AN INTERVENTIONAL, PHASE 1b, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, MULTI-CENTER, DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF SISUNATOVIR IN PEDIATRIC PARTICIPANTS UP TO AGE 60 MONTHS WITH RESPIRATORY SYNCYTIAL VIRUS (RSV) LOWER RESPIRATORY TRACT INFECTION (LRTI)
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Sponsor: Pfizer

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1
Title P a ge
A N I N T E R V E N TI O N A L, P H A S E 1 b , R A N D O MI Z E D, D O U B L E-B LI N D, S P O N S O R -
O P E N, P L A C E B O -C O N T R O L L E D, M U L TI -C E N T E R, D O S E -FI N DI N G S T U D Y T O 
E V A L U A T E S A F E T Y, T O L E R A BI LI T Y A N D P H A R M A C O KI N E TI C S O F 
SI S U N A T O VI R I N P E DI A T RI C P A R TI CI P A N T S U P T O A G E 6 0 M O N T H S WI T H 
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) L O W E R R E S PI R A T O R Y T R A C T 
I N F E C TI O N ( L R TI)
St u d y I nter ve nti o n N u m ber:
P F -0 7 9 2 3 5 6 8
St u d y I nter ve nti o n N a me:
Sis u nat o vir
U S I N D N u m ber:
1 4 3 4 7 9
E U C T N u m ber:
2 0 2 3 -5 0 4 4 2 5 -3 9 -0 0
Cli nic al Tri als. g o v I D:  
N C T 0 6 1 0 2 1 7 4
Pe di atric I n vesti g ati o n al Pl a n N u m ber:
PI P: E M E A -0 0 2 5 2 9 -PI P 0 1 -1 8
Pr ot oc ol N u m ber:
C 5 2 4 1 0 0 9
P h ase:
P hase 1 b
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 St u d y t o Lear n A b o ut t he Safet y, T olera bilit y a n d Bl o o d L e vels of St u d y Me dici ne (calle d sis u nat o vir) i n 
I nfa nts a n d C hil dre n wit h R S V L o wer Res pirat or y Tract I nfecti o n
T his d oc u me nt a n d acc o mpa n yi n g materials c o ntai n c o nfi de ntial i nf or mati o n bel o n gi n g t o Pfizer. E xce pt as 
ot her wise a gree d t o i n writi n g, b y acce pti n g or re vie wi n g t hese d oc u me nts, y o u a gree t o h ol d t his 
i nf or mati o n i n c o nfi de nce a n d n ot c o p y or discl ose it t o ot hers (e xce pt w here re q uire d b y a p plica ble la w ) or 
use it f or u na ut h orize d p ur p oses. I n t he e ve nt of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfizer m ust 
be pr o m ptl y n otifie d.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2
D oc u me nt Hist or y
D oc u me nt 
Versi o n D ate
A me n d me nt 4
1 1 Marc h 2 0 2 4
A me n d me nt 3
2 7 Ja n uar y 2 0 2 4
A me n d me nt 2
1 3 Se pte m ber 2 0 2 3
A me n d me nt 1
2 6 J u ne 2 0 2 3
Ori gi nal pr ot oc ol
1 4 A pril 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 4 ( 1 1 M arc h
2 0 2 4)
O ver all R ati o n ale f or  t he A me n d me nt: T he pri mar y  p ur p ose of t his a me n dme n t is t o
a d dress t he ne w me dicati o n restricti o ns o n aci d re d uci n g a ge nts (e g, P PI , H 2 bl oc kers a n d 
a ntaci ds) base d o n p reli mi nar y res ults fr o m a D DI st u d y ( C 5 2 4 1 0 1 7), i nc or p orate pr ot oc ol 
clarificati o ns, a n d c orrecti o ns t o i de ntifie d err ors .
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 ns
A d de d a d diti o nal b ullet p oi nt t o 
e xcl usi o n criteri o n # 1 6 – “ Has ta ke n 
wit hi n 5 da ys bef ore d osi n g or 
re q uire d uri n g t he d osi n g peri o d of 
t he st u d y, a n y pr ot o n p u m p 
i n hi bit ors. Has ta ke n wit hi n 1 2 
h o urs bef ore d osi n g or re q uire 
d uri n g t he d os i n g peri o d of t he 
st u d y, a n y H 2 bl oc kers.”
Base d o n p reli mi nar y res ults fr o m 
a D DI st u d y ( C 5 2 4 1 0 1 7) of 
sis u nat o vir ta blets i n 
c oa d mi nistrati o n wit h a ntaci ds t hat
s h o we d re d uce d sis u nat o vir plas ma 
e x p os ure .
Secti o n 5. 2 E xcl usi o n Criteria
A d de d t he f oll o wi n g state me nts t o:
Pr o hi bite d Pri or Treat me nt :
“A d mi nistrati o n of pr ot o n p u m p 
i n hi bit ors m ust ha ve e n de d 5 da ys 
pri or t o ra n d o mizati o n ” a n d 
“A d mi nistrati o n of H 2 bl oc kers 
m ust ha ve e n de d at least 1 2 h o urs 
pri or t o ra n d o mizati o n. ”
Pr o hi bite d D u ri n g t he  Da y St u d y
Dr u g A d mi nistrati o n :
“A n y a d mi nistrati o n of pr ot o n p u m p 
i n hi bit ors a n d H 2 bl oc kers is 
pr o hi bite d. T he use of a ntaci ds 
Base d o n preli mi nar y res ults fr o m 
a D DI st u d y ( C 5 2 4 1 0 1 7) of 
sis u nat o vir ta blets i n 
c oa d mi nistrati o n wit h a ntaci ds t hat 
s h o we d si g nifica ntl y re d uce d 
sis u nat o vir plas ma e x p os ure.
Secti o n 6. 9 Pri or a n d 
C o nc o mita nt T hera p y
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
(s uc h as calci u m car b o nate or 
ma g nesi u m h y dr o xi de) is all o we d 
wit h sta g gere d d osi n g (ie, n ot wit hi n 
3 h o urs bef ore or after st u d y dr u g 
a d mi nistrati o n.”
A d de d list of p r ot o n p u m p 
i n hi bit ors a n d H 2 bl oc kers dr u gs t o 
t he pr o hi bite d c o nc o mita nt 
me dicati o n ta ble.
Base d o n preli mi nar y res ults fr o m 
a D DI st u d y ( C 5 2 4 1 0 1 7) of 
sis u nat o vir ta blets i n 
c oa d mi nistrati o n wit h a ntaci ds t hat 
s h o we d si g nifica ntl y re d uce d 
sis u nat o vir plas ma e x p os ure.
A p pe n di x 8 Pr o hi bite d 
C o nc o mita nt Me dicati o ns T hat 
M a y  Res ult i n D DI  
A d de d t he state me nts bel o w t o 
e xcl usi o n criteri o n 1 1 i n Secti o n 1. 1 
a n d e xcl usi o n criteri o n 1 2 i n 
Secti o n 5. 2 :
F irst b ullet p oi nt – “ or e x pecte d t o 
recei ve e q ui vale nt d ose d uri n g st u d y 
dr u g treat me nt .” Sec o n d b ullet p oi nt 
– “ or e x pecte d t o recei ve treat me nt 
wit h t hese t hera pe utics d uri n g st u d y 
dr u g treat me nt. ”
T o pr o vi de a d diti o nal pr ot oc ol 
clarificati o n .
Secti o n 1. 1 S y n o psis a n d
Secti o n 5. 2 E xcl usi o n Criteria
Re m o ve d pre -d ose P K sa m ple 
c ollecti o n o n Da y
u p date d n otes 
f or P K bl o o d sa m ple i n b ot h Ta ble 2 
a n d Ta ble 3, a n d u p date d Ta ble 3 
hea der.
T o re d uce n u m ber of bl o o d dra ws
f or P K sa m ples re q uire d fr o m 4 t o 
3 , a n d t o li mit bl o o d v ol u me 
c ollecte d i n t he st u d y.
Secti o n 1. 3. 1, Ta ble 2 S o A, a n d 
Secti o n 1. 3. 2, Ta ble 3 M ulti ple 
D ose P K Da ys ( F or all C o h orts)
N o n -S u bst a nti al M o dific ati o ns
U p date d Cli nical Trials. g o v I D t o 
N C T 0 6 1 0 2 1 7 4 
T o pr o vi de t he a vaila ble 
i nf or mati o n.
Title pa ge a n d Secti o n 1. 1 
S y n o psis
Re m o ve d U A c ollecti o n at Da y s
a n d 
C 5 2 4 1 0 0 3 st u d y c ollecte d uri ne 
sa m ples a n d pr o vi de d reass uri n g 
safet y data. U A will still be 
c ollecte d at baseli ne a n d is o ne of 
t he refle x tests ( Ta ble 8) t o be d o ne 
s h o ul d t here be c o ncer n f or 
p ote ntial A KI.
Secti o n 1. 3. 1 S o A
Re m o ve d
 Ser vices o n 
D a y  
T o pr o vi de pr ot oc ol clarificati o n 
t hat
ser vices will o nl y 
be a vaila ble at Da y  visit a n d 
o n war ds.
Secti o n 1. 3. 1 S o A
T he fre q ue nc y of c ollecti o n of 
s ocial fact ors was re d uce d t o 
Scree ni n g, Da y  , Da y 
a n d E T 
visit, a n d B o d y Wei g ht assess me nt 
wa s re d uce d t o Scree ni n g, Da y  
 
a n d E T visit o nl y.
T o si m plif y t he n u m ber of 
assess me nts ti me p oi nts. T he data 
e ntr y f or s ocial fact ors is re petiti ve 
a n d c u m ulati ve data wil l be 
ca pt ure d at t he Da y  
a n d Da y
visits. Re peate d wei g ht e ntries d o 
n ot i m pact d osi n g, as d osi n g is 
deter mi ne d base d o n baseli ne 
wei g ht. 
Secti o n 1. 3. 1 S o A
R e mo ve d Rec or d R S V relate d 
Me dical Visits
o n Da ys 2 a n d 3.
T o si m plif y st u d y pr oce d ures
Sec ti o n 1. 3. 1 S o A
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
Re d uce d c ollecti o n of S p O 2 t o o nce 
dail y f or h os pitalize d partici pa nts .
T o be c o nsiste nt wit h R S V 
si g ns/s y m pt o ms c ollecti o n w hic h 
is o nl y o nce dail y.
A d de d t o t he n otes f or St u d y Kit 
dis pe nse d fr o m I R T a n d 
pare nt(s) /le gal g uar dia n i nstr ucte d
o n it s use – “ If pare nt or le gal 
g uar dia n is all o we d t o a d mi nister 
st u d y dr u g w hile h os pitalize d, per 
l ocal re g ulati o ns, trai ni n g s h o ul d 
occ ur pri or t o pare nt or le gal 
g uar dia n st u d y dr u g 
a d mi nistrati o n. ”
T o pr o vi de a d diti o nal pr ot oc ol 
clarificati o n.
Secti o n 1. 3. 1 S o A
Delete d Ta ble 4 C o m plete d 
Sis u nat o vir cli nical st u dies a n d 
Ta ble 5 O ver vie w  of o n g oi n g 
cli nical st u dies a n d i nserte d b ullet 
p oi nts s u m marizi n g t he 7 o n g oi n g 
Sis u nat o vir cli nical st u dies.
C ha n ge d t he state me nt – “ T he 
t h or o u g h Q T st u d y ( C 5 2 4 1 0 1 5) 
de m o nstrate d t hat t he c o nce ntrati o n 
res p o nse a nal yses bet wee n 
sis u nat o vir e x p os ure ( w hic h c o ver a 
c o nce ntrati o n ra n ge u p t o 
a p pr o xi matel y 1. 2 -f ol d t he hi g h 
cli nical e x p os ure a n d 3. 5 -f ol d t he 
pr ojecte d t hera pe utic mea n C ma x 
c o nce ntrati o n st u die d i n P hase 1/ 2 
st u dies), t he ∆∆Q Tc F, a n d H R di d 
n ot i de ntif y si g nal of p ote ntial 
cli nical c o ncer n ( P M A R-E Q D D -
C 5 2 4 b -Pr e -P o c -1 6 6 4)” 
T o: “ T he c o nce ntrati o n res p o nse 
a nal yses di d n ot i de ntif y a Q T 
pr ol o n gati o n si g nal of p ote ntial 
cli nical c o ncer n ( P M A R-E Q D D -
C 5 2 4 b -Pr e -P o c -1 6 6 4).”
T o si m plif y t he pr ot oc ol a n d 
refere nce I B ( versi o n 3, 0 1 Marc h 
2 0 2 4) .
Secti o n 2. 2. 4 Cli nical O ver vie w
A d de d – ( n ot c o u nti n g t he 1 2 
partici pa nts fr o m t he palata bilit y 
st u d y w h o di d n ot s wall o w 
sis u nat o vir).
U p date d t he state me nt – “ T he m ost 
c o m m o nl y re p orte d treat me nt 
relate d T E A Es i n a d ults were i n t he 
GI dis or ders S yste m Or ga n Class:
na usea, diarr hea , a n d a b d o mi nal 
pai n” 
T o: “ T h e m ost c o m m o nl y re p orte d 
all ca usalit y treat me nt relate d 
T E A Es ( ≥1 0 partici pa nts) i n t he 
T o ali g n wit h t he u p date d I B
( versi o n 3, 0 1 Marc h 2 0 2 4) .
Secti o n 2. 2. 4 Cli nical O ver vie w
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
m ulti ple d ose st u dies wit h 
sis u nat o vir i n a d ults were: diarr hea, 
na usea, a b d o mi nal pai n, a n d 
hea dac he .”
A d de d: T he preli mi nar y res ults 
fr o m a D DI st u d y of sis u nat o vir 
ta blets (a d ult f or m ulati o n) i n 
c oa d mi nistrati o n wit h a n aci d 
re d uci n g a ge nt s h o we d a 
si gnifica ntl y re d uce d plas ma 
e x p os ure ( C 5 2 4 1 0 1 7). T hese ne w 
fi n di n gs d o n ot re prese nt a safet y 
c o ncer n; h o we ver, t he re d uce d 
plas ma e x p os ure ma y ha ve a 
p ote ntial i m pact o n t he efficac y of 
sis u nat o vir ta blets.
A d de d - “If t he st u d y partici pa nt is 
h os pitalize d at t he ti me of 
e nr ol me nt a n d it is i de ntifie d t hat 
t he y ( he/s he) c o ul d n ot atte n d t he 
D a y   a n d/ or Da y  visits if 
disc har ge d, t he i n vesti gat or ma y at 
t heir ( his/ her) discreti o n, if l ocal 
re g ulati o ns all o w a n d
ser vices are n ot a vaila ble, kee p t he 
partici pa nt i n t he h os pital f or 
c o n ve nie nce t o e ns ure Da y  a n d/ or 
D a y   assess me nts ca n be 
c o n d ucte d i n c o m plia nce wit h 
pr ot oc o l re q uire me nts.”
T o all o w  sites fle xi bilit y t o 
c o n d uct Da y   a n d/ or Da y  visits 
i n or der t o c o n d uct st u d y 
assess me nts , at i n vesti gat or 
discreti o n, if l ocal re g ulati o ns 
all o w a n d if 
 ser vices 
are u na vaila ble.
Secti o n 6. 5 St u d y I nter ve nti o n 
C o m pl ia nce
U p date d hea der fr o m “Pr o hi bite d 
D uri n g t he St u d y ” t o “Pr o hi bite d 
D uri n g t he  Da y St u d y Dr u g 
A d mi nistrati o n. ”
T o re m o ve d u plicati o n a n d 
i mpr o ve clarit y.
Secti o n 6. 9 Pri or a n d 
C o n c o mita nt T hera p y
Delete d - C ortic oster oi ds e q ui vale nt 
t o pre d nis o ne ≥2 m g/ k g dail y 
i nitiate d f or at least 1 4 c o nsec uti ve 
da ys wit hi n 3 0 da ys pri or t o st u d y 
start a n d d uri n g st u d y dr u g 
a d mi nistrati o n.
N ot a p plica ble. Partici pa nts w o ul d 
ha ve bee n e xcl u de d at scree ni n g. 
Secti o n 6. 9 Pri or a n d 
C o nc o mita nt T hera p y
A d de d – “ f or res pirat or y tract 
i nfecti o n” t o A nti viral a n d delete d –
“ d uri n g t he d osi n g peri o d of t he 
st u d y” a n d “ d uri n g st u d y treat me nt 
peri o d” fr o m s o me of t he liste d 
wa s h o ut peri o d of t he pr o hi bite d 
me dicati o ns.
T o pr o vi de a d diti o nal pr ot oc ol 
clarificati o n.
Secti o n 6. 9 Pri or a n d 
C o nc o mita nt T hera p y
Delet e d “ 3. 6 m L f or 
 
” s o t hat t otal bl o o d sa m pli n g 
v ol u me will be a p pr o xi matel y 3. 9 
m L f or all c o h orts.
U p date d t otal v ol u me of bl o o d 
dr a w n fr o m 4. 6 m L t o 3. 9 m L.
T o ali g n wit h t he u p date s ma de i n 
Secti o n s 1. 3. 2. a n d 1 0. 2 .
Secti o n 8. 1 A d mi nistrati ve & 
Baseli ne Pr oce d ures
Secti o n 8. 3. 4 Cli nical Safet y 
La b orat or y Assess me nts .
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
Re m o ve d – Gl uc ose (ra n d o m) fr o m 
Ta ble 1 0 a n d Lactate de h y dr o ge nase 
( L D H). A d de d L D H t o DI LI 
assess me nt tests.
T o re d uce bl o o d dra w  v ol u me
re q uire d i n t he st u d y. If t here is 
c o ncer n f or he patic i nj ur y, L D H is 
n o w  i ncl u de d i n list of la b orat or y 
assess me nts t o be c o n d ucte d.
Secti o n 1 0. 2, A p pe n di x 2 
Cli nical La b orat or y Tests
U p date d t he f o ot n oti n g o n Ta ble 8
Pr ot oc ol clarifica ti o n a n d 
c o nsiste nc y.
Secti o n 1 0. 2, A p pe n di x 2 
Cli nical La b orat or y Tests
A d de d – “ A d diti o nall y, 
a d mi nistrati o n of pr ot o n p u m p 
i n hi bit ors m ust ha ve e n de d 5 da ys 
pri or t o ra n d o mizati o n a n d 
a d mi nistrati o n of H 2 bl oc kers m ust 
ha ve e n de d at least 1 2 h o urs pri or t o 
ra n d o mizati o n. T he use of a ntaci ds 
is all o we d wit h sta g gere d d osi n g (ie, 
n ot wit hi n 3 h o urs of st u d y dr u g 
a d mi nistrati o n). A n y a d mi nistrati o n 
of pr ot o n p u m p i n hi bit ors or H 2 
bl oc kers is pr o hi bite d d uri n g
treat me nt wit h sis u nat o vir.”
Base d o n preli mi nar y res ults fr o m 
a D DI st u d y ( C 5 2 4 1 0 1 7) of 
sis u nat o vir ta blets i n 
c oa d mi nistrati o n wit h a ntaci ds t hat 
s h o we d si g nifica ntl y re d uce d 
sis u nat o vir plas ma e x p os ure.
Secti o n 1 0. 8 A p pe n di x 8 
Pr o hi bite d C o nc o mita nt 
Me dicati o ns T hat Ma y Res ult 
i n D DI
U p date d – “ F or t he pr oce d ures 
bel o w , t he f oll o wi n g c hr o n ol o g y of 
e ve nts are pr o p ose d ” t o “F or t he 
pr oce d ures bel o w , t he f oll o wi n g 
c hr o n ol o g y of e ve nts are s u g geste d, 
b ut ca n be m o difie d base d o n 
i n vesti gat or discreti o n a n d
a d here nce t o I M P d osi n g i nter val .”
T he hea d er wa s u p date d t o re m o ve 
“Pr o p ose d” a n d a d de d 
“( S u g geste d)”. A d de d i n t he te xt
wa s “scree ni n g o nl y” t o 1 2 lea d 
E C G.
T o clarif y t hat t hese are s u g geste d 
a n d d o n o t nee d t o be f oll o w e d .
Secti o n 1 0. 1 0. 3. A p pe n di x 1 0 C
C hr o n ol o g y of Pr oce d ure s
( S u g geste d)
Se veral a d diti o nal mi n or e dit orial 
c ha n ges were ma de.
T o i m pr o ve clarit y a n d rea da bilit y 
a n d f or mai ntai ni n g c o nsiste nc y 
t hr o u g h o ut t he d oc u me nts.
T hr o u g h o ut Pr ot oc ol
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7
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 .................................................................................................................... 2 3
1. 2. 1. C o h ort De tails............................................................................................. 2 4
1. 3. Sc he d ule of Acti vities ............................................................................................. 2 7
1. 3. 1. S o A ............................................................................................................. 2 7
1. 3. 2. M ulti ple D ose P K Da y s ( F or All C o h orts) ................................................. 3 3
2. I N T R O D U C TI O N ............................................................................................................... 3 4
2. 1. St u d y  Rati o nale ....................................................................................................... 3 4
2. 2. Bac k gr o u n d ............................................................................................................. 3 4
2. 2. 1. N o ncli nical P har mac ol o g y .......................................................................... 3 5
2. 2. 2. N o ncli nical P har mac o ki netics a n d Meta b olis m ......................................... 3 5
2. 2. 3. N o ncli nical Safet y ...................................................................................... 3 6
2. 2. 4. Cli nical O ver vie w ....................................................................................... 3 6
2. 3. Be nefit/ Ris k Assess me nt ......................................................................................... 3 9
2. 3. 1. Ris k Assess me nt ......................................................................................... 4 0
2. 3. 2. Be nefit Assess me nt ..................................................................................... 4 3
2. 3. 3. O verall Be nefit/ Ris k C o ncl usi o n ................................................................4 3
3. O BJ E C TI V E S, E N D P O I N T S, A N D E S TI M A N D S ........................................................... 4 3
4. S T U D Y D E SI G N ................................................................................................................. 4 4
4. 1. O verall Desi g n ......................................................................................................... 4 4
4. 1. 1. D ose Fi n di n g a n d St o p pi n g R ules ..............................................................4 6
4. 2. Scie ntific Rati o nale f or St u d y  Desi g n..................................................................... 4 7
4. 2. 1. Patie nt I n p ut I nt o Desi g n ............................................................................ 4 8
4. 2. 2. Di versit y  of St u d y P o p ulati o n .................................................................... 4 8
4. 2. 3. Rati o nale f or C o m parat or ...........................................................................4 9
4. 3. J ustificati o n f or D ose ..............................................................................................4 9
4. 4. E n d of St u d y  Defi niti o n .......................................................................................... 5 0
5. S T U D Y P O P U L A T I ON ......................................................................................................5 0
5. 1. I ncl usi o n Criteria ..................................................................................................... 5 1
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8
5. 2. E xcl usi o n Criteria .................................................................................................... 5 2
5. 3. Li fest yle C o nsi derati o ns.......................................................................................... 5 5
5. 4. Scree n Fail ures ........................................................................................................ 5 5
5. 5. Criteria f or Te m p oraril y  Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/ A d mi nistrati o n of St u d y  Inter ve nti o n ........................... 5 5
6. S T U D Y I N T E R V E N TI O N( S) A N D C O N C O MI T A N T T H E R A P Y ................................. 5 5
6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d ........................................................................ 5 5
6. 1. 1. A d mi nistrati o n ............................................................................................ 5 7
6. 2. Pre parati o n, Ha n dli n g, St ora ge, a n d Acc o u nta bilit y ............................................... 5 8
6. 2. 1. Pre parati o n a n d Dis pe nsi n g ........................................................................ 5 9
6. 3. Assi g n me nt t o St u d y I nter ve nti o n ........................................................................... 6 0
6. 4. Bli n di n g ................................................................................................................... 6 0
6. 4. 1. Bli n di n g of Partici pa nts .............................................................................. 6 1
6. 4. 2. Bli n di n g of Site Pers o n nel .......................................................................... 6 1
6. 4. 3. Bli n di n g of t he S p o ns or .............................................................................. 6 1
6. 4. 4. Se nsiti ve Cli nical Data ............................................................................... 6 1
6. 4. 5. Brea ki n g t he Bli n d ...................................................................................... 6 1
6. 5. St u d y  Inter ve nti o n C o m plia nce ............................................................................... 6 1
6. 6. D ose M o dificati o n ................................................................................................... 6 2
6. 7. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d of t he St u d y ...................... 6 2
6. 8. Treat me nt of O ver d ose ............................................................................................ 6 2
6. 9. Pri or a n d C o nc o mita nt T hera p y .............................................................................. 6 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 ........................................................................... 6 4
7. 1. Disc o nti n uati o n of St u d y  Inter ve nti o n .................................................................... 6 4
7. 1. 1. P ote ntial Cases of Ac ute Ki d ne y  Inj ur y ..................................................... 6 5
7. 1. 2. L i ver I nj ur y.................................................................................................6 6
7. 1. 3. E C G C ha n ges ..............................................................................................6 7
7. 1. 4. C O VI D -1 9 ................................ ..................................................................6 7
7. 2. Partici pa nt Disc o nti n uati o n/ Wit h dra wal Fr o m t he St u d y .......................................6 7
7. 2. 1. Wit h dra wal of C o nse nt ...............................................................................6 8
7. 3. L ost t o F oll o w -U p ................................................................................................... 6 8
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S ...............................................................6 9
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9
8. 1. A d mi nistrati ve a n d Baseli ne Pr oce d ures ................................................................. 6 9
8. 1. 1. Baseli ne Pr oce d ures .................................................................................... 7 0
.................................................................................... 7 0
.................................................................................... 7 1
8. 2. Efficac y  Assess me nts..............................................................................................7 1
8. 2. 1. Si g ns a n d S y m pt o ms of R S V ..................................................................... 7 1
8. 2. 2. D osi n g a n d Palata bilit y  q uesti o n naire (e Diar y).......................................... 7 1
8. 3. Safet y Assess me nts ................................................................................................. 7 1
8. 3. 1. P h y sical E xa mi nati o ns ................................................................................ 7 1
8. 3. 2. Vital Si g ns .................................................................................................. 7 2
8. 3. 2. 1. Bl o o d Press ure a n d P ulse Rate / Heart Rate ............................. 7 2
8. 3. 2. 2. Te m perat ure a n d Res pirat or y  Rate............................................ 7 2
8. 3. 2. 3. O x y ge n Sat urati o n ..................................................................... 7 2
8. 3. 3. Electr ocar di o gra ms ..................................................................................... 7 3
8. 3. 4. Cli nical Safet y  La b orat or y Assess me nts.................................................... 7 4
8. 3. 4. 1. Alter nati ve Facilities f or Cli nical Safet y  La b orat or y 
Assess me nt ........................................................................................7 6
8. 3. 5. Me dicall y  Atte n de d Visits.......................................................................... 7 6
8. 4. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her Safet y Re p orti n g ................. 7 6
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y  f or C ollecti n g A E a n d S A E I nf or mati o n....... 7 6
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer Safet y ............................................... 7 7
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F ................... 7 7
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es .......................................................... 7 7
8. 4. 3. F oll o w -U p of A Es a n d S A Es ...................................................................... 7 8
8. 4. 4. Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es...........................................7 8
8. 4. 5. E n vir o n me ntal E x p os ure, E x p os ure D uri n g Pre g na nc y  or 
Breastfee di n g, a n d Occ u pati o nal E x p os ure ..................................................... 7 8
8. 4. 5. 1. E x p os ure D uri n g Pre g na nc y ...................................................... 7 9
8. 4. 5. 2. E x p os ure D u ri n g Breastfee di n g ................................................ 8 0
8. 4. 5. 3. Occ u pati o nal E x p os ure ............................................................. 8 0
8. 4. 6. Car di o vasc ular a n d Deat h E ve nts ...............................................................8 0
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 .............................................................................. 8 1
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0
8. 4. 8. A d verse E ve nts of S pecial I nterest............................................................. 8 1
8. 4. 8. 1. Lac k of Eff icac y........................................................................ 8 1
8. 4. 9. Me dical De vice Deficie ncies ...................................................................... 8 1
8. 4. 1 0. Me dicati o n Err ors ..................................................................................... 8 1
8. 5. P har mac o ki netics .................................................................................................... 8 2
8. 6. G e netics ................................................................................................................... 8 3
8. 6. 1. S pecifie d Ge netics ...................................................................................... 8 3
8. 7. Bi o mar kers .............................................................................................................. 8 3
8. 7. 1. P har mac o d y na mic Bi o mar kers ................................................................... 8 3
8. 7. 2. S pecifie d Ge ne E x pressi o n ( R N A) Researc h ............................................. 8 4
8. 7. 3. S pecifie d Pr otei n Researc h ......................................................................... 8 4
8. 7. 4. S pecifie d Meta b ol o mic Researc h ...............................................................8 4
8. 7. 5. Retai ne d Researc h Sa m ples f or Bi o mar kers ............................................... 8 4
8. 8. I m m u n o ge nicit y Assess me nts ................................................................................. 8 4
8. 9. Healt h Ec o n o mics ................................................................................................... 8 4
9. S T A TI S TI C A L C O N SI D E R A TI O N S ................................................................................ 8 4
9. 1. Statistical H y p ot heses ............................................................................................. 8 4
9. 2. A nal y sis Sets ........................................................................................................... 8 5
9. 3. Statistical A nal y ses ................................................................................................. 8 5
9. 3. 1. Ge neral C o nsi derati o ns ............................................................................... 8 5
9. 3. 2. Pri mar y  E n d p oi nt(s).................................................................................... 8 6
9. 3. 3. Sec o n dar y  E n d p oi nt(s)/ Esti ma n d(s) A nalys is............................................ 8 6
9. 3. 4. Tertiar y / E x pl orat or y E n d p oi nt(s) A nal ys is ................................................ 8 6
9. 3. 5. Safet y A nal ys es ..........................................................................................8 6
9. 3. 6. Ot her A nal ys es ............................................................................................ 8 7
9. 3. 6. 1. Bi o mar ker Assess me nt ..............................................................8 7
9. 4. I nteri m A nal ys es ..................................................................................................... 8 7
9. 5. Sa m ple Size Deter mi nati o n ..................................................................................... 8 7
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L 
C O N SI D E R A TI O N S .......................................................................................................... 8 9
1 0. 1. A p pe n di x 1: Re g ulat or y , Et hical, a n d St u d y O versi g ht C o nsi derati o ns............... 8 9
1 0. 1. 1. Re g ulat or y a n d Et hical C o nsi derati o ns ....................................................8 9
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1
1 0. 1. 1. 1. Re p orti n g of Safet y  Iss ues a n d Seri o us Breac hes of t he 
Pr ot oc ol or I C H G C P .........................................................................8 9
1 0. 1. 2. Fi na ncial Discl os ure ................................................................................. 9 0
1 0. 1. 3. I nf or me d C o nse nt/ Asse nt Pr ocess ............................................................ 9 0
1 0. 1. 3. 1. Electr o nic C o nse nt .................................................................. 9 1
1 0. 1. 4. Data Pr otecti o n ......................................................................................... 9 1
1 0. 1. 5. C o m mittees Str uct ure ............................................................................... 9 2
1 0. 1. 5. 1. Data M o nit ori n g C o m mittee ................................................... 9 2
1 0. 1 . 6. Disse mi nati o n of Cli nical St u d y Data ......................................................9 2
1 0. 1. 7. Data Q ualit y Ass ura nce ............................................................................ 9 3
1 0. 1. 8. S o urce D oc u me nts .................................................................................... 9 5
1 0. 1 . 9. Use of Me dical Rec or ds............................................................................9 5
1 0. 1. 1 0. St u d y  a n d Site Start a n d Cl os ure ............................................................ 9 6
1 0. 1. 1 1. P u blicati o n P olic y ................................................................................... 9 6
1 0. 1. 1 2. S p o ns or’s Me dicall y  Q ualifie d I n di vi d ual..............................................9 7
1 0. 2. A p pe n di x 2: Cli nical La b orat or y  Tests................................................................. 9 8
1 0. 3. A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E val uati n g, F oll o w -U p, a n d Re p orti n g ..................................................................... 9 9
1 0. 3. 1. Defi niti o n of A E ....................................................................................... 9 9
1 0. 3. 2. Defi niti o n of a n S A E .............................................................................. 1 0 0
1 0. 3. 3. Rec or di n g/ Re p orti n g a n d F oll o w -U p of A Es a n d/ or S A Es D uri n g 
t he Acti ve C ollecti o n Peri o d.......................................................................... 1 0 1
1 0. 3. 4. Re p orti n g of S A Es .................................................................................. 1 0 5
1 0. 4. A p pe n di x 4: Ge netics .......................................................................................... 1 0 6
1 0. 5. A p pe n di x 5: L i ver Safet y: S u g geste d Acti o ns a n d F oll o w-U p Assess me nts ..... 1 0 6
1 0. 6. A p pe n di x 6: Ki d ne y  Safet y M o nit ori n g G ui deli nes ........................................... 1 1 0
1 0. 6. 1. La b orat or y  Assess me nt of C ha n ge i n Ki d ne y F u ncti o n a n d 
Detecti o n of Ki d ne y  Inj ur y ............................................................................ 1 1 0
1 0. 6. 2. A ge -S pecific Ki d ne y  F u ncti o n Calc ulati o ns..........................................1 1 0
1 0. 6. 3. A d vers e E ve nt Gra di n g f or Ki d ne y Safety La b orat or y  
A b n or malities ................................................................................................. 1 1 2
1 0. 7. A p pe n di x 7: E C G Fi n di n gs of P ote ntial Cli nical C o ncer n ................................. 1 1 4
1 0. 8. A p pe n di x 8: Pr o hi bite d C o nc o mita nt Me dicati o ns T hat Ma y  Res ult i n D DI..... 1 1 5
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2
1 0. 9. A p pe n di x 9: C o u ntr y  S pecific Re q uire me nts...................................................... 1 1 9
1 0. 9. 1. Ar ge nti na ................................................................................................ 1 1 9
1 0. 1 0. A p pe n di x 1 0: Pr ot oc ol S pecific A p pe n dices .................................................... 1 2 0
1 0. 1 0. 1. A p pe n di x 1 0 A: Si g ns a n d S y m pt o ms Attri b uta ble t o R S V .................. 1 2 0
1 0. 1 0. 2. A p pe n di x 1 0 B: Bac k gr o u n d a n d S ocial Fact ors ................................... 1 2 0
1 0. 1 0. 3. A p pe n di x 1 0 C: C hr o n ol o g y  of Pr oce d ures ( S u g geste d) ...................... 1 2 1
1 0. 1 0. 4. A p pe n di x 1 0 D: D osi n g a n d Palata bilit y  Q uesti o n naire (e Diar y)......... 1 2 2
1 0. 1 1. A p pe n di x 1 1: Pr ot oc ol A me n d me nt Hist or y ..................................................... 1 2 5
1 0. 1 2. A p pe n di x 1 2: A b bre viati o ns ............................................................................. 1 4 1
1 1. R E F E R E N C E S ................................................................................................................ 1 4 7
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3
LI S T O F T A B L E S
Ta ble 1.
C o h ort Details ...........................................................................................2 4
Ta ble 2.
S o A ........................................................................................................... 2 7
Ta ble 3.
M ulti ple D ose P K Da y s ( F or All C o h orts) ............................................... 3 3
Ta ble 4.
C o h ort 1 D ose Rec o m me n dati o ns ............................................................ 5 0
Ta ble 5.
Differe ntiati n g DI KI a n d DI CI  i n Pe diatric Partici pa nts.......................... 6 6
Ta ble 6.
Bl o o d Dra w All o wa nces f or Eac h A ge Ba n d ........................................... 7 5
Ta ble 7.
V ol u me ( m L) of Bl o o d t o be Dra w n fr o m Partici pa nts i n All 
C o h orts ...................................................................................................... 7 5
Ta ble 8.
Pr ot oc ol Re q uire d La b orat or y  Assess me nts............................................. 9 8
Ta ble 9.
Ser u m creati ni ne refere nce val ues t o assess ki d ne y f u ncti o n i n 
ne o nates a n d i nfa nts < 1 y ear of a ge [ 1 7] ............................................... 1 1 1
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4
1. P R O T O C O L S U M M A R Y 
1. 1. S y n o psis
Pr ot oc ol Title :
A n i nter ve nti o nal, P hase 1 b , ra n d o mize d, d o u ble-bli n d, s p o ns or -o pe n, place b o -c o ntr olle d, 
m ulti -ce nter, d ose-fi n di n g st u dy t o e val uate safet y, t olera bilit y, a n d p har mac o ki netics of 
sis u nat o vir i n pe diatric partici pa nts u p t o a ge 6 0 m o nt hs wit h Res pirat or y  S yn c y tial Vir us 
( R S V) Lo wer R es pirat or y Tract I nfecti o n ( L R TI).
Brief Title :
A St u d y  t o Lear n A b o ut t he Safety, T olera bilit y a n d Bl o o d L e vels of a St u d y  Me dici ne 
(calle d sis u nat o vir) i n I nfa nts a n d C hil dre n wit h R S V Lo wer Res pirat or y  Tract I nfecti o n.
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:
1 4 3 4 7 9
E U C T N u m ber:
2 0 2 3 -5 0 4 4 2 5 -3 9 -0 0
Cli nic al Tri als. g o v I D:  
N C T 0 6 1 0 2 1 7 4
Pe di atric I n vesti g ati o n al Pl a n N u m ber:
PI P: E M E A -0 0 2 5 2 9 -PI P 0 1 -1 8
Pr ot oc ol N u m ber:
C 5 2 4 1 0 0 9
P h ase:
P hase 1 b
R ati o n ale:
T he p ur p ose of t his st u d y is t o esta blis h safet y, t olera bilit y, p har mac o ki netic (P K ) a n d 
g ui da nce f or d osi n g of sis u nat o vir i n a pe diatric p o p ulati o n ( 1 da y  t o 6 0 m o nt hs of a ge) wit h 
R S V -L R TI , f or f urt her cli nical de vel o p me nt of sis u nat o vir. Palata bilit y assess me nts will als o 
be c o n d ucte d t o ai d i n t he de vel o p me nt of pe diatric f or m ulati o ns of sis u nat o vir. 
O bjecti ves, E n d p oi nts, a n d Esti m a n ds:
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y: 
Pri m ar y:
Pri m ar y:

T o e val uate t he safet y a n d t olera bilit y 
of sis u nat o vir c o m pare d t o place b o i n 
partic ipa nts wit h R S V -L R TI.

I nci de nce of T E A Es.

I nci de nce of A Es a n d S A Es 
lea di n g t o disc o nti n uati o ns.

I nci de nce of cli nicall y si g nifica nt 
a b n or mal la b orat or y val ues a n d
vital si g ns.

N ot 
a p plica ble
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 5
O bjecti ves
E n d p oi nts
Esti m a n ds
Sec o n d ar y: 
Sec o n d ar y:
Sec o n d ar y:

T o c haracterize t he P K of sis u nat o vir i n 
partici pa nts wit h R S V -L R TI.

Plas ma c o nce ntrati o ns of 
sis u nat o vir at stea d y state ( Da y
or later).

N ot 
a p plica ble
A b bre viati o ns: A E(s) = a d verse e ve nt(s); L R TI = l o w er res pirat or y tract i nfecti o n; P K = p har mac o ki netic(s); 
R S V = res pirat or y s y nc ytial vir us; S A E(s) = seri o us a d verse e ve nt(s); T E A E = treat me nt e mer ge nt a d verse 
e ve nt;
O ver all Desi g n:
T his st u d y  is a ra n d o mize d, d o u ble-bli n d, s p o ns or -o pe n, place b o -c o ntr olle d, m ultice nter 
st u d y i n R S V-i nfecte d o ut patie nt a n d h os pitalize d ne o nates, i nfa nts , a n d c hil dre n, 1 da y u p t o 
6 0 m o nt hs of a ge wit h R S V -L R TI . T his is a d ose fi n di n g st u d y t o e val uate t he P K, safety,
a n d t olera bilit y of sis u nat o vir. 
 
 

C o h ort s 1 a n d 2:
A:
B: 
C: 
D:

C o h ort 3 :
E :
F :
B :
D
Alt h o u g h ne o nates are defi ne d b y  t he W orl d Healt h Or ga nizati o n ( W H O ) as 0-2 7 da y s ol d, 
 
Sis u nat o vir or place b o will be a d mi nister e d e ver y 
(
i n a 
 rati o, f or a peri o d 
of 
f or all c o h orts. Sis u nat o vir d oses e x pecte d t o 
pr o d uce s ys te mic stea d y-state e x p os ures c o m para ble t o t he
a d ult d ose will be 
e val uate d i n d osi n g C o h ort 1.
Base d o n a nal ys is of P K a n d safety data fr o m C o h ort 1, o pti o nal C o h ort 2 ( 2 A, 2 B, 2 C, 2 D) 
ma y  be use d f or f urt her d ose refi ne me nt t o m ore cl osel y matc h t he
 i n a d ults or 
t o gat her a d diti o nal data o n d oses use d i n C o h ort 1 . O nl y   
will be e nr olle d 
i n 
 T he o pti o nal C o h ort 3 ( 3 E , 3 F , 3 B , 3 D) ma y be use d if a d diti o nal 
e x p os ure, safet y, or t olera bilit y  data f or a gi ve n d ose i n o ne or m ore of t he
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 6
is nee de d. T he 
i n C o h ort 3 f oc us o n t h ose a ges m ost s usce pti ble  
(less t ha n 
). Eac h c o h ort will e nr oll 
partici pa nts i n eac h d ose gr o u p (
acti ve:
place b o). I n case of recr uit me nt c halle n ges f or 
a n y c o h ort i n t he st u d y, a mi ni m u m of
partici pa nts will be e nr olle d (
acti ve:
place b o).
T he S p o ns or will ma ke t he fi nal decisi o n of d oses f or t he c o h orts , i ncl u di n g rec o m me n dati o n
t o re peat a d ose or o pe ni n g e nr oll me nt of t he s u bse q ue nt c o h ort. A n i n de pe n de nt e xter nal 
data m o nit ori n g c o m mittee ( E -D M C) will re vie w t he u n bli n de d safet y a n d c o nce ntrati o n data 
after c o m pleti o n of Da y 
 visit f or eac h c o h ort (a p pr o xi matel y
partici pa nts ,  partici pa nts 
if t here are recr uit me nt c halle n ges) t o e ns ure t he safety of partici pa nts. T he E -D M C a p pr o val 
of t he S p o ns or’ s rec o m me n dati o n will be i n de pe n de ntl y assesse d f or eac h of t he differe nt a ge 
gr o u ps a n d will be base d o n t he safet y/ t olera bility a n d c o nce ntrati o n data ( ie, c o h orts 
). If S p o ns or rec o m me n ds re peati n g t he d ose, a n a d diti o nal
partici pa nts recei vi n g acti ve dr u g a n d
place b o ma y  be e nr olle d i n t he sa me a ge gr o u p 
wit hi n t he sa me c o h ort.  
Partici pa nts ma y  be re place d at S p o ns or discreti o n f or t he f oll o wi n g reas o ns: if t he 
partici pa nt’s pare nt(s)/le gal g uar dia n wit h dra ws c o nse nt, if t he partici pa nt misses a n y  d ose 
bef ore pr o vi di n g t he 
 sa m ple o n Da y
or
 if t he partici pa nt misses 
a n y P K sa m ples, if t he I M P is disc o nti n ue d, if t he partici pa nt’s R S V test res ult at scree ni n g 
are n ot c o nfir me d b y t he ce ntral la b orat or y R S V test res ult , if partici pa nt was e x p ose d t o a 
pr o hi bite d c o nc o mita nt me dicati o n or if Da y  1 R S V R N A le vel b y R T-q P C R is less t ha n t he 
l o wer li mit of q ua ntificati o n.
N u m ber of P artici p a nts:
A p pr o xi matel y  a ma xi m u m of 1 0 8 e val ua ble partici pa nts 
i n eac h c o h ort +
a d diti o nal i n 
eac h c o h ort if necessar y) a n d mi ni m u m of a p pr o xi matel y
e val ua ble partici pa nts will be 
e nr olle d ( base d o n a mi ni m u m of
partici pa nts per c o h ort) a n d recei ve st u d y i nter ve nti o n.
N ote: " E nr olle d" mea ns a partici pa nt ’s, or t heir pare nt(s)/le gal g uar dia n’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 n d 
ra n d o mizati o n. 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 after scree ni n g. P ote ntial partici pa nts 
w h o are scree ne d f or t he p ur p ose of de ter mi ni n g eli gi bilit y f or t he st u dy, b ut d o n ot 
partici pate i n t he st u d y, are n ot c o nsi dere d e nr olle d, u nless ot her wise s pecifie d b y t he 
pr ot oc ol. 
St u d y P o p ul ati o n:
K e y  incl usi o n a n d e xcl usi o n criteria are liste d bel o w .
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 7
I ncl usi o n Criteri a 
Partici pa nts m ust meet t he f oll o wi n g ke y  i ncl usi o n criteria t o be eli gi ble f or e nr oll me nt i nt o 
t he st u d y:
1.
Partici pa nts 1 d a y  t o ≤6 0 m o nt hs of a ge a n d wei g ht ≥2. 5 k g t o ≤2 3 k g.
2.
A p ositi ve R S V dia g n ostic test wit h res ult a vaila ble i n s o urce d oc u me nt t o c o nfir m 
eli gi bilit y eit her acc or di n g t o r o uti ne site practice or I n vesti gat or sites ma y use R S V 
p oi nt - of-care (P O C ) test kits t hat are pr o vi de d f or t his st u d y. R S V dia g n ostic test , a nti ge n 
or m olec ular test is acce pta ble, a n d s h o ul d be c ollecte d wit hi n
h o urs of ra n d o mizati o n.
3.
E vi de nce of L R TI b y t he prese nce of ≥1 fr o m a n y of t he f oll o wi n g 4 cate g ories (a 
t hr o u g h d):
a.
I ncrease d res pirat or y rate f or a ge:

< 2 m o nt hs: ≥6 0 b p m

≥2 t o < 1 2 m o nt hs: ≥5 0 b p m

≥1 2 t o ≤6 0 m o nt hs: ≥4 0 b p m
b.
S p O 2 < 9 5 % o n r o o m air
c.
I ncrease d res pirat or y eff ort as e vi de nce d b y ≥1 of t he f oll o wi n g:

Gr u nti n g wit h e x pirati o n

Nasal flari n g

Retracti o ns
d.
O ne or m ore of t he f oll o wi n g e xa m fi n di n gs o n a usc ultati o n:

W heezi n g

R h o nc hi

Rales or crac kles
4.
R S V -relate d si g ns a n d/ or s ym pt o ms m ust be prese nt f or ≤
d a y s at ti me of 
ra n d o mizati o n. 
E xcl usi o n Criteri a 
Partici pa nts wit h a n y  of t he f oll o wi n g c haracteristics/c o n diti o ns will be e xcl u de d:
1.
Pre mat ure i nfa nts ( gestati o nal a ge less t ha n 3 5 wee ks) A N D < 1 y ear of p ost -natal a ge. 
N ote: I nfa nts 3 5 - a n d 3 6- wee k gestati o nal a ge are per mitte d if t he y  wei g h at least 2. 5 k g 
a n d are at least 2 m o nt hs p ost -natal a ge. 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 8
2.
 wit h i ntra uteri ne gr o wt h restricti o n defi ne d by ha vi n g 3 or 
m ore of t he f oll o wi n g: 

Birt h wei g ht < 1 0t h perce ntile o n p o p ulati o n -base d or c ust o mize d gr o wt h c harts 

Hea d circ u mfere nce < 1 0t h perce ntile 

Le n gt h < 1 0t h perce ntile  

Pre natal dia g n osis of fetal gr o wt h restricti o n

Mater nal pre g na nc y  i nf or mati o n ass ociate d wit h fetal gr o wt h restricti o n (e g, 
mater nal h y perte nsi o n, pr e-ecla m psia)
3.
A n y  cli nicall y si g nifica nt electr ocar di o gra m ( E C G) a b n or mality i n a partici pa nt's me dical 
hist or y , or i n t he pre -d ose E C G t hat per i n vesti gat or j u d ge me nt ma y  affect partici pa nt 
safety or i nter pretati o n of st u d y res ults. N ote: If si n us tac h y cardia is prese nt, a n d n ot 
w orse t ha n e x pecte d d ue t o t he u n derl y i n g disease, partici pa nt ma y be c o nsi dere d at 
i n vesti gat or discreti o n, if t he si n us tac h ycar dia is n ot e x pecte d t o i nterfere wit h 
e val uati o n of res p o nse t o st u d y i nter ve nti o n.
4.
K n o w n hist or y  of he patic disease, c o ncer n f or acti ve ac ute or c hr o nic viral he patitis, or 
ac ute he patic fail ure. 
5.
Partici pa nts >
da y s o nl y: K n o w n hist or y of as partate a mi n otra nsferase ( A S T ), ala ni ne 
a mi n otra nsferase ( A L T ) or T bili a b n or malities > 2 × u p per li mit of n or mal ( U L N ) wit hi n 
6 m o nt hs of scree ni n g. La b orat or y  assess me nts n ot re q uire d at scree ni n g f or partici pa nts
>
 da ys u nless dee me d necessar y b y t he i n vesti gat or t o c o nfir m n or mal he patic 
f u ncti o n. N ote: Partici pa nts wit h hist or y  of ele vate d bilir u bi n d ue t o ne o natal 
h y per bilir u bi ne mia t hat is res ol ve d, wit h T Bili val ues wit hi n refere nce ra n ge , m a y  be 
e nr olle d.
6.
Hist or y  of e pile psy or seiz ures. Partici pa nts wit h a hist or y of fe brile seiz ures will be 
per mitte d t o e nr oll.
7.
E x pecte d t o recei ve or has recei ve d a n a nti viral f or a n ot her res pirat or y viral i nfecti o n (e g, 
i nfl ue nza or C O VI D-1 9) wit hi n 1 0 da y s of scree ni n g.
8.
S us pecte d or c o nfir me d cli nicall y  si g nifica nt m o derate or se vere bacterial i nfecti o n (e g, 
bacterial p ne u m o nia, bactere mia), t hat ma y  i nterfere with t he e val uati o n of res p o nse t o 
t he st u d y i nter ve nti o n, at i n vesti gat or discreti o n. Partici pa nt s wit h mil d, l ocalize d 
i nfecti o ns s uc h as otitis me dia or uri nar y  tract i nfecti o n (U TI ) ca n be i ncl u de d.
9.
E vi de nce of se vere res pirat or y  fail ure re q uiri n g i n vasi ve mec ha nical ve ntilati o n or 
e xtrac or p oreal me m bra ne o x y ge nati o n ( E C M O ). N ote : Partici pa nts re q uiri n g n o n-
i n vasi ve ve ntilati o n, i ncl u di n g hi g h fl o w nasal ca n n ula ( H F N C) a n d c o nti n u o us p ositi ve 
air wa y press ure ( C P A P), re mai n eli gi ble f or t he st u d y.
1 0. K n o w n t o ha ve si g nifica nt c o m or bi dities, i ncl u di n g ge netic dis or ders (e g, tris o m y  2 1); 
car di o p ul m o nar y diseases (e g, he m o d yna micall y  si g nifica nt c o n ge nital heart disease); 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 9
si g nifica nt p ul m o nar y disease ( e g, c ystic fi br osis); hist or y of s ur ger y f or dia p hra g matic 
her nia; a n y here ditar y or ac q uire d meta b olic diseases, he mat ol o gical or ot her 
mali g na nc y ; or is k n o w n t o be HI V p ositi ve; has e vi de nce of se vere ne ur ol o gic 
i m pair me nt or de vel o p me ntal dela y t hat w o ul d li mit t he a bilit y t o a d mi nister 
i n vesti gati o nal me dici nal pr o d uct (I M P) or e val uate t he safet y  or cli nical res p o nse t o 
I M P. N ote: Preter m p artici pa nts (if < 3 5 wee ks gestati o nal a ge m ust be at least o ne y ear 
p ost -natal a ge ) wit h br o nc h o p ul m o nar y  d ys plasia (c hr o nic l u n g disease of pre mat urity) 
re mai n eli gi ble f or e nr oll me nt. 
1 1. I m m u n os u p pressi ve disease (e g, b o ne marr o w or or ga n tra ns pla ntati o n or pri mar y 
i m m u ne deficie ncies) O R pr ol o n ge d use of i m m u ne-wea ke ni n g me dicati o ns. 

