A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of a Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 11 Through 15 Months of Age Who Previously Received the PCV10 Primary Series
Phase: PHASE2
Conditions: Healthy Participants
Sponsor: Pfizer

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P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
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A P H A S E 2 , R A N D O MI Z E D, O P E N -L A B E L T RI A L T O D E S C RI B E T H E S A F E T Y 
A N D I M M U N O G E NI CI T Y O F A M O N O V A L E N T P N E U M O C O C C A L 
C O N J U G A T E C A N DI D A T E A D MI NI S T E R E D A S A 2 -D O S E S E RI E S I N H E A L T H Y 
T O D D L E R S 1 1 T H R O U G H 1 5 M O N T H S O F A G E W H O P R E VI O U S L Y R E C E I V E D 
T H E P C V 1 0 P RI M A R Y S E RI E S
St u d y I nter ve nti o n N u m ber :
P F -0 7 8 3 1 6 9 5
St u d y I nter ve nti o n N a me:
N/ A
U S I N D N u m ber:
N/ A
E U C T N u m ber:
2 0 2 3 -5 0 5 1 5 4 -1 8 -0 0
Cli nic al Tri als. g o v I D:
T B D
Pe di atric I n vesti g ati o n al Pl a n N u m ber:
T B D
Pr ot oc ol N u m ber:
C 4 8 0 1 0 0 2
P h ase:
2
S p o ns or Le g al A d dress:
Pfizer I nc.
6 6 H u ds o n B o ule var d East
Ne w Y or k, N Y 1 0 0 0 1
Brief Title: A P hase 2 Safet y a n d I mm u n o ge nicit y  St u d y  of a M o n o vale nt P ne u m oc occal 
C o nj u gate Ca n di date i n Healt hy T o d dlers
T his d oc u me nt a n d acc o m pa n yi n g materials c o ntai n c o nfi de ntial i nf or mati o n bel o n gi n g t o Pfizer. E xce pt as 
ot her wise a gree d t o i n writi n g, b y acce pti n g or re vie wi n g t hese d oc u me nt s, yo u  a gree t o h ol d t his 
i nf or mati o n i n c o nfi de nce a n d n ot c o p y or discl ose it t o ot hers (e xce pt w here re q uire d b y a p plica ble la w ) or 
use it f or u na ut h orize d p ur p oses. I n t he e ve nt of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfizer m ust 
be pr o m ptl y n otifie d.
 

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D oc u me nt Hist or y
D oc u me nt
Versi o n D at e
Pr ot oc ol A me n d me nt 1
1 5 Se p te m ber 2 0 2 3
Ori gi nal pr ot oc ol
3 1 Ma y  2 0 2 3
T his a me n d me nt i nc or p orates all re visi o ns t o date, i ncl u di n g a me n d me nts ma de at t he 
re q uest of c o u ntr y healt h a ut h orities a n d I R Bs/ E Cs a n d a n y pr ot oc ol a d mi nistrati ve c ha n ge 
letter(s).
Pr ot oc ol A me n d me nt S u m m ar y of C h a n ges T a ble
Pr ot oc ol A me n d me nt 1 ( 1 5 Se pte m ber 2 0 2 3 )
O ver all R ati o n ale f or t he A me n d me nt: T o pr o vi de scie ntific rati o nale f or partici pa nt 
selecti o n a n d t o pr o vi de f urt her clarificati o n re gar di n g e x pl orat or y assa ys.
Desc ri pti o n of C h a n ge .
Brief R ati o n ale
Secti o n # a n d N a me
N o n -s u bst a nti al M o dific ati o n(s)
A d de d rele va nt data fr o m 
p u blicati o ns a n d bac k gr o u n d 
i nf or mati o n wit hi n t he 
a p pr o priate secti o ns.
A d de d s u bsecti o n 4. 2. 2
“ Rati o nale f or Selecti o n of 
T o d dler P o p ulati o n”
T o pr o vi de scie ntific 
j ustificati o n f or a ge of 
partici pa nts
Secti o n 2. 1 St u d y  Rati o nale, 
Secti o n 2. 2 Bac k gr o u n d, 
Secti o n 4. 2 Scie ntific 
Rati o nale f or St u d y  Desi g n
A d de d “i m m u n o ge nicit y” t o 
“a d diti o nal assess me nts”
T o clarif y  t hat e x pl orat or y 
assa ys, if perf or me d, are
li mite d t o o nl y 
i m m u n ol o gical assa ys.
Secti o n 8. 2 Efficac y  a n d/ or 
I m m u n o ge nicity 
Assess me nts
 

