A PHASE 3 PROTOCOL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS AT HIGH RISK OF SEVERE RSV DISEASE
Phase: PHASE3
Conditions: RESPIRATORY SYNCYTIAL VIRUS (RSV)
Sponsor: Pfizer

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1
A P H A S E 3 P R O T O C O L T O E V A L U A T E T H E S A F E T Y, T O L E R A BI LI T Y, A N D 
I M M U N O G E NI CI T Y O F R E S PI R A T O R Y S Y N C Y TI A L VI R U S ( R S V) 
P R E F U SI O N F S U B U NI T V A C CI N E I N A D U L T S A T HI G H RI S K O F 
S E V E R E R S V DI S E A S E
St u d y I nter ve nti o n N u m ber:
P F -0 6 9 2 8 3 1 6
St u d y I nter ve nti o n N a me:
Res pirat or y  S yn c y tial Vir us ( R S V) Vacci ne
U S I N D N u m ber:
0 1 7 9 3 1
E u dr a C T / E U C T N u m ber:
N ot A p plica ble
Cli nic al Tri als. g o v I D:  
N C T 0 5 8 4 2 9 6 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 3 6 7 1 0 2 3
P h ase:
3
S p o ns or Le g al A d dress:
Pfizer I nc.
6 6 H u ds o n B o ule var d East
Ne w Y or k, N Y 1 0 0 0 1
Brief Title: A P hase 3 Pr ot oc ol t o E val uate t he Safet y, T olera bility, a n d I m m u n o ge nicit y 
of R S V pre F i n A d ults at H i g h R is k of Se vere R S V Disease 
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 p tl y n otifie d.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
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
1 8 A u g 2 0 2 3
Ori gi nal pr ot oc ol
0 7 Mar
2 0 2 3
T his a me n d me nt i nc or p orates all re visi o ns t o date, i ncl u di n g a me n d me nts ma de at t he 
re q uest of c o u ntr y healt h a ut h orities a n d I R Bs/ E Cs a n d a n y pr ot oc ol a d mi nistrati ve c ha n ge 
letter(s).
Pr ot oc ol A me n d me nt S u m m ar y of C h a n ges T a ble
A m e n d me nt 1 ( 1 8 A u g ust 2 0 2 3 )
O ver all R ati o n ale f or t he A me n d me nt:
T o i ncrease t he sa m ple size i n S u bst u d y A b y  a n a d diti o nal 1 50 partici pa nts a n d a d d a n 
a d diti o nal esti ma n d f or t he pri mar y  i m m u n o ge nicit y o bjecti ve.
U p date d c orres p o n di n g 
details i n t he S u bst u d y  A o bjecti ves a n d statistical met h o ds secti o ns. S ur veilla nce of defi ne d 
A E SI s a d de d f or b ot h s u bst u dies.
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
S u bst a nti al M o dific ati o n(s)
U p date d te xt w it h res pect t o 
i ncrease d recr uit me nt t o S u bst u d y A.
T o o btai n data fr o m a n a d diti o nal 
1 5 0 i n di vi d uals i n S u bst u d y A 
per fee d bac k fr o m F D A/ C B E R.
Secti o n 1. 1 S y n o psis
Secti o n 4 St u d y Desi g n
Secti o n 1 0. 7. 1. 2 Sc he ma: 
S u bst u d y A
Secti o n 1 0. 7. 4 St u d y Desi g n f o r 
S u bst u d y A
Secti o n 1 0. 7. 9 Statistical 
C o nsi derati o ns f or S u bst u d y A
A d de d a n a d diti o nal esti ma n d t o t he 
pri mar y i m m u n o ge nicit y o bjecti ve of 
S u bst u d y A.
T o deter mi ne t he d iffere nce i n 
ser ores p o nse rate of R S V A a n d 
R S V B ser u m N Ts at 1 m o nt h 
after vacci nati o n wit h R S V pre F 
bet w e e n partici pa nts i n 
St u d y C 3 6 7 1 0 2 3 a n d i n 
C 3 6 7 1 0 1 3.
Secti o n 1 0. 7. 3 O bjecti ves, 
E n d p oi nts , a n d Esti ma n ds f or 
S u bst u d y A
Secti o n 1 0. 7. 4 St u d y Desi g n f or 
S u bst u d y A
Secti o n 1 0. 7. 9 Statistical 
C o nsi derati o ns f or S u bst u d y A
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
A d de d A E SI s ur veilla nce t hr o u g h t he
e n d of st u d y partici pati o n.
U p date d ris k te xt wit h t hese e ve nts of 
i nterest.
Dia g n osis of G uillai n -Barre 
s y n dr o me, ac ute p ol y ne ur o pat h y 
wit h o ut a n u n derl yi n g eti ol o g y, 
atrial fi brillati o n, preter m 
deli ver y ( deli ver y at 
3 7 0/ 7 we e ks’ gestati o n), a n d 
h y perte nsi ve dis or ders of 
pre g na nc y are c o nsi dere d A E SIs.
Secti o n 8. 4. 8 A d verse E ve nt s of 
S pecial I nterest
Secti o n 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
Secti o n 1. 1 S y n o psis
Secti o n 2. 3. 1 Ris k Assess me nt
Secti o n 1 0. 7. 1. 3 Sc he d ule of 
Acti vities: S u bst u d y A
Secti o n 1 0. 7. 4. 1 O verall Desi g n 
( S u bst u d y A)
Secti o n 1 0. 7. 8. 4 S u bst u d y A 
Pr oce d ures
Secti o n 1 0. 7. 9. 3. 2 Pri mar y 
E n d p oi nt(s)/ Esti ma n ds(s) A nal ysis 
( S u bst u d y A)
Secti o n 1 0. 8. 1. 3 Sc he d ule of 
Acti vities: S u bst u d y B
Secti o n 1 0. 8. 4. 1 O verall Desi g n 
( S u bst u d y B)
Secti o n 1 0. 8. 8. 4 S u bst u d y B 
Pr oce d ures
Secti o n 1 0. 8. 9. 3. 2 Pri mar y 
E n d p oi nt(s)/ Esti ma n ds(s) A nal ysis 
( S u bst u d y B)
Cli nicaltrials. g o v refere nce a n d 
sp o ns or le gal a d dress a d de d t o t he 
title pa ge.
T o u p date t o reflect trial p osti n g 
t o cli nicaltrials. g o v.
T itle pa ge
Re m o ve d refere nce t o “ master” w he n 
descri bi n g t he pr ot oc ol.
Per C B E R fee d bac k o n use of 
“ master pr ot oc ol” ter mi n ol o g y.
Title a n d t hr o u g h o ut t he e ntire
pr ot oc ol
N o ns u bst a nti al M o dific ati o n(s)
U p date d t he te xt wit h res pect t o t he 
F D A a p pr o val of R S V pre F 
( A br ys v o ™) f or mar keti n g i n 
i n di vi d uals 6 0 years of a ge a n d ol der 
i n t he U S a n d a p pr o vals of 
pr o p h ylactic m o n ocl o nal a nti b o dies 
f or R S V.
T o ca pt ure u p date d i nf or mati o n 
o n a p pr o vals f or R S V vacci ne 
a n d m o n ocl o nal a nti b o dies .
Secti o n 1. 1 S y n o psis
Secti o n 2 I ntr o d ucti o n
Secti o n 7. 2 Partici pa nt 
Disc o nti n uati o n/ Wit h dra wal F r o m 
t he St u d y
Secti o n 1 1 Refere nces
U p date d te xt w it h res pect t o ot her 
trials wit hi n t he Pfizer R S V pr o gra m.
T o ca pt ure u p dates o n trial 
stat uses a n d res ults.
Secti o n 1. 1 S y n o psis
Secti o n 2. 2. 1 Cli nical O ver vie w
A d de d a p pe n di x pr o vi di n g g ui da nce 
f or p ote ntial partici pa nts wit h c hr o nic 
sta ble HI V i nfecti o n.
T o pr o vi de f urt her g ui da nce f or 
sites.
Secti o n 1 0. 6 A p pe n di x 6 : Criteria 
f or All o wi n g I ncl usi o n of 
P artici pa nts W it h C hr o nic Sta ble 
HI V I nfecti o n
Secti o n 1 0. 7. 5. 2 E xcl usi o n Criteria 
( S u bst u d y A)
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
Secti o n 1 0. 7. 8. 4. 1 Visit 1 0 1 –
Vacci nati o n ( Cli nic, Da y 1)
( S u bst u d y A Pr oce d ures)
Secti o n 1 0. 8. 5. 2 E xcl usi o n Criteria 
( S u bst u d y B)
Secti o n 1 0. 8. 8. 4. 1 Visit 2 0 1 –
Vacci nati o n 1 ( Cli nic, Da y 1) 
( S u bst u d y B Pr oce d ures)
U p date d te xt f or e xcl usi o n criteria, 
t e mp orar y dela y criteria , a n d 
pr o hi bite d me dicati o n lists i n 
S u bst u d y A.
T o pr o vi de f ur t her clarificati o n t o 
sites o n w hic h m o n ocl o nal 
a nti b o dies a n d c ortic oster oi ds are 
e xcl u de d or re q uire te m p orar y 
dela y. Details a d de d re gar di n g 
partici pa nts re mai ni n g i n a 
t e mp orar y dela y at t he ti me of 
e nr oll me nt cl os ure a n d acti o ns t o 
ta ke if pr o hi bite d me dicati o ns are 
ta ke n.
Secti o n 1 0. 7. 5. 2 E xcl usi o n Criteria 
Secti o n 1 0. 7. 5. 5 Criteria f or 
T e m p oraril y Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/
A d mi nistrati o n of St u d y 
I nter ve nti o n
Secti o n 1 0. 7. 6. 7 Pri or a n d 
C o nc o mita nt T hera p y f or 
S u bst u d y A
U p date d te xt f or e xcl usi o n criteria, 
t e mp orar y dela y criteria , a n d 
pr o hi bite d me dicati o n lists i n 
S u bst u d y B.
T o pr o vi de f urt her clarificati o n t o 
sites o n w hic h m o n ocl o nal 
a nti b o dies are e xcl u de d or 
re q uire te m p orar y dela y. Details 
a d de d re gar di n g partic i pa nts 
r e mai ni n g i n a te m p orar y dela y at 
t he ti me of e nr oll me nt cl os ure 
a n d acti o ns t o ta ke if pr o hi bite d 
me dicati o ns are ta ke n.
Secti o n 1 0. 8. 5. 2 E xcl usi o n Criteria
Secti o n 1 0. 8. 5. 5 Criteria f or 
T e m p oraril y Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/
A d mi nistrati o n of St u d y 
I nter ve nti o n
Secti o n 1 0. 8. 6. 7 Pri or a n d 
C o nc o mita nt T hera p y f or 
S u bst u d y A
A d de d c hec k mar ks f or kit all ocati o n 
via t he I R T a n d e-diar y trai ni n g f or 
t he sec o n d st u d y i nter ve nti o n 
a d mi nistrati o n i n S u bst u d y B.
T o ali g n t he pr ot oc ol w it h 
pr ocesses carrie d o ut pri or t o t he 
sec o n d a d mi nistrati o n of st u d y 
i nter ve nti o n i n S u bst u d y B.
Secti o n 1 0. 8. 1. 3 Sc he d ule of 
Acti vities : S u bst u d y B
Secti o n 1 0. 8. 8. 4. 2 Visit 2 0 2 –
Vacci nati o n 2 ( Cli nic, 2 8 t o 3 5 
Da y s After Vacci nati o n at Visit 
2 0 1) ( S u bst u d y B Pr oce d ures)
U p date d te xt t o clarif y res pirat or y 
rate at baseli ne, o versi g ht a n d 
re p orti n g of misse d react o ge nicit y 
e-diar y da ys , a n d bl o o d sa m ple 
disc o nti n uati o n.
T o ali g n t he pr ot oc ol w it h 
acti vities a n d pr ocesses ca pt ure d 
i n ot her st u d y d oc u me ntati o n.
Secti o n 1. 3 Sc he d ule of Acti vities
Secti o n 8 St u d y Assess me nts a n d 
Pr oce d ures
Secti o n 8. 3. 2 Vital Si g ns
Secti o n 8. 3. 4 Electr o nic Diar y f or 
React o ge nicit y
Secti o n 9. 3. 1 Ge neral 
C o nsi de rati o ns ( Statistical 
A nal yses)
Secti o n 1 0. 7. 1. 3 Sc he d ule of 
Acti vities: S u bst u d y A
Secti o n 1 0. 7 . 8. 1. 1 R S V Vacci ne
A nti b o d y Testi n g ( S u bst u d y A)
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
Secti o n 1 0. 8. 1. 3 Sc he d ule of 
Acti vities: S u bst u d y B
Secti o n 1 0. 8. 8. 1. 1 R S V Vacci ne 
A nti b o d y Testi n g ( S u bst u d y B)
A d de d refere nce t o P S S A f or 
re p orti n g of safet y i nf or mati o n t o 
Pfizer Safet y a n d e dite d te xt i n li ne 
wit h c urre nt pr ocess.
T o ca pt ure t he re p orti n g pr ocess 
t o Pfizer Safet y via P S S A.
Secti o n 8. 4 A d verse E ve nts , 
S eri o us A d verse E ve nts , a n d Ot her 
Safet y Re p orti n g
Secti o n 1 0. 2 A p pe n di x 2: A d verse 
E ve nt s: 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
Re m o ve d ris k relate d t o t he 
C O VI D -1 9 pa n de mic.
C ha n ge t o pa n de mic stat us wa s 
declare d i n Ma y 2 0 2 3.
Secti o n 1. 1 S y n o psis
Secti o n 2. 3. 1 Ris k Assess me nt
Mi n or e dit orial c ha n ges.
C orrecti o ns or mi n or e dits i n li ne 
wit h a me n d me nt a n d te m plate 
u p dates a n d/ or t o i m pr o ve clarit y 
a n d na vi gati o n t hr o u g h o ut t he
d oc u me nt f or sites.
All
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6
T A B L E O F C O N T E N T S
LI S T O F T A B L E S ...................................................................................................................1 3
1. P R O T O C O L  S U M M A R Y................................................................................................... 1 4
1. 1. S y n o psis .................................................................................................................. 1 4
1. 2. Sc he ma .................................................................................................................... 1 8
1. 3. Sc he d ule of Acti vities ............................................................................................. 1 8
2. I N T R O D U C TI O N ............................................................................................................... 1 8
2. 1. St u d y  Rati o nale....................................................................................................... 1 9
2. 2. Bac k gr o u n d ............................................................................................................. 2 0
2. 2. 1. Cli nical O ver vie w ....................................................................................... 2 1
2. 3. Be nefit/ Ris k Assess me nt ......................................................................................... 2 3
2. 3. 1. Ris k Assess me nt ......................................................................................... 2 5
2. 3. 2. Be nefit Assess me nt ..................................................................................... 2 7
2. 3. 3. O verall Be nefit/ Ris k C o ncl usi o n ................................................................ 2 7
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 ........................................................... 2 7
4. S T U D Y D E SI G N ................................................................................................................. 2 7
4. 1. O verall Desi g n ......................................................................................................... 2 7
4. 2. Scie ntific Rati o nale f or St u d y  Desi g n..................................................................... 2 7
4. 2. 1. Di versit y  of St u d y P o p ulati o n .................................................................... 2 8
4. 3. J ustificati o n f or D ose ..............................................................................................2 8
4. 4. E n d of St u d y  Defi niti o n .......................................................................................... 2 8
5. S T U D Y P O P U L A T I ON ...................................................................................................... 2 8
5. 1. I ncl usi o n Criteria ..................................................................................................... 2 8
5. 2. E xcl usi o n Criteria .................................................................................................... 2 9
5. 3. Li fest yle C o nsi derati o ns.......................................................................................... 2 9
5. 4. Scree n Fail ures ........................................................................................................ 2 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 ........................... 2 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 .................................2 9
6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d ........................................................................ 2 9
6. 1. 1. A d mi nistrati o n ............................................................................................ 3 0
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7
6. 1. 2. Me dical De vices ......................................................................................... 3 0
6. 2. Pre parati o n, Ha n dli n g, St ora ge, a n d Acc o u nta bilit y ............................................... 3 0
6. 2. 1. Pre parati o n a n d Dis pe nsi n g ........................................................................ 3 1
6. 3. Assi g n me nt t o St u d y I nter ve nti o n ........................................................................... 3 2
6. 4. Bli n di n g ................................................................................................................... 3 2
6. 5. St u d y  Inter ve nti o n C o m plia nce ............................................................................... 3 2
6. 6. D ose M o dificati o n ................................................................................................... 3 2
6. 7. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d of t he St u d y ...................... 3 2
6. 8. Treat me nt of O ver d ose ............................................................................................ 3 3
6. 9. Pri or a n d C o nc o mita nt T hera p y .............................................................................. 3 3
6. 9. 1. Pr o hi bite d C o nc o mita nt Vacci nati o ns a n d Treat me nts .............................. 3 3
6. 9. 2. Per mitte d C o nc o mita nt Vacci nati o ns a n d Treat me nts ............................... 3 3
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 ........................................................................... 3 3
7. 1. Disc o nti n uati o n of St u d y  Inter ve nti o n .................................................................... 3 3
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 ....................................... 3 4
7. 2. 1. Wit h dra wal of C o nse nt ............................................................................... 3 4
7. 3. L ost t o F oll o w -U p ................................................................................................... 3 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 ...............................................................3 5
8. 1. A d mi nistrati ve a n d Baseli ne Pr oce d ures ................................................................. 3 5
8. 1. 1. Tele healt h Visits ......................................................................................... 3 6
8. 2. I m m u n o ge nicit y Assess me nts ................................................................................. 3 6
8. 2. 1. R S V Vacci ne A nti b o d y  Testi n g ................................................................. 3 6
8. 2. 2. E x pl orat or y  Assa ys, Incl u di n g I m m u n o ge nic it y Assess me nts a n d 
Assa y  De vel o p me nt......................................................................................... 3 7
8. 2. 3. Bi ol o gical Sa m ples ..................................................................................... 3 7
8. 3. Safet y Assess me nts ................................................................................................. 3 7
8. 3. 1. P h y sical E xa mi nati o ns ................................................................................ 3 7
8. 3. 2. Vital Si g ns .................................................................................................. 3 8
8. 3. 3. Cli nical Safet y  La b orat or y Assess me nts.................................................... 3 8
8. 3. 4. Electr o nic Diar y  f or React o ge nicit y........................................................... 3 8
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8
8. 3. 4. 1. Gra di n g Scales ........................................................................... 3 9
8. 3. 4. 2. L ocal Reacti o ns .........................................................................3 9
8. 3. 4. 3. S y ste mic E ve nts ........................................................................ 4 0
8. 3. 4. 4. Te m perat ure .............................................................................. 4 1
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 ................. 4 2
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y  f or C ollecti n g A E a n d S A E I nf or mati o n....... 4 3
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer Safet y ............................................... 4 3
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 ................... 4 4
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es .......................................................... 4 4
8. 4. 3. F oll o w -U p of A Es a n d S A Es ...................................................................... 4 4
8. 4. 4. Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es........................................... 4 4
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 ..................................................... 4 5
8. 4. 5. 1. E x p os ure D uri n g Pre g na nc y ......................................................4 5
8. 4. 5. 2. E x p os ure D uri n g Breastfee di n g ................................................ 4 7
8. 4. 5. 3. Occ u pati o nal E x p os ure ............................................................. 4 7
8. 4. 6. Car di o vasc ular a n d Deat h E ve nts ...............................................................4 7
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 .............................................................................. 4 7
8. 4. 8. A d verse E ve nts of S pecial I nterest ............................................................. 4 8
8. 4. 8. 1. Lac k of Efficac y ........................................................................ 4 8
8. 4. 9. Me dical De vice Deficie ncies ...................................................................... 4 8
8. 4. 9. 1. Ti me Peri o d f or Detecti n g Me dical De vice Deficie ncies ......... 4 9
8. 4. 9. 2. Re g ulat or y  Re p orti n g Re q uire me nts f or De vice 
Deficie ncies ....................................................................................... 4 9
8. 4. 1 0. Vacci nati o n Err ors .................................................................................... 4 9
8. 5. P har mac o ki netics .................................................................................................... 5 0
8. 6. Ge netics ................................................................................................................... 5 1
8. 6. 1. S pecifie d Ge netics ...................................................................................... 5 1
8. 7. Bi o mar kers .............................................................................................................. 5 1
8. 8. I m m u n o ge nicit y Assess me nts ................................................................................. 5 1
8. 9. Healt h Ec o n o mics ................................................................................................... 5 1
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9
8. 1 0. U nsc he d ule d React o ge nicit y  Visit........................................................................ 5 1
9. S T A TI S TI C A L C O N SI D E R A TI O N S ................................................................................ 5 2
9. 1. Statistical H y p ot hesis ..............................................................................................5 3
9. 1. 1. Esti ma n ds .................................................................................................... 5 3
9. 1. 2. M ulti plicit y  A dj ust me nt.............................................................................. 5 3
9. 2. A nal y sis Sets ........................................................................................................... 5 3
9. 3. Stati stical A nal yses ................................................................................................. 5 3
9. 3. 1. Ge neral C o nsi derati o ns ............................................................................... 5 3
9. 3. 1. 1. A nal y ses f or Bi nar y Data.......................................................... 5 4
9. 3. 1. 2. A nal y ses f or C o nti n u o us Data................................................... 5 4
9. 4. I nteri m A nal ys es ..................................................................................................... 5 5
9. 5. Sa m ple Size Deter mi nati o n ..................................................................................... 5 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 .......................................................................................................... 5 6
1 0. 1. A p pe n di x 1: Re g ulat or y , Et hical, a n d St u d y O versi g ht C o nsi derati o ns............... 5 6
1 0. 1. 1. Re g ulat or y  a n d Et hical C o nsi derati o ns .................................................... 5 6
1 0. 1. 1. 1. Re p orti n g of Safet y  Iss ues a n d Seri o us Breac hes of t he 
Pr ot oc ol or I C H G C P ......................................................................... 5 6
1 0. 1. 2. Fi na ncial Discl os ure ................................................................................. 5 7
1 0. 1. 3. I nf or me d C o nse nt Pr ocess ........................................................................ 5 7
1 0. 1. 3. 1. Electr o nic C o nse nt .................................................................. 5 8
1 0. 1. 4. Data Pr otecti o n ......................................................................................... 5 8
1 0. 1. 5. C o m mittees Str uct ure ............................................................................... 5 9
1 0. 1. 5. 1. Data M o nit ori n g C o m mittee ................................................... 5 9
1 0. 1. 6. Disse mi nati o n of Cli nical St u d y  Data ...................................................... 5 9
1 0. 1. 7. Data Q ualit y Ass ura nce ............................................................................ 6 0
1 0. 1. 8. S o urce D oc u me nts ....................................................................................6 1
1 0. 1. 9. Use of Me dical Rec or ds ............................................................................6 2
1 0. 1. 1 0. St u d y  a n d Site Start a n d Cl os ure ............................................................6 2
1 0. 1. 1 1. P u blicati o n P olic y ...................................................................................6 3
1 0. 1. 1 2. S p o ns or’s Me dicall y  Q ualifie d I n di vi d ual..............................................6 4
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0
1 0. 2. A p pe n di x 2: 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 .....................................................................6 5
1 0. 2. 1. Defi niti o n of A E ....................................................................................... 6 5
1 0. 2. 2. Defi niti o n of a n S A E ................................................................................ 6 6
1 0. 2. 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............................................................................ 6 8
1 0. 2. 4. Re p orti n g of S A Es .................................................................................... 7 1
1 0. 2. 5. Ne wl y Dia g n ose d C hr o nic Me dical C o n diti o ns ....................................... 7 2
1 0. 3. A p pe n di x 3: C o ntrace pti ve a n d Barrier G ui da nce ................................................ 7 2
1 0. 4. A p pe n di x 4: 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 ....... 7 3
1 0. 5. A p pe n di x 5: 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 M e dical De vice St u dies ............................................. 7 5
1 0. 5. 1. Defi niti o n of A E a n d A D E ....................................................................... 7 5
1 0. 5. 2. Defi niti o n of S A E, S A D E, a n d U S A D E .................................................. 7 5
1 0. 5. 3. Defi niti o n of De vi ce Deficie nc y ...............................................................7 6
1 0. 5. 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 ...................................................................................................... 7 6
1 0. 6. A p pe n di x 6: 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 I nfecti o n .................................................................................................. 7 9
1 0. 7. A p pe n di x 7: S u bst u d y  A....................................................................................... 8 0
1 0. 7. 1. S u bst u d y  A S u m mar y............................................................................... 8 0
1 0. 7. 1. 1. S y n o psis .................................................................................. 8 0
1 0. 7. 1. 2. Sc he ma: S u bst u d y  A ...............................................................8 0
1 0. 7. 1. 3. Sc he d ule of Acti vities: S u bst u d y  A ........................................ 8 0
1 0. 7. 2. I ntr o d ucti o n f or S u bst u d y  A..................................................................... 8 2
1 0. 7. 2. 1. St u d y  Rati o nale....................................................................... 8 2
1 0. 7. 2. 2. Bac k gr o u n d .............................................................................8 2
1 0. 7. 2. 3. Be nefit/ Ris k Assess me nt......................................................... 8 2
1 0. 7. 3. O bjecti ves, E n d p oi nts, a n d Esti ma n ds f or S u bst u d y  A............................ 8 2
1 0. 7. 4. St u d y  Desig n f or S u bst u d y  A................................................................... 8 4
1 0. 7. 4. 1. O verall Desi g n ......................................................................... 8 4
1 0. 7. 4. 2. Scie ntific Rati o nale f or S u bst u d y A Desi g n ........................... 8 4
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1
1 0. 7. 4. 3. J ustificati o n f or D ose ..............................................................8 5
1 0. 7. 4. 4. E n d of St u d y  Defi niti o n .......................................................... 8 5
1 0. 7. 5. St u d y  P o p ulati o n f or S u bst u d y A............................................................. 8 5
1 0. 7. 5. 1. I ncl usi o n Criteria ..................................................................... 8 5
1 0. 7. 5. 2. E xcl usi o n Criteria.................................................................... 8 6
1 0. 7. 5. 3. L ifest yle C o nsi derati o ns.......................................................... 8 8
1 0. 7. 5. 4. Scree n Fail ures ........................................................................ 8 8
1 0. 7. 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  
I nter ve nti o n........................................................................................ 8 8
1 0. 7. 6. St u d y  Inter ve nti o n a n d C o nc o mita nt T hera p y  f or S u bst u d y A................ 8 9
1 0. 7. 6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d f or S u bst u d y  A............... 8 9
1 0. 7. 6. 2. Bli n di n g f or S u bst u d y  A ......................................................... 9 0
1 0. 7. 6. 3. St u d y  Inter ve nti o n C o m plia nce ............................................... 9 1
1 0. 7. 6. 4. D ose M o dificati o n ................................................................... 9 1
1 0. 7. 6. 5. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d of 
t he St u d y............................................................................................ 9 1
1 0. 7. 6. 6. Treat me nt of O ver d ose ............................................................ 9 1
1 0. 7. 6. 7. Pri or a n d C o nc o mita nt T hera p y f or S u bst u d y A..................... 9 2
1 0. 7. 7. Disc o nti n uati o n of St u d y  Inter ve nti o n a n d Partici pa nt 
Disc o nti n uati o n/ Wit h dra wal f or S u bst u d y  A...................................................9 3
1 0. 7. 8. St u d y  Assess me nts a n d Pr oce d ures f or S u bst u d y A................................. 9 4
1 0. 7. 8. 1. I m m u n o ge nicit y  Assess me nts................................................. 9 4
1 0. 7. 8. 2. Safet y Assess me nts ................................................................. 9 4
1 0. 7. 8. 3. 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................................................................................ 9 5
1 0. 7. 8. 4. S u bst u d y  A Pr oce d ures ........................................................... 9 5
1 0. 7. 9. Statistical C o nsi derati o ns f or S u bst u d y A ................................................ 9 9
1 0. 7. 9. 1. Statistical H y p ot heses ............................................................. 9 9
1 0. 7. 9. 2. A nal y sis Sets ......................................................................... 1 0 0
1 0. 7. 9. 3. Statistical A nal y sis ................................................................ 1 0 1
1 0. 7. 9. 4. I nteri m A nal ys is.................................................................... 1 0 3
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2
1 0. 7. 9. 5. Sa m ple Size Deter mi nati o n................................................... 1 0 3
1 0. 8. A p pe n di x 8: S u bst u d y  B ..................................................................................... 1 0 5
1 0. 8. 1. S u bst u d y  B S u m mar y ............................................................................. 1 0 5
1 0. 8. 1. 1. S y n o psis ................................................................................ 1 0 5
1 0. 8. 1. 2. Sc he ma: S u bst u d y  B..............................................................1 0 5
1 0. 8. 1. 3. Sc he d ule of Acti vities: S u bst u d y  B....................................... 1 0 5
1 0. 8. 2. I ntr o d ucti o n f or S u bst u d y  B ................................................................... 1 0 7
1 0. 8. 2. 1. St u d y  Rati o nale..................................................................... 1 0 7
1 0. 8. 2. 2. Bac k gr o u n d ........................................................................... 1 0 7
1 0. 8. 2. 3. Be nefit/ Ris k Assess me nt ....................................................... 1 0 7
1 0. 8. 3. O bjecti ves, E n d p oi nts, a n d Esti ma n ds f or S u bst u d y  B ..........................1 0 7
1 0. 8. 4. St u d y  Desi g n f or S u bst u d y B ................................................................. 1 0 8
1 0. 8. 4. 1. O verall Desi g n ....................................................................... 1 0 8
1 0. 8. 4. 2. Scie ntific Rati o nale f or S u bst u d y B Desi g n .......................... 1 0 8
1 0. 8. 4. 3. J ustificati o n f or D ose ............................................................ 1 0 8
1 0. 8. 4. 4. E n d of St u d y  Defi niti o n ........................................................ 1 0 9
1 0. 8. 5. St u d y  P o p ulati o n f or S u bst u d y B ........................................................... 1 0 9
1 0. 8. 5. 1. I ncl usi o n Criteria ................................................................... 1 0 9
1 0. 8. 5. 2. E xcl usi o n Criteria .................................................................. 1 1 0
1 0. 8. 5. 3. L ifest yle C o nsi derati o ns........................................................ 1 1 2
1 0. 8. 5. 4. Scree n Fail ures ...................................................................... 1 1 2
1 0. 8. 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  
I nter ve nti o n...................................................................................... 1 1 2
1 0. 8. 6. St u d y  Inter ve nti o n a n d C o nc o mita nt T hera p y  f or S u bst u d y B .............. 1 1 2
1 0. 8. 6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d ...................................... 1 1 3
1 0. 8. 6. 2. Bli n di n g f or S u bst u d y  B........................................................ 1 1 4
1 0. 8. 6. 3. St u d y  Inter ve nti o n C o m plia nce ............................................. 1 1 4
1 0. 8. 6. 4. D ose M o dificati o n ................................................................. 1 1 4
1 0. 8. 6. 5. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d of 
t he St u d y.......................................................................................... 1 1 5
1 0. 8. 6. 6. Treat me nt of O ver d ose .......................................................... 1 1 5
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 3
1 0. 8. 6. 7. Pri or a n d C o nc o mita nt T hera p y f or S u bst u d y  B................... 1 1 5
1 0. 8. 7. Disc o nti n uati o n of St u d y  Inter ve nti o n a n d Partici pa nt 
Disc o nti n uati o n/ Wit h dra wal f or S u bst u d y  B................................................. 1 1 7
1 0. 8. 8. St u d y  Assess me nts a n d Pr oce d ures f or S u bst u d y B............................... 1 1 7
1 0. 8. 8. 1. I m m u n o ge nicit y  Assess me nts............................................... 1 1 7
1 0. 8. 8. 2. Safet y Assess me nts ...............................................................1 1 7
1 0. 8. 8. 3. 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 1 8
1 0. 8. 8. 4. S u bst u d y  B Pr oce d ures.......................................................... 1 1 8
1 0. 8. 9. Statistical C o nsi derati o ns f or S u bst u d y B .............................................. 1 2 4
1 0. 8. 9. 1. Statistical H y p ot heses ........................................................... 1 2 4
1 0. 8. 9. 2. A nal y sis Sets ......................................................................... 1 2 4
1 0. 8. 9. 3. Statistical A nal y sis ................................................................ 1 2 5
1 0. 8. 9. 4. I nteri m A nal ys is.................................................................... 1 2 7
1 0. 8. 9. 5. Sa m ple Size Deter mi nati o n ................................................... 1 2 7
1 0. 9. A p pe n di x 9: A b bre viati o ns ................................................................................. 1 2 8
1 1. R E F E R E N C E S ................................................................................................................ 1 3 2
LI S T O F T A B L E S
Ta ble 1.
Hi g h -Le vel O ver vie w of S u bst u dies i n Pr ot oc ol ......................................2 7
Ta ble 2.  
Gra di n g Scale f or L ocal Reacti o ns........................................................... 4 0
Ta ble 3.
Gra di n g Scale f or S ys te mic E ve nts .......................................................... 4 1
Ta ble 4.
Ra n ges f or Fe ver ....................................................................................... 4 2
Ta ble 5.
Pri mar y  E n d p oi nt A nalys es .................................................................... 1 0 1
Ta ble 6.
Sec o n dar y  E n d p oi nt A nal yses ................................................................1 0 3
Ta ble 7.
P o wer t o S h o w N o ni nferi orit y  of R S V A a n d R S V B Ser u m 
Ne utralizi n g Titers i n S u bst u d y  A i n St u d y C 3 6 7 1 0 2 3 C o m pare d t o 
A d ults ≥6 0 Years of A ge i n St u d y C 3 6 7 1 0 1 3 ........................................ 1 0 4
Ta ble 8.
Pri mar y  E n d p oi nt A nalys es .................................................................... 1 2 5
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 4
1. P R O T O C O L S U M M A R Y 
1. 1. S y n o psis 
R S V is a n i m p orta nt ca use of se vere res pirat or y  disease ass ociate d wit h hi g h m or bi dit y a n d 
m ortalit y  i n ol der a d ults ≥6 0 ye ars of a ge a n d a d ults ≥1 8 y ears of a ge wit h u n derl y i n g 
c hr o nic me dical c o n diti o ns or w h o are i m m u n oc o m pr o mise d.  After R S V nat ural i nfecti o n, 
t here is o nl y a relati vel y s h ort d urati o n of i m m u nit y. C urre ntl y , n o s pecific effecti ve 
treat me nts f or R S V e xist. C urre nt treat me nts c o nsist pri maril y  of s u p p orti ve care.  O n 
3 1 Ma y  2 0 2 3, base d o n efficac y a n d safety data fr o m t he st u d y i n t he ol der a d ult p o p ulati o n 
( C 3 6 7 1 0 1 3), t he F D A a p pr o ve d R S V pre F ( A br ys v o™) f or mar keti n g i n i n di vi d uals 6 0 years 
of a ge a n d ol der i n t he U S. T here is c urre ntl y  n o lice nse d vacci ne t o pre ve nt R S V i nfecti o n 
i n yo u n ger a d ults , a n d f urt her st u dies are re q uire d f or a d ults wit h wea ke ne d i m m u ne s y ste ms.
T he o nl y  ot her a vaila ble pr o p h ylactic meas ures are m o n ocl o nal a nti b o dies, w hic h are li mite d 
t o use i n i nfa nts a n d c hil dre n u p t o 2 4 m o nt hs of a ge .  T heref ore, t here is a n i m p orta nt u n met 
me dical nee d t o de vel o p a n ef fecti ve vacci ne t o b o ost t he i m m u ne res p o nse s ufficie ntly t o 
pr otect i m m u n oc o m pr o mise d a d ults a n d a d ults u n der 6 0 y ears of a ge at hi g h ris k of se vere 
R S V disease.
T his is a P hase 3 st u d y  t o e val uate t he safety, t olera bilit y , a n d i m m u n o ge nicit y of R S V pre F
i n a d ults at hi g h ris k of se vere R S V disease a n d i m m u n oc o m pr o mise d a d ults . St u d y i n g t he 
safety, a n d/ or t olera bilit y, a n d/ or i m m u n o ge nicit y of R S V pre F u n der a si n gle pr ot oc ol, rat her 
t ha n se parate pr ot oc ols, will all o w a n or ga nize d a p pr oac h t hat ca n be easil y a da pte d as 
differe nt c o u ntries’ lice ns ure re q uire me nts are i nc or p orate d.  T his a p pr oac h will be n ot o nl y  
m ore e x pe diti o us t o i m ple me nt b ut als o m ore rea dil y  u n dersta n da ble f or i n vesti gati o nal sites.
Pr ot oc ol Title:
A P hase 3 Pr ot oc ol t o E val uate the Safet y , T olera bilit y, a n d I m m u n o ge nicit y of Res pirat or y 
S y n c y tial Vir us ( R S V) Pref usi o n F S u b u nit Vacci ne i n A d ults at Hi g h Ris k o f Se vere R S V 
Disease
Brief Title:
A P hase 3 Pr ot oc ol 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 i n 
A d ults at Hi g h Ris k of Se vere R S V Disease
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:
0 1 7 9 3 1
E u dr a C T / E U C T N u m ber:
N ot A p plica ble
Cli nic al Tri als. g o v I D:  
N C T 0 5 8 4 2 9 6 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 3 6 7 1 0 2 3
P h ase:
3
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 5
R ati o n ale :
St u d y  C 3 6 7 1 0 1 3 ( N C T 0 5 0 3 5 2 1 2) is a n o n g oi n g P hase 3 trial i n ~ 4 5, 0 0 0 partici pa nts
desi g ne d t o ge nerate safet y , i m m u n o ge nicit y, a n d efficac y data f or Pfizer’s R S V pre F vacci ne 
ca n di date.  Pr o of t hat t he vacci ne is efficaci o us i n pre ve nti n g L R TI  ca use d b y R S V i n ol der 
a d ults ( ≥6 0 y ears of a ge ) was de m o nstrate d i n t his st u d y.  I n t he pri mar y a nalys is, pr otecti o n 
a gai nst LR TI -R S V defi ne d b y  2 or m ore sy m pt o ms de m o nstrate d a 6 6. 7 % vacci ne effic a c y.  
V acci ne efficac y of 8 5. 7 % was o bser ve d i n partici pa nts wit h t he pri mar y e n d p oi nt of 
L R TI -R S V defi ne d b y  3 or m ore R S V-ass ociate d s ym pt o ms.  O n 3 1 Ma y  2 0 2 3, base d o n 
efficac y a n d safety data fr o m t his st u d y i n t he ol der a d ult p o p ulati o n, t he F D A a p pr ove d 
R S V pre F ( A br y s v o) f or i n di vi d uals 6 0 years of a ge a n d ol der i n t he U S.
St u d y  C 3 6 7 1 0 1 3 e nr olle d partici pa nts ≥6 0 ye ars of a ge w h o were hea lt h y or ha d sta ble 
c hr o nic me dical c o n diti o ns , i ncl u di n g C O P D, ast h ma, a n d C H F , b ut pr o hi bite d t he 
e nr oll me nt of a d ults 1 8 t hr o u g h < 6 0 ye ars of a ge a n d all i m m u n oc o m pr o mise d a d ults. 
Gi ve n t hat i n di vi d uals 1 8 t hr o u g h 6 0 y ears of a ge wit h hi g h -ris k me dical c o n diti o ns are at 
si g nifica nt ris k of m or bi dit y a n d m ortality d ue t o R S V i nfecti o n a n d gi ve n t he se verit y of 
R S V disease o bser ve d i n i m m u n oc o m pr o mise d h osts 1 8 years of a ge a n d ol der , it is 
i m porta nt t hat t he safety a n d i m m u ne res p o nse t o vacci nati o n a m o n g t his c o h ort are
i n vesti gate d. I n or der t o o btai n i nf or mati o n re gar di n g t he safety a n d i m m u n o ge nicit y  a m o n g 
hi g h -ris k partici pa nts, re prese ntati ve me dical c o n diti o ns (a n d t heir res pecti ve treat me nts) 
ha ve bee n selecte d f or t he c urre nt st u d y.
Me dical c o n diti o ns a n d ass ociate d treat me nts ha ve 
bee n selecte d o n t he basis of t he s u bsta ntial m or bi dit y / m ortalit y ass ociate d wit h R S V 
i nfecti o n, feasi ble recr uit me nt ti meli nes, re g ulat or y re q uire me nts, a n d t he a bilit y t o 
ge neralize safet y a n d i m m u n o ge nicit y res ults o verall.
O bjecti ves , E n d p oi nts , a n d Esti m a n ds :
Please refer t o t he s u bst u d y  a p pe n dices f or t he o bjecti ves, e nd p oi nts , a n d esti ma n ds of eac h 
s u bst u d y.
O ver all Desi g n:
T his is a P hase 3 pr ot oc ol t hat will assess t he safet y, t olera bilit y, a n d i m m u n o ge nicit y of 
Pfizer’s R S V pre F i n a d ults at hi g h ris k of se vere R S V disease . Eac h s u bst u d y  desi g n is 
detaile d se paratel y, a n d t hese s u bst u dies ma y be c o n d ucte d i n parallel, as re q uire d by t he 
cli nical pla n, wit hi n t he fra me w or k of t his pr ot oc ol.
S u bst u d y A Desi g n
T his is a P hase 3, m ultice nter, ra n d o mize d, d o u ble- bli n d e d, place b o-c o ntr olle d st u d y t hat 
will assess t he safet y , t olera bilit y, a n d i m m u n o ge nicit y of Pfizer’s R S V pre F i n a d ults 1 8 t o 
< 6 0 ye ars of a ge c o nsi dere d t o be at hi g h ris k of R S V disease d ue t o certai n c hr o nic me dical 
c o n diti o ns.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 6
A p pr o xi matel y  6 7 5 partici pa nts ≥1 8 t o < 6 0 y ears of a ge c o nsi dere d at hi g h ris k of R S V 
disease d ue t o certai n c hr o nic me dical c o n diti o ns , e xcl u di n g i m m u n oc o m pr o misi n g 
c o n diti o ns , will be ra n d o mize d t o recei ve a si n gle 1 2 0-µ g d ose of R S V pre F or place b o i n a 
2: 1 rati o.  E nr oll me nt will be m o nit ore d t o hel p e ns ure distri b uti o n of vacci nati o n acr oss t he 
a ge ra n ge.   T he d urati o n of st u d y  partici pati o n f or eac h partici pa nt will be 6 m o nt hs, wit h 
3 sc he d ule d visits.
All partici pa nts will ha ve bl o o d dra w n at baseli ne pri or t o vacci nati o n a n d at 1 m o nt h after 
vacci nati o n t o assess i m m u n o ge nicit y. I m m u n o ge nicit y elicite d at 1 m o nt h after vacci nati o n 
wit h R S V pre F i n S u bst u d y  A will be bri d ge d t o t he i m m u n o ge nicity of partici pa nts 6 0 y ears 
of a ge a n d ol der i n t he C 3 6 7 1 0 1 3 st u d y , i n w hic h R S V pre F efficac y was de m o nstrate d.
L ocal reacti o n a n d s yste mic e ve nt data will be c ollecte d i n a n e-diar y  f or 7 da ys after st u d y 
vacci nati o n ( Da y s 1 t hr o u g h 7, w here Da y 1 is t he da y of vacci nati o n).  Re p orte d Gra de 3 
react o ge nicit y will be assesse d b y t he st u d y site t o deter mi ne if a n u nsc he d ule d visit is 
re q uire d.
F or all partici pa nts, A Es will be c ollecte d fr o m i nf or me d c o nse nt t hr o u g h 1 m o nt h f oll o wi n g 
st u d y i nter ve nti o n a d mi nistrati o n, a n d A E SI s, N D C M Cs , a n d S A Es will be c ollecte d fr o m 
i nf or me d c o nse nt t hr o u g h o ut st u d y partici pati o n.  In a d diti o n, A Es occ urri n g u p t o 4 8 h o urs 
after bl o o d dra ws t hat are relate d t o st u d y pr oce d ures will be c ollecte d.
S u bst u d y B Desi g n
T his is a P hase 3, si n gle-ar m, o pe n -la bel, m ultice nter st u d y t hat will assess t he safety, 
t olera bilit y, a n d i m m u n o ge nicit y of Pfizer’s R S V pre F i n i m m u n oc o m pr o mise d a d ults.
A p pr o xi matel y  2 0 0 im m u n oc o m pr o mise d a d ults ≥1 8 ye ars of a ge will recei ve 2 1 2 0- µ g
d oses of R S V pre F wit h a n i nter val of 1 m o nt h . A p pr o xi matel y  1 0 0 partici pa nts will be 
≥6 0 ye ars of a ge a n d a p pr o xi matel y 1 0 0 partici pa nts will be ≥1 8 t o < 6 0 ye ars of a ge.
E nr oll me nt will be m o nit ore d t o hel p e ns ure distri b uti o n of vacci nati o n acr oss t he a ge ra n ge s
a n d u n derl yi n g i m m u n oc o m pr o misi n g c o n diti o ns. T he d urati o n of st u d y  partici pati o n f or 
eac h partici pa nt will be 7 m o nt hs, wit h 4 sc he d ule d visits.  All partici pa nts will ha ve bl o o d 
dra w n at baseli ne pri or t o vacci nati o n a n d at 1 m o nt h after (eac h) vacci na ti o n t o assess 
i m m u n o ge nicity. 
L ocal reacti o n a n d s ys te mic e ve nt data will be c ollecte d i n a n e-diar y  f or 7 da ys after st u d y 
vacci nati o n ( Da y s 1 t hr o u g h 7, w here Da y 1 is t he da y of vacci nati o n). Re p orte d Gra de 3 
react o ge nicit y will be assesse d b y t he stu d y  site t o deter mi ne if a n u nsc he d ule d visit is 
re q uire d.  
F or all partici pa nts, A Es will be c ollecte d fr o m i nf or me d c o nse nt t hr o u g h 1 m o nt h f oll o wi n g 
t he last st u d y i nter ve nti o n a d mi nistrati o n, a n d A E SI s, N D C M Cs , a n d S A Es will be c ollecte d 
fr o m i nf or me d c o nse nt t hr o u g h o ut st u dy partici pati o n. I n a d diti o n, A Es occ urri n g u p t o 
4 8 h o urs after bl o o d dra ws t hat are relate d t o st u d y  pr oce d ures will be c ollecte d.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 7
N u m ber of P artici p a nts:
S u bst u d y A: A p pr o xi matel y  6 7 5 partici pa nts will be e nr olle d i n t he st u d y.
S u bst u d y B: A p pr o xi matel y  2 0 0 partici pa nts will be e nr olle d i n t he st u d y . 
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. A partici pa nt will be c o nsi dere d e nr olle d if t he 
i nf or me d c o nse nt is n ot wit h dra w n pri or t o partici pati n g i n a n y  st u d y acti vit y.
St u d y P o p ul ati o n :
Please refer t o t he s u bst u d y  a p pe n dices f or t he i ncl usi o n a n d e xcl usi o n criteria of eac h 
s u bst u d y.
St u d y Ar ms a n d D ur ati o n :
Please refer t o t he s u bst u d y  a p pe n dices f or t he st u d y ar ms a n d d urati o n of eac h s u bst u d y.
St atistic al Met h o ds :
Please refer t o t he s u bst u d y  a p pe n dices f or t he statistical met h o ds of eac h s u bst u d y .
Et hic al C o nsi der ati o ns :
T he a vaila ble safet y, i m m u n o ge nicit y, 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 s u p p ort a fa v ora ble be nefit/ris k pr ofile a n d s u p p ort t he cli nical de vel o p me nt of t he 
vacci ne. 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 partici pa nts i n t his st u d y.
R S V pre F is a n F gl y c o pr otei n s u b u nit sta bilize d i n t he pref usi o n c o nf or mati o n , eliciti n g
str o n g ne utralizi n g a nti b o dies as esta blis he d i n t he a d ult st u dies a n d has alrea dy s h o w n 
efficac y i n pre ve nti n g L R TI  i n ol der a d ults a n d se vere LR TI  i n i nfa nts b or n t o vacci nate d 
m ot hers. 
Base d o n t he e x perie nce wit h R S V pre F, t he p ote ntial ris ks ar e:

L ocal reacti o ns , s uc h as i njecti o n site re d ness, i njecti o n site s welli n g, a n d i njecti o n 
site pai n; s yste mic e ve nts, s uc h as fati g ue, hea dac he, m uscle pai n, a n d j oi nt pai n; a n d 
fe ver.

O ne case of G uillai n -Barre s y n dr o me a n d 1 case of Miller Fis her s y n dr o me ( b ot h 
wit h a pla usi ble te m p oral relati o ns hi p wit h vacci nati o n) were i de ntifie d i n 
St u d y  C 3 6 7 1 0 1 3 c o n d ucte d i n ol der a d ults 6 0 years of a ge a n d ol der.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 8
T he st u d y  pr oce d ure-relate d ris ks i ncl u de:

Ve ni p u nct ure will be perf or me d d uri n g t he st u d y.
1. 2. Sc he m a
Please refer t o t he s u bst u d y  a p pe n dices f or t he sc he ma of eac h st u d y.
1. 3. S c he d ule of Acti v ities
T he S o A ta ble pr o vi des a n o ver vie w of t he pr ot oc ol visits a n d pr oce d ures. Refer t o t he 
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 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.   Base d o n re vie w of data, at Pfizer’s discreti o n, st u d y  visits, bl o o d sa m ple 
c ollecti o n/a nal ys is, or ot her pr oce d ures ma y be halte d or disc o nti n ue d if i n t he best i nterests 
of a partici pa nt (e g, s h o ul d t he partici pa nt be f o u n d t o n ot meet certai n eli gi bilit y  criteria 
after a d mi nistrati o n of st u d y i nter ve nti o n).
F or t he S u bst u d y  A S o A , refer t o Secti o n 1 0. 7. 1. 3 .
F or t he S u bst u d y  B S o A , refer t o Secti o n 1 0. 8. 1. 3 .
2. I N T R O D U C TI O N
Pfizer is c urre ntl y  de vel o pi n g a vacci ne, R S V pre F, f or t he pre ve nti o n of L R TI-R S V b y  
pr otecti n g a d ults 6 0 years of a ge a n d ol der via direct i m m u nizati o n a n d mater nal 
i m m u nizati o n d uri n g pre g na nc y.  O n 3 1 Ma y  2 0 2 3, base d o n efficac y a n d safety data fr o m 
t he st u d y i n t he ol der a d ult p o p ulati o n ( C 3 6 7 1 0 1 3), t he F D A a p pr o ve d R S V pre F 
( A br ys v o™) f or mar keti n g i n i n di vi d uals 6 0 years of a ge a n d ol der i n t he U S. 1
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 
i nfa nts, ol der a d ults , a n d t h ose wit h healt h c o n diti o ns t hat p ut t he m at i ncrease d ris k of 
se vere R S V a n d c o m plicati o ns . 
T here are 2 a nti ge nic varia nts of R S V, R S V A a n d R S V B, t hat c ocirc ulate. 2 Li ke i nfl ue nza, 
R S V i nfecti o n t ypicall y 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 fall 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 wit h rai ny seas o ns b ut are m ore u n pre dicta ble a n d 
fre q ue ntly c o nti n u o us. 3  
Ol der 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 ns of u n derl yi 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 a ss 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.4 H o we ver y o u n ger 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 9
at-ris k p o p ulati o ns ha ve bee n f o u n d t o ha ve si g nifica nt se q uelae fr o m se vere R S V disease , 
i ncl u di n g I C U a d missi o n a n d mec ha nical ve ntilati o n. At -ris k a d ults (1 8 ye ars of a ge a n d 
ol der ) i ncl u de patie nts wit h car di o p ul m o nar y or re nal disease, a n d i m m u n oc o m pr o mise d 
patie nts , i ncl u di n g S O T a n d H S C T reci pie nts, patie nts o n c he m ot hera p y treat me nt or
i m m u n o m o d ulat or dr u gs, a n d ot hers.5 ,6 ,7 I n o ne st u d y, wit h a mea n a ge of 5 3. 7 8 a m o n g 
H S C T a n d 5 5 a m o n g S O T reci pie nts, t he m ortalit y rate fr o m R S V-L R TI was 4. 9 % a n d 
1 0. 7 % f or H S C T a n d S O T reci pie nts, 6 res pecti vel y,w hic h is c o m para ble t o ol der a d ults.8
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 6 0, 0 0 0 t o 1 6 0, 0 0 0 
h os pitalizati o ns a n d 6, 0 0 0 t o 1 3 , 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 ,9 ,1 0 ,1 1 ,1 2 a n d 4 0, 0 0 0 t o 6 0, 0 0 0 h os pitalizati o ns als o occ ur a m o n g t h ose < 6 5 years of a ge 
a n n uall y, m ost of w hic h w o ul d be a m o n g pers o ns wit h c hr o nic me dical 
c o n diti o ns .9 ,1 2 ,1 3 ,1 4 ,1 5 ,1 6 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 y i n g wit hi n 1 year of h os pitalizati o n.1 7
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 year t o ye ar. 1 8  T he i nci de nce rate 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). 1 9 ,2 0  H o we ver, t he b ur de n of a d ult R S V disease is u n deresti mate d 
si nce R S V disease i n a d ults is diffic ult t o dia g n ose base d o n cli nical si g ns a n d s y m pt o ms 
al o ne, 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, a n d e ve n w he n testi n g 
is c o n d ucte d, R S V i nfecti o n is m ore diffic ult t o detect wit h a si n gle dia g n ostic s peci me n d ue 
t o l o wer viral l oa ds a m o n g a d ults.2 1
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 ydrati 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 h os pitalize d se verel y i m m u n oc o m pr o mise 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 , ma ki n g 
vacci nati o n a hi g h pri orit y. 2 0 ,2 2
2. 1. St u d y R ati o n ale
R S V is a n i m p orta nt ca use of se vere res pirat or y  disease i n ol der a d ults a n d a d ults ≥1 8 ye ars 
of a ge wit h healt h c o n diti o ns t hat p ut t he m at i ncrease d ris k of se vere R S V a n d/ or
c o m plicati o ns a n d t hat are ass ociate d wit h a hi g h rate of m or bi dit y  a n d m ortalit y.2 3 ,2 4
A d ults ≥1 8 y ears of a ge c o nsi dere d at hi g h ris k f or se vere R S V disease i ncl u de* : 

I n di vi d uals w h o ha ve c hr o nic p ul m o nar y  (i ncl u di n g ast h ma), car di o vasc ular 
(e xcl u di n g is olate d hy perte nsi o n), re nal, he patic, ne ur ol o gic, he mat ol o gic, or 
meta b olic dis or ders (i ncl u di n g dia betes mellit us).

I m m u n oc o m pr o mise d h osts .
* Ris k fact ors are a da pte d fr o m t he C D C g ui da nce o n p e o ple at h i gh er ris k of i nfl ue nza
co m plicati o ns .2 5
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 0
St u d y  C 3 6 7 1 0 1 3 e nr olle d partici pa nts ≥6 0 ye ars of a ge w h o were healt h y  or ha d sta ble 
c hr o nic me dical c o n diti o ns , i ncl u di n g C O P D, ast h ma, a n d C H F, b ut pr o hi bite d t he 
e nr oll me nt of a d ults a ges 1 8 t o < 6 0 years of a ge a n d all i m m u n oc o m pr o mise d a d ults.
L i mite d data o n safet y a n d i m m u n o ge nicit y e xist f or a d ults 1 8 t o < 6 0 ye ars of a ge wit h 
healt h c o n diti o ns t hat place t he m at hi g her ris k of R S V disease as well as 
i m m u n oc o m pr o mise d i n di vi d uals.  O n 3 1 Ma y  2 0 2 3, base d o n efficac y a n d safety data fr o m 
t he st u d y i n t he ol der a d ult p o p ulati o n ( C 3 6 7 1 0 1 3), t he F D A a p pr o ve d R S V pre F ( A br y s v o) 
f or mar keti n g i n i n di vi d uals 6 0 years of a ge a n d ol der i n t he U S. 1 T here is c urre ntl y n o 
lice nse d vacci ne t o pre ve nt R S V i nfecti o n i n yo u n ger a d ults , a n d f urt her st u dies are re q uire d 
f or a d ults wit h wea ke ne d i m m u ne s yste ms.
After R S V nat ural i nfecti o n, i m m u nit y is c o nsi dere d t o be s h ort-li ve d.2 ,2 6 C urre nt treat me nts 
c o nsist pri maril y of s u p p orti ve care. T he o nl y ot her a vaila ble pr o p h yl actic meas ures are 
m o n ocl o nal a nti b o dies, w hic h are li mite d t o use i n i nfa nts a n d c hil dre n u p t o 2 4 m o nt hs of 
a ge.2 7 ,2 8 ,2 9  T heref ore, t here is a n i m p orta nt u n met me dical nee d t o de vel o p a n effecti ve 
vacci ne t o b o ost t he i m m u ne res p o nse s ufficie ntl y t o pr otect a d ults 1 8 ye ars of a ge a n d ol der
wit h u n derl y i n g me dical c o n diti o ns , i ncl u di n g a n i m m u n oc o m pr o mise d state, t hat p ut t he m 
at i ncrease d ris k of se vere R S V a n d/ or c o m plicati o ns a gai nst R S V disease .
St u d y i n g t he safety, a n d/ or t olera bilit y, a n d/ or i m m u n o ge nicit y of R S V pre F i n a d ults at hi g h 
ris k of se vere R S V disease a n d i m m u n oc o m pr o mise d a d ults u n der a si n gle pr ot oc ol, rat her 
t ha n se parate pr ot oc ols, will all o w a n or ga nize d a p pr oac h t hat ca n be easil y a da pte d as 
differe nt c o u ntries’ lice ns ure re q uire me nts are i nc or p orate d.  
T his a p pr oa c h will be n ot o nl y m ore e x pe diti o us t o i m ple me nt b ut als o m ore rea dily 
u n dersta n da ble f or i n vesti gati o nal sites.
2. 2. B ac k gr o u n d 
T he vacci ne i n vesti gate d i n t his st u d y  is a bi vale nt R S V pref usi o n F s u b u nit vacci ne 
( R S V pre F) de vel o pe d by 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 hl y 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 elic its m uc h hi g 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 mat c 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 wit h t he sa me a nti ge ns, d ose, a n d f or m ulati o n: 

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 v ia acti ve 
i m m u nizati o n.

M ater n al:
P re ve nti o n of L R TI -R S V a n d se vere L R TI -R S V i n i nfa nts fr o m birt h t hr o u g h 
6   m o nt hs of a ge by acti ve i m m u nizati o n of pre g na nt i n di vi d uals .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 1
Pfizer’s P hase 1 a n d 2 st u dies de m o nstrate d p r o of t hat R S V pre F elicits r o b ust ne utralizi n g 
a nti b o dies in a d ults t hat persiste d f or at least 1 2 m o nt hs after vacci nati o n ( St u dies C 3 6 7 1 0 0 1 
a n d C 3 6 7 1 0 0 2) a n d t hat a si n gle 1 2 0 -µ g d ose of R S V pre F ha d 1 0 0 % o bser ve d efficac y  
a gai nst R T-P C R – c o nfir me d s ym pt o matic R S V i nfecti o n i n a h u ma n c halle n ge m o del 
( St u d y WI 2 5 7 5 2 1). Pr o of t hat t he vacci ne is efficaci o us i n pre ve nti n g L R TI ca use d b y R S V 
i n ol der a d ults ≥6 0 y ears of a ge was de m o nstrate d i n a P hase 3 st u d y  (St u d y C 3 6 7 1 0 1 3) .  I n 
t he pri mar y a nal ysis, pr otecti o n a gai nst LR TI -R S V defi ne d b y 2 or m ore s y m pt o ms 
de m o nstrate d a 6 6. 7 % vacci ne efficac y . A v acci ne efficac y of 8 5. 7 % was o bser ve d i n 
partici pa nts wit h t he pri mar y  e n d p oi nt of L R TI-R S V defi ne d b y  3 or m ore R S V-ass ociate d 
s ym pt o ms . A d diti o nall y , the C 3 6 7 1 0 0 8 P hase 3 mate r nal st u dy rece ntly de m o nstrate d
effecti veness i n pre ve nti n g R S V-ass ociate d se vere LR TI  i n i nfa nts b or n t o m ot hers w h o 
recei ve d R S V pre F.
2. 2. 1. Cli nic al O ver vie w
A d ult Pr o gr a m St u dies
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. 3 0 T he pe diatric pr o gra m has rece ntl y i nitiate d wit h t he P hase 1 
p orti o n of a P hase 1/ 2/ 3 st u d y ( C 3 6 7 1 0 1 6).

I n t he P hase 1/ 2 C 3 6 7 1 0 0 1 st u d y ( N C T 0 35 2 9 7 7 3) , 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 years of a ge recei ve d t he 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 ars a ge gr o u p, R S V N T 5 0 G M F Rs were hi g h acr oss all ar ms, 
ra n gi n g fr o m 9 t hr o u g h 1 3 fr o m bef ore vacci nati o n t o 1 m o nt h after vacci nati o n a n d 
fr o m 3 t hr o u g h 4 fr o m bef ore vacci nati o n t o 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 s ys te mic e ve nts were mil d or m o derate i n se verity. T he pr 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 st u d y i nter ve nti o n.

I n the P hase 1/ 2 C 3 6 7 1 0 0 2 st u d y (N C T 0 3 5 7 2 0 6 2) i n 2 5 0 ol der a d ults 6 5 t hr o u g h 
8 5 ye ars of a ge, 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 were st u die d . 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 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 2
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 vely). N o i ncrease i n G M Ts was o bser ve d 
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 (N C T 0 5 0 9 6 2 0 8) 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 e 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 safet y 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 p ri mar y 
a nal ys es s h o we d t hat t he rati o of ne utralizi n g 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 safet y pr ofile.

A P hase 2a, ra n d o miz e d, d o u ble -b li n de d, p lace b o-c o ntr olle d st u d y t o eval uate t he 
safet y, im m u n o ge nicit y , a n d efficac y of R S V pre F i n a vir us c halle n ge m o del i n 
h ealt h y ad 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 healt h y partici pa nts 
1 8 t o 5 0 y ears 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 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 is well t olerate d a n d has a n acce pta ble safet y pr ofile. T he st u d y  has 
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 
res pirat or y i nfecti o n i n a mil d-t o-m o derate disease m o del.

St u d y  C 3 6 7 1 0 1 3 (N C T 0 5 0 3 5 2 1 2) 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 e 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 t he pre ve nti o n of L R TI -R S V i n a d ults 6 0 years 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, ha ve bee n 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 L R TI -R S V cases. Interi m a nal ys is 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 a n d a de m o nstrate d 
vacci ne efficac y of 6 6. 7 % . A v acci ne efficac y of 8 5. 7 % was o bser ve d i n partici pa nts 
wit h t he pri mar y  e n d p oi nt of LR TI -R S V defi ne d b y  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 safety c o ncer ns. 3 0 ,3 1  O n 
3 1 Ma y
2 0 2 3, t he F D A a p pr o ve d R S V pre F ( A br ys v o) f or mar keti n g i n i n di vi d uals 
6 0 ye ars of a ge a n d ol der i n t he U S. 1
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 3

St u d y  C 3 6 7 1 0 0 6 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 e d st u d y. A p pr o xi matel y  1 4 0 0 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 was t o de m o nstrate t hat t he i m m u ne 
res p o nses ge nerate d wit h a 1 2 0 -μ g R S V pre F d ose 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. Res ults 
de m o nstrate 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 SII 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.

C 3 6 7 1 0 1 6 is a P hase 1/ 2/ 3 st u d y  i n partici pa nts 2 t o < 1 8 y ears of a ge at hi g h ris k of 
R S V disease i nitiate d i n J u ne 2 0 2 3. T he st u d y  c o nsists of 2 p hases: P hase 1 a n d 
P hase 2/ 3. P hase 1 is a n o pe n -la bel, a ge desce n di n g, d ose-fi n di n g st u d y a n d 
P hase 2/ 3 is a place b o -c o ntr olle d, ra n d o mize d, d o u ble -bli n d e d st u d y t o e val uate t he 
safety, t olera bilit y, a n d i m m u n o ge nicit y of R S V pre F. B ot h t he 1 2 0 - µg d ose le vel a n d 
a 6 0- µg d ose le vel will be e val uate d. U p t o 1 2 0 partici pa nts are e x pecte d t o be 
e nr olle d i n t he P hase 1 c o h ort a n d u p t o 1 8 6 0 partici pa nts will be e nr olle d i n t he 
P hase 2/ 3 c o h ort.

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 hase 2 b a n d 
P hase 3 st u dies i n pre g na nt w o me n a n d t heir i nfa nts 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 d e d i n t he 
R S V pre F I B.
2. 3. Be nefit/ Ris k Assess me nt

R S V i nfecti o n is a maj or ca use of se vere m or bi dit y a m o n g o l der ad ults wit h 
u n derl y i n g car di o p ul m o nar y c o n diti o ns a n d ca n ca use se vere l o wer res pirat or y 
se q uelae res ulti n g i n h os pitalizati o n a n d res pirat or y failure .3 2 R S V i nci de nce rates 
a m o n g h os pitalize d patie nts 8 5 ye ars of a ge a n d ol der ha ve bee n f o u n d t o be si milar 
t o c hil dre n 1 t o 2 ye ars of a ge i n Sc otla n d, E n gla n d, a n d t he Net herla n ds.3 3  
F urt her m ore, a d ult i m m u n oc o m pr o mise d patie nts of a n y a ge , partic ularl y H S C T a n d 
S O T patie nts as well as pers o ns wit h u n derl yi n g heart a n d l u n g disease, are at ris k f or 
m ore se vere c o m plicati o ns of R S V disease, i ncl u di n g h os pitalizati o ns a n d IC U 
a d missi o n .3 4 Ris k fact ors f or pr o g ressi o n of R S V disease t o viral pne u m o nia a n d 
ot her c o m plicati o ns i ncl u de a n i m m u n oc o m pr o mise d state, u n derl yi n g heart a n d l u n g 
disease, a n d li vi n g i n a l o n g-ter m care facilit y.3 5 I n o ne st u d y, wit h a mea n a ge of 
5 3. 7 8 a m o n g H S C T a n d 5 5 a m o n g S O T patie nts , t he m ortalit y  fr o m L R TI-R S V was
4. 9 % a n d 1 0. 7 % f or H S C T a n d S O T reci pie nts, res pecti vel y.6

Sta n dar d - of-care treat me nt f or R S V i n o l der ad ults is lar gel y s u p p orti ve, w hile 
tar gete d t hera pies ha ve bee n de vel o pe d f or t he pe diatric p o p ulati o n, i ncl u di n g a 
pr o p h y lactic h u ma nize d m o n ocl o nal a nti b o d y, pali viz u ma b ( S yna gis, Astra Ze neca), 
t hat bi n ds t he R S V F glyc o pr otei n , is rec o m me n de d f or use o nly i n hi g h -ris k i nfa nts, 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 4
a n d ca n pre ve nt i nfa nt R S V diseas e. 3 6 A ne wer h u ma nize d m o n ocl o nal a nti b o d y  
tar geti n g t he pref usi o n c o nf or mati o n of R S V F gl yc o pr otei n, nirse vi ma b ( Be y f ort us, 
Astra Ze neca a n d Sa n ofi) , was rece ntly a p pr o ve d i n t he U S t o pre ve nt LR TI -R S V
re q uiri n g me dical atte nti o n a n d R S V-ass ociate d h os pit alizati o n i n healt h y i nfa nts a n d 
c hil dre n u p t o 2 4 m o nt hs of a ge a n d ha d bee n a p pr o ve d f or a si milar i n dicati o n i n t he 
E U i n N o ve m ber 2 0 2 2 .2 8 ,2 9  A m o n g i m m u n oc o m pr o mise d a n d 
n o ni m m u n oc o m pr o mise d a d ults 1 8 ye ars of a ge a n d ol der , oral a n d i n hale d ri ba viri n 
has bee n us e d as a n off -la bel treat me nt of R S V i nfecti o n, s h o wi n g a decrease i n 
m ortalit y  i n s o me retr os pecti ve c o h orts.3 7 ,3 8

Wit h t he lac k of direct a nti viral t hera pies f or t he treat me nt of R S V disease, t he 
li mitati o n of m o n ocl o nal a nti b o d y pr o p hyl a xis f or i nfa nts a n d c hil dre n u p t o
2 4 m o nt hs of a ge , a n d t he a bse nce of a lice nse d vacci ne t o pre ve nt R S V disease i n 
a d ults u n der 60 y ears of a ge , t here e xists a n u n met me dical nee d f or a ge nts t hat ca n 
pr o vi de pr o p h yl a xis a gai nst R S V disease f or a d ults of all a ges wit h hi g h -ris k me dical 
c o n diti o ns f or se vere R S V disease, i ncl u di n g a n i m m u n oc o m pr o mise d state.
M ore detaile d i nf or mati o n a b o ut t he k n o w n a n d e x pecte d be nefits a n d ris ks a n d reas o na bl y 
e x pecte d A Es of R S V pre F ma y  be f o u n d i n t he I B, w hic h is t he S R S D f or t his st u d y . 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 5
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): R S V pre F 
Pfizer has i de ntifie d t he m ost c o m m o n ris ks f or 
R S V pre F as l ocal reacti o ns, s uc h as i njecti o n site 
re d ness, i njecti o n site s welli n g, a n d i njecti o n site 
pai n, a n d s yste mic e ve nts, s uc h as fati g ue, 
hea dac he, diarr hea, j oi nt pai n, na usea, v o miti n g, 
m uscle pai n, a n d fe ver.
G uillai n -Barre s y n dr o me has bee n i de ntifi e d as a 
p ote ntial ris k f or R S V pre F.
Ot her e ve nts of i nterest i ncl u de atrial fi brillati o n, 
p ol y ne ur o pat h y, preter m birt h ( deli ver y at 3 7 0/ 7 
wee ks’ gestati o n) , a n d h y perte nsi ve dis or ders of 
pre g na nc y.
T he i de ntifie d a d verse reacti o ns i n l ocal pr o d uct 
la bels ma y var y de pe n di n g o n t he re q uire me nts of 
t he res pecti ve re g ulat or y a ut h orities (e g, E U-S m P C 
a n d U S PI).
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. 3 9
Data a vaila ble fr o m c o m plete d a n d o n g oi n g st u dies 
s h o we d a l o w i nci dence 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. 3 0 ,4 0  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. 
I n St u d y C 3 6 7 1 0 1 3, c o n d ucte d i n a d ults 6 0 years of 
a ge a n d ol der, t here was 1 case of G uillai n -Barre 
sy n dr o me a n d 1 case of Miller Fis her s y n dr o me 
( b ot h wit h a pla usi ble te m p oral relati o ns hi p wit h 
vacci nati o n). B ot h cases ha d c o nf o u n di n g fact ors 
or alter nati ve eti ol o g y. 
I n St u d y C 3 6 7 1 0 1 3, c o n d ucte d i n a d ults 6 0 years of 
a ge a n d ol der, t here was a n o nsi g nifica nt n u merical 
i mbala nce i n t he n u m ber of cases of atrial 
fi brillati o n re p orte d f or i n di vi d uals w h o recei ve d 
R S V pre F c o m pare d t o i n di vi d uals w h o recei ve d t he 
place b o. M ost of t he partici pa nts w h o ha d atrial 
fi brillati o n a n d recei ve d R S V pre F ha d a pree xisti n g 
me dical hist or y of atrial fi brillati o n a n d/ or car diac 
disease. 4 1
I n St u d y C 3 6 7 1 0 0 8, c o n d ucte d i n pre g na nt 
i n di vi d uals, t here were n o statisticall y mea ni n gf ul 
i mbala nces bet wee n R S V pre F a n d place b o 
reci pie nts i n t he o verall rates of preter m birt h ( 5. 7% 
[ 9 5 % CI: 4. 9, 6. 5] vers us 4. 7 % [ 9 5 % CI: 4. 1, 5. 5], 

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.

All st u d y partici pa nts will be o bser ve d f or at 
least 3 0 mi n utes after vacci nati o n.

A E s a n d S A Es will be c ollecte d t hr o u g h o ut t he 
st u d y. 

A D M C will re vie w all safet y data t hr o u g h o ut 
t he st u d y.

S pecific refere nces t o ris ks a n d e ve nts of 
i nterest are ma de wit hi n t he I C D, wit h 
re p orti n g i nstr ucti o ns if a case is s us pecte d.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 6
res pecti vel y). H o we ver, a n u merical i m bala nce was 
o bser ve d i n u p per -mi d dle -i nc o me c o u ntries 
bet w ee n R S V pre F a n d place b o reci pie nts. 
O utc o mes i n t he pre mat ure i nfa nts were si milar 
bet w ee n t he 2 gr o u ps.
I n St u d y C 3 6 7 1 0 0 8, c o n d ucte d i n pre g na nt 
i n di vi d uals, t here was a n o nsi g nifica nt n u merical 
i mbala nce i n h y perte nsi ve dis or ders of pre g na nc y 
re p orte d f or partici pa nts w h o recei ve d R S V pre F 
c o m pare d t o partici pa nts w h o recei ve d t he place b o.  
T he maj orit y of preter m a n d h y perte nsi ve dis or ders 
occ urre d m ore t ha n 3 0 da ys f oll o wi n g vacci nati o n. 
St u d y Pr oce d ures 
Ve ni p u nct ure will be perf or me d d uri n g t he st u d y. 
T here is t he ris k of blee di n g, br uisi n g, he mat o ma 
f or mati o n, a n d i nfecti o n at t he ve ni p u nct ure site.
O nl y a p pr o priatel y q ualifie d pers o n nel will o btai n 
t he bl o o d dra w.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 7
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 bst u d y  A are detaile d i n Secti o n 1 0. 7. 2. 3 .
Be nefits t o i n di vi d ual partici pa nts e nr olle d i n S u bst u d y  B are detaile d i n Secti o n 1 0. 8. 2. 3 .
2. 3. 3. O ver all Be nefit/ Ris k C o ncl usi o n
Ta ki n g i nt o acc o u nt t he meas ures t o mi ni mize ris k t o st u d y  partici pa nts, t he p ote ntial ris ks 
i de ntifie d i n ass ociati o n wit h R S V pre F 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 partici pa nts.
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
F or S u bst u d y A – s pecific o bjecti ves, e n d p oi nts, a n d esti ma n ds, refer t o Secti o n 1 0. 7. 3 .
F or S u bst u d y  B– s pecific o bjecti ves, e n d p oi nts, a n d esti ma n ds, refer t o Secti o n 1 0. 8. 3 .
4. S T U D Y D E SI G N
4. 1. O ver all Desi g n
T his is a P hase 3 pr ot oc ol t hat will assess t he safet y, t olera bilit y, a n d i m m u n o ge nicit y of 
Pfizer’s R S V pre F i n a d ults at hi g h ris k of se vere R S V disease . Eac h s u bst u d y desi g n is 
detaile d se paratel y i n t he res pecti ve s u bst u d y a p pe n di ces. S u bst u dies ma y  be c o n d ucte d i n 
parallel, as re q uire d b y t he cli nical pla n, wit hi n t he fra me w or k of t his pr ot oc ol.  Ta ble 1
pr o vi des a n o ver vie w of t he s u bst u dies. F or m ore details o n st u d y  desi g ns, refer t o t he 
a p pe n di x of eac h s u bst u d y: S u bst u d y A (Secti o n 1 0. 7. 4 ) a n d S u bst u d y B (Secti o n 1 0. 8. 4 ).
T a ble 1.
Hi g h -Le vel O ver vie w of S u bst u dies i n Pr ot oc ol
P h ase
Gr o u p/ A ge
St u d y I nter ve nti o n
R a n d o miz ati o n
/ Bli n d
N u m ber of 
D oses t o Be 
A d mi nistere d 
D uri n g St u d y
A p pr o x i mate 
N u m ber of 
P artici p a nts
S u bst u d y A:  E v al u ati o n of R S V pre F i n a d ults ≥1 8 t o < 6 0 ye ars of a ge at hi g h ris k of R S V dise ase
3
≥1 8 Y ears t o < 6 0 years
R S V pre F 1 2 0 µ g
2: 1
D o u ble -bli n d e d
1
6 7 5
Place b o
S u bst u d y B :  E v al u ati o n of R S V pre F i n i m m u n oc o m pr o mise d a d ults ≥1 8 ye ars of a ge
3
≥1 8 Y ears t o < 6 0 years
R S V pre F 1 2 0 µ g
O pe n -la bel
2
1 0 0
≥6 0 Y ears of a ge
1 0 0
4. 2. Scie ntific R ati o n ale f or St u d y Desi g n
Refer t o Secti o n 2. 1 f or t he rati o nale f or t he desi g n of t he o verall st u d y.
See t he su bst u d y  a p pe n dices f or t he rati o nales s u p p orti n g eac h s u bst u dy.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 8
4. 2. 1. Di versit y of St u d y P o p ul ati o n
Reas o na ble atte m pts will be ma de t o e nr oll partici pa nts w h o ali g n wit h t he p o p ulati o n 
distri b uti o n of t he c o u ntr y(ies) i n w hic h t he st u d y is c o n d ucte d, i n t he pr ot oc ol-s pecifie d a ge 
gr o u p, a n d wit h t he distri b uti o n of c haracteristics , t o e ns ure t he st u dy p o p ulati o n is 
re prese ntati ve of t he p o p ulati o n t hat will be nefit fr o m R S V pre F i n cli nical practice.
4. 3. J ustific ati o n f or D ose
T he d ose a n d f or m ulati o n of R S V pre F selecte d f or use i n t his st u d y  are base d o n t he safet y 
a n d i m m u n o ge nicit y data fr o m 3 P hase 1/ 2 st u dies a n d t he efficac y  a nalys es i n t he h u ma n 
c halle n ge st u d y a n d 2 o n g oi n g P hase 3 st u dies. T here were n o s u bsta ntial differe nces 
o bser ve d bet wee n t he i m m u n o ge nicit y or react o ge nicit y  of t he 1 2 0-μ g a n d 2 4 0 -μ g d ose 
le vels of t he f or m ulati o n wit h o ut Al( O H)3.  T he 1 2 0-µ g d ose, wit h o ut a n y a dj u va nts, has 
bee n s h o w n t o ha ve l o w react o ge nicit y  a n d a n acce pta ble safety pr ofile a n d will be t he d ose 
gi ve n i n t his st u d y.
4. 4. E n d of St u d y Defi niti o n
T he e n d of eac h s u b 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 
s u bst u d y.  A partici pa nt is c o nsi dere d t o ha ve c o m plete d t he st u d y  if he/s he has c o m plete d all 
peri o ds of t he st u d y, i ncl u di n g t he last visit.
T he e n d of t he st u d y o verall is t he last visit of t he last partici pa nt i n t he last su bst u d y  t o be 
c o m plete d.
Eac h s u bst u d y ma y be a nal yze d, re p orte d, a n d discl ose d se paratel y.
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 op ulati o n i ncl u di n g, w here 
per mitte d u n der l ocal re g ulati o ns, a ge, se x, race, a n d et h nicit y . T he f oll o wi n g eli gi bilit y  
criteria are desi g ne d t o select partici pa nt s f or w h o m partici pati o n i n t he st u d y  is c o nsi dere d 
a p pr o priate. All rele va nt me dical a n d n o n me dical c o n diti o ns s h o ul d be ta ke n i nt o 
c o nsi derati o n w he n deci di n g w het her a partic ular partici pa nt is s uita ble f or t his pr ot oc ol.
Pr os pecti ve a p pr o val of pr ot oc ol de viati o ns t o recr uit me nt a n d e nr oll me nt criteria , als o 
k n o w n as pr ot oc ol wai vers or e xe m pti o ns, is n ot per mitte d.
5. 1. I ncl usi o n Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n t h is st u d y o nl y if all of t he f oll o wi n g criteria ap pl y:
See Secti o n 1 0. 7. 5. 1 f or S u bst u d y A– s pecific i ncl usi o n criteria.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 9
See Secti o n 1 0. 8. 5. 1 f or S u bst u d y B– s pecific i ncl usi o n criteria.
5. 2. E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m t he st u d y if a n y of t he f oll o wi n g criteria a p pl y:
See Secti o n 1 0. 7. 5. 2 f or S u bst u d y A– s pecific e xcl usi o n criteria.
See Secti o n 1 0. 8. 5. 2 f or S u bst u d y B –s pecific e x cl usi o n criteria.
5. 3. Lifest yle C o nsi der ati o ns
T here are n o lifest y le restricti o ns re q uire d f or t he partici pa nts i n t his st u d y.
All pre g na ncies disc o vere d i n fe male partici pa nts a n d fe male part ners of male partici pa nts
d uri n g st u d y partici pati o n, w hic h be gi ns after o btai ni n g i nf or me d c o nse nt as descri be d i n
Secti o n 8. 4. 1 , will be rec or de d i n acc or da nce wit h t he E D P (see Secti o n 8. 4. 5. 1 ) a n d E D B 
(see Secti o n 8. 4. 5. 2 ) re p orti n g pr ocesses.
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 differe nt 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 v e nti o n
See Secti o n 1 0. 7. 5. 5 f or S u bst u d y A– s pecific te m p orar y dela y criteria.
See Secti o n 1 0. 8. 5. 5 f or S u bst u d y B – s pecific te m p orar y dela y criteria.
6. S T U D Y I N T E R V E N TI O N( S ) A N D C O N C O MI T A N T T HE R A P Y
St u d y  i nter ve nti o ns are all pres pecifie d i n vesti gati o nal a n d me dical de vices, a n d ot her 
i nter ve nti o ns (e g, s ur gical a n d be ha vi oral) i nte n de d t o be a d mi nistere d t o t he st u d y 
partici pa nts d uri n g t he st u d y  c o n d uct. 
6. 1. St u d y I nter ve nti o n(s) A d mi nistere d
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 6. 1 .
F or S u bst u d y  B, refer t o Secti o n 1 0. 8. 6. 1 .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 0
6. 1. 1. A d mi nistr ati o n
Partici pa nts will recei ve st u d y  i nter ve nti o n as all ocate d by t he I R T i n acc or da nce wit h t he 
s u bst u d y’s S o A.
St u d y  i nter ve nti o n s h o ul d be a d mi nistere d i ntra m usc ularly 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, u nless me dicall y c o ntrai n dicate d, i n w hic h case t he i njecti o n ma y 
be a d mi nistere d i n t he 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 me as ures f or ma na ge me nt of a n ac ute 
h y perse nsiti vit y  reacti o n m ust be a vaila ble i n acc or da nce wit h l ocal g ui deli nes f or sta n dar d 
i m m u nizati o n practices.
A d mi nistrati o n of st u d y  i nter ve nti o ns will be perf or me d b y  a n a p pr o priatel y q ualifie d, 
trai ne d, a n d vaccine- e x perie nce d me m ber of t he st u d y staff (e g, p hys icia n, n urse, p h ysicia n’s 
assista nt, n urse practiti o ner, p har macist, or me dical assista nt) as all o we d b y l ocal, state, a n d 
i nstit uti o nal g ui da nce. 
St u d y  i nter ve nti o n a d mi nistrati o n details will be rec or de d o n t he C R F.
S ee Secti o n 1 0. 7. 6. 1 f or f urt her st u dy i nter ve nti o n a d mi nistrati o n details f or S u bst u d y  A.
S ee Secti o n 1 0. 8. 6. 1 f or f urt her st u dy i nter ve nti o n a d mi nistrati o n details f or S u bst u d y  B.
6. 1. 2. Me dic al De vices
I n t his st u dy, me dical de vices bei n g de pl o ye d are f or t he rec o nstit uti o n dil ue nt f or t he st u d y 
i nter ve nti o n (R S V pre F or place b o). T he st u d y i nter ve nti o n s u p plies are pr o vi de d i n a kit t hat 
c o ntai ns t he st u d y i nter ve nti o n ( R S V pre F or place b o l yo p hilize d p o w der i n a vial), 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 me dical de vice use are pr o vi de d i n t he I PM.
All me dical de vice deficie ncies (i ncl u di n g malf u ncti o n, use err or, a n d i na de q uate la beli n g) 
s hall be d oc u me nte d a n d re p orte d by t he i n vesti gat or t hr o u g h o ut t he cli nical i n vesti gati o n 
(see Secti o n 8. 4. 9 ) a n d a p pr o priately ma na ge d b y t he s p o ns or.
6. 2. Pre p ar ati o n , H a n dli n g , St or a ge , a n d Acc o u nt a bilit y

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 maintai ne d d uri n g tra nsit f or all st u d y  i nter ve nti o ns 
recei ve d a n d a ny 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 ppl y , pre pare, a n d/ or a d mi nister st u d y i nter ve nti o n. 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 1

All st u d y  i nter ve nti o ns m ust be st ore d i n a sec ure, e n vir o n me ntall y c o ntr olle d, a n d 
m o nit ore d ( ma n ual or a ut o mate d rec or di n g) area i n acc or da nce wit h t he la bele d 
st ora ge c o n diti o ns wit h access li mite d t o t he i n vesti gat or a n d a ut h orize d site staff. 
At a mi ni m u m, dail y  mi ni m u m a n d ma xi m u m te m perat ures f or all site st ora ge 
l ocati o ns m ust be d oc u me nte d a n d a vaila ble u p o n re q uest. Data f or n o n w or ki n g da y s 
m ust i n dicate t he mi ni m u m a n d ma xi m u m te m perat 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 o ns ta ke n. T he site s h o ul d acti vely 
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 missi o n t o use t he st u d y  
i nter ve nti o n. S pecific details re gar di n g t he e xc ursi o n defi niti o n a n d i nf or mati o n t o 
re p ort f or eac h e xc ursi o n will be pr o vi de d t o t he site i n t he IP M.