Ha s recei ve d c ortic oster oi ds e q ui vale nt t o pre d nis o ne ≥2 m g / k g daily f or at least 
1 4 c o nsec uti ve da y s wit hi n 3 0 da ys pri or t o st u d y start or e x pecte d t o recei ve 
e q ui vale nt d ose d uri n g st u d y  dr u g treat me nt. I n hale d/ ne b ulize d or t o pical (s ki n, 
e yes, or ears) c ortic oster oi ds are per mitte d, e xce pt t h ose pr o hi bite d.

Has recei ve d treat me nt wit h bi ol o gics (e g, i nfli xi ma b, uste ki n u ma b), 
i m m u n o m o d ulat ors (e g, met h otre xate, 6 M P, azat hi o pri ne) or ca ncer 
c he m ot hera p y wit hi n 9 0 da y s pri or t o st u d y start or e x pecte d t o rec ei ve treat me nt 
wit h t hese t hera pe utics d uri n g st u d y dr u g treat me nt .
1 2. A n y  me dical, de vel o p me ntal, or be ha vi oral c o n diti o n (i ncl u di n g hist or y of self-har mf ul 
be ha vi ors) 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.
1 3. Malf or mati o n of t he gastr oi ntesti nal tract i ncl u di n g u nres ol ve d p yl oric ste n osis, hist or y  
of necr otizi n g e nter oc olitis, s h ort b o wel, or ot her si g nifica nt c o n diti o n t hat w o ul d alter 
dr u g a bs or pti o n or i ncrease t he ris k of diarr hea.
1 4. Has si g nifica nt oral a n d/ or ma xill ofacial malf or mati o ns t hat w o ul d li mit t he a bilit y  t o 
a d mi nister IM P.
1 5. Baseli ne 1 2 -lea d E C G wit h Q Tc F ≥4 5 0 ms. 
St u d y Ar ms a n d D ur ati o n:
T otal d urati o n of st u d y  partici pati on f or eac h partici pa nt is ~ 5 wee ks ( Scree ni n g 1 -2 da y s; 
Treat me nt peri o d is
da y s ( 2 d oses dail y D a y 1 t o Da y  5) or 6 d a y s (if o nl y  1 d ose recei ve d
o n D a y  1) f or a t otal of 
 d oses; F oll o w -u p peri o d is 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 0
). If t he partici pa nt recei ves o nly o ne d ose o n da y 1, d osi n g w ill c o nti n ue u ntil 
D a y  6, t o c o m plete t he 
 d oses. 
St u d y I nter ve nti o n(s)
I nter ve nti o n N a me
P F -0 7 9 2 3 5 6 8 ( sis u n at o vir)
Pl ace b o f or P F -0 7 9 2 3 5 6 8 
(sis u n at o vir)
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 or m ul ati o n
ca ps ule 
dis perse d i n
f or oral R O A or nas o gastric t u be 
R O A 
Matc hi n g E x peri me ntal
dis perse d 
i n 
 f or oral 
R O A or nas o gastric t u be R O A
U nit D ose Stre n gt h(s)
m g/ m L ( 5 0 m g sis u nat o vir 
i nt o 
Matc hi n g E x peri me ntal
R o ute of A d m i nistr ati o n
Oral or nas o gastric t u be
Oral or nas o gastric t u be
St u d y Ar m(s)
A r m  Title
S is u nat o vir
Place b o
A r m  Descri pti o n
P artici pa nts will recei ve 
 d oses 
of sis u nat o vir,
Partici pa nts will recei ve 
 d oses 
of p lace b o,
St atistic al Met h o ds:
A s ufficie nt n u m ber of partici pa nts will be scree ne d t o ac hie ve a p pr o xi matel y  
e val ua ble 
partici pa nts ra n d o mize d t o st u d y  i nter ve nti o n acr oss c o h orts. T he n u m ber ra n d o mize d ma y 
be i ncrease d if S p o ns or rec o m me n ds re peati n g a d ose, ie, a n a d diti o nal
acti ve a n d 
place b o ma y  be e nr olle d i n t he sa me c o h ort. T his t otals t o a p pr o xi matel y a ma xi mu m of
1 0 8 e val ua ble partici pa nts (
i n eac h c o h ort +
a d diti o nal i n eac h c o h ort if necessar y) t o be 
e nr olle d a n d recei ve st u d y i nter ve nti o n . T he sa m ple size is e m piricall y  selecte d a n d is n ot 
base d o n statistical p o wer calc ulati o n. T he mi ni m u m n u m ber of partici pa nts ( base d o n a 
mi ni m u m of
 partici pa nts per C o h ort) is a p pr o xi matel y 
e val ua ble partici pa nts as C o h orts 
2 ( 2 A, 2 B, 2 C , 2 D) a n d 3 (3 E, 3 F, 3 B , 3 D) are o pti o nal i n t he st u d y.
S afet y A n al ysis:
All safet y a nal ys es will be perf or me d o n t he safet y a nal ys is set, w hic h is defi ne d as all 
partici pa nts ra n d o ml y assi g ne d t o st u d y i nter ve nti o n a n d w h o ta ke at least 1 d ose of st u d y 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 1
i nter ve nti o n. Partici pa nts will be a nal yz e d acc or di n g t o t he pr o d uct (sis u n at o vir / place b o) 
t he y act ually recei ve d .
A Es, bl o o d press ure ( B P ), p ulse rate, S p O2, a n d safet y la b orat or y data will be re vie we d a n d 
s u m marize d o n a n o n g oi n g basis d uri n g t he st u dy t o e val uate t he safet y of partici pa nts. A n y 
cli nical la b orat or y or vital si g n a b n or malit y of p ote ntial cli nical c o ncer n will be descri be d. 
Safet y  data will be prese nte d i n ta b ular a n d/ or gra p hical f or mat a n d s u m marize d 
descri pti vel y, w here a p pr o priate.
P h ar m ac o ki netic A n al ysis:
T he fi nal p o p ulati o n P K m o del will be use d t o si m ulate plas ma c o nce ntrati o n -ti me c ur ves f or 
sis u nat o vir f or i n di vi d uals a n d t o calc ulate p ost-h oc esti mates of P K para meters ( C L , Cma x , 
C mi n , A U C a n d t½ ) b y a ge gr o u p. 
T he plas ma c o nce ntrati o ns of sis u nat o vir will be liste d a n d descri pti vel y s u m marize d b y  
n o mi nal P K sa m pli n g ti me , treat me nt, a ge gr o u p, a n d c o h ort . I n di vi d ual partici pa nt a n d 
s u m mar y pr ofiles ( mea n a n d me dia n pl ots) of t he plas ma c o nce ntrati o ns data will be pl otte d 
b y  treat me nt, a ge gr o u p usi n g act ual a n d n o mi nal ti mes, res pecti vely. Mea n a n d me dia n 
pr ofiles will be prese nte d o n b ot h li near a n d se mi -l o g scales. 
Data per mitti n g, ge o metric mea ns of P K para meters esti mate d fr o m t he fi nal p o p ulati o n P K 
m o del will be s u m marize d descri pti vel y b y treat me nt a n d a ge gr o u p. 
Et hic al C o nsi der ati o ns :
R S V is u bi q uit o us a n d is k n o w n t o i nfect al m ost all c hil dre n b y 2 years of a ge. T here is a n 
u n met nee d f or treat me nt of R S V i nfecti o n a n d c urre nt ma na ge me nt pri maril y  c o nsists of 
s u p p orti ve care. T he res ults of pre vi o us st u dies of sis u nat o vir s u p p ort t he i n vesti gati o n of 
sis u nat o vir f or t he treat me nt of R S V i nfecti o n. T he p ur p ose of t his d o u ble -bli n d, place b o -
c o ntr olle d st u d y is t o esta blis h safet y, t olera bilit y, P K a n d g ui da nce f or d osi n g of sis u nat o vir
i n a pe diatric p o p ulati o n ( u p t o 6 0 m o nt hs) wit h R S V-L R TI  f or f urt her cli nical de vel o p me nt 
of sis u nat o vir i n t he pe diatric p o p ulati o n. 
T he trial -s pecific ris ks a n d b ur de ns f or partici pa nts i ncl u de t he re q uire me nt f or m ulti ple 
visits, wit h o ne visit of e x te n de d d urati o n , disc o mf orts w hile u n der g oi n g st u d y assess me nts 
(e g, bl o o d dra ws, nas o p har yn geal s wa bs), a n d t he t otal bl o o d v ol u mes re q uire d. T he st u d y 
als o i ncl u des t he ne o nat al p o p ulati o n wit h R S V -L R TI , wit h si milar ris ks a n d b ur de ns as 
descri be d a b o ve . Base d o n cli nical st u dies wit h sis u nat o vir t h us far, gastr oi ntesti nal
s ym pt o ms were t he m ost c o m m o nl y  re p orte d a d verse e ve nts. N o ncli nical st u dies s u g geste d 
t hat t he p ote ntial ris ks f or sis u nat o vir ma y  i ncl u de car di o vasc ular, gastr oi ntesti nal, a n d 
he pat o biliar y  sys te m effects. T he d oses pr o p ose d i n t his st u d y  pr o vi de e x p os ures well bel o w 
t he P K st o p pi n g li mit N o O bser ve d A d verse Effect L e vels (N O A E Ls ). A d diti o nall y , t he 
pr o p ose d d oses are tar geti n g stea dy- state e x p os ures c o m para ble t o
i n a d ults, 
w hic h were f o u n d t o r o b ustl y decrease viral l oa d a n d alle viate R S V sy m pt o ms relati ve t o 
place b o ( C 5 2 4 1 0 0 2). 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 be nefit t o partici pa nts wit h R S V -L R TI  a n d t he p ote ntial ris ks 
i de ntifie d i n ass ociati o n wit h sis u nat o vir, t his d ose-fi n di n g st u d y is j ustifie d b y t he 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 2
a ntici pate d be nefits of sis u nat o vir i n t he cli nical de vel o p me nt of sis u nat o vir f or t he pe diatric 
p o p ulati o n wit h R S V -L R TI .
T here are c urre ntl y  n o ap pr o ve d R S V a nti virals a vaila ble, a n d t h us n o acti ve c o ntr ol ca n be 
pr o p ose d as c o m parat or. T he c o m parat or f or t his st u d y  is partici pa nts recei vi n g place b o. 
Eac h c o h ort e val uate d i n t he st u d y  will ha ve partici pa nts o n place b o. T he place b o gr o u p is 
re q uire d f or assessi n g t he safety, t olera bilit y, a n d palata bilit y of t he st u dy i nter ve nti o n. All 
partici pa nts (i ncl u di n g partici pa nts recei vi n g place b o) e nr olle d i n t he st u d y will recei ve t he 
S O C.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 3
1. 2. Sc he m a

C o h orts i n ora n ge are o pti o nal.

T otal N ca n ra n ge fr o m
t o a p pr o xi matel y a ma xi m u m 1 0 8 e val ua ble partici pa nts.

N = 
sis u nat o vir:
place b o) i n C o h orts 1, 2 a n d 3
( A, B, C a n d D i n C o h orts 1 a n d 
C o h ort 2 ; E, F, B a n d D i n C o h ort 3
), mi ni m u m N of 
sis u nat o vir:
place b o). 

A ge ba n d
 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 4

C o h orts 1 A, 1 B, 1 C ca n r u n c o nc urre ntl y.

C o h ort  
r a n d o mize d
re vie we d b y E-D M C .

E- D M C data re vie w f or eac h C o h ort after Da y
c o m pleti o n.

If S p o ns or rec o m me n ds re peati n g t he d ose, a d diti o nal
acti ve a n d
place b o ma y be e nr olle d i n t he sa me c o h ort (li mit o nce per 
c o h ort). 

See Ta ble 1 bel o w f or C o h ort details .
1. 2. 1. C o h ort Det ails
T a ble 1 .
C o h ort Det ails
C o h ort
A ge B a n d
Ti mi n g of 
C o h orts
Size *
D os e
O bjecti ve
O pti o n al
C o h ort
E- D M C 
C o nce ntr ati o n 
a n d S afet y 
Re vie w
C o h ort 1
1 A
Parallel: 1 A, 
1 B, 1 C
Acti ve:
Place b o); 
 
(total 
 d oses) 
c o m para ble t o 
 
)
Assess 
safet y, P K 
a n d 
t olera bilit y
N o
Y es
1 B
Parallel: 1 A, 
1 B, 1 C
Acti ve:
Place b o); 
 
(total 
 d oses) 
c o m para ble t o 
 
Assess 
safet y, P K 
a n d 
t olera bilit y
N o
Yes
1 C
Parallel: 1 A, 
1 B, 1 C
Acti ve:
Place b o); 
 
(total 
 d oses) 
c o m para ble t o 
 
)
Assess 
safet y, P K 
a n d 
t olera bilit y
N o
Yes
1 D
After 
Acti ve:
Place b o); 
Assess 
safet y, P K 
N o
Yes
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 5
T a ble 1 .
C o h ort Det ails
C o h ort
A ge B a n d
Ti mi n g of 
C o h orts
Size *
D os e
O bjecti ve
O pti o n al
C o h ort
E- D M C 
C o nce ntr ati o n 
a n d S afet y 
Re vie w
 
a n d 
t olera bilit y
C o h ort 2
2 A
After 
Acti ve 
Place b o); 
Fi nal 
deter mi nati o n of 
d ose a n d d osi n g 
re gi me n b y 
S p o ns or
D ose -
refi ne me nt
or 
a d diti o nal 
data
Yes
Yes
2 B
After 
Acti ve 
Place b o); 
Fi nal 
deter mi nati o n of 
d ose a n d d osi n g 
re gi me n b y 
S p o ns or
D ose -
refi ne me nt
or 
a d diti o nal 
data
Yes
Yes
2 C
After 
Acti ve 
Place b o); 
Fi nal 
deter mi nati o n of 
d ose a n d d osi n g 
re gi me n b y 
S p o ns or
D ose -
refi ne me nt
or 
a d diti o nal 
data
Yes
Yes
2 D
After 
Acti ve 
Place b o); 
Fi nal 
deter mi nati o n of 
d ose a n d d osi n g 
re gi me n b y 
S p o ns or
Assess 
safet y, P K 
a n d 
t olera bilit y
Yes
Yes
C o h ort 3
3 E
After 
C o h ort(s)  
 
Acti ve 
Place b o); 
Base d o n 
C o h ort(s) 1 
a n d/ or 2
A d diti o nal 
data i n 
y o u n ger 
partici pa nts
Yes
Yes
3 F
After 
C o h ort(s)  
 
Acti ve 
Place b o); 
Base d o n 
C o h ort(s) 1 
a n d/ or 2
A d diti o nal 
data i n 
y o u n ger 
partici pa nts
Yes
Yes
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 6
T a ble 1 .
C o h ort Det ails
C o h ort
A ge B a n d
Ti mi n g of 
C o h orts
Size *
D os e
O bjecti ve
O pti o n al
C o h ort
E- D M C 
C o nce ntr ati o n 
a n d S afet y 
Re vie w
3 B
After 
C o h ort(s)  
 
Acti ve 
Place b o); 
Base d o n 
C o h ort(s) 1 
a n d/ or 2
A d diti o nal 
data i n 
y o u n ger 
partici pa nts 
Yes
Yes
3 D
After 
C o h ort(s) 
Acti ve 
Place b o); 
Base d o n 
C o h ort(s) 1 
a n d/ or 2
A d diti o nal 
data i n 
y o u n ger 
partici pa nts 
Yes
Yes
* I n case of e nr oll me nt c halle n ges: mi ni m u m
Acti ve
Place b o); If S p o ns or rec o m me n ds re peati n g t he d ose: a d diti o nal
Acti ve:
Place b o) per mitte d
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 7
1. 3. Sc he d ule of Acti vities
T he S o A  ta ble pr o vi des a n o ver vie w of t he pr ot oc ol visits a n d pr oce d ures. Refer t o t he S T U D Y  AS S E S S M E N T S A N D 
P R O C E D U R E S secti o n of t he pr ot oc ol f or detaile d i nf or mati o n o n eac h pr oce d ure a n d assess me nt re q uire d f or c o m plia nce wit h t he 
pr ot oc ol. 
T he i n vesti gat or ma y  sc he d ule visits ( u n pla n ne d visits) i n a d diti 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. 
1. 3. 1. S o A 
T a ble 2 .
S o A 
Visit I de ntifier
Scree n
Tre at me nt Peri o d
F/ U
E T
N otes
A b bre vi ati o ns use d i n t his 
t a ble m a y be f o u n d i n 
A p pe n di x 1 2 (Secti o n
1 0. 1 2 )
D a y -1 
t o D a y 
1
D a y 1
D a y 
D a y
D a y  
D a y 
D a y
Pri or t o D a y 
D a y rel ati ve t o st art of st u d y i nter ve nti o n ( D a y 1).

visit t o c ollect P K bl o o d s a m ple
p ost d ose .
Visit Wi n d o w
+ 1 da y
+ 1 da y
± 2 da ys
± 2 da ys
+ 1 da y
Visit t y pe
E T: if E T occ urs after Da y  
visit , 
visit all o we d (f oll o w Da y 
acti vities). E T pri or t o Da y  
s h o ul d be i n pers o n visit ( 
.
Da y
 visit ca n occ ur i n pers o n if nee de d .
I nf or me d c o nse nt(s) f or 
st u d y, a n d asse nt (if 
a p pr o priate)
X

I nf or me d c o nse nt m ust be o btai ne d pri or t o u n der g oi n g a n y st u d y-
s pecific pr oce d ures.

See Secti o n 1 0. 1. 3 .
Scree n f or i ncl usi o n/ 
e xcl usi o n criteria
X  
X

See S ecti o n 5. 1 a n d Secti o n 5. 2 .

F or Ar ge nti n a, see E xcl usi o n Criteri o n 2 3 .
De m o gra p hics
X

See Secti o n 8. 1. 1 .
Re gistrati o n/ ra n d o mizati o n  
X  
X

Ra n d o mizati o n all o we d o n da y of scree ni n g after c o m pleti o n of 
all scree ni n g assess me nts.

At re gistrati o n, partici pa nt e nr oll me nt n u m ber a n d d ose le vel 
all ocati o n assi g ne d.
Me dic al Hist or y a n d 
P h ysic al E x a m i n ati o n
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 8
T a ble 2 .
S o A 
Visit I de ntifier
Scree n
Tre at me nt Peri o d
F/ U
E T
N otes
A b bre vi ati o ns use d i n t his 
t a ble m a y be f o u n d i n 
A p pe n di x 1 2 (Secti o n
1 0. 1 2 )
D a y -1 
t o D a y 
1
D a y 1
D a y
D a y
D a y  
D a y
D a y
Pri or t o D a y 
D a y rel ati ve t o st art of st u d y i nter ve nti o n ( D a y 1).

visit t o c ollect P K bl o o d s a m ple 
p ost d ose .
Visit Wi n d o w
+ 1 da y
+ 1 da y
± 2 da ys
± 2 da ys
+ 1 da y
Visit t y pe
E T: if E T occ urs after Da y  
visit ,
visit all o we d (f oll o w Da y 
acti vities). E T pri or t o Da y  
s h o ul d be i n pers o n visit ( 
.
Da y
 visit ca n occ ur i n pers o n if nee de d .
Me dical hist or y i ncl u di n g 
bac k gr o u n d fact ors ;
A p pe n di x 1 0 B # 1
X

See S ecti o n 8. 1. 1 a n d A p pe n di x 1 0 B # 1 i n Secti o n 1 0. 1 0. 2 .
C ollect s ocial fact ors;
A p pe n di x 1 0 B # 2
X
X  
X  
X

See A p pe n di x 1 0 B # 2 i n Secti o n 1 0. 1 0. 2 .
P h ysical E xa mi nati o n 
(rec or de d i n s o urce 
d oc u me nt)
X  
X
X  
X  
X
X

Da y 1 c o m plete p h ysical e xa m pre -d ose .

After Da y 1, brief p h ysical e xa m.

See Secti o n 8. 3. 1 .

See A p pe n di x 1 0 C i n Secti o n 1 0. 1 0. 3 f or s u g geste d c hr o n ol o g y of 
assess me nts.
B o d y Wei g ht
X
X
X

See Secti o n 8. 3. 1 .
Le n gt h / Hea d
Circ u mfere nce
X

See Secti o n 8. 3. 1 .
Vital si g ns i ncl u di n g S p O 2
X  
X
X  
X  
X
X

Bef ore P K, N P s wa bs a n d I M P a d mi nistrati o n ( See A p pe n di x 1 0 C
i n Secti o n 1 0. 1 0. 3 f or pr o p ose d c hr o n ol o g y of  assess me nt).

If h os pitalize d c ollect o nce dail y u ntil disc har ge a n d per S o A after 
disc har ge . See Secti o n 8. 3. 2 .
1 2 -Lea d E C G 
X

E C G ma y be perf or me d after scree ni n g as nee de d per i n vesti gat or 
discreti o n .

See Secti o n 8. 3. 3 f or E C G details.

See A p pe n di x 1 0 C i n Secti o n 1 0. 1 0. 3 f or pr o p ose d c hr o n ol o g y of 
assess me nt.
Rec or d S u p ple me ntal O 2
nee d
X  
X  
X  
X  
X  
X  
X  
X

See Secti o n 8. 3. 2. 3 .
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 2 9
T a ble 2 .
S o A 
Visit I de ntifier
Scree n
Tre at me nt Peri o d
F/ U
E T
N otes
A b bre vi ati o ns use d i n t his 
t a ble m a y be f o u n d i n 
A p pe n di x 1 2 (Secti o n
1 0. 1 2 )
D a y -1 
t o D a y 
1
D a y 1
D a y 
D a y
D a y  
D a y
D a y
Pri or t o D a y 
D a y rel ati ve t o st art of st u d y i nter ve nti o n ( D a y 1).

visit t o c ollect P K bl o o d s a m ple
p ost d ose .
Visit Wi n d o w
+ 1 da y
+ 1 da y
± 2 da ys
± 2 da ys
+ 1 da y
Visit t y pe
E T: if E T occ urs after Da y  
visit ,
visit all o we d (f oll o w Da y
acti vities). E T pri or t o Da y 
s h o ul d be i n pers o n visit ( 
.
Da y
 visit ca n occ ur i n pers o n if nee de d .
L a b Assess me nts

See Secti o n 8. 3. 4 f or bl o o d v ol u mes a n d a d diti o nal i nf or mati o n.

See A p pe n di x 2 i n Secti o n 1 0. 2 f or Cli nical La b orat or y tests t o be 
d o ne.

F or la b orat or y c ollecti o n v ol u mes, see Secti o n 8. 3. 4 .
R S V Dia g n ostic Test 
X

Wit hi n 
h o urs of ra n d o mizati o n See Secti o n s 5. 1 , 8. 1 .
Safet y La bs ( C B C, 
C he mistr y
X  
X
X  
X
X

c o h ort 
: li ver f u ncti o n ( A S T, A L T, T b ili)
m ust be re vie we d pri or t o Da y
d osi n g.  

All ot her c o h orts ( 
da ys ol d) s h o ul d ha ve t he Da y 1 p re-d ose 
li ver f u ncti o n tests ( A S T, A L T, T b ili) or dere d stat, if p ossi ble.

Safet y la bs ca n be d o ne at scree ni n g or pre -d ose o n Da y 1 .

Pr e - d ose ( Scree ni n g/ Da y 1) pr ot oc ol-s pecifie d safet y la bs d o n ot 
nee d t o be re peate d if perf or me d as part of sta n dar d of care wit hi n 
2 4 h o urs pri or t o first d ose o n Da y 1. T his i ncl u des la bs c o n d ucte d 
pri or t o si g ni n g of t he I C D a n d t hese la b res ults will be e ntere d i n 
t he C R F f or t he Scree ni n g/ Da y 1 visit.

Da y 
a n d/ or Da y 
safet y la bs c o m plete d wit hi n t he st u d y 
s pecifie d wi n d o w f or t hat visit, d o n ot nee d t o be ti me d wit h t he 
P K sa m ple c ollecti o n. 

If Da y 
safet y la bs are d o ne o n Da y 
bl o o d v ol u me a ll o wa nces 
s h o ul d be re vie we d pri o r t o Da y la b c ollecti o ns (see Ta ble 7 ).

If E T occ urs after Da y  visit, safet y la bs n ot re q uire d .
U A
X  
X

U A ca n be c ollecte d eit her at scree ni n g o r Da y 1, a n d at a n y ti me 
d uri n g t he visit.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 0
T a ble 2 .
S o A 
Visit I de ntifier
Scree n
Tre at me nt Peri o d
F/ U
E T
N otes
A b bre vi ati o ns use d i n t his 
t a ble m a y be f o u n d i n 
A p pe n di x 1 2 (Secti o n
1 0. 1 2 )
D a y -1 
t o D a y 
1
D a y 1
D a y
D a y
D a y  
D a y
D a y
Pri or t o D a y 
D a y rel ati ve t o st art of st u d y i nter ve nti o n ( D a y 1).

 visit t o c ollect P K bl o o d s a m ple
p ost d ose .
Visit Wi n d o w
+ 1 da y
+ 1 da y
± 2 da ys
± 2 da ys
+ 1 da y
Visit t y pe
E T: if E T occ urs after Da y 
visit ,
visit all o we d (f oll o w Da y 
acti vities). E T pri or t o Da y   s h o ul d be i n pers o n visit  
.
Da y
 visit ca n occ ur i n pers o n if nee de d .
P K Bl o o d Sa m ple
X  
X
X

See A p pe n di x 1 0 C i n Secti o n 1 0. 1 0. 3 f or s u g geste d c hr o n ol o g y 
of assess me nts .

Da y
a n d Da y
P K sc he d ule i n Ta ble 3 . 

Da y : If p ost-d ose P K la bs at 
 p ost-d ose 
is n ot c ollecte d o n Da y
t hese p ost-d ose P K la bs m ust be 
c ollecte d o n Da y
 Da y 
: P K pre -d ose la b ma y be ti me d wit h 
safet y la bs t o mi ni mize bl o o d dra ws.  

If E T occ urs after treat me nt peri o d, P K sa m ple d oes n ot nee d t o 
be c ollecte d .

See S ecti o n 8. 5 .
St u d y I nter ve nti o n a n d 
Ot her Tre at me nts
Pri or/c o nc o mita nt 
treat me nt(s)
X  
X
 
 
 

X  
X

See Secti o n 6. 9 .
I M P a d mi nistrati o n
X  
X  
X  
X

d osi n g Da ys 1 t o
or 
( T otal   d oses).

I M P ( o ne d ose) t o be a d mi nistere d t o partici pa nt d uri n g visit o n 
Da y 1, Da y 
a n d Da y

F or t he da y of e xte n de d p ost d ose P K c ollecti o n ( Da y 
or Da y
), 
t he d ose a d mi nistere d at visit m ust be i n t he m or ni n g f or 
partici pa nts i n a n o ut patie nt setti n g .

See Secti o n 6 .

See A p pe n di x 1 0 C i n Secti o n 1 0. 1 0. 3 f or s u g geste d c hr o n ol o g y of 
assess me nts.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 1
T a ble 2 .
S o A 
Visit I de ntifier
Scree n
Tre at me nt Peri o d
F/ U
E T
N otes
A b bre vi ati o ns use d i n t his 
t a ble m a y be f o u n d i n 
A p pe n di x 1 2 (Secti o n
1 0. 1 2 )
D a y -1 
t o D a y 
1
D a y 1
D a y
D a y
D a y  
D a y 
D a y 
Pri or t o D a y 
D a y rel ati ve t o st art of st u d y i nter ve nti o n ( D a y 1).

visit t o c ollect P K bl o o d s a m ple
p ost d ose .
Visit Wi n d o w
+ 1 da y
+ 1 da y
± 2 da ys
± 2 da ys
+ 1 da y
Visit t y pe
E T: if E T occ urs after Da y  
visit ,
visit all o we d (f oll o w Da y 
acti vities). E T pri or t o Da y 
s h o ul d be i n pers o n visit  
.
Da y
: visit ca n occ ur i n pers o n if nee de d .
St u d y kit dis pe nse d fr o m 
I R T a n d pare nt (s)/le gal 
g uar dia n i nstr ucte d o n its use
X

Pare nt or le gal g uar dia n re vie w of d osi n g vi de o , d osi n g 
i nstr ucti o ns a n d trai ni n g of I M P a d mi nistrati o n o n Da y 1 , or pri or 
t o disc har ge if h os pitalize d, a n d s u bse q ue ntl y as nee de d . If pare nt 
or le gal g uar dia n is all o we d t o a d mi nister st u d y dr u g w hile 
h os pitalize d, per l ocal re g ulati o ns, trai ni n g s h o ul d occ ur pri or t o 
pare nt or le gal g uar dia n st u d y dr u g a d mi nistrati o n. 

Pare nt or le gal g uar dia n s h o ul d be ta u g ht o n Da y 1 or pri or t o 
g oi n g h o me if h os pitalize d, h o w t o pre pare t he d ose a n d 
de m o nstrate u n dersta n di n g, u n der t he s u per visi o n of t he H C P .
I M P c o m plia nce
X  
X  
X  
X  
X

Da y 
visit – Retrie val of use d a n d u n use d I M P b ottles after 
c o m pleti o n of  
Da y
d osi n g, as a p plica ble .

Re vie w e Diar y c o m plia nce dail y .

See Secti o n 6. 5 .
Assess me nts
R S V -ass ociate d si g ns a n d 
s y m pt o ms (c ollecte d b y 
H C P)
X  
X
X  
X  
X
X

Da y 1 c ollecte d pre -d ose .

C ollecte d dail y if h os pitalize d u ntil ti me of disc har ge .

C ollecte d if partici pa nt has a n u n pla n ne d i n pers o n visit bet wee n 
Da ys  
t o

See Secti o n 8. 2. 1 .
Palata bilit y assess me nt f or 
oral dis persi o n
t hr o u g h e Diar y b y  pare nt(s)/ 
le gal g uar dia n//H C P
X  
X  
X  
X

D o ne after eac h d os e.

See A p pe n di x 1 0 D i n Secti o n 1 0. 1 0. 4 . Als o see Secti o n 8. 2. 2 .
E x plai n e Diar y 
X

E x plai n e Diar y c o m pleti o n re q uire me nts t o partici pa nt’s pare nt/ 
le gal g uar dia n a n d assist wit h access t o t he e Diar y (s uc h as 
d o w nl oa di n g t he a p p or iss ue a pr o visi o ne d de vice, if re q uire d ).
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 2
T a ble 2 .
S o A 
Visit I de ntifier
Scree n
Tre at me nt Peri o d
F/ U
E T
N otes
A b bre vi ati o ns use d i n t his 
t a ble m a y be f o u n d i n 
A p pe n di x 1 2 (Secti o n
1 0. 1 2 )
D a y -1 
t o D a y 
1
D a y 1
D a y 
D a y
D a y  
D a y
D a y 
Pri or t o D a y 
D a y rel ati ve t o st art of st u d y i nter ve nti o n ( D a y 1).

visit t o c ollect P K bl o o d s a m ple 
p ost d ose .
Visit Wi n d o w
+ 1 da y
+ 1 da y
± 2 da ys
± 2 da ys
+ 1 da y
Visit t y pe
E T: if E T occ urs after Da y 
visit ,
visit all o we d (f oll o w Da y 
acti vities). E T pri or t o Da y 
s h o ul d be i n pers o n visit ( 
).
Da y 
 visit ca n occ ur i n pers o n if nee de d .
Rec or d R S V relate d Me dical 
Visits
X  
X
X  
X  
X  
X

R S V relate d me dical visits a partici pa nt has atte n de d si nce t he last 
assess me nt will be c ollecte d. Me dical visits i ncl u de t h ose 
pr o vi de d b y a n H C P: o ut patie nt or i n patie nt visit, e mer ge nc y 
r o o m or ur ge nt care visit.

See Secti o n 8. 3. 5 .
Seri o us a n d n o nseri o us A E 
m o nit ori n g
X  
X
 
 
 

X  
X
Bi o m ar ker Assess me nts
See l a b or at or y m a n u al.
R S V R N A Assess me nts 
( N P)
X
X  
X  
X
[ X]
X

Da y  N P s wa b sa m ple is c ollecte d pre -d ose f or R S V R N A 
assess me nt a n d 
( See S ecti o n 8. 7 ).

F or N P  s wa bs c ollecte d p ost-Da y 1 ( See Secti o n 8. 7 ).

If partici pa nt has a n u n pla n ne d i n pers o n visit bet wee n Da ys
thr o u g h Da y
or a n i n pers o n visit f or t he Da y  
visit, a n N P 
s wa b [ X] ma y be c ollecte d f or R S V R N A assess me nt at PI a n d 
pare nt discreti o n ( See S ecti o n 8. 7 ).
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 3
1. 3. 2. M ulti ple D ose P K D a ys ( F or All C o h orts )
T a ble 3 .
M ulti ple D ose P K D a ys ( F o r All C o h orts )
Visit I de ntifier
Tre at me nt Peri o d
N otes
St u d y D a y ( wi n d o w)
D a y 
(+ 1 )
D a y 
(+ 1 )
visit t o c ollect P K s a m ples u p t o
p ost -d ose
H o urs After M or ni n g D ose
0
0
H o ur 0 = pre -d ose s a m ple c ollecti o n
St u d y i nter ve nti o n 
a d mi nistrati o n
X
X
P K bl o o d sa m ple
X  
X  
X

Da y  If p ost -d ose P K la bs at 
p ost -d ose are n ot c ollecte d o n Da y 
t hese
p ost -d ose P K sa m ples m ust be c ollecte d o n Da y 

Da y  p re-d ose P K c ollecti o n o nl y a n d ca n be ti me d wit h safet y la b c ollecti o n
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 4
2. I N T R O D U C TI O N
Sis u nat o vir ( P F-0 7 9 2 3 5 6 8, f or merl y R V 5 2 1) is a p ote nt i n hi bit or of R S V F pr otei n me diate d 
cell-t o-cell f usi o n t hat is c urre ntly bei n g i n vesti gate d i n partici pa nts wit h R S V L R TI . 
2. 1. St u d y R ati o n ale 
T he p ur p ose of t his st u d y is t o esta blis h safet y, t olera bilit y, P K , a n d g ui da nce f or d osi n g of 
sis u nat o vir i n a pe diatric p o p ulati o n (1 da y  u p t o 6 0 m o nt hs of a ge ) wit h R S V-L R TI  f or 
f urt her cli nical de vel o p me nt of sis u nat o vir. T his st u d y  will pr o vi de a d diti o nal safety, 
t olera bilit y a n d P K data at a ges pre vi o usly e val uate d i n C 5 2 4 1 0 0 3 t o i nf or m d ose selecti o n i n 
f ut ure st u dies a n d will als o pr o vi de t his data i n a br oa der pe diatric p o p ulati o n (
 ol d a n d c hil dre n
ol d) t o i nf or m d ose selecti o n i n f ut ure st u dies.
Palata bilit y  assess me nts will als o be c o n d ucte d t o ai d i n t he de vel o p me nt of pe diatric 
f or m ulati o ns of sis u nat o vir. 
2. 2. B ac k gr o u n d 
R S V is u bi q uit o us a n d is k n o w n t o i nfect al m ost all c hil dre n b y  2 years of a ge [ 1 ]. The 
cli nical ma nifestati o n of R S V i nfecti o n is t ypicall y  mil d u p per res pirat or y tract ill ness. 
H o we ver, i n i nfa nts, y o u n g c hil dre n, i m m u n oc o m pr o mise d a n d t he el derl y, it ca n ca use 
se vere L R TI. I n a sys te matic a nalys is of t he gl o bal R S V disease b ur de n i n 2 0 1 9, a n esti mate d 
3 3 milli o n e pis o des of ac ute L R TI a n d 3. 6 milli o n ac ute L R TI h os pitalizati o ns were 
attri b ute d t o R S V disease i n c hil dre n less t ha n 5 ye ars ol d [2 ]. At least 1 0 1, 0 0 0 deat hs 
w orl d wi de were re p orte d i n c hil dre n < 5 ye ars of a ge, wit h a s u bsta ntial b ur de n of se vere 
cases a n d fatalities occ urri n g i n c hil dre n bel o w 6 m o nt hs of a ge a n d i n t h ose resi di n g i n l o w -
a n d mi d dle-i nc o me c o u ntries. I nfa nts < 6 m o nt hs of a ge are n ote d t o be at t he hi g hest ris k of 
se vere R S V disease, w hic h ca n lea d t o h os pitalizati o n, IC U a d missi o n a n d e ve n deat h [3 ,4 ]. 
T he c urre nt ma na ge me nt of R S V i nfecti o n i ncl u des li mite d treat me nt meas ures, primaril y 
c o nsisti n g of s u p p orti ve care, a n d pre ve ntati ve meas ures . T here is o nl y o ne a nti viral
a p pr o ve d , ri ba viri n, a n ucle osi de a nal o g ue, b ut cli nical use is restricte d d ue t o its li mite d 
a nti viral p ote nc y, deli ver y r o ute, t o xicit y a n d terat o ge nic p ote ntial [5 ]. Pre ve ntati ve meas ures 
f or pe diatric R S V i ncl u de 2 m o n ocl o nal a nti b o dies a n d t he mater nal R S V vacci ne. T he 
m o n ocl o nal a nti b o d y  Sy na gis ( pali viz u ma b) i nteracts wit h F gl yc o pr otei n of t he R S V vir us
a n d is ap pr o ve d i n t he U S , E U [6 ,7 ] a n d ot her c o u ntries . Pali viz u ma b has bee n s h o w n t o 
pr o vi de pr otecti o n i n i nfa nts at ris k of se vere disease, b ut nee ds t o be gi ve n bef ore i nfecti o n 
a n d is a d mi nistere d m o nt hl y t hr o u g h o ut t he wi nter seas o n [7 ]. It is a p pr o ve d f or use i n 
i nfa nts wit h a hist or y of pre mat urity, he m o d y na m icall y si g nifica nt car diac disease, or c hr o nic 
l u n g disease of pre mat urit y. I n N o ve m ber 2 0 2 2, Nirse vi ma b, a m o n ocl o nal a nti b o d y  t o t he 
R S V f usi o n ( F) pr otei n t hat has a n e xte n de d half -life, was a p pr o ve d f or pre ve nti o n of R S V -
L R TI i n ne w b or ns a n d i nfa nts d uri n g t heir first R S V seas o n i n t he E U [8 ]. A p pr o val was 
e x pa n de d t he U S i n J ul y 2 0 2 3 w here ne o nates a n d i nfa nts are eli gi ble d uri n g t heir first R S V 
seas o n, a n d t h ose < 2 4 m o nt hs of a ge are eli gi ble if t he y re mai n v ul nera ble d uri n g t heir 
sec o n d seas o n[9 ]. A br y s v o is t he first R S V vacci ne i n dicate d f or p assi ve i m m u nizati o n of 
i nfa nts fr o m birt h t hr o u g h 6 m o nt hs of a ge f oll o wi n g a d mi nistrati o n of t he vacci ne t o t he 
m ot her d uri n g pre g na nc y. W hile m o n ocl o nal a nti b o dies a n d mater nal R S V vacci nati o n are 
ai me d at pre ve nti o n of R S V disease, there re mai ns a n o n g oi n g u n met cli nical nee d f or a n 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 5
effecti ve t hera p y f or R S V disease i n c hil dre n, a n d a n u m ber of ne w treat me nts are i n 
de vel o p me nt.  
Sis u nat o vir is a ne w oral, n o n -bi ol o gic treat me nt t hat tar gets t he R S V F pr otei n. A p pr o ve d 
pr o p h y lactic m o n ocl o nal a nti b o dies ( Pali viz u ma b a n d Nirse vi ma b) [7 ] [8 ] i n certai n 
c o u ntries als o tar get t he R S V F pr otei n. Sis u nat o vir ( P F -0 7 9 2 3 5 6 8) is a p ote nt i n hi bit or of 
R S V F pr otei n me diate d cell -t o-cell f usi o n a n d e xerts a nti viral acti vity a gai nst R S V b y  
i n hi biti n g viral e ntr y i nt o h ost cells. In t his wa y , F pr otei n i n hi biti o n ma y re d uce b ot h viral 
re plicati o n a n d pat h ol o g y, re d uci n g t he se verity of R S V -L R TI . T h us, sis u nat o vir ma y 
pr o vi de cli nical be nefit t o pe diatric partici pa nts wit h R S V disease. 
T he sis u nat o vir precli nical pr ofile, as well as t he safet y a n d t olera bilit y data fr o m t he first 
h u ma n d osi n g st u dies, pr o vi de a str o n g rati o nale f or t he c onti n ue d cli nical de vel o p me nt of 
sis u nat o vir. 
2. 2. 1. N o ncli nic al P h ar m ac ol o g y
I n vitr o, sis u nat o vir has de m o nstrate d p ote nt i n hi biti o n of
 
 Sis u nat o vir treat me nt res ulte d i n a si g nifica nt re d ucti o n  
.
I n vi v o, sis u nat o vir res ulte d i n a mar ke d re d ucti o n i n l u n g vir us titer i n a Bal b/ C m o use 
m o del of R S V i nfecti o n.
 
See t he c urre nt I B f or f urt her details .
2. 2. 2. N o n cli nic al P h ar m ac o ki netics a n d Met a b olis m
I n a ni mal p har mac o ki netic st u dies sis u nat o vir s h o we d pr ol o n ge d ti me t o Tma x , m o derate-hi g h 
C L , hi g h v ol u me of distri b uti o n, a n d oral bi oa vaila bilit y of 4 6 %, 4 2%- 1 3 2 %, a n d 6 3 % i n 
m o use, rat, a n d d o g, res pecti vel y. 
Plas ma pr otei n bi n di n g of sis u nat o vir was l o w t o m o derate acr oss s pecies, wit h a vera ge 
fracti o n u n b o u n d of 
, 0. 2 2 6, 0. 0 5 9 3, 
a n d 0.1 9 8 i n m o use, rat, d o g a n d g ui nea pi g, 
a n d h u ma n res pecti vely. F oll o wi n g si n gle oral d ose a n d u n der c o n diti o ns of stea d y state
d osi n g i n t he rat , sis u nat o vir de m o nstrates e xte nsi ve distri b uti o n t o t he l u n gs res ulti n g i n hi g h 
l u n g t o plas ma rati o.
Sis u nat o vir is a s u bstrate of
effl u x a n d is meta b olize d pri maril y  b y 
Sis u nat o vir was e val uate d f or p ote ntial i n hi biti o n of 
 i n vitr o. O verall, 
t he pri mar y D DI ris ks f or sis u nat o vir are i n hi biti o n of 
 a n d p ote ntial ris k f or 
i n hi biti o n of
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 6
See t he c urre nt I B f or f urt her details.
2. 2. 3. N o ncli nic al S afet y
See t he c urre nt I B f or f urt her details.
2. 2. 4. Cli nic al O ver vie w
Sis u nat o vir was disc o vere d a n d i nitiall y  de vel o pe d t hr o u g h P hase 2 by R e Viral Lt d., w hic h 
beca me a w h oll y o w ne d s u bsi diar y of Pfizer o n 0 9 J u n e 2 0 2 2. 
T o date, 9 cli nical st u dies ha ve bee n c o m plete d wit h sis u nat o vir ; a t otal of 2 6 4 healt h y a d ult 
partici pa nts ( n ot c o u nti n g t he 1 2 partici pa nts fr o m t he palata bilit y st u d y w h o di d n ot s wall o w 
sis u nat o vir) a n d 4 1 pe diatric patie nts wit h R S V -L R TI  recei ve d sis u nat o vir i n t hese st u dies. 
K e y  desi g n feat ures of t he c o m plete d cli nical st u dies are pr o vi de d i n t he I B, a n d s u m maries 
of t he ke y cli nical p har mac ol o g y , cli nical efficac y a n d cli nical safety data fr o m t he 
c o m plete d st u dies are pr o vi de d i n t he secti o ns bel o w. 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 7
I n a n R S V c halle n ge st u d y ( C 5 2 4 1 0 0 2), sis u nat o vir treat me nt res ulte d i n a statisticall y 
si g nifica nt re d ucti o n i n A U C of R S V viral l oa d c o m pare d wit h place b o; 5 5. 2 5 % ( p = 0. 0 0 7) 
a n d 6 3. 0 5 % ( p = 0. 0 0 2) f or t he 2 0 0 m g a n d 3 5 0 m g sis u nat o vir d ose gr o u ps res pecti vel y 
( d ose d q 1 2 h f or 5 da ys). Res ults f or t he A U C of t otal s ym pt o m sc ore were c o nsiste nt wit h 
t he viral l oa d A U C. Ge o metric mea n A U Cs of t otal s y m pt o m sc ore were 1 9 5. 5 6, 3 0. 7 9 - a n d 
3 1. 7 6- h o urs × sc ore f or place b o, 2 0 0 m g sis u nat o vir a n d 3 5 0 m g sis u nat o vir, res pecti vel y. 
T he re d ucti o n i n A U Cs of t otal s y m pt o m sc ore c o m pare d wit h place b o was statisticall y  
si g nifica nt f or b ot h sis u nat o vir treat me nt gr o u ps; p = 0. 0 0 9 ( 8 4. 2 6%) a n d p = 0. 0 0 2 ( 8 3. 7 6 %), 
( Wilc o x o n Ra n k S u m test) f or t he 2 0 0 m g a n d 3 5 0 m g sis u nat o vir d ose gr o u ps, res pecti vely.
T here are 7 o n g oi n g st u dies:

A P hase 1 m ulti ple site st u d y  ( C 5 2 4 1 0 1 2) i n a d ults t o assess t he effects of he patic 
i m pair me nt o n t he p har mac o ki netics of sis u nat o vir. 

A P hase 1 si n gle site st u d y  ( C 5 2 4 1 0 1 3) t o assess t he relati ve bi oa vaila bilit y of 
sis u nat o vir f oll o wi n g si n gle oral d ose of differe nt f or m ulati o ns u n der fe d a n d faste d 
c o n diti o ns i n healt h y a d ult partici pa nts.

A P hase 1 m ulti ple site st u d y  ( C 5 2 4 1 0 1 6) i n a d ults t o assess t he effects of re nal 
i m pair me nt o n t he P K of sis u nat o vir.

A P hase 1 si n gle site st u d y  ( C 5 2 4 1 0 1 7) t o assess t he effects of a pr ot o n p u m p 
i n hi bit or o n t he P K of sis u nat o vir i n healt h y a d ult partici pa nts.

A P hase 1 si n gle site st u d y  ( C 5 2 4 1 0 1 8) t o assess t he P K, safety, a n d t olera bilit y  
f oll o wi n g si n gle a n d m ulti ple d oses of sis u nat o vir i n C hi nese healt h y a d ult 
partici pa nts.

A P hase 1 b m ulti ple site st u d y  ( C 5 2 4 1 0 0 9) t o assess t he safety, t olera bilit y,  a n d P K 
of sis u nat o vir i n pe diatric partici pa nts u p t o a ge 6 0 m o nt hs wit h R S V L R TI.

