COMIRNATY Intramuscular Injection for 6 Months to 4 Years Old (Monovalent: Omicron XBB.1.5) Special Investigation for Booster Immunization in Children Aged 6 Months to 4 Years
Conditions: SARS-CoV-2, COVID-19
Sponsor: Pfizer

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8  7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate f or Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 of 3 5  
 
 
( A p pe n di x) 
 
 
 
C O MI R N A T Y I ntr a m usc ul ar I njecti o n f or 6 M o nt hs t o 4 Ye ars Ol d 
( m o n o v ale nt: O micr o n X B B. 1. 5) 
S peci al i n vesti g ati o n f or b o oster i m m u niz ati o n i n c hil dre n a ge d 6 m o nt hs t o 4 ye ars 
N o n-i nter ve nti o n al F ull Pr ot oc ol 
 
 
 
 
 
 
 
Pfizer Ja pa n I nc.  
 
 
T his d oc u me nt c o ntai ns 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 his  d oc u me nt , y o u a gree t o h ol d t his i nf or mati o n i n c o nfi de nce a n d n ot 
c o p y or discl ose it t o ot hers (e xce pt w here re q uire d b y a p plica ble la w) or use it f or u na ut h orize d p ur p oses. 
I n t he e ve nt of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfizer m ust be pr o m ptl y n otifie d. 
 
 
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 of 3 5  
 
S T U D Y I N F O R M A TI O N  
Title  
C O MI R N A T Y I ntra m usc ular I njecti o n f or 6 
M o nt hs t o 4 Years Ol d ( m o n o vale nt: O micr o n 
X B B. 1. 5) 
S pecial i n vesti gati o n f or b o oster i m m u nizati o n i n 
c hil dre n a ge d 6 m o nt hs t o 4 years 
Pr ot oc ol I D  
C 4 5 9 1 0 5 7  
Pr ot oc ol versi o n i de ntifier  
Ver. 1  
D ate  
2 3 Oct o ber 2 0 2 3  
Acti ve s u bst a nce  
Ra xt ozi na mera n  
M e dici n al pr o d uct  
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 
m o nt hs t o 4 years ol d  
Rese arc h q uesti o n a n d o bjecti ves  
T o c ollect i nf or mati o n o n a d verse e ve nts, 
react o ge nicit y e ve nts (l ocal reacti o ns a n d s yste mic 
reacti o ns), a n d C O VI D- 1 9 t hat occ ur s u bse q ue nt t o 
t he f o urt h vacci nati o n wit h t his pr o d uct i n c hil dre n 
a ge d 6 m o nt hs t o 4 years w h o recei ve d t he first 
b o oster i m m u nizati o n wit h t his pr o d uct (f o urt h 
vacci nati o n wit h t his pr o d uct) after i nitial 
i m m unizati o n u n der act ual use, a n d t o c o nfir m its 
safet y i n t he earl y sta ge. 
A ut h or  
 
 
 
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)
P P D
P P D

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 3 of 3 5  
 
1.  T A B L E O F C O N T E N T S  
 
1. T A B L E O F C O N T E N T S  ........................................................................................................................... 3 
2. LI S T O F A B B R E VI A TI O N S  .................................................................................................................... 6 
3. R E S P O N SI B L E P A R TI E S  ........................................................................................................................ 7 
4. A M E N D M E N T S A N D U P D A T E S  ........................................................................................................... 8 
5. MI L E S T O N E S ........................................................................................................................................... 8 
6. R A TI O N A L E A N D B A C K G R O U N D  ...................................................................................................... 8 
7. R E S E A R C H Q U E S TI O N A N D O BJ E C TI V E S  ........................................................................................ 9 
7. 1. Safet y S pecificati o ns  .................................................................................................................... 9 
8. R E S E A R C H M E T H O D S  ........................................................................................................................ 1 0 
8. 1. St u d y Desi g n  .............................................................................................................................. 1 0 
8. 2. Setti n g  ........................................................................................................................................ 1 0 
8. 2. 1. Re gistrati o n criteria  ...................................................................................................... 1 0 
8. 2. 2. E xcl us i o n criteria ......................................................................................................... 1 1 
8. 2. 3. St u d y sites  .................................................................................................................... 1 1 
8. 2. 4. Pla n ne d st u d y peri o d .................................................................................................... 1 1  
8. 2. 5. St u d y pr oce d ures .......................................................................................................... 1 2  
8. 2. 6. O bser vati o n peri o d ....................................................................................................... 1 2  
8. 3. Varia bles  .................................................................................................................................... 1 3 
8. 3. 1. C haracteristics of vacci nate d partici pa nt s .................................................................... 1 4 
8. 3. 2. Stat us of b o oster i m m u nizati o n wit h t his pr o d uct ........................................................ 1 5  
8. 3. 3. C o nc o mita nt me dicati o ns  ............................................................................................. 1 5 
8. 3. 4. E n d- of-st u d y/ disc o nti n uati o n rec or d ............................................................................ 1 5  
8. 3. 5. I nf or mati o n o n i n oc ulati o n of ot her vacci nes .............................................................. 1 6  
8. 3. 6. I nf or mati o n o n C O VI D-1 9 pat h o ge n ( S A R S -C o V -2) test  ........................................... 1 6 
8. 3. 7. I nf or mati o n o n C O VI D- 1 9 ........................................................................................... 1 6 
8. 3. 8. A d verse e ve nts  ............................................................................................................. 1 6 
8. 3. 9.  React o ge nicit y e ve nts (l ocal reacti o ns a n d s yste mic reacti o ns) ( healt h o bser vati o n 
diar y) ............................................................................................................................ 1 8  
8. 4. Data s o urces  ............................................................................................................................... 2 0 
8. 5. St u d y size  ................................................................................................................................... 2 0 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 4 of 3 5  
 
8. 5. 1. Pla n ne d sa m ple s ize ..................................................................................................... 2 0 
8. 5. 2. Rati o nale f or sa m ple size  ............................................................................................. 2 0 
8. 6. Data ma na ge me nt  ....................................................................................................................... 2 1 
8. 6. 1. Case re p ort f or ms ( C R Fs)/ Electr o nic data rec or d  ........................................................ 2 1 
8. 6. 2. Rec or d rete nti o n  ........................................................................................................... 2 1 
8. 6. 3. Data c ollecti o n met h o d  ................................................................................................ 2 2 
8. 6. 4. Partici pa nt  re gistrati o n ( E D C) ...................................................................................... 2 2 
8. 6. 5. P oi nts t o c o nsi der f or c o m pleti o n, re visi o n, a n d s u b missi o n of case re p ort f or m 
( E D C) ........................................................................................................................... 2 2 
8. 7. Data a nal ysis  .............................................................................................................................. 2 2 
8. 7. 1. Defi niti o n of a nal ysis set  .............................................................................................. 2 3 
8. 7. 2. Safet y a nal ysis .............................................................................................................. 2 3 
8. 7. 3. A nal ysis of react o ge nicit y e ve nts (l ocal reacti o ns a n d s yste mic reacti o ns [ healt h 
o bser vati o n diar y]) ....................................................................................................... 2 3  
8. 7. 4. A nal ysis of I nf or mati o n o n C O VI D- 1 9 ....................................................................... 2 3  
8. 8. Q ualit y c o ntr ol ........................................................................................................................... 2 3  
8. 9. Li mitati o ns of t he researc h met h o ds  .......................................................................................... 2 3 
8. 1 0. Ot her as pects  ............................................................................................................................ 2 3 
9. P R O T E C TI O N O F H U M A N P A R T I CI P A N TS ..................................................................................... 2 4  
9. 1. Partici pa nt  i nf or mati o n .............................................................................................................. 2 4 
9. 2. Partici pa nt  c o nse nt ..................................................................................................................... 2 4 
9. 3. Partici pa nt  wit h dra wal  ............................................................................................................... 2 5 
9. 4. I nstit uti o nal re vie w b oar d (I R B)/ Et hics c o m mittee ( E C) .......................................................... 2 5 
9. 5. Et hical c o n d uct of t he st u d y ....................................................................................................... 2 5  
1 0. M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E R E A C TI O N S  ............. 2 6 
1 0. 1. Rec or ds a n d re p ort re q uire me nts ............................................................................................. 2 6  
1 0. 2. Re p orti n g peri o d ...................................................................................................................... 2 7  
1 0. 3. Ca usalit y assess me nt  ................................................................................................................ 2 7 
1 0. 4. Defi niti o ns of safet y e ve nts ...................................................................................................... 2 8 
1 0. 4. 1.  A d verse e ve nts  ........................................................................................................... 2 8 
1 0. 4. 2. Seri o us a d verse e ve nts  ............................................................................................... 2 9 
1 0. 4. 3. Sce nari os necessitati n g r e p orti n g t o Pfizer Safet y wit hi n 2 4 h o urs ........................... 3 0  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 5 of 3 5  
 
1 1. SI N G L E R E F E R E N C E S A F E T Y D O C U M E N T  .................................................................................. 3 2 
1 2. P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S  ............................ 3 2 
1 3. N A M E, A N D A D D R E S S O F C O N T R A C T O R A S W E L L A S S C O P E O F W O R K C O N T R A C T E D  3 2 
1 4. A D DI TI O N A L M E A S U R E S T H A T M A Y B E T A K E N B A S E D O N T H E S T U D Y R E S U L T S A N D 
C RI T E RI A F O R D E T E R MI N A TI O N O F T H E I NI TI A TI O N  ............................................................. 3 3 
1 5. S C H E D U L E D TI MI N G O F MI L E S T O N E S A N D T H EI R R A TI O N A L E S F O R E V A L U A TI O N O F 
S T U D Y I M P L E M E N T A TI O N S T A T U S A N D R E S U L T S A N D R E P O R TI N G T O T H E P M D A  ..... 3 3 
1 6. O T H E R N E C E S S A R Y M A T T E R S  ...................................................................................................... 3 3 
1 7. C O N T A C T I N F O R M A TI O N  ................................................................................................................ 3 4 
1 7. 1. C o ntact i nf or mati o n f or i n q uiries a b o ut t he st u d y ................................................................... 3 4  
1 7. 2. C o ntact i nf or mati o n f or i n q uiries a b o ut t he E D C s yste m ........................................................ 3 4  
1 8. R E F E R E N C E S  ...................................................................................................................................... 3 4 
1 9. LI S T O F T A B L E S  ................................................................................................................................. 3 4 
2 0. LI S T O F FI G U R E S  ............................................................................................................................... 3 4 
A P P E N DI X 1. LI S T O F S T A N D A L O N E D O C U M E N T S  ........................................................................ 3 5 
A P P E N DI X 2. A D DI TI O N A L I N F O R M A TI O N  ....................................................................................... 3 5 
 
 
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 6 of 3 5  
 
2.  LI S T O F A B B R E VI A TI O N S  
A b bre vi ati o n  Defi niti o n  
E C  
Et hics c o m mittee /
 
E C M O  
E xtrac or p oreal me m bra ne o x y ge nati o n/
 
I R B 
I nstit uti o nal re vie w b oar d/
 
I C U 
I nte nsi ve care u nit/
 
S A P  
Statistical a nal ysis pla n/
 
V A E D  
Vacci ne -ass ociate d e n ha nce d disease/
 
V A E R D  
Vacci ne -ass ociate d e n ha nce d res pirat or y disease/
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 7 of 3 5  
 
3.  R E S P O N SI B L E P A R TI E S  
T he Ja pa n G o o d P ost- mar keti n g St u d y Practice officer  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 8 of 3 5  
 
4.  A M E N D M E N T S A N D U P D A T E S  
Pr ot oc ol 
versi o n 
i de ntifier 
D ate  
T y pe of 
a me n d m e nt 
(s u bst a nti al or 
a d mi nistr ati ve)  
Pr ot oc ol secti o n(s) 
c h a n ge d 
S u m m ar y of 
a me n d m e nt(s)  
Re as o n  
Ver. 1  
2 3 
Oct o ber 
2 0 2 3  
N/ A  
N/ A  
N/ A  
N/ A  
 
5.  MI L E S T O N E S  
Milest o ne  
Pl a n ne d d ate  
Start of data c ollecti o n  
0 8 Dece m ber 2 0 2 3 
S tart of data c ollecti o n ( date of re gistrati o n of t he first 
partici pa nt  re gistere d) 
0 8 Dece m ber 2 0 2 3 
E n d of data c ollecti o n  
2 8 A pril 2 0 2 4 
E n d of data c ollecti o n ( date of release of t he data base)  
2 4 Se pte m ber 2 0 2 4 
Fi nal st u d y re p ort  
2 3 Dece m ber 2 0 2 4 
 
