HIV R N A s u p presse d f or 2 ye ars, C D 4 cell c o u nt 
s h o ul d ha ve bee n o btai ne d wit hi n 1 2 m o nt hs bef ore e nr oll me nt.

If C D 4 cell c o u nt is > 5 0 0/ m m 3 a n d HIV R N A s u p presse d f or 2 y ears, t he C D 4 cell c o u nt 
meas ure me nt is o pti o nal.
K n o w n H C V Infecti 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 Infecti 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 Bs A g prese nt f or ≥6 m o nt hs 
a n d t he f oll o wi n g:

H Be 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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6 0
1 0. 1 2. A p pe n di x 1 2 : A b bre vi ati o ns
T he f oll o wi n g is a list of a b bre viati o ns t hat ma y be use d i n t he pr ot oc ol.
A b bre viati 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
Al( O H) 3
al u mi n u m h ydr o xi de
A L T
ala ni ne a mi n otra nsferase
A S T
as partate a mi n otra nsferase
A N M A T
Ar ge nti na Nati o nal A d mi nistrati o n of Dr u gs, F o o d a n d Me dical De vices
A V
atri o ve ntric ular
A x M P
a u xiliar y me dici nal pr o d uct
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’s 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
C D C
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n
C F R
C o de of Fe deral Re g ulati o ns
C H F
c o n gesti ve heart fail ure
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 olla b orati o n
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 P D
c hr o nic o bstr ucti ve p ul m o nar y  disease
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 Trials
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
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6 1
A b bre viati o n
Ter m
D U
dis pe nsa ble u nit
E C
et hics c o m mittee
E C C
e mer ge nc y c o ntact car d
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
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 dra C T
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
FI H
first-i n-h u ma n
F S H
f ollicle-sti m ulati n g h or m o ne
G C P
G o o d Cli nical Practice
G G T
ga m ma -gl uta m y l tra nsferase
G M F R
ge o metric mea n f ol d rise
G M R
ge o metric mea n rati o
G M T
ge o metric mea n titer
H A
he ma g gl uti ni n
H AI
he ma g gl uti nati o n i n hi biti o n assa y
H Be
he patitis B e
H Be A g
he patitis B e a nti ge n
H Bs 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
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6 2
A b bre viati o n
Ter m
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 M
i ntra m usc ular
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 a p plicati o n
I N R
i nter nati o nal n or malize d rati o
I P A L
in vesti gati o nal p r o d uct a cc 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 C
i nter nal re vie w c o m mittee
I R T
i nteracti ve res p o nse tec h n ol o g y
I S O
I nter nati o nal Or ga nizati o n f or Sta n dar dizati o n
K DI G O
Ki d ne y  Disease I m pr o vi n g Gl o bal O utc o mes
L A I V
li ve atte n uate d infl ue nza v acci ne
L B
l o wer b o u n d
L B B B
left b u n dle bra nc h bl oc k
L F T
li ver f u ncti o n test
L N P
li pi d na n o particle
L R TI
l o wer res pirat or y tract ill ness
L R TI -R S V 
R S V -ass ociate d l o wer res pirat or y tract ill ness
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
m R N A - 1 2 7 3
m R N A -1 2 7 3 S A R S -C o V -2 vacci ne ( M o der na)
N/ A
n ot a p plica ble
N A
ne ura mi ni dase
NI M P
n o ni n vesti gati o nal me dici nal pr o d uct
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6 3
A b bre viati o n
Ter m
N T
ne utralizi n g titer
O mi
O micr o n
P F S
prefille d s yri n ge(s)
PI
pri nci pal i n vesti gat or
P P E
pers o nal pr otecti ve e q ui p me nt
P S S A
Pfizer’s 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
R S V
res pirat or y sy n c ytial vir us
R S V A
res pirat or y sy n c ytial vir us s u b gr o u p A
R S V B
res pirat or y sy n c ytial vir us s u b gr o u p B
R S V pre F
res pirat or y sy n c ytial vir us sta bilize d pref usi o n F s u b u nit vacci ne
R T -P C R
re verse tra nscri pti o n –p ol y merase c hai n reacti o n
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 -C o V - 2
se vere ac ute res pirat or y s yn dr o me c or o na vir us 2 
Scr
ser u m creati ni ne
Sc y s
ser u m c ystati n C
S D
sta n dar d de viati o n
SI I V
seas o nal i nacti vate d i nfl ue nza vacci ne
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 b ili
t otal bilir u bi n
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6 4
A b bre viati o n
Ter m
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
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 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
C CI

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6 5
1 1. R E F E R E N C E S
1
Griffi n M R, C offe y C S, Ne uzil K M, et al. Wi nter vir uses: i nfl ue nza- a n d res pirat or y 
s yn c y tial vir us-relate d m or bi dit y i n c hr o nic l u n g disease. Arc h I nter n Me d. 