A P hase 2/ 3 m ulti ple site st u d y  ( C 5 2 4 1 0 0 7) t o i n vesti gate efficac y a n d safet y of oral 
sis u nat o vir c o m pare d wit h place b o i n n o n-h os pitali ze d s ym pt o matic a d ults wit h R S V 
i nfecti o n w h o are at ris k of pr o gressi o n t o se vere ill ness.
I n a d ult st u dies, t he a d mi nistrati o n of sis u nat o vir was well t olerate d at all d oses, d osa ge 
f or ms a n d d osi n g re gi me ns teste d. I n t he a d ult healt h y partici pa nts treate d t o date, t he 
occ urre nce of T E A Es c o nsi dere d relate d t o sis u nat o vir has bee n l o w. T he m ost c o m m o nl y  
re p orte d all ca usalit y  T E A Es (≥1 0 partici pa nts) i n t he m ulti ple d ose st u dies wit h sis u nat o vir
i n a d ults were : diarr hea, na usea , a b d o mi nal pai n , a n d hea dac he. T hese T E A Es ha ve bee n 
mil d t o m o derate i n i nte nsit y  a n d res ol ve d wit h o ut se q uelae.
I n t he pe diatric st u dy C 5 2 4 1 0 0 3 1 9 partici pa nts were e nr olle d i n Part A (si n gle d ose) a n d 
3 2 partici pa nts were e nr olle d i n Part B ( m ulti ple d ose). I n Part A 1 3 T E A Es were re p orte d b y 
1 1 ( 5 7. 9 %) partici pa nts , of w hic h 5 T E A Es re p orte d f or 5 ( 2 6. 3 %) s u bjects were c o nsi dere d 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 8
treat me nt-relate d (t hr o m b oc yt osis ( 1), si n us arr h yt h mia ( 1) a n d v o miti n g ( 3)). All T E A Es 
were of mil d or m o derate i nte nsit y . D uri n g Part B of t he st u d y , 3 8 T E A Es were re p orte d b y 
1 2 ( 3 8. 7 %) partici pa nt s, of w hic h 3 T E A Es re p orte d f or 3 ( 9. 7 %) partici pa nts were 
c o nsi dere d treat me nt relate d ( v o miti n g, diarr h oea a n d t hr o m b oc yt osis ( 1 eac h)). All T E A E s
were of mil d or m o derate i nte n sit y. I n b ot h Part A a n d Part B, n o cli nicall y si g nifica nt tre n d 
was o bser ve d i n cli nical la b orat or y para meters, vital si g ns, or E C G res ults. Please see t he I B 
f or f urt her i nf or mati o n.
As of 2 0 Ja n uar y 2 0 2 4 , t here ha ve bee n n o S A Es attri b uta ble t o sis u nat o vir a n d n o deat hs i n 
t he cli nical st u dies. T here has bee n o ne seri o us A E of fe ver re p orte d i n t he pe diatric st u dy 
( C 5 2 4 1 0 0 3) i n a c hil d h os pitalize d wit h R S V i nfecti o n w h o recei ve d a si n gle d ose of 
sis u nat o vir. T his was c o nsi dere d seri o us beca use it pr ol o n ge d h os pitalizati o n, b ut t he S A E 
was re p orte d as n ot relate d t o I MP . I n st u d y C 5 2 4 1 0 0 2 t here was 1 S A E of s u b -ac ute 
m y ocar ditis re p orte d f or a partici pa nt o n place b o; t his was c o nsi dere d t o be ca usall y relate d 
t o t he c halle n ge vir us. 
I n a d ults, sis u nat o vir is sl o wl y a bs or be d reac hi n g ma xi m u m plas ma c o nce ntrati o ns (tma x ) at 
–
h o urs wit h a relati vel y m o derate cleara nce, res ulti n g i n a half -life of
 h o urs i n 
healt h y  partici pa nts, res ulti n g i n stea dy state c o nce ntrati o ns bei n g reac he d after 
a p pr o xi matel y 
da ys of d osi n g a n d a
 f ol d acc u m ulati o n of e x p os ure. A U C a n d C ma x
val ues
 
F oll o wi n g  da y s of d osi n g, t he varia bilit y i n P K para meters was  
 wit h % C V 
ra n gi n g fr o m
%-
% f or C
ma x a n d 
%-
% f or A U C
1 2.
T he effect of f o o d o n t he si n gle d ose p har mac o ki netics was assesse d f or t he 
 
F or t he
t he e xte nt of s yste mic e x p os ure t o sis u nat o vir ( ge o metric 
mea n A U C i nf u n der fe d a n d faste d c o n diti o ns) was 3 5 7 a n d 2 2 1 n g• h/ m L res pecti vel y , wit h 
t he bet wee n-s u bject varia bilit y bei n g 
u n der fe d c o n diti o ns ( C V  
% c o m pare d wit h 
%). T he rati o of fe d/faste d was  
% ( 9 0 % CI:  
% -
%) f or C
ma x a n d 
% ( 9 0 % 
CI   
 –
%) f or A U C i nf. It s h o ul d be n ote d t hat t he
 faste d res ults fr o m C 5 2 4 1 0 0 1 
were 
t ha n t y picall y see n i n ot her st u dies wit h  
m g a d mi nistere d u n der fasti n g 
c o n diti o ns, res ulti n g i n a n
rati o of fe d/faste d i n t his st u d y. For t he 
t he e xte nt of s yste mic e x p os ure t o sis u nat o vir ( ge o metric mea n A U C i nf)
u n der fe d a n d faste d c o n diti o ns was  
 n g• h/ m L res pecti vel y, wit h t he bet wee n -
s u bject varia bilit y bei n g 
u n der faste d c o n diti o ns ( C V
% c o m pare d wit h 
%). T he rati o of fe d/faste d was  
% ( 9 0 % CI: 
–
%) f or C
ma x a n d  
% 
( 9 0 % CI:  
% –
%) f or A U C i nf. 
St u d y  C 5 2 4 1 0 0 4 de m o nstrate d t hat t he dis p ositi o n of sis u nat o vir is affecte d b y  
 
 F urt her m ore, sis u nat o vir was de m o nstrate d t o be 
 s o d ose a dj ust me nts f or c o m p o u n ds t hat are  
 
 ma y nee d t o be c o nsi dere d.
N o partici pa nt i n st u d y C 5 2 4 1 0 0 1 ha d a Q Tc F i nter val c ha n ge fr o m baseli ne > 3 0 ms. 
F urt her m ore, n o si g nifica nt Q Tc pr ol o n gati o n was detecte d i n C- Q T a nal ys es perf or me d i n 
S A D partici pa nts ( C 5 2 4 1 0 0 1), M A D partici pa nts ( C 5 2 4 1 0 0 1) or D DI st u d y partici pa nts 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 3 9
( C 52 4 1 0 0 4). T he c o nce ntrati o n res p o nse a nalys es di d n ot i de ntif y a Q T pr ol o n gati o n si g nal 
of p ote ntial cli nical c o ncer n ( P M A R -E Q D D -C 5 2 4 b -Pre -P oc - 1 6 6 4).
T he p reli mi nar y res ults fr o m a D DI st u dy of sis u nat o vir ta blets (a d ult f or m ulati o n) i n
c oa d mi nistrati o n wit h a n aci d re d uci n g a ge nt s h o we d a si g nifica ntl y re d uce d plas ma 
e x p os ure ( C 5 2 4 1 0 1 7). T hese ne w fi n di n gs d o n ot re prese nt a safet y c o ncer n; h o we ver, t he 
re d uce d plas ma e x p os ure ma y ha ve a p ote ntial i m pact o n t he efficac y of sis u nat o vir ta blets.
M ore detaile d i nf or mati o n a b o ut res ults of cli nical st u dies f or sis u nat o vir 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.
2. 3. Be nefit/ Ris k Assess me nt
T he sis u nat o vir precli nical pr ofile, as well as t he safet y a n d t olera bilit y data fr o m t he first i n 
h u ma n st u dies, pr o vi de rati o nale f or t he c o nti n ue d i n vesti gati o n of sis u nat o vir. T he p ur p ose 
of t his st u d y  is t o esta blis h safety, t olera bilit y, P K a n d g ui da nce f or d osi n g of sis u nat o vir i n a 
pe diatric p o p ulati o n ( u p t o 6 0 m o nt hs) wit h R S V -L R TI.
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 sis u nat o vir is a vaila ble i n t he I B, w hic h is t he S R S D f or t his st u d y . Refer t o 
t he St u d y Inter ve nti o n(s) ta ble i n Secti o n 6. 1. 1 f or a c o m plete descri pti o n of S R S Ds.
C urre ntl y , n o s pecific h u ma n ris ks ha ve bee n i de ntifie d; p ost ulate d ris ks base d o n n o ncli nical 
st u dies are s u m marize d i n Secti o n 2. 2 . T he cli nical i m pact of t hese p ote ntial ris ks will be 
mi ni mize d t hr o u g h sta n dar d, i nte nsi ve, patie nt m o nit ori n g of t he partici pa nts f oll o wi n g 
a d mi nistrati o n of m ulti ple oral d oses of t he st u d y i nter ve nti o n.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 0
2. 3. 1. Ris k Assess me nt
P ote nti al Ris k of Cli nic al 
Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k
Miti g ati o n Str ate g y
St u d y I nter ve nti o n: S is u n at o vir
He pat o biliar y s yste m effects
 
 
I n c o m plete d cli nical st u dies, mil d tra nsie nt as y m pt o matic ele vati o ns 
of li ver e nz y mes ha ve bee n o bser ve d i n a fe w partici pa nts.
Safet y m o nit ori n g i ncl u di n g la b orat or y (ie, 
tra nsa mi nases, G G T) a n d A E m o nit ori n g. 
Gastr oi ntesti nal effects
 
 
I n c o mplete d cli nical st u dies sis u nat o vir has bee n ass ociate d wit h mil d 
or m o derate GI A Es .
Partici pa nts will be cl osel y e val uate d t o m o nit or 
f or GI A Es .
Car di o vasc ular effects
 
.
T o date, P hase 1 st u dies i n healt h y a d ult partici pa nts a n d a P hase 2 
st u d y i n pe diatric partici pa nts has n ot s h o w n cli nicall y si g nifica nt 
c ha n ges i n safet y la b orat or y para meters (i ncl u di n g tr o p o ni n i n 
C 5 2 4 1 0 0 1), E C Gs a n d vital si g ns , relate d t o sis u nat o vir.
A t h or o u g h Q T st u d y ( C 5 2 4 1 0 1 5) w as c o n d ucte d t o assess t he effect 
of sis u nat o vir o n Q T i nter val. T he c o nce ntrati o n -res p o nse a nal yses 
bet w ee n sis u nat o vir e x p os ure w hic h c o ver a c o nce ntrati o n ra n ge u p t o 
a p pr o xi matel y 1. 2 -f ol d t he hi g h cli nical e x p os ure a n d 3. 5-f ol d t he 
pr ojecte d t hera pe utic mea n C ma x c o nce ntrati o n st u die d i n P hase 1/ 2 
st u dies a n d t he Δ Δ Q Tc F a n d H R, di d n ot i de ntif y si g nal of p ote ntial 
cli nical c o ncer n (ie , Q T pr ol o n gati o n). 
M o nit ori n g will i ncl u de vital si g ns, a n d baseli ne 
as well as e ve nt dri ve n E C G assess me nts. 
E xcl usi o n of partici pa nts wit h a n y cli nicall y 
si g nifica nt E C G a b n or malit y i n a partici pa nt’s 
me dical hist or y, or i n t he pre -d ose E C G t hat per 
i n vesti gat or j u d ge me nt ma y affect partici pa nt 
safet y or i nter pretati o n of st u d y res ults.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 1
P ote nti al Ris k of Cli nic al 
Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k
Miti g ati o n Str ate g y
Ot her
i nteracti o ns ma y b e 
a 
f or t he st u d y.
Vital si g ns a n d a p h ysical e xa mi nati o n 
be perf or me d d uri n g
 i nteracti o ns, w hic h ma y miss cli nicall y rele va nt si g ns. 
Di gitall y illiterate pare nt(s)/le gal g uar dia n or pare nt/le gal g uar dia n 
wit h li mite d i nter net access ma y be e xcl u de d.
T he 
visit o n Da y  all o ws t he H C P t o 
m o nit or t he partici pa nt’s well bei n g 
re q uiri n g t he partici pa nt t o  
t he site. 
T here is a n i n pers o n visit t he ne xt da y (D a y
a n d a n y a d verse e ve nt assesse d b y 
ca n 
be a p pr o pr iatel y acti o ne d. E diar y t hat i ncl u des 
D osi n g q uesti o n naire ca n be d o ne at h o me a n d 
t heref ore n ot i m pacte d wit h Da y 
as 
visit . Site ca n m o nit or d osi n g c o m plia nce . D a y  
site visit i s all o we d , if nee de d as well.
visit is o pti o nal at Da y  
 h o we ver,
site visit all o we d per i n vesti gat or discreti o n .
I ncl usi o n # 6 re q uires pare nt(s)/le gal g uar dia n t o 
c o m pl y wit h all sc he d ule d visits, i n vesti gati o nal 
pla n, la b orat or y tests a n d ot her st u d y pr oce d ures 
a n d s h o ul d be a vaila ble f or tele p h o ne c o ntact wit h 
site staff f or t he d urati o n of t he st u d y.
I M P pre parati o n a n d 
a d mi nistrati o n is a m ulti -ste p
pr ocess t hat ca n i m pact 
c o m plia nce , a n d if i nc orrectl y 
d o ne, ma y i m pact t he st u d y
data .
I M P a d mi nistrati o n is a ge a n d wei g ht base d. I M P dis pe nse d i n b ottles 
nee ds t o be dis perse d i n t he ri g ht v ol u me of dil ue nt b y t he 
pare nt(s)/le gal g uar dia n/ H C P as a p plica ble ( Secti o n 6. 1 a n d Secti o n 
6. 2 ). T he pre pare d I M P i n t he dil ue nt is a dis persi o n a n d ca n i m pact 
t he pla n ne d d ose gi ve n t o t he partici pa nt.
a n d
are n ot per mitte d
f or t he st u d y
Trai ni n g i nstr ucti o ns a n d vi de os o n I M P 
pre parati o n a n d a d mi nistrati o n w ill be pr o vi de d t o 
i n vesti gat ors, site staff a n d pare nt(s)/le gal 
g uar dia n. F or o ut patie nt partici pa nts, I M P 
a d mi nistrati o n d uri n g visit o n Da ys
will be 
d o ne b y pare nt(s)/ le gal g uar dia n u n der t he 
o bser vati o n of t he H C P. F or I n patie nt partici pa nts, 
I M P a d mi nistrati o n will be d o ne b y t he H C P , or 
b y pare nt (s)/le gal g uar dia n, if per mitte d b y l ocal 
p olic y .
 ma y be t he dil ue nt f or
partic ipa nts a n d ma y mi ni mize ris k of 
t o 
if t his is use d as a dil ue nt. F or i nfa nts, 
the v ol u me of t he st u d y i nter ve nti o n will be a 
s mall v ol u me c o m pare d t o v ol u me of a n i nfa nt’s 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 2
P ote nti al Ris k of Cli nic al 
Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k
Miti g ati o n Str ate g y
fee d ( u p t o 5. 4 m L , base d o n 9 5 t h perce ntile 
wei g ht f or a 2 -year -ol d ).  
I mpact t o partici pa nt wit h 
re gar d t o st u d y partici pati o n, 
i ncl u di n g assess me nts a n d 
visits.
Cli nical ma na ge me nt of partici pa nt w he n t here is worse ni n g of R S V 
i nfecti o n res ulti n g i n h os pitalizati o n.
C o nti n ui n g i n t he st u d y w he n partic i pa nt is e nr olle d as a n i n patie nt 
a n d is disc har ge d later.
St u d y Da y 
or re q uires a n e xte n de d sta y at t he site (if t he 
partici pa nt is o ut patie nt at t he ti me of visit ) ca n be es peciall y 
c halle n gi n g. 
Disc o mf orts/c o ncer ns d uri n g st u d y c o n d uct f or assess me nts i ncl u di n g 
E C G, nasal s wa bs, bl o o d dra ws a n d bl o o d v ol u mes.
Selecti o n of sites wit h ca pa bilities t hat all o w  f or 
ma na ge me nt of partici pa nts wit h c ha n ges fr o m a n 
o ut patie nt t o i n patie nt or i n patie nt t o o ut patie nt
setti n gs.
 o n D a y
or  
m iti gate t he 
c halle n ges wit h a n
f or partici pa nts 
i n t he o ut patie nt setti n g.
F or t he 5- wee k d urati o n of t he st u d y, t he 
assess me nts , i ncl u di n g bl o o d dra w s a n d N P 
s wa bs, ha ve bee n ke pt t o a mi ni m u m f or all 
c o h orts w here feasi ble .
T here are c urre ntl y n o a p pr o ve d R S V a nti virals 
a n d t h us pr o vi di n g place b o d oes n ot lea d t o 
a d diti o nal ris ks f or t he partici pa nt. T he efficac y of 
sis u nat o vir is still bei n g e val uate d. All 
partici p a nts ( place b o or sis u nat o vir) will c o nti n ue 
t o recei ve sta n dar d of care.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 3
2. 3. 2. Be nefit Assess me nt
T he pr o p ose d d oses i n t his st u d y are tar geti n g stea d y-state e x p os ures c o m para ble t o  
m g 
i n a d ults, w hic h were f o u n d t o r o b ustly decrease viral l oa d a n d alle viate R S V 
s ym pt o ms relati ve t o place b o ( C 5 2 4 1 0 0 2). O n t his basis, t he p ote ntial be nefit t o i n di vi d ual 
st u d y partici pa nts w h o recei ve acti ve treat me nt ma y i ncl u de a s h orter ti me t o cli nical 
rec o ver y, pre ve nti o n of h os pitalizati o n, a n d a lo wer pr o ba bilit y  of pr o gressi n g t o m ore se vere 
ill ness or deat h. T he p ote ntial be nefit of t he st u dy is t hat it ma y pr o vi de a ne w treat me nt 
o pti o n f or pe diatric partici pa nts wit h R S V -L R TI .
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 a n u n prece de nte d s ur ge i n pe diatric R S V i nfecti o ns d uri n g 2 0 2 2- 2 0 2 3, 
a n u n met nee d f or treat me nt of R S V i nfecti o n, a n d 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 sis u nat o vir i n t his d ose -fi n di n g 
st u d y are j ustifie d by t he a ntici pate d be nefits i n t he cli nical de vel o p me nt of sis u nat o vir f or 
t he pe diatric p o p ulati o n wit h R S V-L R TI .
T here are c urre ntl y  n o a p pr o ve d R S V a nti virals a vaila ble, a n d t h us n o acti ve c o ntr ol ca n be 
pr o p ose d as c o m parat or. T he c o m parat or f or t h is st u d y is partici pa nts recei vi n g place b o. 
Eac h c o h ort e val uate d i n t he st u d y  will ha ve partici pa nts o n place b o. T he place b o gr o u p is 
re q uire d f or assessi n g t he safety, t olera bilit y, a n d palata bilit y of t he st u dy i nter ve nti o n. All 
partici pa nts (i ncl u di n g partici pa nts recei vi n g place b o) e nr olle d i n t he st u d y  will recei ve t he 
S O C.
3. O B J E C TI V E S, E N D P OI N T S, A N D E S TI M A N D S
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y: 
Pri m ar y:
Pri m ar y:
T o e val uate t he safet y a n d 
t olera bilit y of sis u nat o vir 
c o m pare d t o place b o i n 
partici pa nts wit h R S V -L R TI.

I nci de nce of T E A Es.

I nci de nce of A Es a n d S A Es 
lea di n g t o disc o nti n uati o ns.

I nci de nce of cli nicall y 
si g nifica nt a b n or mal la b orat or y 
val ues a n d vital si g ns.

N ot a p plica ble
Sec o n d ar y: 
Sec o n d ar y:
Sec o n d ar y:
T o c haracterize t he P K of 
sis u nat o vir i n partici pa nts wit h 
R S V -L R TI.

Plas ma c o nce ntrati o ns of 
sis u nat o vir at stea d y state ( Da y
or later).

N ot a p plica ble
Terti ar y: 
Terti ar y:
Terti ar y:
T o descri be t he viral l oa d i n N P
sa m ples o ver ti me i n partici pa nts
wit h R S V -L R TI.

Viral l oa d meas ure d via R T -
q P C R i n N P s wa bs o ver ti me
(i ncl u di n g b ut n ot li mite d t o 
c ha n ge fr o m baseli ne at eac h 
sa m ple d visit a n d pr o p orti o n of 

N ot a p plica ble
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 4
O bjecti ves
E n d p oi nts
Esti m a n ds
partici pa nts wit h B L O Q at Da y 
T o descri be si g ns a n d s y m pt o ms 
assesse d b y H C P o ver ti me i n 
partici pa nts wit h R S V -L R TI

Si g ns a n d s y m pt o ms o ver ti me
(i ncl u di n g b ut n ot li mite d t o 
c ha n ge fr o m baseli ne at Da y
a n d pr o p orti o n of partici pa nts 
wit h eac h si g n at Da y

N ot A p plica ble
T o assess t he o verall palata bilit y 
of pre pare d oral dis persi o n i n 
partici pa nts wit h R S V -L R TI 

Res p o nses t o palata bilit y 
q uesti o n naire (e g, partici pa nt 
res p o nse t o me dicati o n) at all 
ti me p oi nts (s pecifie d i n 
pr ot oc ol).

N ot a p plica ble
 
 
 

Viral l oa d i n N P s wa bs a n d R S V
si g ns a n d s y m pt o ms o ver ti me i n 
-partici pa nts
 

N ot a p plica ble
4. S T U D Y D E SI G N
4. 1. O ver all Desi g n
T his st u d y  is a ra n d o mize d, d o u ble-bli n d, s p o ns or-o pe n, place b o -c o ntr olle d, m ultice nter 
st u d y i n R S V-i nfecte d o ut patie nt a n d h os pitalize d ne o nates, i nfa nts , a n d c hil dre n, a ge d 1 da y 
u p t o 6 0 m o nt hs of a ge wit h R S V -L R TI ; t his is a d ose fi n di n g st u d y t o e val uate t he P K, 
safety, a n d t olera bilit y of sis u nat o vir. 
 

C o h orts 1 a n d 2:
A:
B:
C:
D:

C o h ort 3:
E :
F : 
B :
D:
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 5
Alt h o u g h ne o nates are defi ne d b y t he W H O as 0-2 7 da y s ol d [1 0 ]
 
 
Sis u nat o vir or place b o will be a d mi nistere d  
i n a 
rati o, f or a peri o d of 
 
 f or all c o h orts. Eac h c o h ort will e nr oll
partici pa nts i n eac h 
d ose gr o u p (
acti ve:
place b o). I n case of recr uit me nt c halle n ges f or a n y c o h ort i n t he 
st u d y, a mi ni m u m of
partici pa nts will be e nr olle d 
acti ve:
place b o).
Sis u nat o vir d oses e x pecte d t o pr o d uce s ys te mic stea d y-state e x p os ures c o m para ble t o t he
m g
a d ult d ose will be e val uate d i n d os i n g C o h ort 1. C o h orts 1 A, 1 B, a n d 1 C will 
i nitiate i n parallel.
 will recei ve sis u nat o vir or place b o, e x pecte d t o 
pr o d uce s ys te mic stea d y-state e x p os ures c o m para ble t o t he
m g
i n a d ults. T he
 ma y be e nr olle d o nl y after E-D M C re vie w of C o h ort 
data.
Base d o n a nal ys is of P K a n d safety data fr o m C o h ort 1, t he o pti o nal C o h ort 2 ( 2 A, 2 B, 2 C , 
2 D ) ma y be use d f or f urt her d ose refi ne me nt t o m ore cl osely matc h t he  
m g d ose i n
or t o gat her a d diti o nal data o n d oses use d i n C o h ort 1. T he d ose f or C o h ort  
will be base d 
o n C o h ort 
. O nl y  
will be e nr olle d
i n 
 D ose re gi me ns f or C o h ort 2 will be pr o vi de d via a di gital s y ste m (e g, I WR S) 
u p o n i nc or p orati o n of a d diti o nal data fr o m a d ults ( C 5 2 4 1 0 0 6) i nt o t he P o p P K m o del a n d 
c o n d ucti n g si m ulati o ns. D oses i n C o h ort 2 will n ot e xcee d e x p os ures f o u n d t o be well 
t olerate d i n a d ults i n S t u d y C 5 2 4 1 0 0 6.
T he o pti o nal C o h ort 3 ( 3 E, 3 F, 3 B , 3 D) ma y be use d if a d diti o nal data ( e x p os ure, safet y,
t olera bilit y data) f or a gi ve n d ose i n o ne or m ore of t he
 is nee de d. T he 
 i n C o h ort 3 f oc us o n t h ose a ges m ost s usce pti ble 
 
 (less t ha n 
. T he s pecific d ose a n d
 i n t he o pti o nal 
C o h ort 3 will be deter mi ne d u p o n re vie w of C o h orts 1 a n d / or 2 P K a n d safet y  data b ut will 
n ot e xcee d e x p os ures f o u n d t o be well t olerate d i n a d ults i n S t u d y C 5 2 4 1 0 0 6. S p o ns or will 
deter m i ne w hic h a ge gr o u ps i n C o h ort 3 nee d a d diti o nal e x p os ure, safet y or t olera bilit y data 
f or a gi ve n d ose. D ose re gi me ns f or C o h ort 3 will be pr o vi de d via a di gital s yste m (e g,
I W R S).
T he S p o ns or will ma ke t he fi nal decisi o n of d oses f or t he c o h orts , i ncl u din g rec o m me n dati o n 
t o re peat a d ose or o pe ni n g e nr oll me nt of t he s u bse q ue nt c o h ort. A n i n de pe n de nt e xter nal 
data m o nit ori n g c o m mittee ( E-D M C) will re vie w t he u n bli n de d safet y a n d c o nce ntrati o n data 
after c o m pleti o n of Da y 
visit f or eac h c o h ort (a p pr o xi matel y
partici pa nts ,
partici pa nts 
if t here are recr uit me nt c halle n ges) t o e ns ure t he safety of partici pa nts. T he E -D M C a p pr o val 
of S p o ns or’s rec o m me n dati o n will be i n de pe n de ntl y  assesse d f or eac h of t he differe nt a ge 
gr o u ps a n d will be base d o n t he safety/ t olera bility a n d c o nce ntrati o n data (ie,
). I n t he e ve nt t hat t here is a safety si g nal of c o ncer n, all 
ra n d o mizati o ns m ust be halte d b y t he S p o ns or u ntil t he E -D M C has c o m plete d t heir re vie w 
a n d has rec o m me n de d t hat f urt her ra n d o mizati o n ma y c o nti n ue. A n earlier meeti n g of t he 
E- D M C ca n be c o n ve ne d, as warra nte d, a n d base d o n t he res ults of t he E- D M C re vie w, t he 
E- D M C ma y  rec o m me n d t o t he S p o ns or t hat a d ose of sis u nat o vir be ter mi nate d. If S p o ns or
rec o m me n ds re peati n g t he d ose, a n a d diti o nal 
partici pa nts recei vi n g acti ve dr u g a n d 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 6
place b o ma y  be e nr olle d i n t he sa me a ge gr o u p wit hi n t he sa me c o h ort (li mit o nce per 
c o h ort).  
Partici pa nts ma y  be re place d at S p o ns or discreti o n f or t he f oll o wi n g reas ons: if t he 
partici pa nt’s pare nt(s) /le gal g uar dia n wit h dra ws c o nse nt , if t he partici pa nt miss es a n y d ose 
bef ore pr o vi di n g t he 
sa m ple o n Da y 
or
if t he partici pa nt miss es
a n y P K sa m ples , if I M P is disc o nti n ue d , or if t he partici pa nt ’s R S V test res ults at scree ni n g 
are n ot c o nfir me d b y t he ce ntral la b orat or y R S V test res ult, if partici pa nt was e x p ose d t o a 
pr o hi bite d c o nc o mita nt me dicati o n or if Da y  1 R S V R N A le vel b y  R T-q P C R is less t ha n t he 
l o wer li mit of q ua ntificati o n.
Partici pa nt(s) wit h discre pa nt ce ntral la b orat or y  R S V test res ult will n ot be i ncl u de d i n t he 
pri mar y  a nalys is.
F or eac h partici pa nt, t he st u d y  will ha ve a ma xi m u m d urati o n of a p pr o xi matel y 5 wee ks. 
T his i ncl u des a scree ni n g peri o d of 1- 2 da y s, a
d a y  Treat me nt peri o d a n d a 
 
 foll o w -u p peri o d
T he hi g hest, well -
t olerate d d ose will be deter mi ne d f or t he c orres p o n di n g a ge ba n d i n t his st u d y. 
A p pr o xi matel y  a ma xi m u m of 1 0 8 partici pa nts 
i n eac h c o h ort +
a d diti o nal i n eac h 
c o h ort if necessar y) will be e nr olle d. T he mi ni m u m n u m ber of partici pa nts ( base d o n a 
mi ni m u m of
partici pa nts per C o h ort) is a p pr o xi matel y 
e val ua ble partici pa nts as C o h orts 
2 ( 2 A, 2 B, 2 C ) a n d 3 ( 3 E, 3 F, 3 B, 3 D) are o pti o nal i n t he st u d y.
T he st u d y  will be c o n d ucte d as a d o u ble-bli n d, s p o ns or -o pe n st u d y a n d will be c o n d ucte d 
gl o ball y wit h t he n u m ber of st u d y sites yet t o be deter mi ne d -. 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 ( Secti o n 6. 7 ).
4. 1. 1. D ose F i n di n g a n d S t o p pi n g R ules
T he S p o ns or will ma ke t he fi nal decisi o n of d oses f or t he c o h orts , i ncl u di n g rec o m me n dati o n 
t o re peat a d ose or o pe ni n g e nr oll me nt of t he s u bse q ue nt c o h ort. T he E -D M C a p pr o val of t he 
S p o ns or’s rec o m me n dati o n t o re peat a d ose or o pe ni n g e nr oll me nt of t he s u bse q ue nt c o h ort 
will be i n de pe n de ntl y assesse d f or eac h of t he differe nt a ge gr o u ps a n d will be base d o n t he 
safety/ t olera bilit y a n d c o nce ntrati o n data .
Re peat d osi n g at t he assesse d d ose le v el or pr o gressi o n t o t he hi g her d ose le vel will n ot occ ur
if:

Mea n C
ma x
n g/ m L a n d Mea n A U C 2 4
n g• h/ m L , wit hi n a n a ge ba n d ( 
 
)
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 7
D osi n g or e nr oll me nt i nterr u pti o n will occ ur if a n y  of t he f oll o wi n g is o bser ve d:
•
Deat h of a partici pa nt d uri n g partici pati o n i n t he st u d y  recei vi n g st u d y i nter ve nti o n 
(sis u nat o vir) a n d assesse d as p ossi bl y , pr o ba bly, or defi nitel y relate d t o st u d y 
i nter ve nti o n (sis u nat o vir) b y t he I n vesti gat or(s) a n d/ or S p o ns or.
•
T w o or m ore S A Es i n t he sa me S O C i n t he st u d y  recei vi n g st u d y i nter ve nti o n 
(sis u nat o vir) assesse d as p ossi bl y , pr o ba bly, or defi nitel y  relate d t o st u d y i nter ve nti o n 
(sis u nat o vir) by t he I n vesti gat or(s) a n d/ or S p o ns or.
•
Se vere n o nseri o us A Es, c o nsi dere d as, at least, p ossi bl y  relate d t o st u dy i nter ve nti o n 
(sis u nat o vir), i n 2 partici pa nts (recei vi n g sis u nat o vir), i n de pe n de nt of wit hi n or n ot wit hi n 
t he sa me or ga n class, i n dicati n g d ose li miti n g i nt olera nce.
•
T w o or m ore partici pa nts recei vi n g st u d y i nter ve nti o n (sis u nat o vir) e x perie nce t he sa me
or a si milar A E t hat is assesse d as se vere i n i nte nsit y  a n d i n t he o pi ni o n of t he E-D M C 
a n d/ or S p o ns or, re prese nt a n u nacce pta ble ris k t o partici pa nts e nr olle d i n t he trial.  
•
If t w o or m ore partici pa nts recei vi n g st u d y i nter ve nti o n (sis u nat o vir) de vel o p si milar 
cli nicall y si g nifica nt la b orat or y, or vital si g n a b n or malities, i n t he sa me or ga n class, 
i n dicati n g d ose li miti n g i nt olera nce. 
If a ny of t he a b o ve criteria are f ulfille d, restart of d osi n g will o nl y be p ossi ble if a gree d b y 
t he E-D M C. S h o ul d a cle ar n o n-I M P ca use f or a ny of t he a b o ve be i de ntifie d, t he st u d y  ma y 
c o nti n ue.
4. 2. Scie ntific R ati o n ale f or St u d y Desi g n
T his st u d y  is a ra n d o mize d, d o u ble-bli n d, s p o ns or -o pe n, place b o -c o ntr olle d, m ultice nter 
st u d y i n R S V-i nfecte d o ut patie nt a n d h os pitalize d ne onates, i nfa nts , a n d c hil dre n, 1 da y  u p t o 
6 0 m o nt hs of a ge wit h R S V -L R TI . T his is a d ose fi n di n g st u d y t o e val uate t he P K, safet y,
a n d t olera bilit y of sis u nat o vir. T he c urre nt st u d y  will pr o vi de a d diti o nal data at a ges 
pre vi o usl y  e val uate d i n C 5 2 4 1 0 0 3 a n d will als o e val uate a br oa der pe diatric p o p ulati o n 
(
ol d a n d c hil dre n
 ol d) t o i nf or m d ose selecti o n i n 
f ut ure st u dies. Si nce c hil dre n are a v ul nera ble p o p ulati o n, a n E- D M C is use d i n t his st u d y  t o 
e ns ure t he safety o f partici pa nts.
T he safet y a n d P K of sis u nat o vir ha ve n ot bee n st u die d t o -date i n
 b ut t his 
 gr o u p 
is n ote d t o be at t he
[3 ,4 ]. A d diti o nall y, e x pa n di n g t he 
safety a n d P K i nf or mati o n of sis u nat o vir
t o i nf or m f ut ure 
st u dies ca n hel p e ns ure c orrect d ose re gi me ns t o hel p pre ve nt acute L R TI h os pitalizati o n 
attri b ute d t o R S V disease i n c hil dre n less t ha n 5 ye ars ol d [2 ]. 
T here are c urre ntl y  n o a p pr o ve d R S V a nti virals a vaila ble, a n d t h us n o acti ve c o ntr ol ca n be 
pr o p ose d as c o m parat or. T he c o m parat or f or t his st u d y  is partici pa nts recei vi n g place b o. 
Eac h c o h ort e val uate d i n t he st u d y  will ha ve partici pa nts o n place b o. T he place b o gr o u p is 
re q uire d f or assessi n g t he safety, t olera bilit y, a n d palata bilit y of t he st u dy i nter ve nti o n. All 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 8
partici pa nts (i ncl u di n g partici pa nts recei vi n g place b o) e nr olle d i n t he st u d y will recei ve t he 
S O C.
Acc or di n g t o t he D DI ris k assess me nt f or sis u nat o vir as descri be d i n Secti o n 2. 2. 2 , 
sis u nat o vir is a
of
 F or t his reas o n, se nsiti ve 
 
 are pr o hi bite d i n t his st u d y. Si nce sis u nat o vir is a
 
are als o 
pr o hi bite d. Lastl y , d ue t o p ote ntial ris k of 
 i n hi biti o n, se nsiti ve s u bstrates 
of t hese tra ns p orters ma y be a d mi nistere d wit h ca uti o n d uri n g treat me nt peri o d .
4. 2. 1. P at ie nt I n p ut I nt o Desi g n 
Pare ntal s ur ve y s are bei n g c o n d ucte d t o e val uate feasi bilit y of st u d y recr uit me nt, o pti mize 
st u d y partici pati o n, a n d c ollect fee d bac k o n h o w t o e n ha nce p ote ntial e d ucati o nal materials 
a vaila ble f or partici pa nt’s pare nt(s)/le gal g uar dia n s.
4. 2. 2. Di versit y of St u d y P o p ul ati o n
Di versit y  of st u d y p o p ulati o n i n t his pr ot oc ol a p plies t o sites i n t he U S o nl y. T he di versit y 
strate g y will i ncl u de sites wit h t he p ote ntial t o s u p p ort t he recr uit me nt of di verse pe diatric 
p o p ulati o ns. Reas o na ble at te m pts will be ma de t o e nr oll partici pa nts t hat are re prese ntati ve 
of t he patie nt p o p ulati o n t hat will be treate d wit h sis u nat o vir i n cli nical practice. T he 
f oll o wi n g strate gies ma y be e x pl ore d i n s u p p ort of di verse recr uit me nt eff orts:

Selecti n g sites t ha t ha ve access t o di verse pe diatric partici pa nts 

Creati n g a n d c o m pleti n g i n di vi d ual site recr uit me nt pla ns i n c olla b orati o n wit h sites

Ha ve pr oacti ve disc ussi o ns wit h i n vesti gat or sites t hr o u g h o ut t he e nr oll me nt peri o d t o 
assess a n d ree val uate site s pecifi c strate gies as nee de d t o best p ositi o n eac h site f or t he 
m ost di verse re prese ntati o n e nr oll me nt o utc o mes

De vel o pi n g recr uit me nt a n d rete nti o n materials wit h c ult urall y  a n d li n g uisticall y 
a p pr o priate la n g ua ge a n d i ma ger y  t o res o nate wit h u n derre prese nte d po p ulati o ns

Tra nslati n g all patie nt -faci n g materials i nt o U S S pa nis h

Pr o vi di n g i n vesti gat ors wit h recr uit me nt materials f or b ot h p ote ntial partici pa nts a n d 
ot her Healt hcare Pr o vi ders

E d ucati n g site staff o n t he i m p orta nce of i ncl u di n g di verse partici pa nts

M o nit or di verse e nr oll me nt t o i de ntif y  p ote ntial o p p ort u nities t o i ncl u de di verse 
p o p ulati o ns
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 4 9
4. 2. 3. R ati o n ale f or C o m p ar at or
T here are c urre ntl y  n o a p pr o ve d R S V a nti virals a vaila ble, a n d t h us n o acti ve c o ntr ol ca n be 
pr o p ose d as c o m parat or. T he c o m parat or f or t his st u d y is partici pa nts recei vi n g place b o. 
Eac h c o h ort e val uate d i n t he st u d y  will ha ve partici pa nts o n place b o. T he place b o gr o u p is 
re q uire d f or assessi n g t he safety, t olera bilit y, a n d palata bilit y of t he st u dy i nter ve nti o n. 
All partici pa nts (i ncl u di n g partici pa nts recei vi n g place b o) e nr olle d i n t he st u d y  will recei ve 
t he S O C. Partici pa nts e nr olle d i n t he st u d y w hile i n t he o ut patie nt setti n g ma y c o nti n ue i n t he 
st u d y if h os pitalize d at i n vesti gat or discreti o n. C 5 2 4 1 0 0 3 st u d y  t hat c o m plete d recr uit me nt, 
was c o n d ucte d t o c haracterize t he P K pr ofile, safet y a n d vir ol o gic res p o nse t o sis u nat o vir i n 
R S V -i nfecte d h os pitalize d c hil dre n a ge d 1 m o nt h - 3 6 m o nt hs a n d i ncl u de d a n o pe n-la bel 
Part A ( 1. 0, 2. 0 a n d 2. 5 m g/ k g si n gle d ose) a n d d o u ble -bli n d Part B (
 
; 2. 5 m g/ k g, 3. 5 m g/ k g a n d 5 m g/ k g q 1 2 h × 5 da y s). I nitial pe diatric d ose 
rec o m me n dati o ns f or C o h ort 1 A, 1 B, a n d 1 C are base d o n o bser ve d c o nce ntrati o ns i n St u d y 
C 5 2 4 1 0 0 3 wit h i nter p olati o n of pre dicte d e x p os ures, relati ve t o e x p os ure of  
m g 
 i n 
a d ults. 
4. 3. J ustific ati o n f or D ose
T he c urre nt st u d y  will e val uate safety, t olera bilit y, P K , a n d g ui da nce f or f ut ure d osi n g of 
sis u nat o vir i n a br oa der pe diatric p o p ulati o n ( 1 da y t o 6 0 m o nt hs of a ge) wit h R S V-L R TI  f or 
f urt her cli nical de vel o p me nt of sis u nat o vir.
T o i n vesti gate t he effect of sis u nat o vir o n cli nical acti vit y  f oll o wi n g R S V i nfecti o n, a viral 
c halle n ge cli nical st u d y i n healt h y a d ult partici pa nts was c o n d ucte d w here d oses of 2 0 0 m g 
or 3 5 0 m g Q 1 2 × 5 da y s were a d mi nistere d f oll o wi n g i n oc ulati o n of a n R S V i nfecti o n 
( C 5 2 4 1 0 0 2). I n t his st u d y, at b ot h d oses e val uate d, sis u nat o vir r o b ustl y decrease d viral l oa d 
a n d alle viate d R S V s y m pt o ms relati ve t o place b o. W hile statisticall y  si g nifica nt differe nces 
were n ot o bser ve d bet wee n t he t w o d ose le vels relati ve t o place b o, t he 3 5 0 m g d ose effect 
was n u mericall y lar ger t ha n t he 2 0 0 m g d ose. Pe diatric d oses are e x pecte d t o pr o d uce 
s yste mic stea dy- state e x p os ures c o m para ble t o t he a d ult d ose of 2 0 0 m g q 1 2 h t hat was f o u n d 
t o be effecti ve i n treati n g viral l oa d a n d sy m pt o ms of R S V i n t he c halle n ge st u d y .
A d diti o nall y , sis u nat o vir was a d mi nistere d i n a c o m plete d e x -U S P hase 2 st u d y  ( C 5 2 4 1 0 0 3, 
pre vi o usl y  R E V C 0 0 3) t o c haracterize t he P K pr ofile, safety a n d vir ol o gic res p o nse t o 
sis u nat o vir i n R S V-i nfecte d h os pitalize d c hil dre n a ge d 1 m o nt h -3 6 m o nt hs. Partici pa nts 
1 m o nt h t o < 6 m o nt hs of a ge were a d mi nistere d sis u nat o vir u p t o 2. 5 m g/ k g q 1 2 h f or 5 da ys. 
Partici pa nts 6 m o nt hs t o 3 6 m o nt hs of a ge were a d mi nistere d sis u nat o vir u p t o 5. 0 m g/ k g 
q 1 2 h f or 5 da y s. T he hi g hest d ose i n eac h a ge gr o u p pr o vi de d mea n e x p os ures a b o ve E C 9 0
a n d bel o w t he pre-s pecifie d u p per e x p os ure li mit of 2 9 4 n g/ m L. O verall, sis u nat o vir was 
f o u n d t o be safe f or i nfa nts a n d c hil dre n ≥1 m o nt h t o ≤3 6 m o nt hs . T hese res ults s u p p ort t he 
c urre nt st u d y t o esta blis h safet y, t olera bilit y, P K , a n d g ui da nce f or d osi n g of sis u nat o vir i n a 
br oa der pe diatric p o p ulati o n ( 1 da y  u p t o 6 0 m o nt hs) wit h R S V-L R TI  f or f urt her cli nical 
de vel o p me nt of sis u nat o vir.
I nitial pe diatric d ose rec o m me n dati o ns f or C o h ort 1 A, 1 B, a n d 1 C are base d o n o bser ve d 
c o nce ntrati o ns i n St u d y C 5 2 4 1 0 0 3 wit h i nter p olati o n of pre dicte d e x p os ures, relati ve t o 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 0
e x p os ure of  
m g 
 i n a d ults. T he pr o p ose d starti n g d ose of sis u nat o vir f or partici pa nts 
is  
m g/ k g a n d f or partici pa nts  
) is  
m g/ k g (see Ta ble 4 ). T hese d oses are 
t ha n t h ose a d mi nistere d i n 
, w hic h were well bel o w t he P K st o p pi n g li mit 
N O A E Ls. 
T a ble 4.
C o h ort 1 D ose Rec o m me n d ati o ns
 ( preli mi n ar y) Ge o Me a n ( % C V)
Ge o Me a n 
( % C V)
 
 
( n = 1 1)
3. 5 m g/ k g
( n = 3)
Pre dicte d
Pre dicte d 
5 m g/ k g
( n = 2)
C tr o u g h S S
4 2 ( 1 9 0 )
1 7 ( 2 0 0 )
6 9 ( 3 0 )
C ma x S S
1 1 1 ( 1 4 6)
3 6 ( 2 4 9 )
1 8 1 ( 9 8 )
A U C S S
8 6 9 ( 1 2 1)
2 6 4 ( 2 2 4)
1 3 8 0 ( 7 9)
Base d o n a nal ys is of P K a n d safety data fr o m C o h ort 1, t he d oses f or C o h ort 2 ma y  be 
a dj uste d t o m ore cl osel y matc h t he  
m g d ose i n 
or t o gat her a d diti o nal data o n 
d oses use d i n C o h ort 1. T o s u p p ort t his, a n iterati ve p o p ulati o n P K m o del is bei n g de vel o pe d 
t o s u p p ort f urt her pe diatric d ose rec o m me n dati o ns. T his m o del is de vel o pe d wit h s uccessi ve 
u p dates a n d vali dati o ns fr o m all a vaila ble a d ult a n d pe diatric data as st u dies c o m plete, 
i ncl u di n g Part A a n d B of C 5 2 4 1 0 0 3. It is a ntici pate d t hat t he wei ght- base d d ose will be 
a dj uste d f or pe diatric patie nts b y  a ge, base d o n mat urati o n of  
li ver f u ncti o n. T he 
 d ose of sis u nat o vir f or
will be deter mi ne d after 
e val uati o n of 
 T he s pecific d ose a n d 
 i n o pti o nal C o h ort 3 
will be deter mi ne d u p o n re vie w of C o h orts 1 a n d / or 2 b ut will n ot e xcee d e x p os ures f o u n d t o 
be well t olerate d i n a d ults ( C 5 2 4 1 0 0 6). S p o ns or will deter mi ne w hic h a ge gr o u ps i n C o h ort 3 
nee d a d diti o nal e x p os ure, safet y or t olera b ilit y data f or a gi ve n d ose.
4. 4. E n d of St u d y Defi niti o n
T he e n d of t he st u d y is defi ne d as t he date of t he last visit of t he last partici pa nt i n t he st u d y 
s h o w n i n t he S o A f or t he last partici pa nt i n t he trial gl o bally.
A partici pa nt i s c o nsi dere d t o ha ve c o m plete d t he st u d y if t he y ha ve c o m plete d all peri o ds of 
t he st u d y, i ncl u di n g t he last visit s h o w n i n t he S o A .
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 nts are e nr olled, 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 ni n g t o ol is utilize d f or st u d y 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 nts f or w h o m partici pati o n i n t he st u d y  is c o nsi dere d 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 1
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 he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y 
at scree ni n g u nless ot her wise i n dicate d:
A ge a n d Se x:
1.
Partici pa nts 1 d a y t o ≤6 0 m o nt hs of a ge a n d wei g ht ≥2. 5 k g t o ≤2 3 k g.
Dise ase C h ar acteristics:
2.
A p ositi ve R S V dia g n ostic test wit h res ult a vaila ble i n s o urce d oc u me nt t o c o nfir m 
eli gi bilit y eit her acc or di n g t o r o uti ne site practice or I n vesti gat or sites ma y use R S V P O C 
test kits t hat are pr o vi de d f or t his st u d y. R S V dia g n os tic test, a nti ge n or m olec ular test is 
acce pta ble, a n d s h o ul d be c ollecte d wit hi n
h o urs of ra n d o mizati o n. 
3.
E vi de nce of L R TI b y t he prese nce of ≥1 fr o m a n y of t he f oll o wi n g 4 cate g ories (a 
t hr o u g h d):
a.
I ncrease d res pirat or y rate f or a ge:

< 2 m o nt hs: ≥6 0 b p m

≥2 t o < 1 2 m o nt hs: ≥5 0 b p m

≥1 2 t o ≤6 0 m o nt hs: ≥4 0 b p m 
b.
S p O 2 < 9 5 % o n r o o m air
c.
I ncrease d res pirat or y eff ort as e vi de nce d b y ≥1 of t he f oll o wi n g:

Gr u nti n g wit h e x pirati o n

Nasal flari n g

Retracti o ns
d.
O ne or m ore of t he f oll o wi n g e xa m fi n di n gs o n a usc ultati o n:

W heezi n g

R h o nc hi

Rales or crac kles
4.
R S V relate d si g ns a n d/ or s ym pt o ms m ust be prese nt f or ≤
d a y s at ti me of 
ra n d o mizati o n. 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 2
Ot her I ncl usi o n Criteri a:
5.
T he pare nt(s)/le gal g uar dia n of t he partici pa nt ha ve pr o vi de d writte n i nf or me d c o nse nt 
f or the partici pa nt t o partici pate. De pe n di n g o n t he a ge of t he partici pa nt a n d acc or di n g t o 
l ocal re q uire me nts, partici pa nts will als o be as ke d t o pr o vi de asse nt as a p pr o priate 
( ver bal).
6.
P artici pa nts’ pare nt(s)/le gal g uar dia n(s) a n d partici pa nts, as a ge a p pr o p riate, w h o are
willi n g a n d a ble t o c o m pl y wit h all sc he d ule d visits, i n vesti gati o nal pla n, la b orat or y tests, 
a n d ot her st u d y pr oce d ures. Partici pa nts’ pare nt(s)/le gal g uar dia n s h o ul d be a vaila ble f or 
tele p h o ne c o ntact wit h site staff f or t he d urati o n of t he st u d y.
5. 2. E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m t he st u d y  if a n y of t he f oll o wi n g criteria a p pl y:
Me dic al C o n diti o ns:
1.
A n y  me dical, de vel o p me ntal, or be ha vi oral c o n diti o n (i ncl u di n g hist or y of self-har mf ul 
be ha vi ors) or la b orat or y  a b n or malit y t hat ma y i ncrease t he ris k of st u d y partici pati o n or, 
i n t he i n vesti gat or’s j u d g me nt, ma ke t he partici pa nt i na p pr o priate f or t he st u d y.
2.
Pre mat ure i nfa nts ( gestati o nal a ge less t ha n 3 5 wee ks) A N D < 1 y ear of p ost-natal a ge. 
N ote: I nfa nts 3 5- a n d 3 6-wee k gest ati o nal a ge are per mitte d if t he y wei g h at least 2. 5 k g 
a n d are at least 2 m o nt hs p ost -natal a ge. 
3.
 wit h i ntra uteri ne gr o wt h restricti o n defi ne d by ha vi n g 3 or 
m ore of t he f oll o wi n g: 

Birt h wei g ht < 1 0t h perce ntile o n p o p ulati o n- b ase d or c ust o mize d gr o wt h c harts 

Hea d circ u mfere nce < 1 0t h perce ntile 

Le n gt h < 1 0t h perce ntile  

Pre natal dia g n osis of fetal gr o wt h restricti o n

Mater nal pre g na nc y  i nf or mati o n ass ociate d wit h fetal gr o wt h restricti o n (e g, 
h y perte nsi o n , pre -ecla m psia)
4.
A n y  cli nicall y si g nifica nt E C G a b n or malit y i n a partici pa nt's me dical hist or y, or i n t he 
pre -d ose E C G t hat per i n vesti gat or j u d ge me nt ma y  affect partici pa nt safety or 
i nter pretati o n of st u dy res ults. N ote : If si n us tac hycar dia is prese nt, a n d n ot w orse t ha n 
e x pecte d d ue t o u n derl yi n g disease, partici pa nt ma y  be c o nsi dere d at i n vesti gat or 
discreti o n , if t he si n us tac h ycar dia is n ot e x pecte d t o i nterfere wit h e val uati o n of res p o nse 
t o st u d y i nter ve nti o n.
5.
K n o w n hist or y  of he patic disease, c o ncer n f or acti ve ac ute or c hr o nic viral he patitis, or 
ac ute he patic fail ure. 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 3
6.
Partici pa nts > 
da y s o nl y: K n o w n hist or y of A S T, A LT, or T bili a b n or malities > 2 ×
U L N wit hi n 6 m o nt hs of scree ni n g . La b orat or y  assess me nts n ot re q uire d at scree ni n g f or 
partici pa nts >
 da y s u nless dee me d necessar y b y t he i n vesti gat or t o c o nfir m n or mal 
he patic f u ncti o n. N ote : Partici pa nts wit h hist or y of ele vate d bilir u bi n d ue t o ne o natal 
h y per bilir u bi ne mia t hat is res ol ve d wit h T Bili val ues wit hi n refere nce ra n ge ma y  be 
e nr olle d.
7.
H ist or y of e pile psy or seiz ures. Partici pa nts wit h a hist or y of fe brile seiz ures will be 
per mitte d t o e nr oll.
8.
E x pecte d t o recei ve or has recei ve d a n a nti viral f or a n ot her res pirat or y viral i nfecti o n ( e g,
i nfl ue nza or C O VI D-1 9) wit hi n 1 0 da y s of scree ni n g.
9.
S us pecte d or c o nfir me d cli nicall y  si g nifica nt m o derate or se vere bacterial i nfecti o n ( e g,
bacterial p ne u m o nia, bactere mia), t hat ma y  i nterfere wit h t he e val uati o n of res p o nse t o 
t he st u d y i nter ve nti o n at i n vesti gat or discreti o n. Partici pa nts wit h mil d, l oc alize d 
i nfecti o ns s uc h as otitis me dia or U TI ca n be i ncl u de d.
1 0. E vi de nce of se vere res pirat or y  fail ure re q uiri n g i n vasi ve mec ha nical ve ntilati o n or 
E C M O . N ote : Partici pa nts re q uiri n g n o n-i n vasi ve ve ntilati o n, i ncl u di n g hi g h fl o w nasal 
ca n n ula ( H F N C) a n d c o n ti n u o us p ositi ve air wa y press ure (C P A P ), re mai n eli gi ble f or t he 
st u d y.
1 1. K n o w n t o ha ve si g nifica nt c o m or bi dities, i ncl u di n g ge netic dis or ders (e g, tris o m y  2 1); 
car di o p ul m o nar y diseases (e g, he m o dy na micall y si g nifica nt c o n ge nital heart disease) ; 
si g nifica nt p ul m o nar y  disease (e g, c ystic fi br osis); hist or y of s ur ger y f or dia p hra g matic 
her nia; a n y here ditar y or ac q uire d meta b olic diseases, he mat ol o gical or ot her 
mali g na nc y ; or is k n o w n t o be HI V p ositi ve; has e vi de nce of se vere ne ur ol o gic 
i m pair me nt or de vel o p me ntal dela y t hat w o ul d li mit t he a bilit y t o a d mi nister I M P or 
e val uate t he safet y or cli nical res p o nse t o I M P. N ote: P reter m partici pa nts (if < 3 5 wee ks 
gestati o nal a ge m ust be at least o ne y ear p ost -natal a ge) wit h br o nc h o p ul m o nar y  
d y s plasia (c hr o nic l u n g disease of pre mat urit y) re mai n eli gi ble f or e nr oll me nt.
1 2. I m m u n os u p pressi ve disease (e g, b o ne marr o w or or ga n tra ns pla ntati o n or pri mar y  
i m m u ne deficie ncies) O R pr ol o n ge d use of i m m u ne-wea ke ni n g me dicati o ns .