6.  R A TI O N A L E A N D B A C K G R O U N D  
N o vel c or o na vir us i nfecti o n ( C O VI D - 1 9) is a n i nfecti o us disease ca use d b y se vere ac ute res pirat or y s y n dr o me 
c or o na vir us 2 ( S A R S‑ C o V‑ 2), a vir us of a ni mal ori gi n. T he pat h o ge nicit y of S A R S -C o V -2 i n h u ma ns was first 
c o nfir me d i n C hi na, a n d it ra pi dl y s prea d gl o ball y t hr o u g h h u ma n- t o- h u ma n tra ns missi o n. 
C or o na vir uses are e n vel o pe d vir uses w h ose ge n o me is p ositi ve-se nse, si n gle-stra n de d R N A t hat e nc o des f o ur 
str uct ural pr otei ns. Of t hese f o ur str uct ural pr otei ns, s pi ke gl yc o pr otei n ( S pr otei n), is a n i m p orta nt tar get f or 
vacci ne de vel o p me nt. T he Pfizer/ Bi o N Tec h C O VI D - 1 9 vacci ne, B N T 1 6 2 b 2 ( C O MI R N A T Y i ntra m usc ular 
i njecti o n), is a li pi d na n o particle ( L N P)-f or m ulate d, n ucle osi de-m o difie d m R N A ( m o d R N A) vacci ne t hat 
e nc o des t he S pr otei n carr yi n g P 2 m utati o ns ( P 2 S). 
As of  J ul y 2 0 2 3, C O MI R N A T Y is a vaila ble i n m ore t ha n 1 2 0 c o u ntries a n d re gi o ns. 
I n Ja pa n, s pecial a p pr o val was gra nte d f or C O MI R N A T Y i ntra m usc ular i njecti o n o n Fe br uar y 1 4, 2 0 2 1; f or 
b ot h C O MI R N A T Y R T U i ntra m usc ular i njecti o n a n d C O MI R N A T Y i ntra m usc ular i njecti o n f or 5 t o 1 1 years 
ol d o n Ja n uar y 2 1, 2 0 2 2; f or C O MI R N A T Y R T U i ntra m usc ular i njecti o n ( Bi vale nt: Ori gi nal/ O micr o n B A. 1) as 
well as C O MI R N A T Y R T U i ntra m usc ular i njecti o n ( Bi vale nt: Ori gi nal/ O micr o n B A. 4 - 5) o n Se pte m ber 1 2 a n d 
Oct o ber 5, 2 0 2 2, res pecti vel y; f or C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d o n Oct o ber 
5, 2 0 2 2; a n d f or C O MI R N A T Y i ntra m usc ular i njecti o n f or 5 t o 1 1 years ol d ( Bi vale nt: Ori gi nal/ O micr o n B A. 4-
5) o n Fe br uar y 2 8, 2 0 2 3. As a res ult of c o m pre he nsi ve c o nsi derati o n of t he data o btai ne d t h us far a n d t he 
c urre nt stat us of i nfecti o n wit h varia nt strai ns i n Ja pa n all t o get her, it was c o nsi dere d necessar y i n ter ms of 
p u blic healt h t hat a s yste m t hat e na bles a d mi nistrati o n of m o n o vale nt vacci nes w hic h are e x pecte d t o be m o re 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 9 of 3 5  
 
effecti ve f or O micr o n s u b varia nt X B B. 1. 5 t o pe o ple of all a ges be als o esta blis he d i n Ja pa n fr o m t he pers pecti ve 
of pre ve nti n g t he s prea d of C O VI D- 1 9. T o t his e n d, Pfizer a n d Bi o N Tec h o btai ne d a p pr o val f or partial c ha n ges 
t o t he a p pr o ve d ite ms of t he ma n ufact uri n g a n d mar keti n g a p pr o val o n Se pte m ber 1, 2 0 2 3, t o a d d i nitial 
i m m u nizati o n a n d b o oster i m m u nizati o n wit h m o n o vale nt vacci ne ( O micr o n X B B. 1. 5 s u b varia nt) t o t he 
i n dicati o n “ pre ve nti o n of i nfecti o n b y S A R S-C o V -2” f or C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 
4 years ol d, C O MI R N A T Y i ntra m usc ular i njecti o n f or 5 t o 1 1 years ol d, a n d C O MI R N A T Y R T U i ntra m usc ular 
i njecti o n f or si n gle pers o n use. 
T he res ults o btai ne d i n a n o verseas cli nical st u d y ( C 4 5 9 1 0 4 8 S u bst u d y B), w hic h was c o n d ucte d i n c hil d re n 
recei vi n g a b o oster s h ot of t he e xisti n g bi vale nt vacci ne a da pte d t o O micr o n varia nts ( Ori gi nal/ O micr o n B A. 4-
5), re veale d n o ne w safet y s pecificati o ns, b ut as t here e xist n o data o n safet y after b o oster i m m u nizati o n wit h 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5) 
( herei nafter referre d t o as “t his dr u g”) i n c hil dre n a ge d 6 m o nt hs t o 4 years i n Ja pa n lea di n g u p t o t he prese nt 
partial c ha n ge a p pr o val, it is c o nsi dere d hi g hl y necessar y t o c ollect p ost- mar keti n g safet y data. Acc or di n gl y, a 
s pecial i n vesti gati o n was pla n ne d wit h t he ai m of c o nfir mi n g safet y after b o oster i m m u nizati o n i n c hil dre n a ge d 
6 m o nt hs t o 4 years i n Ja pa n. 
T his st u d y s hall be c o n d ucte d i n strict c o m plia nce wit h t he “ Mi nistr y of Healt h, La b o ur a n d Welfare ( M H L W) 
Or di na nce o n t he Sta n dar d f or P ost- mar keti n g St u dies a n d Cli nical Trials of Me dical Pr o d ucts” ( M H L W 
Or di na nce N o. 1 7 1, date d Dece m ber 2 0, 2 0 0 4), t he “ E nf orce me nt of t he M H L W Or di na nce o n t he Sta n dar d f or 
P ost - mar keti n g St u dies a n d Cli nical Trials of Me dical Pr o d ucts” ( P F S B N otificati o n N o. 1 2 2 0 0 0 8, date d 
Dece m ber 2 0, 2 0 0 4), t he “ M H L W Or di na nce o n t he Sta n dar d f or P ost- mar keti n g Safet y C o ntr ol of Me dical 
Pr o d ucts, Q uasi -me dical Pr o d ucts, C os metics, Me dical De vices, a n d Re ge nerati ve Me dical Pr o d ucts” ( M H L W 
Or di na nce N o. 1 3 5, date d Se pte m ber 2 2, 2 0 0 4), t he “ E nf orce me nt of t he M H L W Or di na nce o n t he Sta n dar d f or 
P ost - mar keti n g Safet y C o ntr ol of Me dical Pr o d ucts, Q uasi-me dical Pr o d ucts, C os metics, Me dical De vices, a n d 
Re ge nerati ve Me dical P r o d ucts” ( P F S B N otificati o n N o. 0 8 1 2- 4, date d A u g ust 1 2, 2 0 1 4), t he “ M H L W 
Or di na nce t o Partiall y A me n d t he M H L W Or di na nce o n t he Sta n dar d f or P ost- mar keti n g St u dies a n d Cli nical 
Trials of Me dical Pr o d ucts” ( M H L W Or di na nce N o. 1 1 6, date d Oct o ber 2 6, 2 0 1 7), a n d t he “ A n n o u nce me nt of 
t he M H L W Or di na nce t o Partiall y A me n d t he M H L W Or di na nce o n t he Sta n dar d f or P ost-mar keti n g St u dies 
a n d Cli nical Trials of Me dical Pr o d ucts ( Re gar di n g t he M H L W Or di na nce o n t he Sta n dar d f or P ost- mar keti n g 
St u dies a n d Cli nical Trial s of Me dical Pr o d ucts)” ( P S E H B N otificati o n N o. 1 0 2 6- 1, date d Oct o ber 2 6, 2 0 1 7). 
7.  R E S E A R C H Q U E S TI O N A N D O B J E C TI V E S  
T o c ollect i nf or mati o n o n a d verse e ve nts, react o ge nicit y e ve nts (l ocal reacti o ns a n d s yste mic reacti o ns), a n d 
C O VI D - 1 9 o bser ve d after t he f o urt h vacci nati o n wit h t his pr o d uct i n c hil dre n a ge d 6 m o nt hs t o 4 years (as of 
t he date of t he f o urt h vacci nati o n wit h t his pr o d uct) w h o recei ve d t heir first b o oster i m m u nizati o n wit h t his 
pr o d uct ( herei nafter, t he f o urt h vacci nati o n wit h t his pr o d uct) a fter t he i nitial i m m u niz ati o n u n der act ual use, 
a n d t o c o nfir m its safet y i n t he earl y sta ge.  
7. 1.  S afet y S pecific ati o ns  
[I m p ort a nt I de ntifie d Ris ks] 
•  
S h oc k, a na p h yla xis  
•  
M y ocar ditis, pericar ditis  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 0  of 3 5  
 
[I m p ort a nt P ote nti al Ris ks] 
•  
Vacci ne -ass ociate d e n ha nce d disease ( V A E D) a n d vacci ne -ass ociate d e n ha nce d res pirat or y disease 
( V A E R D) 
•  
G uillai n -Barre s y n dr o me  
8.  R E S E A R C H M E T H O D S  
8. 1.  St u d y Desi g n  
T his is a m ultice nter c o h ort st u d y. T he i n vesti gat or will rec or d i nf or mati o n re q uire d b y t his st u d y i n case re p ort 
f or ms ( C R Fs) base d o n i nf or mati o n o btai ne d fr o m t he preli mi nar y e xa mi nati o n s heet or me dical i nter vie ws, 
etc., a n d rec or ds s uc h as me dical rec or ds. A healt h o bser vati o n diar y will be distri b ute d t o vacci nate d 
i n di vi d uals partici pati n g i n t his st u d y, a n d t he y will be re q ueste d t o rec or d i nf or mati o n o n react o ge nicit y e ve nts 
(l ocal reacti o ns a n d s yste mic reacti o ns, i ncl u di n g p yre xia) after vacci nati o n wit h t his pr o d uct. 
T he i n vesti gat or will c ollect t he healt h o bser vati o n diar y after t he e n d of t he o bser vati o n peri o d of ea c h C R F, 
a n d c hec k t he details of rec or ds ot her t ha n s y m pt o ms at t he vacci nati o n site a n d ge neral s y m pt o ms s pecifie d i n 
t he diar y (i ncl u di n g t he i nf or mati o n o n C O VI D-1 9) as nee de d a n d rec or d t he m as a d verse e ve nts. T he 
i n vesti gat or s h o ul d rec or d t he s y m pt o ms at t he vacci nati o n site (l ocal reacti o ns) a n d ge neral s y m pt o ms 
i ncl u di n g p yre xia (s yste mic reacti o ns) s pecifie d i n t he healt h o bser vati o n diar y i n t he C R F as ite ms of t he healt h 
o bser vati o n diar y as is i n or der t o a v oi d o verla p wit h a d verse e ve nts e val uate d b y p h ysicia ns. 
All assess me nts descri be d i n t his f ull pr ot oc ol are perf or me d as part of n or mal cli nical practice or sta n dar d 
practice g ui deli nes f or t he partici pa nt  p o p ulati o n a n d healt hcare pr o vi der s pecialt y i n t he c o u ntries w here t his 
n o n-i nter ve nti o nal st u d y is bei n g c o n d ucte d.  
8. 2.   Setti n g  
8. 2. 1.  Re gistr ati o n criteri a  
Partici pa nt s m ust meet all of t he f oll o wi n g criteria t o be eli gi ble f or i ncl usi o n i n t he st u d y. As a g ui de, 
partici pa nt  re gistrati o n will be perf or me d wit hi n n o m ore t ha n 1 5 da ys fr o m t he date of t he f o urt h vacci nati o n 
wit h t his pr o d uct.  
1.  Partici pa nt s w h o are 6 m o nt hs t o 4 years ol d at t he ti me of t he f o urt h vacci nati o n wit h t his pr o d uct. 
2.  Partici pa nt s w h o are recei vi n g t he first b o oster i m m u nizati o n wit h t his pr o d uct (f o urt h vacci nati o n wit h t his 
pr o d uct) after t he i nitial i m m u nizati o n.  
3.  Partici pa nt s f or w h o m writte n c o nse nt was o btai ne d fr o m t heir le gall y acce pta ble re prese ntati ves ( pare nts or 
le gal g uar dia ns) re gar di n g t heir partici pati o n i n t he st u d y u p o n u n dersta n di n g t he e x pla nat or y d oc u me nt 
descri bi n g t he c o nte nt of t his st u d y, i ncl u di n g t hat t he y will be as ke d t o rec or d partici pa nt ’s s y m pt o ms i n 
t he healt h o bser vati o n diar y. 
W he n a partici pa nt  has t he ca pacit y t o pr o vi de asse nt, c o nse nt s h o ul d be o btai ne d fr o m t he pe diatric 
partici pa nt  hi m/ herself usi n g t he asse nt f or m.  
Refer t o t he latest pac ka ge i nsert of t his pr o d uct f or "i n dicati o ns" a n d " d osa ge a n d a d mi nistrati o n" w he n 
a d mi nisteri n g t his pr o d uct. 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 1  of 3 5  
 
[I n dicati o ns] 
Pre ve nti o n of i nfecti o n wit h S A R S -C o V -2  
[ D osa ge a n d a d mi nistrati o n] T he pr o d uct is dil ute d wit h 2. 2 m L of Ja pa nese P har mac o p oeia p h ysi ol o gical 
sali ne. F or i nitial i m m u nizati o n, partici pa nts are vacci nate d i ntra m usc ularl y at a 
d ose of 0. 2 m L 3 ti mes i n t otal. T he sec o n d d ose is us uall y gi ve n at a 3- wee k 
i nter val, a n d t he t hir d d ose is gi ve n after at least 8 wee ks ha ve passe d si nce t he 
sec o n d vacci nati o n. F or b o oster i m m u nizati o n, partici pa nt s are vacci nate d 
i ntra m usc ularl y at a d ose of 0. 2 m L. 
[ Preca uti o ns re gar di n g d osa ge a n d a d mi nistrati o n ( b o oster i m m u nizati o n)] 
Partici pa nt s:  
T h ose a ge d 6 m o nt hs t o 4 years wit h a hist or y of pre vi o us vacci nati o n wit h 
S A R S -C o V -2 vacci nes f or i nitial i m m u nizati o n or b o oster i m m u nizati o n. Base d 
o n t he state of S A R S- C o V - 2 pa n de mic a n d i n di vi d ual bac k gr o u n d fact ors, etc., 
t he necessit y of bo oster i m m u nizati o n s h o ul d be deter mi ne d i n c o nsi derati o n of 
be nefits a n d ris ks.  
Vacci nati o n i nter val:  
Ge nerall y, partici pa nt s ca n recei ve vacci nati o n after at least 3 m o nt hs ha ve 
passe d si nce t he pre vi o us S A R S -C o V -2 vacci nati o n.  
 