2 0 0 2; 1 6 2( 1 1): 1 2 2 9 - 3 6. D OI : 1 0. 1 0 0 1/arc hi nte. 1 6 2. 1 1. 1 2 2 9.
2
Wats o n A, Wil ki ns o n T M A . Res pirat or y viral i nfecti o ns i n t he el derly. T her A d v Res pir 
Dis. 2 0 2 1; 1 5: 1 -1 7. D OI : 1 0. 1 1 7 7/ 1 7 5 3 4 6 6 6 2 1 9 9 5 0 5 0 .
3
C e nters f or Disease C o ntr ol a n d Pre ve nti o n . I ncrease d res pirat or y vir us acti vit y, 
es pecially am o n g chil dre n, earl y i n t he 2 0 2 2 -2 0 2 3 fall a n d w i nter. 0 4 N o v 2 0 2 2 . 
A vaila ble fr o m: htt ps://e mer ge nc y .c dc. g o v/ ha n/ 2 0 2 2/ ha n 0 0 4 7 9.as p. Accesse d: 1 6 N o v 
2 0 2 2.
4
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. I nteri m C O VI D - 1 9 im m u nizati o n sc he d ule 
f or p ers o ns 6 m o nt hs of a ge a n d o l der. Oct 2 0 2 2. A vaila ble fr o m: 
htt ps:// w w w.c dc. g o v/ vacci nes/c o vi d- 1 9/ d o w nl oa ds/ C O VI D- 1 9- i m m u nizati o n-sc he d ule-
a ges-6 m o nt hs -ol der. p df . Accesse d: 1 6 N o v 2 0 2 2.
5
Pfizer. Pfizer an n o u nces p ositi ve t o p-li ne d ata of P hase 3 g l o bal m ater nal im m u nizati o n 
trial f or its b i vale nt res pirat or y sy n c ytial v ir us ( R S V) v acci ne ca n di date [ 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 n o u nces-p ositi ve -t o p-li ne-data -p hase - 3-trial-ol der . Accesse d: 1 6 N o v 2 0 2 2.
6
Wa n g W. T olera bilit y  of h ypert o nic i njecta bles. I nt J P har m. 2 0 1 5;4 9 0( 1 - 2): 3 0 8- 1 5.
7
N o n y  P, Girar d P, C ha ba u d S , et al. Im pact of os m olalit y  o n b ur ni n g se nsati o ns d uri n g 
a n d i m me diatel y after i ntra m usc ular i njecti o n of 0. 5 ml of vacci ne s us pe nsi o ns i n 
healt h y  a d ults. Vacci ne. 2 0 0 1; 1 9( 2 7) : 3 6 4 5- 5 1.
8
Hall C B, Si m őes E A F, A n ders o n L J. Cli nical a n d e pi de mi ol o gic feat ures of res pirat or y 
s yn c y tial vir us. C urr T o p Micr o bi ol Im m u n ol. 2 0 1 3; 3 7 2: 3 9 -5 7.
9
C ha d ha M, Hir ve S, Ba ncej C, et al. H u ma n res pirat or y  sy nc yt ial vir us a n d i nfl ue nza 
seas o nalit y patter ns— earl y fi n di n gs fr o m t he W H O gl o bal res pirat or y  sy n c ytial vir us 
s ur veilla nce. I nfl ue nza Ot her Res p Vir uses. 2 0 2 0; 1 4( 1 6): 6 3 8- 4 6.
1 0
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. I ncrease d r es pirat or y vir us acti vit y, 
es pecially am o n g chil dre n, earl y i n t he 2 0 2 2 -2 0 2 3 fall a n d w i nter. N o v 2 02 2. A vaila ble 
fr o m: htt ps://e mer ge nc y.c dc. g o v/ ha n/ 2 0 2 2/ ha n 0 0 4 7 9.as p. Accesse d: 1 6 N o v 2 0 2 2. 