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C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
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T A B L E O F C O N T E N T S
LI S T O F T A B L E S .....................................................................................................................8
1. P R O T O C O L  S U M M A R Y..................................................................................................... 9
1. 1. S y n o psis .................................................................................................................... 9
1. 2. Sc he ma .................................................................................................................... 1 5
1. 3. Sc he d ule of Acti vities ............................................................................................. 1 6
2. I N T R O D U C TI O N ............................................................................................................... 1 7
2. 1. St u d y  Rati o nale ....................................................................................................... 1 8
2. 2. Bac k gr o u n d ............................................................................................................. 1 8
2. 2. 1. Cli nical O ver vie w ....................................................................................... 1 9
2. 3. Be nefit/ Ris k Assess me nt ......................................................................................... 1 9
2. 3. 1. Ris k Assess me nt ......................................................................................... 2 0
2. 3. 2. Be nefit Assess me nt ..................................................................................... 2 2
2. 3. 3. O verall Be nefit/ Ris k C o ncl usi o n ................................................................ 2 2
3. O BJ E C TI V E S, E N D P O I N T S, A N D E S TI M A N D S ........................................................... 2 2
4. S T U D Y D E SI G N ................................................................................................................. 2 3
4. 1. O verall Desi g n ......................................................................................................... 2 3
4. 2. Scie ntific Rati o nale f or St u d y  Desi g n..................................................................... 2 5
4. 2. 1. C o u ntr y  Selecti o n ....................................................................................... 2 5
4. 2. 2. Rati o nale f or Selecti o n of T o d dler P o p ulati o n ........................................... 2 5
4. 2. 3. Rati o nale f or C o m parat or ........................................................................... 2 6
4. 3. J ustificati o n f or D ose ..............................................................................................2 6
4. 4. E n d of St u d y  Defi niti o n .......................................................................................... 2 6
5. S T U D Y P O P U L A T I ON ......................................................................................................2 6
5. 1. I ncl usi o n Criteria ..................................................................................................... 2 7
5. 2. E xcl usi o n Criteria .................................................................................................... 2 7
5. 3. Li fest yle C o nsi derati o ns.......................................................................................... 2 9
5. 4. Scree n Fail ures ........................................................................................................ 2 9
5. 5. Criteria f or Te m p oraril y  Dela yi n g 
E nr oll me nt/ Ra n d o mizati o n/ A d mi nistrati o n of St u d y  Inter ve nti o n ...........................2 9
6. S T U D Y I N T E R V E N TI O N( S) A N D C O N C O MI T A N T T H E R A P Y .................................3 0
6. 1. St u d y  Inter ve nti o n(s) A d mi nistere d ........................................................................ 3 0
 