8. 2. 2.  E xcl usi o n criteri a  
T here are  n o e xcl usi o n criteria f or t his st u d y. 
8. 2. 3.  St u d y sites  
T his st u d y will be c o n d ucte d at a p pr o xi matel y 1 0 t o 2 0 i nstit uti o ns w hic h ha ve a gree d t o c o o perate wit h t his 
i n vesti gati o n, a n d w here a s yste m t o perf or m vacci nati o n wit h t his pr o d uct has bee n sec ure d. 
8. 2. 4.  Pl a n ne d st u d y peri o d  
T he pla n ne d peri o d c o vere d b y t his st u d y is as f oll o ws. 
•  
I n vesti gati o n peri o d: Fr o m t he date of t he f o urt h vacci nati o n of t he first partici pa nt  re gistere d t o t he e n d 
date of t he o bser vati o n peri o d f or t he last re gistere d partici pa nt  (sc he d ule d fr om Dece m ber 2 0 2 3 t o 2 8 A pril 
2 0 2 4) 
•  
Re gistrati o n peri o d: Fr o m t he date of t he f o urt h vacci nati o n of t he first partici pa nt  re gistere d t o t he date of 
re gistrati o n of t he last partici pa nt  re gistere d (sc he d ule d fr o m Dece m ber 2 0 2 3 t o 1 5 A pril 2 0 2 4) 
Partici pa nt s w h o recei ve vacci nati o n bef ore 3 1 Marc h 2 0 2 4, w hic h pres u ma bl y c orres p o n ds t o t he ti me w he n 
b o oster i m m u nizati o n starte d i n fall 2 0 2 3 will e n d, are re gistere d.  
E ve n if t he tar get sa m ple size of 6 0 is ac hie ve d bef ore 3 1 Marc h 2 0 2 4, re gistrati o n of partici pa nt s w h o ha ve 
bee n  a d mi nistere d a b o oster i m m u nizati o n b y 3 1 Marc h 2 0 2 4 will be c o nti n ue d u ntil 1 5 A pril 2 0 2 4 i n or der t o 
c ollect as ma n y partici pa nt s as p ossi ble. 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 2  of 3 5  
 
8. 2. 5.  St u d y pr oce d ures  
8. 2. 5. 1.  St u d y m et h o d  
Ce ntral re gistrati o n s yste m: T his st u d y will be c o n d ucte d wit h Ce ntral re gistrati o n s yste m t hat partici pa nt s w h o 
meet t he c o n diti o ns of t his st u d y will be re gistere d u ntil data are c ollecte d o n a t he tar get n u m ber of partici pa nt s. 
T he i n vesti gat or will re gister  partici pa nt s w h o meet t he re gistrati o n criteria ( 8. 2. 1) a n d are gi ve n t he f o urt h 
vacci nati o n wit h t his pr o d uct bef ore 3 1 Marc h 2 0 2 4 wit hi n n o m ore t ha n a p pr o xi matel y 1 5 da ys fr o m t he date 
of t he f o urt h vacci nati o n wit h t his pr o d uct. 
T his st u d y will be c o n d uct e d i n partici pa nt s w h o ha ve bee n vacci nate d wit h t his pr o d uct at c o ntract sites after 
mar keti n g a p pr o val. 
8. 2. 6.  O bser v ati o n peri o d  
T he o bser vati o n peri o d will be fr o m t he date of t he f o urt h vacci nati o n wit h t his pr o d uct ( Da y 1) t o 2 8 da ys after 
t he f o urt h vacci nati o n. 
H o we ver, f or t h ose w h o wit h dra w fr o m t he st u d y, i nf or mati o n u p t o t he ti me of wit h dra wal will be c ollecte d. 
 
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 3  of 3 5  
 
8. 3.  V ari a bles  
T his st u d y will be c o n d ucte d acc or di n g t o t he f oll o wi n g sc he d ule of acti vities. 
T a ble 1. V ari a bles 
Varia ble  
Re gistrati o n 
f or m 
C R F 
I D n u m b er 
 
* 
Ge n d er  
 
* 
Birt h y ear a n d m o nt h (a g e i n m o nt hs or y ears)  
 
* 
Eli gi bilit y  
 
 
Date of b o oster i m m u nizati o n (f o urt h 
v acci n ati o n) wit h t his pr o d u ct  
 
* 
Disease hist or y ( me dical hist or y/c o m plicati o ns)  
 
 
Aller g y i nf or mati o n  
 
 
Hist or y of S A R S -C o V -2 i nfecti o n  
 
 
I nf or mati o n o n i nitial C O VI D-1 9 v acci n e 
i m m u nizati o n (first t o t hir d) 
 
 
Hist or y of ot h er v acci n ati o ns  
( wit hi n 1 m o nt h pri or t o t h e f o urt h v acci n ati o n 
wit h t his dr u g)  
 
 
Stat us of b o oster i m m u nizati o n (f o urt h 
v acci n ati o n) wit h t his pr o d u ct  
 
 
React o g e nicit y e v e nts (l o cal reacti o ns a n d 
s yste mic reacti o ns) 
( Healt h o bser v ati o n diar y) 
 
 
I nf or mati o n o n i n o c ulati o n of ot her v acci n es 
( o n a n d after t h e f o urt h v acci n ati o n wit h t his 
pr o d u ct)  
 
 
I nf or mati o n o n C O VI D-1 9 p at h o g e n test 
( w h et h er t h e test was p erf or me d, test d ate (sa m ple 
c ollecti o n d ate), test t y p e, a n d test res ults)  
 
 
I nf or mati o n o n C O VI D-1 9 ( prese n ce or a bse n ce 
of C O VI D -1 9 o nset, d ate of dia g n osis, d etails of 
treat me nt, o utc o me) 
 
 
A d v erse e v e nts (i n cl u di n g seri o us a d v erse e v e nts)  
 
 
C o n c o mita nt me dicati o ns  
 
 
E n d -of -st u d y/ disc o nti n u ati o n rec or d (i n cl u di n g 
t h e reas o n if disc o nti n u e d) 
 
 
* S o me ele me nts i n t h e Re gistrati o n F or m are a ut o maticall y reflecte d i n t h e C R F. T h e i n v esti g at or s h o ul d c h ec k a n d u p d ate t he 
C R F as nee de d.  
 
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 4  of 3 5  
 
Fi g ure 1 . Sc he d ule 
 
 
 
 
C R F  
 
E ntr y i n h ealt h o bser v ati o n 
diar y  
 
 
 
C ollecti o n/ v erificati o n of 
h ealt h o bser v ati o n diar y  
 
 
 
 
8. 3. 1.  C h ar acteristics of v acci n ate d p artici p a nt s 
1.  E nter t he i nf or mati o n at t he ti me of t he f o urt h vacci nati o n wit h t his pr o d uct i n t he re gistrati o n f or m. 
•  
I D n u m ber 
•  
Ge n der  
•  
Birt h year a n d m o nt h (if m o nt h a n d year of birt h ca n n ot be pr o vi de d, a ge i n m o nt hs or years at t he ti me 
of t he f o urt h vacci nati o n wit h t his pr o d uct s hall be e ntere d) 
•  
Eli gi bilit y  
•  
Date of t he f o urt h vacci nati o n wit h t his pr o d uct 
2.  T he f oll o wi n g i nf or mati o n will be rec or de d i n t he C R F at t he ti me of t he f o urt h vacci nati o n wit h t his 
pr o d uct 
•  
Cli nical hist or y ( me dical hist or y/c o m plicati o ns *)  
*: Diseases prese nt at t he ti me of t he f o urt h vacci nati o n w it h t his pr o d uct, i ncl u di n g o besit y, are 
c o nsi dere d "c o m plicati o ns." 
•  
Aller g y i nf or mati o n ( prese nce or a bse nce of aller g y, t y pe of aller g y, a n d i nf or mati o n o n aller ge ns) 
•  
Hist or y of S A R S -C o V -2 i nfecti o n  
 
If S A R S-C o V - 2 i nfecti o n hist or y is " prese nt," prese nce or a bse nce of C O VI D - 1 9 o nset s h o ul d be 
rec or de d (" prese nt" s h o ul d be selecte d if t here are s y m pt o ms, a n d "a bse nt" if t here are n o 
s y m pt o ms) 
 
If C O VI D- 1 9 o nset is " prese nt," prese nce or a bse nce of acti o ns/ pr oce d ures ta ke n ( *a d mi nistrati o n 
of C O VI D -1 9 treat me nt dr u gs *, h os pitalizati o n, o x y ge n a d mi nistrati o n, I C U a d missi o n, use of 
mec ha nical ve ntilati o n, use of E C M O) s h o ul d be rec or de d   
*: Treat me nt dr u gs wit h a n i n dicati o n f or use i n S A R S- C o V -2 i nfecti o n  
•  
I nf or mati o n o n i nitial i m m u nizati o n wit h C O VI D - 1 9 vacci nes ( dates of a d mi nistrati o n of first t o t hir d 
vacci nati o n a n d na mes of vacci nes)  
F o urt h 
2 8 d a ys fr o m t h e f o urt h 
v acci n ati o n wit h t his pr o d u ct  
7 d a ys  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 5  of 3 5  
 
•  
Hist or y of ot her vacci nati o ns ( prese nce or a bse nce of vacci nes a n d na mes of vacci nes [ wit hi n 1 m o nt h 
pri or t o t he date of t he f o urt h vacci nati o n wit h t his pr o d u ct])  
8. 3. 2.  St at us of b o oster i m m u niz ati o n wit h t his pr o d uct  
T he f oll o wi n g i nf or mati o n will be rec or de d f or t he stat us of t he f o urt h vacci nati o n wit h t his pr o d uct. 
•  
Date of vacci nati o n (t he date of t he f o urt h vacci nati o n wit h t his pr o d uct o n t he Re gistrati o n F or m will 
be a ut o maticall y reflecte d i n t he C R F)  
•  
L ot n u m ber 
•  
vacci nati o n site  
•  
I n oc ulati o n d ose 
8. 3. 3.  C o nc o mit a nt m e dic ati o ns  
F or dr u gs use d c o nc o mita ntl y o n a n d after t he date of t he f o urt h vacci nati o n wit h t his pr o d uct a n d dr u gs use d 
f or treat me nt of a d verse e ve nts, i nf or mati o n t o t he e n d date of t he o bser vati o n peri o d will be e ntere d. 
•  
Dr u g na me ( pr o d uct na me) 
•  
Treat me nt peri o d (t he start date of treat me nt if n o c o nc o mita nt dr u gs are use d at t he ti me of t he f o urt h 
vacci nati o n wit h t his pr o d uct, or t he e n d date of treat me nt if n o c o nc o mita nt dr u gs are use d at t he e n d 
of t he o bser vati o n peri o d, s h o ul d be e ntere d.) 
8. 3. 4.  E n d - of-st u d y/ disc o nti n u ati o n rec or d 
T he i n vesti gat or will e nter t he e n d date of t he o bser vati o n peri o d ( date of fi nal o bser vati o n), i.e., t he date of 
c o nfir mati o n of i nf or mati o n o n t he partici pa nt  after 2 8 da ys of t he f o urt h vacci nati o n wit h t his pr o d uct ( or 
t hereafter). 
F or c o nfir mati o n of partici pa nt  i nf or mati o n, i n q uiries b y tele p h o ne, etc. are acce pta ble. 
If partici pa nt  i nf or mati o n ca n n ot be c o nfir me d e ve n after 1 m o nt h has passe d si nce t he e n d date of t he 
o bser vati o n peri o d usi n g t he a b o ve - descri be d met h o d, a n d t he date of fi nal c o nfir mati o n of partici pa nt  
i nf or mati o n d oes n ot fall wit hi n t he o bser vati o n peri o d, t he date of last c o nfir mati o n of partici pa nt  i nf or mati o n 
s h o ul d be e ntere d as t he date of disc o nti n uati o n of t he o bser vati o n peri o d ( date of fi nal o bser vati o n), al o n g wit h 
t he reas o n f or disc o nti n uati o n. 
1.  
Date of c o m pleti o n ( disc o nti n uati o n) of t he o bser vati o n peri o d ( date of fi nal o bser vati o n) 
2.  
E n d of st u d y or reas o n f or disc o nti n uati o n 
•  
E n d of st u d y 
•  
A d verse e ve nts 
•  
Deat h  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 6  of 3 5  
 
•  
L ost t o f oll o w - u p 
•  
C o nse nt wit h dra wal  
•  
Ot her  
8. 3. 5.  I nf or m ati o n o n i n oc ul ati o n of ot her v acci nes 
T he i n vesti gat or will c o nfir m t he prese nce or a bse nce of ot her vacci nes i n oc ulate d o n a n d after t he date of t he 
f o urt h vacci nati o n wit h t his pr o d uct d uri n g t he o bser vati o n peri o d a n d e nter t he i nf or mati o n. If partici pa nt s 
recei ve ot her vacci nati o ns d uri n g t he o bser vati o n peri o d, t he t y pe of vacci ne a n d t he date of vacci nati o n s h o ul d 
be e ntere d.  
8. 3. 6.  I nf or m ati o n o n C O VI D-1 9 p at h o ge n ( S A R S -C o V -2) test  
T he i n vesti gat or will c o nfir m t he prese nce or a bse nce of t he test f or C O VI D- 1 9 pat h o ge n ( S A R S -C o V -2) 
c o n d ucte d f or partici pa nt s d uri n g t he o bser vati o n peri o d a n d e nter t he i nf or mati o n. If a pat h o ge n test is 
perf or me d, f or eac h test perf or me d, t he test date (sa m ple c ollecti o n date), test t y pe, a n d test res ults s h o ul d be 
rec or de d i n t he C R F. 
8. 3. 7.  I nf or m ati o n o n C O VI D- 1 9 
T he i n vesti gat or will c o nfir m t he prese nce or a bse nce of t he o nset of C O VI D- 1 9 d uri n g t he o bser vati o n peri o d 
a n d e nter t he i nf or mati o n. 
•  
Prese nce or a b se nce of C O VI D- 1 9 o nset (“ prese nt” s h o ul d be selecte d if t here are s y m pt o ms, a n d 
“a bse nt” if t here are n o s y m pt o ms)  
If t he o nset of C O VI D- 1 9 is “ prese nt,” t he f oll o wi n g i nf or mati o n s h o ul d als o be e ntere d. 
•  
Date of dia g n osis of C O VI D- 1 9 
•  
Prese nce or a bse nce o f acti o ns/ pr oce d ures ta ke n (a d mi nistrati o n of C O VI D- 1 9 treat me nt dr u gs *, 
h os pitalizati o n, o x y ge n a d mi nistrati o n, I C U a d missi o n, use of mec ha nical ve ntilati o n, use of E C M O) 
*: Treat me nt dr u gs wit h a n i n dicati o n f or use i n S A R S- C o V -2 i nfecti o n  
•  
O utc o me (res ol ve d/rec o vere d, res ol ve d wit h se q uelae, deat h, n ot res ol ve d, a n d u n k n o w n) a n d date of 
o utc o me 
T he o utc o me s h o ul d be f oll o we d u p as m uc h as p ossi ble e ve n after t he e n d of t he o bser vati o n peri o d. 
8. 3. 8.  A d verse e ve nts  
Occ urre nce of a d verse e ve nts fr o m t he date of t h e f o urt h vacci nati o n wit h t his pr o d uct t o t he e n d date of t he 
o bser vati o n peri o d s h o ul d be c o nfir me d, a n d t he f oll o wi n g i nf or mati o n s h o ul d be e ntere d. Partici pa nt  c o n diti o n 
m ust be o bser ve d after vacci nati o n wit h t his pr o d uct f or a certai n peri o d of ti me, a n d if ac ute reacti o ns s uc h as 
s h oc k a n d a na p h yla xis are o bser ve d, a p pr o priate meas ures s h o ul d be ta ke n a n d t he details s h o ul d be rec or de d as 
a d verse e ve nts.  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 7  of 3 5  
 