1 1
M urata Y, False y  A R. Res pirat or y sy n c ytial vir us i nfecti o n i n a d ults. A nti vir T her. 
2 0 0 7; 1 2( 4 Pt B): 6 5 9 -7 0.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6 6
1 2
False y  A, He n nesse y P A, F or mica M A, et al. Res pirator y  s yn c y tial vir us i nfecti o n i n 
el derl y a n d hi g h -ris k a d ults. N E n gl J Me d. 2 0 0 5; 3 5 2( 1 7): 1 7 4 9- 5 9.
1 3
Ac kers o n B, Tse n g H F, S y  LS, et al. Se vere m or bi dit y  a n d m ortalit y ass ociate d wit h 
res pirat or y sy n c ytial vir us vers us i nfl ue nza i nfecti o n i n h os pitalize d ol der a d ults. Cli n 
I nfect Dis. 2 0 1 9; 6 9( 2): 1 9 7- 2 0 3.
1 4
S u n dara m M E, Meece J K, Sifa kis F, et al. Me dicall y  atte n de d res pirat or y s yn c y tial vir us 
i nfecti o ns i n a d ults a ge d ≥5 0 y ears: cli nical c haracteristics a n d o utc o mes. Cli n I nfect
Dis. 2 0 1 4; 5 8( 3): 3 4 2 - 9.
1 5
Bel o n gia E A, Ki n g J P, Kie ke B A, et al. Cli nical feat ures, se verit y , a n d i nci de nce of 
R S V ill ness d uri n g 1 2 c o nsec uti ve seas o ns i n a c o m m u nit y  c o h ort of a d ults ≥6 0 y ears 
ol d. O pe n F or u m I nfect Dis. 2 0 1 8; 5( 1 2): of y 3 1 6.
1 6
W y ffels V, Kari b ur yo F, Ga vart S F, et al. A real -w orl d a nal ys is of patie nt c haracteristics 
a n d pre dict ors of h os pitalizati o n a m o n g U S Me dicare be neficiaries wit h res pirat or y  
s yn c y tial vir us i nfecti o n. A d v T her. 2 0 2 0; 3 7( 3): 1 2 0 3- 1 7.
1 7
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1 8
C u n ha B A. I nfl ue nza: hist orical as pects of e pi de mics a n d pa n de mics. I nfect Dis Cli n 
N ort h A m. 2 0 0 4; 1 8( 1): 1 4 1 -5 5.
1 9
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 Inter n Me d. 2 0 0 0; 1 6 0( 2 1): 3 2 4 3 - 7.
2 0
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 1
Hal l E. I nfl ue nza. C ha pter 1 2. I n: Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. Hall E, 
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2 2
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 3
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 4
Fra ncis T Jr, Sal k J E, Brace W M. T he pr otecti ve effect of vacci nati o n a gai nst e pi de mic 
i nfl ue nza B. J A M A. 1 9 4 6; 1 3 1: 2 7 5- 8.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6 7
2 5
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2 0 1 5; 6 4( 3 0): 8 1 8 - 2 5.
2 6
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c ult ure-deri ve d a n d e g g -deri ve d i nacti vate d s u b u nit i nfl ue nza vacci nes i n healt h y  ad ults. 
Cli n I nfect Dis. 2 0 1 0; 5 1( 9): 9 9 7- 1 0 0 4.
2 7
Bels he R B. T he nee d f or q ua dri vale nt vacci ne a gai nst seas o nal i nfl ue nza. Vacci ne. 
2 0 1 0; 2 8( S u p pl 4): D 4 5 - 5 3.
2 8
Bresee J S, Fr y  A M, Sa m b hara S, et al. I nacti vate d i nfl ue nza vacci nes. C ha pter 3 1. I n: 
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Else vier; 2 0 1 8: 4 5 6 -8 8.e 2 1.
2 9
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. Ta ble. I nfl ue nza vacci nes – U nite d States, 
2 0 2 0- 2 1 i nfl ue nza seas o n. A vaila ble fr o m: 
htt ps:// w w w.c dc. g o v/fl u/ pr ofessi o nals/aci p/ 2 0 2 2- 2 0 2 3 /aci p-ta ble. ht m. Accesse d: 0 7
N o v 2 0 2 2.