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6. 1. 1. A d mi nistrati o n ............................................................................................ 3 1
6. 1. 2. Me dical De vices (if P C V 1 0 I s S u p plie d i n P F Ss) ...................................... 3 2
6. 2. Pre parati o n, Ha n dli n g, St ora ge, a n d Acc o u nta bilit y ............................................... 3 2
6. 2. 1. Pre parati o n a n d Dis pe nsi n g ........................................................................ 3 3
6. 3. Assi g n me nt t o St u d y I nter ve nti o n ........................................................................... 3 3
6. 4. Bli n di n g ................................................................................................................... 3 4
6. 4. 1. Bli n di n g of Partici pa nts .............................................................................. 3 4
6. 4. 2. Bli n di n g of Site Pers o n nel .......................................................................... 3 4
6. 4. 3. Bli n di n g of t he S p o ns or .............................................................................. 3 4
6. 5. St u d y  Inter ve nti o n C o m plia nce ............................................................................... 3 4
6. 6. D ose M o dificati o n ................................................................................................... 3 4
6. 7. C o nti n ue d Access t o St u d y  Inter ve nti o n After t he E n d of t he St u d y ...................... 3 5
6. 8. Treat me nt of O ver d ose ............................................................................................ 3 5
6. 9. Pri or a n d C o nc o mita nt T hera p y .............................................................................. 3 5
6. 9. 1. Pr o hi bite d D uri n g t he St u d y ....................................................................... 3 5
6. 9. 2. Per mitte d C o nc o mita nt Vacci nes a n d Treat me nts ...................................... 3 6
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L ........................................................................... 3 6
7. 1. Disc o nti n uati o n of St u d y  Inter ve nti o n .................................................................... 3 6
7. 2. Partici pa nt Disc o nti n uati o n/ Wit h dra wal Fr o m t he St u d y ....................................... 3 7
7. 2. 1. Wit h dra wal of C o nse nt ............................................................................... 3 8
7. 3. L ost t o F oll o w -U p ................................................................................................... 3 8
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S ...............................................................3 9
8. 1. A d mi nistrati ve Pr oce d ures ...................................................................................... 3 9
8. 2. Efficac y  a n d/ or I m m u n o ge nicit y Assess me nts....................................................... 3 9
8. 2. 1. Bi ol o gical Sa m ples ..................................................................................... 4 0
8. 3. Safet y Assess me nts ................................................................................................. 4 0
8. 3. 1. Cli nical Assess me nt.................................................................................... 4 1
8. 3. 1. 1. Te m perat ure .............................................................................. 4 1
8. 3. 1. 2. P osti njecti o n O bser vati o n ......................................................... 4 1
8. 3. 2. Cli nical Safet y  La b orat or y Assess me nts.................................................... 4 1
8. 3. 3. Partici pa nt Electr o nic Diar y .......................................................................4 1
0
 

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C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
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8. 3. 3. 1. Gra di n g Scale f or Pr o m pte d E ve nts.......................................... 4 2
8. 4. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her Safet y Re p orti n g ................. 4 5
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y  f or C ollecti n g A E a n d S A E I nf or mati o n....... 4 6
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer Safet y ...............................................4 7
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F................... 4 7
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es .......................................................... 4 7
8. 4. 3. F oll o w -U p of A Es a n d S A Es ...................................................................... 4 7
8. 4. 4. Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es........................................... 4 8
8. 4. 5. E n vir o n me ntal E x p os ure, E x p os ure D uri n g Pre g na nc y  or 
Breastfee di n g, a n d Occ u pati o nal E x p os ure ..................................................... 4 8
8. 4. 5. 1. E x p os ure D uri n g Pre g na nc y ...................................................... 4 8
8. 4. 5. 2. E x p os ure D uri n g Breastfee di n g ................................................ 5 0
8. 4. 5. 3. Occ u pati o nal E x p os ure ............................................................. 5 0
8. 4. 6. Car di o vasc ular a n d Deat h E ve nts ...............................................................5 0
8. 4. 7. Disease -Relate d E ve nts a n d/ or Disease -Relate d O utc o mes N ot 
Q ualif yi n g as A Es or S A Es .............................................................................. 5 0
8. 4. 8. A d verse E ve nts of S pecial I nterest ............................................................. 5 0
8. 4. 8. 1. Lac k of Eff icac y........................................................................ 5 0
8. 4. 9. Me dical De vice Deficie ncies ...................................................................... 5 1
8. 4. 9. 1. Ti me Peri o d f or Detecti n g Me dical De vice Deficie ncies ......... 5 1
8. 4. 9. 2. F oll o w -U p of Me dical De vice Deficie ncies.............................. 5 1
8. 4. 9. 3. Pr o m pt Re p orti n g of De vice Defici e ncies t o t he S p o ns or ........ 5 1
8. 4. 9. 4. Re g ulat or y  Re p orti n g Re q uire me nts f or De vice 
Deficie ncies ....................................................................................... 5 2
8. 4. 1 0. Vacci nati o n Err ors .................................................................................... 5 2
8. 5. P har mac o ki netics ....................................................................................................5 3
8. 6. Ge netics ................................................................................................................... 5 3
8. 6. 1. S pecifie d Ge netics ...................................................................................... 5 3
8. 6. 2. Retai ne d Researc h Sa m ples f or Ge netics ................................................... 5 3
8. 7. Bi o mar kers .............................................................................................................. 5 3
8. 8. I m m u n o ge nicit y Assess me nts ................................................................................. 5 3
8. 9. Healt h Ec o n o mics ................................................................................................... 5 3
 