T he i nf or mati o n i n t he healt h o bser vati o n diar y (see Secti o n 8. 3. 9) c ollecte d fr o m t he pare nts ( or le gal 
g uar dia ns) of partici pa nt s s h o ul d be re vie we d. If t here are a n y rec or ds ot her t ha n t he s y m pt o ms at t he 
vacci nati o n site a n d ge neral s y m pt o ms s pecifie d i n t he diar y (i ncl u di n g C O VI D- 1 9 i nf or mati o n), t he details 
s h o ul d be verifie d as nee de d, a n d s h o ul d be rec or de d as a d verse e ve nts. T he i n vesti gat or s h o ul d rec or d t he 
s y m pt o ms at t he vacci nati o n site (l ocal reacti o ns) a n d ge neral s y m pt o ms i ncl u di n g p yre xia (s ys te mic reacti o ns) 
s pecifie d i n t he healt h o bser vati o n diar y i n t he C R F as is, w hile a v oi di n g o verla p wit h a d verse e ve nts e val uate d 
b y p h ysicia ns. 
Als o, f urt her i n vesti gati o n s h o ul d be se paratel y c o n d ucte d, if dee me d necessar y b y Pfizer, f or partici pa nt s w h o 
e xperie nce d seri o us a d verse reacti o n, or a d verse reacti o ns n ot liste d i n t he pac ka ge i nsert.  
•  
Prese nce or a bse nce of a d verse e ve nt  
•  
Na me of a d verse e ve nt  
•  
Se verit y  
•  
Date of occ urre nce  
•  
Prese nce or a bse nce of treat me nt  
•  
Seri o us ness  
•  
O utc o me (i ncl u di n g  t he date of o utc o me) 
•  
Ca usal relati o ns hi p t o t his pr o d uct 
8. 3. 8. 1.  Se verit y assess m e nt ( a d verse e ve nts)  
T he i n vesti gat or will assess t he ma xi m u m se verit y of a d verse e ve nts a n d seri o us a d verse e ve nts re p orte d d uri n g 
t he o bser vati o n peri o d fr o m o nset of a d verse e ve nts t o c o nfir mati o n of o utc o me a n d classif y t he m i nt o o ne of 
t he f oll o wi n g cate g ories. Se verit y is defi ne d as f oll o ws. 
T a ble 2 . Defi niti o n of Se verit y 
Se verit y  
Defi niti o n  
Mil d  
N ot i nterferi n g wit h us ual acti vities of vacci nate d partici pa nt s 
M o derate  
I nterferi n g wit h us ual acti vities of vacci nate d partici pa nt s t o s o me 
e xte nt 
Se vere  
Mar ke dl y i nterferi n g wit h us ual acti vities of vacci nate d partici pa nt s 
Life -t hreate ni n g 
Life -t hreate ni n g, or necessitati n g ur ge nt i nter ve nti o n 
8. 3. 8. 2.  Criteri a f or seri o us ness  
T he i n vesti gat or will select a n d e nter t he a p plica ble seri o us ness of seri o us a d verse e ve nts re p orte d d uri n g t he 
o bser vati o n peri o d. Seri o us ness is defi ne d as f oll o ws. 
•  
Res ults i n deat h  
•  
Life -t hreate ni n g 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 8  of 3 5  
 
•  
Re q uires h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n 
•  
Res ults i n persiste nt or si g nifica nt disa bilit y/ malf u ncti o n  
•  
Ca use a c o n ge nital a n o mal y/ birt h defect  
•  
Ot her me dicall y i m p orta nt e ve nts  
8. 3. 9.  Re act o ge nicit y e ve nts (l oc al re acti o ns a n d s yste mic re acti o ns) ( he alt h o bser v ati o n di ar y)  
A healt h o bser vati o n diar y will be distri b ute d t o t he pare nts ( or le gal g uar dia ns) of partici pa nt s partici pati n g i n 
t his st u d y, a n d t he y will be re q ueste d t o rec or d i nf or mati o n o n react o ge nicit y e ve nts after vacci nati o n wit h t his 
pr o d uct. React o ge nicit y e ve nts are defi ne d as l ocal reacti o ns (s y m pt o ms at t he vacci nati o n site) a n d s yste mic 
reacti o ns ( ge neral s y m pt o ms i ncl u di n g p yre xia). 
If partici pa nt s are y o u n ger t ha n 2 years of a ge at t he ti me of t he f o urt h vacci nati o n wit h t his pr o d uct, t he pare nts 
( or le gal g uar dia ns) of partici pa nts will o bser ve t he partici pa n t f or l ocal reacti o ns (i njecti o n site te n der ness, 
re d ness, a n d i njecti o n site s welli n g) a n d s yste mic reacti o ns ( p yre xia, decrease d a p petite, s o m n ole nce, a n d 
irrita bilit y) i n partici pa nts f or 7 da ys after vacci nati o n wit h t his pr o d uct a n d rec or d t he m i n t he diar y (if 
s y m pt o ms persist f or 8 da ys a n d m ore, t he date of s y m pt o m res ol uti o n s h o ul d be rec or de d). 
If partici pa nt s are 2 years or ol der at t he ti me of t he f o urt h vacci nati o n wit h t his pr o d uct, t he pare nts ( or le gal 
g uar dia ns) of partici pa nt  will o bser ve partici pa nt s f or l ocal reacti o ns (i njecti o n site pai n, re d ness, a n d i njecti o n 
site s welli n g) a n d s yste mic reacti o ns ( p yre xia, v o miti n g, diarr h oea, hea dac he, malaise, c hills, m yal gia a n d 
art hralgia) f or 7 da ys after vacci nati o n wit h t his pr o d uct a n d rec or d t he m i n t he diar y (if s y m pt o ms persist f or 8 
da ys a n d m ore, t he date of s y m pt o m res ol uti o n s h o ul d be rec or de d). 
T he i n vesti gat or will c ollect t he healt h o bser vati o n diar y after t he e n d of t he o bser vati o n peri o d (c ollecti o n b y 
mail is als o acce pta ble).If t here are rec or ds ot her t ha n s y m pt o ms at t he vacci nati o n site a n d ge neral s y m pt o ms 
s pecifie d i n t he diar y (i ncl u di n g t he C O VI D- 1 9 i nf or mati o n), c hec k t he details of t he i nf or mati o n ( or c o nfir m b y 
tele p h o ne, etc.) as nee de d a n d rec or d t he m as a d verse e ve nts. T he i n vesti gat or s h o ul d rec or d t he s y m pt o ms at 
t he vacci nati o n site (l ocal reacti o ns) a n d ge neral s y m pt o ms i ncl u di n g p yre xia (s yste mic reacti o ns) s pecifie d i n 
t he healt h o bser vati o n diar y i n t he C R F as ite ms of t he healt h o bser vati o n diar y as is, w hile a v oi di n g o verla p 
wit h a d verse e ve nts e val uate d b y p h ysicia ns. 
8. 3. 9. 1.  Se verit y assess m e nt ( he alt h o bser v ati o n di ar y)  
T he se verit y use d b y t he pare nts ( or le gal g uar dia ns) of partici pa nt s w he n e val uati n g s y m pto ms at t he 
vacci nati o n site (l ocal reacti o ns) a n d ge neral s y m pt o ms i ncl u di n g p yre xia (s yste mic s y m pt o ms) will be rec or de d 
i n t he healt h o bser vati o n diar y b y usi n g t he f oll o wi n g i n dices. 
T he se verit y classificati o n will be set i n acc or da nce wit h t he “ F o o d a n d Dr u g A d mi nistrati o n G ui da nce f or 
i n d ustr y: t o xicit y gra di n g scale f or healt h y a d ult a n d a d olesce nt v ol u nteers e nr olle d i n pre ve nti ve vacci ne 
cli nical trials.” I n t he diar y, e x pressi o ns w hic h are eas y t o u n dersta n d a n d c orres p o n d wit h eac h gra de will be 
use d ( n ot i nterferi n g wit h acti vities = n o c ha n ge i n dail y life; i nterferi n g wit h acti vities = i nfl ue nce o n dail y life; 
i nterferi n g wit h dail y acti vities = ma ki n g dail y life diffic ult). 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 1 9  of 3 5  
 
T a ble 3 . Se verit y Cl assific ati o n of L oc al Re acti o ns  
 
P artici p a nt  
a ge  
Mil d  
Gr a de 1  
M o der ate  
Gr a de 2  
Se vere  
Gr a de 3  
I njecti o n site pai n 
2 years a n d 
ol der  
N ot i nterferi n g wit h 
acti vities  
I nterferi n g wit h 
acti vities  
I nterferi n g wit h 
dail y acti vities  
I njecti o n site 
te n der ness 
Y o u n ger t ha n 
2 years  
C o m plai n of pai n w he n 
t o uc he d li g htl y 
(e. g., w hi m per, fr o w n, 
resist, p ull t he ar m 
a wa y) 
C o m plai n of pai n 
w hile cr yi n g 
w he n t o uc he d 
li g htl y 
Ar m (le g) 
m o ve me nt is 
i m paire d 
Re d ness  
4 years a n d 
y o u n ger  
0. 5 – 2. 0 c m  
> 2. 0 – 7. 0 c m  
> 7. 0 c m  
I njecti o n site 
s welli n g 
4 years a n d 
y o u n ger  
0. 5 – 2. 0 c m  
> 2. 0 – 7. 0 c m  
> 7. 0 c m  
 
T a ble 4 . Se verit y Cl assific ati o n of S yste mic Re acti o ns ( 2 ye ars a n d ol der) 
 
Mil d  
Gr a de 1  
M o der ate  
Gr a de 2  
Se vere  
Gr a de 3  
V o miti n g  
1 or 2 ti mes wit hi n 
2 4 h o urs * 
3 ti mes or m ore wit hi n 
2 4 h o urs * 
I ntra ve n o us fl ui d 
re place me nt ( dri p 
i nf usi o n) * * 
Diarr h oea  
Wit hi n 2 4 h o urs *  
2 t o 3 e pis o des of faeces 
s oft 
Wit hi n 2 4 h o urs *  
4 t o 5 e pis o des of faeces 
s oft 
Wit hi n 2 4 h o urs *  
6 or m ore e pis o des of 
faeces s oft 
Hea dac he  
N ot i nterferi n g wit h 
acti vities  
Sli g htl y i nterferi n g wit h 
acti vities  
I nterferi n g wit h dail y 
acti vities  
Fati g ue * * */ Malaise  
N ot i nterferi n g wit h 
acti vities  
Sli g htl y i nterferi n g wit h 
acti vities  
I nterferi n g wit h dail y 
acti vities  
C hills  
N ot i nterferi n g wit h 
acti vities  
Sli g htl y i nterferi n g wit h 
acti vities  
I nterferi n g wit h dail y 
acti vities  
Ne w or w orse ne d 
m yal gia  
N ot i nterferi n g wit h 
acti vities  
Sli g htl y i nterferi n g wit h 
acti vities  
I nterferi n g wit h dail y 
acti vities  
Ne w or w orse ne d 
art hral gia 
N ot i nterferi n g wi t h 
acti vities  
Sli g htl y i nterferi n g wit h 
acti vities  
I nterferi n g wit h dail y 
acti vities  
* “ Wit hi n 2 4 h o urs” is e x presse d as “ 1 da y” i n t he diar y.  
* * “I ntra ve n o us fl ui d re place me nt ( dri p i nf usi o n)” is descri be d as “ dri p i nf usi o n” i n t he diar y. 
* * * “ Fati g ue” is descri be d as “ malaise” i n t he diar y.  
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 0  of 3 5  
 
T a ble 5. Se verit y Cl assific ati o n of S yste mic Re acti o ns ( y o u n ger t h a n 2 ye ars) 
 
Mil d  
Gr a de 1  
M o der ate  
Gr a de 2  
Se vere  
Gr a de 3  
Decrease d a p petite  
Decrease d i nterest i n f o o d  
Decrease d f o o d i nta ke  
Ref usal t o eat  
S o m n ole nce  
I ncrease d or pr ol o n ge d 
slee p ti me 
Sli g htl y i nterferi n g wit h 
dail y acti vities  
L oss of i nterest i n 
n or mal dail y acti vities  
Irrita bilit y 
Eas y t o pacif y  
Re q uire m ore care  
U na ble t o pacif y, ca n’t 
st o p cr yi n g 
 