Has recei ve d c ortic oster oi ds e q ui vale nt t o pre d nis o ne ≥2 m g/ k g dail y f or at least 
1 4 c o nsec uti ve da ys wit hi n 3 0 da ys pri or t o st u d y start or e x pecte d t o recei ve e q ui vale nt 
d ose d uri n g st u d y dr u g treat me nt. I n hale d/ ne b ulize d or t o pical (s ki n, e yes or ears) 
c ortic oster oi ds are per mitte d, e xce pt t h ose pr o hi bite d (see Sect i o n 6. 9 ).

Has recei ve d treat me nt wit h bi ol o gics (e g, i nfli xi ma b, uste ki n u ma b), i m m u n o m o d ulat ors 
(e g, met h otre xate, 6 M P, azat hi o pri ne) or ca ncer c he m ot hera py wit hi n 9 0 da ys pri or t o 
st u d y start or e x pecte d t o recei ve treat me nt wit h t hese t hera pe utics d uri n g st u d y  dr u g 
treat me nt.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 4
1 3. Malf or mat i o n of t he gastr oi ntesti nal tract i ncl u di n g u nres ol ve d pyl oric ste n osis, hist or y  
of necr otizi n g e nter oc olitis, s h ort b o wel, or ot her si g nifica nt c o n diti o n t hat w o ul d alter 
dr u g a bs or pti o n or i ncrease t he ris k of diarr hea.
1 4. Has si g nifica nt oral a n d/ or ma xill ofacial malf or mati o ns t hat w o ul d li mit t he a bilit y t o 
a d mi nister IM P.
Pri or/ C o nc o mit a nt T her a p y:
1 5. Aller g y  t o test me dicati o n or c o nstit ue nts.
1 6. C urre nt use of a n y pr o hi bite d c o nc o mita nt me dicati o n(s) . Refer t o A p pe n di x 8 .

Has ta ke n wit hi n 5 half -li ves pl us 1 4 da y s bef ore d osi n g, or re q uires d uri n g t he 
d osi n g peri o d of t he st u d y, a n y dr u g t hat c o ul d i m pact t he P K of t he i n vesti gati o nal 
pr o d uct, i ncl u di n g a n y prescri pti o n me dicati o ns, O T C me dicati o ns, her bal re me dies 
or d ietar y s u p ple me nts c o ntai ni n g St. J o h n’s W ort or t he c o ns u m pti o n of  
 
 pr o d ucts as t hese are k n o w n t o be  
 
 

Has ta ke n wit hi n 5 da y s bef ore d osin g or re q uire d uri n g t he d osi n g peri o d of t he 
st u d y, a ny pr ot o n p u m p i n hi bit ors. Has ta ke n wit hi n 1 2 h o urs bef ore d osi n g or re q uire 
d uri n g t he d osi n g peri o d of t he st u d y , a n y H 2 bl oc kers.
1 7. Has recei ve d treat me nt wit h ri ba viri n ( oral or i n hale d) wit hi n 3 0 da ys  of scree ni n g. 
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
1 8. Pre vi o us a d mi nistrati o n wit h a n i n vesti gati o nal pr o d uct ( dr u g or vacci ne) wit hi n 3 0 da y s 
( or as deter mi ne d by t he l ocal re q uire me nt) or 5 half -li ves prece di n g t he first d ose of 
st u d y i nter ve nti on use d i n t his st u d y  ( w hic he ver is l o n ger). Partici pati o n i n st u dies of 
ot her i n vesti gati o nal pr o d ucts ( dr u g or vacci ne) at a n y  ti me d uri n g t heir partici pati o n i n 
t his st u d y.
N ote: l ocal re g ulati o ns or ot her fact ors ma y  re q uire m ore t ha n 3 0 da ys.
Di a g n ostic Assess me nts
1 9. Baseli ne 1 2- lea d E C G wit h Q Tc F ≥4 5 0 ms. 
2 0.
ol d ) wit h a ny of t he f oll o wi n g la b orat or y  
a b n or malities at scree ni n g: 

T otal bilir u bi n > 2 × U L N 

A S T > 2 × U L N

A L T > 2 × U L N
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 5
Ot her E xcl usi o n Criteri a:
2 1. Ot her a c ute or c hr o nic me dical or la b orat or y a b n or malit y t hat ma y i ncrease t he ris k 
ass ociate d wit h st u d y partici pati o n or i n vesti gati o nal pr o d uct a d mi nistrati o n or ma y  
i nterfere wit h t he i nter pretati o n of st u d y res ults a n d, i n t he j u d g me nt of t he I n vesti gat or, 
w o ul d ma ke t he partici pa nt i na p pr o priate f or e ntr y i nt o t his st u d y.
2 2. M ore t ha n 1 partici pa nt per h o use h ol d.
2 3. F or Ar ge nti na partic i pa nts O N L Y, as per l ocal re g ulati o ns, e vi de nce t hat partici pa nt is 
p ositi ve f or HI V, H B V , or H C V i nfecti o n base d o n m ot her’s ser ol o g y  res ults d uri n g 
pre g na nc y  or t he partici pa nt’s ser ol o gies.
5. 3. Lifest yle C o nsi der ati o ns
N o restricti o ns are re q uire d.
5. 4. Scree n F ail ures
Scree n fail ures are defi ne d as partici pa nts w h o asse 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.
I n di vi d uals w h o d o n ot meet t he criteria f or partici pati o n i n t his st u d y (scree n fail ure) ma y 
n ot be rescree ne d.  
5. 5. Criteri a f or Te m p or aril y Del a yi n g E nr o ll 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
N ot A p plica ble
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 n o n-i n vesti gati o nal me dici nal 
pr o d ucts, me dical de vices, a n d ot her i nter ve nt i o ns (e g, s ur gical a n d be ha vi oral) i nte n de d t o 
be a d mi nistere d t o t he st u d y partici pa nts d uri n g t he st u d y  c o n d uct. 
F or t he p ur p oses of t his pr ot oc ol, st u d y  i nter ve nti o n refers t o sis u nat o vir or matc hi n g 
place b o.
6. 1. St u d y I nter ve nti o n(s) A d mi nistere d
Sis u nat o vir f or m ulati o n e val uate d i n t his st u d y  is a 
, sa me as t he f or m ulati o n e val uate d 
i n t he C 5 2 4 1 0 0 3 st u d y. T he matc hi n g place b o is f or m ulate d as a dr y  ble n d of ma n nit ol a n d 
micr ocr y stalli ne cell ul ose. T he dr y ble n ds are fille d i nt o h ydr o x y p r o pyl  met h ylcell ul ose 
( h ypr o mell ose) ca ps ules. Sis u nat o vir a n d place b o are a d mi nistere d
f or d a y s (2 d oses 
dail y D a y  1-D a y  ) / 6 da y s (if n ot starte d wit h 2 d oses o n Da y  1) f or a t otal of  
d oses. 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 6
St u d y  i nter ve nti o n will be a d mi nistere d t o t he partici pa nt b y  a pare nt, le gal g uar dia n, or 
H C P.
St u d y I nter ve nti o n(s)
I nter ve nti o n N a me
P F -0 7 9 2 3 5 6 8 ( sis u n at o vir)
Pl ace b o f or P F -0 7 9 2 3 5 6 8 
(sis u n at o vir)
T y pe
Dr u g
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 or m ul ati o n
ca ps ule 
dis perse d i n 
 
 f or oral R O A or 
nas o gastric t u be R O A 
Matc hi n g E x peri me ntal
dis perse d 
i n 
f or oral 
R O A or nas o gastric t u be R O A 
U nit D ose Stre n gt h(s) *
m g/ m L ( 5 0 m g sis u nat o vir 
i nt o 
 
)
Matc hi n g E x peri me ntal
D os a ge Le vel(s)
C o h ort 1 A:  
m g/ k g
   
d oses 
C o h ort 1 B, 1 C: 
 m g/ k g 
 
 d oses
C o h ort 1 D, C o h ort 2, C o h ort 3: 
T B D 
;
 d oses
R o ute of A d m i nistr ati o n
Oral or nas o gastric t u be
Oral or nas o gastric t u be
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 
pr o vi de d t o sites i n blister car ds. 
Site staff will pre pare i n di vi d ual 
d oses i n b ottles f or 
a d mi nistrati o n.
Eac h blister car d a n d b ottle will 
be la bele d as re q uire d per c o u ntr y 
re q uire me nt.
Bli n de d
St u d y i nter ve nti o n will be 
pr o vi de d t o sites i n blister car ds. 
Site staff will pre pare i n di vi d ual 
d oses i n b ottles f or 
a d mi nistrati o n.
Eac h blister car d a n d b ottle will 
be la bele d as re q uire d per c o u ntr y 
re q uire me nt.
Bli n de d
S R S D
I B
I B
C urre nt/ F or mer N a me(s) or 
Ali as(es)
sis u nat o vir
P F -0 7 9 2 3 5 6 8
Place b o
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 7
St u d y I nter ve nti o n(s)
I nter ve nti o n N a me
P F -0 7 9 2 3 5 6 8 ( sis u n at o vir)
Pl ace b o f or P F -0 7 9 2 3 5 6 8 
(sis u n at o vir)
R V 5 2 1
St u d y Ar m(s)
A r m  Title
sis u nat o vir
Place b o
A r m  Descri pti o n
Partici pa nts will recei ve 
sis u nat o vir ( d ose as i n dicate d i n 
a b o ve ta ble) ;   d oses,
Partici pa nts will recei ve place b o ; 
 d oses,
6. 1. 1. A d mi nistr ati o n
A d mi nistrati o n of st u d y  i nter ve nti o n(s) will be perf or me d by pare nt(s)/le gal g uar dia n f or 
o ut patie nt partici pa nts.
A d mi nistrati o n of st u d y  i nter ve nti o n(s) at t he site will be perf or me d b y a n a p pr o priatel y 
q ualifie d a n d trai ne d me m ber of t he st u d y staff or pare n t(s)/le gal g uar dia n as all o we d b y 
l ocal, state, a n d i nstit uti o nal g ui da nce f or i n patie nt partici pa nts. 
F oll o wi n g a d mi nistrati o n of t he first d ose of st u d y i nter ve nti o n(s), partici pa nts will be 
o bser ve d f or 3 0 mi n utes b y  a n a p pr o priately q ualifie d a n d trai ne d me m ber of t he st u d y staff.
A p pr o priate me dicati o n a n d ot her s u p p orti ve meas ures f or ma na ge me nt of a me dical 
e mer ge nc y will be a vaila ble i n acc or da nce wit h l ocal g ui deli nes a n d i nstit uti o nal g ui deli nes
as nee de d .
St u d y  pers o n nel will re vie w d ose a d mi nistrati o n re q uire me nts wit h t he partici pa nt’s 
pare nt(s)/le gal g uar dia n, as a p pr o priate, bef ore a d mi nistra ti o n a n d t hr o u g h o ut t he st u d y as 
necessar y . Pare nt(s)/ le gal g uar dia n m ust be trai ne d b y t he site staff o n Da y 1, or pri or t o 
g oi n g h o me if h os pitalize d, o n t he pre parati o n a n d a d mi nistrati o n of t he st u d y  i nter ve nti o n.
T he I M P will be pr o vi de d as bli n de d kits (sis u nat o vir or place b o) i n acc or da nce wit h t he 
ra n d o mizati o n sc he d ule. 
I M P a d mi nistrati o n will be b y oral r o ute, eit her via s yri n ge b y pare nt(s), le gal g uar dia n(s), or 
t he healt h care pr ofessi o nal. T o facilitate pe diatric a d mi nistrati o n, t he sis u nato vir  
 
, a n d a 
pre deter mi ne d v ol u me of dil ue nt is a d de d t o f or m a dis persal b y  t he pare nt(s)/le gal 
g uar dia n/ H C P as a p plica ble. After dis persi n g t he  
 i n t he dil ue nt b y s ha ki n g, t he re q uire d 
d ose is ta ke n u p i nt o a s yri n ge a n d t he n a d mi nistere d t o t he partici pa nt. Eac h d ose s h o ul d be 
a d mi nistere d wit hi n 
of ra n d o mizati o n f or all partici pa nts a n d 
 
 i n acc or da nce wit h t heir assi g ne d d osa ge a n d dosi n g re gi me n. T o all o w t he 
partici pa nt t o select a c o n ve nie nt
d osi n g sc he d ule, t he ti mi n g of d osi n g f or t he 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 8
sec o n d d ose ma y be a dj uste d sli g htl y b ut s h o ul d be ta ke n at least 4 h o urs after, b ut n o later 
t ha n  
after t he first d ose. T he re mai ni n g d oses s h o ul d be ta ke n e ver y  
 
I M P s h o ul d be a d mi nistere d t o t he partici pa nt i n a cal m state. Fee di n g wit hi n 3 0 mi n utes
pri or t o d osi n g a n d wit hi n 3 0 mi n utes after d osi n g s h o ul d be rec or de d i n t he e Diar y.
I nstr ucti o ns
 
 will be pr o vi de d 
i n t he IP Ma n ual. D osi n g a n d A d mi nistrati o n I nstr ucti o ns will als o be i ncl u de d i n t he I P 
ma n u al f or t he pare nt(s)/ le gal g uar dia n/H C P t o a d mi nister t he st u d y i nter ve nti o n at t he st u d y 
site, h o me a n d h os pital as a p plica ble. I n a d diti o n, pare nt(s), le gal g uar dia n or H C P will be 
pr o vi de d wit h D osi n g I nstr ucti o ns, i ncl u di n g a trai ni n g vi de o, i n or der to ai de i n d osi n g at 
h o me. 
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 M P will be st ore d u n der a m bie nt c o n diti o ns bet wee n 1 5° C a n d 2 5° C. T he 
 i n b ottle 
has a n 
s helf life,
has a
 s helf life. 
1.
T he i n vesti gat or or desi g nee m ust c o nfir m t hat a p pr o priate c o n diti o ns (e g, te m perat ure) 
ha ve bee n mai ntai ne d d uri n g tra nsit f or all st u d y  i nter ve nti o ns recei ve d a n d a n y 
discre pa ncies are re p orte d a n d res ol ve d bef ore use of t he st u d y  i nter ve nti o n. 
2.
O nl y  partici pa nts e nr olle d i n t he st u d y ma y recei ve st u d y i nter ve nti o n a n d o nl y 
a ut h orize d site staff ma y  s u p pl y, pre pare, a n d/ or a d mi nister st u d y i nter ve nti o n.
3.
All st u d y  i nter ve nti o ns m ust be st ore d i n a sec ure, e n vir o n me ntall y c o ntr olle d, a n d 
m o nit ore d ( ma n 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. Dat a f or n o n w or ki n g da ys m ust i n dicate t he 
mi ni m u m a n d ma xi m u m te m perat ures si nce pre vi o usl y  d oc u me nte d u p o n ret ur n t o 
b usi ness.
4.
A n y  e xc ursi o ns fr o m t he st u d y i nter ve nti o n la bel st ora ge c o n diti o ns s h o ul d be re p orte d t o 
Pfizer u p o n disc o ver y  al o n g wit h acti o ns ta ke n. T he site s h o ul d acti vely p urs ue o pti o ns 
f or ret ur ni n g t he st u dy i nter ve nti o n t o la bele d st ora ge c o n diti o ns, as s o o n as p ossi ble. 
O nce a n e xc ursi o n is i de ntifie d, t he st u d y i nter ve nti o n m ust be q uara nti ne d a n d n ot use d 
u ntil Pfizer pr o vi des per missi o n t o use t he st u d y  i nter ve nti o n. S pecific details re gar di n g 
t he e xc ursi o n defi niti o n a n d i nf or mati o n t o re p ort f or eac h e xc ursi o n will be pr o vi de d t o 
t he site i n t he site pr oce d ures.
5.
A n y  st ora ge c o n diti o ns state d i n t he S R S D will be s u perse de d b y t he st ora ge c o n diti o ns 
state d o n t he la bel. Site staff will i nstr uct partici pa nt’s pare nt(s)/le gal g uar dia ns o n t he 
pr o per st ora ge re q uire me nts f or ta ke -h o me st u d y  i nter ve nti o n. See t he I P M f or st ora ge 
c o n diti o ns of t he st u d y i nter venti o n o nce dis pe nse d.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 5 9
6.
St u d y  i nter ve nti o ns s h o ul d be st ore d i n t heir ori gi nal c o ntai ners u ntil pre parati o n f or 
dis pe nsi n g be gi ns f or a partici pa nt.
7.
T he i n vesti gat or, i nstit uti o n, hea d of t he me dical i nstit uti o n ( w here a p plica ble), or 
a ut h orize d site staff i s res p o nsi ble f or st u d y i nter ve nti o n acc o u nta bilit y, rec o nciliati o n, 
a n d rec or d mai nte na nce (ie, recei pt, rec o nciliati o n, a n d fi nal dis p ositi o n rec or ds), s uc h as 
t he IP A L or s p o ns or -a p pr o ve d e q ui vale nt. All st u d y i nter ve nti o ns will be acc o u nte d f or 
usi n g a st u d y i nter ve nti o n acc o u nta bility f or m/rec or d. All st u d y i nter ve nti o n t hat is ta ke n 
h o me b y  t he partici pa nt’s pare nt(s)/le gal g uar dia n, b ot h use d a n d u n use d, m ust be 
ret ur ne d t o t he i n vesti gat or b y t he partici pa nt’s pare nt(s)/le gal g uar dia n. Ret ur ne d st u d y 
i nter ve nti o n m ust n ot be re dis pe nse d t o t he p artici p a nt’s p are nt(s)/le g al g u ar di a ns.
8.
F urt her g ui da nce a n d i nf or mati o n f or t he fi nal dis p ositi o n of u n use d st u d y  i nter ve nti o ns 
are pr o vi de d i n t he IP M. All destr ucti o n m ust be a de q uatel y d oc u me nte d. If destr ucti o n is 
a ut h orize d t o ta ke place at t he i n vesti gat or site, t he i n vesti gat or m ust e ns ure t hat t he 
materials are destr o ye d i n c o m plia nce wit h a p plica ble e n vir o n me ntal re g ulati o ns, 
i nstit uti o nal p olic y, a n d a n y s pecial i nstr ucti o ns pr o vi de d b y Pfizer.
U p o n i de ntificati o n of a pr o d uct c o m plai nt, n otif y t he s p o ns or 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
A q ualifie d staff me m ber will o btai n blister car d usi n g I R T c o ntai ner n u m ber, 
 
a n d als o pr o vi de t he la bel wit h 
t he i nstr ucti o ns o n t he b ottle.
A 
sec o n d staff me m ber will verif y t he dis pe nsi n g a n d i nstr ucti o ns o n t he la bels of t he 
d oc u me nts. T he partici pa nt’s pare nt(s)/le gal g uar dia n s h o ul d be i nstr ucte d t o mai ntai n t he 
pr o d uct i n t he b ottle pr o vi de d t hr o u g h o ut t he c o urse of d osi n g a n d ret ur n t he u n use d b ottles 
t o t he site at t he e n d of t he st u d y. T he re q uire d n u m ber of b ottles f or t he st u d y wit h I M P will 
be pr o vi de d t o t he pare nt(s)/le gal g uar dia n f or t he st u d y, base d o n wei g ht- base d d ose 
a dj uste d b y a ge, o n t he da y  of ra n d o mizati o n if o ut patie nt a n d o n disc har ge fr o m t he h os pital 
if i n patie nt.
F or o ut patie nt partici pa nts, eac h pare nt(s )/le gal g uar dia n will a d d a defi ne d v ol u me of 
per mitte d dil ue nt pri or t o oral a d mi nistrati o n o n a m g/ k g basis t o eac h b ottle. After 
i n t he dil ue nt b y s ha ki n g, t he re q uire d d ose is ta ke n u p i nt o a s yri n ge a n d 
t he n a d mi nistere d t o t he participa nt. 
If h os pitalize d, t he st u d y pers o n nel will a d d a defi ne d v ol u me of per mitte d dil ue nt pri or t o 
oral/ N G t u be a d mi nistrati o n o n a m g/ k g basis t o eac h b ottle (g ui da nce o n t he per mitte d 
dil ue nts will be pr o vi de d i n t he I n vesti gati o na l Pr o d uct (IP) Ma n ual; als o see 
Ta ble i n Secti o n 6. 1 ). T he re q uire d v ol u me of t he res ulta nt dis persi o n will be a d mi nistere d t o 
t he partici pa nt acc ordi n g t o t he prescri be d d ose re q uire d.
Pre pare d dis persi o n s h o ul d be d ose d wit hi n
h o urs.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 0
Eac h partici pa nt will be a d mi nistere d t he v ol u me re q uire d f or t he a ge -ra n ge s pecifie d d ose 
de pe n di n g o n t he wei g ht of t he partici pa nt. 
If t he partici pa nt misses a dose of I M P wit hi n t he per mitte d a d mi nistrati o n wi n d o w, , t he 
partici pa nt’s pare nt(s)/le gal g uar dia n s h o ul d a d mi nister it as s o o n as p ossi ble , b ut n o later 
t ha n
h o urs after t he ti me it is us uall y  ta ke n, a n d res u me t he n or mal d osi n g sc he d ule. 
Partici pa nts s h o ul d n ot d o u ble u p t he ne xt d ose of st u d y dr u g t o “ ma ke u p” w hat ha d bee n 
misse d. D osi n g s h o ul d be st o p pe d at t he e n d of t he treat me nt peri o d (
 d oses t otal). 
Sis u nat o vir a n d place b o will be pre pare d b y q ualifie d bli n de d site pers o n nel acc or di n g t o t he
I P M. T he st u dy i nter ve nti o n will be a d mi nistere d i n a bli n de d fas hi o n t o t he partici pa nts.
I M P will be si n gle use.
T he f oll o wi n g will be rec or de d i n t he e Diar y (A p pe n di x 1 0 D Secti o n 1 0. 1 0. 4 ):

D ate, start ti me of pre parati o n a n d ti me of eac h d ose a d mi nistere d

A d mi nistrat or of t he st u d y i nter ve nti o n : Pare nt(s)/le gal g uar dia n O R H C P

R o ute of a d mi nistrati o n: oral or nas o gastric t u be f or eac h d ose a d mi nistere d

I nf or mati o n o n fee di n g wit hi n 3 0 mi n utes bef ore a n d after d osi n g

Palata bilit y  q uesti o n naire after e ver y  d osi n g
See t he I P Ma n ual 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. 
6. 3. Assi g n me nt t o St u d y I nter ve nti o n
All ocati o n of partici pa nts t o treat me nt gr o u ps will pr ocee d t hr o u g h t he use of a n I R T s yste m. 
T he site pers o n nel (st u d y c o or di nat or or s pecifie d desi g nee) will be re q uire d t o e nter or select 
i nf or mati o n i ncl u di n g b ut n ot li mite d t o t he user’s I D a n d pass w or d, t he pr ot oc ol n u m ber, 
a n d t he partici pa nt n u m ber. T he site pers o n nel will t he n be pr o vi de d wit h a ra n d o mizati o n 
n u m ber c orres p o n di n g t o t he assi g ne d treat me nt gr o u p, a n d D U or c o ntai ner n u m ber(s) w he n 
st u d y i nter ve nti o n is bei n g s u p plie d via t he I RT s yste m. T he I R T s ys te m will pr o vi de a 
c o nfir mati o n re p ort c o ntai ni n g t he partici pa nt n u m ber, ra n d o mizati o n n u m ber, a n d D U or 
c o ntai ner n u m ber assi g ne d. T 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 at t he st u d y visits s u m marize d i n t he S o A . 
T he st u d y -s pecific IR T ref ere nce ma n ual a n d I PM will pr o vi de t he c o ntact i nf or mati o n a n d 
f urt her details o n t he use of t he IR T s y ste m.
6. 4. Bli n di n g
T his is a d o u ble -bli n d, s p o ns or -u n bli n de d st u d y . 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 1
6. 4. 1. Bli n di n g of P artici p a nts
Partici pa nts a n d t heir pare nt(s)/le gal g uar dia n will be bli n de d t o t heir assi g ne d st u d y 
i nter ve nti o n.
6. 4. 2. Bli n di n g of Site Pers o n nel
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 d y i nter ve nti o n. 
Partici pa nts will be assi g ne d t o recei ve st u d y i nter ve nti o n acc or di n g t o t he assi g ne d treat me nt 
gr o u p fr o m t he ra n d o mizati o n sc he me. I n vesti gat ors will re mai n bli n de d t o eac h partici pa nt’s 
assi g ne d st u d y i nter ve nti o n t hr o u g h o ut t he c o urse of t he st u d y. 
I n t he e ve nt of a Q uality Ass ura nce a u dit, t he a u dit or(s) will be all o we d access t o u n bli n de d 
st u d y i nter ve nti o n rec or ds at t he site(s) t o verif y t hat ra n d o mizati o n/ dis pe nsi n g has bee n d o ne 
acc uratel y.
6. 4. 3. Bli n di n g of t he S p o ns or
As t his is a s p o ns or -o pe n st u d y , t he s p o ns or ma y c o n d uct u n bli n de d re vie ws of t he data 
d uri n g t he c o urse of t he st u d y  f or the p ur p ose of safet y assess me nt, facilitati n g d ose fi n di n g 
decisi o ns, facilitati n g P K/ P D m o deli n g, a n d/ or s u p p orti n g cli nical de vel o p me nt. 
6. 4. 4. Se nsiti ve Cli nic al D at a 
Se nsiti ve cli nical data are data c ollecte d i n t his st u d y  t hat ha ve t he p ote ntial t o u n bli n d a 
partici pa nt’s treat me nt assi g n me nt. Access t o se nsiti ve cli nical data will be restricte d t o 
a ut h orize d i n di vi d uals u ntil t he st u d y has bee n u n bli n de d. T he f oll o wi n g data varia bles are 
c o nsi dere d se nsiti ve cli nical data: Assi g ne d treat me nt gr o u p ( Acti ve vers us place b o); P K 
para meters .
6. 4. 5. 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 
treat me nt 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 treat me nt 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 p artici pa nt. If a partici pa nt’s treat me nt 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 I RT refere nce ma n ual a n d I PM will pr o vi de t he c o ntact i nf or mati o n a n d 
f urt her details o n t he use of t he IR T s y ste m.
6. 5. St u d y I nter ve nti o n C o m pli a nce
W he n t he i n di vi d ual d ose is pre pare d
o n site , t he pre parati o n of t he d ose will be c o nfir me d 
b y  a sec o n d q ualifie d me m ber of t he st u d y site staff.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 2
W he n partici pa nts are d ose d at t he site
as a n o ut patie nt , t he y will recei ve st u d y i nter ve nti o n 
directl y  fr o m t he pare nt(s)/le gal g uar dia n u n der me dical s u per visi o n. 
T he date a n d ti me of eac h d ose a d mi nistere d will be r ec or de d i n t he e Diar y (A p pe n di x 1 0 D
i n Secti o n 1 0. 1 0. 4 ). T he d ose of st u d y i nter ve nti o n a n d st u d y partici pa nt i de ntificati o n will 
be c o nfir me d at t he ti me of d osi n g 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. St u d y site pers o n nel will e xa mi ne eac h partici pa nt’s 
m o ut h t o e ns ure t hat t he st u d y  i nter ve nti o n was i n geste d, if a p plica ble.
W he n partici pa nt’s pare nt(s)/le gal g uar dia ns a d mi nister st u d y  i nter ve nti o n(s) at h o me, 
c o m plia nce wit h st u d y i nter ve nti o n will be assesse d at t he ne xt c o nsec uti ve visit. C o m plia nce 
will be assesse d b y direct q uesti o ni n g a n d c o u nti n g ret ur ne d b ottles wit h i nitiall y  dis pe nse d 
st u d y i nter ve nti o n at t he e n d of t he st u d y a n d d oc u me nte d i n t he s o urce d oc u me nts a n d 
e Diar y. Deviati o n(s) fr o m t he prescri be d d osa ge re gi me n s h o ul d be rec or de d i n t he C R F.
A rec or d of t he n u m ber of st u d y  i nter ve nti o n d oses dis pe nse d t o a n d a d mi nistere d t o eac h 
partici pa nt m ust be mai ntai ne d a n d rec o ncile d wit h st u d y  i nter ve nti o n a n d c o m plia nce 
rec ords. I nter ve nti o n start a n d st o p dates, i ncl u di n g dates f or i nter ve nti o n dela y s will als o be 
rec or de d i n t he C R F.
If t he st u dy partici pa nt is h os pitalize d at t he ti me of e nr ol me nt a n d it is i de ntifie d t hat t he y 
( he/s he) c o ul d n ot atte n d t he Da y  a n d/ or Da y  visits if disc har ge d, t he i n vesti gat or ma y at 
t heir ( his/ her) discreti o n, if l ocal re g ulati o ns all o w a n d  
 ser vices are n ot 
a vaila ble, kee p t he partici pa nt i n t he h os pital f or c o n ve nie nce t o e ns ure Da y   a n d/ or Da y  
assess me nts ca n be c o n d uct e d i n c o m plia nce wit h pr ot oc ol re q uire me nts.
Partici pa nts ma y be re place d at S p o ns or discreti o n as descri be d i n Secti o n 4. 1 a n d 
Secti o n 9. 5 .
A n y de viati o n fr o m pr ot oc ol-s pecifie d d osi n g (e g, misse d si n gle d ose or partial d ose) s h o ul d 
be rec or de d as a pr ot oc ol de viati o n a n d t he i n vesti gat or or desi g nee is t o c o u nsel t he 
partici pa nt/ g uar dia n a n d e ns ure ste ps are ta ke n t o i m pr o ve c o m plia nce.
6. 6. D ose M o dific ati o n 
D ose m o dificati o n wit hi n a c o h ort is n ot all o we d . F or f urt her details o n d ose selecti o n f or 
eac h c o h ort, see Secti o n 4. 1 .
6. 7. 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
N o st u d y  i nter ve nti o n will be pr o vi de d t o partici pa nts at t he e n d of t heir st u d y  partici pati o n. 
It is e x pecte d t hat partici pa nts will be treate d as re q uire d wit h sta n dar d-of -care treat me nts, as 
a d vise d b y t heir us ual care p h ysicia n.
6. 8. Tre at me nt of O ver d ose
F or t his st u d y , a n y si ngle d ose of sis u nat o vir greater t ha n t he prescri be d dail y  d ose of st u dy 
i nter ve nti o n 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.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 3
I n t he e ve nt of a n o ver d ose, t he i n vesti gat or/treati n g p hys icia n 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 a n d la b orat or y  a b n or malities as 
me dicall y  a p pr o priate a n d f oll o w-u p u ntil res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise 
e x plai ne d, or t he partici pa nt is l ost t o f oll o w -u p (as defi ne d i n Secti o n 7. 3 ). 
3.
D oc u me nt t he q ua ntit y of t he e xcess d ose as well as t he d urati o n of t he o ver d ose i n t he 
C R F.
4.
O ver d ose is re p orta ble t o Pfizer Safet y  o nl y w he n ass oci ate d wit h a n S A E.
5.
O btai n a bl o o d sa m ple f or P K a nal ys is wit hi n 2 4 h o urs fr o m t he da y of t he last o ver d ose.
Decisi o ns re gar di n g d ose i nterr u pti 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.   
Pare nt (s)/le gal g uar dia n s h o ul d st ore t he st u d y i nter ve nti o n o ut of reac h of c hil dre n t o a v oi d 
a n y sit uati o ns t hat c o ul d res ult i n o ver d osi n g.
6. 9. Pri or a n d C o nc o mit a nt T her a p y

Use of f oll o wi n g a nti viral will be rec or de d i n t he C R F

Pri or treat me nt wit h Nirse vi ma b 
Pr o hi bite d Pri or Tre at me nts

Pr o hi bite d co nc o mita nt m e dicati o ns that m a y res ult i n D DI ( Secti o n 1 0. 8 ) 

Recei pt of c ortic oster oi ds e q ui vale nt t o pre d nis o ne ≥2 m g / k g dail y f or at least 1 4 
c o nsec uti ve da ys wit hi n 3 0 da y s pri or t o st u d y start.

A nti virals wit hi n 1 0 da y s of scree ni n g.  

Treat me nt wit h ri ba viri n ( oral or i n hale d) wit hi n 3 0 da y s of scree ni n g.

T reat me nt wit h bi ol o gics (e g, i nfli xi ma b, uste ki n u ma b), i m m u n o m o d ulat ors (e g, 
met h otre xate, 6 M P, azat hi o pri ne) or ca ncer c he m ot hera p y wit hi n 9 0 da ys pri or t o 
st u d y start.

Has ta ke n wit hi n 5 half -li ves pl us 1 4 da ys bef ore d osi n g a n y dr u g t hat c o ul d 
i m pact t he P K of t he i n vesti gati o nal pr o d uct, i ncl u di n g a ny prescri pti o n 
me dicati o ns, O T C me dicati o ns, her bal re me dies or dietar y  s u p ple me nts 
c o ntai ni n g St. J o h n’s W ort or t he c o ns u m pti o n of 
 
 as t hese are k n o w n t o be 
 
 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 4

A d mi ni strati o n of pr ot o n p u m p i n hi bit ors m ust ha ve e n de d 5 da ys pri or t o 
ra n d omizati o n.

A d mi nistrati o n o f H 2 bl oc kers m ust ha ve e n de d at least 1 2 h o urs pri or t o 
ra n d o mizati o n.

Pre vi o us a d mi nistrati o n wit h a n i n vesti gati o nal pr o d uct ( dr u g or vacci ne) wit hi n 
3 0 da y s ( or as deter mi ne d b y t he l ocal re q uire me nt) or 5 half-li ves prece di n g t he 
first d ose of st u d y i nter ve nti o n use d i n t his st u d y ( w hic he ver is l o n ger).
Pr o hi bite d D uri n g t he
 D a y St u d y Dr u g A d mi nistr ati o n 

Pr o hi bite d co nc o mita nt m e dicati o ns that m a y res ult i n D DI ( Secti o n 1 0. 8 ).

Bi ol o gics (e g, i nfli xi ma b, uste ki n u ma b), i m m u n o m o d ulat ors (e g, met h otre xate, 
6 M P, azat hi o pri ne) or ca ncer c he m ot hera p y .

A nti virals f or res pirat or y tract i nfecti o n.

R e q uires a n y dr u g or f o o d t hat c o ul d i m pact t he P K of t he i n vesti gati o nal pr o d uct, 
i ncl u di n g a ny prescri pti o n me dicati o ns, O T C me dicati o ns, her bal re me dies or 
dietar y  s u p ple me nts c o ntai ni n g St. J o h n’s W ort or t he c o ns u m pti o n of 
 
 pr o d ucts as t hese are k n o w n t o be 

A n y  a d mi nistrati o n of pr ot o n p u m p i n hi bit ors a n d H 2 bl oc kers is pr o hi bite d . T he 
use of a ntaci ds (s uc h as calci u m car b o nate or ma g nesi u m h y dr o xi de ) is all o we d
wit h sta g gere d d osi n g (ie, n ot wit hi n 3 h o urs bef ore or after st u d y dr u g 
a d mi nistrati o n ).
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L
7. 1. Disc o nti n u ati o n of St u d y I nter ve nti o n
It ma y be necessar y f or a partici pa nt t o per ma ne ntl y  disc o nti n ue st u d y i nter ve nti o n. Reas o ns 
f or per ma ne nt disc o nti n uati o n of st u d y i nter ve nti o n i ncl u de t he f oll o wi n g:

Deat h

Occ urre nce of a n A E or a n y  ot her c o n diti o n p osi n g a ris k t o a partici pa nt or 
je o par dizi n g a safe c o nti n uati o n of t he st u d y treat me nt f or t he res pecti ve 
partici pa nt (as j u d ge d b y t he i n vesti gat or, a n d/ or t he nati o nal c o or di nat ors, a n d/ or 
t he Me dical M o nit or a n d t he st u d y s p o ns or)

Missi n g a n y d ose pri or t o t he
 dra w 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 5

Re q uire me nt of pr o hi bite d c o nc o mita nt m e dicati o ns d uri n g t he st u dy ( See 
A p pe n di x 8 i n Secti o n 1 0. 8 )

St u d y  ter mi nate d b y s p o ns or
Disc o nti n uati o n of st u d y  i nter ve nti o n d oes n ot re prese nt wit h dra wal fr o m t he st u d y. If st u dy 
i nter ve nti o n is per ma ne ntl y disc o nti n ue d, t he partici pa nt s h o ul d re mai n i n t he st u d y t o be 
e val uate d f or f oll o w-u p visits . U n pla n ne d visits f oll o wi n g per ma ne nt disc o nti n uati o n of 
st u d y i nter ve nti o n, if nee de d will be c o n d ucte d per Da y 
visit i n t he S o A . 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 
recei pt of st u dy i nter ve nti o n or als o fr o m st u d y  pr oce d ures, f urt her st u dy 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. 1. 1. P ote nti al C ases of Ac ute Ki d ne y I nj ur y
See A p pe n di x 6 i n Secti o n 1 0. 6 f or ki d ne y safety m o nit ori n g g ui deli nes a n d disc o nti n uati o n 
criteria.
Partici pa nts e x p ose d t o I M P de m o nstrati n g tra nsie nt or s ustai ne d i ncrease i n Screat ( wit h 
decrease i n Screat -base d e G F R ) re q uire e x pe dite d e val uati o n t o differe ntiate A KI fr o m DI CI. 
DI CI  is defi ne d as tra ns p orter-me diate d effect relate d t o altere d re nal t u b ular creati ni ne 
ha n dli n g wit h o ut hist ol o gical i nj ur y . 
Differe nti ati n g Ac ute Ki d ne y I nj ur y fr o m DI CI: 
A KI m a y  be d ue t o o ne or m ore ty pes of i nj ur y, i ncl u di n g DI KI. Differe ntiati o n of DI KI 
fr o m ot her ca uses of A KI a n d fr o m DI CI, m a y  re q uire cli nical, ra di o gra p hic, hist o pat h ol o gic, 
a n d la b orat or y assess me nts, as well as ne p hr ol o g y c o ns ultati o n.
Screat i ncrease is defi ne d as:
I nf a nts a n d C hil dre n ≥2 8 d a ys ol d a n d < 1 2 ye ars ol d :
(i) Screat i ncrease ≥0. 3 m g/ d L ( ≥2 6. 5 µ m ol/ L ) wit hi n 4 8 h o urs O R 
(ii) Screat i ncrease ≥1. 5 ti mes baseli ne k n o w n or s us pecte d t o ha ve occ urre d wit hi n t he pri or 
7 da y s
Ne o n ates < 2 8 d a ys ol d: 
(i) Screat i ncrease ≥1. 5 t o 1. 9 ti mes fr o m baseli ne ( pre vi o us l o west val ue) k n o w n or 
s us pecte d t o ha ve occ urre d wit hi n t he pri or 7 da ys O R 
(ii) Screat i ncrease ≥0. 3 m g/ d L ( ≥2 6. 5 μ m ol/ L ) wit hi n 4 8 h o urs.

Base d o n t he assess me nts perf or me d, s us pecte d A KI (i ncl u di n g DI KI) ma y be 
differe ntiate d fr o m DI CI  as f oll o ws i n Ta ble 5 .
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 6
T a ble 5.
Differe nti ati n g DI KI a n d DI CI i n Pe di atric P artici p a nts
A KI (i ncl u di n g DI KI)
A n y o ne of t he bel o w
DI CI
Sc ys & Screat
Si m ulta ne o us, c o nfir me d Sc ys i ncrease of 
≥0. 3 m g/ L a n d c o nfir me d Screat i ncrease 
of ≥0. 3 m g/ d L p ost -baseli ne.
C o nfir me d Screat i ncrease of
≥0. 3 m g/ d L p ost -baseli ne wit h o ut 
si m ulta ne o us c o nfir me d i ncrease of
≥0. 3 m g/ L i n Sc ys p ost -baseli ne .
Al b u mi n uria
C o nfir me d al b u mi n uria i ncrease (see 
A p pe n di x 6 , Secti o n 1 0. 6 , f or Gra des A 1 
t o A 3 q ua ntitati o n) 
N o al b u mi n uria i ncrease
Uri ne v ol u me
Uri ne v ol u me < 0. 5 m L/ k g/ h f or 6 
c o nsec uti ve h o urs (if m o nit ore d)
N o uri ne v ol u me decrease
Re gar dless of t he prese nce or a bse nce of i ncrease i n Screat, DI KI a n d ot her ca uses of A KI 
ma y  be s us pecte d if eit her t here is (i) ne w-o nset or w orse ni n g al b u mi n uria or pr otei n uria are 
detecte d or (ii) uri ne v ol u me (if meas ure d) is < 0. 5 m L / k g/ h f or 6 c o nsecuti ve h o urs.
F oll o w -u p Assess me nts
T he partici pa nt s h o ul d ret ur n t o t he site f or e val uati o n as s o o n as p ossi ble, prefera bl y wit hi n 
4 8 h o urs of a ware ness of t he a b n or mal re nal f u ncti o n res ult. E val uati o n s h o ul d i ncl u de 
p h y sical e xa mi nati o n, la b orat or y tests, detaile d me dical a n d s ur gical hist or y, re vie w of all 
me dicati o ns (i ncl u di n g recreati o nal dr u gs a n d s u p ple me nts [ her bal]), fa mil y  hist or y, se x ual 
hist or y , tra vel hist or y, bl o o d tra nsfusi o n, a n d p ote ntial occ u pati o nal e x p os ure t o c he micals. If 
a p pr o priate, ne p hr ol o g y  c o ns ultati o n ma y be rec o m me n de d t o facilitate differe ntiati o n of 
re nal pare nc hy m al disease, pre-re nal az ote mia, a n d p ost-re nal o bstr ucti o n. All c o nfir me d 
cases of cli nicall y rele va nt decrease i n ki d ne y f u ncti o n s h o ul d be c o nsi dere d p ote ntial cases 
of DI KI if n o ot her reas o n f or t he ki d ne y f u ncti o n a b n or malities has bee n f o u n d.
La b orat or y  assess me nts s h o ul d i ncl u de si m ulta ne o us ser u m c ystati n C ( Sc ys) a n d ser u m 
creati ni ne ( Screat) tests. Re nal f u ncti o n s h o ul d be e val uate d usi n g t he a p pr o priate e q uati o n or 
creati ni ne refere nce val ues descri be d i n A p pe n di x 6 ( Secti o n 1 0. 6 ). Assess me nts of uri ne 
al b u mi n -t o-creati ni ne rati o or uri ne v ol u me ma y  als o be perf or me d as a p pr o priate.
7. 1. 2. Li ver I nj ur y
A partici pa nt w h o meets t he criteria of p ote ntial DI LI ( H y ’s la w) case as descri be d i n 
A p pe n di x 5 i n Secti o n 1 0. 5 or if t he y  meet eit her of t he bel o w criteria, will be wit h dra w n 
fr o m st u d y i nter ve nti o n.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 7

Partici pa nts > 3 0 da y s ol d wit h fi n di n g of pre-d ose A S T, A L T or T bili > 2 × U L N; 

A n y  partici pa nt d uri n g st u d y  i nter ve nti o n wit h at least 2 of t he f oll o wi n g la bs A S T, A L T 
or T bili i ncrease b y > 2 U L N. 
7. 1. 3. E C G C h a n ges 
A partici pa nt w h o meets eit her b ullete d criteri o n will be wit h dra w n fr o m t he st u d y  
i nter ve nti o n. 

Q Tc F > 5 0 0 ms.