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Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
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C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
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8. 1 0. St u d y  Pr oce d ures................................................................................................... 5 4
8. 1 0. 1 . Visit 1 – D ose 1 ( Da y  1)........................................................................... 5 4
8. 1 0. 2. Visit 2 – D ose 1 F oll o w - U p Visit ( 2 8-4 2 Da y s After Visit 1).................. 5 6
8. 1 0. 3. Visit 3 – D ose 2 ( 5 6 -7 0 Da y s After Visit 1/ D ose 1)................................. 5 7
8. 1 0. 4. Visit 4 – D ose 2 F oll o w - U p Visit ( 2 8-4 2 Da y s After Visit 3).................. 5 9
8. 1 0. 5. U nsc he d ule d Visits ................................................................................... 6 0
9. S T A TI S TI C A L C O N SI D E R A TI O N S ................................................................................ 6 1
9. 1. Statistical H y p ot hesis ..............................................................................................6 1
9. 1. 1. Esti ma n ds .................................................................................................... 6 1
9. 2. A nal y sis Sets ........................................................................................................... 6 2
9. 3. Statistical A nal y ses ................................................................................................. 6 2
9. 3. 1. Ge neral C o nsi derati o ns ............................................................................... 6 3
9. 3. 1. 1. A nal y ses f or Bi nar y Data.......................................................... 6 3
9. 3. 1. 2. A nal y ses f or C o nti n u o us Data................................................... 6 3
9. 3. 1. 3. Ge o metric Mea ns ...................................................................... 6 3
9. 3. 1. 4. Ge o metric Mea n F ol d Rises ...................................................... 6 3
9. 3. 1. 5. Re verse C u m ulati ve Distri b uti o n C ur ves .................................. 6 4
9. 3. 2. Pri mar y  E n d p oi nt(s)/ Esti ma n d(s) A nalys is................................................ 6 4
9. 3. 3. Sec o n dar y E n d p oi nt(s)/ Esti ma n d(s) A nal ys is............................................ 6 4
9. 3. 4. E x pl orat or y  E n d p oi nt(s) A nal ys is ..............................................................6 5
9. 4. I nteri m A nal ys es ..................................................................................................... 6 5
9. 4. 1. A nal y sis Ti mi n g.......................................................................................... 6 5
9. 5. Sa m ple Size Deter mi nati o n ..................................................................................... 6 6
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L 
C O N SI D E R A TI O N S .......................................................................................................... 6 7
1 0. 1. A p pe n di x 1: Re g ulat or y , Et hical, a n d St u d y O versi g ht C o nsi derati o ns............... 6 7
1 0. 1. 1. Re g ulat or y an d Et hical C o nsi derati o ns .................................................... 6 7
1 0. 1. 1. 1. Re p orti n g of Safet y  Iss ues a n d Seri o us Breac hes of t he 
Pr ot oc ol or I C H G C P ......................................................................... 6 7
1 0. 1. 2. Fi na ncial Discl os ure ................................................................................. 6 8
1 0. 1. 3. I nf or me d C o nse nt Pr ocess ........................................................................ 6 8
1 0. 1. 4. Data Pr otecti o n ......................................................................................... 6 9
 