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 I P 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 dy i nter ve nti o n acc o u nta bilit y 
f or m/rec or d. 

F urt her g ui da nce a n d i nf or mati o n f or t he fi na l dis p ositi o n of u n use d st u d y 
i nter ve nti o ns are pr o vi de d i n t he IP M. All destr ucti o n m ust be a de q uatel y 
d oc u me nte d. If destr ucti o n is a ut h orize d t o ta ke place at t he i n vesti gat or site, t he 
i n vesti gat or m ust e ns ure t hat t he materials are destr o ye d i n c o m plia nce wit h 
a p plica ble e n vir o n me ntal re g ulati o ns, i nstit uti o nal p olic y , a n d a n y s pecial i nstr ucti o ns 
pr o vi de d b y Pfizer.
U p o n i de ntificati o n of a pr o d uct c o m plai nt, n otif y t he s p o ns or wit hi n 1 b usi ness da y  of 
disc o ver y  as descri be d i n t he IP M.
6. 2. 1. Pre p ar ati o n a n d Dis pe nsi n g
See t he I P M f or i nstr ucti o ns o n h o w t o pre pare t he st u d y i nter ve nti o n f or a d mi nistrati o n. 
St u d y  i nter ve nti o n s h o ul d be pre pare d a n d dis pe nse d b y a n a p pr o priately q ualifie d a n d 
e x perie nce d me m ber of t he st u d y  staff (e g, p h ysicia n, n urse, p h ysicia n’s assista nt, n urse 
practiti o ner, p har mac y  assista nt/tec h nicia n, or p har macist) as all o we d b y l ocal, state, a n d 
i nstit uti o nal g ui da nce. A sec o n d staff me m ber will verif y  t he pre parati o n a n d dis pe nsi n g.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 2
6. 3. Assi g n me nt t o St u d y I nter ve nti o n
All ocati o n (ran d o mizati o n) of partici pa nts t o vacci ne gr o u ps, a n d/ or t he assi g n me nt of st u d y  
i nter ve nti o n t o be dis pe nse d t o t he partici pa nt, as a p plica ble t o t he s u bst u d y, will pr ocee d 
t hr o u g h t he use of a n I RT s y ste m. 
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 u bst u d y  S o A. 
T he st u d y -s pecific IR T refere nce ma n ual a n d I P M will pr o vi de t he c o ntact i nf or mati o n a n d 
f urt her details o n t he use of t he IR T s y ste m.
F or f urt her details f or S u bst u d y  A, refer t o Secti o n 1 0. 7. 6. 1 .
F or f urt her details f or S u bst u d y  B, refer t o Secti o n 1 0. 8. 6. 1 .
6. 4. Bli n di n g
Bli n di n g arra n ge me nts f or partici pa nts, site pers o n nel, a n d t he s p o ns or f or S u bst u d y  A are 
detaile d i n Secti o n 1 0. 7. 6. 2 .
Bli n di n g arra n ge me nts f or partici pa nts, site pers o n nel, a n d t he s p o ns or f or S u bst u d y  B are 
detaile d i n Secti o n 1 0. 8. 6. 2 .  S u bst u d y  B is a n o pe n-la bel st u d y.
6. 5. St u d y I nter ve nti o n C o m pli a nce
W he n partici pa nts are d ose d at t he site, t he y  will recei ve st u d y i nter ve nti o n directl y fr o m t he 
i n vesti gat or or desi g nee, u n der me dical s u per visi o n. T he date a n d ti me as well as t he 
a nat o mical l ocati o n of eac h d ose a d mi nistere d i n t he cli nic will be rec or de d i n t he s o urce 
d oc u me nts a n d rec or de d i n t he C R F. T he d ose of t he 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 b y  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.
T he site will c o m plete t he re q uire d d osa ge Pre parati o n Rec or d l ocate d i n t he I P M. T he use 
of t he Pre parati o n Rec or d is preferre d, b ut it d oes n ot precl u de t he use of a n e xisti n g 
a p pr o priate cli nical site d oc u me ntati o n s yste m.
T he e xisti n g cli nical site's d oc u me ntati o n 
s yste m s h o ul d ca pt ure all perti ne nt/re q uire d i nf or mati o n o n t he pre parati o n a n d 
a d mi nistrati o n of t he d ose. T his ma y  be use d i n place of t he Pre parati o n Rec or d after 
a p pr o val fr o m t he s p o ns or a n d/ or desi g nee.
6. 6. D ose M o dific ati o n
N ot a p plica ble.
6. 7. C o nti n ue d Access t o St u d y I nter ve nti o n A fter t he E n d of t he St u d y
N o st u d y  i nter ve nti o n will be pr o vi de d t o partici pa nts at t he e n d of t heir st u d y partici pati o n.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 3
6. 8. Tre at me nt of O ver d ose
F or t his st u d y , a n y d ose of st u d y i nter ve nti o n greater t ha n 1 d ose of st u d y  i nter ve nti o n wit hi n 
a 2 4- h o ur ti me peri o d will be c o nsi dere d a n o ver d ose.
T here is n o s pecific treat me nt f or a n o ver d ose.
I n t he e ve nt of a n o ver d ose, t he i n vesti gat or s h o ul d:
1.
C o ntact t he st u d y me dical m o nit or wit hi n 2 4 h o urs.
2.
Cl osel y  m o nit or t he partici pa nt f or a ny A Es/ S A Es as me dicall y a p pr o priate a n d 
f oll o w u p u ntil res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, or t he 
partici pa nt is l ost t o f oll o w-u p (as defi ne d i n Secti o n 7. 3 ).
3.
D oc u me nt t he q ua ntit y of t he e xcess d ose as well as t he d urati o n of t he o ver d ose i n 
t he C R F.
4.
O ver d ose is re p orta ble t o Pfizer Safet y  o nly w he n ass ociate d wit h a n S A E.
6. 9. Pri or a n d C o nc o mit a nt T her a p y
6. 9. 1. Pr o hi bite d C o nc o mit a nt V acci n ati o ns a n d Tre at me nts
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 6. 7. 1 .
F or S u bst u d y  B, refer t o Secti o n 1 0. 8. 6. 7. 1 .
6. 9. 2. Per mitte d C o nc o mit a nt V acci n ati o ns a n d Tre at me nts
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 6. 7. 2 .
F or S u bst u d y  B, refer t o Secti o n 1 0. 8. 6. 7. 2 .
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
S u bst u d y  A is a si n gle-d ose s u bst u d y ; t heref ore, t his secti o n is n ot a p plica ble t o t hat 
s u bst u d y.
S u bst u d y  B: It ma y be necessar y f or a partici pa nt t o per ma ne ntly 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).
D isc 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 ntl y disc o nti n ue d, t he partici pa nt s h o ul d re mai n i n t he st u d y t o be 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 4
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 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 
receipt 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, f urt her st u d y f oll o w-u p, a n d/ or 
f ut ure c ollecti o n of a d diti o nal i nf or mati o n.
7. 2. P artici p a nt Disc o nti n u ati o n/ Wit h dr a w al F r o m t he St u d y
A partici pa nt ma y  wit h dra w fr o m t he st u d y at a ny ti me at their o w n re q uest . Reas o ns f or 
disc o nti n uati o n fr o m t he st u d y  i ncl u de t he f oll o wi n g:

Ref use d f urt her st u d y pr oce d ures;

L ost t o f oll o w - u p;

Deat h;

St u d y  ter 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;

Select p r ot oc ol de viati o ns ( N ote: R ecei pt of a n R S V vacci ne o utsi de of t he st u d y  will 
res ult i n st u d y wit h dra wal).
If a partici pa nt wit h dra ws fr o m t he st u d y, t he y m a 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 the 
site st u d y rec or ds a n d n otif y t he s p o ns or acc or di n gl y.
If t he partici pa nt wit h dra ws fr o m t he st u d y a n d als o wit h dra ws c o nse nt (see Secti o n 7. 2. 1 ) 
f or discl os ure of 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 ( S u bst u d y B) a n d/ or
acti ve st u d y partici pati o n (e g, bi ol o gical sa m ple c ollecti 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 foll o we d f or pr ot oc ol -s pecifie d safet y 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 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 5
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 with dra wal is o nl y  fr o m 
f urt her recei pt of st u d y i nter ve nti o n or als o fr o m s pecifie d st u d y pr oce d ures a n d/ or 
p ost vacci nati o n safet 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 blicl y a vaila ble 
i nf or mati o n s h o ul d be use d t o deter mi ne vital stat us o nl y as a p pr o priately directe d i n 
acc or da nce wit h l ocal la w.
7. 3. L ost t o F ol l o w- U p
A partici pa nt will be c o nsi dere d l ost t o f oll o w- u p if t he partici pant 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 atte n d a re q uire d st u d y visit:

T he site m ust atte m pt t o c o ntact t he partici pa nt a n d resc he d ule t he misse d visit as 
s o o n as p ossi ble.
Co u nsel t he partici pa nt o n t he i m p orta nce of mai ntai ni n g t he 
assi g ne d visit sc he d ule, a n d ascertai n w het her t he partici pa nt wis hes t o a n d/ or s h o ul d 
c o nti n ue i n t he st u d y;

Bef ore a partici pa nt is dee me d l ost t o f oll o w- u p, t he i n vesti gat or or desi g nee m ust 
ma ke e ver y  eff ort t o re gai n c o ntact wit h t he partici pa nt ( w here p ossi ble, 3 tele p h o ne 
calls a n d, if necessar y, a certifie d letter t o t he partici pa nt’s last k n o w n maili n g 
a d dress or l ocal e q ui vale nt met h o ds). T hese c o ntact atte m pts s h o ul d be d oc u me nte d 
i n t he partici pa nt’s me dical rec or d;

S h o ul d t he partici pa nt c o nti n ue t o be u nreac ha ble, t he partici pa nt will be c o nsi dere d 
t o ha ve wit h dra w n fr o m t he st u d y. 
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
See Secti o n 1 0. 7. 8 f or assess me nts a n d pr oce d ures s pecific t o S u bst u d y A.
See Secti o n 1 0. 8. 8 f or assess me nts a n d pr oce d ures s pecific t o S u bst u d y  B.
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.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 6
A d here nce t o t he st u d y desi g n re q uire me nts, i ncl u di n g t h ose s pecifie d i n t he S o A, is esse ntial 
a nd 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 as descri be d. H o we ver, it is a ntici pate d t hat fr o m ti me t o ti me t here ma y  be 
circ u msta nces o utsi de t he c o ntr ol of t he i n vesti gat or t hat ma ke it u nfeasi ble t o perf or m t he 
test. I n t hese cases, t he i n vesti gat or m ust ta ke all ste ps necessar y t o e ns ure t he safety a n d 
well -bei n g of t he partici pa nt . W he n a pr ot oc ol -re q uire d test ca n n ot be perf or me d, t he 
i n vesti gat or will d oc u me nt t he reas o n f or t he misse d test a n d a ny c orrecti ve a n d pre ve nti ve 
acti o ns t hat t he y ha ve ta ke n t o e ns ure t hat re q uire d pr ocesses are a d here d t o as s o o n as 
p ossi ble. T he st u d y  tea m m ust be i nf or me d of t hese i nci de nts i n a ti mel y ma n ner.
F or sa m ples bei n g c ollecte d a n d s hi p pe d, detaile d c ollecti o n, pr ocessi n g, st ora ge, a n d 
s hi p 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. T ele 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 safety of st u d y partici pati o ns at sc he d ule d visits per t he S o A or u nsc he d ule d 
visits.
T ele 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. Assess me nts t hat ma y be perf or me d 
d uri n g a tele healt h visit are descri be d i n t he S o A.
St u d y  partici pa nts m ust be re mi n de d t o pr o m ptl y n otif y site staff a b o ut a ny c ha n ge i n t heir 
healt h stat us.
8. 2. I m m u n o ge nicit y Assess me nts
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 8. 1 .
F or S u bst u d y  B, refer t o Secti o n 1 0. 8. 8. 1 .
8. 2. 1. R S V V acci ne A nti b o d y Testi n g
R efer t o Secti o n 1 0. 7. 8. 1. 1 f or S u bst u d y  A details o n R S V v acci ne anti b o d y  testi n g.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 7
Refer t o Secti o n 1 0. 8. 8. 1. 1 f or S u bst u d y B details o n R S V v acci ne anti b o d y  testi n g. 
8. 2. 2. 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  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 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 vacc i ne.
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 
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 alre a d y c ollecte d fr o m t h ose sa m ples will still be use d f or t his researc h. 
T he bi ol o gical sa m ples ma y be s hare d wit h ot her researc hers as l o n g as c o nfi de ntialit y  is 
mai ntai ne d a n d n o testi n g of t he partici pa nt’s D N A is perf or me d.
F or bl o o d sa m pli n g details, r efer t o t he a p pe n di x of eac h s u bst u d y.
8. 3. S afet y Assess me nts
Pla n ne d ti me p oi nts f or all safet y  assess me nts are pr o vi de d i n t he S o A .
U nsc he d ule d safet y
meas ure me nts m a y  be o btai ne d at a n y ti me d uri n g t he st u d y t o assess a n y percei ve d safet y 
iss ues.
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 8. 2 .
F or S u bst u d y  B, refer t o Secti o n 1 0. 8. 8. 2 .
8. 3. 1. P h ysic al E x a mi n ati o ns
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, a p h ys ical e xa mi nati o n will be perf or me d.
P h y sical e xa mi nati o n fi n di n gs c ollecte d d uri n g t he st u d y will be c o nsi dere d s o urce data a n d 
will n ot be re q uire d t o be re p orte d, u nless ot her wise n ote d. A n y u nt o war d p h ysical 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 8
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 me et t he 
defi niti o n of a n A E or S A E ( Secti o n 1 0. 2 ) m ust 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
T he partici pa nt’s b o d y t e m perat ure will be meas ure d pri or t o st u d y  vacci nati o n as per us ual 
cli nical practice. Res pirat or y  rate at baseli ne will als o be assesse d.
A n y  u nt o war d vital si g n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d 
meet t he defi niti o n of a n A E or S A E ( Secti o n 1 0. 2 ) m ust 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. 3. Cli nic al S afet y L a b or at or y Assess me nts
Cli nical safet y  la b orat or y assess me nts will n ot be c ollecte d i n t his st u d y.
8. 3. 4. Electr o nic Di ar y f or Re act o ge nicit y
Partici pa nts will be re q uire d t o c o m plet e a react o ge nicit y e-diar y , 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 pers o nal de vice of t he partici pa nt , a n d will be 
as ke d t o m o nit or a n d rec or d l ocal reacti o ns, s ys te mic e ve nts, a n d te m perat ure eac h e ve ni n g 
f or 7 d a y s fr o m t he day of a d mi nistrati o n of st u d y i nter ve nti o n (react o ge nicit y peri o d).  
Partici pa nts will recei ve re mi n ders t o c o m plete t he react o ge nicit y e -diar y  o n a dail y basis, 
starti n g o n t he da y of st u d y i nter ve nti o n a d mi nistrati o n ( Da y 1) t hr o u g h Da y 7.
T he e -diar y  all o ws rec or di n g of t hese assess me nts o nl y  wit hi n a fi xe d ti me wi n d o w eac h da y, 
t h us pr o vi di n g t he acc urate re prese ntati o n of t he partici pa nt’s e x perie nce at t hat ti me.
Data o n l ocal reacti o ns, s yste mic e ve nts, a n d te m perat ure rec or de d i n t he e -diar y  will be 
tra nsferre d electr o nicall y t o t he e-diar y  ve n d or, w here t he y will be a vaila ble f or re vie w b y 
i n vesti gat ors, t heir q ualifie d desi g nees, a n d s p o ns or staff at all ti mes via a n i nter net-base d 
p ortal.  At i nter vals a gree d t o b y  t he ve n d or a n d Pfizer, t hese data will be tra nsferre d 
electr o nicall y t o Pfizer f or a nalys is a n d re p orti n g.  T hese data d o n ot nee d t o be rec or de d by 
t he i n vesti gat or i n t he C R F, e xce pt f or t he f oll o wi n g c o n diti o ns:

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. 2. 3 .

A n y  l ocal reacti o ns or syste mic e ve nts occ urr i n g wit hi n t he first 3 0 mi n utes after st u d y 
vacci nati o n m ust be rec or de d o n t he A E pa ge of t he C R F.

If a partici pa nt wit h dra ws beca use of pr o m pte d e ve nts rec or de d i n t he e-diar y , t he 
e ve nt(s) s h o ul d be rec or de d o n t he A E pa ge of t he C R F, re gar dless of w het her t he 
i n vesti gat or c o nsi ders t he e ve nt(s) t o be cli nicall y si g nifica nt.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 9

If a partici pa nt misse d re p orti n g a n y da y  i n t he e-diar y  a n d re p orts a n e ve nt t o t he st u d y 
site i nstea d, t he e ve nt s h o ul d be rec or de d o n t he A E pa ge of t he C R F.

T he i n vesti gat or or desi g nee m ust o btai n st o p dates f or a n y reacti o ns o n g oi n g o n t he last 
da y  t hat t he 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.
I n vesti gat ors ( or a p pr o priatel y q ualifie d desi g nees) are re q uire d t o re vie w t he e-diar y  data 
o nli ne at fre q ue nt i nter vals t o e val uate partici pa nt c o m plia nce a n d as part of t he o n g oi n g 
safety re vie w.
Please n ote t hat all pr o visi o ne d e- diar y  de vices m ust be c ollecte d per t he S o A 
(Secti o n 1 0. 7. 1. 3 a n d Secti o n 1 0. 8. 1. 3 ).
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 9
8. 3. 4. 2. L oc al Re acti o ns
D uri n g t he react o ge nicit y 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 s y m pt o ms i n t he e -diar y .
Re d ness a n d s welli n g will be meas ure d b y t he partici pa nt a n d rec or de d i n meas uri n g de vice 
u nits (ra n ge: 1 t o 2 1; a n e ntr y  i n t he e-diar y  of 2 1 will be de n ote d as ≥2 1) a n d t he n 
cate g orize d d uri n g a nal ysis as a bse nt, mil d, m o derate, or se vere base d o n t he gr a di n g scale i n 
Ta ble 2 .  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 
scale: 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 2.
If a se vere ( Gra de 3) l ocal reacti o n is re p orte d i n t he react o ge nicity e -diar y , a tele p h o ne 
c o ntact s h o ul d occ ur t o ascertai n f urt her details a n d deter mi ne w het her a site visit is 
cli nicall y i n dicate d.
O nl y  a n i n vesti gat or or a q ualifie d desi g nee is a ble t o 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 di call 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, i n t he case of pai n at t he 
i njecti o n site o nl y, c o ntact wit h t he partici pa nt. If a partici pa nt e x perie nces a 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 Gra de 4 reacti o n will be 
c ollecte d as a n A E o n t he C R F. T he e ve nt will be gra de d usi n g t he A E i nte nsit y  gra di n g 
scale (Secti o n 1 0. 2. 3 ).
If a l ocal reacti o n persists be yo n d t he e n d of t he e -diar y  peri o d, t he partici pa nt will be 
re q ueste d t o re p ort t hat i nf or mati o n a n d/ or a ny ne w A Es t hat de vel o p t o t he i n vesti gat or.  
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 0
T he i n vesti gat or will e nter t his a d diti o nal i nf or mati o n i n t he partici pa nt’s s o urce n otes a n d 
C R F.
T a ble 2 .
Gr a di n g Sc ale f or L oc al Re acti o ns
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
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 0 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 0 meas uri n g 
de vice u nits)
Necr osis
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 at t he 
i njecti o n site
a.
O nl y a n i n vesti gat or or q ualifie d desi g nee is a ble t o 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, i n t he case of pai n at t he i njecti o n site o nl y, 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. 2. 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  peri o d, partici pa nts will be as ke d t o assess 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 a n d t o rec or d t he s y m pt o ms 
i n t he e-diar y  i n t he e ve ni n g.  T he sy m pt o ms will be assesse d b y t he partici pa nt as a bse nt, 
mil d, m o derate, or se ve re acc or di n g t o t he gra di n g scale i n Ta ble 3 .
If a se vere ( Gra de 3) s yste mic e ve nt is re p orte d i n t he react o ge nicity e -diar y, a tele p h o ne 
c o ntact s h o ul d occ ur t o ascertai n f urt her details a n d deter mi ne w het her a site visit is 
cli nicall y i n dicate d.
O nl y  a n i n vesti gat or or q ualifie d desi g nee is a ble t o 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. If a 
partici pa nt e x perie nces a Gra de 4 s ys te mic e ve nt, t he i n vesti gat or m ust i m me diately n otif y 
t he s p o ns or.  A Gra de 4 e ve nt will be c ollecte d as a n A E o n t he C R F. T he e ve nt will be 
gra de d usi n g t he A E i nte nsit y  gra di n g scale (Secti o n 1 0. 2. 3 ).
F urt her, if a s ys te mic e ve nt persists be y o n d t he e n d of t he e -diar y  peri o d, t he partici pa nt will 
be re q ueste d t o re p ort t hat i nf or mati o n a n d/ or a n y ne w A Es t hat de vel o p t o t he i n vesti gat or. 
T he i n vesti gat or will e nter t his a d diti o nal i nf or mati o n i n t he partici pa nt’s s o urce n otes a n d
C R F.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 1
T a ble 3.
Gr a di n g Sc ale f or S yste mic E ve nts
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 i n 
e-diaries)
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
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 V 
h y drati o n
E m er ge nc y r o o m 
visit 
or h os pitalizati o n 
f or se vere v o miti 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
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
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 is a ble t o 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. 2. 3 .
8. 3. 4. 4. Te m per at ure
A di gital t her m o meter will be gi ve n t o t he partici pa nt wit h i nstr ucti o ns o n h o w t o meas ure 
te m perat ure at h o me. Te m perat ure will be c ollecte d i n t he react o ge nicity e -diar y  i n t he 
e ve ni n g dail y d uri n g t he react o ge nicit y e -diar y  re p orti n g peri o d. It will als o be c ollecte d at 
a n y ti me d uri n g t he react o ge nicit y re p orti n g peri o d t hat fe ver is s us pecte d. 
Fe ver is defi ne d as a te m perat ure of ≥3 8. 0° C ( ≥1 0 0. 4° F). T he hi g hest te m pe rat 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 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 2
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 d uri n g a nal ys is as mil d, 
m o derate, or se vere base d o n t he i nte nsit y  gra di n g scale pr o vi de d i n Ta ble 4 .
I n t he e ve nt of a fe ver o n t he last da y t he diar y was c o m plete d, te m perat ure will be meas ure d 
dail y  u ntil t he fe ver has res ol ve d ( 1 da y of te m perat ure less t ha n 3 8. 0° C [ 1 0 0. 4° F]) i n or der 
t o c ollect a st o p date i n t he C R F.
If a fe ver of > 3 8. 9° C ( > 1 0 2. 0° F) is re p orte d i n t he 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 q ualifie d desi g nee is a ble t o 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 oc u me ntati o n fr o m a n ot her me dic all 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. 2. 3 .
T a ble 4.
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 is a ble t o 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. 2. 3 .
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. 2 .
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
Se cti o n 1 0. 5 . De vice deficie ncies are c o vere d i n Secti o n 1 0. 5. 3 .
A Es ma y  arise fr o m sy m pt o ms or ot her c o m plai nts re p orte d t o t he i n vesti gat or b y  t he 
partici pa nt ( or, w he n a p pr o priate, b y a care gi ver, s urr o gate, or t he partici pa nt's le gall y 
a ut h orize d re prese ntati ve), or t he y ma y arise fr o m cli nical fi n di n gs of t he in vesti gat or or 
ot her healt hcare pr o vi ders (cli nical si g ns, test res ults, etc).
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detecti n g, d oc u me nti n g, a n d 
rec or di n g e ve nts t hat meet t he defi niti o n of a n A E or S A E a n d re mai n res p o nsi ble t o p urs ue 
a n d o btai n a de q uate i nf or mati o n b ot h t o deter mi ne t he o utc o me a n d t o assess w het her t he 
e ve nt meets t he criteria f or classificati o n as a n S A E or ca use d t he partici pa nt t o disc o nti n ue 
the st u d y i nter ve nti o n (see Secti o n 7. 1 ). 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 3
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 
a p pr o xi matel y 1 m o nt h f oll o wi n g t he last a d mi nistrati o n of t he st u d y i nter ve nti o n, a n d 
A E SI s, N D C M Cs , a n d S A Es will b e c ollecte d fr o m i nf or me d c o nse nt t hr o u g h o ut st u d y 
partici pati o n.  I n a d diti o n, A Es occ urri n g u p t o 4 8 h o urs after bl o o d dra ws t hat are relate d t o 
st u d y pr oce d ures will be c ollecte d.
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 , or 
d isc o nti n ues fr o m t he st u d y, beca use of a n A E or S A E, t he A E or S A E m ust be rec or de d o n 
t he C R F a n d t he S A E re p orte d via P S S A or usi n g t he Vacci ne S A E Re p ort 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 n y 
S A E, i ncl u di n g a deat h, at a n y  ti me after a partici pa nt has c o ncl u de d st u d y partici pati o n , a n d 
t he y c o nsi der t he e ve nt t o be reas o na bl y relate d t o t he st u d y i nter ve n ti 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 via P S S A or usi n g t he Vacci ne S A E Re p ort F or m.
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer S afet y
All S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d as descri be d i n 
Secti o n 8. 4. 1 are re p orte d t o Pfizer Safet y via P S S A or usi n g t he Vacci ne S A E Re p ort F or m
i m me diatel y u p o n a ware ness a n d u n der n o circ u msta nce s h o ul d t his e xcee d 2 4 h o urs, as 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 4
i n dicate d i n Secti o n 1 0. 2 . T he i n vesti gat or will s u b mit a n y  u p date d S A E data t o t he s p o ns or 
wit hi n 2 4 h o urs of it s bei n g a vaila ble.
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F
All n o nseri o us A Es a n d S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d , 
w hic h be gi ns after o btai ni n g i nf or me d c o nse nt as descri be d i n Secti o n 8. 4. 1 , will be rec or de d 
o n t he A E secti o n of t he C R F.
T he i n vesti gat or is t o rec or d o n t he C R F all direct l 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 Es a n d S A E s 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. 2 .
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 ur re nces.
8. 4. 3. F oll o w -U p of A Es a n d S A Es
After t he i nitial A E or S A E re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y  f oll o w eac h 
partici pa nt at s u bse q ue nt visits/c o ntacts. F or eac h e ve nt, t he i n vesti gat or m ust p urs ue a n d 
o btai n a de q uate i nf or mati o n u ntil res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, 
or t he partici pa nt is l ost t o f oll o w- u p (as defi ne d i n Secti o n 7. 3 ).
I n ge neral, f oll o w-u p i nf or mati o n will i ncl u de a descri pti o n of t he e ve nt i n s ufficie nt detail t o 
all o w f or a c o m plete me dical assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of 
p ossi ble ca usalit y . A n y i nf or mati o n rele va nt t o t he e ve nt, s uc h as c o nc o mita nt me dicati o ns 
a n d ill nesses, m ust be pr o vi de d. I n t he case of a partici pa nt deat h, a s u m mar y of a vaila ble 
a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o Pfizer Safet y. 
F urt her i nf or mati o n o n f oll o w -u p pr oce d ures is pr o vi de d i n Secti o n 1 0. 2 .
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 nti al 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.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 5
T he s p o ns or has a le gal res p o nsi bilit y  t o n otif y b ot h t he l ocal re g ulat or y a ut h orit y a nd 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, I R 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 fe male partici pa nt is f o u n d t o be pre g na nt w hile recei vi n g or after disc o nti n ui n g 
st u d y i nter ve nti o n.

A male partici pa nt w h o is recei v i 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  nee dlestic k i nj ur y , i n halati o n, or 
s ki n c o ntact.

A male fa mil y me m ber or healt hcare pr o vi der w h o has bee n e x p ose d t o t he st u d y  
i nter ve nti o n b y nee dlestic k i nj ur y , i n halati o n, or s ki n c o ntact t he n i nse mi nates his 
fe male part ner pri or t o or ar o u n d t he ti me of c o nce pti o n.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 6
T he i n vesti gat or m ust re p ort E D P t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nitial i nf or mati o n s u b mitte d 
s h o ul d i ncl u de t he a ntici pate d date of deli ver y (see bel o w f or i nf or mati o n relate d t o 
ter mi nati o n of pre g na nc y). 

If E D P occ urs i n a partici pa nt/ partici pa nt’s part ner, t he i n vesti gat or m ust re p ort t his 
i nf or mati o n t o Pfizer Safet y via P S S A or usi n g t he Vacci ne S A E Re p ort F or m a n d a n 
E D P S u p ple me ntal F or m, 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 t he e n d of 
t he st u d y.

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 via P S S A or usi n g t he Vacci ne S A E Re p ort F or m a n d 
E D P S u p ple me ntal F or m. Si nce t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he 
partici pa nt e nr olle d i n t he st u d y , t he i nf or mati o n is n ot rec or de d o n a C R F; h o we ver, 
a c o p y of t he c o m plete d re p ort is mai ntai ne d i n t he i n vesti gat or site file.
F oll o w -u p is c o n d ucte d t o o btai n ge nera l i nf or mati o n o n t he pre g na nc y a n d its o utc o me f or 
all E D P re p orts wit h a n u n k n o w n o utc o me. T he i n vesti gat or will f oll o w t he pre g na nc y  u ntil 
c o m pleti o n ( or u ntil pre g na nc y  ter mi nati o n) a n d n otif y Pfizer Safety of t he o utc o me as a 
f oll o w-u p t o t he i nitial re p ort. I n t he case of a li ve birt h, t he str uct ural i nte grit y 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 nically p ossi ble, t he str uct ural i nte grit y of t he 
ter mi nate d fet us s h o ul d be assesse d by 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 maly 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, c o n ge nital a n o mal y), t he i n vesti gat or s h o ul d f oll o w t he pr oce d ures 
f or re p orti n g S A Es. A d diti o nal i nf or mati o n a b o ut pre g na nc y  o utc o mes that 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 wit hi n 1 m o nt h of birt h s h o ul d be re p orte d, wit h o ut re gar d 
t o ca usalit y, as S A Es. In 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 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 7
t he partici pa nt was gi ve n t he Pre g na nt Part ner Release of I nf or mati o n F or m t o pr o vi de t o his 
part ner.
8. 4. 5. 2. E x p os ure D uri n g Bre astfee di n g
A n E D B o cc urs if:

A fe male partici pa nt is f o u n d t o be breastfee di n g w hile recei vi n g or after 
disc o nti n ui n g st u d y  i nter ve nti o n.