C ha n ge fr o m baseli ne: Q Tc F ≥6 0 ms 
If a cli nicall y si g nifica nt fi n di n g is i de ntifie d (i ncl u di n g, b ut n ot li mite d t o, c ha n ges fr o m 
baseli ne i n Q Tc F after e nr oll me nt), t he i n vesti gat or or q ualifie d desi g nee will deter mi ne if 
t he partici pa nt ca n c o nti n ue i n t he st u d y a n d if a n y c ha n ge i n partici pa nt ma na ge me nt is 
nee de d. T his re vie w of t he E C G pri nte d at t he ti me of c ollecti o n m ust be d oc u me nte d. A n y 
ne w cli nicall y rele va nt fi n di n g s h o ul d be re p orte d as a n A E.
7. 1. 4. C O VI D -1 9 
If a partici pa nt has C O VI D-1 9 d uri n g t he st u d y , t his s h o ul d be re p orte d as a n A E or S A E (as 
a p pr o priate) a n d a p pr o priate me dical i nter ve nti o n pr o vi de d .
St u d y  treat me nt m a y c o nti n ue u nless t he i n vesti gat or/treati n g p h ys icia n is c o ncer ne d a b o ut 
t he safety of t he partici pa nt, or if t he partici pa nt will be starte d o n a n a nti vira l, i n w hic h case 
st u d y i nter ve nti o n s h o ul d be disc o nti n ue d .
It is rec o m me n de d t hat t he i n vesti gat or disc uss te m p orar y or per ma ne nt disc o nti n uati o n of 
st u d y i nter ve nti o n wit h t he st u d y me dical m o nit or.
7. 2. P artici p a nt Disc o nti n u ati o n/ Wit h dr a w al Fr o m t he St u d y 
A partici pa nt ma y  wit h dra w fr o m t he st u d y at a ny ti me at t heir o w n re q uest, or at t he re q uest 
of t he pare nt (s)/le gal g uar dia n. 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;

I n vesti gat or decisi o n;

St u d y  ter mi nate d b y s p o ns or;
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 8

Wit h dra wal of c o nse nt/asse nt b y  pare nt(s)/le gal g uar dia n or by a c hil d w h o has
pr o vi de d asse nt d uri n g a n y  p hase of t he st u d y
At t he ti me of disc o nti n ui n g fr o m t he st u d y,  if p ossi ble, a n early disc o nti n uat i o n visit s h o ul d 
be c o n d ucte d. See t he S o A f or assess me nts t o be c ollecte d at t he ti me of st u d y 
disc o nti n uati o n a n d f oll o w- u p a n d 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.
T he earl y disc o nti n uati o n visit a p plies o nl y  t o partici pa nts w h o are e nr olle d/ra n d o mize d a n d 
t he n are pre mat urel y wit h dra w n fr o m t he st u d y. Partici pa nts/ partici pa nt’s pare nt(s)/le gal 
g uar dia n s h o ul d be q uesti o ne d re gar di n g t heir reas o n f or wit h dra wal.  
T he partici pa nt will be per ma ne ntl y disc o nti n ue d fr o m t he st u d y i nter ve nti o n a n d t he st u d y at 
t hat ti me.
If a partici pa nt/ partici pa nt’s pare nt(s)/le gal g uar dia n wit h dra ws fr o m t he st u d y, t he y ma y 
re q uest destr ucti o n of a n y re mai ni n g sa m ples ta ke n a n d n ot teste d, a n d t he i n vesti gat or m ust 
d oc u me nt a n y s u c h re q uests i n t he site st u d y rec or ds a n d n otif y t he s p o ns or acc or di n gly.
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 asse 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 asse nt.
7. 2. 1. Wit h dr a w al of C o nse nt 
Partici pa nts/ partici pa nt ’s pare nt(s)/le gal g uar dia n w h o re q uest t o disc o nti n ue recei pt of st u d y 
i nter ve nti o n will re mai n i n t he st u d y a n d m ust c o nti n ue t o be f oll o we d f or pr ot oc ol-s pecifie d 
f oll o w-u p pr oce d ures. T he o nl y e xce pti o n t o t his is w he n a partici pa nt ’s pare nt(s)/le gal 
g uar dia n s pecificall y wit h dra ws c o nse nt/asse nt f or a n y f urt her c o ntact wit h t he m or pers o ns 
pre vi o usl y  a ut h orize d b y t he partici pa nt’s pare nt(s)/le gal g uar dia n t o pr o vi de t his 
i nf or mati o n. Pare nt(s)/le gal g uar dia n s s h o ul d n otif y t he i n vesti gat or i n writi n g of t he 
decisi o n t o wit h dra w c o nse nt fr o m f ut ure f oll o w- u p, w he ne ver p ossi ble. T he wit h dra wal of 
c o nse nt s h o ul d be e x plai ne d i n detail i n t he me dical rec or ds b y  t he i n vesti gat or, as t o w het her 
t he wit h dra wal is o nly fr o m f urt her rec ei pt of st u d y i nter ve nti o n or als o fr o m st u d y 
pr oce d ures a n d/ or p osttreat me nt st u d y f oll o w u p a n d e ntere d o n t he a p pr o priate C R F pa ge. I n 
t he e ve nt t hat vital stat us ( w het her t he partici pa nt is ali ve or dea d) is bei n g meas ure d, 
p u blicl y  a vaila ble i nf or matio 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 priatel y  
directe d i n acc or da nce wit h l ocal la w.
7. 3. L ost t o F oll o w -U p 
A partici pa nt will be c o nsi dere d l ost t o f oll o w -u p if t he partici pa nt/ partici pa nt ’s 
pare nt(s)/le gal g uar dia n 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.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 6 9
T he f oll o wi n g acti o ns m ust be ta ke n if a partici pa nt/ partici pa nt’s pare nt(s)/le gal g uar dia n 
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’s pare nt(s)/le gal g uar dia n a n d 
resc he d ule t he misse d visit as s o o n as p ossi ble. C o u nsel t he partici pa nt’s 
pare nt(s)/le gal g uar dia n 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’s pare nt(s)/le gal g uar dia n 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’s pare nt(s)/le gal g uar dia n 
( w here p ossi ble, 3 tele p h o ne calls an d, if necessar y , a certifie d letter t o t he 
partici pa nt’s pare nt(s)/le gal g uar dia n’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’s pare nt(s )/le gal g uar dia n 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 . 
Partici pa nts ma y be re place d at S p o ns or discreti o n as descri be d i n Secti o n 4. 1 a n d 
Secti o n 9. 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
8. 1. A d mi nistr ati ve a n d B aseli ne Pr oce d ures
T he i n ves ti 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 e ns ure c orrect assi g nme nt t o t he a ge gr o u p a n d criticall y 
e val uate t he safet y pr ofile b y a ge. L o cal re g ulati o ns ma y  a p pl y f or c ollecti o n of f ull date of 
birt h. 
St u d y  pr oce d ures a n d t heir ti mi n g are s u m marize d i n t he S o A . Pr ot oc ol wai vers or 
e xe m pti o ns are n ot all o we d.
A d here nc e t o t he st u d y desi g n re q uire me nts, i ncl u di n g t h ose s pecifie d i n t he S o A , is esse ntial 
a n d 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 bil it 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.
A L T, A S T, T Bili la b assess me nts f or 
 c o h ort ( wit hi n 2 4 h o urs of scree ni n g) a n d 
m olec ular R S V testi n g c o n d ucte d as part of t he partici pa nt’s sta n dar d of care a n d o btai ne d 
bef ore si g ni n g of t he I CD ma y  be utilize d f or eli gi bilit y p ur p oses pr o vi de d t he pr oce d ures 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 0
met t he pr ot oc ol s pecifie d- criteria a n d were perfor me d wit hi n t he ti me fra me defi ne d i n t he 
S o A ( Secti o n 1. 3 ) a n d as s pecifie d i n Secti o n 5. 1 a n d 5. 2 .
Safet y  la bs c o n d ucte d as part of t he partici pa nt’s ro uti ne cli nical ma na ge me nt (e g, bl o o d 
c o u nt) a n d o btai ne d bef ore si g ni n g of t he I C D , ma y  be utilize d f or scree ni n g or baseli ne 
p ur p oses, pr o vi de d t he safet y  la bs met t he pr ot oc ol-s pecifie d criteria a n d were perf or me d 
wit hi n t he ti me fra me defi ne d i n t he S o A .
Scree ni n g R S V d ia g n ostic test i nf or mati o n d o ne t o c o nfir m eli gi bilit y s h o ul d be c ollecte d i n 
C R F , if a vaila ble i n s o urce d oc u me nt a n d t his s h o ul d i ncl u de t ype of test (a nti ge n or R T -
P C R), date a n d ti me of testi n g ,
E ver y ef f ort s h o ul d be ma de t o e ns ure t hat pr ot oc ol re q uire d tests a n d pr oce d ures are 
c o m plete d as descri be d. H o we ver, it is a ntici pate d t hat fr o m ti me t o ti me t here ma y be 
circ u msta nces o utsi de t he c o ntr ol of t he i n vesti gat or t hat ma ke it u nfeasi ble t o pe rf 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.
Safet y /la b orat or y/a nalyt e res ults t hat ha ve bee n c ollecte d f or t he p ur p oses of t his st u d y  a n d 
c o ul d u n bli n d t he st u d y will n ot be re p orte d t o i n vesti gati ve sites or ot her bli n de d pers o n nel 
u ntil t he st u d y  has bee n u n bli n de d.
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 pme nt i nstr ucti o ns a n d c o ntact i nf or mati o n will be pr o vi de d t o t he i n vesti gat or site pri or 
t o i nitiati o n of t he st u d y.
T he t otal bl o o d sa m pli n g v ol u me f or i n di vi d ual partici pa nts i n t his st u d y  is a p pr o xi matel y u p 
t o 3. 9 m L  f or all c o h orts ( See Secti o n 8. 3. 4 ). T he act ual c ollecti o n ti mes of bl o o d sa m pli n g 
ma y  c ha n ge. A d diti o nal bl o o d sa m ples ma y be ta ke n f or safety assess me nts at ti mes 
s pecifie d by Pfizer, pr o vi de d t he t otal v ol u me ta ke n d uri n g t he st u d y d oes n ot e xcee d t he 
a m o u nts s pecifie d f or t he differe nt a ge gr o u ps i n Secti o n 8. 3. 4 .
8. 1. 1. B aseli ne Pr oce d ures
Pla n ne d ti me p oi nts f or c ollecti o n of me dical hist or y , bac k gr o u n d a n d s ocial fact ors 
(A p pe n di x 1 0 B Secti o n 1 0. 1 0. 2 ), a n d de m o gra p hy are pr o vi de d i n t he S o A ( Secti o n 1. 3 ). 
T he se m ust be rec or de d i n t he C R F a n d s h o ul d als o i ncl u de i nf or mati o n o n gestati o nal a ge , 
d ate of birt h , a ge at scree ni n g, a n d da ys si nce o nset of si g ns a n d/ or s ym pt o ms. L o cal 
re g ulati o ns ma y a p ply f or c ollecti o n of f ull date of birt h.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 1
8. 2. Effic ac y Assess me nts
8. 2. 1. Si g ns a n d S y m pt o ms of R S V
Si g ns a n d S ym pt o ms of R S V will be c ollecte d b y t he H C P per t he S o A ( Secti o n 1. 3 ) d uri n g 
sc he d ule d visits . See A p pe n di x 1 0 A (Secti o n 1 0. 1 0. 1 ). 
8. 2. 2. D osi n g a n d P al at a bilit y q uesti o n n aire (eDi ar y)
A n e Diar y  will be pr o vi de d t o t he pare nt(s)/le gal g uar dia n/ H C P. P artici pa nt’s pare nt(s)/le gal 
g uar dia n or H C P will rec or d st u d y i nter ve nti o n a d mi nistrati o n a n d t he taste attri b utes of I M P 
usi n g t he S p o ns or -pr o vi de d e Diar y t hat i ncl u des t he D osi n g a n d Palata bilit y  Q uesti o n naire 
per t he S o A (see A p pe n di x 1 0 D i n Secti o n 1 0. 1 0. 4 ). 
Staff will re vie w t he st u d y e Diar y dai l y d uri n g t he treat me nt peri o d as s pecifie d i n t he S o A
( Secti o n 1. 3 ).
8. 3. S afet y Assess me nts
Pla n ne d ti me p oi nts f or all safet y  assess me nts are pr o vi de d i n t he S o A . U nsc he d ule d safety 
meas ure me nts 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.
8. 3. 1. P h ysic al E x a mi n ati o ns
A c o m plete p h ys ical e xa mi nati o n will i ncl u de, at a mi ni m u m, assess me nts of t he 
car di o vasc ular, res pirat or y, gastr oi ntesti nal, a n d ne ur ol o gical s ys te ms i ncl u di n g a sy m pt o m -
directe d e xa mi nati o n a n d ge neral c o n diti o n. 
Hei g ht a n d wei g ht will be meas ure d a n d rec or de d. Meas ure me nt of le n gt h a n d hea d 
circ u mfere nce will be perf or me d f or c hil dre n < 2 years of a ge o nl y. A ge -a p pr o priate 
t o ols i ncl u di n g sta di o meters f or meas uri n g hei g ht i n c hil dre n 2 years of a ge or ol der s h o ul d 
be use d .
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 2
A brief p h ys ical e xa mi nati o n will i ncl u de, at a mi ni m u m, assess me nts of t he car di o vasc ular 
s yste m, res pirat or y a n d gastr oi ntesti nal s yste ms.
P h y sical e xa mi nati o n f or res pirat or y sys te m i ncl u des l u n g a usc ultati o n, e val uati o n of 
res pirat or y eff ort (e g, retracti o ns) a n d vital si g ns (res pirat or y rate a n d S p O2). 
I n vesti gat ors s h o ul d pa y s pecial atte nti o n t o cli nical si g ns relate d t o pre vi o us seri o us 
ill nesses. 
P h y sical e xa mi nati o n fi n di n gs c ollecte d d uri n g t he st u d y will be c o nsi dere d s o urce rec or d 
a n d will n ot be re q uire d t o be re p orte d, e xce pt as re q uire d i n A p pe n di x 1 0 A a n d S o A . A n y 
u nt o war d p h ys ical e xa mi nati o n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d
a n d meet t he defi niti o n of a n A E or S A E ( A p pe n di x 3 ) m ust be re p orte d acc or di n g t o t he 
pr ocesses i n Secti o ns 8. 4. 1 t o 8. 4. 3 .
8. 3. 2. Vit al Si g ns
A n y  u nt o war d vital si g n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d 
meet t he defi niti o n of a n A E or S A E ( A p pe n di x 3 ) m ust be re p orte d acc or di n g t o t he 
pr ocesses i n Secti o ns 8. 4. 1 t o 8. 4. 3 . 
Vital si g ns s h o ul d be meas ure d wit h a ge -a p pr o priate t o ols i ncl u di n g, i nfa nt a n d c hil d p ulse 
o xi meters attac h me nts f or meas uri n g heart rate a n d o x y ge n sat urati o n, a n d pe diatric-size d 
bl o o d press ure c uffs.
8. 3. 2. 1. Bl o o d Press ure a n d P ulse R ate / He art R ate
B P a n d P R meas ure me nts will be assesse d wit h a c o m pletel y  a ut o mate d de vice. Ma n ual 
tec h ni q ues will be use d o nl y if a n a ut o mate d de vice is n ot a vaila ble. B P will be assesse d 
usi n g a c orrect c uff f or t he ar m size.
B P a n d P R will be ta ke n bef ore bl o o d c ollecti o n f or la b orat or y  tests a n d c o nsist of a si n gle 
meas ure me nt of P R a n d B P meas ure me nts . T he B P a n d P R rea di n gs will be rec or de d o n t he 
C R F.
8. 3. 2. 2. Te m per at ure a n d Res pir at or y R ate
Te m perat ure ( T y m pa nic, Rectal or S ki n) a n d R R will be assesse d a n d rec or de d o n t he C R F. 
A v oi d rectal te m perat ure assess me nts i n c hil dre n less t ha n 6 wee ks ol d . Te m perat ure s h o ul d 
be assesse d usi n g t he sa me met h o d f or all st u d y  visits. D oc u me nt t he hi g hest res pirat or y  rate 
at t he ti me of assess me nt i n t he C R F.
8. 3. 2. 3. O x y ge n S at ur ati o n
O x y ge n sat urati o n fi n di n gs c ollecte d d uri n g t he st u d y will be rec or de d o n t he C R F i ncl u di n g 
a n y su p ple me ntal O 2 re q uire me nt. D oc u me nt t he l o west S p O 2 val ue, w hile o n r o o m air if 
safe a n d feasi ble t o d o s o, at t he ti me of assess me nt i n t he C R F .
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 3
8. 3. 3. Electr oc ar di o gr a ms
A si n gle E C G will be c ollecte d at scree ni n g, a n d as s pecifie d i n t he S o A ( Secti o n 1. 3 ) of t his 
pr ot oc ol usi n g a n E C G s yste m t hat a ut o maticall y  calc ulates t he H R a n d meas ures P R, Q T, 
Q Tc F, a n d Q R S i nter vals. All sc he d ule d E C Gs s h o ul d be perf or me d after t he partici pa nt has 
rested q uietl y f or at least 5 mi n utes i n a s u pi ne p ositi o n. 
It is rec o m me n de d t hat a c o nsiste nt place me nt of lea ds is ma de t hr o u g h o ut t he w h ole 
d urati o n of t he st u d y  f or t he sa me partici pa nt .
I n y o u n g c hil dre n, t he ri g ht ve ntricle n or mall y e xte n ds t o t he ri g ht si de of t he ster n u m. T o 
a p pr o priatel y dis pla y  ri g ht ve ntric ular p ote ntials, E C Gs f or c hil dre n i n t he u n der fi ve-ye ar 
a ge gr o u p m ust i ncl u de a n alter nate lea d (‘ V 4 R’) o n t he ri g ht si de of t he c hest, at a p oi nt 
a nal o g o us t o t he left-si de d V 4.
Prec or dial lea ds:

V 1: 4t h i nterc ostal s pace, ri g ht ster nal b or der

V 2: 4t h i nterc ostal s pace, left ster nal b or der

V 3: mi d wa y  bet wee n V 2 a n d t he place me nt of V 4 i n a d ults ( 5t h i nterc ostal s pace, left 
mi d -cla vic ular li ne)

V 4 R: 5t h i nterc ostal s pace, ri g ht mi d -cla vic ular li ne. Use t his lea d f or V 4 R, m ust la bel as 
s uc h o n E C G.

V 5: a nteri or a xillar y li ne, sa me h oriz o ntal pla ne as V 4

V 6: mi d -a xillar y li ne, sa me h oriz o ntal li ne as V 4
Li m b lea ds:

Place o n t o p part of ar m or le g f or less m uscle i nterfere nce

F or restless i nfa nts a n d y o u n g c hil dre n , t he Mas o n-Li kar lea d place me nt ca n be 
e m pl o ye d: t he 4 li m b electr o des are place d a nteri orl y  o n t he left a n d ri g ht s h o ul der a n d 
left a n d ri g ht si de of t he l o wer t ors o t o pre ve nt artefact ca use d by t he m o ve me nt of t he 
ar ms a n d le gs .
T he s cree ni n g a n d a n y u n pla n ne d E C G data c ollecte d will be s u b mitte d t o a ce ntral 
la b orat or y f or meas ure me nt a n d i nter pretati o n. T he fi nal E C G re p ort fr o m t he ce ntral 
la b orat or y s h o ul d be mai ntai ne d i n t he partici pa nt’s s o urce d oc u me ntati o n a n d be t he fi nal 
i nter pretati o n of t he E C G rec or di n g. A n y cli nicall y si g nifica nt E C G fi n di n gs wit h   t he 
baseli ne/ Da y  1 E C G, or u n pla n ne d E C Gs, m a y  p ote ntiall y be A Es (A p pe n di x 7 i n 
Secti o n 1 0. 7 ) a n d s h o ul d be e val uate d f urt her, as cli nicall y warra nte d.
I n s o me cases, it ma y be a p pr o priate t o re peat a b n or mal E C Gs t o r ule o ut i m pr o per lea d 
place me nt as c o ntri b uti n g t o t he E C G a b n or malit y.  It is i m p orta nt t hat lea ds be place d i n t he 
sa me p ositi o ns eac h ti me i n or der t o ac hie ve precise E C G rec or di n gs. If a mac hi ne-rea d Q Tc 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 4
val ue is pr ol o n ge d, as defi ne d a b o ve, re peat meas ure me nts ma y  n ot be necessar y if a 
q ualifie d me dical pr o vi der’s i nter pretati o n deter mi nes t hat t he Q Tc F val ues are i n t he 
acce pta ble ra n ge.
E C G val ues of p ote ntial cli nical c o ncer n are liste d i n A p pe n di x 7 i n Secti o n 1 0. 7 .
8. 3. 4. Cli nic al S afet y L a b or at or y Assess me nts 
See A p pe n di x 2 f or t he list of cli nical safety la b orat or y  tests t o be perf or me d a n d t he S o A f or 
t he ti mi n g a n d fre q ue nc y. All pr ot oc ol re q uire d- la b orat or y assess me nts, as defi ne d i n 
A p pe n di x 2 , m ust be c o n d ucte d i n acc or da nce wit h t he la b orat or y ma n ual a n d t he S o A . 
U nsc he d ule d cli nical la b orat or y  meas ure me nts ma y be o btai ne d at a n y ti me d uri n g t he st u d y 
t o assess a ny percei ve d safet y iss ues.   
La b orat or y  safety para meters will be gra de d acc or di n g t o D AI D S T a ble f or Gra di n g t he 
Se verit y  of A d ult a n d Pe diatric A d verse E ve nts [1 1 ].
T he i n vesti gat or m ust re vie w t he la b orat or y  re p ort, d oc u me nt t his re vie w, a n d rec or d an y  
cli nicall y si g nifica nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E secti o n of t he C R F .
Cli nicall y  si g nifica nt a b n or mal la b orat or y test fi n di n gs are t h ose t hat are n ot ass ociate d wit h 
t he u n derlyi n g disease, u nless j u d ge d b y  t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or 
t he partici pa nt's c o n diti o n.
All la b orat or y  tests wit h val ues c o nsi dere d cli nicall y si g nifica nt a n d a b n or mal d uri n g 
partici pati o n i n t he st u d y  or wit hi n 
s h o ul d 
be re peate d u ntil t he val ues ret ur n t o n or mal or baseli ne or are n o l o n ger c o nsi dere d 
cli nicall y si g nifica nt by t he i n vesti gat or or st u d y me dical m o nit or .
If s uc h val ues d o n ot ret ur n t o n or mal/ baseli ne wit hi n a peri o d of ti me j u d ge d reas o na ble b y 
t he i n vesti gat or, t he eti ol o gy s h o ul d be i de ntifie d , a n d t he s p o ns or n otifie d.
See A p pe n di x 5 i n Secti o n 1 0. 5 f or s u g geste d acti o ns a n d f oll o w-u p assess me nts i n t he e ve nt 
of p ote ntial DI LI.
See A p pe n di x 6 i n Secti o n 1 0. 6 f or i nstr ucti o ns f or la b orat or y testi n g t o m o nit or ki d ne y 
f u ncti o n a n d re p orti n g la b orat or y test a b n or malities.
Ta ble 6 pr o vi des t he bl o o d v ol u me all o we d t o be dra w n i n partici pa nts ( ne o nates, i nfa nts,
a n d c hil dre n ) u p t o 6 0 m o nt hs of a ge. All safet y  la bs s h o ul d be d o ne l ocall y o nl y. E ver y  
eff ort s h o ul d be ma de t o li mit t he a m o u nt of bl o o d c ollecte d fr o m eac h partici pa nt o ver t he 
d urati o n of t he st u d y . T he ma xi m u m a m o u nt of bl o o d c ollecte d fr o m eac h partici pa nt o ver 
t he d urati o n of t he st u dy,  i ncl u di n g a ny e xtra assess me nts t hat ma y be re q uire d, will n ot 
e xcee d t he v ol u mes i n Ta ble 6 . Re peat or u nsc he d ule d sa m ples are all o we d base d o n cli nical 
j u d g me nt f or partici pa nt safety or f or tec h nical iss ues wit h t he sa m ples. T he t otal bl o o d 
v ol u mes f or t he differe nt a ge gr o u ps ta ke i nt o acc o u nt t he esti mate d bl o o d v ol u me f or 
partici pa nts at t he fift h perce ntile f or wei g ht i n eac h of t he c o h orts [1 2 ,1 3 ] a n d t otal bl o o d 
v ol u mes. Per t hese criteria, 1 % of t otal bl o o d v ol u me is all o we d t o be dra w n wit hi n 2 4 h o urs 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 5
a n d 3 % of t otal bl o o d v ol u me is all o we d t o be dra w n wit hi n 4 wee ks. T hese v ol u mes are 
s h o w n i n Ta ble 7 f or all c o h orts.
A 1- d a y ol d c hil d is t he y o u n gest s u bject t o be e nr olle d i n t he st u d y . It is calc ulate d t hat a 
1- d a y ol d c hil d ma y  wei g h 2. 5 k g a n d has 9 0 m L of bl o o d/ k g. T heref ore, a 1-d a y  ol d c hil d 
li kel y has a t otal bl o o d v ol u me of 2 2 5 m L . Per t he criteria of 1 % of t otal bl o o d v ol u me 
all o we d t o be dra w n wit hi n 2 4 h o urs a n d 3 % of t otal bl o o d v ol u me all o we d t o be dra w n 
wit hi n 4 wee ks, t his e q uals a n all o wa nce of 2. 2 5 m L  of bl o o d i n 2 4 h o urs a n d 6. 7 5 m L of 
b l o o d i n 4 wee ks f or a 2. 5 k g c hil d.
T a ble 6.
Bl o o d Dr a w All o w a nces f or E ac h A ge B a n d
5 t h Perce ntile Wei g ht ( k g)
3. 5
6
8
2. 5
Bl o o d V ol u me ( m L/ k g)
8 0
8 0
8 0
9 0
T otal Bl o o d V ol u me ( m L)
2 8 0
4 8 0
6 4 0
2 2 5
2 4 h o ur ma x = 1 % ( m L)
2. 8
4. 8
6. 4
2. 2 5
4 w ee k ma x = 3 % ( m L)
8. 4
1 4. 4
1 9. 2
6. 7 5
T a ble 7 .  
V ol u me ( m L) of Bl o o d t o be Dr a w n fr o m P artici p a nts i n All C o h orts 
Assess me nt/ Pr oce d ure
St u d y Visit
T ot al
Scree ni n g
C B C
a
0. 5
0. 5
0. 5
1. 5 m L
C he mistr y Pa nel
a
0. 5
0. 5
0. 5
1. 5 m L
P K Bl o o d sa m ple
N A
2 × 0. 3
1 × 0. 3
0 . 9m L
T otal
1. 0 m L
1. 6 m L 
1. 3 m L
3 . 9m L
a. Esti mate d v ol u mes pr o vi de d f or l ocal safet y la bs, C B C a n d c he mistr y pa nel .
L ocal la b orat ories are t o be use d f or t his st u d y. Qualifie d st u d y  site pers o n nel m ust or der, 
recei ve, a n d re vie w res ults. Site staff m ust c ollect t he l ocal la b orat or y refere nce ra n ges a n d 
certificati o ns/accre ditati o ns f or fili n g at t he s ite. La b orat or y  test res ults are t o be pr o vi de d t o 
t he site staff as s o o n as p ossi ble. T he l ocal la b orat or y  re p orts s h o ul d be file d i n t he 
partici pa nt’s s o urce d oc u me nts/ me dical rec or ds. Rele va nt data fr o m t he l ocal la b orat or y  
re p ort s h o ul d be rec or de d o n t he C R F. I n a d diti o n, I n vesti gat ors m ust i de ntif y a n d rec or d
t heir l ocal la b orat or y met h o d f or a nalys is of Screat (e g,a n o n-is ot o pe dil uti o n mass 
s pectr o metr y (ID M S) tracea ble met h o d; a n e nz y matic assa y , or I D M S tracea ble assa y t o 
assess Screat i n t he C R F.
Pr ot oc ol -s pecifie d safety la b orat or y e val uati o ns ma y  be c o n d ucte d at a l ocal la b orat or y as 
s pecifie d i n t he So A a n d ca n be c ollecte d at h o me, if per mitte d b y  l ocal re g ulati o ns. T he 
l ocal la b orat or y m a y be a sta n dal o ne i nstit uti o n or wit hi n a h os pital. 
If l ocal la bs are use d, sites m ust be a ware of t he I R B/ E C rec o m me n dati o ns o n bl o o d v ol u mes 
a n d pr o vi de a p pr o priate trai ni n g t o t he sites.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 6
8. 3. 4. 1. Alter n ati ve F acilities f or Cli nic al S afet y L a b or at or y Assess me nt
N ot A p plica ble
8. 3. 5. Me dic all y Atte n de d Visits
R S V relate d me dical visits a partici pa nt has atte n de d si nce t he last assess me nt will be 
c ollecte d. Me dical visits i ncl u de t h ose pr o vi de d b y  an H C P: o ut patie nt or i n patie nt visit, 
e mer ge nc y r o o m or ur ge nt care visit.
8. 4. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her S afet y Re p orti n g
T he defi niti o ns of a n A E a n d a n S A E ca n be f o u n d i n A p pe n di x 3 .
A Es ma y  arise fr o m sy m pt o ms or ot her c o m plai nts re p orte d t o t he i n vesti gat or b y  t he 
partici pa nt ( or , w he n a p pr o priate, b y a care gi ver, surr o gate, or t he partici pa nt ’s 
pare nt(s)/le gal g uar dia n ), or t he y m a y arise fr o m cli nical fi n di n gs of t he i n vesti gat or or ot her 
healt hcare pr o vi ders (cli nical si g ns, test res ults, etc).
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detec ti n g, d oc u me nti n g, a n d 
rec or di n g e ve nts t hat meet t he defi niti o n of a n A E or S A E a n d re mai n res p o nsi ble t o p urs ue 
a n d o btai n a de q uate i nf or mati o n b ot h t o deter mi ne t he o utc o me a n d t o assess w het her t he 
e ve nt meets t he criteria f or classificati o n as a n S A E or ca use d t he partici pa nt t o disc o nti n ue 
t he st u d y i nter ve nti o n (see Secti o n 7. 1 ). 
D uri n g t he acti ve c ollecti o n peri o d as descri be d i n Secti o n 8. 4. 1 , eac h partici pa nt’s 
pare nt (s)/le gal g uar dia n 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 pare nt(s)/le gal g uar dia n pr o vi des 
i nf or me d c o nse nt, w hic h is o btai ne d bef ore u n der g oi n g a ny st u d y- relate d pr oce d ure a n d/ or 
recei vi n g st u dy i nter ve nti o n, t hr o u g h a n d i ncl u di n g a mi ni m u m of 2 8 cale n dar da y s, e xce pt 
as i n dicate d bel o w, after t he last a d mi nistrati o n of t he st u d y  i nter ve nti o n. 
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 onc 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.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 7
If t he pare nt(s)/le gal g uar dia n wit h dra ws t he partici pa nt 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 pare nt(s)/le gal g uar dia n per ma ne ntl y  disc o nti n ues or te m p oraril y disc o nti n ues st u d y 
i nter ve nti o n (beca use of a n A E or S A E, t he A E or S A E m ust be rec or de d o n t he C R F a n d t he 
S A E re p orte d usi n g t he C T  S A E Re p ort F or m/ P S S A. 
I n vesti gat ors are n ot o bli gate d t o acti vely see k i nf or mati o n o n A Es or S A Es 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 nti o n, t he i n vesti gat or m ust 
pr o m ptl y  re p ort t he S A E t o Pfizer via P S S A.
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer S afet y
Al l S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d as descri be d i n 
Secti o n 8. 4. 1 are re p orte d t o Pfizer Safet y o n t he CT S A E Re p ort F or m / P S S A i m me diatel y 
u p o n a ware ness a n d u n der n o circ u msta nce s h o ul d t his e xcee d 2 4 h o urs, as i n dicate d i n
A p pe n di x 3 i n Secti o n 1 0. 3 . T he i n vesti gat or will s u b mit a n y u p date d S A E data t o t he 
s p o ns or wit hi n 2 4 h o urs of its 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 asse nt as descri be d i n Secti o n 8. 4. 1 , will be rec or de d 
o n t he A E secti o n of t he C R F .  
T he i n vesti gat or is t o rec or d o n t he C R F all directl y  o bser ve d a n d all s p o nta ne o usl y re p orte d 
A 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 the 
i n vesti gat or t o pr o vi de clarit y a n d u n dersta n di n g of t he e ve nt i n t he c o nte xt of t he cli nical 
st u d y.
8. 4. 2. Met h o d of Detecti n g A 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 Es a n d t he 
pr oce d ures f or c o m pleti n g a n d tra n s mitti n g S A E re p orts are pr o vi de d i n A p pe n di x 3 .
Care will be ta ke n n ot t o i ntr o d uce bias w he n detecti n g A 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 ’s pare nt(s)/le gal g uar dia n is t he preferre d 
met h o d t o i n q uire a b o ut A E occ urre nces.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 8
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 uf ficie nt detail t o 
all o w f or a c o m plete me dical assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of 
p ossi b le 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 h er i nf or mati o n o n f oll o w -u p pr oce d ures is pr o vi de d i n A p pe n di x 3 .
8. 4. 4. Re g ul at or y Re p orti n g Re q uire me nts f or S A Es
Pr o m pt n otificati o n b y  t he i n vesti gat or t o t he s p o ns or of a n S A E is esse ntial s o t hat le gal 
o bli gati o ns a n d et hical res p o nsi bilities t o war d t he safet y of partici pa nts a n d t he safet y of a 
st u d y i nter ve nti o n u n der cli nical i n vesti gati o n are met.
T he s p o ns or has a le gal res p o nsi bilit y  t o n otif y b ot h t he l ocal re g ulat or y a ut h orit y a n d ot her 
re g ulat or y a ge ncies a b o ut t he safety of a st u d y i nter ve nti o n u n der cli nical i n vesti gati o n. T he 
s p o ns or will c o m pl y wit h c o u ntr y-s pecific re g ulat or y re q uire me nts relati n g t o safety 
re p orti n g t o t he re g ulat or y a ut h ority,  IR Bs/ 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 Rs 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 e x p os ures t o t he st u d y i nter ve nti o n u n der st u d y are re p orta ble to Pfizer Safet y  
wit hi n 2 4 h o urs of i n vesti gat or a ware ness.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 7 9
8. 4. 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 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 ow 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 r o utes of e x p os ure, e g, 
i n gesti o n, 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 r o utes of e x p os ure, e g, i n gesti o n, i n halati o n, or s ki n c o ntact a n d 
t he n i nse mi nates his fe male part ner pri or t o or ar o u n d t he ti me of c o nce pti o n.
T he i n vesti gat or m ust re p ort E D P  t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nitial i nf or mati o n s u b mitte d 
s h o ul d i ncl u de t he a ntici pate d date of deli ver y (see bel o w f or i nf or mati o n relate d t o 
ter mi nati o n of pre g na nc y). 

If E D P occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, t he i n vesti gat or m ust re p ort 
i nf or mati o n t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m/ P S S A a n d a n E D P 
S u p ple me ntal F or m or via P S S A. Si nce t he e x p os ure i nf or mati o n d oes n ot pertai n t o 
t he partici pa nt e nr olle d i n t he st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; 
h o we ver, a c o p y of t he c o m plete d re p ort is mai ntai ne d i n t he i n vesti gat or site file.
F oll o w -u p is c o n d ucte d t o o btai n ge neral i nf or mati o n o n t he pre g na nc y  a n d its o utc o me f or 
all E D P re p orts wit h a n u n k n o w n o utc o me. T he i n vesti gat or will f oll o w t he pre g na nc y  u ntil 
c o m pleti o n ( or u ntil pre g na nc y  ter mi nati o n) a n d n otif y Pfizer Safety of t he o utc o me as a 
f oll o w-u p t o t he i nitial re p ort. I n t he case of a li ve birt h, t he str uct ural i nte 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 nl ess 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, or c o n ge nital a n o mal y i n a li ve-b or n ba b y, a ter mi nate d fet us, a n 
i ntra uteri ne fetal de mise, or a ne o natal deat h), 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 u t pre g na nc y o utc o mes t hat are re p orte d t o 
Pfizer Safet y  as S A Es f oll o ws: 

S p o nta ne o us a b orti o n i ncl u di 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;
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 0

Ne o natal deat hs t hat occ ur wit hi n 1 m o nt h of birt h s h o ul d be re p orte d, wit h o ut re gar d 
t o ca usalit y, as S A Es. I n a d diti o n, i nfa nt deat hs after 1 m o nt h s h o ul d be re p orte d as 
S A Es w he n t he i n vesti gat or assesses t he i nfa nt deat h as relate d or p ossi bl y  relate d t o 
e x p os ure t o t he st u d y i nter ve nti o n. 
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). In t he case of pater nal e x p os ure, t he 
i n vesti gat or will pr o vi de t he partici pa nt wit h t he Pre g na nt Part ner Release of I nf or mati o n 
F or m t o deli ver t o his part ner. T he i n vesti gat or m ust d oc u me nt i n t he s o urce d oc u me nts t hat 
t he partici pa nt was gi ve n t he Pre g na nt Part ner Release of I nf or mati o n F or m t o pr o vi de t o his 
part ner.
8. 4. 5. 2. E x p os ure D uri n g Bre astfee di n g
A n E D B occ urs if:

A fe male 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 all 
p ossi ble r o utes of e x p os ure, e g, i n gesti o n, i n halati o n, or s ki n c o ntact.  
T he i n vesti gat or m ust re p ort E D B t o Pfizer Safet y  wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nf or mati o n m ust be re p orte d 
usi n g t he C T S A E Re p ort F or m or via P S S A . W he n E D B occ urs i n t he setti n g of 
e n vir o n me ntal e x p os ure, t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d 
i n t he st u d y, s o t he i nf or mati o n is n ot rec or de d o n a C R F. H o we ver, a c o p y of t he c o m plete d 
re p ort is mai ntai ne d i n t he i n vesti gat or site file.
A n E D B re p ort is n ot create d w he n a Pfizer dr u g s pecifi call y 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 da 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 ve sti gat or m ust re p ort a n y i nsta nce of occ u pati o nal e x p os ure t o Pfizer Safety wit hi n 2 4 
h o urs of t he i n vesti gat or ’s a ware ness usi n g t he C T S A E Re p ort F or m or via P S S A , 
re gar dless of w het her t here is a n ass ociate d S A E. Si nce t he i nf or mati o n a b o ut t he 
occ u pati o nal e x p os ure d oes n ot pertai n t o a partici pa nt e nr olle d i n t he st u d y , t he i nf or mati o n 
is n ot rec or de d o n a C R F; h o we ver, a c o p y of t he c o m plete d re p ort is mai ntai ne d i n t he 
i n vesti gat or site file.
8. 4. 6. C ar di o v asc ul ar a n d De at h E ve nts
N ot a p plica ble.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 1
8. 4. 7. Dise ase -R e l ate d E ve nts a n d/ or Dise ase-Rel ate d O utc o mes N ot Q u alif yi n g as A Es 
or S A Es
N ot a p plica ble.
8. 4. 8. A d verse E ve nts of S peci al I nterest
N ot a p plica ble.
8. 4. 8. 1. L ac k of Effic ac y
T his is a d ose -fi n di n g a n d he nce t his secti o n is n ot a p plica ble. 
8. 4. 9.
Me dic al De vice Deficie ncies
N ot a p plica ble.
8. 4. 1 0. Me dic ati o n Err ors
Me dicati 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.
Me dicati o n err ors are rec or de d a n d re p orte d as f ol l o ws:
Rec or de d o n t he 
Me dic ati o n Err or P a ge 
of t he C R F
Rec or de d o n t he 
A d verse E ve nt P a ge 
of t he C R F
Re p orte d o n t he C T S A E 
Re p ort F or m/ P S S A t o 
Pfizer S afet y Wit hi n 2 4 
H o urs of A w are ness
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 me dicati o n err or
O nl y  if ass ociate d wit h a n 
S A E
Me dicati o n err ors i ncl u de:

Me dicati 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 me dicati o n err ors or uses o utsi de of w hat is f oresee n i n t he pr ot oc ol t hat d o 
or d o n ot i n v ol ve t he st u d y  partici pa nt.

T he a d mi nistrati o n of e x pire d st u d y  i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect st u d y  i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect d osa ge;

T he a d mi nistrati o n of st u d y  i nter ve nti o n t hat has u n der g o ne te m perat ure e xc ursi o n 
fr o m t he s pecifie d st ora ge ra n ge, u nless it is deter mi ne d b y t he s p o ns or t hat t he st u d y 
i nter ve nti o n u n der q uesti o n is acce pta ble f or use.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 2
W het her or n ot t he me dicati 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 me dicati o n err ors occ urri n g t o a st u d y partici pa nt are rec or de d o n t he 
me dicati o n err or pa ge of t he C R F , w hic h is a s pecific versi o n of t he A E pa ge a n d, if 
a p plica ble, a n y ass ociate d seri o us a n d n o nseri o us A E(s) are rec or de d o n t he A E pa ge of t he 
C R F.
I n t he e ve nt of a me dicati 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.
Me dicati o n err ors s h o ul d be re p orte d t o Pfizer Safet y wit hi n 2 4 h o urs o n a C T  S A E Re p ort 
F or m or via P S S A o nl y w he n ass oci ate d wit h a n S A E.
8. 5. P h ar m ac o ki netics 
Bl o o d sa m ples ( ve n o us c ollecti o n) of a p pr o xi matel y  0. 3 m L , t o pr o vi de a mi ni m u m of 
0. 0 8 m L of plas ma , will be c ollecte d f or meas ure me nt of c o nce ntrati o ns of sis u nat o vir as 
s pecifie d i n t he S o A i n Secti o n 1. 3 . 
I nstr ucti o ns f or t he c ollecti o n a n d ha n dli n g of bi ol o gical sa m ples will be pr o vi de d i n t he 
la b orat or y ma n ual or b y t he s p o ns or. T he act ual date a n d ti me ( 2 4-h o ur cl oc k ti me) of eac h 
sa m ple will be rec or de d.
If a partici pa nt ca n n ot atte n d visits, P K sa m ples ma y be c ollecte d via
t o 
meas ure sis u nat o vir c o nce ntrati o ns.
T he act ual ti mes ma y  c ha n ge, b ut t he n u m ber of sa m ples will re mai n t he sa me. All eff orts
will be ma de t o o btai n t he sa m ples at t he e xact n o mi nal ti me relati ve t o d osi n g. C ollecti o n of
sa m ples wit hi n 1 0 % of t he n o mi nal ti me relati ve t o d osi n g (e g, wit hi n 3 6 mi n utes of a 6 -h o ur 
sa m ple) will n ot be ca pt ure d as a pr ot oc ol de viati o n, as l o n g as t he e xact ti me of t he 
c ollecti o n is n ote d o n t he s o urce d oc u me nt a n d t he C R F. 
Sa m ples c ollecte d f or a nal y ses of sis u nat o vir plas ma c o nce ntrati o n ma y als o be use d t o 
e val uate safet y or efficac y as pects relate d t o c o ncer ns arisi n g d uri n g or after t he st u d y, f or 
meta b olite i de ntificati o n a n d/ or e val uati o n of t he bi oa nal y tical met h o d, or f or ot her i nter nal 
e x pl orat or y p ur p oses. T he e x pl orat or y res ults ma y n ot be re p orte d i n t he C S R. Resi d ual 
sa m ples fr o m t he P K c ollecti o n ma y be use d f or e x pl orat or y m olec ular a n d pr ote o mic 
bi o mar kers.
Sa m ples c ollecte d f or meas ure me nt of plas ma c o nce ntrati o ns of sis u nat o vir will be a nal yz e d 
usi n g vali date d a nal yt ical met h o ds i n c o m plia nce wit h a p plica ble S O Ps. P ote ntial 
meta b olites ma y  be a nalyze d wit h eit her vali date d or e x pl o rat or y met h o ds.
T he P K sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns pr o vi de d t o 
t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y. A n y  de viati o ns fr o m t he P K sa m ple 
ha n dli n g pr oce d ure (e g, sa m ple c ollecti o n a n d pr ocessi n g ste ps, i nteri m st ora ge, or s hi p pi n g 
c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d , a n d re p orte d t o t he s p o ns or. 
O n a case -b y -case basis, t he s p o ns or ma y  ma ke a deter mi nati o n as t o w het her sa m ple 
i nte grity has bee n c o m pr o mise d.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 3
Dr u g c o nce ntrati o n i n f or mati o n t hat ma y u n bli n d t he st u d y will n ot be re p orte d t o 
i n vesti gat or sites or bli n de d pers o n nel u ntil t he st u d y has bee n u n bli n de d.
A n y  c ha n ges i n t he ti mi n g or a d diti o n of ti me p oi nts f or a n y pla n ne d st u dy assess me nts m ust 
be d oc u me nte d a n d a p pr o ve d b y  t he rele va nt st u d y tea m me m ber a n d t he n arc hi ve d i n t he 
s p o ns or a n d site st u d y files b ut will n ot c o nstit ute a pr ot oc ol de viati o n. T he IR B/ E C will be 
i nf or me d of a ny s afet y iss ues t hat re q uire alterati o n of t he safet y m o nit ori n g sc he me or 
a me n d me nt of t he I C D.
8. 6. Ge netics
8. 6. 1. S pecifie d Ge netics
S pecifie d ge 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
Nas o p har y n geal ( N P) s wa bs f or bi o mar ker researc h are re q uire d a n d will be c ollecte d fr o m 
all partici pa nts i n t his st u d y as s pecifie d i n t he S o A i n Secti o n 1. 3 :

N P S w a b Assess me nts

A baseli ne N P s wa b sa m ple (ta ke n pre -d ose) will be use d t o meas ure R S V R N A 
le vels b y  q ua ntitati ve R T-P C R , viral se q ue nci n g a n d t o assess f or R S V a n d ot her 
res pirat or y pat h o ge ns. T his test will n ot be use d t o deter mi ne st u d y  eli gi bilit y. T he 
pat h o ge n pa nel assess me nt will be batc he d f or a nal y sis a n d t he res ult will n ot be 
a vaila ble t o t he sites f or real ti me cli nical ma na ge me nt. 

All N P s wa b sa m ples will be a nal yz e d t o meas ure R S V R N A le vels b y  q ua ntitati ve
R T -P C R (i ncl u des a n i nter nal q uality c o ntr ol f or sa m ple c ollecti o n) a n d will be 
utilize d f or viral se q ue nci n g t o e val uate p ote ntial ge netic viral varia nts . N P sa m ples 
will be c ollecte d b y a n H C P d uri n g a site/ 
/i n patie nt visit.

 
 
a n d if per mitte d b y l ocal re g ulati o ns. H u ma n g e netic 
a nal ys es will n ot be perf or me d o n t he N P sa m ples.

Resi d uals of all N P sa m ples ma y  be retai ne d be yo n d t he e n d of t he st u d y  t o e na ble 
t he a nalys es descri be d a b o ve a n d relate d bi o mar k er researc h o n t he st u d y i nter ve nti o n 
a n d disease, if s ufficie nt sa m ples are a vaila ble. St ora ge a n d s hi p pi n g i nstr ucti o ns will 
be i n acc or da nce wit h t he la b orat or y  ma n ual. Ge netic a nal ys es will n ot be perf or me d 
o n t hese N P s wa b sa m ples. Partici pa nt c o nfi dentialit y  will be mai ntai ne d.
8. 7. 1. P h ar m ac o d y n a mic Bi o m ar kers
P har mac o d y na mic bi o mar ker a nal ys es are n ot e val uate d i n t his st u d y .
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 4
8. 7. 2. S pecifie d Ge ne E x pressi o n ( R N A) Rese arc h 
S pecifie d ge ne e x pressi o n ( R N A) researc h is n ot i ncl u de d i n t his st u d y .
8. 7. 3. S pecifie d Pr otei n Rese arc h 
S pecifie d pr otei n researc h is n ot i ncl u de d i n t his st u d y .
8. 7. 4. S pecifie d Met a b ol o mic Rese arc h 
S pecifie d meta b ol o mic researc h is n ot i ncl u de d i n t his st u d y .
8. 7. 5. Ret ai ne d Rese arc h S a m ples f or Bi o m ar kers
Retai ne d researc h sa m ples will n ot be i ncl u de d i n t hi s 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 n ot i ncl u de d i n t his st u d y .
8. 9. He alt h Ec o n o mics
Healt h ec o n o mics/ me dical res o urce utilizati o n a n d healt h ec o n o mics para meters are n ot 
e val uate d i n t his st u d y.
9. S T A TI S TI C A L C O N SI D E R A TI O N S
Detail e d met h o d ol o g y f or s u m mar y a n d statistical a nalys es of t he data c ollecte d i n t his st u d y  
is o utli ne d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or. 
T he S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc ol w here a p pr o priate; h o we ver, a n y maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
9. 1. St atistic al H y p ot heses
T here are n o statistical h y p ot heses f or t his st u d y .
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 5
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 
" E nr olle d" mea ns a partici pa nt’s, or t heir pare nt(s)/le gal 
g uar dia n ’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 n d 
ra n d o mizati o n. 
F ull a nal ys is set 
All partici pa nts ra n d o ml y  assi g ne d t o st u d y i nter ve nti o n 
a n d w h o ta ke at least 1 d ose of st u d y  i nter ve nti o n.
Safet y  a nalys is set
All partici pa nts ra n d o ml y  assi g ne d t o st u d y i nter ve nti o n 
a n d w h o ta ke at least 1 d ose of st u d y  i nter ve nti o n. 
Partici pa nts will be a nal yze d acc or di n g t o t he pr o d uct 
(sis u nat o vir / place b o) t he y act ually recei ve d .
P K C o nce ntrati o n
P o p ulati o n
All partici pa nts ra n d o ml y  assi g ne d t o st u d y i nter ve nti o n 
a n d w h o ta ke at least 1 d ose of st u d y  i nter ve nti o n a n d i n 
w h o m at least 1 c o nce ntrati o n val ue ca n be re p orte d.
P K Para meter A nal ys is
P o p ulati o n
All partici pa nts ra n d o ml y  assi g ne d t o st u d y i nter ve nti o n 
a n d w h o ta ke at least 1 d ose of st u d y  i nter ve nti o n a n d i n 
w h o m at least 1 of t he P K para meters of i nterest ca n be 
re p orte d.
Bi o mar ker A nal ys is 
P o p ulati o n
All partici pa nts ra n d o ml y  assi g ne d t o st u d y i nter ve nti o n 
a n d w h o ta ke at least 1 d ose of st u d y  i nter ve nti o n a n d i n 
w h o m at least 1 of t he meas ure d para meters of i nterest ca n 
be re p orte d.
9. 3. St atistic al A n al yses
T he S A P will be de vel o pe d a n d fi nalize d bef ore a n y  a nalys es are 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.
9. 3. 1. Ge ner al C o nsi der ati o ns
Details of t he a nal y ses will be pr o vi de d i n t he Statistical A nal ysis Pla n.
Descri pti ve statistics f or all e n d p oi nts will be pr o vi de d o verall a n d by c o h ort, a ge a n d 
treat me nt gr o u p, w he n a p plica ble.
T he n u m ber of partici pa nts scree ne d, e nr olle d, c o m pleti n g t he I M P a d mi nistrati o n, a n d 
c o m pleti n g t he st u d y will be s u m marize d. T he reas o n f or all disc o nti n uati o ns will be 
s u m marize d o verall a n d b y c o h ort, a ge a n d treat me nt gr o u p.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 6
Baseli ne de m o gra p hic a n d ot her c haracteristics will be ta b ulate d a n d s u m marize d b y c o h ort , 
a ge a n d treat me nt gr o u p. Q ua ntitati ve varia bles will be descri be d b y sta n dar d de scri pti ve 
statistics ( mea n, sta n dar d de viati o n, mi ni m u m, a n d ma xi m u m), a n d q ualitati ve varia bles will 
be s u m marize d b y  fre q ue nc y ta bles wit h n u m ber a n d pr o p orti o n i n eac h cate g or y ( wit h t he 
c orres p o n di n g sa m ple sizes).
I n ge neral, f or c o nti n u o us e n d p oi nts, descri pti ve statistics ( mea n, sta n dar d de viati o n, 
mi ni m u m, a n d ma xi m u m) will be pr o vi de d. F or bi nar y  e n d p oi nts, t he pr o p orti o n of 
partici pa nts wit h t he e ve nt will be s u m marize d o verall a n d b y c o h ort , a ge a n d treat me nt 
gr o u p. F or cate g orical e n d p oi nts, t he pr o p orti o n of partici pa nts f or eac h cate g or y  will be 
s u m marize d o verall a n d b y c o h ort, a ge, a n d treat me nt gr o u p.
9. 3. 2. Pri m ar y E n d p oi nt(s)
T he pri mar y  e n d p oi nts are relate d t o safety/ t olera bilit y wit h a nalys is as descri be d i n 
Secti o n 9. 3. 5
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 he fi nal p o p ulati o n P K m o del will be use d t o si m ulate plas ma c o nce ntrati o n -ti me c ur ves f or 
sis u nat o vir f or i n di vi d uals a n d t o calc ulate p ost-h oc esti mates of P K para meters ( C L / F, Cma x , 
C mi n , A U C a n d t½ ) b y a ge gr o u p. 
T he plas ma c o nce ntrati o ns of sis u nat o vir will be liste d a n d descri pti vel y s u m marize d b y  
n o mi nal P K sa m pli n g ti me, treat me nt, a ge gr o u p , a n d c o h ort. I n di vi d ual partici pa nt a n d 
s u m mar y pr ofiles ( mea n a n d me dia n pl ots) of t he plas ma c o nce ntrati o ns data will be pl otte d 
b y  treat me nt, a ge gr o u p usi n g act ual a n d n o mi nal ti mes, res pecti vel y. Mea n a n d me dia n 
pr ofiles will be prese nte d o n b ot h li near a n d se mi -l o g scales. 
Data per mitti n g, ge o metric mea ns of P K para meters esti mate d fr o m t he fi nal p o p ulati o n P K 
m o del will be s u m marize d descri pti vel y b y treat me nt a n d a ge gr o u p . A sta n d -al o ne 
p o p ulati o n P K m o deli n g a n d si m ulati o n a nal y sis pla n will be pre pare d, a n d t he res ults will be 
re p orte d i n a sta n d-al o ne re p ort, o utsi de of t he cli nical st u d y re p ort.
9. 3. 4. Terti ar y/ E x pl or at or y E n d p oi nt(s) A n al ysis
Tertiar y / E x pl orat or y e n d p oi nts ma y n ot be re p orte d i n t he C S R a n d ma y be re p orte d 
se paratel y. Descri pti ve s u m maries will be prese nte d, if a p plica ble. F urt her details will be 
pr o vi de d i n S A P.
9. 3. 5. S afet y A n al yses
All safet y a nal ys es will be perf or me d o n t he safet y p o p ulati o n.
A Es, B P, p ulse rate, S P O 2, a n d safety la b orat or y data will be re vie we d a n d s u m marize d o n 
a n o n g oi n g b asis d uri n g t he st u d y t o e val uate t he safety of partici pa nts. A n y cli nical 
la b orat or y a n d vital si g n a b n or malities of p ote ntial cli nical c o ncer n will be descri be d. Safet y 
data will be prese nte d i n ta b ular a n d/ or gra p hical f or mat a n d s u m marize d descri pti vel y, 
w here a p pr o priate.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 7
Me dical hist or y  a n d p h ysical e xa mi nati o n a n d ne ur ol o gical e xa mi nati o n i nf or mati o n, as 
a p plica ble, c ollecte d d uri n g t he c o urse of 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 . H o we ver, a ny u nt o war d fi n di n gs 
i de ntifie d o n p h ysical a n d/ or ne ur ol o gical e xa mi nati o ns c o n d ucte d d uri n g t he acti ve 
c ollecti o n peri o d will be ca pt ure d as A Es, if t h ose fi n di n gs meet t he defi niti o n of a n A E. 
Data c ollecte d at scree ni n g t hat are use d f or i n cl usi o n/e xcl usi o n criteria, s uc h as la b orat or y  
data, E C Gs, a n d vital si g ns, 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. De m o gra p hic data c ollecte d at scree ni n g will be re p orte d. 
Data o n pre mat ure birt h a n d s ocial fact ors c ollecte d at scree ni n g a n d d uri n g t he st u dy will be 
re p orte d.
9. 3. 6. Ot her A n al yses 
9. 3. 6. 1. Bi o m ar ker Assess me nt
Bi o mar ker data c ollecte d d uri n g t he trial m a y  be retai ne d f or f ut ure a nalys es. T he res ults of 
bi o mar ker a nal ys es (e xce pt Viral R N A titres) are n ot pla n ne d t o be i ncl u de d i n t he C S R.
9. 4. I nteri m A n al yses
N o f or mal i nteri m a nal ys is will be c o n d ucte d f or t his st u d y. As t his is a s p o ns or-o pe n st u d y, 
t he s p o ns or ma y c o n d uct u n bli n de d re vie ws of t he data d uri n g t he c o urse of t he st u d y f or t he 
p ur p ose o f safety assess me nt, facilitati n g P K/ P D m o deli n g f or d ose c o nfir mati o n pri or t o 
o pe ni n g t he ne xt a ge c o h ort, b usi ness decisi o ns re gar di n g f ut ure pr oject pla n ni n g a n d/ or 
s u p p orti n g cli nical de vel o p me nt.
Data fr o m eac h c o h ort of t he st u d y  ma y be re p orte d i n a n i nteri m re p ort s h o ul d t he S p o ns or 
deter mi ne a n i nteri m re p ort is warra nte d. All a nal y sis will be descri pti ve i n nat ure.
9. 5. S a m ple Size Deter mi n ati o n
T he sa m ple size has bee n c h ose n e m piricall y  t o pr o vi de safety a n d t olera bilit y  i nf or mati o n 
a n d is n ot base d o n statistical p o wer calc ulati o n. T here will be u p t o t hree d osi n g c o h orts
(c o h orts 2 [ 2 A, 2 B, 2 C, 2 D] a n d 3 [3 E, 3 F , 3 B, 3 D] are o pti o nal):