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1 0. 1. 5. C o m mittees Str uct ure ............................................................................... 7 0
1 0. 1. 5. 1. Data M o nit ori n g C o m mittee ................................................... 7 0
1 0. 1. 6. Disse mi nati o n of Cli nical St u d y  Data ...................................................... 7 0
1 0. 1. 7. Data Q ualit y Ass ura nce ............................................................................ 7 1
1 0. 1. 8. S o urce D oc u me nts .................................................................................... 7 2
1 0. 1 . 9. Use of Me dical Rec or ds............................................................................7 3
1 0. 1. 1 0. St u d y  a n d Site Start a n d Cl os ure ............................................................ 7 3
1 0. 1. 1 1. P u blicati o n P olic y ................................................................................... 7 4
1 0. 1. 1 2. S p o ns or’s Me dicall y  Q ualifie d I n di vi d ual.............................................. 7 5
1 0. 2. A p pe n di x 2: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E val uati n g, F oll o w -U p, a n d Re p orti n g ..................................................................... 7 6
1 0. 2. 1. Defi niti o n of A E ....................................................................................... 7 6
1 0. 2. 2. Defi niti o n of a n S A E ................................................................................ 7 7
1 0. 2. 3. Rec or di n g/ Re p orti n g a n d F oll o w -U p of A Es a n d/ or S A Es D uri n g 
t he Acti ve C ollecti o n Peri o d............................................................................ 7 9
1 0. 2. 4. Re p orti n g of S A Es .................................................................................... 8 2
1 0. 3. A p pe n di x 3: L i ver Safet y: S u g geste d Acti o ns a n d F oll o w -U p Assess me nts ....... 8 4
1 0. 4. A p pe n di x 4: Ki d ne y  Safet y M o nit ori n g G ui deli nes ............................................. 8 6
1 0. 4. 1. La b orat or y  Assess me nt of C ha n ge i n Ki d ne y F u ncti o n a n d 
Detecti o n of Ki d ne y  Inj ur y .............................................................................. 8 6
1 0. 4. 2. A g e-S pecific Ki d ne y  F u ncti o n Calc ulati o n Rec o m me n dati o ns............... 8 6
1 0. 4. 2. 1. I nfa nts ( 1 M o nt h t o 2 Years) a n d Ne o nates ( 1 M o nt h) 
— Sc h wartz E q uati o n........................................................................ 8 6
1 0. 4. 3. A d verse E ve nt Gra di n g f or Ki d ne y  Safety La b orat or y  
A b n or malities ................................................................................................... 8 6
1 0. 5. A p pe n di x 5 : A Es, A D Es, S A Es, S A D Es, U S A D Es, a n d De vice 
Deficie ncies: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, E val uati n g, 
F oll o w -U p, a n d Re p orti n g i n Me dic al De vice St u dies ............................................. 8 7
1 0. 5. 1. Defi niti o n of A E a n d A D E ....................................................................... 8 7
1 0. 5. 2. Defi niti o n of S A E, S A D E, a n d U S A D E ..................................................8 7
1 0. 5. 3. Defi niti o n of De vice Deficie nc y ...............................................................8 8
1 0. 5. 4. Rec or di n g/ Re p orti n g a n d F oll o w- U p of Me dical De vice 
Deficie ncies ...................................................................................................... 8 8
1 0. 5. 5. Re p orti n g of S A Es .................................................................................... 9 0
 

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1 0. 5. 6. Re p orti n g of S A D Es ................................................................................. 9 0
1 0. 6. A p pe n di x 6: A b bre viati o ns ................................................................................... 9 1
1 1. R E F E R E N C E S .................................................................................................................. 9 4
LI S T O F T A B L E S
Ta ble 1.
Gra di n g Scales f or L ocal Reacti o ns ......................................................... 4 3
Ta ble 2.
Gra di n g Scales f or S y ste mic E ve nts ......................................................... 4 4
Ta ble 3.
Ra n ges f or Fe ver ....................................................................................... 4 5
Ta ble 4.
Pr o ba bilit y  of Detecti n g at Least 1 A d verse E ve nt .................................. 6 6
 