A fe male n o n partici pa nt is f o u n d t o be breastfee di n g w hile bei n g e x p ose d or ha vi n g 
bee n e x p ose d t o st u d y i nter ve nti o n (ie, e n vir o n me ntal e x p os ure). A n e xa m ple of 
e n vir o n me ntal E D B is a fe male fa mily me m ber or healt hcare pr o vi der w h o re p orts 
t hat s he is breastfee di n g after ha vi n g bee n e x p ose d t o t he st u d y i nter ve nti o n b y  
nee dlestic k i nj ur y , i n halati o n, or s ki n c o ntact.
T he i n vesti gat or m ust re p ort E D B t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nf or mati o n m ust be re p orte d
via P S S A or usi n g t he Vacci ne S A E Re p ort F or m. W he n E D B occ urs i n t he setti n g of 
e n vir o n me ntal e x p os ure, t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d 
i n t he st u d y, s o t he i nf or mati o n is n ot rec or de d o n a C R F. H o we ver, a c o p y  of t he c o m plete d 
re p ort is mai ntai ne d i n t he i n vesti gat or site file.
A n E D B re p ort is n ot create d w he n a Pfizer dr u g s pecifically a p pr o ve d f or use i n 
breastfee di n g w o me n (e g, vita mi ns) is a d mi nistere d i n acc or d a nce wit h a ut h orize d use. 
H o we ver, if t he i nfa nt e x perie nces a n S A E ass ociate d wit h s uc h a dr u g, t he S A E is re p orte d 
t o get her wit h t he E D B .
8. 4. 5. 3. Occ u p ati o n al E x p os ure
T he i n vesti gat or m ust re p ort a n y i nsta nce of occ u pati o nal e x p os ure t o Pfizer Safety wit hi n 
2 4 h o urs of t he i n vesti gat or’s a ware ness via P S S A or usi n g t he Vacci ne S A E Re p ort F or m, 
re gar dless of w het her t here is a n ass ociate d S A E. Si nce t he i nf or mati o n a b o ut t he 
occ u pati o nal e x p os ure d oes n ot pertai n t o a partici pa nt e nr olle d i n t he st u d y, t he i nf or mati o n 
is n ot rec or de d o n a C R F; h o we ver, a c o py of t he c o m plete d re p ort 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.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 8
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 i n S u bst u d y A a n d S u bst u d y B:

Dia g n osis of G uillai n- Barre s y n dr o me

Dia g n osis of ac ute p ol y n e ur o pat h y wit h o ut a n u n derl yi n g eti ol o g y

Dia g n osis of atrial fi brillati o n

Preter m deli ver y  ( deli ver y at 3 7 0/ 7 wee ks’ gestati o n)

Dia g n osis of a h y perte nsi ve dis or der of pre g na nc y
Details of t he A E SIs liste d a b o ve are f urt her defi ne d i n t he i n vesti gat or site file.
All A E SI s m ust be re p orte d as a n A E or S A E f oll o wi n g t he pr oce d ures descri be d i n 
Secti o ns 8. 4. 1 t hr o u g h 8. 4. 4 fr o m t he ti me t he partici pa nt pr o vi des i nf or me d c o nse nt t hr o u g h 
t he e n d of st u d y partici pati o n . A n A E SI  is t o be rec or de d as a n A E or S A E o n t he C R F. I n 
a d diti o n, a n A E SI t hat is als o a n S A E m ust be re p orte d via P S S A or usi n g t he Vacci ne S A E 
Re p ort F or m.
A E SI s are e xa mi ne d as part of r o uti ne safety 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 ysis 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 m e 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.
8. 4. 8. 1. L ac k of Effic ac y
T his secti o n is n ot a p plica ble f or t his st u d y , as efficac y is yet t o be de m o nstrate d i n t he st u d y 
p o p ulati o n.
8. 4. 9. Me dic al De vice Deficie ncies
Me di cal de vices bei n g pr o vi de d f or use i n t his st u d y  are t h ose liste d i n Secti o n 6. 1. 2 . I n 
or der t o f ulfill re g ulat or y re p orti n g o bli gati o ns w orl d wi de, t he i n vesti gat or is res p o nsi ble f or 
t he detecti o n a n d d oc u me ntati o n of e ve nts meeti n g t he defi niti o ns of de vice deficie nc y t hat 
occ ur d uri n g t he st u d y wit h s uc h de vices.
T he defi niti o n of a m edical d e vice deficie nc y ca n be f o u n d i n Secti o n 1 0. 5 .
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 wi ll 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 S ecti o n 8. 4. 1 t hr o u g h Secti o n 8. 4. 4 a n d
Secti o n 1 0. 2 of t he pr ot oc ol.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 9
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 h e de vice a n d e ve n i nte nti o nal mis use, etc. 
If t he i n vesti gat or lear ns of a n y 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 i n vesti gat or will pr o m ptl y  n otif y t he s p o ns or.
Refer t o Secti o n 1 0. 5. 4 f or i nstr ucti o ns f or d oc u me nti n g a n d re p orti n g m e dical d e vice 
deficie ncies .
8. 4. 9. 2. Re g ul at or y Re p orti n g Re q uire me nts f or De vice Deficie ncies
T he i n vesti gat or will pr o m ptl y  re p ort all de vice deficie ncies occ urri n g wit h a n y  me dical 
de vice pr o vi de d f or use i n t he st u d y  i n or der f or t he s p o ns or t o f ulfill t he le gal res p o nsi bilit y 
t o n otif y a p pr o priate re g ulat or y a ut h orities a n d ot her e ntities a b o ut certai n safety i nf or mati o n 
relati n g t o me dical de vices bei n g use d i n cli nical st u dies.
T he i n vesti gat or 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 he a 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 I R B/ E C.
N ote: T here are a d diti o nal re p orti n g o bli gati o ns f or me dical de vice deficie ncies t hat are 
p ote ntia ll 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 wri ti n g 
w het her t he y  c o ul d ha ve le d t o a n S A E. T hese s hall be re p orte d t o t he re g ulat or y  
a ut h orities a n d I R Bs/ E Cs as re q uire d b y nati o nal re g ulati o ns.
8. 4. 1 0. V acci n ati o n Err ors
Vacci 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. 
Vacci nati o n err ors are rec or de d a n d re p orte d as f oll o ws:
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 0
Rec or de d o n t he 
Me dic ati o n Err or P a ge 
of t he C R F
Rec or de d o n t he 
A d verse E ve nt P a ge 
of t he C R F
Re p orte d vi a P S S A or o n 
t he V acci ne S A E Re p ort 
F or m t o Pfizer S afet y 
Wit hi n 2 4 H o urs of 
A w are ness
All (re gar dless of w het her 
ass ociate d wit h a n A E)
A n y  A E or S A E ass ociate d 
wit h t he vacci nati o n err or
O nl y  if ass ociate d wit h a n 
S A E
Vacci nati o n err ors i ncl u de:

Vacci nati o n err ors i n v ol vi n g partici pa nt e x p os ure t o t he st u d y  i nter ve nti o n;

P ote ntial vacci nati o n err ors or uses o utsi de of w hat is f oresee n i n t he pr ot oc ol t hat d o 
or d o n ot i n v ol ve t he st u d y  partici pa nt;

T he a d mi nistrati o n of e x pire d st u d y  i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect st u d y  i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect d osa ge;

T he a d mi nistrati o n b y  a n i nc orrect r o ute;

T he a d mi nistrati o n of st u d y  i nter ve nti o n t hat has u n der g o ne te m perat ure e xc ursi o n 
fr o m t he s pecifie d st ora ge ra n ge, u nless it is deter mi ne d b y  t he s p o ns or t hat t he st u d y 
i nter ve nti o n u n der q uesti o n is acce pta ble f or use.
W het her or n ot t he vacci nati o n err or is acc o m pa nie d b y  a n A E, as deter mi ne d b y t he 
i n vesti gat or, s uc h vacci nati o n err or s occ urri n g t o a st u d y partici pa nt are rec or de d o n t he 
me dicati o n err or pa ge of t he C R F a n d, if a p plica ble, a n y ass ociate d seri o us a n d n o nseri o us
A Es 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.
Vacci 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 via P S S A or usi n g a 
Vacci ne S A E Re p ort F or m o nl y w he n ass oci ate d wit h a n S A E .
8. 5. P h ar m ac o ki netics 
P har mac o ki netic para meters are n ot e val uate d i n t his st u d y . 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 1
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 .
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
I m m u n o ge nicity assess me nts are descri be d i n Secti o n 8. 2 a n d t he a p pe n di x of eac h s u bst u d y.
8. 9. He alt h Ec o n o mics
Healt h ec o n o mics/m e dical res o urce u tilizati o n a n d h ealt h ec o n o mics para meters are n ot 
e val uate d i n t his st u d y.
8. 1 0. U nsc he d ule d Re act o ge nicit y Visit 
If a se vere l ocal reacti o n (Secti o n 8. 3. 4. 2 ), sys te mic e ve nt (Secti o n 8. 3. 4. 3 ), or fe ver 
(Secti o n 8. 3. 4. 4 ) is re p orte d i n t he react o ge nicity e -diar y , a tele p h o ne c o ntact 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, sys te 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. 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 pa rtici 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 t he 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.
A n y  o n g oi n g reacti o ns m ust be assesse d at t he ne xt sc he d ule d 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 dy 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 te m perat ure.

Meas ure t he partici pa nt’s heart rate.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 2

Meas ure t he partici pa nt’s bl o o d press ure (seate d).

Meas ure t he mi ni m u m a n d ma xi m u m dia meters of re d ness (if prese nt) o n t he ar m in 
w hic h t he st u d y i nter ve nti o n was a d mi nistere d.

Meas ure t he mi ni m u m a n d ma xi m u m dia meters of s welli n g (if prese nt) o n t he ar m i n 
w hic h t he st u d y i nter ve nti o n was a d mi nistere d.

Assess if necr osis is prese nt at t he i njecti o n site o n t he ar m i n w hic h t he st ud y  
i nter ve nti o n was a d mi nistere d .

Assess if a n y e xf oliati ve der matitis is prese nt.

Assess a n y i njecti o n site pai n t hat is prese nt in t he ar m i n w hic h t he st u d y 
i nter ve nti o n was a d mi nistere d 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. 2 .

Assess a n y s ys te mic e ve nts (fati g ue, hea dac he, na usea, v o miti n g, diarr hea, m uscle 
pai n, or j oi nt pai n) t hat are pres e nt 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. 3 .

As k t he partici pa nt if he/s he atte n de d a n e mer ge nc y  r o o m visit or was h os pitalize d.

F or se vere pai n at t he i njecti o n site res ulti n g i n a n e mer ge nc y  r o o m visit or 
h os pitalizati o n, se vere s y ste mic e ve nts ass ociate d wit h a n e mer ge nc y r o o m visit or 
h os pitalizati o n, a n y  necr osis o n t he ar m i n w hic h t he st u d y i nter ve nti o n was
a d mi nistere d, or e xf oliati ve der matitis, t he i n vesti gat or or q ualifie d desi g nee m ust 
assess t hese e ve nts i n acc or da nce wit h t he i nte nsit y  A E gra di n g scale pr o vi de d i n 
Secti o n 1 0. 2 .

Rec or d A Es, S A Es, a n d N D C M Cs 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 will c o m plete t he C R Fs.

T he st u d y  staff ma y c o ntact t he partici pa nt t o o btai n a d diti o nal i nf or mati o n o n e ve nts 
e ntere d i nt o t he e -diar y , as a p pr o priate.
9. S T A TI S TI C A L C O N SI D E R A TI O N S
M et h o d ol o g y f or s u m mar y a n d statistical a nalys es of t he data c ollecte d i n t his st u d y is 
descri be d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or. 
T he S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc ol w here a p pr o priate; h o we ver, a n y maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 3
9. 1. St a tistic al H y p ot hesis
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 9. 1 .
F or S u bst u d y B, refer t o Secti o n 1 0. 8. 9. 1 .
9. 1. 1. Esti m a n ds
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 9. 1. 1 .
F or S u bst u d y  B, refer t o Secti o n 1 0. 8. 9. 1. 1.
9. 1. 2. M ulti plicit y A dj ust me nt
N o m ulti plicit y  a dj ust me nt will be a p plie d acr oss t he s u b st u dies.
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 9. 1. 2 .
F or S u bst u d y  B, refer t o Secti o n 1 0. 8. 9. 1. 2 .
9. 2. A n a l ysis Sets
Refer t o t he res pecti ve a p pe n di x f or eac h s u bst u d y.
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 9. 2 .
F or S u bst u d y  B, refer t o Secti o n 1 0. 8. 9. 2.
9. 3. St atistic al A n al yse s
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 e rf 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.
Refer t o eac h s u bst u d y a p pe n di x f or a descri pti o n of t he statistical a nal ys es f or t he s u bst u d y 
e n d p oi nts.
F or S u bst u d y  A, refer t o Secti o n 1 0. 7. 9 .
F or S u bst u d y  B, refer t o Secti o n 1 0. 8. 9 .
9. 3. 1. Ge ner al C o nsi der ati o ns
U nless state d ot her wise, “v acci ne gr o u p ” i n t his secti o n refers t o partici pa nts recei vi n g 
R S V pre F or place b o i n S u bst u d y  A, or R S V pre F i n S u bst u d y  B. CI s f or all e n d p oi nts i n t he 
statistical a nal ysis 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 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 4
T he sa fety a nal ys es are base d o n t he safet y p o p ulati o n. Partici pa nts will be s u m marize d b y  
vacci ne gr o u p acc or di n g t o t he st u d y  i nter ve nti o ns t he y act ually recei ve d. 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 da 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 partiall y c o m plete 
e-diar y  data (ie, 1-6 da y s of e-diar y  data are a vaila ble), it is e x pecte d t hat t hese missi n g 
e-diar y  d a y s w o ul d be q uerie d b y t he i n vesti gat or a n d a n y mi sse d re p orte d react o ge nicit y 
w o ul d be e ntere d i n t he A E C R F ; t heref ore, t he pri mar y a nalys is will use react o ge nicit y 
rec or de d i n t he A E C R F t o i m p ute t he partiall y  misse d e-diar y  data t o esti mate t he 
react o ge nicit y rates d uri n g t he 7-d a y  peri o d. 
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 ns. A n a d diti o nal a nal ysis will be perf or me d base d o n t he mI T T 
p o p ulati o n if t here is a lar ge e n o u g h differe nce i n sa m ple size bet wee n t he mI T T p o p ulati o n 
a n d t he e val ua ble i m m u n o ge nicit y p o p ulati o n(s). Partici pa nts will be s u m marize d acc or di n g 
t o t he gr o u p ( R S V pre F or place b o i n S u bst u d y A, or R S V pre F i n S u bst u d y B) 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 ( %), 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 2
T he 9 5 % CI f or t he differe nce i n 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 4 3 met h o d. T he 9 5 % CI  will be prese nte d i n ter ms of perce nta ge.
9. 3. 1. 2. A n a l 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 metr ic 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- distri 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 h e 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 % CIs 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
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 5
distri b uti o n f or t he mea n differe nce o n t he l o garit h m scale a n d e x p o ne ntiati n g t he c o nfi de nce 
li mits.
9. 3. 1. 2. 3. 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 fr o m partici pa nts w h o recei ve d R S V pre F i n S u b st u d y A t o partici pa nts 
≥6 0 ye ars of a ge fr o m St u d y C 3 6 7 1 0 1 3 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 an 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
I nteri m a nalys es will be deter mi ne d b y s u bst u d y, a n d details are pr o vi de d i n eac h 
c orres p o n di n g a p pe n di x as necessar y .
9. 5. S a m ple Size Deter mi n ati o n
Sa m ple size will be deter mi ne d b y  s u bst u d y, a n d details are pr o vi de d i n eac h c orres p o n di n g 
a p pe n di x.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 6
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L C O N SI D E R A TI O N S
1 0. 1. A p pe n di x 1: Re g ul at or y, Et hic al, a n d St u d y O versi g ht C o nsi der ati o ns
1 0. 1. 1. Re g ul at or y a n d Et hic al C o nsi der ati o ns
T his st u d y  will be c o n d ucte d i n acc or da nce wit h t he pr ot oc ol a n d wit h t he f oll o wi n g:

C o nse ns us et hical pri nci ples deri ve d fr o m i nter nati o nal g ui deli nes , i ncl u di n g t he 
Declarati o n of Helsi n ki a n d CI O M S I nter nati o nal Et hical G ui deli nes ;

A p plica ble I C H G C P g ui deli nes ;

A p plica ble la ws a n d re g ulati o ns , i ncl u di n g a p plica ble pri vac y la ws.
T he pr ot oc ol, pr ot oc ol a me n d me nts, I C D, S R S D(s) , a n d ot her rele va nt d oc u me nts 
(e g, a d vertise me nts) m ust be re vie we d a n d a p pr o ve d b y t he s p o ns or, s u b mitte d t o a n IR B/ E C 
b y  t he i n vesti gat or, a n d re vie we d a n d a p pr o ve d b y t he I R B/ E C bef ore t he st u d y is i nitiate d.
A n y  a me n d me nts t o t he pr ot oc ol will re q uire I R B/ E C a p pr o val bef ore i m ple me ntati o n of 
c ha n ges ma de t o t he st u d y desi g n, e xce pt f or c ha n ges necessar y  t o eli mi nate a n i m me diate 
hazar d t o st u d y  partici pa nts.
Pr ot oc ols a n d a n y s u bsta ntial a me n d me nts t o t he pr ot oc ol will re q uire healt h a ut h orit y  
a p pr o val pri or t o i nitiati o n e xce pt f or c ha n ges necessar y t o eli mi nate a n i m me diate hazar d t o 
st u d y partici pa nts.
T he i n vesti gat or will be res p o nsi ble f or t he f oll o wi n g:

Pr o vi di n g writte n s u m maries of t he stat us of t he st u d y  t o t he I R B/ E C a n n uall y or 
m ore fre q ue ntl y  i n acc or da nce wit h t he re q uire me nts, p olicies, a n d pr oce d ures 
esta blis he d b y t he I R B/ E C;

N otif y i n g t he I R B/ E C of S A Es or ot her si g nifica nt safety fi n di n gs as re q uire d b y  
I RB/ E C pr oce d ures ;

Pr o vi di n g o versi g ht of t he c o n d uct of t he st u d y at t he site a n d a d here nce t o 
re q uire me nts of 2 1 C F R, I C H G C P g ui deli nes, t he I R B/ E C, E ur o pea n re g ulati o n 
5 3 6/ 2 0 1 4 f or cli nical st u dies, E ur o pea n Me dical De vice Re g ulati o n 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) by 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 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 7
I n a d diti o n, t he i n vesti gat or will i nf or m Pfizer i m me diatel y of a n y ur ge nt safety meas ures 
ta ke n by t he i n vesti gat or t o pr otect t he st u d y partici pa nt s a gai nst a ny i m me diate hazar d, a n d 
of a n y seri o us breac hes of t his pr ot oc ol or of t he I C H G C P g ui 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 o cess
T he i n vesti gat or or t he i n vesti gat or’s re prese ntati ve will e x plai n t he nat ure of t he st u d y, 
i ncl u di n g t he ris ks a n d be nefits, t o t he partici pa nt a n d a ns wer all q uesti o ns re gar di n g t he 
st u d y. T he partici pa nt s h o ul d be gi ve n s ufficie nt ti me a n d o p p ort u nit y  t o as k q uesti o ns a n d 
t o deci de w het her or n ot t o partici pate i n t he trial.
Partici pa nts m ust be i nf or me d t hat t heir partici pati o n is v ol u ntar y . Partici pa nts will be 
re q uire d t o si g n a state me nt of i nf or me d c o nse nt t hat meets t he re q uire me nts of 2 1 CF 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 nal st u d y -relate d data will be use d b y t he 
s p o ns or i n acc or da nce wit h l ocal data pr otecti o n la w. T he le vel of discl os ure m ust als o be 
e x plai ne d t o t he partici pa nt .
T he partici pa nt m ust be i nf or me d t hat t heir me dical r ec 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 p a nt was e nr olle d i n t he st u d y a n d t he date o n w hic h t he writte n c o nse nt was 
o btai ne d. T he a ut h orize d pers o n o btai ni n g t he i nf or me d c o nse nt m ust als o si g n t he I C D.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 8
Partici pa nts m ust be rec o nse nte d t o t he m ost c urre nt versi o n of t he I R B/ E C-a p pr o ve d I CD (s) 
d uri n g t heir partici pati o n i n t he st u d y as re q uire d per l ocal re g u lati o ns.
A c o p y of t he I C D (s) m ust be pr o vi de d t o t he partici pa nt.
Partici pa nts w h o are rescree ne d are re q uire d t o si g n a ne w I C D.
1 0. 1. 3. 1. Electr o nic C o nse n t
Partici pa nts ma y  be a ble t o e x perie nce t he i nf or me d c o nse nt pr ocess b y electr o nic mea ns 
(e C o nse nt). T he e C o nse nt pr ocess i ncl u des a n electr o nic prese ntati o n of t he i nf or me d 
c o nse nt d oc u me nt (eI C D), cli nical trial e d ucati o nal c o m p o ne nts (as a p plica ble), a n d 
electr o nic si g nat ures (if all o we d b y  l ocal re g ulati o ns). T he use of e C o nse nt d oes n ot re place 
or alter t he I C D c o nte nt or i nf or me d c o nse nt pr ocess as descri be d a b o ve. T he e C o nse nt 
pr ocess c o m plies wit h a p plica ble re g ulati o ns a n d s p o ns or p olicies t o e ns ure relia bilit y  a n d 
data pri vac y .
1 0. 1. 4. D at a Pr otecti o n
All parties will c o m pl y  wit h all a p plica ble la ws, i ncl u di n g la ws re gar di n g t he i m ple me ntati o n 
of or ga nizati o nal a n d tec h nical meas ures t o e ns ure pr otecti o n of partici pa nt data.
Partici pa nts’ pers o nal data will be st ore d at t he st u d y  site i n e ncry pte d electr o nic a n d/ or pa per 
f or m a n d will be pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o e ns ure t hat o nl y  
a ut h orize d st u d y staff ha ve access. T he st u d y site will i m ple me nt a p pr o priate tec h nical a n d 
or ga nizati o nal meas ures t o e ns ure t hat t he pers o n al 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 ui re d b y la w.
T o 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 po 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 par tici pa nts 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 nts’ pers o nal data c o nsiste nt 
wit h t he cl i 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 meas 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 Ps o n h o w t o res p o n d i n t he e ve nt of u na ut h orize d access, use, or 
discl os ure of s p o ns or i nf or mati o n or s y ste ms.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 9
1 0. 1. 5. C o m mittees Str uct ure
1 0. 1. 5. 1. D at a M o nit ori n g C o m mittee 
T his st u d y  will use a D M C. T he D M C is i n de pe n de nt of t he st u d y  tea m a n d i ncl u des a mi x 
of i nter nal a n d e xter nal me m bers. T he D M C c harter descri bes t he r ole of t he D M C i n m ore 
detail.
T he D M C will be res p o nsi ble f or o n g oi n g m o nit ori n g of t he safet y  of partici pa nts i n t he 
st u d y acc or di n g t o t he c harter. T he rec o m me n dati o ns ma de b y  t he D M C will be f or war de d 
t o t he a p pr o priate a ut h orize d Pfizer pers o n nel f or re vie w a n d fi nal decisi o n. Pfizer will 
c o m m u nicate s uc h decisi o ns, w hic h ma y  i ncl u de s u m maries of a ggre gate a nal y ses of 
e n d p oi nt e ve nts a n d of safet y data t hat are n ot e n d p oi nts, t o re g ulat or y a ut h orities a n d 
i n vesti gat ors, as a p pr o priate.
1 0. 1. 6. Disse mi n ati o n of Cli nic al St u d y D at a
Pfizer f ulfills its c o m mit me nt t o p u blicl y  discl ose cli nical st u d y res ults t hr ou g h p osti n g t he 
res ults of st u dies o n w w w.cli nicaltrials. g o v ( Cli nical Trials. g o v), t he E u dra C T/ C TIS , a n d/ or 
w w w. pfizer.c o m, a n d ot her p u blic re gistries a n d we bsites i n acc or da nce wit h a p plica ble l ocal 
la ws/re g ulati o ns. I n a d diti o n, Pfizer re p orts st u d y res ults o utsi de of t he re q uire me nts of l ocal 
la ws/re g ulati o ns p urs ua nt t o its S O Ps.
I n all cases, st u dy res ults are re p orte d b y Pfizer i n a n o bjecti ve, acc urate, bala nce d, a n d 
c o m plete ma n ner a n d are re p orte d re gar dless of t he o utc o me of t he st u d y or t he c o u ntr y  i n 
w hic h t he st u d y  was c o n d ucte d.
w w w.cli nicaltrials. g o v
Pfizer p osts cli nical trial res ults o n w w w.cli nicaltrials. g o v f or Pfizer-s p o ns ore d i nter ve nti o nal 
st u dies (c o n d ucte d i n patie nts) t hat e val uate t he safet y a n d/ or efficac y of a pr o d uct, 
re gar dless of t he ge o gra p hical l ocati o n i n w hic h t he st u d y is c o n d ucte d. T hese r es ults are 
s u b mitte d f or p osti n g i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y U S la w.
E u dra C T / C TIS
Pfizer p osts cli nical trial res ults o n E u dra C T / C TIS f or Pfizer-s p o ns ore d i nter ve nti o nal st u dies 
i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y E U re q uire me nts.
w w w. pfizer.c o m
Pfizer p osts C S R s y n o p ses a n d plai n-la n g ua ge st u d y res ults s u m maries o n w w w. pfizer.c o m 
f or Pfizer-s p o ns ore d i nter ve nti o nal st u dies at t he sa me ti me t he c orres p o n di n g st u d y res ults 
are p oste d t o w w w.cli nicaltrials. g o v.
C S R s y n o pses will ha ve pers o nall y  i de ntifia ble 
i nf or mati o n a n o ny m ize d.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 0
D oc u me nts wit hi n mar keti n g a p plicati o ns
Pfizer c o m plies wit h a p plica ble l ocal la ws/re g ulati o ns t o p u blis h cli nical d oc u me nts i ncl u de d 
i n mar keti n g a p plicati o ns. Cli nical d oc u me nts i ncl u de s u m mar y  d oc u me nts a n d C S Rs 
i ncl u di n g t he pr ot oc ol a n d pr ot oc ol a me n d me nts, sa m ple C R Fs, a n d S A P s. Cli nical 
d oc u me nts will ha ve pe rs o nall y i de ntifia ble i nf or mati o n a n o n ymize d.
Data shari n g
Pfizer pr o vi des researc hers sec ure access t o partici pa nt -le vel data or f ull C S Rs f or t he 
p ur p oses of “ b o na -fi de scie ntific researc h” t hat c o ntri b utes t o t he scie ntific u n dersta n di n g of 
t he disease, tar get, or c o m p o u n d class. Pfizer will ma ke data fr o m t hese trials a vaila ble 
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 nally 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 y pte d 
electr o nic a n d/ or pa per f or m a n d are pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o 
pre ve nt access b y u na ut h orize d t hir d parties.
Q T L s are pre defi ne d para meters t hat are m o nit ore d d uri n g t he st u d y . I mp 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.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 1
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 or i n g), met h o ds, res p o nsi bilities, a n d 
re q uire me nts, i ncl u di n g ha n dli n g of n o nc o m plia nce iss ues a n d m o nit ori n g tec h ni q ues 
(ce ntral, virt ual , or o n-site m o nit ori n g), are pr o vi de d i n t he data ma na ge me nt pla n a n d 
m o nit ori n g p la n mai ntai ne d a n d utilize d b y  t he s p o ns or or desi g nee.
T he s p o ns or or desi g nee is res p o nsi ble f or t he data ma na ge me nt of t his st u d y , i ncl u di n g 
q ualit y  c hec ki n g of t he data.
Rec or ds a n d d oc u me nts, i ncl u di n g si g ne d I C D s, pertai ni n g t o t he c o n d uct of t his st u d y m ust 
be retai ne d b y t he i n vest i gat or f or 1 5 ye ars after st u d y c o m pleti o n u nless l ocal re g ulati o ns or 
i nstit uti o nal p olicies re q uire a l o n ger rete nti o n peri o d. N o rec or ds ma y  be destr o ye d d uri n g 
t he rete nti o n peri o d wit h o ut t he writte n a p pr o val of t he s p o ns or. N o rec or ds ma y  be 
tra nsferre d t o a n ot her l ocati o n or part y wit h o ut writte n n otificati o n t o t he s p o ns or.
T he i n vesti gat or m ust e ns ure t hat t he rec or ds c o nti n ue t o be st ore d sec urel y f or as l o n g as 
t he y are mai ntai ne d.
W he n partici pa nt data are t o be delete d, t he i n vesti gat or will e ns ure t hat all c o pies of s uc h 
data are pr o m ptl y  a n d irre v oca bly delete d fr o m all s yste ms.
T he i n 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 g at 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 re s ol ve a n y discre pa ncies t hat are 
i de ntifie d bet wee n t he st u d y data a n d t he partici pa nt’s me dical rec or ds. T he i n vesti gat or will 
pr o m ptl y  pr o vi de c o pies of t he i ns pecti o n fi n di n gs t o t he s p o ns or or its a ge nt. Bef ore 
res p o nse s u b missi o n t o t he re g ulat or y a ut h orities, t he i n vesti gat or will pr o vi de t he s p o ns or or 
its a ge nts wit h a n o p p ort u nit y t o re vie w a n d c o m me nt o n res p o nses t o a ny 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 xist e nce of t he partici pa nt a n d s u bsta ntiate t he 
i nte grity of t he data c ollecte d. S o urce d oc u me nt s are file d at t he i n vesti gat or site.
Data re p orte d o n t he C R F or e ntere d i n t he e C R F t hat are fr o m s o urce d oc u me nts m ust be 
c o nsiste nt wit h t he s o urce d oc u me nts or t he discre pa ncies m ust be e x plai ne d . T he 
i n vesti gat or ma y nee d t o re q uest pre vi o us me dical rec or ds or tra nsfer rec or ds, de pe n di n g o n 
t he st u d y. Als o, c urre nt me dical rec or ds m ust be a vaila ble.
Defi niti o n of w hat c o nstit utes a s o urce d oc u me nt a n d its ori gi n ca n be f o u n d i n t he S o urce 
D oc u me nt L ocat or , w hic h is mai ntai ne d b y t he s p o ns or.
Descri pti o n of t he use of t he c o m p uterize d s yste m is d oc u me nte d i n t he d ata m a na ge me nt 
p lan , w hic h is mai ntai ne d b y t he s p o ns or.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 2
T he i n vesti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce rec or d) t hat s u p p orts t he 
i nf or mati o n e ntere d i n t he C R F.
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 mplete, a n d verifia ble fr o m s o urce d oc u me nts; 
t hat t he safety a n d ri g hts of partici pa nts are bei n g pr otecte d; a n d t hat t he st u d y is bei n g 
c o n d ucte d i n acc or da nce wit h t he c urre ntl y a p pr o ve d pr ot oc ol a n d a n y ot her st u d y  
a gree me nts, IC H G C P g ui deli nes , a n d all a p plica ble re g ulat or y re q uire me nts.
1 0. 1. 9. Use of Me dic al Rec or ds
I n certai n sit uati o ns, s p o ns or re vie w of re dacte d c o pies of partici pa nt me dical rec or ds f or 
S A E re p orti n g m a y  be perf or me d, w here et hically a n d scie ntificall y j ustifie d a n d per mitte d 
b y  l ocal re gulati o ns, t o e ns ure partici pa nt safet y. 
D ue t o t he p ote ntial f or a partici pa nt t o be rei de ntifie d fr o m t heir me dical rec or ds, t he 
f oll o wi n g acti o ns m ust be ta ke n w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or 
desi g nee:

T he i n vesti gat or or site st aff m ust re dact pers o nal i nf or mati o n fr o m t he me dical 
rec or d. T he pers o nal i nf or mati o n i ncl u des, b ut is n ot li mite d t o, t he f oll o wi n g: 
partici pa nt na mes or i nitials , partici pa nt dates (e g, birt h date, date of h os pital 
a d missi o n/ disc har ge, date of deat h), partici pa nt i de ntificati o n n u m bers (e g, S ocial 
Sec urit y  n u m ber, healt h i ns ura nce n u m ber, me dical rec or d n u m ber, 
h os pital/i nstit uti o n i de ntifier), partici pa nt l ocati o n i nf or mati o n (e g, street a d dress, 
cit y, c o u ntr y, p ostal c o de, IP a d dress), partici pa nt c o ntact i nf or mati o n
(e g, tele p h o ne/fa x n u m ber, e mail a d dress).

Eac h me dical rec or d m ust be tra ns mitte d t o t he s p o ns or or s p o ns or desi g nee usi n g 
s yste ms wit h tec h nical a n d or ga nizati o nal sec urit y meas ures t o e ns ure t he pr otecti o n 
of pers o nal data (e g, Fl ore nc e is t he preferre d s ys te m if a vaila ble). 

T here ma y  be u n pla n ne d sit uati o ns w here t he s p o ns or ma y re q uest me dical rec or ds 
(e g, s hari n g me dical rec or ds s o t hat t he s p o ns or ca n pr o vi de st u d y-relate d a d vice t o 
t he i n vesti gat or). T he me dical rec or ds s h o ul d be s u b mitte d acc or di n g t o t he 
pr oce d ure descri be d a b o ve. 
1 0. 1. 1 0. St u d y a n d Site St art a n d Cl os ure
T he st u d y  start date is t he date of t he first partici pa nt’s first visit.
T he s p o ns or desi g nee 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 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 3
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 
I RB/ E C or l ocal healt h a ut h orities, t he s p o ns or ’s pr oce d ures, or t he I CH G C P 
g ui deli nes ;

I na de q uate recr uit me nt of partici pa nts b y  t he i n vesti gat or;

Disc o nti n uati o n of f urt her st u d y  i nter ve nti o n de vel o p me nt.
If t he st u d y 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 reg 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 ny c o nflict 
bet wee n t he c o ntract a n d t his pr ot oc ol , t he c o ntract will c o ntr ol as t o ter mi nati o n ri g hts.
1 0. 1. 1 1. P u blic ati o n P olic y
F or m ultice nter trials, t he pri mar y  p u blicati o n will be a joi nt p u blicati o n de vel o pe d b y t he 
in vesti gat or a n d Pfizer re p orti n g t he pri mar y e n d p oi nt(s) of t he st u d y c o veri n g all st u d y sites . 
T he i n vesti gat or a grees t o refer t o t he pri mar y  p u blicati o n i n a n y s u bse q ue nt p u blicati o ns. 
Pfizer will n ot pr o vi de a n y fi na ncial c o m pe nsati o n f or t he i n vesti gat or’s partici pati o n i n t he 
pre parati o n of t he pri mar y c o n gress a bstract, p oster, prese ntati o n, or pri mar y ma n uscri pt f or 
t he st u d y.
I n vesti gat ors are free t o p u blis h i n di vi d ual ce nter res ults t hat t he y dee m t o be cli nicall y 
mea ni n gf ul after p u blicati o n of t he o verall res ults of t he st u d y  or 1 2 m o nt hs after pri mar y 
c o m pleti o n date or st u d y c o m pleti o n at all sites, w hic he ver occ urs first, s u bject t o t he ot her 
re q uire me nts descri be d i n t his secti o n.
T he i n vesti 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 blic ati o n or 
a n y ot her ty pe of discl os ure of t he st u d y res ults (c ollecti vel y, “ pu blicati o n”) bef ore it is 
s u b mitte d or ot her wise discl ose d a n d will s u b mit all p u blicati o ns t o Pfizer 3 0 da y s bef ore 
s u b missi o n. If a ny pate nt acti o n is re q uire d t o pr otect i ntellect ual pr o pert y ri g hts, t he 
i n vesti gat or a grees t o dela y t he discl os ure f or a peri o d n ot t o e xcee d a n a d diti o nal 6 0 da ys 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 4
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 ny pre vi o usl y u n discl ose d 
c o nfi de ntial i nf or mati o n bef ore discl os ure, e xce pt f or a n y st u d y- i nter ve nti o n or Pfizer-relate d 
i nf or mati o n necessar y f or t he a p pr o priate scie ntific prese ntati o n or u n dersta n di n g of t he 
st u d y res ults. F or j oi nt p u blicati o ns, sh o ul d t here be disa gree me nt re gar di n g i nter pretati o n 
a n d/ or prese ntati o n of s pecific a nal ys is res ults, res ol uti o n of, a n d res p o nsi bilit y f or, s uc h 
disa gree me nts will be t he c ollecti ve res p o nsi bilit y  of all a ut h ors of t he p u blicati o n.
F or all p u blicati o ns relati n g t o t he st u d y , t he i n vesti gat or a n d Pfizer will c o m pl y wit h 
rec o g nize d et hical sta n dar ds c o ncer ni n g p u blicati o ns a n d a ut h ors hi p, i ncl u di n g t h ose 
esta blis he d b y t he I nter nati o nal C o m mittee of Me dical J o ur nal E dit ors. T he i n vesti gat or will 
discl ose a n y relati o ns hi p wit h Pfizer a n d a n y rele va nt p ote ntial c o nflicts of i nterest, i ncl u di n g 
a n y fi na ncial or pers o nal relati o ns hi p wit h Pfizer, i n a n y p u blicati o ns. A ll a ut h ors will ha ve 
access t o t he rele va nt statistical ta bles, fi g ures , a n d re p orts (i n t heir ori gi nal f or mat) re q uire d 
t o de vel o p t he p u blicati o n .
1 0. 1. 1 2. S p o ns or’s Me dic all y Q u alifie d I n di vi d u al 
T he 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 d y d oc u me ntati o n/st u d y  p ortal or ot her electr o nic 
s yste m. 
T o 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 n c y p h o ne n u m ber acti ve 2 4 h o urs/ da y, 7 da ys per wee k, a n d ( d) Pfizer C all C e nter 
n u m ber .
T he E C C is i nte n de d t o a u g me nt, n ot re place, t he esta blis he d c o m m u nicati o n pat h wa y s 
bet wee n t he partici pa nt a n d t heir i n vesti gat or a n d site staff, a n d bet wee n t he i n ve sti gat or a n d 
s p o ns or st u d y tea m. T he E C C is o nl y  t o be use d b y healt hcare pr ofessi o nals n ot i n v ol ve d i n 
t he researc h st u dy, 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 b e use d w he n t he i n vesti gat or a n d site staff 
are u na vaila ble. T he Pfizer Call Ce nter n u m ber is n ot f or use b y  t he partici pa nt directl y; 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 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 5
1 0. 2. A p pe n di x 2 : 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. 2. 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 d y  i nter ve nti o n.

N ote : A n A E ca n t heref ore be a ny u nfa v ora ble a n d u ni nte n de d si g n (i ncl u di n g a n 
a b n or mal la b orat or y fi n di n g), sy m pt o m, or disease ( ne w or e xacer bate d) 
te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n.
E ve nts Meeti n g
t he A E Defi niti o n

A n y  a b n or mal la b orat or y test res ults ( he mat ol o g y, cli nical c he mistr y, or uri nal ysis) 
or ot her safet y assess me nts (e g, E C G, ra di ol o gical sca ns, vital si g n meas ure me nts), 
i ncl u di n g t h ose t hat w orse n fr o m baseli ne, c o nsi dere d cli nicall y si g nifica nt i n t he 
me dical a n d scie ntific j u d g me nt of t he i n vesti gat or . A n y a b n or mal test res ults t hat 
meet a n y of t he c o n diti o ns bel o w m ust be rec or de d as a n A E:

Is ass ociate d wit h acc o m pa n yi n g sy m pt o ms .

Re q uir es 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 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 6
E ve nts N O T Meeti n g t he A E Defi niti o n

A n y  cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs or ot her a b n or mal safety 
assess me nts t hat are ass ociate d wit h t he u n derl yi n g disease, u nless j u d ge d b y  t he 
i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he partici pa nt’s c o n diti o n.

T he disease/ dis or der bei n g st u die d or e x pecte d pr o gressi o n, si g ns, or s y m pt o ms of 
t he disease/ dis or der bei n g st u die d, u nless m ore se vere t ha n e x pecte d f or t he 
partici pa nt’s c o n diti o n.

Me dical or s ur gical pr oce d ure (e g, e n d osc o p y, a p pe n dect o m y): t he c o n diti o n t hat 
lea ds to t he pr oce d ure is t he A E.

Sit uati o ns i n w hic h a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).

A ntici pate d da y -t o-d a y  fl uct uati o ns of pree xisti n g disease(s) or c o n diti o n(s) prese nt 
or detecte d at t he start of t he st u d y  t hat d o n ot w orse n.
1 0. 2. 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 ore of t he criteri a liste d bel o w:
a.
Res ults i n de at h
b.
Is life-t hre ate ni n g
T he ter m “life-t hreate ni n g” i n t he defi niti o n of “seri o us” refers t o a n e ve nt i n w hic h t he 
partici pa nt was at ris k of deat h at t he ti me of t he e ve nt. It d oes n ot refer t o a n e ve nt 
t hat h y p ot heticall y  mi g ht ha ve ca use d deat h if it were m ore se vere.
c.
Re q uires i n p atie nt h os pit aliz ati o n or pr ol o n g ati o n of e xisti n g h os pit aliz ati o n
I n ge neral, h os pitalizati o n si g nifies t hat t he partici pa nt has bee n a d mitte d ( us uall y 
i n v ol vi n g at least a n o ver ni g ht sta y) at t he h os pital or e mer ge nc y war d f or o bser vati o n 
a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he p h y sicia n’s office or 
o ut patie nt setti n g. C o m plicati o ns t hat occ ur d uri n g h os pitalizati o n are A Es . If a 
c o m plicati o n pr ol o n gs h os pitalizati o n or f ulfills a n y ot her seri o us criteria, t he e ve nt is 
seri o us. W he n i n d o u bt as t o w het her “ h os pitalizati o n” occ urre d or was necessar y , t he 
A E s h o ul d be c o nsi dere d seri o us.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

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

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 8
1 0. 2. 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 Es via P S S A or o n t he Vacci ne S A E Re p ort F or m t o Pfizer Safet y t hr o u g h o ut 
t he acti ve c ollecti o n peri o d. T hese re q uire me nts are deli neate d f or 3 t y pes of e ve nts: ( 1) 
S A Es; ( 2) n o nseri o us A Es; a n d ( 3) e x p os ure t o t he st u d y  i nter ve nti o n u n der st u d y d uri n g 
pre g na nc y  or breastfee di n g, a n d occ u pati o nal e x p os ure. 
It s h o ul d be n ote d t hat P S S A or t he Vacci ne S A E Re p ort F or m f or re p orti n g of S A E 
i nf or mati o n is n ot t he sa me as t he A E pa ge of t he C R F. W he n t he sa me data are c ollecte d, 
t he f or ms m ust be c o m plete d i n a c o nsiste nt man 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 
via P S S A or t he Vacci ne S A E Re p ort F or m f or re p orti n g of S A E i nf or mati o n.
S afet y E ve nt
Rec or de d o n t he C R F
Re p orte d vi a P S S A or o n 
t he Vacci ne S A E Re p ort 
F or m t o Pfizer S afet y 
Wit hi n 2 4 H o urs of 
A w are ness
S A E
All
All
N o nseri o us A E
All
N o ne
E x p os ure t o t he st u d y  
i nter ve nti o n u n der st u dy 
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 dy t o 
a n o n partici pa nt ( n ot 
i n v ol vi n g E D P or E D B)
N o ne. E x p os ure t o a st u d y  
n o n partici pa nt is n ot 
c ollecte d o n t he C R F
T he e x p os ure ( w het her or 
n ot t here is a n ass ociate d 
A E or S A E) m ust be 
rep orte d * * *
*
E D P ( wit h or wit h o ut a n ass ociate d A E or S A E): a n y pre g na nc y i nf or mati o n is re p orte d t o Pfizer 
Safet y via P S S A or usi n g t he Vacci ne S A E Re p ort F or m a n d E D P S u p ple me ntal F or m. 
* * E D B is re p orte d t o Pfizer Safet y via P S S A or usi n g t he Vacci ne S A E Re p ort F or m, w hic h w o ul d 
als o i ncl u de details of a n y S A E t hat mi g ht be ass ociate d wit h t he E D B. 
* * * E n vir o n me nt al or occ u p ati o n al e x p os ure: A E s or S A Es ass ociate d wit h occ u pati o nal e x p os ure 
are re p orte d t o Pfizer Safet y via P S S A or u si n g t he Vacci ne S A E Re p ort F or m. 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 9

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 ort 
F or m/ A E or S A E C R F pa ge.