8. 3. 9. 2.  E v al u ati o n of p yre xi a ( he alt h o bser v ati o n di ar y) 
T he pare nts/ g uar dia ns of partici pa nt s will meas ure b o d y te m perat ure at h o me a n d rec or d eac h da y i n t he healt h 
o bser vati o n diar y t he hi g hest b o d y te m perat ure t o o ne deci mal place as i nf or mati o n o n p yre xia. At t he ti me of 
a nal ysis, p yre xia will be classifie d acc or di n g t o t he criteria s h o w n i n Ta ble 6. 
T a ble 6. Se verit y Cl assific ati o n of P yre xi a 
 
Mil d  
Gr a de 1  
M o der ate  
Gr a de 2  
Se vere  
Gr a de 3  
M ost se vere  
Gr a de 4  
P yre xia  
≥3 8. 0 – 3 8. 4 ° C  
> 3 8. 4 – 3 8. 9 ° C  
> 3 8. 9 – 4 0. 0 ° C  
> 4 0 ° C  
 
 
8. 4.  D at a s o urces  
I n t his st u d y, t he i n vesti gat or will e xtract necessar y i nf or mati o n base d o n t he f ull pr ot oc ol fr o m t he i nf or mati o n 
o btai ne d fr o m t he preli mi nar y e xa mi nati o n s heet a n d t he healt h o bser vati o n diar y c o m plete d b y t he pare nts ( or 
le gal g uar dia ns) of partici pa nt s partici pati n g i n t his st u d y, as well as me dical i nter vie ws, etc., a n d rec or ds 
i ncl u di n g me dical rec or ds. 
E val uati o n of l ocal reacti o ns a n d s yste mic reacti o ns after vacci nati o n rec or de d b y t he pare nts ( or le gal 
g uar dia ns) of partici pa nt s partici pati n g i n t his st u d y i n t he healt h o bser vati o n diar y, will be use d. 
8. 5.  St u d y size  
8. 5. 1.  Pl a n ne d s a m ple size  
6 0 partici pa nts will be c ollecte d as t he partici pa nt s t o be i ncl u de d i n t he safet y a nal ysis set. 
8. 5. 2.  R ati o n ale f or s a m ple size  
T he tar get sa m ple size (safet y a nal ysis set) was set t o be 6 0 partici pa nt s base d o n feasi bilit y. If 6 0 partici pa nt s 
ca n be c ollecte d, a n a d verse e ve nt t hat occ urs wit h a tr ue i nci de nce of 3 % ca n be o bser ve d i n at least o ne 
partici pa nt  wit h a pr o ba bilit y of 8 3 %, w hic h w o ul d ma ke it p ossi ble t o u n dersta n d tre n ds i n i nci de nce of 
react o ge nicit y e ve nts. 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 1  of 3 5  
 
Partici pa nt s w h o recei ve vacci nati o n bef ore 3 1 Marc h 2 0 2 4, w hic h pres u ma bl y c orres p o n ds t o t he ti me w he n 
b o oster i m m u nizati o n starte d i n fall 2 0 2 3 will e n d, are re gistere d.  
E ve n if t he tar get sa m ple size of 6 0 is ac hie ve d bef ore 3 1 Marc h 2 0 2 4, re gistrati o n of partici pa nt s w h o ha ve 
bee n a d mi nistere d a b o oster i m m u nizati o n b y 3 1 Marc h 2 0 2 4 will be c o nti n ue d u ntil 1 5 A pril 2 0 2 4 i n or der t o 
c ollect as ma n y partici pa nt s as p ossi ble.  
8. 6.  D at a m a n a ge m e nt  
8. 6. 1.  C ase re p ort f or ms ( C R Fs)/ Electr o nic d at a rec or d  
As use d i n t his f ull pr ot oc ol, t he ter m C R F s h o ul d be u n derst o o d t o refer t o a n electr o nic d at a rec or d  
de pe n di n g o n t he data c ollecti o n met h o d use d i n t his st u d y. 
A C R F is re q uire d a n d s h o ul d be c o m plete d f or eac h i ncl u de d partici pa nt . T he c o m plete d ori gi nal C R Fs are t he 
s ole pr o pert y of Pfizer a n d s h o ul d n ot be ma de a vaila ble i n a n y f or m t o t hir d parties, e xce pt f or a ut h orize d 
re prese ntati ves of Pfizer or a p pr o priate re g ulat or y a ut h orities, wit h o ut writte n per missi o n fr o m Pfizer. T he 
i n vesti gat or s hall e ns ure t hat t he C R Fs are sec urel y st ore d at t he st u d y sites i n e ncr y pte d electr o nic 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 pre ve nt access b y u na ut h orize d t hir d parties.  
T he i n vesti gat or has ulti mate res p o nsi bilit y f or t he c ollecti o n a n d re p orti n g of all cli nical, safet y, a n d la b orat or y 
data e ntere d o n t he C R Fs a n d a n y ot her data c ollecti o n f or ms (s o urce d oc u me nts) a n d e ns uri n g t hat t he y are 
acc urate, a ut he ntic/ ori gi nal, attri b uta ble, c o m plete, c o nsiste nt, le gi ble, ti mel y (c o nte m p ora ne o us), e n d uri n g, a n d 
a vaila ble w he n re q uire d.  T he C R Fs m ust be si g ne d b y t he i n vesti gat or or b y a n a ut h orize d staff me m ber t o 
attest t hat t he data c o ntai ne d o n t he C R Fs are tr ue. A n y c orrecti o ns t o e ntries ma de i n t he C R Fs or s o urce 
d oc u me nts m ust be date d, i nitiale d or sta m pe d wit h c orrecti o n seal, a n d e x plai ne d (if necessar y) a n d s h o ul d n ot 
o bsc ure t he ori gi nal e ntr y. 
I n m ost cases, t he s o urce d oc u me nts are t he h os pital or p h ysicia ns’ c hart. I n t hese cases, data c ollecte d o n t he 
C R Fs m ust matc h t h ose c harts.  
I n s o me cases, t he C R F ma y als o ser ve as t he s o urce d oc u me nt. I n t hese cases, a d oc u me nt s h o ul d be a vaila ble 
at t he i n vesti gat or site a n d at Pfizer t hat clearl y i de ntifies t h ose data t hat will be rec or de d o n t he C R F, a n d f or 
w hic h t he C R F will sta n d as t he s o urce d oc u me nt. 
8. 6. 2.  Rec or d rete nti o n  
T he r ec or ds relate d t o t his st u d y s h o ul d be retai ne d at t he st u d y site u ntil t he E n d of St u d y Letter b y Pfizer is 
recei ve d or d uri n g t he peri o d defi ne d b y t he st u d y site, w hic he ver is l o n ger. 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 2  of 3 5  
 
8. 6. 3.  D at a c ollecti o n m et h o d  
8. 6. 3. 1.  C ase re p ort f or m ( E D C)  
T he data f or t his st u d y will be c ollecte d a n d c o nfir me d b y usi n g t he electr o nic s yste m o n t he i nter net desi g ne d 
f or c ollecti n g p ost- mar keti n g s ur ve y data (Electr o nic Data Ca pt ure , ED C).  
8. 6. 3. 2.  He alt h o bser v ati o n di ar y 
T he pare nts ( or le gal g uar dia ns) of partici pa nts partici pati n g i n t his st u d y will be as ke d t o fill o ut t he healt h 
o bser vati o n diar y f or 7 da ys after t he f o urt h vacci nati o n wit h t his pr o d uct (if s y m pt o ms persist f or 8 da ys or 
m ore, t he date of disa p peara nce of t he s y m pt o ms s h o ul d be rec or de d). T he i n vesti gat or will c ollect t he healt h 
o bser vati o n diar y at 2 8 da ys after t he f o urt h vacci nati o n wit h t his pr o d uct fr o m t he pare nts ( or le gal g uar dia ns) 
of t he st u d y partici pa nt s a n d re vie w its c o nte nts, a n d t he n e nter i n t he E D C t he s y m pt o ms at t he vacci nati o n site 
(l ocal reacti o ns) a n d ge neral s y m pt o ms i ncl u di n g p yre xia (s yste mic reacti o ns) rec or de d o n t he healt h 
o bser vati o n diar y. 
8. 6. 4.  P artici p a nt  re gistr ati o n ( E D C)  
T he i n vesti gat or will e nter i nf or mati o n o n t he vacci nees t o be st u die d o n t he re gistrati o n scree n of E D C 
(re gistrati o n f or m) a n d sa ve t he data. Partici pa nt  re gistrati o n will be perf or me d wit hi n n o m ore t ha n 
a p pr o xi matel y 1 5 da ys after t he f o urt h vacci nati o n wit h t his pr o d uct. 
8. 6. 5.  P oi nts t o c o nsi der f or c o m pleti o n, re visi o n, a n d s u b missi o n of c ase re p ort f or m ( E D C) 
8. 6. 5. 1.  D at a e ntr y  
T he i n vesti gat or s h o ul d c hec k t he s ur ve y ite ms a n d e nter t he data i nt o E D C base d o n t he preli mi nar y 
e xa mi nati o n s heet c o m plete d b y t he partici pa nt s, rec or ds i ncl u di n g me dical rec or ds, or i nf or mati o n i n t he healt h 
o bser vati o n diar y. 
8. 6. 5. 2.  D at a re visi o n 
U p o n recei vi n g q uer y fr o m Pfizer o n t he c o nte nts of t he C R F (f oll o w- u p s ur ve y), t he i n vesti gat or will a gai n 
c hec k t he c o nte nts of preli mi nar y e xa mi nati o n s heet, rec or ds s uc h as me dical rec or ds, or i nf or mati o n i n t he 
healt h o bser vati o n diar y, a n d as re q uire d, c orrect t he rele va nt secti o ns a n d sa ve t he data. 
8. 6. 5. 3.  S u b missi o n  
After data e ntr y a n d re visi o n are c o m plete d, C R Fs s h o ul d be si g ne d electricall y b y t he i n vesti gat or f oll o wi n g 
c o nfir mati o n of e ntr y i n t he C R Fs or f oll o w- u p s ur ve y, a n d i nf or mati o n e ntere d i n E D C b y Pfizer. 
8. 7.  D at a a n al ysis  
Detaile d met h o d ol o g y f or s u m mar y a n d statistical a nal yses of data c ollecte d i n t his st u d y will be d oc u me nte d i n 
a Statistical A nal ysis Pla n ( S A P), w hic h will be date d, file d, a n d mai ntai ne d  b y Pfizer. T he S A P ma y m o dif y t he 
pla ns o utli ne d i n t he f ull pr ot oc ol, a n d a n y maj or m o dificati o ns of pri mar y e n d p oi nt defi niti o ns or t heir a nal yses 
will als o be reflecte d i n a pr ot oc ol a me n d me nt. 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 3  of 3 5  
 
8. 7. 1.  Defi niti o n of a n al ysis set  
T he safet y a nal ysis set ( S A S) c o nsists of a f ull a nal ysis set ( F A S) t hat is as cl oser as p ossi ble t o all pa rtici pa nt 
w h o recei ve d t he f o urt h vacci nati o n wit h t his pr o d uct. 
8. 7. 2.  S afet y a n al ysis 
T he e ve nts e ntere d i n t he C R F s u b mitte d b y t he i n vesti gat or f or w hic h t he ca usal relati o ns hi p wit h t his pr o d uct 
ca n n ot be r ule d o ut will be ha n dle d as a d verse reacti o ns, a n d t he n u m ber a n d pr o p orti o n of partici pa nt s wit h 
a d verse reacti o ns ([ %]: n u m ber of partici pa nt s wit h a d verse reacti o ns/ n u m ber of partici pa nt s i ncl u de d i n safet y 
a nal ysis) will be ta b ulate d. E x pl orat or y a nal yses will be perf or me d as nee de d.  
8. 7. 3.  A n al ysis of re act o ge nicit y e ve nts (l oc al re acti o ns a n d s yste mic re acti o ns [ he alt h o bser v ati o n di ar y]) 
L ocal reacti o ns a n d s yste mic reacti o ns rec or de d i n t he healt h o bser vati o n diar y c ollecte d b y t he i n vesti ga t or 
fr o m st u d y partici pa nts will be ha n dle d as react o ge nicit y e ve nts, a n d t he n u m ber a n d pr o p orti o n of partici pa nt s 
wit h eac h e ve nt will be ta b ulate d. E x pl orat or y a nal yses will be perf or me d as nee de d. 
8. 7. 4.  A n al ysis of I nf or m ati o n o n C O VI D- 1 9 
B y usi n g t he i nf or mati o n o n C O VI D - 1 9 e ntere d i n t he C R F s u b mitte d b y t he i n vesti gat or, partici pa nt s w h o are 
c o nsi dere d t o be i n a se vere c o n diti o n will be i de ntifie d, a n d t he n u m ber a n d pr o p orti o n of t he partici pa nt s will 
be ta b ulate d wit h refere nce t o t he se verit y classificati o n i n t he  " G ui da nce f or Treat me nt of N o vel C or o na vir us 
I nfecti o n ( C O VI D- 1 9)." E x pl orat or y a nal yses will be perf or me d as nee de d. 
8. 8.  Q u alit y c o ntr ol 
Pri or t o c o n d ucti n g t he st u d y, t he site staff will e x plai n t o t he i n vesti gat or a b o ut t he c o nte nts of t he f ull pr ot oc ol, 
etc. a n d as k t he i n vesti gat or t o c o m plete a case re p ort f or m base d o n me dical i nter vie ws base d o n t he 
preli mi nar y e xa mi nati o n s heet a n d t he healt h o bser vati o n diar y, a n d rec or ds s uc h as me dical rec or ds. 
8. 9.  Li mit ati o ns of t he rese arc h m et h o ds  
T here m a y be p ote ntial li mitati o ns i n t his st u d y:  
1.  Si nce n o c o ntr ol gr o u p is i ncl u de d i n t he st u d y, t here is a li mitati o n i n deter mi ni n g w het her or n ot t he ris k 
of de vel o pi n g a d verse e ve nts a n d a d verse reacti o ns i ncreases wit h a d mi nistrati o n of t his pr o d uct. 
2.  D ue c o nsi derati o n ma y n ot be gi ve n t o c o nf o u n di n g fact ors d ue t o i ns ufficie nt bac k gr o u n d i nf or mati o n 
c ollecte d. 
3.  Si nce t his st u d y c ollects i nf or mati o n fr o m me dical i nter vie ws base d o n t he preli mi nar y e xa mi nati o n s heet 
a n d t he healt h o bser vati o n dia r y a n d rec or ds s uc h as me dical rec or ds, s pecifie d data ma y n ot be c ollecte d or 
ma y be missi n g.  
8. 1 0.  Ot her as pects  
N ot a p plica ble.  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 4  of 3 5  
 