3 0
Par di N, H o ga n MJ, P orter F W, et al. m R N A vacci nes - a ne w era i n vacci n ol o g y. Nat 
Re v Dr u g Disc o v . 2 0 1 8; 1 7( 4): 2 6 1 - 7 9.
3 1
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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.
3 2
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2 - preli mi nar y  re p ort. N E n gl J Me d. 2 0 2 0; 3 8 3( 2 0): 1 9 2 0 - 3 1.
3 3
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C o V - 2 vacci ne. N E n gl J Me d. 2 0 2 1; 3 8 4( 5): 4 0 3-1 6.
3 4
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. Safet y  of C O VI D-1 9 vacci nes. A vaila ble 
fr o m: htt ps:// w w w.c dc. g o v/c or o na vir us/ 2 0 1 9 -nc o v/ vacci nes/safet y/ safet y- of-
vacci n es. ht ml #: ~:te xt = Be nefits % 2 0 of % 2 0 Vacci nati o n % 2 0 O ut wei g h % 2 0t he, % 2 C % 2 0i n
cl u di n g % 2 0 C O VI D % 2 D 1 9 % 2 0 vacci nati o n. U p date d: 2 1 N o v 2 0 2 2 . Accesse d: 2 7 N o v
2 0 2 2.
3 5
C D C C O VI D - 1 9 Res p o nse Tea m, F o o d a n d Dr u g A d mi nistrati o n. Aller gic reacti o ns 
i ncl u di n g a na p hyl a xis after recei pt of t he first d ose of Pfizer- Bi o N Tec h C O VI D- 1 9 
vacci ne — U nite d States, Dece m ber 1 4 – 2 3, 2 0 2 0. M M W R M or b M ortal W kl y  Re p. 
2 0 2 1; 7 0( 2): 4 6 -5 1.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

P F -0 7 9 4 1 3 1 4 (R S V S u b u nit a n d I nfl ue nza m o d R N A C o m bi nati o n Vacci ne )
Pr ot oc ol C 5 4 0 1 0 0 1
Fi nal Pr ot oc ol A me n d me nt 1 , 3 0 Ma y
2 0 2 3   
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 0 1 A pril 2 0 2 2 )
Pa ge 1 6 8
3 6
Wit ber g G, Bar da N, H oss S, et al. M y ocar ditis after C o vi d -1 9 vacci nati o n i n a lar ge 
healt h care or ga nizati o n . N E n gl J Me d. 2 0 2 1; 3 8 5( 2 3): 2 1 3 2- 9.
3 7
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. M y ocar ditis a n d p ericar ditis after m R N A 
C O VI D - 1 9 vacci nati o n. A vaila ble fr o m: htt ps:// w w w.c dc. g o v/c or o na vir us/ 2 0 1 9 -
nc o v/ vacci nes/safet y/ m y ocar ditis. ht ml U p date d : 2 7 Se p 2 0 2 2. Accesse d: 2 7 N o v 2 0 2 2.
3 8
U S F o o d a n d Dr u g A d mi nistrati o n. G ui da nce f or i n d ustr y : t o xicit y gra di n g scale f or 
healt h y  a d ult a n d a d olesce nt v ol u nteers e nr olle d i n pre ve nti ve vacci ne cli nical trials. 
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3 9
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infecti o n a n d m R N A C O VI D - 1 9 vacci nati o n - P C O R net, U nite d States, Ja n uar y  2 0 2 1-
Ja n uar y 2 0 2 2. M M W R M or b M ortal W kl y Re p. 2 0 2 2; 7 1( 1 4): 5 1 7- 2 3. 
4 0
A gresti A. I ntr o d ucti o n: distri b uti o ns a n d i nfere nce f or cate g orical data. C ha pter 1. I n: 
A gresti A, e d. Cate g orical data a nal ys is. 2 n d e d. H o b o ke n, NJ: J o h n Wile y & S o ns; 
2 0 0 2: 1 - 3 5.
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)

D o c u m e nt A p pr o v al R e c or d
D o c u m e nt N a m e:
D o c u m e nt Titl e:
Si g n e d B y:
D at e( G M T)
Si g ni n g C a p a cit y
0 9 0 1 7 7 e 1 9 d 9 8 3 8 d d\ A p pr o v e d\ A p pr o v e d O n: 3 0- M a y- 2 0 2 3 1 9: 3 5 ( G M T)
P P D
P P D