T here ma y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are 
re q ueste d by Pfizer Safet y. I n t his case, all partici pa nt i de ntifiers, wit h t he 
e xce pti o n of t he partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he me dical 
rec or ds bef ore s u b missi o n to Pfizer Safet y .  Refer t o Secti o n 1 0. 1. 9 f or acti o ns t hat 
m ust be ta ke n w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or de si g nee.

T he i n vesti gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n si g ns, 
s ym pt o ms, a n d/ or ot her cli nical i nf or mati o n. W he ne ver p ossi ble, t he dia g n osis 
( n ot t he i n di vi d ual si g ns/s ym pt o ms) will be d oc u me nte d as t he A E or S A E.
Assess me nt of I nte nsit y

T he i n vesti gat or will ma ke a n assess me nt of i nte nsit y  f or eac h A E a n d S A E 
re p orte d d uri n g t he st u dy 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 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 0
Assess me nt of C a us alit y

T he i n vesti gat or is o bli gate d t o assess t he relati o ns hi p bet wee n st u d y i nter ve nti o n 
a n d eac h occ urre nce of eac h A E or S A E. T he i n vesti gat or will use cli nical 
j u d g me nt t o deter mi ne t he relati o ns hi p.

A “reas o na ble p ossi bilit y” of a relati o ns hi p c o n ve ys t hat t here are facts, e vi de nce, 
a n d/ or ar g u me nts t o s u g gest a ca usal relati o ns hi p, rat her t ha n a relati o ns hi p ca n n ot 
be r ule d o ut.

Alter nati ve ca uses, s uc h as u n derl yi n g disease(s), c o nc o mita nt t hera p y, a n d ot her 
ris k fact ors, as well as t he te m p oral relati o ns hi p of t he e ve nt t o st u d y i nter ve nti o n 
a d mi nistrati o n, will be c o nsi dere d a n d i n vesti gate d.

T he i n vesti gat or will als o c o ns ult t he I B a n d/ or pr o d uct i nf or mati o n, f or mar kete d 
pr o d ucts, i n t heir assess me nt.

F or eac h A E or S A E, t he i n vesti gat or m ust d oc u me nt i n t he me dical n otes t hat t he y  
ha ve re vie we d t he A E or S A E a n d ha ve pr o vi de d a n assess me nt of ca usalit y.

T here ma y  be sit uati o ns i n w hic h a n S A E has occ urre d a n d t he i n vesti gat or has 
mi ni mal i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o t he s p o ns or. H o we ver, it is 
ver y i m p ort a nt t h at t he i n vesti g at or al w a ys m a ke a n assess me nt of c a us alit y 
f or e ver y e ve nt bef ore t he i niti al tr a ns missi o n of t he S A E d at a t o t he s p o ns or.

T he i n vesti gat or ma y  c ha n ge t heir o pi ni o n of ca usalit y i n li g ht of f oll o w-u p 
i nf or mati o n a n d se n d a n S A E f oll o w-u p re p ort wit h t he u p date d ca usalit y  
assess me nt.

T he ca usalit y  assess me nt is o ne of t he criteria use d w he n deter mi ni n g re g ulat or y 
re p orti n g re q uire me nts.

If t he i n vesti gat or d oes n ot k n o w w het her or n ot t he st u d y i nter ve nti o n ca use d t he 
e ve nt, t he n t he e ve nt will be ha n dle d as “relate d t o st u d y  i nter ve nti o n” f or re p orti n g 
p ur p oses, as defi ne d b y t he s p o ns or. I n a d diti o n, if t he i n vesti gat or deter mi nes t hat 
a n S A E is ass ociate d wit h st u d y  pr oce d ures, t he i n vesti gat or m ust rec or d t his 
ca usal relati o ns hi p i n t he s o urce d oc u me nts a n d C R F, a n d re p ort s uc h a n 
assess me nt via P S S A or i n t he de dicate d secti o n of t he Vacci ne S A E Re p ort F or m 
a n d i n acc or da nce wit h t he S A E re p orti n g re q uire me nts.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 1
F oll o w -U p 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 hi s ma y i ncl u de a d diti o nal la b orat or y tests or i n vesti gati o ns, 
hist o pat h ol o gical e xa mi nati o ns, or c o ns ultati o n wit h ot her healt hcare pr o vi ders.

If a partici pa nt dies d uri n g partici pati o n i n t he st u d y or d uri n g a rec o g nize d 
f oll o w-u p peri o d, t he i n vesti gat or will pr o vi de Pfizer Safet y wit h a c o p y of a n y 
p ost m orte m fi n di n gs, i ncl u di n g hist o pat h ol o g y . 

Ne w or u p date d i nf or mati o n will be rec or de d i n t he ori gi nall y  s u b mitte d 
d oc u me nts.

T he i n vesti gat or will s u b mit a n y  u p date d S A E data t o t he s p o ns or wit hi n 2 4 h o urs 
of recei pt of t he i nf or mati o n.
1 0. 2. 4. Re p orti n g of S A Es
S A E Re p orti n g t o Pfizer S afet y vi a a n Electr o nic D C T

T he pri mar y  mec ha nis m f or re p orti n g a n S A E t o Pfizer Safet y will be t he 
electr o nic D C T (e g, P S S A or e S A E).

If t he electr o nic sys te m is u na vaila ble, t he n t he site will use t he pa per S A E re p ort 
f or m (see ne xt secti o n) t o re p ort t he e ve nt wit hi n 2 4 h o urs.

T he site will e nter t he S A E data i nt o t he electr o nic D C T (e g, e S A E or P S S A) or 
pa per f or m (as a p plica ble) as so o n as t he data bec o me a vaila ble.

After t he st u d y is c o m plete d at a gi ve n site, t he electr o nic D C T will be ta ke n 
off -li ne t o pre ve nt t he e ntr y of ne w data or c ha n ges t o e xisti n g data.

If a site recei ves a re p ort of a ne w S A E fr o m a st u d y partici pa nt or recei ves u p date d 
data o n a pre vi o usl y  re p orte d S A E after t he electr o nic D C T has bee n ta ke n off- li ne, 
t he n t he site ca n re p ort t his i nf or mati o n o n a pa per S A E f or m (see ne xt secti o n) or 
t o Pfizer Safet y  b y tele p h o ne.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 2
S A E Re p orti n g t o Pfizer S afet y vi a t he V acci ne S A E Re p ort F or m

Facsi mile tra ns missi o n of t he Vacci ne S A E Re p ort F or m is t he bac k - u p met h o d t o 
tra ns mit t his i nf or mati o n t o Pfizer Safet y i n case P S S A is u na vaila ble f or m ore t ha n 
2 4 h o urs .

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 L a yer Sec urit y) or pass w or d-pr otecte d e mail. If 
n o ne of t hese met h o ds ca n be use d, n otificati o n b y tele p h o ne is acce pta ble wit h a 
c o p y of t he Vacci ne S A E Re p ort F or m se nt b y  o ver ni g ht mail or c o urier ser vice.

I nitial n otificati o n via tele p h o ne d oes n ot re place t he nee d f or t he i n vesti gat or t o 
c o m plete a n d si g n t he Vacci ne S A E Re p ort F or m pa ges wit hi n t he desi g nate d 
re p orti n g ti me fra mes.
1 0. 2. 5. Ne wl y Di a g n ose d C hr o nic Me dic al C o n diti o ns
A n N D C M C is defi ne d as a disease or me dical c o n diti o n, n ot pre vi o usl y i de ntifie d, t hat is 
e x pecte d t o be persiste nt or ot her wise l o n g -lasti n g i n its effects (e g, ast h ma).
1 0. 3. A p pe n di x 3 : C o ntr ace pti ve a n d B arrier G ui d a nce 
N ot a p pli ca ble.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 3
1 0. 4. A p pe n di x 4 : 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 p a nt prese nts wit h 
cli nical si g ns/s y m pt o ms, s uc h L F T  res ults s h o ul d be ma na ge d a n d f oll o we d as descri be d 
bel o w.
I n t he maj orit y of DI LI cases, ele vati o ns i n A S T a n d/ or A L T prece de T b ili ele vati o ns 
( > 2 × U L N) by se veral da ys or wee ks. T he i ncrease i n T bi li t ypicall y occ urs w hile 
A S T/ A L T is/are still ele vate d a b o ve 3 × U L N (ie, A S T/ A L T a n d T bili val ues will be ele vate d 
wit hi n t he sa me la b orat or y sa m ple). I n rare i nsta nces, by t he ti me T bili ele vati o ns are 
detecte d, A S T/ A L T val ues mi g ht ha ve decrease d. T his occ urre nce is still re gar de d as a 
p ote ntial DI LI. T heref ore, a b n or mal ele vati o ns i n eit her A S T  O R A L T i n a d diti o n t o T b ili 
t hat meet t he criteria o utli ne d bel o w are c o nsi dere d p ote ntial DI LI (assesse d per H y’s la w 
criteria) cases a n d s h o ul d al wa ys be c o nsi dere d i m p orta nt me dical e ve nts, e ve n bef ore all 
ot her p ossi ble ca uses of li ver i nj ur y  ha ve bee n e xcl u de d.
T he t hres h ol d of la b orat or y  a b n or malities f or a p ote ntial DI LI case de pe n ds o n t he 
partici pa nt ’s i n di vi d ual 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 b ili baseli ne val ues wit hi n t he n or mal ra n ge w h o 
s u bse q ue ntl y prese nt wit h A S T O R A LT val ues ≥3 × U L N A N D a T b ili val ue 
≥2 × U L N wit h n o e vi de nce of he m ol ys is a n d a n al kali ne p h os p hatase val ue 
< 2 × U L N or n ot a vaila ble.

F or partici pa nt s wit h baseli ne A S T O R A L T O R T b ili val ues a b o ve t he U L N, t he 
f oll o wi n g t hres h ol d val ues are use d i n t he defi niti o n me nti o ne d a b o ve, as nee de d, 
de pe n di n g o n w hic h val ues are a b o ve t he U L N at baseli ne:

Pree xisti n g A S T or A L T baseli ne val ues a b o ve t he n or mal ra n ge: A S T or A L T 
val u es ≥2 ti mes t he baseli ne val ues A N D ≥3 × U L N; or ≥8 × U L N ( w hic he ver is 
s maller).
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

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

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 5
1 0. 5. A p pe n di x 5 : 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 dical De vice Deficie nc y
T he defi niti o ns a n d pr oce d ures detaile d i n t his a p pe n di x are i n acc or da nce wit h I S O 1 4 1 5 5
a n d t he E ur o pea n M D R 2 0 1 7/ 7 4 5 f or cli nical de vice researc h (if a p plica ble) . 
B ot h t he i n vesti gat or a n d t he s p o ns or will c o m pl y  wit h all l ocal re p orti n g re q uire me nts f or 
me dical de vices .
T he detecti o n a n d d oc u me ntati o n pr oce d ures descri be d i n t his pr ot oc ol a p pl y  t o all s p o ns or 
me dical de vices pr o vi de d f or use i n t he st u d y (see Secti o n 6. 1. 2 f or t he list of s p o ns or 
me dical de vices).
1 0. 5. 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 Secti o n 1 0. 2. 1 .

A n A D E is defi ne d as a n A E relate d t o t he use of a n i n vesti gati o nal me dical de vice. 
T his defi niti o n i ncl u des a n y  AEs res ulti n g fr o m i ns ufficie nt or i na de q uate
i nstr ucti o ns f or use, de pl o yme nt, i m pla ntati o n, i nstallati o n, or o perati o n, or a n y  
malf u ncti o n of t he i n vesti gati o nal me dical de vice as well as a n y e ve nt res ulti n g 
fr o m use err or or fr o m i nte nti o nal mis use of t he i n vesti gati o nal me dical de vice.
1 0. 5. 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 Secti o n 1 0. 2. 2 .
S A D E Defi niti o n

A n S A D E is defi ne d as a n A D E t hat has res ulte d i n a n y of t he c o nse q ue nces 
c haracteristic of a n S A E.

A n y  de vice deficie nc y t hat mi g ht ha ve le d t o a n S A E if a p pr o priate acti o n ha d n ot 
bee n ta ke n, i nter ve nti o n ha d n ot occ urre d, or circ u msta nces ha d bee n less f ort u nate.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 6
U S A D E Defi niti o n

A U S A D E (als o i de ntifie d as U A D E i n U S Re g ulati o ns 2 1 C F R 8 1 3. 3) is a S A D E
t hat b y  its nat ure, i nci de nce, se verit y, or o utc o me has n ot bee n i de ntifie d i n t he 
c urre nt versi o n of t he ris k a nal ys is ma na ge me nt file.
1 0. 5. 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 bilit y, 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. 5. 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 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 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 c li nical 
practice .

If a n A E (eit her seri o us or n o nseri o us) ass ociate d wit h t he de vice deficie nc y 
occ urs, t he n t he A E m ust be e ntere d i nt o t he A E secti o n of t he C R F.

T he i n vesti gat or will n otif y  t he s p o ns or st u d y tea m b y tele p h o ne or e mail wit hi n 
1 b usi ness da y  of deter mi ni n g t hat t he i nci de nt meets t he pr ot oc ol defi niti o n of a 
me dical de vice deficie nc y.

T he s p o ns or st u d y  tea m will ca pt ure t he re q uire d i nf or mati o n o n t he Me dical 
De vice C o m plai nt f or m al o n g wit h a n y ass ociate d A E (eit her seri o us or 
n o nseri o us) w he n a p plica ble a n d se n d t o t he a p pr o priate pr o d uct q ualit y  c o m plai nt 
gr o u p.

If t he i n vesti gat or 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 in vesti gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 7
si g ns, sy m pt o ms, a n d/ or ot her cli nical i nf or mati o n. W he ne ver p ossi ble, t he 
dia g n osis will be d oc u me nte d i n t he partici pa nt’s me dical rec or d a n d rec or de d as 
t he A E or S A E rat her t ha n t he i n di vi d ual si g ns/s y m pt o ms. All rele va nt details 
relate d t o t he r ole of t he de vice i n re gar d t o t he S A E m ust be i ncl u de d i n t he 
Vacci ne S A E Re p ort F or m/ Me dical De vice C o nstit ue nt S u p ple me ntal F or m as 
o utli ne d i n Secti o n 8. 4. 1. 1 a n d Secti o n 8. 4. 1. 2 .

T here m a y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are 
re q ueste d by Pfizer Safet y. I n t his case, all partici pa nt i de ntifiers, wit h t he 
e xce pti o n of t he partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he me dical 
rec or ds bef ore s u b missi o n t o Pf izer Safet y. Refer t o Secti o n 1 0. 1. 9 f or acti o ns t hat 
m ust be ta ke n w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or desi g nee .

F or de vice deficie ncies, it is ver y  i m p orta nt t hat t he i n vesti gat or descri bes a n y  
c orrecti ve o r 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.
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 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 pr o d uct i nf or mati o n 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 have pr o vi de d a n assess me nt of 
ca usalit y.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 8

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.
F oll o w - Up of Me dic al De vice
D eficie nc y

F oll o w - u p a p plies t o all partici pa nts, i ncl u di n g t h ose w h o disc o nti n ue st u d y 
i nter ve nti o n.

T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uati o ns, as me dicall y i n dicate d or as re q ueste d b y t he 
s p o ns or t o el uci date t he nat ure a n d/ or ca usality of t he de vice deficie nc y as f ull y as 
p ossi ble. T his ma y  i ncl u de a d diti o nal la b orat or y tests or i n vesti gati o ns, 
hist o pat h ol o gical e xa mi nati o ns, or c o ns ultati o n wit h ot her healt hcare pr o vi ders .

Ne w or u p date d i nf or mati o n re gar di n g t he nat ure of t he de vice deficie nc y will be 
rec or de d i n t he ori gi nally c o m plete d Me dical De vice C o m plai nt for m b y  t he 
s p o ns or st u d y tea m.

Ne w or u p date d i nf or mati o n re gar di n g a n y S A E t hat was p ote ntiall y ass ociate d 
wit h t he me dical de vice deficie nc y  will be s u b mitte d t o Pfizer Safet y o n t he 
Vacci ne S A E Re p ort F or m wit hi n 2 4 h o urs of recei pt of t he i nf or mati o n, acc or di n g 
t o t he re q uire me nts pr o vi de d i n Secti o n 1 0. 2 .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 9
1 0. 6. A p pe n di x 6 : Criteri a f or All o wi n g I ncl usi o n of P artici p a nts W it h C hr o nic St a ble 
HI V I nfecti o n
P ote ntial partici pa nts wit h c hr o nic sta ble HI V i nfecti o n ma y be c o nsi dere d f or i ncl usi o n if 
t he y f ulfill t he f oll o wi n g res pecti ve criteria:
K n o w n HI V i nfecti o n

C o nfir me d sta ble HI V disease defi ne d as d oc u me nte d viral l oa d < 5 0 c o pies/ m L  a n d C D 4 
c o u nt > 2 0 0 cells/ m m 3 wit hi n 6 m o nt hs bef ore e nr oll me nt, a n d o n sta ble a ntiretr o viral 
t hera py f or at least 6 m o nt hs.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 0
1 0. 7. A p pe n di x 7: S u bst u d y A
1 0. 7. 1. S u bst u d y A S u m m ar y
1 0. 7. 1. 1. S y n o psis
See Secti o n 1. 1 f or t he st u d y s yn o psis.
1 0. 7. 1. 2. Sc he m a : S u bst u d y A
A d ults ≥1 8 t o < 6 0 ye ars of a ge at hi g h ris k of R S V dise ase
A d ults ≥1 8 t o < 6 0 Y ears of 
A ge
N = 6 7 5
Ra n d o mize d 2: 1
R S V pre F : P lace b o
Visit 1 0 1
( Da y 1)
Visit 1 0 2
( M o nt h 1)
2 8 t o 3 5 D a ys 
A fter Vacci nati o n 1
Visit 1 0 3
( M o nt h 6)
1 7 5 t o 1 8 9 Da ys 
A fter Vacci nati o n 1
Vacci nati o n 1
F oll o w - U p
F oll o w - U p
R S V pre F / place b o
Bl o o d dra w  a n d 
vacci nati o n
Bl o o d dra w
1 0. 7. 1. 3. Sc he d ule of Acti vities : S u bst u d y A
A d ults ≥1 8 t o < 6 0 ye ars of a ge at hi g h ris k of R S V dise ase
Visit N u m ber
1 0 1
1 0 2
1 0 3
Visit Descri pti o n
V acci n ati o n
1- M o nt h 
F oll o w -U p
6- M o nt h S afet y 
F oll o w -U p
Visit Wi n d o w ( D a ys)
D a y 1
2 8 t o 3 5 D a ys 
After 
V acci n ati o n 
at Visit 1 0 1
1 7 5 t o 1 8 9 D a ys 
After V acci n ati o n 
at Visit 1 0 1
T y pe of Visit
Cli nic
Cli nic
Tele p h o ne or 
Cli nic
O btai n i nf or me d c o nse nt
X
Assi g n si n gle partici pa nt n u m ber
X
O btai n de m o gra p h y a n d si g nifica nt me dical hist or y 
data
X
Rec or d c urre nt/f or mer t o bacc o usa ge
X
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 1
Visit N u m ber
1 0 1
1 0 2
1 0 3
Visit Descri pti o n
V acci n ati o n
1- M o nt h 
F oll o w -U p
6- M o nt h S afet y 
F oll o w -U p
Visit Wi n d o w ( D a ys)
D a y 1
2 8 t o 3 5 D a ys 
After 
V acci n ati o n 
at Visit 1 0 1
1 7 5 t o 1 8 9 D a ys 
After V acci n ati o n 
at Visit 1 0 1
T y pe of Visit
Cli nic
Cli nic
Tele p h o ne or 
Cli nic
Perf or m cli nical assess me nt , i ncl u di n g res pirat or y 
rate (a n d p h ysical e xa mi nati o n if dee me d necessar y) 
X
C ollect n o nst u d y vacci ne i nf or mati o n 
X
X
X
C ollect pr o hi bite d me dicati o n s a n d treat me nts 
X
X
X
C o nfir m i ncl usi o n a n d e xcl usi o n criteria
X
O btai n pre vacci nati o n te m perat ure 
X
Re vie w t e mp or ar y  dela y criteria
X
Assi g n ra n d o mizati o n n u m ber
X
O btai n bl o o d sa m ple f or a nti b o d y assess me nt
~ 2 0 m L
~ 2 0 m L
A d mi nister st u d y i nter ve nti o n 
X
Assess ac ute reacti o ns f or at least 3 0 mi n utes after 
st u d y i nter ve nti o n a d mi nistrati o n
X
Dis pe nse meas uri n g de vice a n d di gital t her m o meter
X
Pr o vi de e -diar y trai ni n g o n dail y react o ge nicit y 
q uesti o n naire
X
Assist t he partici pa nt i n d o w nl oa di n g t he st u d y 
a p plicati o n o nt o his or her o w n de vice or iss ue a 
pr o visi o ne d de vice if re q uire d f or e -diar y
X
Re vie w react o ge nicit y e-diar y data
( dail y re vie w is o pti mal d uri n g t he acti ve diar y 
peri o d)
-------------------X --------------------
Re vie w o n g oi n g react o ge nicit y e -diar y s y m pt o ms a n d 
o btai n st o p dates
X
C ollect t he pr o visi o ne d de vice 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
Rec or d A Es as a p pr o priate
X
X
C ollect A E SIs, S A Es , a n d N D C M Cs as a p pr o priate
X
X
X
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 2
1 0. 7. 2. I ntr o d ucti o n f or S u bst u d y A
1 0. 7. 2. 1. St u d y R ati o n ale
S u bst u d y  A will e val uate t he safety, t olera bilit y , a n d i m m u n o ge nicity of Pfizer’s R S V pre F i n 
a d ults c o nsi dere d at hi g h ris k of R S V disease d ue t o certai n c hr o nic me dical c o n diti o ns.
1 0. 7. 2. 2. B ac k gr o u n d
See Secti o n 2. 2 .
1 0. 7. 2. 3. Be nefit/ Ris k Assess me nt
N o a d diti o nal ris ks are i de ntifie d f or S u bst u d y A b e y o n d t h ose detaile 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 ma y  be:

Rece i pt of a p ote ntially efficaci o us R S V vacci ne.

C o ntri b uti n g t o researc h t o hel p ot hers.
1 0. 7. 3. O bjecti ves, E n d p oi nts, a n d Esti m a n ds f or 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 descri be t he safet y pr ofile of 
R S V pre F as meas ure d b y t he 
perce nta ge of partici pa nts ≥1 8 t o < 6 0 
years of a ge wit h hi g h -ris k c hr o nic 
me dical c o n diti o ns re p orti n g l ocal 
reacti o ns, s yste mic e ve nts, A Es, a n d 
S A Es f oll o wi n g st u d y i nter ve nti o n 
a d mi nistrati o n.

L ocal reacti o ns ( pai n at t he 
i njecti o n site, re d ness, a n d 
s welli n g)

S ys te mic e ve nts (fe ver, 
na usea, diarr hea, v o miti n g, 
hea dac he, fati g ue, m uscle 
pai n, a n d j oi nt pai n)

A E s

N D C M Cs

S A Es
I n partici pa nts recei vi n g st u d y 
i nter ve nti o n:

T he pr o p orti o n 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 st u d y i nter ve nti o n 
a d mi nistrati o n.

T he pr o p orti o n of 
partici pa nts re p orti n g 
s yste mic e ve nts wit hi n 
7 da ys f oll o wi n g st u d y 
i nter ve nti o n a d mi nistrati o n.

T he pr o p orti o n of 
partici pa nts re p orti n g A Es 
t hr o u g h 1 m o nt h f oll o wi n g 
st u d y i nter ve nti o n 
a d mi nistrati o n.

T he pr o p orti o n of 
partici pa nts re p orti n g 
N D C M Cs t hr o u g h o ut t he 
st u d y. 

T he pr o p orti o n of 
partici pa nts re p orti n g 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 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 3
O bjecti ves
E n d p oi nts
Esti m a n ds
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 de m o nstrate t hat t he i m m u ne 
res p o nses elicite d b y R S V pre F i n 
a d ults ≥1 8 t o < 6 0 years of a ge w it h 
hi g h -ris k c hr o nic me dical c o n diti o ns 
are n o ni nferi or t o t he i m m u ne 
res p o nses i n vacci nate d a d ults ≥6 0 
years of a ge i n St u d y C 3 6 7 1 0 1 3. 
R S V A a n d R S V B ser u m N Ts
I n partici pa nts w h o recei ve d 
R S V pre F a n d i n c o m plia nce 
wit h t he ke y pr ot oc ol criteria 
(e val ua ble i m m u n o ge nicit y 
p o p ulati o n):

G M T rati o ( G M R), 
esti mate d b y t he rati o of t he 
G M Ts f or R S V A a n d R S V 
B ser u m N Ts at 1 m o nt h 
after vacci nati o n wit h 
R S V pr e F i n 
St u d y C 3 6 7 1 0 2 3 
partici pa nts t o t hat i n St u d y 
C 3 6 7 1 0 1 3 a d ults ≥6 0 years
of a ge .

Differe nce i n ser ores p o nse 
rate of R S V A a n d R S V B 
ser u m N Ts at 1 m o nt h after 
vacci nati o n wit h R S V pre F
bet w ee n partici pa nts i n 
St u d y C 3 6 7 1 0 2 3 a n d i n 
St u d y C 3 6 7 1 0 1 3 . 
Ser ores p o nse is defi ne d as a
p ost vacci nati o n N T ≥4 
ti mes t he L L O Q if baseli ne 
titer is bel o w t he L L O Q; or
a ≥4 -f ol d rise fr o m baseli ne 
if t he baseli ne titer is a b o ve
t he L L O Q .
Sec o n d ar y Im m u n o ge nicit y
Sec o n d ar y Im m u n o ge nicit y
Sec o n d ar y Im 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 R S V pre F i n a d ults ≥1 8 t o 
< 6 0 years of a ge wit h hi g h -ris k 
c hr o nic me dical c o n diti o ns.
R S V A a n d R S V B ser u m 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 i m m u n o ge nicit y 
p o p ulati o n):

G M T of N T s f or R S V A 
a n d R S V B at eac h bl o o d 
sa m pli n g visit.

G M F R of N T s f or R S V A 
a n d R S V B fr o m bef ore 
vacci nati o n t o t he 
p ost vacci nati o n bl o o d 
sa m pli n g visit.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 4
1 0. 7. 4. St u d y Desi g n f or S u bst u d y A
1 0. 7. 4. 1. O ver all Desi g n
T his is a P hase 3, m ultice nter, ra n d o mize d, d o u ble-bli n d e d, place b o-c o ntr olle d st u d y t hat 
will assess t he safet y, t olera bilit y , a n d i m m u n o ge nicit y of Pfizer’s R S V pre F i n a d ults
c o nsi dere d at hi g h ris k of R S V disease d ue t o certai n c hr o nic me dical c o n diti o ns.
A p pr o xi matel y  6 7 5 partici pa nt s ≥1 8 t o < 6 0 y ears of a ge c o nsi dere d at hi g h ris k of R S V 
disease d ue t o certai n c hr o nic me dical c o n diti o ns will be ra n d o miz e d i n a rati o of 2 : 1 t o 
recei ve eit her t he 1 2 0- µ g d ose le vel of R S V pre F or place b o. E nr oll me nt will be m o nit ore d 
t o hel p e ns ure distri b uti o n of vacci nati o n acr oss t he a ge ra n ge.  The d urati o n of st u d y  
partici pa ti o n f or eac h partici pa nt will be a p pr o xi matel y 6 m o nt hs.   A react o ge nicit y  e-diar y  
will be use d b y  partici pa nts f or 7 da ys fr o m t he da y of vaccinati o n. T he acti ve c ollecti o n 
peri o d f or A Es will be t hr o u g h a p pr o xi matel y  1 m o nt h after st u d y i nter ve nti o n a d mi nistrati o n 
a n d f or A E SIs, S A Es , a n d N D C M Cs t hr o u g h a p pr o xi matel y 6 m o nt hs after st u d y 
i nter ve nti o n a d mi nistrati o n.  Bl o o d sa m ples will be ta ke n at baseli ne a n d 1 m o nt h after d ose 
a d mi nistrati o n f or all partici pa nts f or assess me nt of i m m u n o ge nicity.
A d ults wit h hi g h -ris k me dical c o n diti o ns w h o are at si g nifica nt ris k of m or bi dit y  a n d 
m ortalit y  d ue t o R S V i nfecti o n will be i ncl u de d i n t his st u d y . Hi g h-ris k c hr o nic me dical 
c o n diti o ns are defi ne d i n t his s u bst u d y as:

C hr o nic p ul m o nar y  (i ncl u di n g ast h ma), car di o vasc ular (e xcl u di n g is olate d h yperte nsi o n), 
re nal, he patic, ne ur ol o gic, he mat ol o gic, or meta b olic dis or ders (i ncl u di n g dia betes 
mellit us) :

D ur ati o n greater t ha n 6 m o nt hs .

Sta ble d isease n ot re q uiri n g a si g nifica nt c ha n ge i n t hera p y i n t he pre vi o us 
6 wee ks or h os pitalizati o n f or w orse ni n g disease wit hi n 1 2 wee ks bef ore recei pt of 
st u d y i nter ve nti o n.

R e q uires re g ular me dical f oll o w-u p, o n g oi n g me dicati o n, or h os pitalizati o n i n t he 
pre vi o us y ear.

A d diti o nal gr o u ps at hi g h ris k i ncl u de:

Resi de nts of n u rsi n g h o mes a n d ot her l o n g-ter m care facilities. 
1 0. 7. 4. 2. Scie ntific R ati o n ale f or S u bst u d y A Desi g n
See Secti o n 2. 1 .
S u bst u d y  A uses a 1. 5 -f ol d n o ni nferi orit y mar gi n f or G M R a n d a -1 0 % n o ni nferi orit y  mar gi n 
f or ser ores p o nse rates f or b ot h R S V A a n d R S V B , i n or der t o bri d ge t he i m m u ne res p o nse 
fro m t he tar get p o p ulati o n t o S t u d y C 3 6 7 1 0 1 3, w here efficac y  was de m o nstrate d f or 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 5
R S V pre F i n pre ve nti n g L R TI -R S V .
G M Rs of R S V N Ts at 1 m o nt h after vacci nati o n wit h 
R S V pre F a m o n g partici pa nts ( ≥1 8 t o < 6 0 y ears of a ge wit h hi g h-ris k c hr o nic me dical 
c o n diti o ns) fr o m t his st u d y  t o t he partici pa nts ≥6 0 y ears ol d fr o m t he St u d y C 3 6 7 1 0 1 3 
i m m u n o ge nicity s u bset 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. St u d y  
s uccess will be declare d if t he l o wer b o u n d of t he 2-si de d 9 5 % CI f or t he G M R is greater 
t ha n 0.6 6 7 a n d t he l o wer b o u n d of t he 2 -si de d 9 5 % CI  f or ser ores p o nse rate differe nces is 
greater t ha n -1 0 % f or b ot h R S V A a n d R S V B.
1 0. 7. 4. 3. J ustific ati o n f or D ose
See Secti o n 4. 3 .
1 0. 7. 4. 4. E n d of St u d y Defi niti o n
See Secti o n 4. 4 .
1 0. 7. 5. St u d y P o p ul ati o n f or S u bst u d y A
Partici pa nts m ust meet all of t he i ncl usi o n criteria a n d n o ne of t he e xcl usi o n criteria as 
s pecifie d f or S u bst u d y A. N ote, a rece nt s ys te matic literat ure re vie w c ollati n g ris k fact ors f or 
se vere R S V disease a m o n g a d ults f o u n d m ore li mite d data t ha n are a vaila ble f or i nfl ue nza, 
w hic h is m ore wi del y st u die d a m o n g ol der a d ults . H o we ver, fi n di n gs s u g gest t hat se vere 
disease ris k fact ors are si milar f or t hese 2 res pirat or y vir uses.2 5 ,4 4 O n t his basis, 
c o m or bi dit ies n ote d t o be ris k fact ors i n t he i nfl ue nza vacci ne pr o gra m were use d as 
i ncl usi o n criteria f or t his st u d y.
1 0. 7. 5. 1. I ncl usi o n Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n S u b st u d y A o nl y if all of t he i ncl usi o n criteria 
a p pl y:
I nf or me d C o nse nt
1.
Ca pa ble of gi vi n g si g ne d i nf or me d c o nse nt as descri be d i n Secti o n 1 0. 1. 3 , w hic h i ncl u des 
c o m plia nce wit h t he re q uire me nts a n d restricti o ns liste d i n t he I C D a n d i n t his pr ot oc ol.
A ge a n d Se x
2.
Partici pa nts ≥1 8 t o < 6 0 years of a ge at st u d y e nr oll me nt.  
T y pe of P artici p a nt a n d Dise ase C h ar acteristics:
3.
Life e x pecta nc y  ≥1 2 m o nt hs ( 3 6 5 da y s) i n t he o pi ni o n of t he i n vesti gat or at e nr oll me nt.
4.
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, vacci nati o n 
pla n, lifest y le c o nsi derati o ns, a n d ot her st u d y pr oce d ures.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 6
5.
Partici pa nts w h o are c o nsi dere d at hi g h ris k of R S V disease b y virt ue of t he f oll o wi n g:

A d ults wit h c hr o nic p ul m o nar y  (i ncl u di n g ast h ma), car di o vasc ular (e xcl u di n g 
is olate d h yp erte nsi o n), re nal, he patic, ne ur ol o gic, he mat ol o gic, or meta b olic dis or ders 
(i ncl u di n g dia betes mellit us).
C hr o nic me dical c o n diti o ns f or t his s u bst u d y are defi ne d as :

D urati o n greater t ha n 6 m o nt hs .

Sta ble disease n ot re q uiri n g a si g nifica nt c ha n ge i n t hera py i n t he pre vi o us 
6 wee ks or h os pitalizati o n f or w orse ni n g disease wit hi n 1 2 wee ks bef ore recei pt 
of st u d y  i nter ve nti o n.

Re q uires re g ular me dical f oll o w- u p or o n g oi n g me dicati o n or h os pitalizati o n i n 
t he pre vi o us year. 

A d diti o nal gr o u ps at hi g h ris k i ncl u de:

Resi de nts of n ursi n g h o mes a n d ot her l o n g- ter m care facilities.
1 0. 7. 5. 2. E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m S u b st u d y A if a ny of t he f oll o wi n g criteria a p pl y :
Me dic al C o n diti o ns:
1.
Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d ble e di n g t hat w o ul d, i n t he 
o pi ni o n of t he i n vesti gat or, c o ntrai n dicate i ntra m usc ular i njecti o n.
2.
Hist or y  of se vere a d verse reacti o n ass ociate d wit h a 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) or a ny relate d 
vacci ne.
3.
Partici pa nts w h o d o n ot ha ve a de q uate delt oi d m uscle mass t o all o w i ntra m usc ular 
vacci nati o n, i n t he o pi ni o n of t he i n vesti gat or .
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 his t or y a n d/ or la b orat or y/ p h ysical e xa mi nati o n.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 7
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.
N ote : 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 ca n be 
f o u n d i n Secti o n 1 0. 6 , A p pe n di x 6 .
Pri or/ C o nc o mit a nt T her a p y:
7.
I n di vi d uals w h o recei ve c hr o nic sys te mic treat me nt wit h i m m u n os u p pressi ve t hera py, 
i ncl u di n g c yt ot o xic a ge nts, i m m u n os u p pressi ve m o n ocl o nal a nti b o dies, s y ste mic 
c ortic oster oi ds *, e g, f or ca ncer or a n a ut oi m m u ne disease, or ra di ot hera p y, fr o m 6 0 da ys 
bef ore st u d y i nter ve nti o n a d mi nistrati o n or pla n ne d recei pt t hr o u g h o ut t he st u d y . 
* A p plies t o s ys te mic c ortic oster oi ds a d mi nistere d f or ≥1 4 da y s at a d ose of ≥2 0 m g/ d a 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). S y ste mic 
c ortic oster oi ds a d mi nistere d at a d ose of < 2 0 m g / da y of pre d nis o ne or e q ui vale nt are 
per mitte d .  I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b u rsal, 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 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 of t hese me dicati o ns pri or t o t he fi nal 
bl o o d dra w.
N ote : M o n ocl o nal a nti b o dies wit h tar gete d mec ha nis ms of acti o n use d i n t he 
ma na ge me nt of c hr o nic ill nesses (e g, mi grai ne hea dac hes, oste o p or osis) are per mitte d , 
pr o vi de d t he y  d o n ot meet e xcl usi o n criterio n 7.
9.
Pre vi o us vacci nati o n wit h a n y  lice nse d or i n vesti gati o nal R S V vacci ne or pla n ne d recei pt 
d uri n g st u d y partici pati o n.
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
1 0. Partici pati o n i n ot her st u dies i n v ol vi n g a n i n vesti gati o nal pr o d uct wit hi n 2 8 da y s pri or t o 
c o nse nt a n d/ or t hr o u g h a n d i ncl u di n g t he 6 -m o nt h f oll o w -u p visit. 
N ote: T his criter i o n d oes n ot a p pl y t o partici pa nts w h o are partici pati n g i n a f oll o w- u p 
peri o d f or a n ot her st u d y i n v ol vi n g a st u d y i nter ve nti o n t hat is a n i n vesti gati o nal dr u g or 
vacci ne, if recei pt of t he last d ose was at least 6 m o nt hs pri or t o c o nse nti n g f or t his st u d y
a n d t here is n o f urt her d osi n g a ntici pate d fr o m t he pre vi o us st u d y  d uri n g t he partici pa nt’s 
partici pati o n i n t his st u d y .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 8
Ot her E xcl usi o n Criteri a:
1 1. I n vesti gat or site staff directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site staff o t 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. 7. 5. 3. Lifest yle C o nsi der ati o ns
T here are n o lifest y le restricti o ns re q uire d f or t he partici pa nts i n t his st u d y.
All pre g na ncies disc o vere d i n fe male partici pa nts a n d fe male part ners of male partici pa nts,
d uri n g st u d y partici pati o n, w hic h be gi ns after o btai ni n g i nf or me d c o nse nt as descri be d i n 
Secti o n 8. 4. 1 , will be rec or de d i n acc or da nce wit h t he E D P (see Secti o n 8. 4. 5. 1 ) a n d E D B 
(see Secti o n 8. 4. 5. 2 ) re p orti n g pr ocesses.
1 0. 7. 5. 4. Scree n F ail ures
See Secti o n 5. 4 .
1 0. 7. 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 ati o n 
of St u d y I nter ve nti o n
T he f oll o wi n g c o n diti o ns ma y  all o w a partici pa nt t o be ra n d o mize d o nce t he c o n diti o ns ha ve 
res ol ve d a n d t he partici pa nt is ot her wise eli gi ble.  Partici pa nts meeti n g t hese criteria at 
Visit 1 0 1 will be c o nsi dere d scree n fail ures if e nr oll me nt has cl ose d o nce t he c o n dit i o n(s) 
has/ ha ve res ol ve d.

C urre nt fe brile ill ness (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.

Recei pt of a n y li ve vacci ne wit hi n 2 8 da ys bef ore st u d y  i nter ve nti o n a d mi nistrati o n. 
Recei pt of a n y n o nli ve vacci ne (i ncl u di n g 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) wit hi n 1 4 da ys bef ore st u d y i nter ve nti o n a d mi nistrati o n.

A ntici pate d recei pt of a n y n o nst u d y vacci ne wit hi n 1 4 da ys after st u d y i nter ve nti o n 
a d mi nistrati o n.

Recei pt of s h ort -ter m ( < 1 4 da ys) 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 ye 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.
N ote : S yste mic c ortic oster oi ds a d mi nistere d at a d ose of < 2 0 m g/ da y  of pre d nis o ne or 
e q ui vale nt are per mitte d. I nhale d/ ne b ulize d, i ntra -artic ular, i ntra b ursal, or t o pical (s ki n 
or e y es) c ortic oster oi ds are per mitte d.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 9
1 0. 7. 6. St u d y I nter ve nti o n a n d C o nc o mit a nt T her a p y f or S u bst u d y A
F or t he p ur p oses of t his st u d y , st u d y i nter ve nti o n refers t o:

R S V pre F .