C o h orts 1 a n d 2:
A:
B:
C:
D:

C o h ort 3:
E :
F :
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 8
B :
D:
partici pa nts (
acti ve;  place b o) are pla n ne d f or eac h c o h ort s o t hat a p pr o xi matel y
e val ua ble partici pa nts  
 per c o h ort) ma y  be ra n d o mize d i nt o t he st u d y. T he n u m ber 
ra n d o mize d ma y  be i ncrease d if S p o ns or rec o m me n ds re peati n g t he d ose f or a c o h ort (ie, a n 
a d diti o nal 
acti ve a n d
place b o ma y be e nr olle d i n t he sa me c o h ort). T his t otals t o 
a p pr o xi matel y a ma xi m m of 1 0 8 e val ua ble partici pa nts (
i n eac h c o h ort +
a d diti o nal i n 
eac h c o h ort if necessar y). T he sa m ple size f or c o h orts ma y  be re d uce d t o 
acti ve, 
place b o) if t here are e nr oll me nt c halle n ges. T he mi ni m u m n u m ber of partici pa nts is 
a p pr o xi matel y
e val ua ble partici pa nts ( base d o n  partici pa nts per C o h ort) as C o h orts 2 
( 2 A, 2 B, 2 C, 2 D) a n d 3 ( 3 E, 3 F, 3 B, 3 D) are o pti o nal i n t he st u d y.
Partici pa nts ma y be re place d at S p o ns or disc reti o n f or t he f oll o wi n g reas o ns: if t he 
partici pa nt’s pare nt(s)/le gal g uar dia n wit h dra ws c o nse nt, if t he partici pa nt misses a n y  d ose 
bef ore pr o vi di n g t he
 sa m ple o n Da y 
or
 if t he partici pa nt misses 
a n y P K sa m ples, if t he I M P is disc o nti n ue d, if t he partici pa nt’s R S V test res ults at scree ni n g 
are n ot c o nfir me d b y t he ce ntral la b orat or y R S V test res ult , if partici pa nt was e x p ose d t o a 
pr o hi bite d c o nc o mita nt me dicati o n or if Da y  1 R S V R N A le vels b y R T-q P C R is less t ha n t he 
l o wer li mit of q ua ntificati o n.
Partici pa nts w h o disc o nti n ue fr o m t he st u d y f or n o n -safety reas o ns ma y be re place d at t he 
s p o ns or’s discreti o n i n c olla b orati o n wit h t he I n vesti gat or.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 8 9
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 o t oc ol, pr ot oc ol a me n d me nts, IC 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 IR 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 o l 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 IR 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 b le 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 ac hes of t he Pr ot oc ol or I C H G C P
I n t he e ve nt of a ny pr o hi biti o n or restricti o n i m p ose d (ie, cli nical h ol d) b y a n a p plica ble 
re g ulat or y a ut h ority i n a n y area of t he w orl d, or if t he i n vesti gator is a ware of a n y  ne w 
i nf or mati o n t hat mi g ht i nfl ue nce t he e val uati o n of t he be nefits a n d ris ks of t he st u d y 
i nter ve nti o n, Pfizer s h o ul d be i nf or me d i m me diatel y. 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 0
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 nts a gai nst a n y i m me diate hazar d, a n d 
of a n y seri o us breac hes of t his pr ot oc ol or of t he I C H G C P  g ui deli nes t hat t he i n vesti gat or 
bec o mes a ware of.
1 0. 1. 2. Fi n a nci al Discl os ure
I n vesti gat ors a n d s u b-i n vesti gat ors will pr o vi de t he s p o ns or wit h s ufficie nt, acc urate 
fi na ncial i nf or mati o n as re q ueste d t o all o w t he s p o ns or t o s u b mit c o m plete a n d acc urate 
fi na ncial certificati o n or discl os ure state me nts t o t he a p pr o priate re g ulat or y a ut h orities. 
I n vesti gat ors are res p o nsi ble f or pr o vi di n g i nf or mati o n o n fi na ncial i nterests d uri n g t he 
c o urse of t he st u d y a n d f or 1 year after c o m pleti o n of t he st u d y.
1 0. 1. 3. I nf or me d C o nse nt/ Asse nt Pr ocess 
T he i n vesti gat or or t heir re prese ntati ve will e x plai n t he nat ure of t he st u d y  t o t he 
partici pa nt a n d t heir pare nt(s)/le gal g uar dia n 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 a n d t heir pare nt(s)/le gal g uar dia n 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.
W he n c o nse nt is o btai ne d fr o m a partici pa nt’s pare nt(s)/le gal g uar dia n, t he partici pa nt’s 
asse nt (affir mati ve a gree me nt) m ust be s u bse q ue ntl y o btai ne d w he n t he partici pa nt has t he 
ca pacit y t o pr o vi de asse nt, as deter mi ne d b y t he I R B/ E C. If t he i n vesti gat or deter mi nes t hat a 
partici pa nt’s decisi o nal ca pacit y is s o li mite d, t he y ca n n ot reas o na bly be c o ns ulte d, t he n, as 
per mitte d b y  t he I RB/ E C a n d c o nsiste nt wit h l ocal re g ulat or y  a n d le gal re q uire me nts, t he 
partici pa nt’s asse nt ma y  be wai ve d wit h so urce d oc u me ntati o n of t he reas o n asse nt was n ot 
o btai ne d. If t he st u d y partici pa nt d oes n ot pr o vi de t heir o w n asse nt, t he s o urce d oc u me nts 
m ust rec or d w h y t he partici pa nt di d n ot pr o vi de asse nt (f or e xa m ple, t he c hil d is n ot of 
asse nti n g a ge per l ocal re g ulati o ns or p olicies), h o w t he i n vesti gat or deter mi ne d t hat t he 
pers o n si g ni n g t he c o nse nt was t he partici pa nt’s pare nt(s)/le gal g uar dia n, t he c o nse nt si g ner’s 
relati o ns hi p t o t he st u d y partici pa nt, a n d t hat t he partici pa nt’s asse nt was o btai ne d or 
wai ve d. If asse nt is o btai ne d ver bally, it m ust be d oc u me nte d i n t he s o urce d oc u me nts.
If st u d y partici pa nts are mi n ors w h o reac h t he a ge of maj ority or if a c hil d reac hes t he a ge of 
asse nt ( per l ocal I R B/ E C re q uire me nts) d uri n g t he st u d y, as rec o g nize d u n der l o cal la w, t he 
c hil d or a d olesce nt m ust t he n pr o vi de t he a p pr o priate asse nt or c o nse nt t o d oc u me nt t heir 
willi n g ness t o c o nti n ue i n t he st u d y . F or a n a d olesce nt w h o reac hes t he a ge of c o nse nt, 
pare ntal c o nse nt w o ul d n o l o n ger be vali d. If t he e nr oll me nt of e ma nci pate d mi n ors is 
per mitte d b y t he I RB/ E C a n d l ocal la w, t he partici pa nt m ust pr o vi de d oc u me ntati o n of le gal 
stat us t o gi ve c o nse nt wit h o ut t he per missi o n of a le gall y a ut h orize d re prese ntati ve.
Partici pa nts a n d t heir pare nt(s)/le gal g uar dia n m ust be i nf or me d t hat t heir partici pati o n is 
v ol u ntar y . T he partici pa nt’s pare nt(s)/le gal g uar dia n will be re q uire d t o si g n a state me nt of 
i nf or me d c o nse nt t hat meets t he re q uire me nts of 2 1 C F R 5 0, l ocal re g ulati o ns, I C H 
g ui deli nes, HI P A A 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 st u d y  partici pa nt’s pare nt(s)/le gal g uar dia n a n d t he 
st u d y partici pa nt as a p plica ble are 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 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 1
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’s pare nt(s)/le gal g uar dia n m ust be i nf or me d t hat t he partici pa nt’s 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’s pare nt(s)/le gal 
g uar dia n.
T he partici pa nt’s pare nt(s)/le gal g uar dia n m ust be i nf or me d t hat t he partici pa nt’s me dical 
rec or ds ma y be e xa mi ne d b y Cli nical Q uality 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 R B/ 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’s pare nt(s)/le gal g uar dia n 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 c hil d’s 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 c hil d’s pers o nal data, kee pi n g i n mi n d t he 
pri vac y  ri g hts t hat ma y restrict access of ol der a d olesce nts’ me dical rec or ds b y  t heir 
pare nt(s)/le gal g uar dia n i n certai n re gi o ns.
T he s o urce d oc u me ntati o n m ust i ncl u de a state me nt t hat writte n i nf or me d c o nse nt, a n d as 
a p plica ble, asse nt was o btai ne d bef ore t he partici pa nt was e nr ol le d i n t he st u d y a n d t he date 
t he writte n c o nse nt/asse 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 IC D.
Pare nt(s)/le gal g uar dia n a n d t he partici pa nt m ust be rec o nse nte d t o t he m ost c urre nt versi o n 
of t he I C D(s)/ asse nt 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 ulati o ns.
A c o p y of t he I C D(s) a n d asse nt, if writte n, m ust be pr o vi de d t o t he pare nt(s)/le gal 
g uar dia n a n d t he partici pa nt.
1 0. 1. 3. 1. Electr o nic C o nse nt 
Partici pa nts ma y  be a ble t o e x perie nce t he i nf or me d c o nse nt pr ocess b y electr o nic mea ns 
(e C o nse nt). T he e C o nse nt pr ocess i ncl u des a n electr o nic prese ntati o n of t he i nf or me d 
c o nse nt d oc u me nt (eI C D), cli nical trial e d ucati o nal c o m p o ne nts (as a p plica ble), a n d 
electr o nic si g nat ures (if all o we d b y l ocal re g ulati o ns). T he use of e C o nse nt d oes n ot re place 
or alter t he I C D c o nte nt or i nf or me d c o nse nt pr ocess as descri be d a b o ve. T he e C o nse nt 
pr ocess c o m plies wit h a p plica ble re g ulati o ns a n d s p o ns or p olicies t o e ns ure relia bilit y  a n d 
data pri vac y . 
1 0. 1. 4. D at a Pr otecti o n
All parties will c o m pl y  wit h all a p plica ble la ws, i ncl u di n g la ws re gar di n g t he i m ple me ntati o n 
of or ga nizati o nal a n d tec h nical meas ures t o e ns ure pr otecti o n of partici pa nt data.
Partici pa nts ’ pers o nal data will be st ore d at t he st u d y  site i n e ncr ypte d electr o nic a n d/ or pa per
f or m a n d will be pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o e ns ure t hat o nl y 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 2
a ut h orize d st u d y staff ha ve access. T he st u dy site will i m ple me nt a p pr o priate tec h nical a n d 
or ga nizati o nal meas ures t o e ns ure t hat t he pe rs o nal data ca n be rec o vere d i n t he e ve nt of 
disaster. I n t he e ve nt of a p ote ntial pers o nal data breac h, t he st u d y site will be res p o nsi ble f or 
deter mi ni n g w het her a pers o nal data breac h has i n fact occ urre d a n d, if s o, pr o vi di n g breac h 
n otificati o ns as re q uire d b y  la w.
To  pr otect t he ri g hts a n d free d o ms of partici pa nts wit h re gar d t o t he pr ocessi n g of pers o nal 
data, partici pa nts will be assi g ne d a si n gle, partici pa nts - 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 h e s p o ns or will c o ntai n t he n u merical 
c o de; partici pa nt na mes will n ot be tra nsferre d. All ot her i de ntifia ble data tra nsferre d t o t he 
s p o ns or will be i de ntifie d b y t his si n gle, partici pa nt-s pecific c o de. T he st u d y site will 
mai ntai n a c o nfi de ntial list of p artici 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 c li nical st u d y a gree me nt a n d a p plica ble pri vac y la ws.
I nf or mati o n tec h n ol o g y s yste ms use d t o c ollect, pr ocess, a n d st ore st u d y-relate d data are 
sec ure d by t ec h nical a n d or ga nizati o nal sec urit y m eas ures desi g ne d t o pr otect s uc h data 
a gai nst acci de ntal or u nl a 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.
1 0. 1. 5. C o m mittees Str uct ure
1 0. 1. 5. 1. D at a M o nit ori n g C o m mittee 
T his st u d y will use a n E-D M C . T he E -D M C is i n de pe n de nt of t he st u dy tea m a n d i ncl u des 
e xter nal me m bers . T he E -D M C c harter descri bes t he r ole of t he E- D M C i n m ore detail.
T he E- D M C will be res p o nsi ble f or o n g oi n g m o nit ori n g of t he safet y of partici pa nts i n t he 
st u d y acc or di n g t o t he c harter. T he rec o m me n dati o ns ma de by t he E -D M C will be f or war de d 
t o t he a p pr o priate a ut h orize d Pfizer pers o n nel f or re vie w a n d fi nal decisi o n. Pfizer will 
c o m m u nicate s uc h decisi o ns, w hic h ma y  i ncl u de s u m maries of a g gre gate a nal yses of P K a n d 
of safet y data, t o re g ulat or y a ut h orities a n d i n vesti gat ors, as a p pr o priate. 
1 0. 1. 6. Disse mi n ati o n of Cli nic al St u d y D at a
Pfizer f ulfills its c o m mit me nt t o p u blicl y  discl ose cli nical st u d y res ults t hr o u g h p osti n g t he 
res ults of st u dies o n w w w.cli nicaltrials. g o v ( Cli nical Trials. g o v), t he E u dra C T/ C TIS, a n d/ or 
w w w. pfizer .c o m, a n d ot her p u blic re gistries a n d we bsites i n acc or da nce wit h a p plica ble l ocal 
la ws/re g ulati o ns. I n a d diti o n, Pfizer re p orts st u d y res ults o utsi de of t he re q uire me nts of l ocal 
la ws/re g ulati ons 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.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 3
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 ducte d. T hese res 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 TI S
Pfizer p osts cli nical trial res ults o n E u dra C T/ C TI S 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 pses a n d plai n -la n g ua ge st u d y res ults s u m maries o n w w w. pfizer .c o m
f or Pfizer -s p o ns ore d i nter ve nti o nal st u dies at t he sa me ti me t he c orres p o n di n g st u d y res ults 
are p oste d t o w w w.cli nicaltrials . g o v. C S R s y n o pses will ha ve pers o nall y  i de ntifia ble 
i nf or mati o n a n o ny m ize d.
D oc u me nts wit hi n mar keti n g a p plicati o ns
Pfizer c o m plies wit h a p plica ble l ocal la ws/re g ulati o ns t o p u blis h cli nical d oc u me nts i ncl u de d 
i n mar keti n g a p plicati o ns. Cli nical d oc u me nts i ncl u de s u m mar y  d oc u me nts a n d C S Rs 
i ncl u di n g t he pr ot oc ol a n d pr ot oc ol a me n d me nts, sa m ple C R Fs, a n d S A Ps. Cli nical 
d oc u me nts will ha ve pers o nall y  i de ntifia ble i nf or mati o n a n o n ymize d.
Data s hari n g
Pfizer pr o vi des researc hers sec ure access t o p artici 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 ny 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 yses. 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.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 4
G ui da nce o n c o m pleti o n of C R Fs will be pr o vi de d i n t he C R F C o m pleti o n Re q uire me nts 
d oc u me nt.
T he i n vesti gat or m ust e ns ure t hat t he C R Fs are sec urel y st ore d at t he st u d y site i n e ncr ypte d 
electr o nic a n d/ or pa per f or m a n d are pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o 
pre ve nt access b y u na ut h orize d t hir d parties.
Q T L s are pre defi ne d para meters t hat are m o nit ore d d uri n g t he st u d y. I m p orta nt de viati o ns 
fr o m t he Q T Ls a n d a ny 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, IR 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. I t is i m p orta nt t hat t he 
i n vesti gat or(s) a n d t heir rele va nt pers o n nel are a vaila ble d uri n g t he m o nit ori n g visits a n d 
p ossi ble a u dits or i ns pecti o ns a n d t hat s uf ficie nt ti me is de v ote d t o t he pr ocess.
M o nit ori n g details descri bi n g strate g y, i ncl u di n g defi niti o n of st u d y-critical data ite ms a n d 
pr ocesses (e g, ris k -base d i nitiati ves i n o perati o ns a n d q ualit y  s uc h as ris k ma na ge me nt a n d 
miti gati o n strate gies a n d a nal yt ical ris k-base d m o nit ori n g), met h o ds, res p o nsi bilities, a n d 
re q uire me nts, i ncl u di n g ha n dli n g of n o nc o m plia nce iss ues a n d m o nit ori n g tec h ni q ues 
(ce ntral, virt ual, or o n-site m o nit ori n g), are pr o vi de d i n t he data ma na ge me nt pla n a n d 
m o nit ori n g pla 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 n ee 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 Ds, pertai ni n g t o t he c o n d uct of t his st u d y  m ust 
be retai ne d b y t he i n vesti gat or f or 1 5 ye ars after st u d y c o m pleti o n u nless l ocal re g ulati o ns or 
i nstit uti o nal p olicies re q uire a l o n ger rete nti o n peri o d. N o rec or ds ma y be destr o ye d d uri n g 
t he rete nti o n peri o d wit h o ut t he writte n a p pr o val of t he s p o ns or. N o rec or ds ma y be 
tra nsferre d t o a n ot her l ocati o n or party wit h o ut wr itte n n otificati o n t o t he s p o ns or. T he 
i n vesti gat or m ust e ns ure t hat t he rec or ds c o nti n ue t o be st ore d sec urely f or as l o n g as t he y are 
mai ntai ne d.
W he n partici pa nt data are t o be delete d, t he i n vesti gat or will e ns ure t hat all c o pies of s uc h 
data are pr o m p tl y a n d irre v oca bly delete d fr o m all s yste ms.
T he i n vesti gat or(s) will n otif y  t he s p o ns or or its a ge nts i m me diatel y of a n y re g ulat or y 
i ns pecti o n n otificati o n i n relati o n t o t he st u d y. F urt her m ore, t he i n vesti gat or will c o o perate 
wit h t he s p o ns or or its a ge nts t o pre pare t he i n vesti gat or site f or t he i ns pecti o n a n d will all o w 
t he s p o ns or or its a ge nt, w he ne ver feasi ble, t o be prese nt d uri n g t he i ns pecti o n. T he 
i n vesti gat or site a n d i n vesti gat or will pr o m ptl y res ol ve a n y discre pa ncies t hat are i de ntifie d 
bet w ee n t he st u d y data a n d t he partici pa nt ’s me dical rec or ds. T he i n vesti gat or will pr o m ptl y  
pr o vi de c o pies of t he i ns pecti o n fi n di n gs t o t he s p o ns or or its a ge nt. Bef ore res p o nse 
s u b missi o n t o t he re g ulat or y a ut h orities, t he i n vesti gat or will pr o vi de t he s p o ns or or its 
a ge nts wit h a n o p p ort u nit y t o re vie w a n d c o m me nt o n res p o nses t o a n y s uc h fi n di n gs.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 5
1 0. 1. 8. S o urce D oc u me nts
S o urce d oc u me nts pr o vi de e vi de nce f or t he e xiste nce of t he partici pa nt a n d s u bsta ntiate t he 
i nte grity of t he data c ollecte d. S o urce d oc u me nts ar e 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 y ste m is d oc u me nte d i n t he data ma na ge me nt 
pla n , w hic h is mai ntai ne d b y t he s p o ns or. 
T he i n vesti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce rec or d) t hat s u p p orts t he 
i nf or mati o n e ntere d i n t he C R F.
T he s p o ns or or desi g nee will perf or m m o nit ori n g t o c o nfir m t hat data e ntere d i nt o t he C R F 
b y  a ut h orize d site pers o n nel are acc urate, c o m plete, a n d verifia ble fr o m s o urce d oc u me nts; 
t hat t he safety a n d ri g hts of partici pa nts are bei n g pr otecte d; a n d t hat t h e 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
R S V test res ult, safet y la bs a n d assess me nts s uc h as E C 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 g ulati o ns, t o e ns ure partici pa nt safet y. 
D ue t o t he p ote ntial f or a partici pa nt t o be re -i de ntifie d fr o m t heir me dical rec or ds, t he 
f oll o wi n g acti o ns m ust be ta ke n w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or 
desi g nee:

T he i n vesti gat or or site staff m ust re dact pers o nal i nf or mati o n fr o m t he me dical 
rec or d. T he pers o nal i nf or mati o n i ncl u des, b ut is n ot li mite d t o, t he f oll o wi n g: 
partici pa nt na mes or i nitials , partici pa nt dates (e g, birt h date, date of h os pital 
a d missi o n/ disc har ge, date of deat h), partici pa nt i de ntificati o n n u m bers (e g, S ocial 
Sec urit y  n u m ber, healt h i ns ura nce n u m ber, me dical rec or d n u m ber, 
h os pital/i nstit uti o n i de ntifier), p artici 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 nce is t he preferre d sys te m if a vaila ble). 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 6
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 
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 dy- 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.

Sites ma y  be cl ose d earl y if t he y are u na ble t o c o nti n ue t o e nr oll partici pa nts.
If t he st u dy is pre mat urel y ter mi nate d or s us pe n de d, t he s p o ns or s hall pr o m ptl y i nf or m t he 
i n vesti gat ors, t he EC s/I R 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 the a p plica ble re g ulat or y  
re q uire me nts. T he i n vesti gat or s hall pr o m ptl y i nf or m t he partici pa nt a n d s h o ul d ass ure 
a p pr o priate partici pa nt t hera p y a n d/ or f oll o w - u p.
St u d y  ter mi nati o n is als o pr o vi de d f or i n t he cli nical st u d y a gree me nt. If t here is a n y c o nflict 
bet wee n t he c o ntract a n d t his pr ot oc ol, t he c o ntract will c o ntr ol as t o ter mi nati o n ri g hts.
1 0. 1. 1 1. P u blic ati o n P olic y
F or m ultice nter trials, t he pri mar y  p u blicati o n will be a j oi nt p u blicati o n de vel o pe d by t he 
i n vesti gat or a n d Pfizer re p orti n g t he pri mar y e n dp 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 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 7
pre parati o n of t he pr i 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 blicati o n or 
a n y ot her ty pe of discl os ure of t he st u d y res ults (c ollecti vel y , “ p u blicati o n”) bef ore it is 
s u b mitte d or ot her wise discl ose d a n d will s u b mit all p u blicati o ns t o Pfizer 3 0 da y s bef ore 
s u b missi o n. If a ny pate nt acti o n is re q uire d t o pr otect i ntellect ual pr o pert y ri g hts, t he
i n vesti gat or a grees t o dela y t he discl os ure f or a peri o d n ot t o e xcee d a n a d diti o nal 6 0 da ys 
u p o n re q uest fr o m Pfizer. T his all o ws Pfizer t o pr otect pr o prietar y  i nf or mati o n a n d t o pr o vi de 
c o m me nts, a n d t he i n vesti gat or will, o n re q uest, re m o ve a n y pre vi o u sly u n discl ose d 
c o nfi de ntial i nf or mati o n bef ore discl os ure, e xce pt f or a n y st u d y- i nter ve nti o n or Pfizer -relate d 
i nf or mati o n necessar y f or t he a p pr o priate scie ntific prese ntati o n or u n dersta n di n g of t he 
st u d y res ults. F or j oi nt p u blicati o ns, s h o ul d t here be disa gree me nt re gar di n g i nter pretati o n 
a n d/ or prese ntati o n of s pecific a nal ys is res ults, res ol uti o n of, a n d res p o nsi bilit y f or, s uc h 
disa gree me nts will be t he c ollecti ve res p o nsi bilit y  of all a ut h ors of t he p u blicati o n.
F or all p u blicati o ns relati n g t o t he st u d y, t he i n vesti gat or a n d Pfizer will c o m pl y wit h 
rec o g nize d et hical sta n dar ds c o ncer ni n g p u blicati o ns a n d a ut h ors hi p, i ncl u di n g t h ose 
esta blis he d b y t he I nter nati o nal C o m mittee of Me dical J o ur nal E dit ors. T he i n vesti gat or will 
discl ose a n y relati o ns hi p wit h Pfizer a n d a n y  rele va nt p ote ntial c o nflicts of i nterest, i ncl u di n g 
a n y fi na ncial or pers o nal relati o ns hi p wit h Pfizer, i n a n y p u blicati o ns. All a ut h ors will ha ve 
access t o t he rele va nt statistical ta bles, fi g ures, a n d re p orts (i n t heir ori gi nal f or ma t) re q uire d 
t o de vel o p t he p u blicati o n.
1 0. 1. 1 2. S p o ns or’s Me dic all y Q u alifie d I n di vi d u al 
T he s p o ns or will desi g nate a me dicall y q ualifie d i n di vi d ual ( M QI, als o k n o w n as t he me dical 
m o nit or) t o a d vise t he i n vesti gat or o n st u d y- relate d me dical q uesti o ns. T he c o ntact 
i nf or mati o n f or t he st u dy me dical m o nit or is d oc u me nte d i n t he St u d y T ea m C o ntact List 
l ocate d i n t he I n vesti gat or Site File or e q ui vale nt. 
Partici pa nts are pr o vi de d wit h a Pfizer st u d y  i nf or mati o n car d at t he ti me of i nf or me d c o nse nt 
w hic h i n cl u des c o ntact i nf or mati o n f or t heir i n vesti gat or i n case of st u d y- relate d me dical 
q uesti o ns. T he st u d y  i nf or mati o n car d c o ntai ns, at a mi ni m u m, (a) st u d y n u m ber, ( b) 
partici pa nt ’s st u d y i de ntificati o n n u m ber, a n d (c) pri nci pal i n vesti gat or c o ntact i nf or mati o n.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 8
1 0. 2. A p pe n di x 2: Cli nic al L a b or at or y Tests
T he f oll o wi n g safet y la b orat or y  tests will be perf or me d at ti mes defi ne d i n t he S o A
( Secti o n 1. 3 ). A d diti o nal la b orat or y res ults ma y be re p orte d o n t hese sa m ples as a res ult of 
t he met h o d of a nalys is or t he t ype of a nal yz er use d b y t he cli nical la b orat or y, or as deri ve d 
fr o m calc ulate d val ues. T hese a d diti o nal tests w o ul d n ot re q uire a d diti o nal c ollecti o n of 
bl o o d. U nsc he d ule d cli nical la b orat or y  meas ure me nts ma y be o btai ne d at a n y ti me d uri n g t he 
st u d y t o assess a ny percei ve d safet y iss ues.
T a ble 8 .
Pr ot oc ol Re q u ire d L a b or at or y Assess me nts
H e m at ol o g y
C he mistr y
Uri n al ysis
Refle x tests f or DI LI 
a n d DI KI
H e m o gl o bi n
H e m at ocrit
R B C c o u nt
Platelet c o u nt
W B C c o u nt (t otal a n d 
differe ntial)
Mea n cell v ol u me ( M C V)
Mea n cell he m o gl o bi n ( M C H)
M C H c o nce ntrati o n ( M C H C)
Urea a n d creati ni ne
e G F R a
G G T
Calci u m
S o di u m
P otassi u m
C hl ori de
A S T, A L T
T otal bilir u bi n
Al kali ne p h os p hatase
Al b u mi n
T otal pr otei n
C ystati n C
L ocal di pstic k:
p H
Gl uc ose ( q ual)
Pr otei n ( q ual)
Bl o o d ( q ual)
Ket o nes
Nitrites
Le u k oc yte esterase
La b orat or y:
Al b u mi n ( uri ne)
Creati ni ne ( uri ne)
Uri ne al b u mi n t o 
creati ni ne rati o
( A C R)b
DI KI: 
C ystati n C
Creati ni ne
e G F R
U A
Al b u mi n ( uri ne)
Creati ni ne ( uri ne)
Uri ne al b u mi n t o 
creati ni ne rati o 
( A C R)b
DI LI:
Al b u mi n
C K, direct a n d 
i n direct bilir u bi n, 
A S T, A L T, G G T , 
L D H, P T/I N R, 
e osi n o p hil ( %), a n d 
al kali ne p h os p hatase
a.
e G F R calc ulati o n s h o ul d be acc or di n g t o l ocal la borat or y res ult pr o vi de d
b.
if o nl y A C R is pr o vi de d b y t he la b, al b u mi n ( uri ne) a n d creati ni ne ( uri ne) d o n ot nee d t o be c ollecte d
T he i n vesti gat or m ust re vie w t he la b orat or y  re p ort, d oc u me nt t his re vie w, a n d rec or d a ny 
cli nicall y rele va nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E secti o n of t he C R F . 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 9 9
1 0. 3. A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E v al u ati n g, F oll o w -U p, a n d Re p orti n g
1 0. 3. 1. Defi niti o n of A E
A E Defi niti o n

A n A E is a n y u nt o war d me dical occ urre nce i n a patie nt or cli nical st u d y 
partici pa nt, te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n, w het her or n ot 
c o nsi dere d relate d t o t he st u d y  i nter ve nti o n.

N ote: A n A E ca n t heref ore be a n y u nfa v ora ble a n d u ni nte n de d si g n (i ncl u di n g a n 
a b n or mal la b orat or y fi n di n g), sy m pt o m, or disease ( ne w or e xacer bate d) 
te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n.
E ve nts Meeti n g
t he A E Defi niti o n

A n y  a b n or mal la b orat or y test res ults ( he mat ol o g y, cli nical c he mistr y, or uri nal ysis) 
or ot her safet y assess me nts (e g, E C G, ra di ol o gical sca ns, vital si g n meas ure me nts), 
i ncl u di n g t h ose t hat w orse n fr o m baseli ne, c o nsi dere d cli nically si g nifica nt i n t he 
me dical a n d scie ntific j u d g me nt of t he i n vesti gat or. A n y a b n or mal test res ults t hat 
meet a n y of t he c o n diti o ns bel o w m ust be rec or de d as a n A E:

Is ass ociate d wit h acc o m pa n yi n g sy m pt o ms.

Re q uires a d diti o nal dia g n ostic testi n g or me dical/s ur gical i nter ve nti o n.

Lea ds t o a c ha n ge i n st u d y  d osi n g ( o utsi de of a n y pr ot oc ol-s pecifie d d ose 
a dj ust me nts) or disc o nti n uati o n fr o m t he st u d y , si g nifica nt a d diti o nal 
c o nc o mita nt dr u g treat me nt, or ot her t hera p y.

E xacer bati o n of a c hr o nic or i nter mitte nt pree xisti n g c o n diti o n, i ncl u di n g a n 
i ncrease i n eit her fre q ue nc y a n d/ or i nte nsit y of t he c o n diti o n.

Ne w c o n diti o n detecte d or dia g n ose d after st u d y i nter ve nti o n a d mi nistrati o n, e ve n 
t h o u g h it ma y ha ve bee n prese nt bef ore t he start of t he st u d y.

Si g ns, s y m pt o ms, or t he cli nica l se q uelae of a s us pecte d dr u g-dr u g i nteracti o n.

Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d o ver d ose of eit her st u d y  
i nter ve nti o n or a c o nc o mita nt me dicati o n. O ver d ose per se will n ot be re p orte d as 
a n A E or S A E u nless it is a n i nte nti o nal o ver d ose ta ke n wit h p ossi ble 
s uici dal/self- har mi n g i nte nt. S uc h o ver d oses s h o ul d be re p orte d re gar dless of 
se q uelae.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 0
E ve nts N O T Meeti n g t he A E Defi niti o n

A n y  cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs or ot her a b n or mal safety 
assess me nts t hat are ass ociate d wit h t he u n derl yi n g disease, u nless j u d ge d b y  t he 
i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he partici pa nt’s c o n diti o n.

T he disease/ dis or der bei n g st u die d or e x pecte d pr o gressi o n, si g ns, or s y m pt o ms of 
t he disease/ dis or der bei n g st u die d, u nless m ore se vere t ha n e x pecte d f or t he 
partici pa nt’s c o n diti o n.

Me dical or s ur gical pr oce d ure (e g, e n d osc o p y, a p pe n dect o m y): t he c o n diti o n t hat 
lea ds t o t he pr oce d ure is t he A E.

Sit uati o ns i n w hic h a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).

A ntici pate d da y -t o-d a y  fl uct uati o ns of pree xisti n g disease(s) or c o n diti o n(s) prese nt 
or detecte d at t he start of t he st u d y t hat d o n ot w orse n.
1 0. 3. 2. Defi niti o n of a n S A E
A n S A E is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at a n y d ose, meets o ne 
or m 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 ys icia n’s office or 
o ut patie nt setti n g. C o m plicati o ns t hat occ ur d uri n g h os pitalizati o n are A Es. If a 
c o m plicati o n pr ol o n gs h os pitalizati o n or f ulfills a n y ot her seri o us criteria, t he e ve nt is 
seri o us. W he n i n d o u bt as t o w het her “ h os pitalizati o n” occ urre d or was necessar y, t he 
A E s h o ul d be c o nsi dere d seri o us.
H os pitalizati o n f or electi ve t reat me nt of a pree xisti n g c o n diti o n t hat di d n ot w orse n 
fr o m baseli ne is n ot c o nsi dere d a n A E.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 1
d.
Res ults i n persiste nt or si g nific a nt dis a bilit y/i nc a p acit y

T he ter m disa bilit y mea ns a s u bsta ntial disr u pti o n of a pers o n’s a bilit y  t o c o n d uct 
n or mal life f u ncti o ns.

T his defi niti o n is n ot i nte n de d t o i ncl u de e x perie nces of relati vel y mi n or me dical 
si g nifica nce, s uc h as u nc o m plicate d hea dac he, na usea, v o miti n g, diarr hea, 
i nfl ue nza, a n d acci de ntal tra u ma (e g, s prai ne d a n kle), t hat ma y i nterfere wit h or 
pre ve n t e ver yd a y  life f u ncti o ns b ut d o n ot c o nstit ute a s u bsta ntial disr u pti o n.
e.
Is a c o n ge nit al a n o m al y/ birt h defect
f.
Is a s us pecte d tr a ns missi o n vi a a Pfizer pr o d uct of a n i nfecti o us a ge nt, p at h o ge nic 
or n o n p at h o ge nic  
T he e ve nt ma y  be s us pecte d fr o m cli nical s ym 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 c ases 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 serio us.

E xa m ples of s uc h e ve nts i ncl u de i n vasi ve or mali g na nt ca ncers, i nte nsi ve treat me nt 
i n a n e mer ge nc y r o o m or at h o me f or aller gic br o nc h os pas m, bl o o d d yscrasias or 
c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n, or de vel o p me nt of dr u g 
de pe n de nc y  or dr u g a b use.
1 0. 3. 3. Rec or di n g/ Re p orti n g a n d F oll o w -U p of A Es a n d/ or S A Es D uri n g t he Acti ve 
C ollecti o n Peri o d 
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 usi n g t he C T S A E Re p ort F or m or via P S S A t o Pfizer Safet y t hr o u g h o ut 
t he acti ve c ollecti o n peri o d. T hese re q uire me nts are deli neate d f or 3 ty 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. 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 2
It s h o ul d be n ote d t hat t he C T S A E Re p ort F or m /P S S A f or re p orti n g of S A E i nf or mati o n 
is n ot t he sa me as t he A E pa ge of t he C R F. W he n t he sa me data are c ollecte d, t he f or ms 
m ust be c o m plete d i n a c o nsiste nt ma n ner. A Es s h o ul d be rec or de d usi n g c o ncise me dical 
ter mi n ol o g y a n d t he sa me A E ter m s h o ul d be use d o n b ot h t he C R F a n d t he C T S A E 
Re p ort F or m /P S S A f or re p orti n g of S A E i nf or mati o n.
S afet y E ve nt
Rec or de d o n t he C R F
Re p orte d o n t he C T S A E 
Re p ort F or m /P S S A t o 
Pfizer S afet y Wit hi n 2 4 
H o urs of A w are ness
S A E
All
All
N o nseri o us A E
All
N o ne
E x p os ure t o t he st u d y  
i nter ve nti o n u n der st u 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 
re p orte d * * *
*
E D P ( wit h or wit h o ut a n ass ociate d S A E) is re p orte d t o Pfizer Safet y usi n g t he C T S A E Re p ort 
F or m / P S S A a n d E D P S u p ple me ntal F or m or via P S S A. 
* * E D B is re p orte d t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m or via P S S A, w hic h w o ul d als o 
i ncl u de details of a n y S A E t hat mi g ht be ass ociate d wit h t he E D B. 
* * * E n vir o n me nt al or occ u p ati o n al e x p os ure: A E s or S A Es ass ociate d wit h occ u pati o nal e x p os ure 
are re p orte d t o Pfizer Safet y usi n g t he C T S A E Re p ort F or m or via P S S A. 

W he n a n A E or S A E occ urs, it is t he res p o nsi bilit y  of t he i n vesti gat or t o re vie w all 
d oc u me ntati o n (e g, h 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 C T S A E Re p ort F or m/
P S S A A E or S A E C R F pa ge.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 3

T here ma y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are 
re q ueste d by Pfizer Safet y. I n t his case, all partici pa nt i de ntifiers, wit h t he 
e xce pti o n of t he partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he me dical 
rec or ds bef ore s u b missi o n t o Pfizer Safet y. Refer t o Secti o n 1 0. 1. 9 f or acti o ns t hat 
m ust be ta ke n w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or desi g nee.

T he i n vesti gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n si g ns, 
s ym pt o ms, a n d/ or ot her cli nical i nf or mati o n. W he ne ver p ossi ble, t he dia g n osis ( n ot 
t he i n di vi d ual si g ns/s ym pt o ms) will be d oc u me nte d as t he A E or S A E.
Assess me nt of I nte nsit y
T he i n vesti gat or will ma ke a n assess me nt if i nte nsit y  f or eac h A E a n d S A E re p orte d d uri n g 
t he st u d y a n d assi g n it t o 1 of t he f oll o wi n g cate g ories:

Mil d: A t y pe of A E t hat is us uall y  tra nsie nt a n d ma y re q uire o nl y mi ni mal 
treat me nt or t hera pe utic i nter ve nti o n. T he e ve nt d oes n ot ge nerall y i nterfere wit h 
us ual A D L.

M o derate: A t y pe of A E t hat is us uall y  alle viate d wit h a d diti o nal s pecific 
t hera pe utic i nter ve nti o n. T he e ve nt i nterferes wit h us ual A D L, ca usi n g disc o mf ort, 
b ut p oses n o si g nifica nt or per ma ne nt ris k of har m t o t he researc h partici pa nt.  

Se vere: A t y pe of A E t hat i nterr u pts us ual A D L, or si g nifica ntl y affects cli nical 
stat us, or ma y re q uire i nte nsi ve t hera pe utic i nter ve nti o n.

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.
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, wi ll be c o nsi dere d a n d i n vesti gate d.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 4

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 usal it y 
assess me nt.

T he ca usalit y  assess me nt is o ne of t he criteria use d w he n deter mi ni n g re g ulat or y 
re p orti n g re q uire me nts.

If t he i n vesti gat or d oes n ot k n o w w het her or n ot t he st u d y i nter ve nti o n ca use d t he 
e ve nt, t he n t he e ve nt will be ha n dle d as “relate d t o st u d y i nter ve nti o n” f or re p orti n g 
p ur p oses, as defi ne d b y t he s p o ns or. I n a d diti o n, if t he i n vesti gat or deter mi nes t hat 
a n S A E is ass ociate d wit h st u d y  pr oce d ures, t he i n vesti gat or m ust rec or d t his 
ca usal relati o ns hi p i n t he s o urce d oc u me nts a n d C R F, a n d re p ort s uc h a n 
assess me nt i n t he de dicate d secti o n of t he C T S A E Re p ort F or m / P S S A a n d i n 
acc or da nce wit h t he S A E re p orti n g re q uire me nts.
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 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 n ati 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 Safety 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.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 5
1 0. 3. 4. Re p orti n g of S A Es
S A E Re p orti n g t o Pfizer S afet y vi a a n Electr o nic D C T

T he pri mar y  mec ha nis m f or re p orti n g a n S A E t o Pfizer Safet y will be t he 
electr o nic D C T (e g, e S A E or P S S A).

If t he electr o nic sys te m is u na vaila ble, t he n t he site will use t he pa per S A E re p ort 
f or m (see ne xt secti o n) t o re p ort t he e ve nt wit hi n 2 4 h o urs.

T he site will e nter t he S A E data i nt o t he electr o nic D C T (e g, e S A E or P S S A) or 
pa per f or m (as a p plica ble) as s o o n as t he data bec o me a vaila ble.

After t he st u d y is c o m plete d at a gi ve n site, t he electr o nic D C T will be ta ke n 
off -li ne t o pre ve nt t he e ntr y of ne w data or c ha n ges t o e xisti n g data.

If a site recei ves a re p ort of a ne w S A E fr o m a st u d y partici pa nt or recei ves u p date d 
data o n a pre vi o usl y  re p orte d S A E after t he electr o nic D C T has bee n ta ke n off-li ne, 
t he n t he site ca n re p ort t his inf or mati o n o n a pa per S A E f or m (see ne xt secti o n) or 
t o Pfizer Safet y b y tele p h o ne.
S A E Re p orti n g t o Pfizer S afet y vi a t he C T S A E Re p ort F or m

Facsi mile tra ns missi o n of t he C T 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 d o w n 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. I f 
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 C T 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 C T S A E Re p ort F or m pa ges wit hi n t he desi g nate d re p orti n g 
ti me fra mes.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 6
1 0. 4. A p pe n di x 4 : Ge netics
N ot A p plica ble
1 0. 5. A p pe n di x 5 : Li ver S afet y: S u g geste d Acti o ns a n d F oll o w-U p Assess me nts 
T he t hres h ol d of la b orat or y  a b n or malities f or a p ote ntial Dr u g-I n d uce d Li ver I nj ur y ( 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 nts 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 ( H y’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 o r y val ues:
Para meters f or pe diatric he patic d ys f u ncti o n ca n be defi ne d as at least 2 of t he bel o w:

T otal bilir u bi n > 2 × U L N 

A S T > 2 × U L N

A L T > 2 × U L N
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 h ysical assess me nt.
I n a d diti o n t o re peati n g meas ure me nts of A S T a n d A LT a n d T bili f or s us pecte d H y ’s la w 
cases, a d d iti 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/I N R, e osi n o p hil ( %), 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, 
i ncl u di n g fact ors o utli ne d i n t he list bel o w, s h o ul d be c ollecte d as a p plica ble.

Si g ns a n d s y m pt o ms of he pat ot o xicit y  ( na usea, v o miti n g, fati g ue, ja u n dice, R U Q 
pai n)

re vie w of et ha n ol use a n d c o ns u m pti o n

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 dic ati o ns)

recreati o nal dr u g use

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
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 7

s ur ger y

bl o o d tra nsf usi o n

hist or y  of li ver or aller gic disease

p ote ntial occ u pati o nal e x p os ure t o c he micals

e n vir o n me ntal e x p os ures

h o use h ol d/li vi n g arra n ge me nts
F urt her testi n g f or ac ute he patitis A, B, C, D, a n d E i nfecti o n, t otal bile aci ds, li ver i ma gi n g 
(e g, biliar y tract), a n d c ollecti o n of ser u m sa m ples f or aceta mi n o p he n/ paraceta m ol dr u g 
a n d/ or pr otei n a d d uct le vels ma y  be warra nte d.
All cases de m o 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 LT a n d 
T bili 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 li ver e nz y me a b n or malities has y et bee n f o u n d. S uc h p ote ntial DI LI 
( Hy’s la w) cases are t o be re p orte d as S A Es, irres pecti ve of a vaila bilit y of all t he res ults of 
t he i n vesti gati o ns perf or me d t o deter mi ne eti ol o g y of t he li ver e nzy m e a b n or malities.
T he preferre d t u be is t he re d t o p t u be f or li ver tra nsa mi nases ( A L T/ A S T), bilir u bi n a n d 
al kali ne p h os p hatase. F or a d diti o nal i nf or mati o n re gar di n g t he pr o per pe diatric t u bes f or 
t hese la bs, please c o ntact y o ur ce ntral la b.
I n certai n diseases s uc h as rare diseases (e g, D uc he n ne M usc ular
D y str o p h y) t here c o ul d be 
a n a dj ust me nt t o t he li ver e nz yme para meters t o acc o u nt f or t he i ncrease d baseli ne of t he 
partici pa nt e nteri n g t he cli nical trial. Please n ote he patic la bs refere nce ra n ges ma y  differ f or 
a d ult a n d pe diatric p o p ulati o n, certai n diseases a n d la b perf or mi n g t he test.
F or a d diti o nal i nf or mati o n re gar di n g DI LI please see G ui da nce f or I n d ustr y  (f da. g o v).
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 nts, 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 nts 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 nts 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 ors” or are “s usce pti ble.”
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 bili ele vati o ns ( > 2 × 
U L N) b y se veral da ys or wee ks. T he i ncrease i n T bili t y picall 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, b y 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 bili t hat meet t he criteria o utli ne d 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 8
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 nts 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 nts wit h A S T/ A L T a n d T bili baseli ne val ues wit hi n t he n or mal ra n ge w h o 
s u bse q ue ntl y prese nt wit h A S T O R A LT val ues ≥3 × U L N A N D a T bili 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 nts wit h baseli ne A S T O R A L T O R T bili val ues a b o ve t he U L N, t he 
f oll o wi n g t hres h ol d val ues are use d i n t he defi niti o n me nti o ne d a b o ve, as nee de d, 
de pe n di n g o n w hic h val ues are a b o ve t he U L N at baseli ne:

Pree xisti n g A S T or A L T baseli ne val ues a b o ve t he n or mal ra n ge: A S T or A L T 
val ues ≥2 ti mes t he baseli ne val ues A N D ≥3 × U L N; or ≥8 × U L N ( w hic he ver is 
s maller).