9.  P R O T E C TI O N O F H U M A N P A R TI CI P A N T S 
9. 1.  P artici p a nt  i nf or m ati 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 p le 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 pers o nal data. S uc h meas ures will i ncl u de o mitti n g t he na mes of 
vacci nees t o be st u die d or ot her directl y i de ntifia ble data i n a n y re p orts, p u blicati o ns, or ot her discl os ures, e xce pt 
w here re q uire d b y a p plica ble la ws. T he pers o nal data will be st ore d at t he st u d y site i n [e ncr y pte d electr o nic 
a n d/ or pa per] f or m a n d will be [ pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m] t o e ns ure t hat o nl y a ut h orize d 
st u d y staff ha ve access. T he stu d y site will i m ple me nt a p pr o priate tec h nical a n d or ga nizati o nal meas ures t o 
e ns ure t hat t he pers o nal data ca n be rec o vere d i n t he e ve nt of disaster. I n t he e ve nt of a p ote ntial pers o nal data 
breac h, t he st u d y site s hall 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.  
T o pr otect t he ri g hts a n d free d o ms of nat ural pers o ns wit h re gar d t o t he pr ocessi n g of pers o nal data, w he n st u d y 
data are c o m pile d f or tra nsfer t o Pfizer a n d ot her a ut h orize d parties, partici pa nt  na mes will be re m o ve d a n d will 
be re place d b y a si n gle, s pecific, n u merical c o de, base d o n a n u m beri n g s yste m defi ne d b y Pfizer. All ot her 
i de ntifia ble data tra nsferre d t o Pfizer or ot her a ut h orize d parties will be i de ntifie d b y t his si n gle, partici pa nt-
s pecific c o de. T he i n vesti gat or site will mai ntai n a c o nfi de ntial list of partici 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 his or her act ual i de ntit y. I n case of data tra nsfer, Pfizer will 
mai ntai n hi g h sta n dar ds of c o nfi de ntialit y a n d pr otecti o n of partici pa nt s’ pers o nal data c o nsiste nt wit h t he 
cli nical st u d y a gree me nt a n d a p plica ble pri vac y la ws.  
9. 2.  P artici p a nt  c o nse nt 
T he i nf or me d c o nse nt /asse nt d oc u me nts m ust be i n c o m plia nce wit h l ocal re g ulat or y re q uire me nts a n d le gal 
re q uire me nts, i ncl u di n g a p plica ble pri vac y la ws. 
T he i nf or me d c o nse nt/asse nt d oc u me nts use d d uri n g t he i nf or me d c o nse nt pr ocess m ust be re vie we d a n d 
a p pr o ve d b y Pfizer, a p pr o ve d b y t he i nstit uti o nal re vie w b oar d (I R B)/et hics c o m mittee ( E C) bef ore use, a n d 
a vaila ble f or i n s pecti o n b y re g ulat or y a ut h orities. 
T he i n vesti gat or m ust e ns ure t hat eac h st u d y partici pa nt , or his or her le gall y acce pta ble re prese ntati ve, or 
pare nt(s) or le gal g uar dia n if a mi n or, is f ull y i nf or me d a b o ut t he nat ure a n d o bjecti ves of t he st u d y, t he s hari n g 
of data relati n g 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 i n vesti gat or f urt her m ust e ns ure t hat eac h st u d y partici pa nt , 
or his or her le gall y acce pta ble re prese ntati ve, or pare nt(s) or le gal g uar dia n if a mi n or, is f ull y i nf or me d a b o ut 
his or her ri g ht t o access a n d c orrect his or her 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 his or 
her pers o nal data.  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 5  of 3 5  
 
W he ne ver c o nse nt is o btai ne d fr o m a partici pa nt ’s le gall y acce pta ble re prese ntati ve/ pare nt(s) or le gal g uar dia n, 
t he partici pa nt’s asse nt (affir mati ve a gree me nt) m ust s u bse q ue ntl y be 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 det er mi nes t hat a partici pa nt ’s 
decisi o nal ca pacit y is s o li mite d t hat he or s he ca n n ot reas o na bl y be c o ns ulte d, t he n, as per mitte d b y t he I R B/ 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 s o 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 partici pa nt  d oes n ot pr o vi de his or her o w n c o nse 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 c o nse nt (e. g., mi n or, decisi o nall y 
i m paire d a d ult), 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 le gall y 
acce pta ble re prese ntati ve, t he c o nse nt si g ner's relati o ns hi p t o t he partici pa nt  (e. g., pare nt, s p o use), 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 ball y, it m ust be d oc ume nte d i n t he s o urce 
d oc u me nts. 
If a mi n or re gistere d i n t he st u d y reac hes a d ult h o o d d uri n g t he st u d y, t he c o nse nt will be reac q uire d fr o m t he 
partici pa nt  at t he ti me of a d ult h o o d acc or di n g t o l ocal la w t o re mai n i n t he st u d y. 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 st u d y a ge criteria, t he I R B/ E C, a n d l ocal la w, t he y 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 pare nt or le gal g uar dia n. 
T he i n vesti gat or, or a pers o n desi g nate d b y t he i n vesti gat or, will o btai n writte n i nf or me d c o nse nt fr o m eac h 
partici pa nt  or t he partici pa nt ’s le gall y acce pta ble re prese ntati ve, pare nt(s), or le gal g uar dia n a n d t he partici pa nt ’s 
asse nt, w he n a p plica ble, bef ore a n y st u d y‐s pecific acti vit y is perf or me d. T he i n vesti gat or will retai n the ori gi nal 
of eac h partici pa nt ’s si g ne d c o nse nt/asse nt d oc u me nt. 
9. 3.  P artici p a nt  wit h dr a w al 
 St u d y partici pa nts ma y wit h dra w fr o m t he st u d y at a n y ti me at t heir o w n re q uest, or t he y ma y be wit h dra w n at 
a n y ti me at t he discreti o n of t he i n vesti gat or or Pfizer f or safe t y, be ha vi oral, or a d mi nistrati ve reas o ns. I n a n y 
circ u msta nce, e ver y eff ort s h o ul d be ma de t o d oc u me nt t he o utc o me of st u d y partici pa nts, if a p plica ble. T he 
i n vesti gat or w o ul d i n q uire a b o ut t he reas o n f or wit h dra wal a n d f oll o w-u p wit h t he partici pa nt  re gar di ng a n y 
u nres ol ve d a d verse e ve nts. 
If t he st u d y partici pa nt wit h dra ws fr o m t he st u d y, a n d als o wit h dra ws c o nse nt f or discl os ure of f ut ure 
i nf or mati o n, n o f urt her e val uati o ns s h o ul d be perf or me d, a n d n o a d diti o nal data s h o ul d be c ollecte d. Pfizer ma y 
retai n an d c o nti n ue t o use a n y data c ollecte d bef ore s uc h wit h dra wal of c o nse nt. 
9. 4.  I nstit uti o n al re vie w b o ar d (I R B)/ Et hics c o m mittee ( E C) 
T he i nf or me d c o nse nt d oc u me nts use d d uri n g t he i nf or me d c o nse nt pr ocess m ust be re vie we d a n d a p pr o ve d b y 
Pfizer, a p pr o ve d b y t he i nstit uti o nal re vie w b oar d (I R B)/et hics c o m mittee ( E C) bef ore use.  
9. 5.  Et hic al c o n d uct of t he st u d y  
T his st u d y will be c o n d ucte d i n c o m plia nce wit h M H L W Or di na nce i n t he “secti o n 6. R A TI O N A L E A N D 
B A C K G R O U N D”. Als o, t he st u d y will be c o n d ucte d i n acc or da nce wit h le gal a n d re g ulat or y re q uire me nts, as 
well as scie ntific p ur p ose, val ue, a n d ri g or. 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 6  of 3 5  
 
1 0.  M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E R E A C TI O N S  
1 0. 1.  Rec or ds a n d re p ort re q uire m e nts  
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 safet y e ve nts o n t he C R F a n d f or re p orti n g safet y 
e ve nts o n t he n o n-i nter ve nti o nal st u d y ( NI S) a d verse e ve nt m o nit ori n g ( A E M) Re p ort F or m t o Pfizer Safet y. 
T hese re q uire me nts are deli neate d f or t hree t y pes of e ve nts: ( 1) seri o us a d verse e ve nts ( S A Es); ( 2) n o n -seri o us 
A Es (as a p plica ble); a n d ( 3) sce nari os i n v ol vi n g dr u g e x p os ure, i ncl u di n g e x p os ure d uri n g pre g na nc y, e x p os ure 
d uri n g breastfee di n g, me dicati o n err or, o ver d ose, mis use, e xtra vasati o n, lac k of efficac y, a n d occ u pati o nal 
e x p os ure. T hese e ve nts are defi ne d i n t he secti o n “ Defi niti o ns of safet y e ve nts.” 
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 NI S A E M Re p ort 
F or m t o Pfizer S afet y wit hi n 
2 4 h o urs of a w are ness  
S A E  
All  
All  
N o n -seri o us A E 
All  
N o ne  
Sce nari os i n v ol vi n g e x p os ure 
t o a dr u g u n der st u d y, 
i ncl u di n g e x p os ure d uri n g 
pre g na nc y, e x p os ure d uri n g 
breastfee di n g, me dicati o n 
err or, o ver d ose, mis use, 
e xtra vasati o n, lac k of efficac y, 
a n d occ u pati o nal e x p os ure 
All (re gar dless of w het her 
ass ociate d wit h a n A E),  
e xce pt occ u p ati o n al 
e x p os ure 
All (re gar dless of w het her ass ociate d 
wit h a n A E)  
N ote: A n y ass ociate d A E is re p orte d 
t o get her wit h t he e x p os ure sce nari o. 
 
F or eac h A E, t he i n vesti gat or m ust p urs ue a n d o btai n i nf or mati o n a de q uate b ot h t o deter mi ne t he o utc o me of t he 
A E a n d t o assess w het her it meets t he criteria f or classificati o n as a S A E (refer t o secti o n “ Seri o us A d verse 
E ve nts” bel o w).  
Safet y e ve nts liste d i n t he ta ble a b o ve m ust be re p orte d t o Pfizer wit hi n 2 4 h o urs of a ware ness of t he e ve nt b y 
t he i n vesti gat or re g ar dless of w het her t he e ve nt is deter mi ne d b y t he i n vesti g at or t o be rel ate d t o  t his 
pr o d uct . In partic ular, if t he S A E is fatal or life -t hreate ni n g, n otificati o n t o Pfizer m ust be ma de i m me diatel y, 
irres pecti ve of t he e xte nt of a vaila ble e ve nt i nf or mati o n. T his ti mefra me als o a p plies t o a d diti o nal ne w (f oll o w-
u p) i nf or mati o n o n pre vi o usl y f or war de d safet y e ve nt re p orts. I n t h e rare sit uati o n t hat t he i n vesti gat or d oes n ot 
bec o me i m me diatel y a ware of t he occ urre nce of a safet y e ve nt, t he i n vesti gat or m ust re p ort t he e ve nt wit hi n 2 4 
h o urs after lear ni n g of it a n d d oc u me nt t he ti me of his/ her first a ware ness of t he e ve nts. 
F or sa fet y e ve nts t hat are c o nsi dere d seri o us or t hat are i de ntifie d i n t he far-ri g ht c ol u m n of t he ta ble a b o ve t hat 
are re p orta ble t o Pfizer wit hi n 2 4 h o urs of a ware ness, t he i n vesti gat or is o bli gate d t o p urs ue a n d t o pr o vi de a n y 
a d diti o nal i nf or mati o n t o Pfize r i n acc or da nce wit h t his 2 4- h o ur ti mefra me. I n a d diti o n, a n i n vesti gat or ma y be 
re q ueste d b y Pfizer 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. T his i nf or mati o n is m ore 
detaile d t ha n t hat rec or de d o n t he C R F. I n ge neral, t his will i n cl u de a descri pti o n of t he A E i n s ufficie nt detail t o 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 7  of 3 5  
 