Place b o (l y o p hile matc h) .
1 0. 7. 6. 1. St u d y I nter ve nti o n(s) A d mi nistere d f or S u bst u d y A
St u d y I nter ve nti o n(s)
I nter ve nti o n 
n a m e
R S V pre F 
Place b o
T y pe
Vacci ne
Place b o
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
D ose 
f o r mul ati o n
T he acti ve i n gre die nts i n R S V pre F are 2 
sta bilize d R S V pref usi o n F a nti ge ns, i n e q ual 
a mo u nts fr o m vir us s u b gr o u ps A a n d B, i n a 
l yo p hilize d d osa ge f or m f or rec o nstit uti o n.  
T he R S V dr u g pr o d uct will be 1 2 0 µ g of t he 
R S V pref usi o n F a nti ge n.  T he dr u g pr o d uct is 
s u p plie d as a l y o p hilize d w hite ca ke i n a 2-m L 
glass vial, wit h a 1 3 -m m l y o p hilizati o n 
st o p per, al u mi n u m o verseal, a n d fli p-off ca p.
T he dr u g pr o d uct w ill be rec o nstit ute d b y a 
di l ue nt c o nsisti n g of sterile water i n a P F S.  
T he l y o p hilize d dr u g pr o d uct c o ntai ns 
e xci pie nts t hat, after rec o nstit uti o n, will yiel d 
a s ol uti o n as detaile d i n t he I B.
T he fill v ol u me of t he dr u g pr o d uct vial a n d 
dil ue nt P F S are desi g ne d s uc h t hat t he 
1 2 0 -µ g vacci ne d ose is deli vere d b y i njecti n g 
t he e ntire c o nte nts of t he s yri n ge.
Place b o w ill be a l y o p hile matc h t o t he 
vacci ne, w hic h will c o nsist of e xci pie nts 
matc he d t o t h ose use d i n t he R S V pre F 
vacci ne f or m ulati o n, mi n us t he acti ve 
i n gre die nts. 
T he pl ace b o is s u p plie d as a l y o p hilize d 
w hite ca ke i n a 2 -m L glass vial, w it h a 
1 3 -m m l y o p hilizati o n st o p per, al u mi n u m 
o verseal, a n d fli p -off ca p.  T he l y o p hilize d 
w hite ca ke will be rec o nstit ute d b y a dil ue nt 
c o nsisti n g of sterile water i n a P F S.  T he 
p h ysical a p peara nce of t he rec o nstit ute d 
R S V pre F a n d place b o w ill be matc he d, a n d 
S u bst u d y A will be c o n d ucte d i n a 
d o u ble -bli n de d ma n ner.
T he fill v ol u me of t he place b o vial a n d 
dil ue nt P F S is desi g ne d s uc h t hat t he 
i nte n de d place b o d ose is deli vere d b y 
i njectin g t he e ntire c o nte nts of t he s yri n ge 
t o matc h t he 1 2 0-µ g vacci ne d ose. 
U nit d ose 
stre n gt h(s)
1 2 0 µ g
N/ A
R o ute of 
a d mi nistr ati o n
I ntra m usc ular
I ntra m usc ular
S o urci n g
Pr o vi de d ce ntrall y b y t he s p o ns or
Pr o vi de d ce ntrall y b y t he s p o ns or
P ac k a gi n g a n d 
l a beli n g
St u d y i nter ve nti o n will be pac ka ge d wit hi n 
cart o ns la bele d b y Pfizer or its desi g nee i n 
acc or da nce wit h c urre nt g ui deli nes a n d 
a p plica ble l ocal a n d le gal re g ulat or y 
re q uire me nts.
St u d y i nter ve nti o n will be pac ka ge d wit hi n 
cart o ns la bele d b y Pfizer or its desi g nee i n 
acc or da nce wit h c urre nt g ui deli nes a n d 
a p plica ble l ocal a n d le gal re g ulat or y 
re q uire me nts
S R S D
I B
I B
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 0
St u d y Ar ms – S u bst u d y A
A r m  Title
R S V pre F
Place b o
A r m  Descri pti o n
Partici pa nts will recei ve R S V pre F 1 2 0 µ g 
at Visit 1 0 1
Partici pa nts will recei ve place b o at 
Visit 1 0 1
1 0. 7. 6. 1. 1. A d mi nistr ati o n
Partici pa nts will recei ve 1 d ose of st u d y  i nter ve nti o n i n acc or da nce wit h t he s u bst u d y’s S o A
Secti o n 1 0. 7. 1. 3 . F or ot her details re gar di n g st u d y i nter ve nti o n a d mi nistrati o n, see 
Secti o n 6. 1. 1 .  T he st u d y  i nter ve nti o n will be a d mi nistere d i nt o t he delt oi d m uscle, prefera bly 
of t he n o n d o mi na nt ar m u nless me dicall y  c o ntrai n dicate d i n w hic h case t he i njecti o n ma y be 
a d mi nistere d i n t h e d o mi na nt ar m , b y  a p pr o priatel y desi g nate d st u d y staff at t he i n vesti gat or 
site.
1 0. 7. 6. 1. 2. Me dic al De vices
See Secti o n 6. 1. 2 .
1 0. 7. 6. 1. 3. Pre p ar ati o n, H a n dli n g, St or a ge, a n d Acc o u nt a bilit y
See Secti o n 6. 2 .
1 0. 7. 6. 1. 4. Assi g n me nt t o St u d y I nter ve nti o n
See Secti o n 6. 3 .
All ocati o n (ra n d o mizati o n) of partici pa nts t o vacci ne gr o u ps will pr ocee d t hr o u g h t he use of 
a n IR T s ys te m. 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 ot li mite d t o t he user’s I D a n d pass w or d, t he 
pr ot oc ol n u m ber, a n d t he partici pa nt n u m ber. T he site pers o n nel will t he n be pr o vi de d wit h a 
ra n d o mizati o n n u m ber c orres p o n din 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 t he st u d y i nter ve nti o n is bei n g s u p plie d via t he I R T sys te m. T he I R T 
s yste m will pr o vi de a c o nfir mati o n re p ort c o ntai ni n g t he partici pa nt n u m ber, ra n d o mizati o n 
n u m ber, a n d st u d y i nter ve nt i o n all ocati o n assi g ne d. T he c o nfir mati o n re p ort m ust be st ore d 
i n t he site’s files. 
St u d y  i nter ve nti o n will be dis pe nse d as s u m marize d i n t he S o A f or S u bst u d y  A. 
1 0. 7. 6. 2. Bli n di n g f or S u bst u d y A
1 0. 7. 6. 2. 1. Bli n di n g of P artici p a nts
S u bst u d y  A is a d o u ble-bli n de d st u d y . Partici pa nts will be bli n de d t o t heir assi g ne d st u dy 
i nter ve nti o n.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 1
1 0. 7. 6. 2. 2. Bli n di n g of Site Pers o n nel
S u bst u d y  A is d o u ble-bli n de d, as t he p h ys ical a p peara nce of R S V pre F a n d place b o will be 
matc he d.
I n vesti gat ors a n d ot her site staff will be bli n de d t o partici pa nts’ assi g ne d st u dy 
i nter ve nti o n.
1 0. 7. 6. 2. 3. Bli n di n g of t he S p o ns or
T he maj orit y  of s p o ns or staff will be bli n de d t o partici pa nts’ assi g ne d st u d y i nter ve nti o n.  All 
la b orat or y testi n g pers o n nel perf or mi n g ser ol o gical assa ys will re mai n bli n de d t o st u d y 
i nter ve nti o n assi g ne d/recei ve d t hr o u g h o ut t he st u d y . T he f oll o wi n g s p o ns or staff will be 
u n bli n de d (f urt her details will be pr o vi de d i n t he D M C c harter a n d ot her st u d y d oc u me nts):
A n u n bli n de d ve n d or s u p p orti n g i nteracti o ns wit h t he D M C. T his will c o m prise a statisti cia n 
a n d a pr o gra m mer(s).  T he u n bli n de d safet y a nal ysis f or t he D M C will be perf or me d b y 
Pfizer/ ve n d or pr o gra m mers w h o are se parate fr o m t he st u d y .  S p o ns or staff i n v ol ve d i n t he 
assi g n me nt or distri b uti o n of st u d y i nter ve nti o n are als o u n bli n de d.
1 0. 7. 6. 2. 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 
vacci ne 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 vacci ne 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 vacci ne 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.
1 0. 7. 6. 3. St u d y I nter ve nti o n C o m pli a nce
See Secti o n 6. 5 .
1 0. 7. 6. 4. D ose M o dific ati o n
N ot a p plica ble .
1 0. 7. 6. 5. C o nti n ue d Access t o St u d y I nter ve nti o n After t he E n d of t he St u d y
See Secti o n 6. 7.
1 0. 7. 6. 6. Tre at me nt of O ver d ose
See Secti o n 6. 8 .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 2
1 0. 7. 6. 7. Pri or a n d C o nc o mit a nt T her a p y f or S u bst u d y A
T he f oll o wi n g pri or a n d c o nc o mita nt me dicati o ns, vacci nati o ns, a n d treat me nts will be 
rec or de d i n t he C R F:

A n y  vacci nati o ns recei ve d fr o m 2 8 da ys 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 a n d treat me nts liste d i n Secti o n 1 0. 7. 6. 7. 1 ( wit h t he e xce pti o n of 
a nti p yretics a n d ot her pai n me dicati o ns t o pre ve nt s ym pt o ms ), if ta ke n, will be rec or de d 
a n d i ncl u de start a n d st o p dates, na me of t he me dicati o n, d ose, u nit, r o ute, a n d fre q ue nc y .
1 0. 7. 6. 7. 1. Pr o hi bite d C o nc o mit a nt V acci n ati o ns a n d Tre at me nts f or S u bst u d y A
Recei pt of t he f oll o wi n g vacci nes a n d me dicati o ns d uri n g t he ti me peri o ds liste d bel o w ma y  
e xcl u de a partici pa nt fr o m t he per- pr ot oc ol a 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  ( unless d oc u me nte d 
as per Secti o n 7. 2 ). Me dicati o ns s h o ul d n ot be wit h hel d if re q uire d f or a partici pa nt’s 
me dical care.

Recei pt of a n y n o nst u d y R S V vacci ne at a n y ti me pri or t o or d uri n g st u d y partici pati o n.

In vesti gati o nal vacci nes, dr u gs, or me dical de vices are pr o hi bite d d uri n g t he c o urse of t he 
st u d y. 
N ote: 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 will n ot be 
pr o hi bite d d uri n g t he c o urse of t his st u d y if a d mi nistere d m ore t ha n 1 4 da ys pri or t o 
st u d y i nter ve nti o n a d mi nistrati o n or at least 1 4 da ys after st u d y i nter ve nti o n 
a d mi nistrati o n.

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 (IVI G, S CI G) p ri or t o t he fi nal 
bl o o d dra w .
N ote : M o n ocl o nal a nti b o dies wit h tar gete d mec ha nis ms of acti o n use d i n t he 
ma na ge me nt of c hr o nic ill nesses (e g, mi grai ne hea dac hes, oste o p or osis) are per mitte d , 
pr o vi de d t he y  d o n ot meet e xcl usi o n criteri o n 7.

N o nst u d y  vacci nes ma y n ot be gi ve n c o nc o mita ntl y wit h t he st u d y i nter ve nti o n or 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, e xce pt if me dically necessar y (e g, d uri n g 
a n o ut brea k or pa n de mic sit uati o n).

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 ppressa nt me dicati o ns 
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 t hr o u g h c o ncl usi o n of t he st u d y. 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 3

Recei pt of s ys te mic c ortic oster oi ds ( ≥2 0 m g/ da y  of pre d nis o ne or e q ui vale nt) f or 
≥1 4 da y s is pr o hi bite d fr o m 2 8 da ys pri or t o st u d y i nter ve nti o n a d mi nistrati o n t hr o u g h 
D a y  2 8 after a d mi nistrati o n of t he st u d y i nter ve nti o n.
N ote: I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical (s ki n or e y es) 
c ortic oster oi ds are per mitte d.

Pr o p h y lactic a nti p yretics a n d ot her pai n me dicati o n t o pre ve nt sy m pt o ms ass ociate d wit h 
st u d y i nter ve nti o n a d mi nistrati o n are n ot per mitte d bef ore a d mi nistrati o n of st u d y 
i nter ve nti o n.
N ote: 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. 7. 6. 7. 2. Per mitte d C o nc o mit a nt V acci n ati o ns a n d Tre at me nts f or S u bst u d y A

Me dicati o n ot her t ha n t hat descri be d as pr o hi bite d i n Secti o n 1 0. 7. 6. 7. 1 re q uire d f or 
treat me nt of pree xisti n g c o n diti o ns, ac ute ill ness, or t o treat sy m pt o ms ass ociate d wit h 
st u d y i nter ve nti o n a d mi nistrati o n is per mitte d.

Lice nse d vacci nes ma y  be gi ve n d uri n g t he st u d y starti n g 1 4 da ys after st u d y i nter ve nti o n 
a d mi nistrati o n.

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. S y ste mic c ortic oster oi ds a d mi nistere d at a d ose of 
< 2 0 m g/ da y  of pre d nis o ne or e q ui vale nt are per mitte d.

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 wit h 
st u d y i nter ve nti o n a d mi nistrati o n is per mitte d d uri n g t he partici pa nt’s partici pati o n i n t he 
st u d y.
1 0. 7. 7. Disc o nti n u ati o n of St u d y 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 f or S u bst u d y A
S u bst u d y  A is a si n gle-d ose st u d y ; t heref ore, disc o nti n uati o n of st u d y  i nter ve nti o n is n ot 
a p plica ble.
See Secti o n 7. 2 f or i nf or mati o n re gar di n g partici pa nt disc o nti n uati o n/ wit h dra wal fr o m t he 
st u d y.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 4
1 0. 7. 8. St u d y Assess me nts a n d Pr oce d ures f or S u bst u d y A
Refer t o Secti o n 8 a n d t he f oll o wi n g s u bsecti o ns:

Secti o n 8. 1 A d mi nistrati ve a n d Baseli ne Pr oce d ures

Secti o n 8. 1. 1 Tele healt h Visits
1 0. 7. 8. 1. I m m u n o ge nicit y Assess me nts
1 0. 7. 8. 1. 1. R S V V acci ne A nti b o d y Testi n g
Refer t o Secti o n 8. 2. 3 f or ge neral i nf or mati o n re gar di n g use a n d st ora ge of bi ol o gical 
sa m ples.
Bl o o d sa m ples (a p pr o xi matel y  2 0 m L per sa m ple) will be c ollecte d fr o m partici pa nts f or 
i m m u n o ge nicity testi n g as s pecifie d i n t he S u b st u d y A S o A (refer t o Secti o n 1 0. 7. 1. 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 S u b st u d y A is a p pr o xi matel y 
4 0 m L .
R S V A – a n d R S V B– ne utralizi n g a nti b o d y  titers will be meas ure d f or eac h bl o o d sa m ple at 
eac h ti me p oi nt, a n d re p orte d as t he N T s. Sera c ollecte d will be teste d c o nc urre ntl y wit h sera 
c ollecte d bef ore vacci nati o n a n d 1 m o nt h after vacci nati o n wit h R S V pre F fr o m t he St u d y  
C 3 6 7 1 0 1 3 i m m u n o ge nicit y  s u bset ( partici pa nts ≥6 0 ye ars ol d) s o t hat i m m u n o bri d gi n g ca n 
be assesse d. 
Bl o o d sa m ple c ollecti o n ma y  be halte d or disc o nti n ue d u p o n n otificati o n b y Pfizer. T his 
i ncl u des disc o nti n ui n g sa m pli n g i n d ose d partici pa nts w h o are n o l o n ger eli gi ble f or t he 
st u d y as well as disc o nti n uati o n f or gr o u ps of partici pa nts or all partici pa nts.
1 0. 7. 8. 2. S afet y Assess me nts
Pla n ne d ti me p oi nts f or all safet y  assess me nts are pr o vi de d i n t he S o A. U nsc he d ule d safet y 
meas ure me nts ma y  be o btai ne d at a n y ti me d uri n g t he st u d y  t o assess a n y percei ve d safet y 
iss ues.
Refer t o Secti o n 8. 3 a n d t he f oll o wi n g s u bsecti o ns:

Secti o n 8. 3. 1 P h y sical E xa mi nati o ns

Secti o n 8. 3. 2 Vital Si g ns

Secti o n 8. 3. 3 Cli nical Safet y  La b orat or y Assess me nts

Secti o n 8. 3. 4 Electr o nic Di ar y f or React o ge nicit y
E- diar y  assess me nts are i ncl u de d i n S u bst u d y A f or partici pa nts’ re p orti n g of l ocal reacti o ns 
a n d s yste mic e ve nts f or 7 da ys fr o m t he da y of eac h a d mi nistrati o n of t he st u d y i nter ve nti o n. 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 5
Partici pa nts will recei ve re mi n ders t o c o m pl ete t he vacci nati o n e -diar y  o n a dail y basis, 
starti n g o n t he da y of vacci nati o n ( Da y 1) t hr o u g h Da y 7 after eac h vacci nati o n. Refer t o 
Secti o n 8. 3. 4 f or details.
1 0. 7. 8. 3. 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
Refer t o Secti o n 8. 4 a n d t he f oll o wi n g s u bsecti o ns:

Secti o n 8. 4. 1 Ti me Peri o d a n d Fre q ue nc y  f or C ollecti n g A E a n d S A E I nf or mati o n

Secti o n 8. 4. 2 Met h o d of Detecti n g A Es a n d S A Es

Secti o n 8. 4. 3 F oll o w -U p of A Es a n d S A Es

Secti o n 8. 4. 4 Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es

Secti o n 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

Secti o n 8. 4. 6 Car di o vasc ular a n d Deat h E ve nts

Secti o n 8. 4. 7 Disease -Relate d E ve nts a n d/ or Disease -Relate d O utc o mes N ot Q ualif y i n g 
as A Es or S A Es

Secti o n 8. 4. 8 A d verse E ve nts of S pecial I nterest

Secti o n 8. 4. 9 Me dical De vice De ficie ncies

Secti o n 8. 4. 1 0 Vacci nati o n Err ors
1 0. 7. 8. 4. S u bst u d y A Pr oce d ures
1 0. 7. 8. 4. 1. Visit 1 0 1 – V acci n ati o n ( Cli nic, 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 nt. T he s o urce d at a m ust reflect t h at t he 
i nf or me d c o nse nt w as o bt ai ne d bef ore p artici p ati o n i n t he st u d y.
It is a ntici pate d t hat t he pr oce d ures bel o w will be c o n d ucte d i n a ste p wise ma n ner; e ns ure 
t hat pr oce d ures liste d pri or t o st u d y i nter ve nti o n a d mi nistr ati o n are c o n d ucte d pri or t o 
st u d y vacci nati o n.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 6

O btai n writte n i nf or me d c o nse nt 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 IR T 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 di n g:

Heart disease ;

L u n g disease ;

Ast h ma ;

Dia betes mellit us / meta b olic disease;

Li ver disease ;

Re nal disease ;

Ne ur ol o gi c disease;

He mat ol o gic disease ;

Resi de nt of n ursi n g h o me/l o n g -ter m care facilit y.

I n a d diti o n, f or specific criteria f or partici pa nts wit h k n o w n sta ble i nfecti o n wit h HI V,
please re fer t o Secti o n 1 0. 6 , A p pe n di x 6 .

O btai n a n d rec or d c urre nt/f or mer t o bacc o usa ge.

Perf or m a cli nical assess me nt, i ncl u di n g baseli ne res pirat or y  rate. 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.

O btai n details of a n y n o nst u d y  vacci nati o ns, pr o hi bite d me dicati o ns a n d treat me nts as 
descri be d i n Secti o n 1 0. 7. 6. 7 .

E ns ure a n d d oc u me nt t h at all t he i ncl usi o n criteri a a n d n o ne of t he e xcl usi o n 
criteri a are met.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 7

Meas ure a n d rec or d pre vacci nati o n te m perat ure.

E ns ure t hat t he partici pa nt meets n o ne of t he te m p orar y dela y criteria as descri be d i n
Secti o n 1 0. 7. 5. 5 .

O btai n t he partici pa nt’s ra n d o mizati o n n u m ber a n d st u d y  i nter ve nti o n kit n u m ber usi n g 
t he IR T s ys te m. Refer t o t he I R T ma n ual f or f urt her i nstr ucti o ns o n t his pr ocess.

P ri 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 2 0 m L .

Q ualifie d site sta ff me m ber(s) will a d mi nister a si n gle d ose of st u d y i nter ve nti o n i nt o t he 
delt oi d m uscle of t he ( prefera bl y) n o n d o mi na nt ar m, u nless me dicall y c o ntrai n dicate d, i n 
w hic h case t he i njecti o n ma y  be a d mi nistere d i n t he d o mi na nt ar m. Please refer t o t he 
I PM
f or f urt her i nstr ucti o ns o n t his pr oce d ure.

Site staff m ust o bser ve t he partici pa nt f or a n y 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.  Rec or d a n y ac ute reacti o ns i n t he partici pa nt’s s o urce 
d oc u me nts, 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.

E x plai n t he e -diar y  tec h n ol o gies a vaila ble f or t his st u d y (see Secti o n 8. 3. 4) a n d assist t he 
partici pa nt i n d o w nl oa di n g t he st u d y a p plicati o n o nt o his or her o w n de vice or iss ue a 
pr o visi o ne d de vice if re q uire d. 

P r o vi de i nstr ucti o ns o n react o ge nicit y e-diar y  c o m pleti o n a n d as k t he partici pa nt t o 
c o m plete t he react o ge nicit y e-diar y  fr o m Da y 1 t hr o u g h Da y  7, wit h Da y 1 bei n g t he da y 
of vacci nati o n.

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns at t he i njecti o n site a n d a 
t her m o meter f or rec or di n g dail y te m perat ures a n d pr o vi de i nstr ucti o ns o n t heir use.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if he/s he 
e x perie nces a n y of t he f oll o wi n g fr o m Da y  1 t hr o u g h D a y  7 after vacci nati o n ( w here 
D a y 1 is t he da y  of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y visit is 
re q uire d (as detaile d i n Secti o n 8. 1 0 ):

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 > 2 0 meas uri n g de vice u nits 
( greater t ha n 1 0 c m).

Se vere pai n at t he i njecti o n site.

A n y  se vere sys te mic e ve nt.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 8

R e mi n d t he partici pa nt t hat st u d y staff ma y c o ntact hi m or her t o o btai n a d diti o nal 
i nf or mati o n o n e ve nts e ntere d i nt o t he e-diar y .

Re mi n d partici pa nts t o i nf or m t he st u d y  staff of a n y AEs, A E SI s, S A Es, a n d N D C M Cs 
t hat occ ur f or t he d urati o n of t he trial as descri be d i n Secti o n 8. 4 .

Re mi n d t he partici pa nt t o bri n g t he e -diar y  t o t he ne xt visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs a n d t he 
dis pe nser/a d mi nistrat or c o m pletes 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 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 
safety re vie w.
1 0. 7. 8. 4. 2. Visit 1 0 2 – 1 -M o nt h F oll o w -U p ( Cli nic, 2 8 t o 3 5 D a ys After V acci n ati o n at 
Visit 1 0 1)

O btai n details of a n y n o nst u d y vacci nati o ns, a n d pr o hi bite d me dicati o ns a n d treat me nts 
as descri be d i n Secti o n 1 0. 7. 6. 7.

C ollect a bl o o d sa m ple of a p pr o xi matel y 2 0 m L.

Re vie w t he partici pa nt’s e -diar y  data.  C ollect st o p dates of a ny e-diar y e ve nts o n g oi n g 
o n t he last da y  t hat t he e-diar y  was c o m plete d a n d rec or d st o p dates i n t he C R F. A n y 
o n g oi n g reacti o ns m ust be assesse d at t he ne xt c o ntact.

C ollect t he pr o visi o ne d de vice 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.

Rec or d A Es, A E SIs, S A Es, a n d N D C M Cs as descri be d i n Secti o n 8. 4.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
1 0. 7. 8. 4. 3. Visit 1 0 3 – 6 -M o nt h S afet y
F oll o w -U p ( Tele p h o ne or Cli nic , Wit hi n 1 7 5 t o 
1 8 9 D a ys After V acci n ati o n at Visit 1 0 1)

C o ntact t he partici pa nt b y  tele p h o ne. T his visit ca n be c o n d ucte d as a cli nic visit if t he 
i n vesti gat or dee ms it is necessar y f or t he partici pa nt t o be see n i n pers o n.

O btai n details of a n y n o nst u d y  vacci nati o ns, a n d pr o hi bite d me dicati o ns a n d treat me nts 
as descri be d i n Secti o n 1 0. 7. 6. 7. 1 .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 9

Re vie w o n g oi n g react o ge nicit y  e-diar y s ym pt o ms re p orte d as prese nt o n t he last da y  of 
t he e-diar y  a n d o btai n st o p dates. Rec or d st o p dates i n t he C R F if re q uire d.

Rec or d A E SIs, S A Es , a n d N D C M Cs as descri be d i n Secti o n 8. 4.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
1 0. 7. 8. 4. 4. U nsc he d ule d Visit f or Fe ver or a Gr a de 3 or S us pecte d Gr a de 4 Re acti o n
See Secti o n 8. 1 0 .
1 0. 7. 9. St atistic al C o nsi der ati o ns f or S u bst u d y A
See Secti o n 9 f or ge neral pr ot oc ol statistical c o nsi derati o ns a n d see s pecific s u bst u d y 
statistical c o nsi derati o ns bel o w .
1 0. 7. 9. 1. St atistic al H y p ot heses
F or t he pri mar y  i m m u n o ge nicit y o bjecti ve, t here are a t otal of 4 tests (2 f or R S V A a n d 2 f or 
R S V B). T he pri mar y  i m m u n o ge nicity o bjecti ve will be e val uate d b y t he f oll o wi n g n ull 
h y p ot hesis:

H 0: l n( µ1) - l n( µ2) ≤-l n(1. 5) or p 1 - p 2 ≤- 1 0 % vs

H a: l n( µ1) - l n( µ2) > - l n(1. 5) a n d p 1 - p 2 > - 1 0 %
w here -l n( 1. 5) c orres p o n ds t o a 1. 5 -f ol d mar gi n f or n o ni nferi ority i n G M R, l n( µ1) is t he mea n 
of t he nat ural l o garit h m- tra nsf or me d ser u m N T at 1 m o nt h after vacci nati o n fr o m partici pa nts 
w h o recei ve d t he sa me d ose le vel of R S V pre F i n t his st u d y  (partici pa nts ≥1 8 t o < 6 0 y ears of 
a ge wit h hi g h -ris k c hr o nic me dical c o n diti o ns), a n d l n( µ2) is t he mea n of t he nat ural 
l o garit h m-tra nsf or me d ser u m N T fr o m partici pa nts w h o recei ve d R S V pre F i n t he C 3 6 7 1 0 1 3 
st u d y i m m u n o ge nicit y s u bset (partici pa nts ≥6 0 y ears of a ge) ; -1 0 % is a n o ni n feri orit y mar gi n 
f or ser ores p o nse rate, p1 is t he ser ores p o nse rate at 1 m o nt h after vacci nati o n fr o m 
partici pa nts ≥1 8 t o < 6 0 years of a ge w h o recei ve d R S V pre F a n d ha ve hi g h -ris k c hr o nic 
me dical c o n diti o ns , a n d p2 is t he ser ores p o nse rate at 1 m o nt h after vacci nati o n fr o m 
partici pa nts w h o recei ve d R S V pre F i n t he C 3 6 7 1 0 1 3 st u d y  i m m u n o ge nicit y s u bset 
(partici pa nts ≥6 0 y e ars of a ge) .
Ser ores p o nse is defi ne d as a p ost vacci nati o n a nti b o d y  titer ≥4 ti mes t he L L O Q f or a baseli ne 
titer bel o w t he L LO Q (ser o ne gati ve); or a ≥4 -f ol d rise fr o m baseli ne t o after vacci nati o n if 
t he baseli ne titer is a b o ve t he L L O Q (ser o p ositi ve).
N o ni nferi orit y will be declare d if b ot h t he n ull h y p ot hesis of G M R a n d t he n ull h yp ot hesis of 
differe nce i n ser ores p o nse rates a re rejecte d f or b ot h R S V A a n d R S V B ser u m N Ts , wit h a 
t ype I err or ( 2 -si de d) of 5 %.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 0
1 0. 7. 9. 1. 1. Esti m a n ds
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, a n d e x pl orat or y o bjecti ve (if a ny)  
are descri be d i n Secti o n 1 0. 7. 3 . 
T he esti ma n ds t o e val uate t he i m m u n o ge nicit y  o bjecti ves are base d o n t he e val ua ble 
i m m u n o ge nicity p o p ulati o n ( Secti o n 1 0. 7. 9. 2) . T hese esti ma n ds esti mate t he vacci ne effect 
i n t he h yp ot hetical setti n g w here partici pa nts f oll o w t he st u d y  sc he d ules a n d pr ot oc ol 
re q uire me nts as directe d. Missi n g i m m u n o ge nicit y  res ults will n ot be i m p ute d, as M C A R is 
ass u me d.
1 0. 7. 9. 1. 2. M ulti plicit y A dj ust me nt
N o m ulti plicit y  a dj ust me nt will be a p plie d f or t his st u d y beca use all 4 ( 2 e n d p oi nts f or 2 R S V 
s u b gr o u ps) statistical h yp ot heses m ust be rejecte d t o declare n o ni nferi orit y . Eac h of t he 4
statistical tests will use a 2-si de d al p ha le vel of 0. 0 5.
1 0. 7. 9. 2. A n al ysis Sets
F or p ur p oses of a nal y sis, t he f oll o wi n g a nalys is sets are defi ne d f or t his s u bst u d y:
P artici p a nt A n al ysis Set
Descri pti o n
E nr olle d 
All partici pa nts w h o ha ve a si g ne d I C D i n t his s u bst u d y.
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 y ste m i n t his s u bst u d y.
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 i n 
t his s u bst u d y.
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 
T his p o p ulati o n will be defi ne d f or S u bst u d y  A, a n d it 
i ncl u des all partici pa nts w h o meet t he f oll o wi n g criteria:

Are eli gi ble f or S u b st u d y A;

Recei ve t he st u d y i nter ve nti o ns t o w hic h t he y  were 
ra n d o mize d;

Ha ve t he 1 -m o nt h p ost vacci nati o n bl o o d c ollecti o n 
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 assa y  res ult 
1 m o nt h after vacci nati o n;

Ha ve n o maj or pr ot oc ol vi olati o ns fr o m vacci nati 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 dra w .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 1
Defi ne d A n al ysis Set
Descri pti 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 were ra n d o mize d a n d ha d 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
i n t his s u bst u d y.
1 0. 7. 9. 3. St atistic al A n al ysis
T he S A P will be de vel o pe d a n d fi nalize d bef ore a n y  a nalys es are perf or me d a n d will 
descri be t he a nal ys es a n d pr oce d ures f or acc o u nti n g f or missi n g, u n use d, a n d s p uri o us data. 
T his secti o n is a s u m mar y of t he pla n ne d statistical a nal y ses of t he pri mar y  a n d sec o n dar y 
e n d p oi nts.
1 0. 7. 9. 3. 1. Ge ner al C o nsi der ati o ns
Refer t o Secti o n 9. 3. 1 f or ge neral c o nsi derati o ns of t he statistical a nalys es.
F or S u bst u d y  A, unless 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 R S V pre F or place b o. CI s f or all e n d p oi nts i n t he statistical a nal ysis 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.
1 0. 7. 9. 3. 2. Pri m ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis
T a ble 5. 
Pri m ar y E n d p oi nt A n al yses
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 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 sys te mic e ve nts 
(fe ver, na usea, fati g ue, hea dac he, v o miti n g, diarr hea, m uscle 
pai n, a n 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 s (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 A Es t hr o u g h 1 m o nt h f oll o wi n g st u d y i nter ve nti o n 
a d mi nistrati o n a n d all A E SI s, S A E s, a n d N D C M Cs t hr o u g h o ut 
t he st u d y 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 s f or eac h 
vacci ne gr o u p ( Secti o n 9. 3. 1. 1 ).

A 3 -tier a p pr oac h will be use d t o s u m marize A Es. ( 1) Tier 1 
e ve nts are pres pecifie d e ve nt s of cli nical i m p orta nce a n d are 
i de ntifie d i n a list i n t he pr o d uct’s safety re vie w pla n a n d 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 2
T a ble 5. 
Pri m ar y E n d p oi nt A n al yses
E n d p oi nt
St atistic al A n al ysis Met h o ds
descri be d i n detail i n t he S A P. ( 2) Tier 2 e ve nts are c o nsi dere d 
“relati vel y c o m m o n” e ve nts; a Me d D R A P T is defi ne d as a Tier 
2 e ve nt if t here are at least 1 % of partici pa nts i n a n y vacci ne 
gr o u p re p orti n g t he e ve nt, i n a n y  a ge strat u m. ( 3) Tier 3 e ve nts 
are t h ose t hat are neit her Tier 1 n or Tier 2 e ve nts. 

F or Tier 1 a n d Tier 2 e ve nts, t he 9 5 % CI s f or t he differe nce i n 
t he perce nta ge of partici pa nts re p orti n g t he e ve nts bet wee n t he 
R S V pre F gr o u p a n d t he place b o gr o u p will be calc ulate d usi n g 
t he test statistic pr o p ose d b y Mietti ne n a n d N ur mi ne n. I n 
a d diti o n, f or Tier 1 e ve nts, t he as ym pt otic p -val ues will be 
prese nte d f or t he differe nce bet wee n gr o u ps i n t he perce nta ge of 
partici pa nts re p orti n g t he e ve nts, base d o n t he sa me test statistic 
a n d u n der t he ass u m pti o n t hat t he test statistic is as y m pt oticall y 
n or mall y  distri b ute d.  
I m m u n o ge nicity

R S V A a n d R S V B ser u m N Ts at 1 m o nt h after vacci nati o n wit h 
R S V pre F a m o n g partici pa nts w h o recei ve d R S V pre F fr o m 
S u bst u d y  A t o t he partici pa nts ≥6 0 y ears fr o m t he 
St u d y C 3 6 7 1 0 1 3 i m m u n o ge nicit y s u bset will be c o m pare d wit h a 
li near re gressi o n m o del t hat i ncl u des gr o u ps (c urre nt st u d y vs 
C 3 6 7 1 0 1 3 ), c orres p o n di n g baseli ne titers, a n d se x. T he
m o del -a dj uste d G M R c o m pari n g gr o u ps ( 1 8 t o < 6 0 years of a ge 
wit h hi g h ris k i n C 3 6 7 1 0 2 3 S u bst u d y  A vs 6 0 y ears a n d ol der i n 
C 3 6 7 1 0 1 3) a n d c orres p o n di n g 9 5 % CI will be pr o vi de d .

Differe nce i n ser ores p o nse rate of R S V A a n d R S V B ser u m N Ts 
at 1 m o nt h after vacci nati o n wit h R S V pre F a m o n g partici pa nts 
w h o recei ve d R S V pre F fr o m S u bst u d y  A t o t he partici pa nts 
≥6 0 ye ars fr o m t he St u d y C 3 6 7 1 0 1 3 i m m un o ge nicit y  s u bset 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.

Usi n g a 1. 5 -f ol d n o ni nferi orit y mar gi n a n d a n o ni nferi orit y 
mar gi n of -1 0 %, st u d y  s uccess will be declare d if t he l o wer 
b o u n d of t he 2 -si de d 9 5 % CI of m o del -a dj uste d G M R is greater 
t ha n 0. 6 6 7, a n d t he l o wer b o u n d of t he 2-si de d 9 5 % CI of t he 
ser ores p o nse rate differe nce is greater t ha n - 1 0 % f or b ot h R S V A 
a n d R S V B s u b gr o u ps.

E m pirical R C D Cs will be pr o vi de d f or R S V A a n d R S V B ser u m
N Ts at 1 m o nt h after vacci nati o n ( Secti o n 9. 3. 1. 2. 4 ).
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 3
1 0. 7. 9. 3. 3. Sec o n d ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis
T a ble 6 .
Sec o n d ar y E n d p oi nt A n al yses
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 a n d t heir ass ociate d 9 5 % CI s will be descri pti vel y  
s u m marize d, b y vacci ne gr o u p, f or b ot h R S V A a n d R S V 
B ser u m N T s u b gr o u ps at eac h bl o o d sa m pli n g visit
(Secti o n 9. 3. 1. 2. 1 ).