Pree xisti n g val ues of T bili a b o ve t he n or mal ra n ge: T bili 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 bili se parate d by m ore t ha n a fe w wee ks s h o ul d be assesse d 
i n di vi d uall y base d o n cli nical j u d g me nt; a n y case w here u ncertai nt y re mai ns as t o w het her it 
re prese nts a p ote ntial H y’s la w case s h o ul d be re vie we d wit h t he s p o ns or. 
T he partici pa nt s h o ul d ret ur n t o t he i n vesti gat or site a n d be e val uate d as s o o n as p ossi ble, 
prefera bl y wit hi n 4 8 h o urs fr o m a ware ness of t he a b n or mal res ults. T his e val uati o n s h o ul d 
i ncl u de la b orat or y tests, detaile d hist or y, a n d p hys ical assess me nt.
I n a d diti o n t o re peati n g meas ure me nts of A S T  a n d A L T a n d T bili f or s us pecte d H y ’s la w 
cases, a d diti o nal la b orat or y  tests s h o ul d i ncl u de al b u mi n, C K, direct a n d i n direct bilir u bi n, 
G G T , P T/IN R, e osi n o p hils ( %), a n d al 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 parat e t u be of cl otte d bl o o d a n d a n a ntic oa g ulate d t u be of bl o o d f or 
f urt her testi n g, as nee de d, f or f urt her c o nte m p ora ne o us a nalys es at t he ti me of t he rec o g nize d 
i nitial a b n or malities 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 by itself or as a c of or m ulate d 
pr o d uct i n prescri pti o n or o ver -t he-c o u nter me dicati o ns), recreati o nal dr u g, or s u p ple me nt 
( her bal) use a n d c o ns u m pti o n, fa mil y hist or y, se x ual hist or y, tra vel histor y, hist or y of c o ntact 
wit h a ja u n dice d pers o n, s ur ger y, bl o o d tra nsf usi o n, hist or y of li ver or aller gic disease, a n d 
p ote ntial occ u pati o nal e x p os ure t o c he micals, s h o ul d be c ollecte d. F urt her testi n g f or ac ute 
he patitis A, B, C, D, a n d E i nfecti o n, t otal bile aci ds, li ver i ma gi n g (e g, biliar y  tract), a n d 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 0 9
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 bili ele vati o n defi ne d a b o ve s h o ul d be c o nsi dere d p ote ntial DI LI ( H y ’s la w) cases if n o 
ot her reas o n f or t he L F T  a b n or malities has yet bee n f o u n d. S uc h p ote nti al DI LI ( H y’s l a w) 
c ases are t o be re p orte d as S A Es, irres pecti ve of a v ail a bilit y of all t he res u lts of t he 
i n vesti g ati o ns perf or me d t o deter mi ne eti ol o g y of t he L F T a b n or m alities.
A p ote ntial DI LI ( H y ’s la w) case bec o mes a c o nfir me d case o nly after all res ults of 
reas o na ble i n vesti gati o ns ha ve bee n recei ve d a n d ha ve e xcl u de d a n alter nati ve eti ol o g y.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 0
1 0. 6. A p pe n di x 6 : Ki d ne y S afet y M o nit ori n g G ui deli nes
1 0. 6. 1. L a b or at or y Assess me nt of C h a n ge i n Ki d ne y F u ncti o n a n d Detecti o n of Ki d ne y 
I nj ur y
Sta n dar d ki d ne y  safet y m o nit ori n g re q uires assess me nt of baseli ne a n d p ost-baseli ne Screat 
meas ure me nt t o esti mate ki d ne y  f u ncti o n [ Screat-base d e G F R]. Ser u m C y stati n C ( Sc ys) is 
a n alter nati ve t o Screat as a bi o mar ker of ki d ne y f u ncti o n assess me nt a n d has bee n e val uate d 
as a pre dict or of A KI acr oss t he f ull a ge s pectr u m [1 4- 1 6 ]. Baseli ne a n d p ost baseli ne Sc ys 
ma kes it feasi ble t o disti n g uis h A KI fr o m ot her ca uses of Screat i ncrease. If Screat i ncrease is 
c o nfir me d after baseli ne, t he n refle x meas u re me nt of Sc ys is i n dicate d. 
Re gar dless of w het her ki d ne y  f u ncti o n m o nit ori n g tests are re q uire d as a r o uti ne safety 
m o nit ori n g pr oce d ure i n t he st u d y , if t he i n vesti gat or or s p o ns or dee ms it necessar y t o f urt her 
assess ki d ne y safet y a n d q ua ntif y ki d ne y fu ncti o n, t he n t hese test res ults s h o ul d be ma na ge d 
a n d f oll o we d per sta n dar d of care.
P E DI A T RI C S : C urre ntl y, n o Screat pl us Sc y s e G F R e q uati o ns ha ve bee n u ni versall y 
a d o pte d f or pe diatrics. T heref ore, c o m paris o n of baseli ne Screat a n d Sc y s t o p ost-baseli ne
Screat a n d refle x Sc y s are utilize d t o s u p p ort differe ntiati o n of A KI fr o m DI CI.
I n vesti gat ors m ust i de ntif y a n d rec or d t heir l ocal la b orat or y met h o d f or a nal y sis of Screat 
(e g, a n o n-is ot o pe dil uti o n mass s pectr o metr y (n o n -I D M S) tracea ble met h o d; a n e nz ymatic 
assa y, or I D M S tracea ble assa y  t o assess Screat ) i n t he C R F. T he s p o ns or will calc ulate re nal 
f u ncti o n base d o n t he Screat assa y utilize d as s pecifie d i n Secti o n 1 0. 6. 2. 
1 0. 6. 2. A ge -S pecific Ki d ne y F u ncti o n C alc ul ati o n s
A ge Gr o u p
M e t h o d
Cre ati ni ne Ass a y 
e G F R C alc ul ati o n 
All a ges
Sc h wartz/ Bri o n
N o n -I D M S
k × Hei g ht (c m) / Screat
≥ 1 y o 
Be dsi de ( u p date d) Sc h wartz 
E nz y matic or I D M S 
tracea ble assa y
0. 4 1 3 × ( Ht/s Cr)
< 1 y o
N A 
E nz y matic or I D M S 
tracea ble assa y
Use ser u m creati ni ne 
refere nce ra n ges i n Ta ble 9
t o assess re nal f u ncti o n 
K: pr o p orti o nalit y c o nsta nt
Ht i n c m; Screat i n m g/ d L
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 1
T a ble 9. 
Ser u m cre ati ni ne refere nce v al ues t o assess ki d ne y f u ncti o n i n ne o n ates 
a n d i nf a nts < 1 ye ar of a ge [1 7 ]
A ge
Me di a n 
( Pre dicte d) 
Cre ati n i ne 
V al ue
2. 5 %
1 0 %
9 0 %
9 7. 5 %
1 Da y
5 5 u m ol/ L
( 0. 6 2 m g/ d L)
3 7 u m ol/ L
( 0. 4 2 m g/ d L)
4 3 u m ol/ L
( 0. 4 9 m g/ d L)
7 0 u m ol/ L
( 0. 7 9 m g/ d L)
8 1 u m ol/ L
( 0. 9 2 m g/ d L)
2 Da y
4 7 u m ol/ L
( 0. 5 3 m g/ d L)
3 2 u m ol/ L
( 0. 3 6 m g/ d L)
3 6 u m ol/ L
( 0. 4 1 m g/ d L)
6 0 u m ol/ L
( 0. 6 8 m g/ d L)
6 9 u m ol/ L
( 0. 7 8 m g/ d L)
3 Da y
4 2 u m ol/ L
( 0. 4 8 m g/ d L)
2 9 u m ol/ L
( 0. 3 3 m g/ d L)
3 3 u m ol/ L
( 0. 3 7 m g/ d L)
5 4 u m ol/ L
( 0. 6 1 m g/ d L)
6 2 u m ol/ L
( 0. 7 m g/ d L)
4 Da y
3 9 u m ol/ L
( 0. 4 4 m g/ d L)
2 7 u m ol/ L
( 0. 3 1 m g/ d L)
3 1 u m ol/ L
( 0. 3 5 m g/ d L)
5 0 u m ol/ L
( 0. 5 7 m g/ d L)
5 8 u m ol/ L
( 0. 6 6 m g/ d L)
5 Da y
3 7 u m ol/ L
( 0. 4 2 m g/ d L)
2 5 u m ol/ L
( 0. 2 8 m g/ d L)
2 9 u m ol/ L
( 0. 3 3 m g/ d L)
4 8 u m ol/ L
( 0. 5 4 m g/ d L)
5 5 u m ol/ L
( 0. 6 2 m g/ d L)
6 Da y
3 6 u m ol/ L
( 0. 4 1 m g/ d L)
2 4 u m ol/ L
( 0. 2 7 m g/ d L)
2 8 u m ol/ L
( 0. 3 2 m g/ d L)
4 6 u m ol/ L
( 0. 5 2 m g/ d L)
5 3 u m ol/ L
( 0. 6 m g/ d L)
7 Da y
3 4 u m ol/ L
( 0. 3 8 m g/ d L)
2 3 u m ol/ L
( 0. 2 6 m g/ d L)
2 7 u m ol/ L
( 0. 3 1 m g/ d L)
4 4 u m ol/ L
( 0. 5 m g/ d L)
5 1 u m ol/ L
( 0. 5 8 m g/ d L)
2 Wee ks
3 1 u m ol/ L
( 0. 3 5 m g/ d L)
2 1 u m ol/ L
( 0. 2 4 m g/ d L)
2 4 u m ol/ L
( 0. 2 7 m g/ d L)
4 0 u m ol/ L
( 0. 4 5 m g/ d L)
4 6 u m ol/ L
( 0. 5 2 m g/ d L)
3 Wee ks
2 8 u m ol/ L
( 0. 3 2 m g/ d L)
1 9 u m ol/ L
( 0. 2 1 m g/ d L)
2 2 u m ol/ L
( 0. 2 5 m g/ d L)
3 6 u m ol/ L
( 0. 4 1 m g/ d L)
4 1 u m ol/ L
( 0. 4 6 m g/ d L)
4 Wee ks
2 5 u m ol/ L
( 0. 2 8 m g/ d L)
1 7 u m ol/ L
( 0. 1 9 m g/ d L)
2 0 u m ol/ L
( 0. 2 3 m g/ d L)
3 2 u m ol/ L
( 0. 3 6 m g/ d L)
3 7 u m ol/ L
( 0. 4 2 m g/ d L)
2 M o nt hs
2 2 u m ol/ L
( 0. 2 5 m g/ d L)
1 5 u m ol/ L
( 0. 1 7 m g/ d L)
1 7 u m ol/ L
( 0. 1 9 m g/ d L)
2 9 u m ol/ L
( 0. 3 3 m g/ d L)
3 3 u m ol/ L
( 0. 3 7 m g/ d L)
3 M o nt hs
2 0 u m ol/ L
( 0. 2 3 m g/ d L)
1 4 u m ol/ L
( 0. 1 6 m g/ d L)
1 6 u m ol/ L
( 0. 1 8 m g/ d L)
2 6 u m ol/ L
( 0. 2 9 m g/ d L)
3 0 u m ol/ L
( 0. 3 4 m g/ d L)
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 2
T a ble 9. 
Ser u m cre ati ni ne refere nce v al ues t o assess ki d ne y f u ncti o n i n ne o n ates 
a n d i nf a nts < 1 ye ar of a ge [1 7 ]
A ge
Me di a n 
( Pre dicte d) 
Cre ati n i ne 
V al ue
2. 5 %
1 0 %
9 0 %
9 7. 5 %
4 t o 6 M o nt hs
2 0 u m ol/ L
( 0. 2 3 m g/ d L)
1 4 u m ol/ L
( 0. 1 6 m g/ d L)
1 6 u m ol/ L
( 0. 1 8 m g/ d L)
2 6 u m ol/ L
( 0. 2 9 m g/ d L)
3 0 u m ol/ L
( 0. 3 4 m g/ d L)
7 t o 9 M o nt hs
2 0 u m ol/ L
( 0. 2 3 m g/ d L)
1 4 u m ol/ L
( 0. 1 6 m g/ d L)
1 6 u m ol/ L
( 0. 1 8 m g/ d L)
2 6 u m ol/ L
( 0. 2 9 m g/ d L)
3 0 u m ol/ L
( 0. 3 4 m g/ d L)
1 0 -1 2 M o nt hs
2 1 u m ol/ L
( 0. 2 4 m g/ d L)
1 5 u m ol/ L
( 0. 1 7 m g/ d L)
1 7 u m ol/ L
( 0. 1 9 m g/ d L)
2 7 u m ol/ L
( 0. 3 1 m g/ d L)
3 2 u m ol/ L
( 0. 3 6 m g/ d L)
N ote: T he val ues i n m g/ d L ha ve bee n r o u n de d t o t he sec o n d deci mal place.
I n vesti gati o nal sites are res p o nsi ble t o e ns ure t hat t he acc urate a ge-s pecific e q uati o n is 
selecte d a n d t hat t he c orrect u nits are i ncl u de d f or ser u m creati ni ne ( m g/ d L o nl y), a n d a ge 
( years). I n vesti gat ors are e x pecte d t o (i) re vie w a n d c o nfir m c orrect ness of t he ki d ne y  
f u ncti o n calc ulati o n res ults a n d (ii) e val uate t he calc ulate d val ue wit hi n t he c o nte xt of 
hist orical i nf or mati o n a vaila ble t o t he m i n t he partici pa nt’s me dical rec or d. I n vesti gat ors are 
res p o nsi ble f or t he cli nical o versi g ht of t he partici pa nt eli gi bilit y pr ocess, kid ne y  f u ncti o n 
calc ulati o n, a n d d ose selecti o n a n d a dj ust me nts per st u d y  pr ot oc ol. I n vesti gat ors are 
e nc o ura ge d t o direct q uesti o ns or u ncertai nties re gar di n g ki d ne y  f u ncti o n a n d d osi n g t o t he 
Pfizer Cli nical Tea m a n d Me dical M o nit or, if nee de d.
1 0. 6. 3. A d verse E ve nt Gr a di n g f or Ki d ne y S afet y L a b or at or y A b n or m alities
T he K DI G O pr o d uces g ui deli nes re gar di n g ki d ne y diseases pre ve nti o n or ma na ge me nt. F or 
e xa m ple, i n t he K DI G O g ui deli ne re gar di n g c hr o nic ki d ne y  disease, G F R cate g or y 
rec o m me n dati o ns are a vaila ble f or refere nce.
A E gra di n g f or decli ne i n ki d ne y  f u ncti o n will be acc or di n g t o t he m o difie d K DI G O criteria 
f or ne o nates [1 8 ] a n d K DI G O criteria f or i nfa nts a n d c hil dre n ≥2 8 da y s ol d t o < 1 2 years ol d
[1 9 ] as i n dicate d bel o w .  
Criteri a use d 
f or St a gi n g
St u d y 
P o p ul ati o n
St a ge 1
St a ge 2
St a ge 3
M o difie d 
K DI G O Criteri a
All A ges
(i) ≥0. 3 m g/ d L Screat 
i ncrease wit hi n 4 8 
h o urs O R 
(ii) ≥1. 5 t o 1. 9 ti mes 
Screat i ncrease fr o m 
baseli ne ( pre vi o us 
l o west val ue) wit hi n 
pri or 7 da ys)
2. 0 -2. 9 f ol d Screat
i ncrease fr o m 
baseli ne
≥3 f ol d Screat i ncrease 
fr o m baseli ne 
O R
I ncrease i n Screat t o ≥4. 0 
m g/ dl ( ≥3 5 3. 6 m m ol/l
O R 
R R T i nitiati o n 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 3
K DI G O al b u mi n uri a ( A) 
criteri a
A 1
A 2
A 3
Al b u mi n -t o-cre ati ni ne r ati o 
( A C R)
< 3 0 m g/ g
O R     
< 3 m g/ m m ol 
3 0 t o 3 0 0 m g/ g
O R 
3 t o 3 0 m g/ m m ol
> 3 0 0 m g/ g 
O R 
> 3 0 m g/ m m ol
S peci al C o nsi der ati o ns f or Ne o n at al P o p ul ati o ns 
Ne o nates ( < 1 m o nt h of a ge) first fe w wee ks of life ha ve a ser u m creati ni ne val ue t hat reflects 
mater nal creati ni ne le vels. I n a d diti o n, re nal mat urati o n i n t he ne o nates a n d i nfa nts is greatl y 
i m pacte d by pre mat urit y [2 0- 2 2 ].
M o nit ori n g a n d Disc o nti n u ati o n Criteri a f or A ll C o h orts 
P ote nti al Criteri a 
Rec o m me n d ati o ns
M o nit ori n g Criteria
Ne o n ates < 2 8 d a ys ol d: 
(i) Screat i ncrease ≥0. 3 m g/ d L ( ≥2 6. 5 μ m o l/ L) wit hi n 4 8 h o urs O R 
(ii) Screat i ncrease ≥1. 5 t o 1. 9 ti mes fr o m baseli ne ( pre vi o us l o w est 
val ue) k n o w n or s us pecte d t o ha ve occ urre d wit hi n t he pri or 7 da ys) 
I nf a nts a n d c hil dre n ≥2 8 d a ys ol d a n d < 1 2 ye ars ol d: 
(i) Screat i ncrease ≥0. 3 m g/ d L ( ≥2 6. 5 µ m ol/ L) wit hi n 4 8 h o urs O R 
(ii) Screat i ncrease ≥1. 5 ti mes baseli ne k n o w n or s us pecte d t o ha ve 
occ urre d w it hi n t he pri or 7 da ys
Disc o nti n uati o n Criteria

T w o se q ue ntial i ncreases i n ser u m creati ni ne t hat c o nfir m t he a b o ve 
c ha n ges o ver t he scree ni n g or baseli ne val ue as i n dicate d i n t he 
m o nit ori n g criteria.

N ote: If t he ser u m creati ni ne i ncreases ma y be ca use d b y a n 
i de ntifia ble a n d re versa ble reas o n (e g, c o nc o mita nt me dicati o n), t he n
a n a d diti o nal retest ma y be all o we d after disc ussi o n wit h t he me dical 
m o nit or. After retest, a decisi o n f or t he s u bject t o c o nti n ue i n t he 
st u d y will be ma de after disc ussi o n wit h t he me dical m o nit or.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 4
1 0. 7. A p pe n di x 7 : E C G Fi n di n gs of P ote nti al Cli nic al C o ncer n
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 5
1 0. 8. A p pe n di x 8 : Pr o hi bite d C o nc o mit a nt Me dic ati o ns T h at M a y Res ult i n D DI  
T he pr o hi bite d c o nc o mita nt me dicati o ns liste d bel o w s h o ul d n ot be ta ke n wit h sis u nat o vir f or 
t he peri o d of ti me at least e q ual t o 5 half -li ves pl us 1 4 da ys prece di n g the first d ose of st u d y  
i nter ve nti o n, a n d t hr o u g h t he e n d of t he treat me nt peri o d or 5 da y s after last st u d y dr u g 
a d mi nistrati o n f or se nsiti ve 
A d diti o nall y , 
a d mi nistrati o n of pr ot o n p u m p i n hi bit ors m ust ha ve e n de d 5 da y s pri or t o ra n d o mizati o n a n d 
a d mi nistrati o n of H 2 bl oc kers m ust ha ve e n de d at least 1 2 h o urs pri or t o ra n d o mizati o n. T he 
use of a ntaci ds is all o we d wit h sta g gere d d osi n g (ie, n ot w it hi n 3 h o urs bef ore or after st u d y 
dr u g a d mi nistrati o n). A n y  a d mi nistrati o n of pr ot o n p u m p i n hi bit ors or H 2 bl oc kers is 
pr o hi bite d d uri n g treat me nt wit h sis u nat o vir. 
T he Pfizer st u d y tea m is t o be n otifie d of a n y  pr o hi bite d me dicati o ns ta ke n d uri n g t he 
treat me nt peri o d. After c o ns ulti n g wit h t he s p o ns or, t he i n vesti gat or will ma ke a j u d g me nt o n 
t he o n g oi n g partici pati o n of a ny partici pa nt wit h pr o hi bite d me dicati o n use d uri n g t he 
treat me nt peri o d of t he st u d y.
T his list of dr u gs pr o hi bite d f or p ote ntial D DI  c o ncer ns wit h t he I M P ma y be re vise d d uri n g 
t he c o urse of t he st u d y wit h writte n n otificati o n fr o m t he s p o ns or t o i ncl u de or e xcl u de 
s pecific dr u gs or dr u g cate g ories f or vari o us reas o ns (e g, e mer gi n g D DI res ults f or t he I M P, 
a vaila bilit y of ne w i nf or mati o n i n literat ure o n t he D DI p ote ntial of ot her dr u gs) if t he o verall 
be nefit -ris k assess me nt is n ot i m pacte d or if t he c ha n ges d o n ot si g nifica ntl y i m pact t he 
safety of partici pa nts or t he scie ntific val ue of t he trial.  
are pr o hi bite d, as t hese 
me dicati o ns ma y  ha ve mea ni n gf ul
a n d t heref ore 
 
 are als o pr o hi bite d i n t his st u d y. 
 
 m a y  be a d mi nistere d wit h ca uti o n d uri n g treat me nt peri o d.
Alt h o u g h n ot all -i ncl usi ve, a list of me dicati o ns t hat are pr o hi bite d i n t his st u d y  is pr o vi de d 
bel o w. Site staff s h o ul d c o ns ult wit h t he s p o ns or or desi g nee wit h a n y q uesti o ns re gar di n g 
p ote ntial D DI.
I n vesti gat ors s h o ul d c o ns ult t he pr o d uct la bel f or a n y ot her me dicati o n use d d uri n g t he st u d y
f or i nf or mati o n re gar di n g me dicati o n t hat is pr o hi bite d f or c o nc o mita nt use. 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 6
Pr o hi bite d C o nc o mit a nt Me dic ati o ns
Dr u g C ate g or y 
Dr u gs 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 7
Dr u g C ate g or y 
Dr u gs 
Pr ot o n P u m p I n hi bit ors
De xla ns o praz ole
Es o m e praz ole
La ns o praz ole
O m e praz ole
Pa nt o praz ole
Ra be praz ole
V o n o praza n
H 2 Bl oc kers
Ci meti di ne
Fa m oti di ne
Laf uti di ne
Nizati di ne
R o xati di ne
Me dic ati o ns t h at i nter act wit h sis u n at o vir t h at m a y be use d wit h c a uti o n or w here a 
d ose a dj ust me nt m a y be re q uire d (c o ns ult t he pr o d uct l a bel f or i nf or m ati o n)
Dr u g C ate g or y 
Dr u gs 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 8
Dr u g C ate g or y 
Dr u gs 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 1 9
1 0. 9. A p pe n di x 9 : C o u ntr y S pecific Re q uire me nts
1 0. 9. 1. Ar ge nti n a
Per l ocal re g ulati o ns, mater nal ser ol o g y res ults d uri n g pre g na nc y , or partici pa nt ’s ser ol o g y 
res ults f or HI V, H B V, a n d H C V m ust be re vie we d a n d rec or de d i n t he s o urce d oc u me nt at
scree ni n g. If a n y of t hese ser ol o g y res ults are u na vaila ble , t he n t hese m ust be e val uate d f or
t he partic ipa nt t o c o nfir m eli gi bilit y f or e nr oll me nt. 
Base d o n t he ser ol o gical test res ults, t he f oll o wi n g e xcl usi o n will a p pl y : E vi de nce t hat 
partici pa nt is p ositi ve f or HI V, H B V, or H C V i nfecti o n base d o n m ot her ’s ser ol o gy res ults
d uri n g pre g na nc y or t he p articipa nt’s ser ol o gies. 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 0
1 0. 1 0. A p pe n di x 1 0 : Pr ot oc ol S pecific A p pe n dices
1 0. 1 0. 1. A p pe n di x 1 0 A: Si g ns a n d S y m pt o ms Attri b ut a ble t o R S V
Si g ns or S y m pt o ms
Deter mi ni n g d ur ati o n of 
R S V i nfecti o n at 
E nr oll me nt
R S V Si g ns a n d 
S y m pt o ms 
( E ntere d i n C R F)*
Ne w or w orse ni n g n asal 
c o n gesti o n
X
X
Ne w or w orse ni n g r u n n y n ose
X
X
Fe ver ( d oc u me nte d 
te m perat ure of 1 0 0. 4 or 
hi g her) or s u bjecti ve fe ver 
X
X
Ne w or w orse ni n g c o u g h
X
X
A p nea
X
X
I ncrease d res pirat or y rate* * f or 
a ge:
< 2 m o nt hs: ≥6 0 b p m
2 t o < 1 2 m o nt hs: ≥5 0 b p m
≥1 2 t o ≤6 0 m o nt hs: ≥4 0 b p m
X
S p O 2 * * < 9 5 % o n r o o m air
X
Gr u nti n g wit h e x pirati o n
X
X
Nasal flari n g
X
X
Retracti o ns
X
X
W heezi n g
X
X
R h o nc hi
X
X
Rales or crac kles
X
X
Re d uce d a bilit y  t o fee d via 
us ual r o ute f or > 4 -6 h o urs 
X
De h y drati o n d ue t o res pirat or y 
distress re q uiri n g I V h y d rati o n
X
* If a ne w or worse ni n g s y m pt o m (nasal c o n gesti o n, r u n n y n ose or c o u g h) c o nti n ue t o be prese nt at 
s u bse q ue nt visits, t his s h o ul d be d oc u me nte d i n t he C R F, e ve n if t he s y m pt o m is n ot w orse ni n g.
* * S p O 2 a n d R R will be ca pt ure d t hr o u g h vital si g ns c ollecti o n at t he i n pers o n visit
1 0. 1 0. 2. A p pe n di x 1 0 B: B ac k gr o u n d a n d S oci al F act ors
1.
Bac k gr o u n d Fact ors: I nf or mati o n o n t he f oll o wi n g will be c ollecte d f or all partici pa nts at 
Scree ni n g Visit. 

E d ucati o nal le vel of pare nt(s) or le gal g uar dia n(s).

E x p os ure of partici pa nt t o s m o ke (i ncl u di n g t o bacc o s m o ke).
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 1

N u m ber of pers o ns i n t he h o use h ol d ≥1 8 y ears of a ge.

N u m ber of c hil dre n < 1 8 years of a ge i n t he h o use h ol d a n d if t he y atte n d sc h o ol/ 
da y care.
o
N u m ber of c hil dre n i n t he h o use h ol d u n der 6 0 m o nt hs of a ge
o
N u m ber of c hil dre n i n t he h o use h ol d ≥6 0 m o nt hs )

Breastfee di n g i nf or mati o n f or i nfa nt partici pa nt (i ncl u di n g w het her or n ot 
breastfee di n g is e xcl usi ve )
2.
S ocial Fact ors: I nf or mati o n o n t he f oll o wi n g will be c ollecte d per S o A:

C hil dcare/ da y care atte n da nce (f or partici pa nts)

N u m ber of misse d da y s of w or k f or pare nt(s) or le gal g uar dia n(s) d ue t o t he i nfa nt 
partici pa nt’s ill ness. 
1 0. 1 0. 3. A p pe n di x 1 0 C: C hr o n ol o g y of Pr oce d ures ( S u g geste d)
F or t he pr oce d ures bel o w, t he f oll o wi n g c hr o n ol o g y  of e ve nts are s u g geste d, b ut ca n be 
m o difie d base d o n i n vesti gat or discreti o n a n d a d here nce t o I M P d osi n g i nter val:

P h y sical e xa m 

B o d y wei g ht/le n gt h/ hea d circ u mfere nce

Vitals si g ns i ncl u di n g S p O 2

1 2 lea d E C G ( Scree ni n g o nl y)

Bl o o d dra ws ( See S o A Ta ble 3 f or Da ys
a n d )

N P s wa b 

I M P a d mi nistrati o n
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 2
1 0. 1 0. 4. A p pe n di x 1 0 D: D osi n g a n d P al at a bilit y Q uesti o n n aire (eDi ar y)
I nstr ucti o ns:

Q uesti o n naire s h o ul d be fille d o ut b y  pare nt, le gal g uar dia n or He alt hcare pr ofessi o nal .

Please c ollect t he f oll o wi n g i nf or mati o n:
B ac k gr o u n d I nf or m ati o n
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 3
F or e ver y d ose a d mi nistr ati o n, ple ase a ns wer t he f oll o wi n g q uesti o ns:
1.
Was t he pa rtici pa nt a ble t o 
?
☐
Y E S
☐
N O -
☐
N O -
*
☐
1
☐
2
☐
3
*
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 4
2. Di d a d mi nistrati o n ca use a n y of t he f oll o wi n g be ha vi ors wit hi n 1 0 mi n utes fr o m ti me of c o m pleti n g d ose a d mi nistrati o n? 
☐
☐
☐
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 5
1 0. 1 1. A p pe n di x 1 1 : Pr ot oc ol A m e n d me nt Hist or y
A m e n d me nt 3 ( 2 7 J a n u ar y 2 0 2 4)
O ver all R ati o n ale f or  t he A me n d me nt: T he a me n d me nt a d dresses c o m me nts a n d fee d bac k 
recei ve d fr o m re g ulat or y a ge ncies, a n d i nc or p orates pr ot oc ol clarificati o ns, a n d c orrecti o ns t o 
i de ntifie d err ors.
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 ns
F oll o w i n g c ha n ges t o E C G data 
a n d m o nit ori n g are ma de
(i) Re m o ve d E C G fr o m pri mar y 
e n d p oi nt.
(ii) E C G will be perf or me d 
after scree ni n g o nl y as nee de d 
per i n vesti gat or discreti o n.
(iii) U p date d E C G fr o m 
tri plicate t o si n gle.
(i v) E xcl usi o n criteria # 5 ( # 4 i n 
S y n o psis), # 2 0 re m o ve d
( v) E xcl usi o n criteria # 2 2 (# 1 5 
i n S y n o psis) m o difie d t o 
r e mo ve t he E C G tri plicate 
criteria
( vi) Re m o ve d la n g ua ge a b o ut 
me dicati o ns t hat ca n  
 
 i n pri or a n d 
c o nc o mita nt t hera p y
T he t h or o u g h Q T st u d y ( C 5 2 4 1 0 1 5) 
di d n ot i de ntif y si g nal of p ote ntial 
cli nical c o ncer n ( P M A R-E Q D D -
C 5 2 4 b -Pre -P o c -1 6 6 4).
Secti o n 1. 1 S y n o psis, Secti o n 
1. 3. 1 S o A, Secti o n 2. 3. 1 Ris k 
Assess me nt, Secti o n 3 
O bjecti ves, E n d p oi nts a n d 
Esti ma n ds, Secti o n 5. 2 
E xcl usi o n criteria, Secti o n 6. 9 
Pri or a n d C o nc o mita nt 
T hera p y, Secti o n 7. 1. 3 E C G 
C ha n ges, Secti o n 8. 3. 3 
Electr ocar di o gra ms, Secti o n 
9. 3. 5. 1 Electr ocar di o gra m 
A nal yses, Secti o n 1 0. 8 
Pr o hi bite d C o nc o mita nt 
Me dicati o ns T hat Ma y Res ult 
i n D DI, Secti o n 1 0. 1 0. 3 
A p pe n di x 1 0 C: Pr o p ose d 
C hr o n ol o g y of Pr oce d ures
E xte nsi o n of dia g n ostic testi n g 
ti mefra me all o we d f or 
I ncl usi o n Criteria # 2 f or 
partici pa nts t o   h o urs.
T o all o w  R S V dia g n ostic tests 
c o n d ucte d wit hi n   h o urs of 
ra n d o mizati o n t o be use d f or e val uati o n 
of eli gi bilit y, i nstea d of 
 h o urs f or 
partici pa nts > 
da ys ol d a n d 
 h o urs 
f or partici pa nts 
.
Secti o n 1. 1 S y n o psis, Secti o n 
1. 3. 1 S o A ( La b Assess me nts) 
a n d Secti o n 5. 1 I ncl usi o n 
Criteria
E xte nsi o n of R S V relate d si g ns 
a n d/ or s y m pt o ms ti mefra me 
all o we d f or I ncl usi o n Criteria 
# 4 t o 7 da ys f or partici pa nts 
>  da ys ol d.
T o all o w  participa nts >   da ys ol d 
wit h o n g oi n g si g ns a n d/ or s y m pt o ms of 
R S V disease u p t o 7 da ys t o re mai n 
eli gi ble f or partici pati o n. T his is 
ali g ne d wit h t he s y m pt o m wi n d o w 
all o we d f or t he 
 p o p ulati o n (  
 ol d). 
Secti o n 1. 1 S y n o psis a n d 
Secti o n 5. 1 I ncl usi o n Criteria
E xcl usi o n criteria # 1 3 o n 
k n o w n hist or y of re nal fail ure 
r e mo ve d.
Sis u nat o vir is mi ni mall y e xcrete d i n 
uri ne, wit h re nal i m pair me nt n ot 
e x pecte d t o ha ve cli nicall y si g nifica nt 
effects o n P K.
Secti o n 5. 2 E xcl usi o n criteria
Re m o ve d re q uire me nt t o 
re vie w mater nal me dicati o ns i n 
breastfee di n g partici pa nts
Base d o n a vaila ble data ( Dr u gs a n d 
Lactati o n Data base ( Lact Me d ®) –
Nati o nal Ce nter f or Bi otec h n ol o g y 
I nf or mati o n B o o ks helf [ ni h. g o v]), f or 
dr u gs t hat are e xcrete d i n breast mil k, 
t he relati ve d ose i n i nfa nts relati ve t o 
m o t hers is t y picall y ~ 1 % o n a wei g ht-
a dj uste d basis a n d n o greater t ha n 4 % 
Secti o n 1. 3 Sc he d ule of 
Acti vities, Secti o n 5. 2 
E xcl usi o n Criteria, Secti o n 6. 9 
Pri or a n d C o nc o mita nt T hera p y 
a n d Secti o n 1 0. 8 A p pe n di x 8.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 6
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
f or a n y 
t hat has bee n 
assesse d.
Base d o n t hese o bser vati o ns 
it is u nli kel y t hat i n d ucers or i n hi bit ors 
of  
will reac h s ufficie nt 
c o nce ntrati o ns t o mea ni n gf ull y alter t he 
p har mac o ki netics of sis u nat o vir; 
t heref ore, I ncl usi o n/ E xcl usi o n relate d 
t o c o nc o mita nt me dicati o ns i n n ursi n g 
m o t hers are bei n g re m o ve d.
Cli nical O ver vie w u p date d a n d 
i ncl u de d t he t h or o u g h Q T st u d y 
( C 5 2 4 1 0 1 5).
T o pr o vi de a n u p date d s u m mar y of 
o n g oi n g a n d c o m plete d st u dies.
Secti o n 2. 2. 4 Cli nical O ver vie w
N o n -S u bst a nti al m o dific ati o ns
O pti o nal P K 
 
 a n d the tertiar y P K 
e n d p oi nts b y micr osa m pli n g 
tec h ni q ue is re m o ve d.
S us pecte d i nsta bilit y of sis u nat o vir
w hile i n li q ui d w h ole bl o o d state, 
d uri n g t he pr ocess of dr yi n g t he 
c ollecte d  
 micr osa m ples ( base d 
o n assa y met h o d de vel o p me nt a n d 
vali dati o n acti vities) ( P A C L -3, 2 0 Se p 
2 0 2 3).
Secti o n 1. 1 S y n o psis, Secti o n 
1. 3 Sc he d ule of Acti vities, 
Secti o n 3 O bjec ti ves, E n d p oi nts 
a n d Esti ma n ds, Secti o n 8. 3. 4 
Cli nical Safet y La b orat or y 
Assess me nts, Secti o n 8. 5 
P har m ac o ki netics
Sc he ma c orrecte d f or C o h ort 
2 D a ge ba n d.
T o ali g n wit h a ge ba n d f or c o h ort 2 D i n 
t he pr ot oc ol.
Secti o n 1. 2 Sc he ma
A d de d Pre -d ose P K c ollecti o ns 
o n Da y 5 t o t he S o A.
T o ali g n Secti o ns 1. 3. 1 a n d 1. 3. 2.
Secti o n 1. 3. 1 S o A
A d de d n otes o n I M P trai ni n g i n 
t he S o A.
T o i ncl u de t he I M P trai ni n g i n t he S o A.
Secti o n 1. 3. 1 S o A
Clarifie d i n t he S o A, t hat t he 
safet y la b orat or y tests o n Da y  
a n d/ or D a y   d o n ot nee d t o be 
ali g ne d wit h P K sa m ple 
c ollecti o n.
T o pr o vi de fle xi bilit y i n t he ti mi n g of 
safet y la bs a n d re mai n wit hi n t he 
per mitte d bl o o d v ol u me li mits ( Secti o n 
8. 3. 4: Ta ble 1 0) s h o ul d t he safet y la bs 
or bl o o d dra w  alrea d y be d o ne as part 
of st a n dar d of care ( P A C L -7, 2 2 Dec 
2 0 2 3).
Secti o n 1. 3. 1 S o A, Secti o n 
1. 3. 2 M ulti ple D ose P K Da ys 
( F or All C o h orts), Secti o n 2. 3. 1 
Ris k Assess me nt, Secti o n 8. 1 
A d mi nistrati ve a n d Baseli ne 
Pr oce d ures, Secti o n 8. 3. 4 
Cli nical Safet y La b orat or y 
Assess me nts
A d de d t he f oll o wi n g f o ot n ote: 
“ Da y  
 visit ca n occ ur i n 
pers o n if nee d”. 
U p date d t he f oll o wi n g f o ot n ote 
f or R S V ass ociate d si g ns a n d 
s y m pt o ms: “ C ollecte d if 
partici pa nt ha ve u n pla n ne d i n 
pers o n visit bet w ee n Da y   
”.
T o pr o vi de a d diti o nal clari ficati o n.
Secti o n 1. 3. 1 S O A
Clarifie d i n t he S o A, t hat t he 
Pr e -d ose ( Scree ni n g/ Da y 1) 
pr ot oc ol -s pecifie d safet y la bs 
d o n ot nee d t o be re peate d if 
perf or me d as part of sta n dar d of 
care wit hi n 2 4 h o urs pri or t o 
first d ose o n Da y 1. T his 
i ncl u des la bs c o n d ucte d pri or t o 
si g ni n g of t he I C D a n d t hese 
la b res ults will be e ntere d i n t he 
T o re d uce t he b ur de n of bl o o d dra ws 
o n t he partici pa nt a n d/ or re mai n wit hi n 
t he per mitte d bl o o d v ol u me li mits 
( Secti o n 8. 3. 4) s h o ul d t he safet y la bs 
alrea d y be d o ne as part of sta n dar d of 
care a n d perf or me d wit hi n t he ti me 
fra me s pecifie d. ( P A C L-8, 1 1 Ja n 
2 0 2 4)
Secti o n 1. 3. 1 S o A, Secti o n
2. 3. 1 Ris k Assess me nt, Secti o n 
8. 1 A d mi nistrati ve a n d 
Baseli ne Pr oce d ures
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 7
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
C R F f or t he Scree ni n g/ Da y 1 
visit.
Clarifie d t hat t he st u d y 
i nter ve ntio n a d m i nistrati o n 
peri o d of 
ca n be u p t o 6 c o nsec uti ve da ys 
T o clarif y t hat t he I P a d mi nistrati o n 
w o ul d be 
 f or 
da ys if 2 d oses 
a d mi nistere d dail y Da y 1 -Da y  O R f or 
6 da ys if n ot starte d w it h 2 d oses o n 
Da y 1.
Secti o n 1. 1 S y n o psis, Secti o n 
1. 3. 1 S o A, Secti o n 6. 1 St u d y 
I nter ve nti o n(s) A d mi nistere d.
Si m plifie d bac k gr o u n d 
i nf or mati o n f or n o n-cli nical 
secti o ns.
I B is refere nce d.
Secti o n 2. 2. 1 N o ncli nical 
P har m ac ol o g y, Secti o n 2. 2. 2 
N o ncli nical P har mac o ki netics 
a n d Meta b olis m, Secti o n 2. 2. 3 
N o ncli nical Safet y 
A d de d clarificati o n all o wi n g 
pare nts/le gal g uar dia n t o 
a d mi nister st u d y i nter ve nti o n i n 
a n i n patie nt setti n g if per mitte d 
b y l ocal p olic y.
E na ble I P a d mi nistrati o n b y pare nt or 
le gal g uar dia n i n a n i n patie nt setti n g if 
per mitte d b y l ocal p olic y t o pr o vi de 
fle xi bilit y.
Secti o n 2. 3. 1 Ris k Assess me nt, 
Secti o n 6. 1. 1 A d mi nistrati o n
U p date d t he D DI ris k 
i nf or mati o n f or sis u nat o vir.
T o reflect t he latest i nf or mati o n.
Secti o n 4. 2 Scie ntific Rati o nale 
f or St u d y Desi g n
Clarificati o ns pr o vi de d f or t he 
a ge ra n ge a p plica ble f or c o h ort 
1. 
T o ali g n wit h ot her secti o ns i n t he 
pr ot oc ol ( P A C L -4, 2 Oct 2 0 2 3).
Secti o n 4. 3; J ustificati o n f or 
D o se
Clarificati o ns pr o vi de d f or 
Ta ble 6 hea der.
T o clarif y t he a ge ra n ges as i n t he 
C 5 2 4 1 0 0 3 ( P A C L -4, 2 Oct 2 0 2 3)
Secti o n 4. 3; J ustificati o n f or 
D ose
Clarificati o n of e xcl usi o n # 6 
( # 5 i n S y n o psis) t hat f or 
partici pa nts wit h past hist or y of 
ele vate d bilir u bi n d ue t o 
ne o natal h y per bilir u bi ne mia 
t hat has res ol ve d, t he y re mai n 
eli gi ble.
T o pr o vi de clarificati o n t hat if t he 
c o n diti o n, ne o natal h y per bilir u bi ne mia 
is res ol ve d wit h n or malize d T bili 
val ues, t he n t he partici pa nt re mai ns 
eli gi ble ( P A C L-7, 2 2 D ec 2 0 2 3). 
Secti o n 1. 1, S y n o psis, Secti o n 
5. 2 E xcl usi o n criteria
T he ti mi n g of d osi n g f or t he 
sec o n d d ose ma y be a dj uste d 
sli g htl y b ut s h o ul d be ta ke n at 
least 4 h o urs after, b ut n o later 
t ha n  
 after t he first 
d ose. T he re mai ni n g d oses 
s h o ul d be ta ke n e ver y  
 
.
T o all o w  t he partici pa nt t o select a 
c o n ve nie nt
d osi n g sc he d ule.
Secti o n 6. 1. 1 A d mi nistrati o n
Re m o ve Viral l oa d a n d 
Bi o mar ker as se nsiti ve data.
Viral l oa d is c ollecte d at s parse 
ti me p oi nts as a n e x pl orat or y e n d p oi nt 
w it h n o e x pectati o n t o detect 
differe nces bet wee n t he treat me nt 
gr o u ps. Bi o mar ker data is n o l o n ger 
c ollecte d i n t he st u d y ( P A C L -2, 8 Se p 
2 0 2 3).
Secti o n 6. 4. 4 Se nsiti ve Data
Recei pt of R S V vacci ne b y 
partici pa nt’s m ot her will n o 
l o n ger be rec or de d i n t he CR F.
C R F ca pt ure of R S V vacci ne 
i nf or mati o n n ot nee de d ( P A C L-7, 2 2 
Dec 2 0 2 3) .
Secti o n 6. 9 Pri or a n d 
C o nc o mita nt T hera p y
A d de d d urati o n of c hec k f or 
pr o hi bite d c o nc o mita nt 
me dicati o ns.
Clarificati o ns o n d urati o n of c hec k f or 
pr o hi bite d c o nc o mita nt me dicati o ns.
Secti o n 6. 9 Pri or a n d 
C o nc o mita nt T hera p y
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 8
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
U p date d criteria f or 
differe ntiati o n of A KI 
(i ncl u di n g DI KI) a n d DI CI 
T o clarif y t he Sc ys t hres h ol d val ues t o 
assist wit h differe ntiati n g A KI 
(i ncl u di n g DI KI) fr o m DI CI ( P A C L-5, 
1 7 Oct 2 0 2 3).
Secti o n 7. 1. 1 P ote ntial Cases of 
Ac ute Ki d ne y I nj ur y
U p date d Secti o n 8. 3. 2. 1 
hea di n g t o “ Bl o o d Press ure a n d 
P ulse Rate/ Heart Rate”.
F or clarificati o n.
Secti o n 8. 3. 2. 1 Bl o o d Press ure 
a n d P ulse Rate/ Heart Rate
U p date d criteria f or A d verse 
E ve nt Gra di n g f or Ki d ne y 
Safet y La b orat or y 
A b n or m alities.
T o ali g n t he A E gra di n g f or re nal 
f u ncti o n wit hi n t he differe nt pr ot oc ol 
Secti o ns ( 7. 1. 1. P ote ntial Cases of 
Ac ute Ki d ne y I nj ur y, Secti o n 1 0. 6; 
A p pe n di x 6: Ki d ne y Safet y M o nit ori n g 
G ui deli nes a n d Ta ble 2 i n Refere nce 
# 1 9 i n Pr ot oc ol A me n d me nt 2 ( K DI G O 
A KI W or k Gr o u p. K DI G O cli nical 
practice g ui deli ne f or ac ute ki d ne y 
i nj ur y. Ki d ne y I nt S u p pl. 2 0 1 2; 2: 1-1 3 8) 
( P A C L-5, 1 7 Oct 2 0 2 3).
Secti o n 1 0. 6. 3. A d verse E ve nt 
Gra di n g f or Ki d ne y Safet y 
La b orat or y A b n or malities
Re m o ve d Nas o p har y n geal 
s wa bs a n d Viral assess me nts 
fr o m P har mac o d y na mic 
Bi o mar kers a n d pr o vi de d 
a d diti o nal clarificati o n o n N P 
s wa bs.
Clarifie d t hat p har mac o d y na mic 
bi o mar ker a nal yses are n ot e val uate d i n 
t his st u d y ( P A C L-7, 2 2 Dec 2 0 2 3) .
Secti o n 8. 7. Bi o mar ker 
A d de d t he f oll o wi n g criteria f or 
re place me nt of partici pa nts: “if 
partici pa nt w as e x p ose d t o a 
pr o hi bite d c o nc o mita nt 
me dicati o n”.
T o ali g n wit h Secti o n 1 0. 8.
Secti o n 1. 1. S y n o psis, Secti o n 
4. 1. O verall Desi g n, Secti o n 
9. 5. Sa m ple Size Deter mi nati o n
S p o ns or’s c o ntact i nf or mati o n 
M QI has bee n c ha n ge d.
T he pr ocess f or c o ntacti n g a me dicall y 
q ualifie d i n di vi d ual has c ha n ge d fr o m a 
me dical escalati o n pr ocess via a Pfizer 
Call Ce nter t o direct cli nical tea m 
c o ntact usi n g a St u d y Tea m C o ntact 
List. 
T he E mer ge n c y C o ntact Car d is bei n g 
re place d b y a st u d y i nf or mati o n car d 
a n d will n o l o n ger be refere nce d. 
Secti o n 1 0. 1. 1 2. S p o ns or’s 
Me dicall y Q ualifie d I n di vi d ual
A d de d t he f oll o wi n g f o ot n ote t o 
A p pe n di x 2:
If o nl y A C R is pr o vi de d b y t he 
la b, al b u mi n ( uri ne) a n d 
creati ni ne ( uri ne) d o n ot nee d t o 
be c ollecte d.
T o pr o vi de clarificati o n o n data 
c ollecti o n f or A C R.
Secti o n 1 0. 2 Cli nical 
La b orat or y Tests
Re m o ve d “ Please c o ntact t he 
Pe d C o E ( pe dc oe @ pfizer.c o m) 
a n d t he He patic I nj ur y C o u ncil 
f or m ore i nf or mati o n” fr o m 
Secti o n 1 0. 5.
T his is n ot a p plica ble as t he Me dical 
M o nit or is t he c o ntact f or t his st u d y.
Secti o n 1 0. 5 A p pe n di x 5 Li ver 
Safet y: S u g geste d Acti o ns a n d 
F oll o w -U p Assess me nts
M o difie d A p pe n di x 8 
me dicati o n list t o i ncl u de 
Re m o ve d d u plicati o ns a n d i m pr o ve d 
f or mat of me dicati o n ta ble pr o vi de d. 
S ecti o n 1 0. 8 Pr o hi bite d 
C o nc o mita nt Me dicati o ns T hat 
M a y  Res ult i n D DI
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 2 9
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
(ii) T he pr o hi bite d c o nc o mita nt 
me dicati o ns liste d i n A p pe n di x 
8 s h o ul d n ot be ta ke n wit h 
sis u nat o vir f or t he peri o d of 
ti me at least e q ual t o 5 half -
li ves pl us 1 4 da ys prece di n g t he 
first d ose of st u d y i nter ve nti o n, 
a n d t hr o u g h t he e n d of t he 
treat me nt peri o d or 5 da ys after 
st u d y dr u g a d mi nistrati o n f or 
se nsiti ve
(iii) A d diti o nal clarificati o ns o n 
 
A d de d t he f oll o wi n g f o ot n otes 
i n A p pe n di x 1 0 A: 
If a ne w or worse ni n g 
s y m pt o ms ( nasal c o n gesti o n, 
r u n n y n ose or c o u g h) c o nti n ue 
t o be prese nt at s u bse q ue nt 
visits, t his s h o ul d be 
d oc u me nte d i n t he C R F, e ve n if 
t he s y m pt o m is n ot worse ni n g.
S p O 2 a n d R R will be ca pt ure d 
t hr o u g h vital si g ns c ollecti o n at 
the i n pers o n visit.
Clarificati o n o n c ollecti o n of s pecific 
R S V si g ns a n d s y m pt o ms o n C R F.
Secti o n 1 0. 1 0. 1 A p pe n di x 1 0 A: 
Si g ns a n d S y m pt o ms 
Attri b uta ble t o R S V
Se veral a d diti o nal mi n or 
e dit orial c ha n ges ma de.
T o i m pr o ve clarit y a n d rea da bilit y a n d 
f or maintai ni n g c o nsiste nc y t hr o u g h o ut 
t he d oc u me nts.
T hr o u g h o ut Pr ot oc ol
A m e n d me nt 2 ( 1 3 Se pte m ber 2 0 2 3)
O ver all R ati o n ale f or  t he A me n d me nt: T he a me n d me nt a d dresses c o m me nts a n d fee d bac k 
recei ve d fr o m re g ulat or y a ge ncies, a n d i nc or p orates pr ot oc ol clarificati o ns, a n d c orrecti o ns t o 
i de ntifie d err ors.
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 ns
E xcl usi o n criteri o n 1 2 i n 
Secti o n 5. 2 criteri o n 1 1 i n 
s y n o psis) u p date d
(i) m o ve d re nal fail ure a n d 
re nal i ns ufficie nc y t o 
E xcl usi o n Criteria 1 3
(ii) a d de d a n ote t hat preter m 
partici pa nts (if < 3 5 w ee ks 
gestati o nal a ge m ust be at least 
o ne year p ost -natal a ge) w it h 
br o nc h o p ul m o nar y d ys plasia 
(c hr o nic l u n g disease of 
Clarificati o n o n E xcl usi o n criteria # 1 2 
Secti o n 1. 1; S y n o psis, Secti o n 
5. 2; E xcl usi o n Criteria 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 0
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
pre mat urit y) re mai n eli gi ble 
f or e nr oll me nt.
A d de d clarificati o n o n 
defi niti o n of A KI a n d t he 
differe ntiati o n of Ac ute 
Ki d ne yI nj ur y fr o m DI CI base d 
o n a ge -a p pr o priate, pre -
s pecifie d defi niti o ns of ac ute 
ki d ne y i nj ur y.
Re m o ve d e Cr C L f or 
m o nit ori n g ki d ne y f u ncti o n.
T o all o w  f or a ge a p pr o priate pre-
s pecifie d defi niti o ns of Ac ute Ki d ne y 
I nj ur y
Secti o n 7. 1. 1; P ote ntial Cases 
of Ac ute Ki d ne y I nj ur y
A d de d re q uire me nt t o ca pt ure 
l ocal la b orat or y met h o d f or 
a nal ysis of Screat.
T o all o w  f or ki d ne y f u ncti o n 
calc ulati o ns de pe n di n g o n t he t y pe of 
assa y use d t o assess creati ni ne.
Secti o n 8. 3. 4; Cli nical Safet y 
La b orat or y Assess me nts, 
Secti o n 1 0. 6. 1; La b orat or y 
Assess me nt of C ha n ge i n 
Ki d ne y F u ncti o n a n d Detecti o n 
of Ki d ne y I nj ur y
F oll o w i n g c ha n ges ma de 
re gar di n g ge netic a nal yses f or 
i) N P s wa b sa m ples t hat will be 
use d t o meas ure viral R N A 
le vels “ ma y i ncl u de ge netic 
a nal ysis as a n i nter nal c o ntr ol
f or t he assa y”.
ii) 
 
 
 