all o w f or a c o m plete me dical assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of p ossi ble ca usalit y. A n y 
i nf or mati o n rele va nt t o t he e ve nt, s uc h as c o nc o mita nt me dicati o ns a n d ill nesses, m ust be pr o vi de d. I n t he case 
of a partici pa nt  deat h, a s u m mar y of a vaila ble a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o Pfizer 
or its desi g nate d re prese ntati ve.  
1 0. 2.  Re p orti n g peri o d  
F or eac h partici pa nt , t he safet y e ve nt re p orti n g peri o d be gi ns at t he ti me of t he partici pa nt ’s first d ose of t his 
pr o d uct or t he ti me of t he partici pa nt ’s i nf or me d c o nse nt if he or s he is recei vi n g t his pr o d uct at st u d y start, a n d 
lasts t hr o u g h t he e n d of t he o bser vati o n peri o d of t he st u d y, w hic h m ust i ncl u de at least 2 8 cale n dar da ys 
f oll o win g t he last a d mi nistrati o n of t he pr o d uct u n der st u d y; a re p ort m ust be s u b mitte d t o Pfizer Safet y ( or its 
desi g nate d re prese ntati ve) f or a n y of t he t y pes of safet y e ve nts liste d i n t he ta ble a b o ve occ urri n g d uri n g t his 
peri o d. If a partici pa nt  was a d mi nistere d t he pr o d uct u n der st u d y o n t he last da y of t he o bser vati o n peri o d, t he n 
t he re p orti n g peri o d s h o ul d be e xte n de d f or 2 8 cale n dar da ys f oll o wi n g t he e n d of o bser vati o n. M ost ofte n, t he 
date of i nf or me d c o nse nt is t he sa me as t he date of e nr oll me nt. I n s o me sit uati o ns, t here ma y be a la g bet wee n 
t he dates of i nf or me d c o nse nt a n d e nr oll me nt. I n t hese i nsta nces, if a partici pa nt  pr o vi des i nf or me d c o nse nt b ut 
is ne ver e nr olle d i n t he st u d y (e. g., partici pa nt  c ha n ges his/ her mi n d a b o ut partici pati o n), t he re p orti n g peri o d 
e n ds o n t he date of t he decisi o n t o n ot e nr oll t he partici pa nt . 
If t he i n vesti gat or bec o mes a ware of a S A E occ urri n g at a n y ti me after c o m pleti o n of t he st u d y a n d he or s he 
c o nsi ders t he S A E t o be relate d t o t his pr o d uct, t he S A E als o m ust be re p orte d t o Pf izer Safet y. 
1 0. 3.  C a us alit y assess me nt  
T h e i n vesti gat or is re q uire d t o assess a n d rec or d t he ca usal relati o ns hi p. F or all A Es, s ufficie nt i nf or mati o n 
s h o ul d be o btai ne d b y t he i n vesti gat or t o deter mi ne t he ca usalit y of eac h A E. F or A Es wit h a ca usal relati o ns hi p 
t o t his pr o d uct, f oll o w-u p b y t he i n vesti gat or is re q uire d u ntil t he e ve nt a n d/ or its se q uelae res ol ve or sta bilize at 
a le vel acce pta ble t o t he i n vesti gat or, a n d Pfizer c o nc urs wit h t hat assess me nt.  
A n i n vesti gat or’s ca usalit y assess me nt is t he deter mi nati o n of w het her t here e xists a reas o na ble p ossi bilit y t hat 
t his pr o d uct ca use d or c o ntri b ute d t o a n A E. If t he i n vesti gat or’s fi nal deter mi nati o n of ca usalit y is “ u n k n o w n” 
a n d he or s he ca n n ot deter mi ne w het her t his pr o d uct ca use d t he e ve nt, t he safet y e ve nt m ust be re p orte d wit hi n 
2 4 h o urs. 
If t he i n vesti gat or ca n n ot deter mi ne t he eti ol o g y of t he e ve nt b ut he or s he deter mi nes t hat t his pr o d uct di d n ot 
ca use t he e ve nt, t his s h o ul d be clearl y d oc u me nte d o n  t he C R F a n d t he NI S A E M Re p ort F or m. 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 8  of 3 5  
 
1 0. 4.  Defi niti o ns of s afet y e ve nts  
1 0. 4. 1.  A d verse e ve nts  
A n A E is a n y u nt o war d me dical occ urre nce i n a partici pa nt  a d mi nistere d a me dici nal pr o d uct. T he e ve nt nee d 
n ot necessaril y ha ve a ca usal relati o ns hi p wit h t he pr o d uct treat me n t or usa ge. E xa m ples of A Es i ncl u de b ut are 
n ot li mite d t o:  
•  
A b n or mal test fi n di n gs (see bel o w f or circ u msta nces i n w hic h a n a b n or mal test fi n di n g c o nstit utes a n A E); 
•  
Cli nicall y si g nifica nt si g ns a n d s y m pt o ms;  
•  
C ha n ges i n p h ysical e xa mi nati o n fi n di n gs; 
•  
H y per se nsiti vit y; 
•  
Pr o gressi o n/ w orse ni n g of u n derl yi n g disease; 
•  
Lac k of efficac y;  
•  
Dr u g a b use; 
•  
Dr u g de pe n de nc y.  
A d diti o nall y, f or me dici nal pr o d ucts, t he y ma y i ncl u de t he si g ns or s y m pt o ms res ulti n g fr o m: 
•  
Dr u g o ver d ose;  
•  
Dr u g wit h dra wal;  
•  
Dr u g mis use;  
•  
Off -la bel use;  
•  
Dr u g i nteracti o ns; 
•  
E xtra vasati o n; 
•  
E x p os ure d uri n g pre g na nc y;  
•  
E x p os ure d uri n g breastfee di n g;  
•  
Me dicati o n err or;  
•  
Occ u pati o nal e x p os ure.  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 2 9  of 3 5  
 
A b n or mal test fi n di n gs  
T he criteria f or deter mi ni n g w het her a n a b n or mal o bjecti ve test fi n di n g s h o ul d be re p orte d as a n A E are as 
f oll o ws: 
•  
Test res ult is ass ociate d wit h acc o m pa n yi n g s y m pt o ms, a n d/ or 
•  
Test res ult 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, a n d/ or 
•  
Test res ult lea ds t o a c ha n ge i n st u d y d osi n g 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, a n d/ or 
•  
Test res ult is c o nsi dere d t o be a n A E b y t he i n vesti gat or or Pfizer. 
Merel y re peati n g a n a b n or mal test, i n t he a bse nce of a n y of t he a b o ve c o n diti o ns, d oes n ot c o nstit ute a n A E. 
A n y a b n or mal test res ult t hat is deter mi ne d t o be a n err or d oes n ot re q uire re p orti n g as a n A E. 
1 0. 4. 2.  Seri o us a d verse e ve nts  
A S A E is a n y u nt o war d me dical occ urre nce i n a partici pa nt  a d mi nistere d a me dici nal or n utriti o nal pr o d uct 
(i ncl u di n g pe diatric f or m ulas) at a n y d ose t hat: 
•  
Res ults i n deat h;  
•  
Is life-t hreate ni n g; 
•  
Re q uires i n patie nt h os pitalizati o n or pr ol o n gati o n of h os pitalizati o n (see bel o w f or circ u msta nces t hat d o 
n ot c o nstit ute A Es);  
•  
Res ults i n persiste nt or si g nifica nt disa bilit y /i nca pacit y (s u bsta ntial disr u pti o n of t he a bilit y t o c o n d uct 
n or mal life f u ncti o ns);  
•  
Res ults i n c o n ge nital a n o mal y/ birt h defect.  
Me dical a n d scie ntific j u d g me nt is e xercise d i n deter mi ni n g w het her a n e ve nt is a n i m p orta nt me dical e ve nt. A n 
i m p orta nt me dical e ve nt ma y n ot be i m me diatel y life-t hreate ni n g a n d/ or res ult i n deat h or h os pitalizati o n. 
H o we ver, if it is deter mi ne d t hat t he e ve nt ma y je o par dize t he par tici pa nt or ma y re q uire 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 defi niti o n a b o ve, t he i m p orta nt me dical e ve nt s h o ul d be re p orte d as 
seri o us. 
E xa m ples of s uc h e ve nts are 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. 
A d diti o nall y, a n y s us pecte d tra ns missi o n via a Pfizer pr o d uct of a n i nfecti o us a ge nt, pat h o ge nic or n o n-
pat h o ge nic, is c o nsi dere d seri o us. T he e ve nt ma y be s us pecte d fr o m cli nical s y m pt o ms or la b orat or y fi n di n gs 
i n dicati n g a n i nfecti o n i n a partici pa nt  e x p ose d t o a Pfizer pr o d uct. T he ter ms “s us pecte d tra ns missi o n” a n d 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 3 0  of 3 5  
 
“tra ns missi o n” are c o nsi dere d s y n o n y m o us. T hese cases are c o nsi dere d u ne x pecte d a n d ha n dle d as seri o us 
e x pe dite d cases b y p har mac o vi gila nce ( P V) p ers 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.  
 
H os pitalizati o n  
H os pitalizati o n is defi ne d as a n y i nitial a d missi o n (e ve n if less t ha n 2 4 h o urs) t o a h os pital or e q ui vale nt 
healt hcare facilit y or a n y pr ol o n gati o n t o a n e xisti n g a d missi o n. A d missi o n als o i ncl u des tra nsfer wit hi n t he 
h os pital t o a n ac ute/i nte nsi ve care u nit (e. g., fr o m t he ps yc hiatric wi n g t o a me dical fl o or, me dical fl o or t o a 
c or o nar y care u nit, ne ur ol o gical fl o or t o a t u berc ul osis u nit). A n e mer ge nc y r o o m visit d oes n ot necessaril y 
c o nstit ute a h os pitalizati o n; h o we ver, a n e ve nt lea di n g t o a n e mer ge nc y r o o m visit s h o ul d be assesse d f or 
me dical i m p orta nce.  
H os pitalizati o n i n t he a bse nce of a me dical A E is n ot i n itself a n A E a n d is n ot re p orta ble. F or e xa m ple, t he 
f oll o wi n g re p orts of h os pitalizati o n wit h o ut a me dical A E are n ot t o be re p orte d. 
•  
S ocial a d missi o n (e. g., vacci nate d i n di vi d ual/ partici pa nt  has n o place t o slee p) 
•  
A d mi nistrati ve a d missi o n (e. g., f or yearl y e xa m) 
•  
O pti o nal a d missi o n n ot ass ociat e d wit h a preci pitati n g me dical A E (e. g., f or electi ve c os metic s ur ger y)  
•  
H os pitalizati o n f or o bser vati o n wit h o ut a me dical A E  
•  
A d missi o n f or treat me nt of a pre -e xisti n g c o n diti o n n ot ass ociate d wit h t he de vel o p me nt of a ne w A E or 
wit h a w orse ni n g of t he pre-e xisti n g c o n diti o n (e. g., f or w or k- u p of persiste nt pre -treat me nt la b 
a b n or malit y) 
1 0. 4. 3.  Sce n ari os necessit ati n g re p orti n g t o Pfizer S afet y wit hi n 2 4 h o urs  
Sce nari os i n v ol vi n g e x p os ure d uri n g pre g na nc y, e x p os ure d uri n g breastfee di n g, me dicati o n err or, o ver d ose, 
mis use, e xtra vasati o n, lac k of efficac y, a n d occ u pati o nal e x p os ure are descri be d bel o w.  
E x p os ure d uri n g pre g na nc y  
E x p os ure d uri n g breastfee di n g  
Sce nari os of e x p os ure d uri n g breastfee di n g m ust be re p orte d, irres pecti ve of t he prese nce of a n ass oci ate d A E. 
A n e x p os ure d uri n g breastfee di n g re p ort is n ot create d w he n a Pfizer dr u g s pecificall 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 a cc or d wit h a ut h orize d use. H o we ver, if t he i nfa nt 
e x perie nces a n A E ass ociate d wit h  s uc h a dr u g’s a d mi nistrati o n, t he A E is re p orte d t o get her wit h t he e x p os ure 
d uri n g breastfee di n g. 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 3 1  of 3 5  
 
Me dicati o n err or  
A me dicati o n err or is a n y u ni nte nti o nal err or i n t he prescri bi n g, dis pe nsi n g, or a d mi nistrati o n of a me dici nal 
pr o d uct t hat ma y ca use or lea d t o i na p pr o priate me dicati o n use or partici pa nt  har m w hile i n t he c o ntr ol of t he 
healt h care pr ofessi o nal, partici pa nt , or c o ns u mer. S uc h e ve nts ma y be relate d t o pr ofessi o nal practice, healt h 
care pr o d ucts, pr oce d ures, a n d s yste ms i ncl u di n g: prescri bi n g; or der c o m m u nicati o n; pr o d uct la beli n g, 
pac ka gi n g, a n d n o me nclat ure; c o m p o u n di n g; dis pe nsi n g; distri b uti o n; a d mi nistrati o n; e d ucati o n; m o nit ori n g; 
a n d use. 
Me dicati o n err ors i ncl u de: 
•  
Near misses, i n v ol vi n g or n ot i n v ol vi n g a partici pa nt  directl y (e. g., i na d verte nt/err o ne o us a d mi nistrati o n, 
w hic h is t he acci de ntal use of a pr o d uct o utsi de of la beli n g or prescri pti o n o n t he part of t he healt hcare 
pr o vi der or t he partici pa nt /c o ns u mer); 
•  
C o nf usi o n wit h re gar d t o i n ve nte d na me (e. g., tra de na me; bra n d na me). 
T he i n vesti gat or m ust s u b mit t he f oll o wi n g me dicati o n err ors t o Pfizer, irres pecti ve of t he prese nce of a n 
ass ociate d A E/ S A E: 
•  
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 pr o d uct, 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. 
•  
Me dicati o n er r ors t hat d o n ot i n v ol ve a partici pa nt  directl y (e. g., p ote ntial me dicati o n err ors or near misses). 
W he n a me dicati o n err or d oes n ot i n v ol ve partici pa nt  e x p os ure t o t he pr o d uct, t he f oll o wi n g mi ni m u m 
criteria c o nstit ute a me dicati o n err or re p ort:  
•  
A n i de ntifia ble r e p orter; 
•  
A s us pect pr o d uct; 
•  
T he e ve nt me dicati o n err or.  
O ver d ose, mis use, e xtra vasati o n  
Re p orts of o ver d ose, mis use, a n d e xtra vasati o n ass ociate d wit h t he use of a Pfizer pr o d uct are re p orte d t o Pfizer 
b y t he i n vesti gat or, irres pecti ve of t he prese nce of a n ass ociate d A E/ S A E.  
Lac k of efficac y  
Re p orts of lac k of efficac y of a Pfizer pr o d uct are re p orte d t o Pfizer b y t he i n vesti gat or, irres pecti ve of t he 
prese nce of a n ass ociate d A E/ S A E or t he i n dicati o n f or use of t he Pfizer pr o d uct. 
Occ u pati o nal e x p os ure 
Re p orts of occ u pati o nal e x p os ure t o a Pfizer pr o d uct are re p orte d t o Pfizer b y t he i n vesti gat or, irres pecti ve of 
t he prese nce of a n ass ociate d A E/ S A E. 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 3 2  of 3 5  
 