G M F Rs fr o m bef ore vacci nati o n t o 1 m o nt h after 
vacci nati o n will be descri pti vel y  s u m marize d wit h 9 5 % 
CI s, b y vacci ne gr o u p, f or b ot h R S V A a n d R S V B N T 
s u b gr o u ps N Ts (Secti o n 9. 3. 1. 2. 2 ).
1 0. 7. 9. 4. I nteri m A n al ysis
N o i nteri m a nal ys is is pla n ne d.
1 0. 7. 9. 4. 1. A n al ysis Ti mi n g
W he n all pri mar y  safety e n d p oi nts a n d pri mar y i m m u n o ge nicity e n d p oi nt data bec o me 
a vaila ble, S u bst u d y  A will be u n bli n de d f or t he pri mar y  a nalys is. All safet y  data c ollecte d 
t hr o u g h o ut t he st u dy will be clea ne d, a n d pri mar y a n d sec o n dar y i m m u n o ge nicit y data 
t hr o u g h 1 m o nt h after vacci nati o n will als o be clea ne d a n d i ncl u de d i n t he a nalys is, wit h all 
t ype I err or s pe nt i n t his pri mar y  a nalys is. 
1 0. 7. 9. 5. S a m ple Size Deter mi n ati o n
T he sa m ple size of S u bst u d y  A is base d o n de m o nstrati n g n o ni nferi orit y  wit h res pect t o R S V 
A a n d R S V B ser u m N Ts fr o m partici pa nts w h o recei ve d R S V pre F c o m pare d t o ser u m bl o o d 
sa m ples ta ke n fr o m R S V pre F-vacci nate d ol der a d ults fr o m t he C 3 6 7 1 0 1 3 st u d y , usi n g a 
1. 5- f ol d n o ni nferi ority m ar gi n f or G M R a n d a - 1 0 % n o ni nferi ority mar gi n f or differ e nce i n 
ser ores p o nse rate f or b ot h R S V A a n d R S V B. A t otal of 4 c o m paris o ns will be ma de.
P o wer is calc ulate d usi n g P R O C P O W E R i n S A S Versi o n 9. 4. F or eac h c o m paris o n, t he 
pr o ba bilit y  of meeti n g t he n o ni nferi ority criteri o n base d o n t he 9 5 % CI is calc ul ate d. T he 
res ulti n g 4 pr o ba bilities are t he n m ulti plie d t o esti mate t he p o wer f or declari n g o verall 
n o ni nferi orit y  of t he vacci ne ( n o ni nferi ority de m o nstrate d f or b ot h R S V A a n d R S V B).
T he nat ural l o g of N T s is ass u me d t o f oll o w a n or mal distri b uti o n.  T he rati o of G M Ts f or 
partici pa nts w h o recei ve d R S V pre F i n S u bst u d y  A t o t he G M Ts f or matc he d partici pa nts 
w h o recei ve d R S V pre F i n St u d y  C 3 6 7 1 0 1 3 ( partici pa nts ≥6 0 y ears of a ge ) is ass u me d t o be 1
f or b ot h R S V A a n d R S V B (ie , ass u med G M R = 1 ).  C o m m o n assa y S D (i n nat ural 
l o garit h m scale) is ass u me d t o be 1. 1 f or b ot h R S V A a n d R S V B.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 4
T he p o wer calc ulati o n f or differe nce i n ser ore s po nse rate is base d o n a n u nc o n diti o nal e xact 
test. T he differe nce i n ser ores p o nse rate f or partici pa nts w h o recei ve d R S V pre F i n 
S u bst u d y A t o t he ser ores p o nse rate f or matc he d partici pa nts w h o recei ve d R S V pre F i n 
St u d y  C 3 6 7 1 0 1 3 ( partici pa nts ≥6 0 y ears of a ge ) is ass u me d t o be 0 f or b ot h R S V A a n d 
R S V B.  T he c o m m o n ser ores p o nse rate is ass u me d t o be 0. 8 2 f or b ot h R S V A a n d R S V B.  
Wit h e q ual sa mple si zes i n t he 2 gr o u ps (S u bst u d y A partici pa nts vs R S V pre F reci pie nts 
≥6 0 ye ars of a ge fr o m St u d y  C 3 6 7 1 0 1 3), 4 0 0 e val ua ble partici pa nts per a ge gr o u p will 
pr o vi de a n o verall p o wer of 9 1. 2 % t o de m o nstrate t hat t he i m m u ne res p o nse fr o m 
S u bst u d y A is n o ni nferi or t o t he i m m u ne res p o nse fr o m R S V pre F reci pie nts ≥6 0 y ears of a ge 
fr o m St u d y C 3 6 7 1 0 1 3 , w hic h has de m o nstrate d efficac y , usi n g a 1. 5-f ol d n o ni nferi orit y 
mar gi n f or G M R a n d a -1 0 % n o ni nferi orit y mar gi n f or differe nce i n ser ore sp o nse rate .  As 
t he c o m paris o n will use ser ol o g y data fr o m S t u d y C 3 6 7 1 0 1 3, 4 0 0 partici pa nts fr o m t he 
St u d y C 3 6 7 1 0 1 3 i m m u n o ge nicit y s u bset w h o recei ve d R S V pre F a n d met t he e val ua ble 
i m m u n o ge nicity d efi niti o n (ass u mi n g t hat all will ha ve deter mi nate N T res ults) will be 
ra n d o ml y selecte d, a n d t heir sera will be teste d f or N T s at t he sa me ti me wit h all sera 
c ollecte d fr o m t he R S V pre F reci pie nts i n S u bst u d y  A. Wit h a 2: 1 ra n d o mizati o n, ass u mi n g a 
~ 1 0 % n o ne val ua ble rate, a p pr o xi matel y  6 7 5 partici pa nts are e x pecte d t o be e nr olle d i n t his 
st u d y. Refer t o Ta ble 7 f or m ore i nf or mati o n.
T a ble 7.
P o wer t o S h o w N o ni nferi orit y of R S V A a n d R S V B Ser u m Ne utr alizi n g 
Titers i n S u bst u d y A i n St u d y C 3 6 7 1 0 2 3 C o m p are d t o A d ults ≥6 0 Ye ars o f 
A ge i n St u d y C 3 6 7 1 0 1 3
E n d p oi nt  
A nti ge n/
Str ai n f or 
C o m p aris o n
C o m m o n S D
( N at ur al 
L o g)/ Res p o ns e
R ate a
Ass u me d
Differe nce
NI
M ar gi n
b
N E v al u a ble 
R S V pre F Reci pie nts/ Gr o u p
P o w er c
A d ults ≥1 8 t o 
< 6 0 Ye ars of A ge
( St u d y C 3 6 7 1 0 2 3 
S u bst u d y A)
A d ults ≥6 0 Ye ars 
of A ge
( St u d y C 3 6 7 1 0 1 3)
R S V G M R
S u b gr o u p A
1. 1
G M R = 1
1. 5 -F ol d
4 0 0
4 0 0
> 9 9. 9 %
S u b gr o u p B
1. 1
G M R = 1
1. 5 -F ol d
4 0 0
4 0 0
> 9 9. 9 % 
R S V 
d iffere nce i n 
ser ores p o nse 
rate
S u b gr o u p A
8 2 %
0 
- 1 0 % 
4 0 0
4 0 0
9 5. 5 %
S u b gr o u p B
8 2 %
0 
- 1 0 % 
4 0 0
4 0 0
9 5. 5 %
P o w er t o s h o w  NI f or b ot h R S V A a n d R S V B
9 1. 2 %
a.
Refere nce St u d y C 3 6 7 1 0 1 3 .
b. 
T he NI is met if t he l o wer li mit of t he 9 5 % CI f or t he G M T rati o ([ ≥1 8 -year -ol ds t o < 6 0 -year -ol ds i n 
St u d y C 3 6 7 1 0 2 3] / [ ≥6 0 -year -ol ds i n St u d y C 3 6 7 1 0 1 3] ) is > 0. 6 6 7, a n d i f t he l o wer li mit of t he 9 5 % CI f or t he 
differe nce i n ser ores p o nse rate ([≥1 8 -year -ol ds t o < 6 0 -year -ol ds i n St u d y C 3 6 7 1 0 2 3 ] / [ ≥6 0 -year -ol ds i n 
St u d y C 3 6 7 1 0 1 3] ) is >- 1 0 %.
c.
At t he 0. 0 5 al p ha le vel ( 2 -si de d).
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 5
1 0. 8. A p pe n di x 8: S u bst u d y B
1 0. 8. 1. S u bst u d y B S u m m ar y
1 0. 8. 1. 1. S y n o psis
See Secti o n 1. 1 f or t he st u d y s yn o psis.
1 0. 8. 1. 2. Sc he m a : S u bst u d y B
I m m u n oc o m pr o mise d a d ults ≥1 8 ye ars of a ge
I m m u n oc o m pr o mise d 
A d ults ≥1 8 Y ears of A ge
N = 2 0 0
O pe n - La bel R S V pre F
Visit 2 0 1
( Da y 1)
Visit 2 0 2
( M o nt h 1)
2 8 t o 3 5 D a ys
A fter
Vacci nati o n 1
Visit 2 0 3
( M o nt h 2)
2 8 t o 3 5 D a ys 
A fter
Vacci nati o n 2
Visit 2 0 4
( M o nt h 7)
1 7 5 t o 1 8 9 D a ys 
A fter
Vacci nati o n 2
Vacci nati o n 1
Vacci nati o n 2
F oll o w - U p
F oll o w - U p
R S V pre F 
Bl o o d dra w  a n d 
vacci nati o n
Bl o o d dra w  a n d 
vacci nati o n
Bl o o d dra w
1 0. 8. 1. 3. Sc he d ule of Acti vities : S u bst u d y B
I m m u n oc o m pr o mise d a d ults ≥1 8 ye ars of a ge
Visit N u m ber
2 0 1
2 0 2
2 0 3
2 0 4
Visit Descri pti o n
V acci n ati o n 1
V acci n ati o n 2
1- M o nt h 
F oll o w -U p
6- M o nt h 
S afet y 
F oll o w -U p
Visit Wi n d o w ( D a ys)
D a y 1
2 8 t o 3 5 D a ys 
After 
V acci n ati o n 1
2 8 t o 3 5 D a ys 
After 
V acci n ati o n 2
1 7 5 t o 1 8 9 
D a ys After 
V acci n ati o n 2
T y pe of Visit
Cli nic
Cli nic
Cli nic
Tele p h o ne or 
Cli nic
O btai n i nf or me d c o nse nt
X
Assi g n si n gle partici pa nt n u m ber
X
O btai n de m o gra p h y a n d si g nifica nt me dical 
hist or y data
X
Rec or d c urre nt/f or mer t o bacc o usa ge
X
Perf or m cli nical assess me nt , i ncl u di n g 
res pirat or y rate (a n d p h ysical e xa mi nati o n 
if dee me d necessar y) 
X
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 6
Visit N u m ber
2 0 1
2 0 2
2 0 3
2 0 4
Visit Descri pti o n
V acci n ati o n 1
V acci n ati o n 2
1- M o nt h 
F oll o w -U p
6- M o nt h 
S afet y 
F oll o w -U p
Visit Wi n d o w ( D a ys)
D a y 1
2 8 t o 3 5 D a ys 
After 
V acci n ati o n 1
2 8 t o 3 5 D a ys 
After 
V acci n ati o n 2
1 7 5 t o 1 8 9 
D a ys After 
V acci n ati o n 2
T y pe of Visit
Cli nic
Cli nic
Cli nic
Tele p h o ne or 
Cli nic
C ollect n o nst u d y vacci ne i nf or mati o n 
X
X
X
X
C ollect pr o hi bite d me dicati o n 
X
X
X
X
C ollect c o nc o mita nt t hera p y, oral
c ortic oster oi ds, c he m ot hera p y , 
i m m u n ot hera p y, i m m u n o m o d ulat or/
bi ol o gic treat me nts , a n d 
i m m u n os u p pressi ve treat me nt
X
X
X
X
C o nfir m i ncl usi o n a n d e xcl usi o n criteria
X
X
O btai n pre vacci nati o n te m perat ure 
X
X
Re vie w t e mp or ar y  dela y criteria
X
X
O btai n t he partici pa nt’s st u d y i nter ve nti o n 
kit n u m ber usi n g t he I R T s yste m
X
X
O btai n bl o o d sa m ple f or a nti b o d y 
assess me nt
~ 2 0 m L 
~ 2 0 m L 
~ 2 0 m L
A d mi nister st u d y i nter ve nti o n 
X
X
Assess ac ute reacti o ns f or at least 
3 0 mi n utes after st u d y i nter ve nti o n 
a d mi nistrati o n
X
X
Dis pe nse meas uri n g de vice a n d di gital 
t her m o meter
X
Pr o vi de e -diar y trai ni n g o n dail y 
react o ge nicit y q uesti o n naire
X
X
Assist t he partici pa nt i n d o w nl oa di n g t he 
st u d y a p plicati o n o nt o his or her o w n 
de vice or iss ue a pr o visi o ne d de vice if 
re q uire d f or e-diar y
X
Re vie w react o ge nicit y e-diar y data
( dail y re vie w is o pti mal d uri n g t he acti ve 
diar y peri o d)
------------------------------X ------------------------------
Re vie w o n g oi n g react o ge nicit y e -diar y 
s y m pt o ms a n d o btai n st o p dates
X
X
C ollect t he pr o visi o ne d de vice 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
Rec or d A Es as a p pr o priate
X
X
X
C ollect A E SIs, S A Es , a n d N D C M Cs as 
a p pr o priate
X
X
X
X
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 7
1 0. 8. 2. I ntr o d ucti o n f or S u bst u d y B
1 0. 8. 2. 1. St u d y R ati o n ale
S u bst u d y  B will e val uate t he safety, t olera bilit y , a n d i m m u n o ge nicity of Pfizer’s R S V pre F i n
i m m u n oc o m pr o mise d a d ults ≥1 8 y ears of a ge.
1 0. 8. 2. 2. B ac k gr o u n d
See Secti o n 2. 2 .
1 0. 8. 2. 3. Be nefit/ Ris k Assess me nt
N o a d diti o nal ris ks are i de ntifie d f or S u bst u d y B b e y o n d t h ose detaile 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 ma y  be:

Recei pt of a p ote ntiall y efficaci o us R S V vacci ne.

C o ntri b uti n g t o researc h t o hel p ot hers.
1 0. 8. 3. O bjecti ves, E n d p oi nts, a n d Esti m a n ds f or 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 descri be t he safet y pr ofile of 
R S V pre F as meas ure d b y t he 
perce nta ge of 
i m m u n oc o m pr o mise d 
partici pa nts ≥1 8 years of  a ge 
re p orti n g l ocal reacti o ns, 
s yste mic e ve nts, A Es, a n d S A Es
f oll o wi n g st u d y i nter ve nti o n 
a d mi nistrati o n.

L ocal reacti o ns ( pai n at t he 
i njecti o n site, re d ness, a n d 
s welli n g)

S ys te mic e ve nts (fe ver, 
na usea, diarr hea, v o miti n g, 
hea dac he, fati g ue, m uscle 
pai n, a n d j oi nt pai n)

A E s

N D C M Cs

S A Es
I n partici pa nts recei vi n g st u d y 
i nter ve nti o n:

T he pr o p orti o n 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 eac h 
st u d y i nter ve nti o n 
a d mi nistrati o n.

T he pr o p orti o n of partici pa nts 
re p orti n g s yste mic e ve nts 
wit hi n 7 da ys f oll o wi n g eac h 
st u d y i nter ve nti o n
a d mi nistrati o n.

T he pr o p orti o n of partici pa nts 
re p orti n g A Es t hr o u g h 
1 m o nt h f oll o wi n g t he last 
d ose of st u d y i nter ve nti o n 
a d mi nistrati o n.

T he pr o p orti o n of partici pa nts 
re p orti n g N D C M Cs 
t hr o u g h o ut t he st u d y.

T he pr o p orti o n of partici pa nts 
re p orti n g 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 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 8
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y Im m u n o ge nicit y
Pri m ar y Im m u n o ge nicit y
Pri m ar y Im 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 R S V pre F i n 
i m m u n oc o m pr o mise d a d ults ≥1 8 
years of a ge .
R S V A a n d R S V B ser u m 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 
i m m u n o ge nicit y p o p ulati o n):

G M T of N T s f or R S V A a n d 
R S V B at eac h bl o o d sa m pli n g 
visit.

G M F R of N T s f or R S V A a n d 
R S V B fr o m bef ore 
vacci nati o n t o eac h 
p ost vacci nati o n bl o o d 
sa m pli n g visit.
1 0. 8. 4. St u d y Desi g n f or S u bst u d y B
1 0. 8. 4. 1. O ver all Desi g n
T his is a P hase 3, o pe n -la bel, m ultice nter st u d y  t hat will assess t he safety, t olera bilit y , a n d 
i m m u n o ge nicity of Pfizer’s R S V pre F i n i m m u n oc o m pr o mised a d ults.
A p pr o xi matel y  2 0 0 i m m u n oc o m pr o mise d a d ults ≥1 8 y ears of a ge will recei ve a n o pe n -la bel 
1 2 0- µ g d ose of R S V pre F at Visit 2 0 1 a n d Visit 2 0 2 wit h a n i nter val of 1 m o nt h ( 2 d oses).  
Wit hi n S u bst u d y  B, a p pr o xi matel y 1 0 0 partici pa nts will be ≥6 0 y ears of a ge a n d 
a p pr o xi matel y 1 0 0 partici pa nts will be ≥1 8 t o < 6 0 y ears of a ge.  E nr oll me nt will be 
m o nit ore d t o hel p e ns ure distri b uti o n of vacci nati o n acr oss t he a ge ra n ge a n d u n derl y i n g 
i m m u n oc o m pro misi n g c o n diti o ns .  T he d urati o n of st u d y  partici pati o n f or eac h partici pa nt 
will be a p pr o xi matel y  7 m o nt hs.   A react o ge nicit y e -diar y  will be use d by partici pa nts f or 
7 da y s fr o m t he da y of eac h vacci nati o n. T he acti ve c ollecti o n peri o d f or A Es will be 
t hr o u g h a p pr o xi matel y 1 m o nt h after t he last vacci nati o n a n d f or A E SIs, S A Es , a n d 
N D C M Cs t hr o u g h a p pr o xi matel y 6 m o nt hs after t he last vacci nati o n. Bl o o d sa m ples will be 
ta ke n at baseli ne a n d 1 m o nt h after eac h vacci nati o n f or all partici pa nts f or assess m e nt of 
i m m u n o ge nicity.
1 0. 8. 4. 2. Scie ntific R ati o n ale f or S u bst u d y B Desi g n
See Secti o n 2. 1 a n d Secti o n 1 0. 8. 4. 3 .
1 0. 8. 4. 3. J ustific ati o n f or D ose
T he fi nal d ose a n d f or m ulati o n of R S V pre F selecte d f or use i n t his st u d y  are base d o n t he 
safety a n d i m m u n o ge nicit y  data fr o m 3 P hase 1/ 2 st u dies , t he efficac y a nal yses i n t he h u ma n 
c halle n ge st u d y , a n d 2 o n g oi n g P hase 3 st u dies. T here were n o s u bsta ntial differe nces 
o bser ve d bet wee n t he i m m u n o ge nicit y or react o ge nicit y  of t he 1 2 0- μ g a n d 2 4 0 -μ g d ose 
le vels of t he f or m ulati o n wit h o ut Al( O H) 3. T he 1 2 0 -µ g d ose, wit h o ut a n y a dj u va nts, has 
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0 9
bee n s h o w n t o ha ve l o w react o ge nicit y  a n d a n acce pta ble safety pr ofile a n d will be t he d ose 
gi ve n i n t his st u d y .
I m m u n oc o m pr o mise d h osts ha ve bee n f o u n d t o ha ve re d uce d res p o nses t o vari o us vacci nes,
e g, p ne u m oc occal c o nj u gate a n d m R N A S A R S -C o V -2 vacci nes .4 5 ,4 6 ,4 7
T o date, n o data e xist re gar di n g R S V pre F i m m u n o ge nicit y i n t he i m m u n oc o m pr o mise d 
p o p ulati o n.  H o we ver , gi ve n t he data s h o wi n g di mi nis he d res p o nses t o ot her vacci nes, it is 
reas o na ble t o assess i m m u n o ge nicit y after a sec on d d ose of R S V pre F. 
T h ese data a n d t he nee d t o ac hie ve pr otecti o n bef ore R S V seas o n s u p p orts t he strate g y  of 
a d mi nisteri n g a sec o n d d ose 1 m o nt h after i nitial vacci nati o n.
1 0. 8. 4. 4. E n d of St u d y Defi niti o n
See Secti o n 4. 4.
1 0. 8. 5. St u d y P o p ul ati o n f or S u bst u d y B
Partici pa nts m ust meet all of t he i ncl usi o n criteria a n d n o ne of t he e xcl usi o n criteria as 
s pecifie d f or S u bst u d y B.
1 0. 8. 5. 1. I ncl usi o n Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n S u b st u d y B o nl y if all of t he i ncl usi o n criteria 
a p pl y:
I nf or me d C o nse nt
1.
Ca pa ble of gi vi n g si g ne d i nf or me d c o nse nt as descri be d i n Secti o n 1 0. 1. 3 , w hic h i ncl u des 
c o m plia nce wit h t he re q uire me nts a n d restricti o ns liste d i n t he I C D a n d i n t his pr ot oc ol.
A ge a n d Se x
2.
Partici pa nts ≥1 8 y ears of a ge at st u d y e nr oll me nt.  
T y pe of P artici p a nt a n d Dise ase C h ar acteristics:
3.
Life e x pecta nc y  ≥1 2 m o nt hs ( 3 6 5 da ys) i n t he o pi ni o n of t he i n vesti gat or at e nr oll me nt.
4.
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, vacci nati o n 
pla n, lifest y le c o nsi derati o ns, a n d ot her st u d y pr oce d ures.
5.
Partici pa nts w h o are i m m u n oc o m pr o mise d b y  virt ue of t he f oll o wi n g: 

Ha vi n g k n o w n a d va nce d N S C L C wit h at least 1 of t he f oll o wi n g:
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 0

Has r ecei ve d i nitial or mai nte na nce c he m ot hera p y at least 2 wee ks ( 1 4 da ys) 
bef ore e nr oll me nt ( or is treat me nt -naï ve), a n d is n ot e x pecte d t o recei ve 
c he m ot hera p y wit hi n at least 2 wee ks ( 1 4 da y s) after d ose a d mi nistrati o n of i nitial 
vacci nati o n or sec on d vacci nati o n ; a n d/ or

Is recei vi n g c hec k p oi nt i n hi bit or treat me nt ( P D -1/ P D -L 1  i n hi bit or, C T L A- 4 
i n hi bit or) a n d has u n der g o ne at least 1 treat me nt c ycle pri or t o e nr oll me nt; or

Is recei vi n g tar gete d dr u g t hera p y ( E G F R, A L K, R O S 1, B R A F, R E T, M E T, 
N T R K i n hi bit ors) a n d has u n der g o ne at least 1 treat me nt c y cle pri or t o 
e nr oll me nt.
O R

Is c urre ntl y u n der g oi n g mai nte na nce he m o dial ysis treat me nt sec o n dar y t o e n d-sta ge 
re nal disease.
O R

Is o n acti ve i m m u n o m o d ulat or t hera py (e g, T N F α i n hi bit or, t ofaciti ni b , or M T X) f or 
a n a ut oi m m u ne i nfla m mat or y dis or der (e g, i nfla m mat or y art hritis, s uc h as r he u mat oi d 
art hritis, ps oriatic art hritis, a n d j u ve nile i di o pat hic art hritis, or i nfla m mat or y b o wel
disease, s uc h as ulcerati ve c olitis or Cr o h n’s disease) at a sta ble * d ose .
* Sta ble d ose is defi ne d as recei vi n g t he sa me d ose f or at least 3 m o nt hs ( 8 4 da y s) 
wit h n o c ha n ges i n t he 2 8 da y s pri or t o e nr oll me nt.  See als o Secti o n 1 0. 8. 6. 7. 2 f or 
details o n sta ble d ose f or M T X.
O R

Is recei vi n g an S O T ( ki d ne y, li ver, l u n g, or heart) at least 3 m o nt hs ( 8 4 da ys) pri or t o 
e nr oll me nt ( Visit 2 0 1 ) a n d wit h n o ac ute rejecti o n e pis o des wit hi n 2 m o nt hs ( 6 0 da ys) 
pri or t o e nr oll me nt ( Visit 2 0 1).
1 0. 8. 5. 2. E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m S u b st u d y B if a n y of t he f oll o wi n g criteria a p pl y:
Me dic al C o n diti o ns: 
1.
Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d blee di n g t hat w o ul d, i n t he 
o pi ni o n of t he i n vesti gat or, c o ntrai n dicate i ntra m usc ular i njecti o n.
2.
Hist or y  of se vere a d verse reacti o n ass ociate d wit h a vacci ne a n d/ or se vere aller gic 
reacti o n (e g, a nap h y la 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) or a n y relate d 
vacci ne.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 1
3.
Partici pa nts wit h a hist or y  of tra ns pla nt rejecti o n, or P T LD, or partici pa nts w h o ha ve ha d 
treat me nt f or t hese c o n diti o ns wit hi n 3 m o nt hs ( 8 4 da ys) pri or t o st u d y e nr oll me nt.
4.
Partici pa nts w h o d o n ot ha ve a de q uate delt oi d m uscle mass t o all o w i ntra m usc ular 
vacci nati o n, i n t he o pi ni o n of t he i n vesti gat or .
5.
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 orator 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.
N ote : 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 ca n be 
f o u n d i n Secti o n 1 0. 6 , A p pe n di x 6 .
Pri or/ C o nc o mit a nt T her a p y:
6.
Recei pt of i n vesti gati o nal or a p pr o ve d m o n ocl o nal a nti b o dies a gai nst R S V wit hi n 
6 m o nt hs bef ore st u d y i nter ve nti o n a d mi nistrati o n.
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 (IVI G, S CI G) 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 of t hese me dicati o ns pri or t o 
t he fi nal bl o o d dra w.
N ote : Please see t he incl usi o n criteria i n Secti o n 1 0. 8. 5. 1 re gar di n g criteria f or tar gete d 
i m m u n o gl o b uli n t hera pies f or u n derlyi n g me dical c o n diti o ns.
N ote: M o n ocl o nal a nti b o dies wit h tar gete d mec ha nis ms of acti o n use d i n t he 
ma na ge me nt of c hr o nic ill nesses (e g, mi grai ne hea dac hes, oste o p or osis) are per mitte d.
8.
Pre vi o us vacci nati o n wit h a n y  lice nse d or i n vesti gati o nal R S V vacci ne or pla n ne d recei pt 
d uri n g st u d y partici pati o n .
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
9.
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 pr o d uct wit hi n 2 8 da y s pri or t o 
c o nse nt a n d/ or t hr o u g h a n d i ncl u di n g t he 6 -m o nt h f oll o w -u p visit. 
N ote: T his criteri o n d oes n ot a p pl y  t o partici pa nts w h o are partici pati n g i n a f oll o w- u p 
peri o d f or a n ot her st u d y i n v ol vi n g a st u d y i nter ve nti o n t hat is a n i n vesti gati o nal dr u g or 
vacci ne, if recei pt of t he last d ose was at least 6 m o nt hs pri or t o c o nse nti n g f or t his st u d y  
an d t here is n o f urt her d osi n g a ntici pate d fr o m t he pre vi o us st u d y  d uri n g t he partici pa nt’s 
partici pati o n i n t his st u d y .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 2
Ot her E xcl usi o n Criteri a:
1 0. 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 h er 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. 8. 5. 3. Lifest yle C o nsi der ati o ns
T here are n o lifest y le restricti o ns re q uire d f or t he partici pa nts i n t his st u d y.
All pre g na ncies disc o vere d i n fe male partici pa nts a n d fe male part ners of male partici pa nts
d uri n g st u d y partici pati o n, w hic h be gi ns after o btai ni n g i nf or me d c o nse nt as descri be d i n 
Secti o n 8. 4. 1 , will be rec or de d i n acc or da nce wit h t he E D P (see Secti o n 8. 4. 5. 1 ) a n d E D B 
(see Secti o n 8. 4. 5. 2 ) re p orti n g pr ocesses.
1 0. 8. 5. 4. Scree n F ail ures
See Secti o n 5. 4 .
1 0. 8. 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 ati o n 
of St u d y I nter ve nti o n
T he f oll o wi n g c o n diti o ns ma y all o w a partici pa nt t o be vacci nate d o nce t he c o n diti o ns ha ve 
res ol ve d a n d t he partici pa nt is ot her wise eli gi ble.  Partici pa nts meeti n g t hes e criteria at 
Visit 2 0 1 will be c o nsi dere d scree n fail ures if e nr oll me nt has cl ose d o nce t he c o n diti o n(s) 
has/ ha ve res ol ve d.

C urre nt fe brile ill ness (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.

Recei pt of a n y li ve vacci ne wit hi n 2 8 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n. 
Recei pt of a n y n o nli ve vacci ne (i ncl u di n g 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) wit hi n 1 4 da ys bef ore st u d y i nter ve nti o n a d mi nistrati o n.

A ntici pate d recei pt of a n y n o nst u d y vacci ne wit hi n 1 4 da ys after st u d y i nter ve nti o n 
a d mi nistrati o n.
1 0. 8. 6. St u d y I nter ve nti o n a n d C o nc o mit a nt T her a p y f or S u bst u d y B
F or t he p ur p oses of t his st u d y , st u d y i nter ve nti o n refers t o:

R S V pre F .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 3
1 0. 8. 6. 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 n(s)
I nter ve nti o n n a m e
R S V pre F 
T y pe
Vacci ne
Use
E x peri me ntal
I M P or NI M P/ A x M P
I M P
D ose f or m ul ati o n
T he acti ve i n gre die nts i n R S V pre F are 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, i n a l y o p hilize d d osa ge f or m 
f or rec o nstit uti o n.  T he R S V dr u g pr o d uct will be 1 2 0 µ g of t he R S V 
pref usi o n F a nti ge n.  T he dr u g pr o d uct is s u p plie d as a l y o p hilize d w hite ca ke 
i n a 2-m L glass vial, wit h a 1 3 -m m l y o p hilizati o n st o p per, al u mi n u m o verseal, 
a n d fli p -off ca p.
T he dr u g pr o d uct w ill be rec o nstit ute d b y a dil ue nt c o nsisti n g of sterile water 
i n a P F S.  T he l y o p hilize d dr u g pr o d uct c o ntai ns e xci pie nts t hat, after 
rec o nstit uti o n, will yiel d a s ol uti o n as detaile d i n t he I B.
T he fill v ol u me of t he dr u g pr o d uct vial a n d dil ue nt P F S are desi g ne d s uc h 
t hat t he 1 2 0-µ g vacci ne d ose is deli vere d b y i njecti n g t he e ntire c o nte nts of t he 
s yri n ge.
U nit d ose stre n gt h(s)
1 2 0 µ g
R o ute of a d mi nistr ati o n
I ntra m usc ular
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 t he s p o ns or
P ac k a gi n g a n d l a beli n g
St u d y i nter ve nti o n will be pac ka ge d wit hi n cart o ns la bele d b y Pfizer or its 
desi g nee i n acc or da nce wit h c urre nt g ui deli nes a n d a p plica ble l ocal a n d le gal 
re g ulat or y re q uire me nts.
S R S D
I B
St u d y Ar ms – S u bst u d y B
A r m  Title
R S V pre F
A r m  Descri pti o n
Partici pa nts will recei ve R S V pre F 1 2 0 µ g at Visits 2 0 1 a n d 2 0 2
1 0. 8. 6. 1. 1. A d mi nistr ati o n
Partici pa nts will recei ve 2 d oses of st u d y  i nter ve nti o n i n acc or da nce wit h t he s u bst u d y’s 
S o A. F or ot her details re gar di n g st u d y i nter ve nti o n a d mi nistrati o n, see Secti o n 6. 1. 1 .  T he 
st u d y i nter ve nti o n will be a d mi nistere d i nt o t he delt oi d m uscle, prefera bly of t he 
n o n d o mi na nt ar m, u nless me dicall y  c o ntrai n dicate d, i n w hic h case t he i njecti o n ma y be 
a d mi nistere d i n t he d o mi na nt ar m.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 4
1 0. 8. 6. 1. 2. Me dic al De vices
See Secti o n 6. 1. 2 .
1 0. 8. 6. 1. 3. Pre p ar ati o n, H a n dli n g, St or a ge, a n d Acc o u nt a bilit y
See Secti o n 6. 2 .
1 0. 8. 6. 1. 4. Assi g n me nt t o St u d y I nter ve nti o n
See Secti o n 6. 3 .
T he st u d y  i nter ve nti o n t o be dis pe nse d t o t he partici pa nt will be assi g ne d usi n g a n I R T 
s yste m. T he site will utilize t he I R T s yste m t o assi g n t he D U or c o ntai ner n u m ber(s) pri or t o 
t he start of st u d y i nter ve nti o n a d mi nistrati o n f or eac h partici pa nt. T he site will rec or d t he 
st u d y i nter ve nti o n assi g n me nt o n t he a p plica ble C R F, if re q uire d. 
St u d y  i nter ve nti o n will be dis pe nse d at t he st u d y visits as s u m marize d i n t he S o A f or 
S u bst u d y  B.
1 0. 8. 6. 2. Bli n di n g f or S u bst u d y B
S u bst u d y  B is a n o pe n-la bel st u d y.
1 0. 8. 6. 2. 1. Bli n di n g of P artici p a nts
Partici pa nts will n ot 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. 8. 6. 2. 2. Bli n di n g of Site Pers o n nel
I nvesti gat ors a n d ot her site staff will n ot be bli n de d t o partici pa nts’ assi g ne d st u d y 
i nter ve nti o n.
1 0. 8. 6. 2. 3. Bli n di n g of t he S p o ns or
Pfizer staff will be u n bli n de d t o partici pa nts’ assi g ne d st u d y  i nter ve nti o n. 
1 0. 8. 6. 2. 4. Bre a ki n g t he Bli n d
N ot a p plica ble.  S u bst u d y  B is a n o pe n-la bel st u d y.
1 0. 8. 6. 3. St u d y I nter ve nti o n C o m pli a nce
See Secti o n 6. 5.
1 0. 8. 6. 4. D ose M o dific ati o n
Decisi o ns re gar di n g d ose i nterr u pti o ns or m o dificati o ns will be ma de b y  t he i n vesti gat or i n 
c o ns ultati o n wit h t he st u d y  me dical m o nit or as nee de d base d o n t he cli nical e val uati o n of t he 
partici pa nt.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 5
1 0. 8. 6. 5. C o nti n ue d Access t o St u d y I nter ve nti o n After t he E n d of t he St u d y
See Secti o n 6. 7 .
1 0. 8. 6. 6. Tre at me nt of O ver d ose
See Secti o n 6. 8.
1 0. 8. 6. 7. Pri or a n d C o nc o mit a nt T her a p y f or S u bst u d y B
T he f oll o wi n g pri or a n d c o nc o mita nt me dicati o ns, vacci nati o ns, a n d treat me nts will be 
rec or de d i n t he C R F:

A n y  vacci nati o ns recei ve d fr o m 2 8 da ys pri or t o st u d y e nr oll me nt u ntil t he last st u d y 
visit.

Baseli ne a n d c o nc o mita nt t hera py, oral c ortic oster oi ds, che m ot hera p y, i m m u n ot hera p y, 
i m m u n o m o d ulat or/ bi ol o gic treat me nts, a n d im m u n os u p pressi ve re gi me ns . T hese will be 
rec or de d a n d i ncl u de t he na me of t he me dicati o n, start date, d ose, u nit, r o ute, a n d 
fre q ue nc y.

Pr o hi bite d me dicati o ns a n d treat me nts liste d i n Secti o n 1 0. 8. 6. 7. 1 ( wit h t he e xce pti o n of 
a nti p yretics a n d ot her pai n me dicati o ns to pre ve nt s y m pt o ms ), if ta ke n, will be rec or de d 
a n d i ncl u de t he start a n d st o p dates, na me of t he me dicati o n, d ose, u nit, r o ute, a n d 
fre q ue nc y.
1 0. 8. 6. 7. 1. Pr o hi bite d C o nc o mit a nt V acci n ati o ns a n d Tre at me nts
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  ( unless d oc u me nte d 
as per Secti o n 7. 2 ). Me dicati o ns s h o ul d n ot be wit h hel d if re q uire d f or a partici pa nt’s 
me dical care.

Recei pt of a n y n o nst u d y R S V vacci ne at a n y ti me pri or t o or d uri n g st u d y partici pati o n.

I n vesti gati o nal vacci nes, dr u gs, or me dical de vices are pr o hi bite d d uri n g t he c o urse of t he 
st u d y. 
N ote: 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 will n ot be 
pr o hi bite d d uri n g t he c o urse of t his st u d y  if a d mi nistere d m ore t ha n 1 4 da ys pri or t o 
st u d y i nter ve nti o n a d mi nistrati o n or at least 1 4 da ys after st u d y i nter ve nti o n 
a d mi nistrati o n.

Re cei pt of bl o o d/ plas ma pr o d ucts or i m m u n o gl o b uli n (IVI G, S CI G) pri or t o t he fi nal 
bl o o d dra w .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 6
N ote : M o n ocl o nal a nti b o dies wit h tar gete d mec ha nis ms of acti o n use d i n t he 
ma na ge me nt of c hr o nic ill nesses (e g, mi grai ne hea dac hes, oste o p or osis) are per mitte d.

N o nst u d y  vacci nes ma y n ot be gi ve n c o nc o mita ntl y wit h t he st u d y i nter ve nti o n or 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, e xce pt if me dically necessar y (e g, d uri n g 
a n o ut brea k or pa n de mic sit uati o n).

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 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 are n ot per mitte d bef ore a d mi nistrati o n of st u d y 
i nter ve nti o n. 
N ote: 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. 8. 6. 7. 2. Per mitte d C o nc o mit a nt V acci n ati o ns a n d Tre at me nts

Oral c ortic oster oi ds, sta ble M T X, a n d N S AI Ds are per mitte d. 

F or partici pa nts recei vi n g M T X t hera p y, sta ble is defi ne d as recei vi n g M T X f or at least 
3 m o nt hs ( 8 4 da y s) pri or t o Da y 1, wit h n o d ose c ha n ges i n t he 2 8 da y s pri or t o Da y 1, 
a n d n ot e xcee di n g a d ose of 2 5 m g/ wee k. 

F or partici pa nts n ot recei vi n g M T X t hera p y, treat me nt wit h M T X m ust ha ve bee n 
st o p pe d at least 3 m o nt hs ( 8 4 da ys) pri or t o Da y 1 a n d n ot be e x pecte d t o be i nitiate d 
pri or t o D ose 2.

I m m u n os u p pressa nt/a ntirejecti o n dr u gs, i ncl u di n g b ut n ot li mite d t o m yc o p he n olate, 
tacr oli m us, sir oli m us, c ycl os p ori ne, a n d azat hi o pri ne, are per mitte d.

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. 8. 6. 7. 1 re q uire d f or 
treat me nt of pre-e xisti n g c o n diti o ns or ac ute ill ness is per mitte d.

Lice nse d vacci nes ma y  be gi ve n d uri n g t he st u d y starti n g 1 4 da ys after st u d y i nter ve nti o n 
a d mi nistrati o n. 

I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical (s ki n or e y es) c ortic oster oi ds are 
per mitte d.

T he use of a nti p yr etics a n d ot her pai n 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 is per mitte d d uri n g t he partici pa nt’s partici pati o n i n t he 
st u d y.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 7
1 0. 8. 7. Disc o nti n u ati o n of St u d y 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 f or S u bst u d y B
See Secti o n 7 .
1 0. 8. 8. St u d y Assess me nts a n d Pr oce d ures f or S u bst u d y B
Refer t o Secti o n 8 a n d t he f oll o wi n g s u bsecti o ns:

Secti o n 8. 1 A d mi nistrati ve a n d Baseli ne Pr oce d ures

Secti o n 8. 1. 1 Tele healt h Visits
1 0. 8. 8. 1. I m m u n o ge nicit y Assess me nts
1 0. 8. 8. 1. 1. R S V V acci ne A nti b o d y Testi n g
Refer t o Secti o n 8. 2. 3 f or ge neral i nf or mati o n re gar di n g use a n d st ora ge of bi ol o gical 
sa m ples.
Bl o o d sa m ples (a p pr o xi matel y  2 0 m L per sa m ple) will be c ollecte d fr o m partici pa nts f or 
i m m u n o ge nicity testi n g as s peci fie d i n t he st u dy- s pecific S o A (refer t o Secti o n 1 0. 8. 1. 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 S u b st u d y B is a p pr o xi matel y 
6 0 m L .
R S V A – a n d R S V B– ne utralizi n g a nti b o d y  titers will be meas ure d f or eac h bl o o d sa m ple at 
eac h ti me p oi nt, a n d re p orte d as t he N Ts.
Bl o o d sa m ple c ollecti o n ma y be halte d or disc o nti n ue d u p o n n otificati o n b y Pfizer. T his 
i ncl u des disc o nti n ui n g sa m pli n g i n d ose d partici pa nts w h o are n o l o n ger eli gi ble f or t he 
st u d y as well as disc o nti n uati o n f or gr o u ps of partici pa nts or all partici pa nts.
1 0. 8. 8. 2. S afet y Assess me nts
Pla n ne d ti me p oi nts f or all safet y  assess me nts are pr o vi de d i n t he S o A. U nsc he d ule d safet y 
meas ure me nts ma y  be o btai ne d at a n y ti me d uri n g t he st u d y t o assess a n y percei ve d safet y 
iss ues.
Refer t o Secti o n 8. 3 a n d t he f oll o wi n g s u bsecti o ns:

Secti o n 8. 3. 1 P h y sical E xa mi nati o ns

Secti o n 8. 3. 2 Vital Si g ns

Secti o n 8. 3. 3 Cli nical Safet y  La b orat or y Assess me nts

Secti o n 8. 3. 4 Electr o nic Diar y  f or React o ge nicit y
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 8
E- diar y  assess me nts are i ncl u de d i n S u bst u d y B f or partici pa nts’ re p orti n g of l ocal reacti o ns 
a n d s yste mic e ve nts f or 7 da ys fr o m t he da y of eac h a d mi nistrati o n of t he st u d y i nter ve nti o n. 
Partici pa nts will recei ve re mi n ders t o c o m plete t he vacci nati o n e -diar y  o n a dail y basis, 
starti n g o n t he da y of vacci nati o n ( Da y 1) t hr o u g h Da y 7 after eac h vacci nati o n. Refer t o 
Secti o n 8. 3. 4 f or details.
1 0. 8. 8. 3. 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
Refer t o Secti o n 8. 4 a n d t he f oll o wi n g s u bsecti o ns:

Secti o n 8. 4. 1 Ti me Peri o d a n d Fre q ue nc y f or C ollecti n g A E a n d S A E I nf or mati o n

Secti o n 8. 4. 2 Met h o d of Detecti n g A Es a n d S A Es

Secti o n 8. 4. 3 F oll o w -U p of A Es a n d S A Es

Secti o n 8. 4. 4 Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es

Secti o n 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

Secti o n 8. 4. 6 Car di o vasc ular a n d Deat h E ve nts

Secti o n 8. 4. 7 Disease -Relate d E ve nts a n d/ or Disease-Relate d O utc o mes N ot Q ualif y i n g 
as A Es or S A Es

Secti o n 8. 4. 8 A d verse E ve nts of S pecial I nterest

Secti o n 8. 4. 9 Me dical De vice Deficie ncies

Secti o n 8. 4. 1 0 Vacci nati o n Err ors
1 0. 8. 8. 4. S u bst u d y B Pr oce d ures
1 0. 8. 8. 4. 1. Visit 2 0 1 – V acci n ati o n 1 ( Cli nic, D a y 1)
Bef o re e nr oll me nt a n d bef ore a ny 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 nt. T he s o urce d at a m ust reflect t h at t he 
i nf or me d c o nse nt w as o bt ai ne d bef ore p artici p ati o n i n t he st u d y.
It is a ntici pate d t hat t he pr oce d ures bel o w will be c o n d ucte d i n a ste p wise ma n ner; e ns ure 
t hat pr oce d ures liste d pri or t o st u d y i nter ve nti o n a d mi nistr ati o n are c o n d ucte d pri or t o 
st u d y vacci nati o n.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1 9

O btai n writte n i nf or me d c o nse nt 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 safety 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 di n g:

Heart disease ;

L u n g disease ;

Ast h ma ;

Dia betes mellit us / meta b olic disease;

Li ver disease ;

Re nal disease ;

Ne ur ol o gic disease ;

He mat ol o gic disease ;

Hist or y  a n d ty p e of S O T;

O nc ol o g y h ist or y;

A ut oi m m u ne infla m mat or y  dis or ders.