, “a n d if per mitte d 
b y l ocal re g ulati o ns”.
T o pr o vi de m ore s pecifics a n d clarit y 
o n ge netic a nal ysis of N P s wa b a n d 
resi d ual N P s wa b sa m ples.
Secti o n 8. 7; Bi o mar kers
U p date d Ki d ne y f u ncti o n 
calc ulati o ns.
T o all o w  f or a ge-a p pr o priate ki d ne y 
f u ncti o n assess me nt.
Secti o n 1 0. 6. 2; A ge -S pecific 
Ki d ne y F u ncti o n Calc ulati o ns
A E gra di n g f or Ki d ne y Safet y 
La b orat or y A b n or m alities 
u p date d t o use m o difie d 
K DI G O criteria f or ne o nates 
a n d K DI G O criteria f or i nfa nts 
a n d c hil dre n ≥
2 8 d a y s ol d t o 
< 1 2 years ol d.
T o pr o vi de u p dates o n a ge -
a p pr o priate A E gra di n g f or ki d ne y 
safet y la b orat or y a b n or malities.
Secti o n 1 0. 6. 4; 1 0. 6. 4. A d verse 
E ve nt Gra di n g f or Ki d ne y 
Safet y La b orat or y 
A b n or m alities
M o nit ori n g a n d 
Disc o nti n uati o n criteria f or 
ki d ne y f u ncti o n u p date d.
T o defi ne a ge -a p pr o priate A E 
m o nit ori n g a n d disc o nti n uati o n 
criteria f or ki d ne y safet y la b orat or y 
a b n or malities.
Secti o n 1 0. 6. 4; 1 0. 6. 4. A d verse 
E ve nt Gra di n g f or Ki d ne y 
Safet y La b orat or y 
A b n or m alities.
F or partici pa nts i n Ar ge nti na, 
a d de d re q uire me nt of 
d oc u me ntati o n of mater nal 
A d de d l ocal, c o u ntr y ( Ar ge nti na) 
re q uire me nt of d oc u me ntati o n of 
Secti o n 5. 2. E xcl usi o n Criteria; 
Secti o n 1 0. 9; A p pe n di x 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 1
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
ser ol o g y res ults d uri n g 
pre g na nc y, or partici pa nt’s 
ser ol o g y res ults f or HI V, H B V, 
a n d H C V a n d if u na vaila ble, 
testi n g f or t he sa me a n d 
e xcl usi o n of partici pa nt if
p ositi ve f or HI V, H B V, or 
H C V.
ser ol o g y testi n g f or m ot hers of 
partici pa nts, or t he partici pa nts.
9: C o u ntr y S pecific 
re q uire me nts
A d de d re q uire me nt of O pti o nal 
c ollecti o n i n partici pa nts >   
ol d.
Clarifie d t hat o pti o nal 
c ollecti o n is o nl y a p plica ble if 
partici pa nt >
 ol d i n t he 
pr ot oc ol. 
Secti o n 1. 3. 1; S o A, 1. 3. 2; 
M ulti ple D ose P K Da ys ( F or 
All C o h orts), Secti o n 8. 5; 
P har m ac o ki netics
U p date d Cli nical La b orat or y 
tests t o i ncl u de e G F R 
calc ulati o n t o be per l ocal 
la b orat or y.
Delete d te xt as n o l o n ger 
a p plica ble base d o n t he a b o ve -
“; f or e xa m ple: calc ulati o n of 
esti mate d ki d ne y f u ncti o n (ie, 
Sc h wartz e G F R [c hil dre n 
o nl y], or Sc h wartz e G F R 
[ ne wb or ns a n d i nfa nts o nl y] as 
sta n dar d la b safet y test f or 
cli nical st u dies)” 
T o all o w  f or e G F R calc ulati o n per 
l ocal met h o d f or safet y m o nit ori n g
Secti o n 1 0. 2; A p pe n di x 2: 
Cli nical La b orat or y tests
N o n -S u bst a nti al m o dific ati o ns
Re m o ve d d u plicate E xcl usi o n 
Criteri o n 1 7: Has recei ve d 
c ortic oster oi ds e q ui vale nt t o 
pre d nis o ne ≥2 m g/ k g dail y f or 
at least 1 4 c o nsec uti ve da ys 
wit hi n 3 0 da ys pri or t o st u d y 
start.
Criteri o n alrea d y i ncl u de d i n Secti o n 
1. 1; E xcl usi o n Criteri o n 1 2 ( P A C L 1 
– 0 4 A u g ust 2 0 2 3).
Secti o n 1. 1; S y n o psis. 
Re place me nt of partici pa nt at 
s p o ns or discreti o n u p date d t o 
all o w f or re place me nt if Da y 1 
R S V R N A le vels b y R T -q P C R 
is less t ha n t he l o wer li mit of 
q ua ntificati o n.
T o all o w  fle xi bilit y t o re place 
partici pa nts a n d e val uate R S V viral 
l oa d c ha n ge o ver ti me.
Secti o n 1. 1; S y n o psis, Secti o n 
4. 1; O verall Desi g n, Secti o n, 
Secti o n 6. 5; St u d y c o m plia nce, 
Secti o n 7. 3; L ost t o F oll o w -u p, 
9. 5; Sa m ple Size Deter mi nati o n
N ote a d de d t o safet y la bs: If 
E T occ urs after Da y 5 visit, 
safet y la bs n ot re q uire d.
T o ali g n wit h n o re q uire me nt of safet y 
la bs after Da y 5 f or t he st u d y.
Secti o n 1. 3. 1; Ta ble 2 S o A
N ote a d de d t o P K bl o o d 
sa m ple : If E T occ urs after 
treat me nt peri o d, P K sa m ple 
d oes n ot nee d t o be c ollecte d.
T o clarif y P K c ollecti o n a n d o pti o nal 
c ollecti o n f or E T visit base d o n w he n 
t he visit occ urs.
Secti o n 1. 3. 1; Ta ble 2 S o A
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 2
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
N ote i n S o A f or I M P 
a d mi nistrati o n c ha n ge d fr o m 
I M P ( o ne d ose) t o be 
a d mi nistere d t o partici pa nt at 
site o n Da y 1, Da y 
a n d Da y
T o
I M P ( o ne d ose) t o be 
a d mi nistere d t o partici pa nt 
d uri n g visit o n Da y 1, Da y 
a n d Da y
T o ali g n wit h Ta ble 2 w hic h all o ws 
D a y  a n d Da y  visits t o be 
c o n d ucte d t hr o u g h t he Healt h H o me 
ve n d or at t he partici pa nt’s h o me 
(P A C L 1 – 0 4 A u g ust 2 0 2 3).
Secti o n 1. 3. 1; Ta ble 2 S o A
N ote f or Pri or/c o nc o mita nt 
treat me nt(s) a d de d: If 
partici pa nt is breastfee di n g, 
m o t her’s me dicati o ns s h o ul d 
be re vie we d.
T o mi ni mize D DI ris k f or 
partici pa nts.
Secti o n 1. 3. 1; Ta ble 2 S o A
N ote i n S o A t hat Safet y la bs t o 
be re vie w e d i n
a n d t o be or dere d stat if 
feasi ble i n partici pa nts  
 
 ol d, are:  A L T, A S T, a n d 
T bili. 
T o clarif y t he s pec ific c he mistr y la bs 
i n dicate d
Secti o n 1. 3. 1; Ta ble 2 S o A
Re m o ve d c ollecti o n of  
 
 f or Bi o mar kers 
i nte n de d f or S pecifie d Pr otei n 
Researc h.
T o mi ni mize partici pa nt b ur de n f or 
e x pl orat or y researc h i n t his y o u n g 
pe diatric p o p ulati o n ( P A C L 2 0 8 S e pt 
2 0 2 3).
Secti o n 1. 3. 1; S o A, Secti o n 8. 7; 
Bi o mar kers, Secti o n 8. 7. 3; 
S pecifie d Pr otei n researc h, 
Secti o n 8. 3. 4; Cli nical Safet y 
La b orat or y Assess me nts.
A d de d t he f oll o wi n g 
Miti gati o n strate gies f or 
Car di o vasc ular safet y: 
E xcl usi o n of partici pa nts wit h 
hist or y or ris k fact ors f or Q T 
pr ol o n gati o n, t orsa des de 
p oi ntes or c o n ge nital deaf ness. 
E xcl usi o n of partici pa nts wit h 
fa mil y hist or y of l o n g Q T 
s y n dr o me or s u d de n 
u ne x plai ne d deat h.
E xcl usi o n of partici pa nts 
ta ki n g me dicati o ns k n o w n t o 
pr ol o n g t he Q Tc i nter val 
wit hi n 5 half -li ves bef ore 
d osi n g or re q uiri n g d uri n g t he 
d osi n g peri o d.
E xcl usi o n if breast fee di n g 
partici pa nt’s m ot her has ta ke n 
wit hi n 5 half -li ves bef ore 
d osi n g or re q uiri n g d uri n g t he 
I nc or p orate d st u d y miti gati o ns f or 
p ossi ble car di o vasc ular effects i nt o 
t he Ris k Assess me nt Ta ble. 
Secti o n 2. 3. 1; Ta ble 2 S o A
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 3
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
d osi n g peri o d me dicati o n s t hat 
M o ve d E xcl usi o n criteri o n 
i nf or mati o n relate d t o re nal 
f u ncti o n fr o m E xcl usi o n 
criteria # 1 2 t o se parate 
E xcl usi o n Criteri o n # 1 3 a n d 
a d de d n ote wit h e xa m ples of 
re nal a n o malies t hat ma y 
r e mai n eli gi ble. 
T o se parate t he re nal e xcl usi o n 
criteria fr o m ot her c o m or bi dities f or 
clarit y.
T o pr o vi de clarificati o n o n re nal 
a n o malies t hat ma y re mai n eli gi ble 
f or partici pati o n ( P A C L 2, 0 8 Se pt 
2 0 2 3). 
Secti o n 5. 2; E xcl usi o n Criteria
E xcl usi o n Criteri o n # 1 1 i n 
S y n o psis a n d Secti o n 5. 2 
m o difie d t o i ncl u de C P A P: 
E vi de nce of se vere res pirat or y 
fail ure re q uiri n g i n vasi ve 
mec ha nical ve ntilati o n or 
E C M O. N ote: Partici pa nts 
re q uiri n g n o n-i n vasi ve 
ve ntilati o n, i ncl u di n g hi g h fl o w 
nasal ca n n ula ( H F N C) a n d 
c o nti n u o us p ositi ve air wa y 
press ure ( C P A P), re mai n 
eli gi ble f or t h e st u d y.
F urt her clarificati o n o n n o n -i n vasi ve 
ve ntilati o n pr o vi de d
Secti o n 1. 1; S y n o psis, Secti o n 
5. 2; E xcl usi o n Criteria
E xcl usi o n Criteri o n 1 8 
( Pr ot oc ol A me n d me nt 1), 
E xcl usi o n criteria 1 9 i n 
Pr ot oc ol A me n d me nt 2)
c orrecte d fr o m:
Has recei ve d treat me nt wit h 
ri ba viri n ( oral or i n hale d) 
wit hi n 3 da ys of scree ni n g
T o
Has recei ve d treat me nt wit h 
ri ba viri n ( oral or i n hale d) 
wit hi n 3 0 da ys of scree ni n g.
T his c ha n ge is ma de t o ali g n wit h 
Secti o n 6. 9. Pr o hi bite d Pri or 
Treat me nts ( P A C L 4 A u g ust 2 0 2 3).
Secti o n 5. 2; E xcl usi o n Criteria
Pri or/ C o nc o mita nt t hera p y 
re q uire me nts e x pa n de d t o 
m o t hers of partici pa nts i n t he 
st u d y w h o are breast -fee di n g.
T o clarif yi n g t hat si nce t he pr o hi bite d 
me dicati o ns are e xcl usi o nar y f or t he 
partici pa nt, if t he partici pa nt is
breastfe d, t he pr o hi bite d me dicati o ns 
w o ul d si milarl y a p pl y t o m ot hers of 
breastfe d partici pa nts ( P A C L 2 t o be 
fi nalize d)
Secti o n 5. 2; E xcl usi o n Criteria, 
Secti o n 6. 9; Pri or a n d 
C o nc o mita nt T hera p y, Secti o n 
1 0. 8; A p pe n di x 8; Pr o hi bite d 
C o nc o mita nt me dicati o ns
Re m o ve d Care gi ver as t he 
a d mi nistrat or of st u d y 
i nter ve nti o n
T o ali g n wit h t he re q uire me nt i n 
Secti o n 6. 2 of t he pr ot oc ol t hat 
a d mi nistrati o n of st u d y i nter ve nti o n 
be d o ne b y pare nt(s)/le gal g uar dia n 
o nl y ( P A C L 2 0 8 Se pt 2 0 2 3)
Secti o n 6. 1. 1; A d mi nistr ati o n
E dite d te xt t o clarif y rec or di n g 
of fee di n g wit hi n 3 0 mi n utes 
bef ore a n d after d osi n g i n 
e Diar y.
T o clarif y t he c ollecti o n of fee di n g 
i nf or mati o n.
Secti o n 6. 1. 1; A d mi nistrati o n, 
Secti o n 6. 2. 1; Pre parati o n a n d 
Dis pe nsi n g
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 4
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
Clarifie d t he acti o ns f or 
missi n g d ose.
E xcl usi o n criteri o n 1 9 
( Pr ot oc ol A me n d me nt 1), 
E xcl usi o n criteria 2 0 i n 
Pr ot oc ol A me n d me nt 2) 
c ha n ge d fr o m:
E ns ure t hat n o c o nc o mita nt 
me dicati o ns t hat 
 
 are a d mi nistere d t o 
partici pa nts.
T o
Has ta ke n wit hi n 5 half -li ves 
bef ore d osi n g or re q uires 
d uri n g t he d osi n g peri o d of t he 
st u d y a n y me dicati o n t hat 
Secti o n 6. 9 u p date d.
Clarifie d t he was h o ut peri o d f or 
me dicati o ns t hat 
( P A C L 4 A u g ust 2 0 2 3).
Secti o n 5. 2; E xcl usi o n Criteria, 
Secti o n 6. 9; Pr o hi bite d Pri or 
Treat me nts
A d de d t he f oll o wi n g C R F 
c ollecti o n re q uire me nt:
Scree ni n g R S V dia g n ostic test 
i nf or mati o n d o ne t o c o nfir m 
eli gi bilit y s h o ul d be c ollecte d 
i n C R F, if a vaila ble i n s o urce 
d oc u me nt a n d t his s h o ul d 
i ncl u de t y pe of test (a nti ge n or 
R T -P C R), date a n d ti me of 
testi n g, 
T o all o w  f or c ollecti o n of R S V 
dia g n ostic test i nf or mati o n t o 
u n dersta n d discre pa nt test res ults 
s h o ul d it occ ur
Secti o n 8. 1; A d mi nistrati ve a n d 
Baseli ne Pr oce d ures
Re m o ve d “ Plas ma” fr o m 
Resi d ual plas ma sa m ples fr o m 
t he P K c ollecti o n ma y be use d 
f or e x pl orat or y m olec ular a n d 
pr ote o mic bi o mar kers
T o clarif y t hat t he resi d ual sa m ples 
are bl o o d sa m ples a n d n ot plas ma 
Secti o n 8. 5; P har mac o ki netics
A d de d t he f oll o wi n g –
“ A p pr o val was e x pa n de d t he 
U S i n J ul y 2 0 2 3 w here 
ne o nates a n d i nfa nts are 
eli gi ble d uri n g t heir first R S V 
seas o n, a n d t h ose < 2 4 m o nt hs 
of a ge re mai n v ul nera ble 
d uri n g t heir sec o n d seas o n”.
T o u p date pr o p h ylactic treat me nts f or 
R S V
Secti o n 2. 2; Bac k gr o u n d
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 5
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 diti o nal i nf or mati o n 
i ncl u de d f or C 5 2 4 1 0 0 3:  O ne 
partici pa nt ra n d o mize d t o 
place b o w as n ot i ncl u de d i n 
a n y of t he a nal ysis p o p ulati o ns 
gi ve n t he e val ua ble plas ma 
c o nce ntrati o n re p orte d at all 
ti me p oi nts d uri n g t he 
treat me nt peri o d.
T o ali g n wit h I B
Secti o n 2. 2. 4; Cli nical 
O ver vie w
M o ve d Breastfee d i n g 
i nf or mati o n f or i nfa nt 
partici pa nt fr o m S ocial fact ors 
t o Bac k gr o u n d Fact ors. 
T o clarif y t hat t his is re q uire d t o be 
c ollecte d as a bac k gr o u n d fact or
Secti o n 1 0. 1 0. 2; A p pe n di x 1 0 B 
( Bac k gr o u n d a n d S ocial fact ors)
Se veral a d diti o nal mi n or 
e dit orial c ha n ges ma de.
T o i m pr o ve clarit y a n d rea da bilit y a n d 
f or mai ntai ni n g c o nsiste nc y 
t hr o u g h o ut t he d oc u me nts.
T hr o u g h o ut Pr ot oc ol
A m e n d me nt 1 ( 2 6 J u ne 2 0 2 3)
O ver all R ati o n ale f or  t he A me n d me nt: T he pr ot oc ol was a me n de d t o a d dress c o m me nts
recei ve d fr o m t he U S F D A, i nc or p orate pr ot oc ol clarificati o ns, a n d c orrect i de ntifie d err ors.
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 ns
C ha n ge d d osi n g re gi me n f or 
fr o m 
 da ys
Ali g ne d la n g ua ge i n pr ot oc ol 
(i ncl u di n g u p dati n g t he S o As 
f or C o h ort 1 D, re m o vi n g 
Ta bles 3, 5 a n d 1 3; a n d 
m o dif yi n g sc he ma).
T o all o w  f or  da ys 
treat me nt f or C o h ort 1 D
Secti o n 1. 1 ( S y n o psis), Secti o n 1. 2 
( Sc he ma), Secti o n 1. 3 ( S o A), Secti o n 
2. 2 ( Bac k gr o u n d), Secti o n 4. 1 ( O verall 
Desi g n), Secti o n 4. 3 (J ustificati o n of 
D ose), Secti o n 6. 1 ( St u d y 
I nter ve nti o n(s) A d mi nistere d), Secti o n 
7. 1 ( Disc o nti n uati o n of St u d y 
I nter ve ntio n), Secti o n 8. 3. 4 ( Cli nical 
Safet y La b orat or y Assess me nts), 
Secti o n 1 0. 1 0. 4 A p pe n di x 1 0 D ( D osi n g 
a n d Palata bilit y Q uesti o n naire 
(e Diar y))
Re m o ve d t he a ge re q uire me nt 
of “ 
da ys ol d” f or 
E xcl usi o n criteri o n “ E vi de nce 
of se vere res pirat or y fail ure 
re q uiri n g mec ha nical 
ve ntilati o n or e xtrac or p oreal 
me m bra ne o x y ge nati o n 
( E C M O)”.  
Mec ha nical ve ntilati o n 
clarifie d as “i n v asi ve” 
mec ha nical ve ntilati o n
Per F D A fee d bac k .
F urt her clarificati o ns o n 
mec ha nical ve ntilati o n pr o vi de d
Secti o n 1. 1 ( S y n o psis), Secti o n 5. 2 
( E xcl usi o n Criteria)
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 6
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
N ote a d de d: Partici pa nts 
re q uiri n g n o n-i n vasi ve 
ve ntilati o n, i ncl u di n g hi g h 
fl o w nasal ca n n ula ( H F N C), 
r e mai n eli gi ble f or t he st u d y.
A d de d ne w e xcl usi o n 
criteri o n f or 
 
w it h i ntra uteri ne 
gr o w t h restricti o n.
Per F D A fee d bac k
Secti o n 1. 1 ( S y n o psis), Secti o n 5. 2 
( E xcl usi o n Criteria)
Re vise d ca usalit y assess me nt 
b y q ualif yi n g “relate d” as 
p ossi bl y, pr o ba bl y, or 
defi nitel y relate d f or t he 
bel o w  r ul es
Deat h of a partici pa nt d uri n g 
partici pati o n i n t he st u d y 
recei vi n g st u d y i nter ve nti o n 
(sis u nat o vir) a n d assesse d as 
p ossi bl y, pr o b a bl y, or 
defi nitel y relate d t o st u d y 
i nter ve nti o n (sis u nat o vir) b y 
t he I n vesti gat or(s) a n d/ or 
S p o ns or.
T w o or m ore S A Es i n t he 
sa me S O C i n t he st u d y 
recei vi n g st u d y i nter ve nti o n 
(sis u nat o vir) assesse d as 
p ossi bl y, pr o b a bl y, or 
defi nitel y relate d t o st u d y 
i nter ve nti o n (sis u nat o vir) b y 
t he I n vesti gat or(s) a n d/ or 
S p o ns or.
Per F D A fee d bac k
Secti o n 4. 1. 1 ( D ose fi n di n g a n d 
st o p pi n g r ules)
C ha n ge ma de fr o m 
“I n t he e ve nt t hat t here is a 
safet y si g nal of c o ncer n, all 
ra n d o mizati o n m a y be halte d 
b y t he S p o ns or u ntil t he E -
D M C has c o m plete d t heir 
re vie w a n d has rec o m me n de d 
t hat f urt her ra n d o mizati o n 
ma y c o nti n ue”.
T o
“I n t he e ve nt t hat t here is a 
safet y si g nal of c o ncer n, all 
ra n d o mizati o n m ust be halte d 
b y t he S p o ns or u ntil t he E -
D M C has c o m plete d t heir 
re vie w a n d has rec o m me n de d 
Per F D A fee d bac k
Secti o n 4. 1 ( O verall Desi g n)
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 7
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
t hat f urt her ra n d o mizati o n 
ma y c o nti n ue”
C ha n ges ma de t o D DI ris k f or 
D DI ris k calc ulati o ns f or 
usi n g t he t o p d ose of 
 m g 
, is n o w i n t he sa me 
cate g or y as t he ot her
Secti o n 2. 2. 2 ( N o ncli nical 
P har m ac o ki netics a n d Meta b olis m), 
Secti o n 4. 2 ( Scie ntific Rati o nale f or 
St u d y Desi g n), Secti o n 1 0. 8 ( A p pe n di x 
8 Pr o hi bite d C o nc o mita nt Me dicati o ns)
P ote ntial Cases of Ac ute 
Ki d ne y I nj ur y u p date d t o 
ma ke t he m o nit ori n g a n d 
disc o nti n uati o n criteria 
clearer
T o a d dress F D A fee d bac k
Secti o n 7. 1. 1, Secti o n 1 0. 2 ( A p pe n di x 
2), Secti o n 1 0. 6 ( A p pe n di x 6)
C ha n ges ma de t o t he Ris k 
assess me nt 
T o ali g n wit h I B ( Ma y 2 0 2 3)
Secti o n 2. 3 ( Be nefit/ Ris k Assess me nt)
U p dates t o i ncl u de C 5 2 4 1 0 0 3 
pe diatric st u d y res ults i n R S V 
L R TI partici pa nts.
T o i ncl u de res ults fr o m t he 
c o m plete d st u d y a n d ali g n wit h 
I B ( Ma y 2 0 2 3)
Secti o n 2. 2. 4 ( Cli nical O ver vie w )
C ha n ge d Tertiar y E n d p oi nt 
f or O bjecti ve: T o descri be t he 
viral l oa d i n N P sa m ples o ver 
ti me i n partici pa nts wit h 
R S V -L R TI
Fr o m  
“ Viral l oa d meas ure d via R T -
P C R i n N P s wa bs o ver ti me 
(i ncl u di n g b ut n ot li mite d t o 
c ha n ge fr o m baseli ne at D a y 
a n d pr o p orti o n of 
partici pa nts wit h B L O Q at 
D a y   
T o
“ Viral l oa d meas ure d via R T -
q P C R i n N P s wa bs o ver ti me 
(i ncl u di n g b ut n ot li mite d t o 
c ha n ge fr o m baseli ne a t e ac h 
s a m ple d visit a n d pr o p orti o n 
of partici pa nts wit h B L O Q at 
D a y
 
Per F D A fee d bac k
Secti o n 3 ( O bjecti ves, E n d p oi nts, a n d 
Esti ma n ds)
A d de d a n a d diti o nal Tertiar y 
E n d p oi nt f or O bjecti ve “
 
 
”
“ Viral l oa d i n N P s wa bs a n d 
R S V si g ns a n d s y m pt o ms 
o ver ti me i n -partici pa nts  
 
 
Per F D A fee d bac k
Secti o n 3 ( O bjecti ves , E n d p oi nts, a n d 
Esti ma n ds)
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 8
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
 
”
E dite d te xt t o state t hat 
“A d diti o nal N P s wa b sa m ples 
will be c ollecte d per t he S o A
i n Secti o n 1. 3 , a n d will be 
a nal yze d t o meas ure R S V 
R N A le vels b y R T -q P C R. N P 
sa m ples will be c ollecte d b y 
a n H C P d uri n g a site/ 
 
/i n patie nt visit”
Clarifie d resi d ual N P s wa b 
sa m ples ma y be use d f or viral 
se q ue nci n g,
 
 
if s ufficie nt sa m ples are 
a vaila ble.
Per F D A fee d bac k
Secti o n 8. 7 ( Bi o mar kers)
U p date d Sc he d ule of 
Acti vities t o 
(i) i ncl u de 
Visits f or Da y 
a n d E T 
visits
(ii) i ncl u de Site Visits f or 
D a y  
a n d  
visits
(iii) c ollect R S V si g ns a n d 
s y m pt o ms bet wee n Da y
a n d  
if partici pa nt has a n 
u n pla n ne d visit.
(i v) c ollect N P s wa b 
( o pti o nal) bet wee n Da y 
a n d 
 if partici pa nt has a n 
u n pla n ne d visit or a n i n p ers o n 
visit f or t he Da y 
 visit
T o gi ve fle xi bilit y t o partici pa nts 
a n d all o w f or c ollecti o n of 
a d diti o nal N P s wa bs a n d R S V 
si g ns a n d s y m pt o ms o n Da y
Secti o n 1. 3 ( Sc he d ule of Acti vities)
U p date d sc he ma a n d 
mi ni m u m n u m ber of 
partici pa nts t o ali g n wit h t he 
c ha n ge of C o h ort 2 D t o be 
o pti o nal. 
Per F D A fee d bac k
Secti o n 1. 1 ( S y n o psis), Secti o n 1. 2 
( Sc he ma), Secti o n 4. 1 ( O verall 
Desi g n), Secti o n 9. 5 ( Sa m ple Size 
Deter mi nati o n)
U p date d A p pe n di x t o all o w  
f or c ollecti o n of all Si g ns a n d 
S y m pt o ms a n d n ot j ust L R TI 
Si g ns a n d S y m pt o ms p ost -
scree ni n g, d uri n g t he st u d y 
per S o A 
T o f oll o w  R S V i nfecti o n a n d n ot 
j ust L R TI d uri n g t he st u d y
Secti o n 1 0. 1 0. 1. ( A p pe n di x 1 0 A: Si g ns 
a n d S y m pt o ms Attri b uta ble t o R S V)
Re m o ve d 
 as a dil ue nt 
t o pre pare st u d y i nter ve nti o n
T o ali g n wit h re g ulat or y fili 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 6. 1 ( St u d y 
I nter ve nti o n(s) A d mi nistere d)
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 3 9
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
N o n -S u bst a nti al m o dific ati o ns
A d de d “at t he ti me of 
scree ni n g” t o 
(i) “
 
 a n d 
(ii) t o f o ot n otes f or sc he ma
T o e ns ure c o h ort assi g n me nt is 
base d o n a ge deter mi ne d at 
scree ni n g a n d n ot 
ra n d o mizati o n, if scree ni n g a n d 
ra n d o mizati o n d o n ot occ ur o n 
t he sa me da y as d osi n g is
a n d wei g ht base d.
Secti o n 1. 1 ( S y n o psis), Secti o n 1. 2 
( Sc he ma)
Bi o mar ker c ollecti o n met h o d 
i n S o A u p date d 
T o i ncl u de fi n ger pric k f or dr y 
bl o o d s p ot c ollecti o n if 
a p plica ble
Secti o n 1. 3 ( S o A)
Re m o ve d  
 d osi n g fr o m 
D osi n g ( 
)”
T o clarif y a n d a d dress F D A 
fee d bac k t hat d osi n g is  
 
Secti o n 1. 1 ( S y n o psis), Secti o n 1. 2 
( Sc he ma), Secti o n 1. 3 ( S o A), Secti o n 
2. 2 ( Bac k gr o u n d), Secti o n 2. 3. 2 
( Be nefit Assess me nt), 4. 1 ( O verall 
Desi g n), Secti o n 4 . 2. 3 ( Rati o nale f or 
C o m parat or), Secti o n 4. 3 (J ustificati o n 
f or D ose), Secti o n 6. 1 ( St u d y 
I nter ve nti o n(s) A d mi nistere d), a n d 
Secti o n 8. 3. 4 ( Cli nical Safet y 
La b orat or y Assess me nts).
Mi ni m u m ra n ge
( base d o n
partici pa nts per 
c o h ort) is c ha n ge d t o 
mi ni m u m of  
e val ua ble 
partici pa nts ( mi ni m u m of 
per c o h ort).
Mi ni m u m n u m ber of e val ua ble 
partici pa nts a dj uste d base d o n 
c ha n ge i n n o n -o pti o nal c o h orts 
fr o m 5 (c o h orts 1 A, 1 B, 1 C, 1 D, 
2 D) t o 4 (c o h orts 1 A, 1 B, 1 C, 
1 D) a n d base d o n mi ni m u m 
n u m ber of parti ci pa nts as 
per 
c o h ort.
Secti o n 1. 1 ( S y n o psis), Secti o n 4. 1 
( O verall Desi g n), Secti o n 9. 5 ( Sa m ple 
Size Deter mi nati o n)
N ote a d de d t o E xcl usi o n 
criteri o n o n cli nicall y 
si g nifica nt E C G # 3 ( # 4 i n t his 
a me n d me nt) 
N ote: If si n us tac h ycar dia is 
prese nt, a n d n o t w orse t ha n 
e x pecte d d ue t o t he 
u n derl yi n g disease, 
partici pa nt ma y be c o nsi dere d 
if it d oes n ot i nterfere wit h 
e val uati o n of res p o nse t o 
st u d y i nter ve nti o n, at 
i n vesti gat or discreti o n. 
Per F D A fee d bac k, clarificati o n 
a d de d si nce ma n y i nfa nts wit h 
br o nc hi olitis ma y ha ve 
si g nifica nt tac h ycar dia.
Secti o n 1. 1 ( S y n o psis), Secti o n 5. 2 
( E xcl usi o n Criteria)
Pre vi o usl y E xcl usi o n 
criteri o n # 1 2 ( # 1 3 i n t his 
a me n d me nt) c o m bi ne d wit h 
E xcl usi o n criteria # 1 5 a n d 1 6. 
F urt her clarificati o n o n # 1 2 ( # 1 3 
i n t his a men d me nt) pr o vi de d
wit h e xa m ples of 
i m m u n os u p pressi ve treat me nts.
Secti o n 1. 1 ( S y n o psis), Secti o n 5. 2 
( E xcl usi o n Criteria)
U p date d t he ti mefra me i n 
E xcl usi o n criteri o n # 1 9 ( # 2 0 
i n t his a me n d me nt) fr o m 2 8 
da ys t o  
da ys of scree ni n g.
Per F D A fee d bac k
Secti o n 1. 1 ( S y n o psis), Secti o n 5. 2 
E xcl usi o n Criteria), Secti o n 6. 9 ( Pri or 
a n d C o nc o mita nt T hera p y)
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 0
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n # a n d N a m e
C ha n ges t o N o ncli nical a n d 
Cli nical safet y Secti o n.
C ha n ges ma de t o ali g n wit h I B 
( M a y 2 0 2 3).
Secti o n 2. 2. 2 ( N o ncli nical 
P har m ac ol o g y), Secti o n 2. 2. 3 
( N o ncli nical safet y), Secti o n 2. 2. 4 
( Cli nical o ver view)
U p date d “ Ti me of St u d y 
i nter ve nti o n pre parati o n” 
T o
“St art Ti m e of St u d y 
i nter ve nti o n pre parati o n”
Clarificati o n t hat t he ti me of 
pre parati o n of t he st u d y 
i nter ve nti o n is t he start ti me
Secti o n 1 0. 1 0. 4. ( A p pe n di x 1 0 D: 
D osi n g a n d Palata bilit y Q uesti o n naire 
(e Diar y)
Re m o ve d “ 
” fr o m t he 
D osi n g a n d Palata bilit y 
Q uesti o n naire.
O nl y dil ue nt is 
 a n d he nce 
t he q uesti o n is n ot nee de d.
Secti o n 1 0. 1 0. 4. ( A p pe n di x 1 0 D: 
D osi n g a n d Pal ata bilit y Q uesti o n naire 
(e Diar y)
A d de d la n g ua ge o n
sa m ple c ollecti o n s h o ul d be 
d o ne per l ocal r ules a n d 
re g ulati o ns
T o c o m pl y wit h l ocal r ules a n d 
re g ulati o ns
Secti o n 8. 5 ( P har mac o ki netics)
Se veral a d diti o nal mi n or 
e dit orial c ha n ges ma de.
T o i m pr o ve clarit y a n d 
rea da bilit y a n d f or mai ntai ni n g 
c o nsiste nc y t hr o u g h o ut t he 
d oc u me nts.
Pr ot oc ol
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 1
1 0. 1 2. A p pe n di x 1 2 : A b bre vi ati o ns
T he f oll o wi n g is a list of a b bre viati o ns t hat ma y  be use d i n t he pr ot oc ol. 
A b bre vi ati o n
Ter m
6 M P
m erca pt o p uri ne
A 1 t o A 3
al b u mi n uria ( K DI G O al b u mi n uria se verit y sta n dar dizati o n)
A C R
al b u mi n t o creati ni ne rati o
A D L
acti vit y/acti vities of daily li vi n g
A D M E
b bs or pti o n distri b uti o n meta b olis m e xcreti o n
A P D 9 0
acti o n p ote ntial d urati o n at 9 0 % re p olarizati o n
A E
a d verse e ve nt
A E SI
a d verse e ve nt of s pecial i nterest
A KI
ac ute ki d ne y i nj ur y
A L T
ala ni ne a mi n otra nsferase
A L P
al kali ne p h os p hatase
A S T
as partate a mi n otra nsferase
A U C
area u n der t he c ur ve
A U C 2 4
A U C fr o m 0-2 4 h o urs
A U C 1 2
A U C at 1 2 h o urs
A U Ci nf
A U C fr o m ti ne 0 e xtra p olate d t o i nfi nite ti me
A U Css
A U C at stea d y state
A U C ta u
A U C o ver d osi n g i nter val
A V
atri o ve ntric ular
A x M P
a u xiliar y me dici nal pr o d uct
B L O Q
b el o w li mit o f q ua ntificati o n
B P
bl o o d press ure
b p m
beats per mi n ute
Ca v 1. 2
v olta ge -gate d calci u m c ha n nels
C B C
C o m plete bl o o d c o u nt
C F R
C o de of Fe deral Re g ulati o ns
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 L
cleara nce
C ma x
Ma xi m u m dr u g c o nce ntrati o n
C ma x,ss
Ma xi m u m dr u g c o nce ntrati o n at stea d y state
C mi n
Mi ni m u m dr u g c o nce ntrati o n
C o n me ds
C o nc o mita nt me dicati o ns
C O N S O R T
C o ns oli date d Sta n dar ds of Re p orti n g Trials
C O VI D -1 9
c or o na vir us disease 2 0 1 9
C P A P
c o nti n u o us p ositi ve air wa y press ure
Cr Cl
creati ni ne cleara nce
C R F
case re p ort f or m
C R O
c o ntract researc h or ga nizati o n
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 2
A b bre vi ati o n
Ter m
C S R
cli nical st u d y re p ort
Ctr o u g h
tr o u g h c o nce ntrati o n
Ctr o u g h,ss
tr o u g h c o nce ntrati o n at stea dy state
C T
cli nical trial
C TI S
Cli nical Trial I nf or mati o n S y ste m
C V
car di o vasc ular
D AI D S
Di visi o n of AI D S
D C T
data c ollecti o n t o ol
D DI
dr u g -dr u g i nteracti o n 
DI CI
dr u g -i n d uce d creati ni ne i ncrease
DI KI
dr u g -i n d uce d ki d ne y i nj ur y
DI LI
dr u g -i n d uce d li ver i nj ur y
D U
dis pe nsa ble u nit
E C
et hics c o m mittee
E C 9 0
9 0 % ma xi mal effecti ve c o nce ntrati o n
E C G
electr ocar di o gra m or electr ocar di o gra p h y
E C M O
e xtrac or p oreal me m bra ne o x y ge nati o n
e Cr Cl
esti mate d creati ni ne cleara nce
e C R F
electr o nic case re p ort f or m
E D B
e x p os ure d uri n g breastfee di n g
eDiar y
Electr o nic diar y
E -D M C
E xter nal Data M o nit ori n g C o m mittee
E D P
e x p os ure d uri n g pre g na nc y
E C
excl usi o n criteri o n
e G F R
esti mate d gl o mer ular filtrati o n rate
eIC D
electr o nic i nf or me d c o nse nt d oc u me nt
E M A
E ur o pea n Me dici nes A ge nc y
E O T
e n d of treat me nt
e S A E
electr o nic seri o us a d verse e ve nt
E T
Earl y ter mi nati o n
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
f usi o n
fa
fracti o n of d ose a bs or be d
F D A
U . S. F o o d a n d Dr u g A d mi nistrati o n
F E
f o o d effect
f g
fracti o n of d ose t hat esca pes i ntesti nal meta b olis m
FI H
first i n h u ma n
F/ U
f oll o w-u p
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 3
A b bre vi ati o n
Ter m
G 1 t o G 5
Gra de ( K DI G O e G F R cate g or y  sta n dar dizati o n)
G C P
G o o d Cli nical Practice
G D
G estati o n Da y
G G T
ga m ma -gl uta m y l tra nsferase
GI
g astr oi ntesti nal
G L P
G o o d L a b orat or y P ractice
H B V
h e patitis B v ir us
H C P
h ealt h care pr ofessi o nal ; healt h care pr o vi der
H C T
he mat o p oietic cell tra ns pla ntati o n
H C V
h e patitis C v ir us
h E R G
h u ma n et her-à-g o -g o -Relate d Ge ne
H F N C
h i g h fl o w nasal can n ul a
HI P A A
Healt h I ns ura nce P orta bilit y  a n d Acc o u nta bilit y Act
hI P S C -C M
h u ma n -i n d uce d pl uri p ote nt ste m cell-deri ve d car di o m y o c y tes
HI V
h u ma n i m m u n o deficie nc y vir us
H P D
h o urs p ost d ose
H R
heart rate
Ht
hei g ht
H V
healt h y  v ol u nteer
I B
in vesti gat or’s b r oc h ure
I C 5 0
half ma xi mal i n hi bit or y  c o nce ntrati o n
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
inte nsi ve care u nit
I D
i de ntificati o n
I D M S
n o n -is ot o pe dil uti o n mass s pectr o metr y
I M P
i n vesti gati o nal me dici nal pr o d uct
I ND
in vesti gati o nal Ne w Dr u g
I N R
i nter nati o nal n or malize d rati o
I P
i n vesti gati o nal pr o d uct
I P A L
in 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
interacti ve Res p o nse Tec h n ol o g y
I V
intra ve n o us
K
p r o p orti o nalit y c o nsta nt f or Sc h wartz E q uati o n ( ki d ne y f u ncti o n)
K DI G O
k i d ne y d isease: im pr o vi n g g l o bal o utc o mes
L D H
Lactate De h y dr o ge nase
L F T
li ver f u ncti o n test
L R TI
l o wer res pirat or y tract i nfecti o n
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 4
A b bre vi ati o n
Ter m
M 4
d o u ble h y dr o x y lati o n meta b olite
M A D
m ulti ple asce n di n g d ose
M C H
mea n c or p usc ular he m o gl o bi n
M C H C
mea n c or p usc ular he m o gl o bi n c o nce ntrati o n
M C V
mea n c or p usc ular v ol u me
M QI
me dicall y  q ualifie d i n di vi d ual
M T D
m a xi m u m t olerate d d ose
N A
n ot a p plica ble
N A V 1. 5
car diac s o di u m c ha n nel
N G
nas o gastric
NI M P
n o ni n vesti gati o nal me dici nal pr o d uct
N M N
1 -met h y lnic oti na mi de
N O A E L
n o o bser ve d a d verse effect le vel
N P
nas o p har y n geal
N TI
narr o w t hera pe utic i n de x
O D
o nce a da y
O T C
o ver t he c o u nter
P A C L
pr ot oc ol a d mi nistrati ve c ha n ge letter
P C R U
Pfizer Cli nical Researc h U nit
P D
p har mac o d y n a mic(s)
PI
pri nci ple i n vesti gat or
P K
p har mac o ki netic(s)
P M A R
p o p ulati o n m o deli n g a nal ysis re p ort
P O C
p oi nt -of -care
P o p P K
p o p ulati o n p har mac o ki netics
P PI
pr ot o n p u m p i n hi bit ors
P R
p ulse rate
P S S A
Pfizer's Seri o us A E S u b missi o n Assista nt
P T
pr ot hr o m bi n ti me
q 1 2 h
e ver y 1 2 h o urs
Q D
o nce dail y
Q Tc
c orrecte d Q T i nter val
Q T cB
Q Tc Bazett i nter val
Q Tc F
Q Tc Fri dericia i nter val
Q Tc V
Q Tc usi n g Va n de Water’s met h o d
Q T L
q ualit y  t olera nce li mit
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI
C CI
C CI
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 5
A b bre vi ati o n
Ter m
q ual
q ualitati ve
r B A
relati ve bi oa vaila bility
R B C
re d bl o o d cell
R C T
ra n d o mize d c o ntr olle d trial
RI
re nal i m pair me nt
R N A
ri b o n ucleic aci d
R O A
r o ute of a d mi nistrati o n
R R
resti n g rate
R R T
Re nal re place me nt t hera p y
R S V
res pirat or y sy n c ytial vir us
R S V C V
R S V c halle n ge vir us
R S V F
R S V f usi o n
R T -P C R
re verse tra nscri pti o n p ol y merase c hai n reacti o n
R T -q P C R
re verse tra nscri pti o n q ua ntitati ve p ol y merase c hai n reacti o n
R U Q
ri g ht u p per q ua dra nt
S A D
si n gle asce n di n g d ose
S A E
seri o us a d verse e ve nt
S A P
statistical A nal ysis Pla n
Screat
ser u m creati ni ne
Sc y s
ser u m c ystati n C
S o A
sc he d ule of acti vities
S O C
sta n dar d of care
S O P
sta n dar d o perati n g pr oce d ure
S p O 2
o x y ge n sat urati o n
S R S D
si n gle Refere nce Safety D oc u me nt
S U S A R
sus pecte d U ne x pecte d Seri o us A d verse Reacti o n
t 1/ 2
ter mi nal eli mi nati o n half life
T bili
t otal bilir u bi n
T d P
T orsa des de p oi ntes
T E A E
treat me nt e mer ge nt a d verse e ve nt
TI
t hera pe utic i n de x
T ma x
ti me it ta kes t o reac h ma xi m u m c o nce ntrati o n, Cma x
T Q T
t hr o u g h Q T
U A
uri ne a nal ys is
U L N
u p per li mit of n or mal
U R TI
u p per res pirat or y tract i nfecti o n
U S
U nite d States
U TI
uri nar y  tract i nfecti o n
W B C
w hite bl o o d cell
W H O
W orl d healt h Or ga nizati o n
yc A P D 9 0
Ya ma m ot o rate c orrecte d acti o n p ote ntial d urati o n at 9 0 % 
re p olarisati o n
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)
C CI

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 6
A b bre vi ati o n
Ter m
y o
ye ars ol d
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 7
1 1. R E F E R E N C E S
1. 
Si m oes E A F, B o nt L, Ma nz o ni P, et al. Past, Prese nt a n d F ut ure A p pr oac hes t o t he 
Pre ve nti o n a n d Treat me nt of Res pirat or y  S yn c y tial Vir us Infecti o n i n C hil dre n. I nfect 
Dis T her. 2 0 1 8; 7( 1): 8 7 -1 2 0.
2. 
Li Y, Wa n g X, Bla u D M, et al. Gl o bal, re gi o nal, a n d nat i o nal disease b ur de n 
esti mates of ac ute l o wer res pirat or y  i nfecti o ns d ue t o res pirat or y sy nc yt ial vir us i n 
c hil dre n y o u n ger t ha n 5 years i n 2 0 1 9: a s ys te matic a nalys is. La ncet. 
2 0 2 2; 3 9 9( 1 0 3 4 0): 2 0 4 7 -6 4.
3.
R ha B, C ur ns A T, Li vel y J Y, et al. Res pirat or y S y nc yt ial Vir us-Ass ociate d 
H os pitalizati o ns A m o n g Y o u n g C hil dre n: 2 0 1 5 -2 0 1 6. Pe diatrics. 
2 0 2 0; 1 4 6( 1):e 2 0 1 9 3 6 1 1.
4.
La n gle y  J M, Bia nc o V, D o mac h o ws ke J B, et al. I nci de nce of Res pirat or y S yn c y tial 
Vir us L o wer Res pirat or y Tract I nfecti o ns D uri n g t he First 2 Years of Life: A 
Pr os pecti ve St u d y  Acr oss Di verse Gl o bal Setti n gs. J Infect Dis. 2 0 2 2; 2 2 6( 3): 3 7 4 - 8 5.
5.
Ki m L , R ha B, A bra ms o n J S, et al. Ide ntif y i n g Ga ps i n Res pirat or y S yn c y tial Vir us 
Disease E pi de mi ol o g y  i n t he U nite d States Pri or t o t he Intr o d ucti o n of Vacc i nes. Cli n 
I nfect Dis. 2 0 1 7; 6 5( 6): 1 0 2 0- 2 5.
6.
S Y N A GI S ( pali viz u ma b). U S Prescri pti o n I nf or mati o n ( U S PI ); Mar 2 0 1 4, 
Gait hers b ur g, M D: Me d I m m u ne, L L C. A vaila ble fr o m: 
htt ps:// w w w.access data.f da. g o v/ dr u gsatf da _ d ocs/la bel/ 2 0 1 4/ 1 0 3 7 7 0s 5 1 8 5l bl. p df. 
Accesse d: 2 3 Mar 2 0 2 3.
7.
S Y N A GI S ( pali viz u ma b) S m P C. E P A R pr o d uct i nf or mati o n: E M A. A vaila ble fr o m: 
htt ps:// w w w.e ma.e ur o pa.e u/e n/ d oc u me nts/ pr o d uct -i nf or mati o n/s yna gis -e par-pr o d uct -
i nf or mati o n _e n. p df. Accesse d: 2 3 Mar 2 0 2 3.
8.
B E Y F O R T U S ( nirse vi ma b) S m P C. E P A R pr o d uct i nf or mati o n: E M A. A vaila ble 
fr o m: htt ps:// w w w.e ma.e ur o pa.e u/e n/ d oc u me nts/ pr o d uct- i nf or mati o n/ be yf ort us-e par -
pr o d uct -i nf or mati o n _e n. p df. Accesse d: 1 3 A pr 2 0 2 3.
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. 1 7 J ul 
2 0 2 3. 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. Accesse d: 1 4 A u g 2 0 2 3.
1 0.  
W orl d Healt h Or ga nizati o n. Ne w b or n Healt h. Ne w b or n Healt h i n t he Wester n 
Pacific. A vaila ble fr o m: htt ps:// w w w. w h o.i nt/ wes ter n pacific/ healt h-t o pics/ ne w b or n-
healt h #: ~:te xt = A % 2 0 ne w b or n % 2 0i nfa nt % 2 C % 2 0 or % 2 0 ne o nate,t o % 2 0 healt h % 2 0car
e % 2 0is % 2 0l o w. Accesse d: 2 7 Mar 2 0 2 3.
1 1.
U. S. De part me nt of Healt h a n d H u ma n Ser vices NI o H, Nati o nal I nstit ute of Aller g y  
a n d I nfecti o us Diseases, Di vi si o n of AI D S,. Di visi o n of AI D S ( D AI D S). Ta ble f or 
Gra di n g t he Se verit y  of A d ult a n d Pe diatric A d verse E ve nts. J ul 2 0 1 7. A vaila ble 
fr o m: htt ps://rsc. niai d. ni h. g o v/sites/ defa ult/files/ dai ds gra di n gc orrecte d v 2 1. p df . 
Accesse d: 0 8 Mar 2 0 2 3.
1 2. 
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. Cli nical Gr o wt h C harts. J u n 2 0 1 7. 
A vaila ble fr o m: htt ps:// w w w.c dc. g o v/ gr o wt hc harts/cli nical _c harts. ht m . Accesse d: 1 3 
A pr 2 0 2 2.
1 3.
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. W H O Gr o wt h Sta n dar ds Are 
Rec o m me n de d f or Use i n t he U. S. f or I nfa nts a n d C hil dre n 0 t o 2 Years of A ge. Se p 
2 0 1 0. A vaila ble fr o m: 
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( G M T)

Sis u nat o vir ( P F -0 7 9 2 3 5 6 8)
Pr ot oc ol C 5 2 4 1 0 0 9
Fi na l Pr ot oc ol A me n d me n t 4 , 1 1 Marc h 2 0 2 4
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
Pa ge 1 4 8
htt ps:// w w w.c dc. g o v/ gr o wt hc harts/ w h o _c harts. ht m # T he % 2 0 W H O % 2 0 Gr o wt h % 2 0 C
harts . Accesse d: 0 7 A pr 2 0 2 3.
1 4.
Na k hja va n -S ha hra ki B, Y o usefifar d M, Ataei N, et al. Acc urac y of c y stati n C i n 
pre dicti o n of ac ute ki d ne y  i nj ur y i n c hil dre n; ser u m or uri ne le vels: w hic h o ne w or ks 
better? A s y ste matic re vie w a n d meta-a nal ys is. B M C Ne p hr ol. 2 0 1 7; 1 8( 1): 1 2 0.
1 5.
La g os -Are val o P, Palija n A, Vert ull o L, et al. C ys tati n C i n ac ute ki d ne y  i nj ur y 
dia g n osis: earl y  bi o mar ker or alter nati ve t o ser u m creati ni ne? Pe diatr Ne p hr ol. 
2 0 1 5; 3 0( 4): 6 6 5 - 7 6.
1 6.  
X u X, Nie S, X u H, et al. Detecti n g Ne o natal A KI b y  Ser u m Cys tati n C. J A m S oc 
Ne p hr ol. 2 0 2 3; 3 4( 7): 1 2 5 3- 6 3.
1 7.
B oer D P, de Rij ke Y B, H o p W C, et al. Refere nce val ues f or ser u m creati ni ne i n 
c hil dre n y o u n ger t ha n 1 year of a ge. Pe diatr Ne p hr ol. 2 0 1 0; 2 5( 1 0): 2 1 0 7 -1 3.
1 8. 
Za p pitelli M, A m bala va na n N, As ke nazi DJ, et al. De vel o pi n g a ne o natal ac ute 
ki d ne y  i nj ur y researc h defi niti o n: a re p ort fr o m t he NI D D K ne o natal A KI w or ks h o p. 
Pe diatr Res. 2 0 1 7; 8 2( 4): 5 6 9 - 7 3.
1 9.
K DI G O A KI W or k Gr o u p. K DI G O cli nical practice g ui deli ne f or ac ute ki d ne y 
i nj ur y. Ki d ne y Int S u p pl. 2 0 1 2; 2: 1 - 1 3 8.
2 0.
Girar di A, Rasc hi E, Galletti S, et al. Dr u g -i n d uce d re nal i nj ur y i n ne o nates: 
c halle n ges i n cli nical practice a n d pers pecti ves i n dr u g de vel o p me nt. E x pert O pi n 
Dr u g Meta b T o xic ol. 2 0 1 7; 1 3( 5): 5 5 5- 6 5.
2 1.
M u hari - Star k E, B urc kart GJ. Gl o mer ular Filtrati o n Rate Esti mati o n F or m ulas f or 
Pe diatric a n d Ne o natal Use. J Pe diatr P har mac ol T her. 2 0 1 8; 2 3( 6): 4 2 4 - 3 1.
2 2.
Sele ws ki D T, C harlt o n J R, Jett o n J G, et al. Ne o natal Ac ute Ki d ne y  Inj ur y . Pe diatrics. 
2 0 1 5; 1 3 6( 2):e 4 6 3 - 7 3.
0 9 0 1 7 7 e 1 a 0 2 4 3f e 8\ A p pr o v e d\ A p pr o v e d O n: 1 2- M ar- 2 0 2 4 1 4: 4 2 ( 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
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