1 1.  SI N G L E R E F E R E N C E S A F E T Y D O C U M E N T  
I n t his st u d y, t he pac ka ge i nsert of t his pr o d uct i n Ja pa n will ser ve as t he Si n gle Refere nce Safet y D oc u me nt. 
T his d oc u me nt will be use d b y Pfizer Safet y t o assess a n y safet y e ve nts re p orte d t o Pfizer Safet y b y t he 
i n vesti gat or d uri n g t he c o urse of t his st u d y. 
T he si n gle refere nce safet y d oc u me nt s h o ul d be use d b y t he i n vesti gat or f or prescri bi n g p ur p oses a n d g ui da nce.  
1 2.  P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S  
I nf or mati o n c ollecte d i n t his st u d y will be use d f or re p orti n g p ur p oses t o re p ort Mi nistr y of Healt h, La b o ur a n d 
Welfare ( M H L W), P har mace uticals a n d Me dical De vices A ge nc y ( P M D A), Pfizer I nc. w hic h is t he c or p orate 
pare nt of t he s p o ns or of t his st u d y, a n d t he gr o u p c o m pa nies, or re g ulat or y a ge nc y i n ot her c o u ntries. Als o, it 
will be use d f or s u b mitti n g a p plicati o n of ree xa mi nati o n (i ncl u di n g Peri o dic Safet y U p date Re p ort) or re-
e val uati o n, pre parati o n of material f or pr o per use i nf or mati o n of t his pr o d uct, p u blicati o ns, or acti vities f or 
i nf or mati o n pr o visi o n. I n a d diti o n, Pfizer ma y p u blis h t he st u d y res ults t o pr o vi de i nf or mati o n f or pr o per use, as 
nee de d, o n w w w.cli nicaltrials. g o v ( Cli nical Trials. g o v), as prese ntati o ns at aca de mic c o nfere nces, or as 
ma n us cri pts, etc.  
Data o btai ne d fr o m t he partici pa nt s re gistere d i n t his st u d y will be re p orte d t o t he M H L W p urs ua nt t o t he 
P har mace utical a n d Me dical De vice Act. I n t his case, t he data ma y be p u blicl y p oste d i n M H L W’s 
“ P har mace utical a n d Me dical De vice Safet y I nf or mati o n” a n d “ P har mace uticals a n d Me dical De vices 
I nf or mati o n We bsite ( htt p:// w w w.i nf o. p m da. g o.j p)” as a listi n g of partici pa nt s, w hic h will i ncl u de t he na mes of 
dr u gs, a d verse reacti o ns, ge n der, a ge (i ncre me nt of 1 0 years), a n d ot her rele va nt i nf or mati o n.  F urt her m ore, data 
c ollecte d ma y als o be discl ose d if t he M H L W is re q uire d t o discl ose s uc h i nf or mati o n i n acc or da nce wit h t he 
“ Act o n Access t o I nf or mati o n Hel d b y A d mi nistrati ve Or ga ns” ( La w N o. 4 2 date d Ma y 1 4, 1 9 9 9); pr o vi de d 
t hat i n n o e ve nt will t he names of p h ysicia ns, me dical i nstit uti o ns, a n d ot her pers o nal i nf or mati o n be partici pa nt  
t o s uc h discl os ure, n or will it be p oste d or discl ose d. 
 I n t he e ve nt of a n y pr o hi biti o n or restricti o n i m p ose d (e. g., cli nical h ol d) b y a n a p plica ble C o m pete nt A ut h orit y 
i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w i nf or mati o n w hic h 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 a Pfizer pr o d uct, Pfizer s h o ul d be i nf or me d i m me diatel y. 
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 safet y meas ures ta ke n b y t he 
i n vesti gat or t o pr otect t he st u d y partici pa nt s a gai nst a n y i m me diate hazar d, a n d of a n y seri o us breac hes of t his 
NI st u d y f ull pr ot oc ol t hat t he i n vesti gat or bec o mes a ware of. 
1 3.  N A M E, A N D A D D R E S S O F C O N T R A C T O R A S  W E L L A S S C O P E O F W O R K C O N T R A C T E D  
•  
C o m pa n y na me: Pfizer R & D Ja pa n  
A d dress: 3 -2 2 -7, Y o y o gi, S hi b u ya -k u, T o k y o  
Sc o pe of w or k c o ntracte d: W or ks relate d t o pla n ni n g of st u d y, drafti n g of pla n, i m ple me ntati o n of st u d y 
a n d m o nit ori n g, etc. 
 
•  
C o m pa n y na me: Me di data S ol uti o ns 
A d dress: 2 - 7- 2, Mar u n o uc hi, C hi y o da-k u, T o k y o  
Sc o pe of w or k c o ntracte d: Esta blis h me nt, o perati o n a n d mai nte na nce of t he E D C s yste m, etc. 
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 3 3  of 3 5  
 
•  
C o m pa n y na me: E P S C or p orati o n  
A d dress: 2 - 2 3, S hi m o mi ya bic h o, S hi nj u k u-k u, T o k y o  
Sc o pe of w or k c o ntr acte d: Esta blis h me nt of t he E D C s yste m, re gistrati o n, data ma na ge me nt, statistical 
a nal ysis, m o nit ori n g, etc. 
 
•  
C o m pa n y na me: A 2 Healt hcare C or p orati o n  
A d dress: 1 - 4-1 K ois hi ka wa, B u n k y o -k u, T o k y o  
Sc o pe of w or k c o ntracte d: E D C acc o u nt ma na ge me nt, etc.  
 
1 4.  A D DI TI O N A L M E A S U R E S T H A T M A Y B E T A K E N B A S E D O N T H E S T U D Y R E S U L T S A N D 
C RI T E RI A F O R D E T E R MI N A TI O N O F T H E I NI TI A TI O N  
Re vie w t he ris k ma na ge me nt pla n i ncl u di n g t he f oll o wi n g c o nte nts at t he sc he d ule d ti mi n g of milest o nes. 
1.  Re vie w t he necessit y f or c ha n gi n g t he c o nte nts of ris k mi ni mizati o n acti vities f or t he c urre nt safet y 
s pecificati o ns. 
2.  Re vie w t he necessit y f or c ha n gi n g t he c o nte nts of t his st u d y pla n i ncl u di n g t he prese nce or a bse nce of ne w 
safet y s pecificati o ns (c o nti n uati o n of t he st u d y, i m ple me ntati o n of a d diti o nal st u d y, etc.). 
3.  Re vie w t he necessit y f or f or m ulati n g ris k mi ni mizati o n meas ures f or ne w safet y s pecificati o ns.  
1 5.  S C H E D U L E D TI MI N G O F MI L E S T O N E S A N D T H EI R R A TI O N A L E S F O R E V A L U A TI O N O F 
S T U D Y I M P L E M E N T A TI O N S T A T U S A N D R E S U L T S A N D R E P O R TI N G T O T H E P M D A  
Safet y re vie w a n d re p orti n g at t he ti me of pre pari n g t he Peri o dic Safet y U p date Re p orts a n d c o m pleti o n of t he 
st u d y. 
1 6.  O T H E R N E C E S S A R Y M A T T E R S  
1.  A me n d me nt of t he F ull Pr ot oc ol 
Base d o n t he ne w k n o wle d ge t o be o btai ne d acc or di n g t o t he pr o gress of t his st u d y, t he nee d f or a me n d me nt of 
t he pr ot oc ol will be e xa mi ne d a n d t he F ull Pr ot oc ol will be a me n de d if necessar y. Als o, t he nee d f or a me n d me nt 
of t he F ull Pr ot oc ol will be e xa mi ne d a n d t he pr ot oc ol will be a me n de d w he n t he partial c ha n ge i n t he d osa ge 
a n d a d mi nistrati o n or i n dicati o n is a p pr o ve d d uri n g t he ree xa mi nati o n peri o d (e xce pt w he n t he ree xa mi nati o n 
peri o d is ne wl y desi g nate d), etc. 
2.  Acti o ns t o be ta ke n f or a n y pr o ble m or iss ue 
Re visi o n of t he pac ka ge i nsert a n d c o n d uct of a ne w P ost- mar keti n g st u d y or ne w P ost- mar keti n g cli nical trial 
s h o ul d be c o nsi dere d f or t he f oll o wi n g cases: a n y seri o us a n d u n k n o w n a d verse reacti o n is s u g geste d; a 
si g nifica nt i ncrease i n t he fre q ue nc y of a d verse reacti o ns is n ote d; a n y effecti ve ness or safet y c o ncer n c o m pare d 
t o pre-a p pr o val is raise d; rare a d verse reacti o n is s u g geste d.  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 3 4  of 3 5  
 
1 7.  C O N T A C T I N F O R M A TI O N  
1 7. 1.  C o nt act i nf or m ati o n f or i n q uiries a b o ut t he st u d y  
Na me  
P M S Affairs, Pfizer R & D Ja p a n 
A d dress  
3- 2 2- 7, Y o y o gi, S hi b u ya - k u, T o k y o 1 5 1- 8 5 8 9 
F A X  
0 3- 5 3 0 9- 9 1 8 6 
E- mail a d dress  
C M T _I N F _ D R P M S @ pfizer.c o m  
 
1 7. 2.  C o nt act i nf or m ati o n f or i n q uiries a b o ut t he E D C s yste m  
Na me  
Me di data Hel p des k  
B usi ness H o urs  
M o n da ys t hr o u g h Fri da ys: 9: 0 0 – 2 0: 0 0 (e xcl u di n g h oli da ys, year e n d a n d be gi n ni n g) 
T E L  
 ( De dicate d n u m ber f or Pfizer)  
E- mail a d dress  
ja pa n hel p des k @ m ds ol.c o m 
 
1 8.  R E F E R E N C E S  
1.  
G ui da nce f or Treat me nt of N o vel C or o na vir us I nfecti o n ( C O VI D- 1 9)  
2.  
U S F o o d a n d Dr u g A d mi nistrati o n. G ui da nce f or i n d ustr y: t o xicit y gra di n g scale f or healt h y a d ult a n d 
a d olesce nt v ol u nteers e nr olle d i n pre ve nti ve vacci ne cli nical trials. R oc k ville, M D: Ce nt er f or Bi ol o gics 
E val uati o n a n d Researc h; Se pte m ber 2 0 0 7. 
1 9.  LI S T O F T A B L E S  
•  
Pa ge 1 3 . Ta ble 1 . Varia bles 
•  
Pa ge 1 7 . Ta ble 2 . Defi niti o n of Se verit y 
•  
Pa ge 1 9 . Ta ble 3 . Se verit y Classificati o n of L ocal Reacti o ns  
•  
Pa ge 1 9 . Ta ble 4. Se verit y Classificati o n of S yste mic Reacti o ns ( 2 years a n d ol der)  
•  
Pa ge 2 0 . Ta ble 5. Se verit y Classificati o n of S yste mic Reacti o ns ( y o u n ger t ha n 2 years)  
•  
Pa ge 2 0 . Ta ble 6. Se verit y Classificati o n of P yre xia   
2 0.  LI S T O F FI G U R E S  
•  
Pa ge 1 4 . Fi g ure 1. Sc he d ule  
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)
P P D

 
C O MI R N A T Y i ntra m usc ular i njecti o n f or 6 m o nt hs t o 4 years ol d ( M o n o vale nt: O micr o n X B B. 1. 5)  
C 4 5 9 1 0 5 7 N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 1 , 2 3 Oct o ber 2 0 2 3  
 
P FI Z E R C O N FI D E N TI A L  
C T 2 4 -WI -J P N-G P S P 0 1 -R F 0 8 7. 0 N o n -I nter ve nti o nal St u d y Pr ot oc ol Te m plate for Pri mar y Data C ollecti o n St u d y  
1 5 -Se p -2 0 2 2  
P a ge 3 5  of 3 5  
 
A P P E N DI X 1. LI S T O F S T A N D A L O N E D O C U M E N T S  
N ot a p plica ble.  
A P P E N DI X 2. A D DI TI O N A L I N F O R M A TI O N  
1.  
S pecial i n vesti gati o n re gistrati o n f or m  
2.  
S pecial i n vesti gati o n case re p ort f or m 
3.  
T w o t y pes of healt h o bser vati o n diar y ( < 2 years a n d ≥2 years) f or s pecial i n vesti gati o n  
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)

 
T R A N S L A TI O N R E C O R D 
( F O R P O S T- M A R K E TI N G S U R V EI L L A N C E S T U D Y I N J A P A N) 
1 0- J a n- 2 0 1 9 
 
P FI Z E R C O N FI D E N TI A L 
Pa ge 1 of 1 
 
D oc u me nt T y pe 
（Pr ot oc ol ） 
D oc u me nt D ate 
( Ori gi n al) 
2 3 Oct o ber 2 0 2 3 
Pr o gr a m  
C 4 5 9 
St u d y 
C 4 5 9 1 0 5 7 
Ori gi n al L a n g u a ge 
 
Site 
N A 
Tr a nsl ati o n L a n g u a ge 
Is a b ac k 
tr a nsl ati o n 
re q uire d ? 
 
N O 
 
 
F U L L T R A N S L A TI O N A N D R E VI E W I N F O R M A TI O N 
 
Tr a nsl at or Q u alific ati o n 
T y pe 
Tra nslati o n ve n d or 
Tr a nsl ati o n Ve n d or  
H o n ya k u Ce nter I nc. 
Tr a nsl at or N a me 
H o n ya k u Ce nter I nc. 
D ate of Tr a nsl ati o n 
0 2 N O V 2 0 2 3 ~ 1 6 N O V 2 0 2 3 
Re vie wer N a me 
 
D ate of Re vie w 
2 7 N O V 2 0 2 3 
 
 
0 9 0 1 7 7 e 1 9f 4 9f a 4f\ A p pr o v e d\ A p pr o v e d O n: 2 7- N o v- 2 0 2 3 0 6: 5 6 ( G M T)
P P D
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt 
N o n- E n gli s h t e xt