I n a d diti o n, f or specific criteria f or partici pa nts wit h k n o w n sta ble i nfecti o n wit h HI V,
please refer t o Secti o n 1 0. 6 , A p pe n di x 6 .

O btai n a n d rec or d c urre nt/f or mer t o bacc o usa ge.

Perf or m a cli nical assess me nt, i ncl u di n g baseli ne res pirat or y  rate. 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.

O btai n details of a n y n o nst u d y  vacci nati o ns, a n d pr o hi bite d me dicati o ns a n d c o nc o mita nt 
treat me nts as descri be d i n Secti o n 1 0. 8. 6. 7 .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 0

C ollect o n g oi n g oral c ortic oster oi ds, che m ot hera p y , i m m u n ot hera p y, 
i m m u n o m o d ulat or/ bi ol o gic treat me nts, a n d im m u n os u p pressi ve re gi me ns as well as 
t h ose recei ve d (a n d/ or disc o nti n ue d) wit hi n t he last 3 m o nt hs .

E ns ure a n d d oc u me nt t h at all t he i ncl usi o n criteri a a n d n o ne of t he e xcl usi o n 
criteri a are met.

Meas ure a n d rec or d pre vacci nati o n te m perat ure.

E ns ure t hat t he partici pa nt meets n o ne of t he te m p orar y dela y criteria as descri be d i n
Secti o n 5. 5 .

O btai n t he partici pa nt’s st u d y  i nter ve nti o n kit n u m ber usi n g t he I R T sys te m. Refer t o t he 
I R T ma n ual f or f urt her i nstr ucti o ns o n t his pr ocess.

P ri 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 2 0 m L .

Q ualifie d site staff me m ber(s) will a d mi nister a si n gle d ose of st u d y i nter ve nti o n i nt o t he 
delt oi d m uscle of t he ( prefera bl y) n o n d o mi na nt ar m, u nless me dicall y c o ntrai n dicate d, i n 
w hic h case t he i njecti o n ma y  be a d mi nistere d i n the d o mi na nt ar m. Please refer t o t he 
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f or f urt her i nstr ucti o ns o n t his pr oce d ure.

Site staff m ust o bser ve t he partici pa nt f or a n y 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. Rec or d a n y ac ute reacti o ns i n t he partic i pa nt’s s o urce 
d oc u me nts, 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.

E x plai n t he e -diar y  tec h n ol o gies a vaila ble f or t his st u d y (see Secti o n 8. 3. 4) a n d assist t he 
partici pa nt i n d o w nl oa di n g t he st u d y a p plicati o n o nt o his or her o w n de vice or iss ue a 
pr o visi o ne d de vice if re q uire d. 

P r o vi de i nstr ucti o ns o n react o ge nicit y e-diar y  c o m pleti o n a n d as k t he partici pa nt t o 
c o m plete t he react o ge nicit y e-diar y  fr o m Da y 1 t hr o u g h Da y 7, wit h Da y 1 bei n g t he da y 
of vacci nati o n.

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns at t he i njecti o n site a n d a 
t her m o meter f or rec or di n g daily te m perat ures a n d pr o vi de i nstr ucti o ns o n t heir use.

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/s he 
e x perie nces a n y of t he f oll o wi n g fr o m Da y  1 t hr o u g h D a y  7 after vacci nati o n ( w here Da y 
1 is t he da y  of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y visit is re q uire d 
(as detaile d i n Secti o n 8. 1 0 ):

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 1

Re d ness or s welli n g at t he i njecti o n site meas uri n g > 2 0 m eas uri n g de vice u nits 
( greater t ha n 1 0 c m).

Se vere pai n at t he i njecti o n site. 

A n y  se vere sys te mic e ve nt.

R e mi n d t he partici pa nt t hat st u d y staff ma y c o ntact hi m or her t o o btai n a d diti o nal 
i nf or mati o n o n e ve nts e ntere d i nt o t he e-diar y .

Re mi n d partici pa n ts t o i nf or m t he st u d y staff of a n y A Es, A E SI s, S A Es, a n d N D C M Cs 
t hat occ ur f or t he d urati o n of t he trial as descri be d i n Secti o n 8. 4 .

Re mi n d t he partici pa nt t o bri n g t he e -diar y  t o t he ne xt visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs a n d t he 
dis pe nser/a d mi nistrat or c o m pletes 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 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 
safety re vie w.
1 0. 8. 8. 4. 2. Visit 2 0 2 – V acci n ati o n 2 ( Cli nic, 2 8 t o 3 5 D a ys After V acci n ati o n at 
Visit 2 0 1)

O btai n details of a n y n o nst u d y  vacci nati o ns, a n d pr o hi bite d me dicati o ns a n d c o nc o mita nt 
treat me nts as descri be d i n Secti o n 1 0. 8. 6. 7 .

C ollect oral c ortic oster oi ds, c he m ot hera p y, i m m u n ot hera p y, i m m u n o m o d ulat or/ bi ol o gic 
treat me nts, a n d im m u n os u p pressi ve re gi me ns .

E ns ure a n d d oc u me nt t hat t he partici pa nt is still eli gi ble f or vacci nati o n a n d 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.

Meas ure a n d rec or d pre vacci nati o n te m perat ure.

E ns ure t hat t he partici pa nt meets n o ne of t he te m p orar y  dela y criteria as descri be d i n
Secti o n 5. 5.

O btai n t he partici pa nt’s st u d y  i nter ve nti o n kit n u m ber usi n g t he I R T sys te m. Refer t o t he 
I R T ma n ual f or f urt her i nstr ucti o ns o n t his pr ocess.

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  2 0 m L .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 2

Re vie w t he partici pa nt’s e -diar y  data.  C ollect st o p dates of a ny e-diar y e ve nts o n g oi n g 
o n t he last da y  t hat t he e-diar y  was c o m plete d a n d rec or d st o p dates i n t he C R F.  
A n y  o n g oi n g reacti o ns m ust be assesse d at t he ne xt c o ntact.

Q ualifie d site staff me m ber(s) will a d mi nister a si n gle d ose of st u d y i nter ve nti o n i nt o t he 
delt oi d m uscle of t he ( prefera bl y) n o n d o mi na nt ar m, u nless me dicall y c o ntrai n dicate d, i n 
w hic h case t he i nje cti o n ma y be a d mi nistere d i n t he d o mi na nt ar m.  Please refer t o t he 
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f or f urt her i nstr ucti o ns o n t his pr oce d ure.

Site staff m ust o bser ve t he partici pa nt f or a n y 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.  Rec or d a n y ac ute reacti o ns i n t he partici pa nt’s s o urce 
d oc u me nts, 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 mi n d partici pa nt h o w t o c o m plete t he react o ge nicit y  e-diar y a n d as k t he partici pa nt t o 
c o m plete t he react o ge nicit y e-diar y  fr o m Da y 1 t hro u g h Da y  7, wit h Da y 1 bei n g t he da y 
of vacci nati o n.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diatel y if he/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 
D a y 1 is t he da y  of vacci nati o n) t o deter mi ne if a n u nsc he d ule d react o ge nicit y visit is 
re q uire d (as detaile d i n Secti o n 8. 1 0 ):

Fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F).

Re d ness or s wel li n g at t he i njecti o n site meas uri n g > 2 0 meas uri n g de vice u nits 
( greater t ha n 1 0 c m).

Se vere pai n at t he i njecti o n site. 

A n y  se vere sys te mic e ve nt.

Re mi n d t he partici pa nt t hat st u d y  staff ma y c o ntact hi m or her t o o btai n a d diti o nal 
i nf or mati o n o n e ve nts entere d i nt o t he e-diar y .

Re mi n d partici pa nts t o i nf or m t he st u d y  staff of a n y A Es, A E SI s, S A Es, a n d N D C M Cs 
t hat occ ur f or t he d urati o n of t he trial as descri be d i n Secti o n 8. 4 .

Re mi n d t he partici pa nt t o bri n g t he e -diar y  t o t he ne xt visit.

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs a n d t he 
dis pe nser/a d mi nistrat or c o m pletes t he st u d y  inter ve nti o n acc o u nta bilit y  rec or ds.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 3

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 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 
safety re vie w.
1 0. 8. 8. 4. 3. Visit 2 0 3 – 1- M o nt h F oll o w -U p ( Cli nic, 2 8 t o 3 5 D a ys After V acci n ati o n at 
Visit 2 0 2)

O btai n details of a n y n o nst u d y  vacci nati o ns, a n d pr o hi bite d me dicati o ns a n d c o nco mita nt
treat me nts as descri be d i n Secti o n 1 0. 8. 6. 7 .

C ollect oral c ortic oster oi ds, che m ot hera p y, i m m u n ot hera p y, i m m u n o m o d ulat or/ bi ol o gic 
treat me nts, a n d im m u n os u p pressi ve re gi me ns .

C ollect a bl o o d sa m ple of a p pr o xi matel y  2 0 m L .

Re vie w t he partici pa nt’s e -diar y  data.  C ollect st o p dates of a ny e-diar y e ve nts o n g oi n g 
o n t he last da y  t hat t he e-diar y  was c o m plete d a n d rec or d st o p dates i n t he C R F. A n y 
o n g oi n g reacti o ns m ust be assesse d at t he ne xt c o ntact.

C ollect t he pr o visi o ne d d e vice 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.

Rec or d A Es, A E SIs, S A Es, a n d N D C M Cs as descri be d i n Secti o n 8. 4 .

C o m plete t he s o urce d oc u me nts.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
1 0. 8. 8. 4. 4. Visit 2 0 4 – 6- M o nt h S afet y F oll o w -U p ( Tele p h o ne or Cli nic, Wit hi n 1 7 5 t o 
1 8 9 D a ys After V acci n ati o n 2 at Visit 2 0 2)

C o ntact t he partici pa nt b y tele p h o ne. T his visit ca n be c o n d ucte d as a cli nic visit if t he 
i n vesti gat or dee ms it is necessar y f or t he partici pa nt t o be see n i n pers o n.

O btai n details of a n y n o nst u d y  vacci nati o ns, a n d pr o hi bite d me dicati o ns a n d c o nc o mita nt 
treat me nts as descri be d i n Secti o n 1 0. 8. 6. 7 . 

C ollect oral c ortic oster oi ds, che m ot hera p y, i m m u n ot hera p y, i m m u n o m o d ulat or/ bi ol o gic 
treat ments , a n d im m u n os u p pressi ve re gi me ns .

Re vie w o n g oi n g react o ge nicit y  e-diar y s ym pt o ms re p orte d as prese nt o n t he last da y  of 
t he e-diar y  a n d o btai n st o p dates. Rec or d st o p dates i n t he C R F if re q uire d.

Rec or d A E SIs, S A Es , a n d N D C M Cs as descri be d i n Secti o n 8. 4 .

C o m plete t he s o urce d oc u me nts.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 4

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R Fs.
1 0. 8. 8. 4. 5. U nsc he d ule d Visit f or Fe ver o r a Gr a de 3 or S us pecte d Gr a de 4 Re acti o n
See Secti o n 8. 1 0 .
1 0. 8. 9. St atistic al C o nsi der ati o ns f or S u bst u d y B
See Secti o n 9 f or t he ge neral pr ot oc ol statistical c o nsi derati o ns a n d see s u bst u d y-s pecific
statistical c o nsi derati o ns bel o w.
1 0. 8. 9. 1. St atisti c al H y p ot heses
S u bst u d y  B is descri pti ve, wit h o ut a n y  h yp ot hesis testi n g . I m m u n o ge nicity data will be 
descri pti vel y s u m marize d f or t his s u bst u d y a n d ma y be descri pti vel y c o m pare d wit h ot her 
st u d y res ults.
1 0. 8. 9. 1. 1. Esti m a n ds
T he esti ma n ds c orres p o n di n g t o eac h pri m ar y, sec o n dar y , a n d e x pl orat or y o bjecti ve (if a ny)  
are descri be d i n Secti o n 1 0. 8. 3 . 
T he esti ma n ds t o e val uate t he i m m u n o ge nicit y o bjecti ves are base d o n t he e val ua ble 
i m m u n o ge nicity p o p ulati o n ( Secti o n 1 0. 8. 9. 2 ). T hese esti ma n ds esti mate t he vacci ne effect 
i n t he h yp ot hetical setti n g w here partici pa nts f oll o w t he st u d y  sc he d ules a n d pr ot oc ol 
re q uire me nts as directe d. Missi n g i m m u n o ge nicit y  res ults will n ot be i m p ute d, as M C A R is 
ass u me d.
1 0. 8. 9. 1. 2. M ulti plicit y A dj ust me nt
N o m ulti plicit y  a dj ust me nt will be a p plie d f or t his s u bst u d y.
1 0. 8. 9. 2. A n al ysis Sets
F or p ur p oses of a nal y sis, t he f oll o wi n g a nalys is sets are defi ne d:
P artici p a nt A n al ysis Set
Descri pti o n
E nr olle d 
All partici pa nts w h o ha ve a si g ne d I C D i n t his s u bst u d y.
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 y ste m i n t his s u bst u d y.
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
i n t his s u bst u d y.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 5
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 
T his p o p ulati o n will be defi ne d f or S u bst u d y B a n d it 
i ncl u des all partici pa nts w h o meet t he f oll o wi n g criteria:

Are eli gi ble f or S u b st u d y B;

Recei ve d 2 d ose s of st u d y  i nter ve nti o n;

Ha ve t he 1 -m o nt h p ost vacci nati o n ( 1 m o nt h after last 
d ose) bl o o d c ollecti o n 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 assa y  res ult 
1 m o nt h after vacci nati o n ( 1 m o nt h after last d ose);

Ha ve n o maj or pr ot oc ol vi olati o ns fr o m vacci nati o n 
t hr o u g h t he 1-m o nt h p ost vacci n ati o n bl o o d dra w
( 1 m o nt h after last d ose).
mI T T i m m u n o ge nicit y 
p o p ulati o n 
All partici pa nts i n t his s u bst u d y w h o recei ve d st u d y 
i nter ve nti o n a n d ha d 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 dy i nter ve nti o n.
1 0. 8. 9. 3. St atistic al A n al ysis
T he S A P will be de vel o pe d a n d fi nalize d bef ore a n y  a nalys es are perf or me d a n d will 
descri be t he a nal ys es a n d pr oce d ures f or acc o u nti n g f or missi n g, u n use d, a n d s p uri o us data. 
T his secti o n is a s u m mar y of t he pla n ne d statistical a nal ys es of t he pri mar y a n d sec o n dar y 
e n d p oi nts.
1 0. 8. 9. 3. 1. Ge ner al C o nsi der ati o ns
See Secti o n 9. 3. 1 f or ge neral c o nsi derati o ns of t he statistical a nal yses.
1 0. 8. 9. 3. 2. Pri m ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis
T a ble 8. 
Pri m ar y E n d p oi nt A n al yses
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. L o cal 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 (fe ver, na usea, fati g ue, 
hea dac he, v o miti n g, diarr hea, m uscle pai n, a n 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 s e 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 s (Secti o n 9. 3. 1. 1 ).
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 6
T a ble 8. 
Pri m ar y E n d p oi nt A n al yses
E n d p oi nt
St atistic al A n al ysis Met h o ds

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 t he A E SIs, S A E s, a n d N D C M Cs t hr o u g h o ut t he st u d y  
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 s (Secti o n 9. 3. 1. 1 ).

A 3 -tier a p pr oac h will be use d t o s u m marize A Es.  ( 1) Tier 1 
e ve nts are pres pecifie d e ve nts of cli nical i m p orta nce a n d are 
i de ntifie d i n a list i n t he pr o d uct’s safety re vie w pla n a n d 
descri be d i n detail i n t he S A P . ( 2) Tier 2 e ve nts are 
c o nsi dere d “relati vel y c o m m o n” e ve nts; a Me d D R A P T is 
defi ne d as a Tier 2 e ve nt if t here are at least 1 % of 
partici pa nts i n a n y vacci ne gr o u p re p orti n g t he e ve nt, i n a n y  
a ge strat u m. As t here is n o place b o gr o u p i n t his s u bst u d y , 
Tier 2 e ve nt a nal ys is is n ot defi ne d. ( 3) Tier 3 e ve nts are 
t h ose t hat are neit her Tier 1 n or Tier 2 e ve nts.

F or Tier 1 e ve nts, t he 9 5 % CI s f or t he differe nce i n t he 
perce nta ge of partici pa nts re p orti n g t he e ve nts bet wee n t he 
R S V pre F gr o u p fr o m t his s u bst u d y a n d a c o ntr ol will be 
calc ulate d usi n g t he test statistic pr o p ose d b y  Mietti ne n a n d 
N ur mi ne n.
I n a d diti o n, f or Tier 1 e ve nts, t he asy m pt otic 
p- val ues will be prese nte d f or t he differe nce bet wee n gr o u ps 
i n t he perce nta ge of partici pa nts re p orti n g t he e ve nts, base d 
o n t he sa me test statistic a n d u n der t he ass u m pti o n t hat t he 
test statistic is as ym pt oticall y  n or mall y distri b ute d.  T he 
c o ntr ol will be defi ne d i n t he S A P.
I m m u n o ge nicity

G M Ts at eac h a p plica ble bl o o d sa m pli n g visit will be 
descri pti vel y s u m marize d wit h 2 -si de d 9 5 % CIs f or b ot h 
R S V A a n d R S V B N T s u b gr o u ps (Secti o n 9. 3. 1. 2. 1 ).

G M F Rs fr o m bef ore vacci nati o n t o eac h p ost vacci nati o n 
bl o o d sa m pli n g visit will be descri pti vel y s u m marize d wit h 
9 5 % CI s f or b ot h R S V A a n d R S V B N T s u b gr o u ps 
(Secti o n 9. 3. 1. 2. 2) .

G M Ts a n d G M F Rs ma y  als o be s u m marize d f or eac h a ge 
strat u m ( 1 8 t o < 6 0 y ears of a ge a n d ≥6 0 y ears of a g e).
1 0. 8. 9. 3. 3. Sec o n d ar y E n d p oi nt(s)/ Esti m a n d(s) A n al ysis
N ot a p plica ble .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 7
1 0. 8. 9. 4. I nteri m A n al ysis
N o i nteri m a nal ys is is pla n ne d.  
1 0. 8. 9. 4. 1. A n al ysis Ti mi n g
As S u bst u d y  B is o pe n-la bel, data ma y be s u m marize d o n a n o n g oi n g basis f or decisi o n -
ma ki n g.
1 0. 8. 9. 5. S a m ple Size Deter mi n ati o n
S u bst u d y  B e nr oll me nt is n ot base d o n statistical criteri a.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 8
1 0. 9. A p pe n di x 9 : A b bre vi ati o ns
T he f oll o wi n g is a list of a b bre viati o ns t hat ma y be use d i n t he pr ot oc ol.
A b bre vi ati o n
Ter m
A D E
a d verse de vice effect
A E
a d verse e ve nt
A E SI
a d verse e ve nt of s pecial i nterest
A KI
ac ute ki d ne y i nj ur y
A L K
a na plastic l y m p h o ma ki nase
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 x M P
a u xiliar y me dici nal pr o d uct
B R A F
B -t ype Raf pr ot o -o nc o ge ne
C B E R
Ce nter f or Bi ol o gics E val uati o n a n d Researc h ( U nite d States)
C D C
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n ( U nite d States)
C F R
C o de of Fe deral Re g ulati o ns
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 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 trial
C TI S
Cli nical Trial I nf or mati o n S y ste m
C T L A -4
c yt ot o xic T-l ym p h oc y t e– ass ociate d a nti ge n 4
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 M C
data m o nit ori n g c o m mittee
D N A
de o x yri b o n ucleic aci d
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
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2 9
A b bre vi ati o n
Ter m
e-diar y
electr o nic diar y
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 G F R
e pi der mal gr o wt h fact or rece pt or
eIC D
electr o nic i nf or me d c o nse nt d oc u me nt
e S A E
electr o nic seri o us 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 U ni o n Dr u g Re g ulati n g A ut h orities Cli nical Trials 
( E ur o pea n Cli nical Trials Data base)
F D A
F o o d a n d Dr u g A d mi nistrati o n ( U nite d States)
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
HI V
h u ma n i m m u n o deficie nc y vir us
H S C T
he mat o p oietic ste m cell tra ns pla nt
I B
i n vesti gat or’s br oc h ure
I C D
i nf or me d c o nse nt d oc u me nt
I C H
I nter nati o nal C o u ncil f or Har m o nisati o n of Tec h nical 
Re q uire me nts f or P har mace uticals f or H u ma n Use
I C U
i nte nsi ve care u nit
I D
i de ntificati o n
I M P
i n vesti gati o nal me dici nal pr o d uct
I ND
in vesti gati o nal n e w dr u g
I N R
i nter nati o nal n or malize d rati o
I P
i nter net pr ot oc ol
I P A L
i n vesti gati o nal pr o d uct acc o u nta bilit y  l o g
I P M
i n vesti gati o nal pr o d uct ma n ual
I RB
instit uti o nal re vie w b oar d
I R T
i nteracti ve res p o nse tec h n ol o g y
I S O
I nter nati o nal Or ga nizati o n f or Sta n dar dizati o n
I V
i ntra ve n o us
I VI G
i ntra ve n o us i m m u n o gl o b uli n
K DI G O
Ki d ne y  Disease: I mpr o vi n g Gl o bal O utc o mes
L F T
li ver f u ncti o n test
L L O Q
l o wer li mit of q ua ntitati o n
L 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
L S
least s q uare
M C A R
missi n g c o m pletel y at ra n d o m
M D R
me dical de vice re g ulati o n
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 3 0
A b bre vi ati o n
Ter m
Me d D R A
Me dical Dicti o nar y  f or Re g ulat or y Acti vities
M E T
mese nc h y m al e pit helial tra nsiti o n fact or rece pt or
mI T T
m o difie d i nte nt -t o-treat
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 T X
met h otre xate
N/ A
n ot a p plica ble
N D C M C
ne wl y  dia g n ose d c hr o nic me dical c o n diti o n
NI M P
n o ni n vesti gati o nal me dici nal pr o d uct
N S AI D
n o nster oi dal a nti -i nfla m mat or y dr u gs
N S C L C
n o n – s mall-cell l u n g ca ncer
N T
ne utralizi n g titer
N T 5 0
5 0 % ne utralizi n g titer
N T R K
ne ur otr o p hic t yr osi ne rece pt or ki nase
P D -1
pr o gra m me d cell deat h pr otei n 1
P D -L 1
pr o gra m me d cell deat h li ga n d 1
P F S
prefille d s yri n ge
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 T L D
p osttra ns pla nt l y m p h o pr oliferati ve dis or der
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 E T
rearra n ge d d uri n g tra nsfecti o n
R O S 1
c-r os o nc o ge ne 1
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 anal y sis 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
S CI G
s u bc uta ne o us i m m u n o gl o b uli n
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 m P C
s u m mar y of pr o d uct c haracteristics
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 O T
s oli d or ga n tra ns pla nt
S R S D
si n gle refere nce safety d oc u me nt
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 3 1
A b bre vi ati o n
Ter m
S U S A R
s us pecte d u ne x pecte d seri o us a d verse reacti o n
T bili
t otal bilir u bi n
T N Fa
t u m or necr osis fact or al p ha
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
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 3 2
1 1. R E F E R E N C E S
1
F D A . Res pirat or y  sy nc yt ial vir us v acci ne. B L A a p pr o val letter, 3 1 M a y
2 0 2 3 . A vaila ble 
fr o m: htt ps:// w w w.f da. g o v/ me dia/ 1 6 8 8 9 0/ d o w nl oa d . Accesse d: 1 7 J ul 2 0 2 3.
2
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 I m m u n ol . 2 0 1 3; 3 7 2: 3 9 - 5 7.
3
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 nc yt ial vir us 
s ur veilla nce. I nfl ue nza Ot her Res pir Vir uses. 2 0 2 0; 1 4( 6): 6 3 8 - 4 6.
4
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.
5
Griffit hs C, Dre ws SJ, Marc h a nt DJ . Res pirat or y  sy n c ytial v ir us: infecti o n, d etecti o n, 
a n d n e w o pti o ns f or p re ve nti o n a n d treat me nt. Cli n Micr o bi ol Re v . 2 0 1 7; 3 0( 1); 2 7 7-
3 1 9.
6
Pilie P, Wer bel W A, Ri d dell J 4t h , et al. A d ult patie nts wit h res pirat or y s y n c ytial vir us 
i nfecti o n: i m pact of s oli d or ga n a n d he mat o p oietic ste m cell tra ns pla ntati o n o n 
o utc o mes. Tra ns pl I nfect Dis 2 0 1 5 ; 1 7( 4): 5 5 1-7.
7
False y  A R, He n nesse y P A, F or mica M A, et al. Res pirat or y sy n c ytial v ir us i n el derly a n d 
h i g h-ris k ad ults. N E n gl J Me d . 2 0 0 5; 3 5 2 ( 1 7): 1 7 4 9- 5 9.
8
N g u ye n- Va n -Ta m JS, O' Lear y M , Marti n E T , et al: B ur de n of res pirat or y  s yn c y tial vir us 
i nfecti o n i n ol der a n d hi g h-ris k a d ults: a s yste matic re vie w a n d meta-a nal ys is of t he 
e vi de nce fr o m de vel o pe d c o u ntries. E ur Res pir Re v . 2 0 2 2; 3 1 ( 1 6 6): 2 2 0 1 0 5.
9
Mc La u g hli n J M, K ha n F, Be gier E, et al. Rates of m e dicall y atte n de d R S V am o n g U S 
ad ults: a s ys te matic re vie w a n d m eta-a nal ys is. O pe n F or u m I nfect Dis. 
2 0 2 2; 9( 7): ofac 3 0 0.
1 0
T h o m ps o n W W, S ha y  D K, Wei ntra u b E, et al. M ortalit y  ass ociate d wit h i nfl ue nza a n d 
res pirat or y sy n c ytial vir us i n t he U nite d States. J A M A. 2 0 0 3; 2 8 9( 2): 1 7 9-8 6.
1 1
Ha nse n C L, C ha ves S S, De m o nt C, et al. M ortalit y ass ociate d w it h infl ue nza a n d 
res pirat or y sy n c ytial v ir us i n t he U S, 1 9 9 9 -2 0 1 8. J A M A Net w O pe n. 
2 0 2 2; 5( 2):e 2 2 0 5 2 7.
1 2
Mel gar M . A CI P A d ult R S V W or k Gr o u p c o nsi derati o ns. A vaila ble fr o m: 
htt ps:// w w w.c dc. g o v/ vacci nes/aci p/ meeti n gs/ d o w nl oa ds/sli des -2 0 2 2 - 1 0- 1 9-2 0/ 0 4 -R S V -
A d ults -Mel gar -5 0 8. p df. Accesse d: 1 4 Ja n 2 0 2 3.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 3 3
1 3
C D C . Re s pirat or y sy n c ytial vir us (R S V ): researc h & s ur veilla nce. A vaila ble fr o m: 
htt ps:// w w w.c dc. g o v/rs v/researc h/i n de x. ht ml. Accesse d : 2 1 Fe b 2 0 2 3.
1 4
Wi d mer K, Z h u Y, Willia ms J V, et al. Rates of h os pitalizati o ns f or res pirat or y sy n c ytial 
vir us, h u ma n meta p ne u m o vir us, a n d i nfl ue nza v ir us i n o l der ad ults. J I nfect Dis. 
2 0 1 2; 2 0 6( 1): 5 6 -6 2.
1 5
Bra nc he A R, Sai ma n L, Wals h E E, et al. I nci de nce of res pirat or y sy nc yt ial v ir us 
infecti o n am o n g h os pitalize d ad ults, 2 0 1 7 – 2 0 2 0. C li n Infect D is. 2 0 2 2; 7 4( 6): 1 0 0 4- 1 1.
1 6
Z he n g Z, Warre n J L,  S ha pir o E D, et al. Esti mate d inci de nce of res pirat or y 
h os pitalizati o ns attri b uta ble t o R S V infecti o ns acr oss age a n d soci oec o n o mic g r o u ps. 
P ne u m o nia ( Nat ha n). 2 0 2 2; 1 4( 1): 6.
1 7
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 8
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 
infecti o ns i n ad ults age d ≥5 0 y ears: cli nical c haracteristics a n d o utc o mes. Cli n Infect 
Dis. 2 0 1 4; 5 8( 3): 3 4 2 - 9.
1 9
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 ye ars ol d. O pe n F or u m I nfect Dis. 2 0 1 8; 5( 1 2): of y 3 1 6.
2 0
W y ffels V, Kari b ur yo F, Ga vart S, 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 nfectio n. A d v T her. 2 0 2 0; 3 7( 3): 1 2 0 3 - 1 7.
2 1
O n w uc he k wa C, M ore o L M, Me n o n S, et al. U n der- ascertai n me nt of res pirat or y 
s yn c y tial vir us i nfecti o n i n a d ults d ue t o dia g n ostic testi n g li mitati o ns: a s yste matic 
literat ure re vie w a n d meta-a nal ys is. J Infect Dis. 2 0 2 3. D OI : 1 0. 1 0 9 3/i nf dis/jia d 0 1 2 .
2 2
D o mac h o ws ke J B, A n ders o n EJ, G ol dstei n M. T he f ut ure of res pirat or y  sy nc ytial vir us 
disease pre ve nti o n a n d treat me nt. I nfect Dis T her. 2 0 2 1; 1 0( S u p pl 1): S 4 7 -S 6 0.
2 3
Hall C B, Wals h E E, L o n g C E, et al. I m m u nit y t o a n d fre q ue nc y o f rei nfecti o n wit h 
res pirat or y sy n c ytial vir us. J Infect Dis . 1 9 9 1; 1 6 3( 4): 6 9 3 - 8.
2 4
C D C. Res pirat or y  sy n c ytial vir us (R S V ): R S V i n o l der ad ults a n d ad ults wit h chr o nic 
m e dical co n diti o ns . A vaila ble fr o m: htt ps:// w w w.c dc. g o v/rs v/ hi g h-ris k/ ol der-
a d ults. ht ml . Accesse d: 0 1 Mar 2 0 2 3.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 3 4
2 5
C D C. I nfl ue nza (fl u): w h o is at hi g her ris k of fl u c o m plicati o ns. A vaila ble fr o m: 
htt ps:// w w w.c dc. g o v/fl u/ hi g hris k/. Accesse d: 0 1 Mar 2 0 2 3.
2 6
False y A R, Si n g h H K, Wals h E E. Ser u m anti b o d y  deca y i n ad ults foll o wi n g n at ural 
res pirat or y sy n c ytial v ir us infecti o n. J Me d Vir ol . 2 0 0 6 ; 7 8( 1 1):1 4 9 3- 7.
2 7
A merica n Aca de m y  of Pe diatrics C o m mittee o n I nfecti o us Diseases a n d Br o nc hi olitis 
G ui deli nes C o m mittee. P olic y  state me nt— u p date d g ui da nce f or pali viz u ma b 
pr o p h y la xis a m o n g i nfa nts a n d yo u n g c hil dre n at i ncrease d ris k of h os pitalizati o n f or 
res pirat or y sy n c ytial vir us i nfecti o n. Pe diatrics. 2 0 1 4; 1 3 4( 2): 4 1 5-2 0.
2 8
E ur o pea n Me dici nes A ge nc y . Be yf ort us. A vaila ble fr o m: 
htt ps:// w w w.e ma.e ur o pa.e u/e n/ me dici nes/ h u ma n/ E P A R/ be y f ort us. Accesse d: 1 8 J ul 
2 0 2 3.
2 9
F D A. F D A a p pr o ves ne w dr u g t o pre ve nt R S V i n ba bies a n d t o d dlers [ press release]. 
A vaila ble fr o m: htt ps:// w w w.f da. g o v/ ne ws -e ve nts/ press -a n n o u nce me nts/f da- a p pr o ves -
ne w -dr u g -pre ve nt -rs v-ba bies -a n d-t o d dlers. P u blis he d: 1 7 J ul 2 0 2 3. Accesse d: 1 8 J ul 
2 0 2 3.
3 0
Pfizer. Vacci nes a n d Relate d Bi ol o gical Pr o d ucts A d vis or y C o m mittee Meeti n g,
Fe br uar y  2 8 t o Marc h 0 1, 2 0 2 3 . F D A briefi n g d oc u me nt: Res pirat or y  sy n c ytial v ir us 
b i vale nt sta bilize d p ref usi o n F su b u nit v acci ne ( R S V pre F / A br ys v o). F o o d a n d Dr u g 
A d mi nistrati o n we bsite. A vaila ble fr o m: htt ps:// w w w.f da. g o v/ me dia/ 1 6 5 6 2 5/ d o w nl oa d . 
Accesse d: 3 1 J ul 2 0 2 3.
3 1
Pfizer. Pfizer an n o u nces p ositi ve t o p-li ne d ata fr o m P hase 3 trial of o l der ad ults 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 . P u blis he d: 2 5 A u g 2 0 2 2. Accesse d: 3 1 J ul 
2 0 2 3.
3 2
Lee N, L ui G C Y, W o n g K T , et al. Hi g h m or bi dit y a n d m ortalit y  i n ad ults h os pitalize d 
f or res pirat or y sy nc yt ial v ir us infecti o ns . Cli n I nfect Dis . 2 0 1 3; 5 7( 8):1 0 6 9 - 7 7.
3 3
J o ha n nese n C K, va n Wij he M, T o n g S, et al. A ge-specific esti mates of res pirat or y 
sy nc yt ial v ir us- ass ociate d h os pitalizati o ns i n 6 E ur o pea n co u ntries: a ti me series 
anal ys is. J Infect Dis. 2 0 2 2; 2 2 6( S u p pl 1): S 2 9 - 3 7.
3 4
Na m H, Is o n M G . Res pirat or y  sy n c ytial d isease i n h os pitalize d ad ults: a retr os pecti ve 
co h ort st u d y [ abstract 2 7 8 9 ]. O pe n F or u m I nfect Dis . 2 0 1 9; 6(S u p pl 2 ):S 9 8 5 -6 .
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 3 5
3 5
Na m H H, Is o n M G. Res pirat or y  sy n c ytial v ir us i nfecti o n i n ad ults. B MJ .
2 0 1 9; 3 6 6:l 5 0 2 1 .
3 6
Pali viz u ma b, a h u ma nize d res pirat or y  sy n c ytial vir us m o n ocl o nal a nti b o d y, re d uces 
h os pitalizati o n fr o m res pirat or y  s yn c y tial vir us i nfecti o n i n hi g h-ris k i nfa nts. T he 
I M pact-R S V St u d y  Gr o u p. Pe diatrics. 1 9 9 8; 1 0 2( 3 Pt 1): 5 3 1- 7.
3 7
S ha h D P, G ha nt oji S S, S ha h J N, et al. I m pact of aer os olize d ri ba viri n o n m ortalit y  i n 
2 8 0 all o ge neic hae mat o p oietic ste m cell tra ns pla nt reci pie nts wit h res pirat or y  sy n c ytial 
vir us i nfecti o n s. J A nti micr o b C he m ot her. 2 0 1 3; 6 8 ( 8): 1 8 7 2-8 0 .
3 8
W o n gs ura kiat P, S u n ha pa nit S, M ua n g ma n N. Res pirat or y  sy n c ytial vir us-ass ociate d 
ac ute res pirat or y ill ness i n a d ult n o n-i m m u n oc o m pr o mise d patie nts: o utc o mes,
deter mi na nts of o utc o mes, a n d t he effect of oral ri ba viri n treat me nt. I nfl ue nza Ot her 
Res pi r Vir uses. 2 0 2 2; 1 6 ( 4): 7 6 7- 7 9.
3 9
F D A . G ui da nce f or i n d ustr y: t o xicit y gra di n g scale f or healt h y a d ult a n d a d olesce nt 
v ol u nteers e nr olle d i n pre ve nti ve vacci ne cli nical trials. R oc k ville, M D: Ce nter f or 
Bi ol o gics E val uati o n a n d Researc h; Se p 2 0 0 7.
4 0
Pfizer. Vacci nes a n d Relate d Bi ol o gical Pr o d ucts A d vis or y  C o m mittee Meeti n g, Ma y 
1 8, 2 0 2 3. F D A briefi n g d oc u me nt: Res pirat or y  sy nc ytial vir us bi vale nt sta bilize d 
pref usi o n F s u b u nit vacci ne ( R S V pre F/ A br y s v o). F o o d a n d Dr u g A d mi nistrati o n 
we bsite. A vaila ble fr o m: htt ps:// w w w.f da. g o v/ me dia/ 1 6 8 1 8 6/ d o w nl oa d. Accesse d: 1 1 
A u g 2 0 2 3 .
4 1
F D A. A br y s v o. S u m mar y basis f or re g ulat or y acti o n, 3 1 Ma y 2 0 2 3. A vaila ble fr o m: 
htt ps:// w w w.f da. g o v/ me dia/ 1 6 9 7 2 1/ d o w nl oa d?attac h me nt.  Accesse d: 1 6 A u g 2 0 2 3.
4 2
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.
4 3
Mietti ne n O, N ur mi ne n M. C o m parati ve a nal ys is of t w o rates. Stat Me d. 1 9 8 5; 4( 2): 2 1 3-
2 6.
4 4
Be gier E, Nj ue A , N ua b or W,
et al. S y ste matic literat ure re vie w of ris k fact ors f or p o or 
o utc o mes a m o n g ad ults wit h R S V infecti o n [a bstract A R NI 0 2 2 7 ]. A vaila ble fr o m:
htt ps://isir v. or g/site/i ma ges/c o nfere nces/ R S V/ R S V 2 0 2 2/ R S V _ 2 0 2 2 _ A bstracts _ P O S T E
R S % 2 0 Re v % 2 0 Dec 2 2. p df . Accesse d: 2 3 Fe b 2 0 2 3.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)

P F -0 6 9 2 8 3 1 6 ( Res pirat or y S y nc ytial Vir us [ R S V] Vacci ne)
Pr ot oc ol C 3 6 7 1 0 2 3
Fi nal Pr ot oc ol A me n d me nt 1 , 1 8 A u g ust 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)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 3 6
4 5
C hils o n E, Sc ott D A, Sc h m oele -T h o ma B , et al. I m m u n o ge nicit y a n d safet y of t he 1 3 -
vale nt p ne u m oc occal c o nj u gate vacci ne i n patie nts wit h i m m u n oc o m pr o misi n g 
c o n diti o ns: a re vie w of a vaila ble e vi de nce. H u m Vacci n I m m u n ot her.
2 0 2 0; 1 6 ( 1 1):2 7 5 8 - 7 2.
4 6
va n Aalst M, La n ge dij k A C, S pij ker R , et al. T he effect of i m m u n os u p pressi ve a ge nts 
o n i m m u n o ge nicit y of p ne u m oc occal vacci nati o n: a s yste matic re vie w a n d meta-
a nal ys is. Vacci ne. 2 0 1 8; 3 6( 3 9):5 8 3 2 - 4 5. 
4 7
B o yars k y BJ, Wer bel W A, A ver y  R K, et al. A nti b o d y res p o nse t o 2- dose S A R S -C o V - 2 
m R N A v acci ne series i n soli d o r ga n tra ns pla nt reci pie nts. J A M A. 2 0 2 1; 3 2 5( 2 1): 2 2 0 4-6.
0 9 0 1 7 7 e 1 9 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( 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 e 5 7 a c 4 8\ A p pr o v e d\ A p pr o v e d O n: 2 1- A u g- 2 0 2 3 1 2: 5 1 ( G M T)
P P D