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1. P R O T O C O L S U M M A R Y
1. 1. S y n o psis
Pr ot oc ol Title: A P hase 2, Ra n d o mize d, O pe n -La bel Trial t o Descri be t he Safet y a n d 
I m m u n o ge nicity of a M o n o vale nt P ne u m oc occal C o nj u gate Ca n di date A d mi nistere d As a 
2- D ose Series i n Healt h y T o d dlers 1 1 T hr o u g h 1 5 M o nt hs of A ge W h o Pre vi o usl y  Recei ve d 
t he P C V 1 0 Pri mar y  Series
Brief Title: A P hase 2 Safet y a n d I mm u n o ge nicit y  St u d y of a M o n o vale nt P ne u m oc occal 
C o nj u gate Ca n di date i n Healt h y T o d dlers
Re g ul at or y A ge nc y I D N u m ber(s):
U S I N D N u m ber:
N/ A
E U C T N u m ber:
2 0 2 3 -5 0 5 1 5 4 -1 8 -0 0
Cli nic al Tri als. g o v I D:
T B D
Pe di atric I n vesti g ati o n al Pl a n N u m ber:
T B D
Pr ot oc ol N u m ber:
C 4 8 0 1 0 0 2
P h ase:
2
R ati o n ale:
Stre pt oc occ us p ne u m o ni ae ca uses i n vasi ve (e g, me ni n gitis, se psis, bactere mic p ne u m o nia) 
a n d n o ni n vasi ve (e g, otitis me dia [ O M ], n o n bactere mic p ne u m o nia, si n usitis) disease 
ass ociate d wit h si g nifica nt healt hcare b ur de n, m or bi dit y, a n d m ortality. T he 1 3 -vale nt 
p ne u m oc occal c o nj u gat e vacci ne ( Pre v nar 1 3® ; 1 3 v P n C) was lice nse d m ore t ha n a deca de 
a g o b y  t he F o o d a n d Dr u g A d mi nistrati o n ( F D A ) a n d ot her re g ulat or y a ge ncies ar o u n d t he 
w orl d, i ncl u di n g t he E ur o pea n Me dici nes A ge nc y ( E M A), f or use i n i nfa nts a n d yo u n g 
c hil dre n f or t he pre ve nti o n of p ne u m oc occal disease. T he 2 0- vale nt p ne u m oc occal c o nj u gate 
vacci ne ( 2 0 v P n C ) was de vel o pe d t o e x pa n d pr otecti o n a gai nst p ne u m oc occal i n vasi ve 
disease a n d p ne u m o nia . T he vacci ne has bee n a p pr o ve d b y t he F D A a n d E M A f or a d ults 
≥1 8 ye ars of a ge a n d is bei n g de vel o pe d f or use i n t he pe diatric p o p ulati o n. 2 0 v P n C c o ntai ns 
t he i de ntical p ol ysacc hari de c o nj u gates a n d e xci pie nts as 1 3 v P n C b ut wit h c o nj u gate 
p ol y sacc hari des f or 7 a d diti o nal ser ot ypes.
B ot h 1 3 v P n C a n d 2 0 v P n C c o ntai n t he sa me c o nj u gate f or ser oty pe 3 ( p ne u m oc occal ser ot y pe 
3 c o nj u gate [ P n C 3 ]). Alth o u g h t here is e vi de nce of direct pr otecti o n b y 1 3 v P n C a gai nst 
in vasi ve p ne u m oc occal d isease (I P D) a n d p ne u m o nia d ue t o ser ot y pe 3, ser ot y pe 3 still 
acc o u nts f or a maj orit y of resi d ual 1 3 v P n C -t ype p ne u m oc occal disease i n c hil dre n i n 
c o u ntries t hat ha ve i ntr o d uce d 1 3 v P n C i nt o t heir nati o nal i m m u nizati o n pr o gra ms ( NI Ps). 
I n c hil dre n 5 y ears of a ge i n t he E ur o pea n U ni o n ( E U), 7 % t o 1 0 % of I P D is ca use d by 
ser ot ype 3 . T heref ore, t here is a n o p p ort u nit y t o e val uate ne w a p pr oac hes t hat ma y e n ha nce 
t he i m m u ne res p o nse t o t his ser ot yp e . A P hase 1 st u d y i n a d ults was c o n d ucte d t o e val uate 
t he safety a n d i m m u n o g e nicit y of differe nt f or m ulati o ns t o e n ha nce ser oty p e 3 i m m u ne 
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 0
res p o nses, i ncl u di n g
m o dificati o ns , use of a n 
 
, a n d
. T he m o n o vale nt p ne u m oc occal
c o nj u gate ca n di date (m P n C ca n di date ) use d i n t his st u d y  was selecte d f or f urt her 
de vel o p me nt base d o n data fr o m t he P hase 1 st u d y i n a d ults. I n t he a d ult P hase 1 st u d y, t he
 
T his ra n d o mize d, o pe n -la bel, P hase 2 st u d y is desi g ne d t o descri be t he safet y a n d 
i m m u n o ge nicity of a n m P n C ca n di date i n c hil dre n 1 1 t hr o u g h 1 5 m o nt hs of a ge w h o ha ve 
pre vi o usl y  recei ve d t he 2- d ose 1 0- vale nt p ne u m oc occal c o nj u gate vacci ne ( P C V 1 0 ) pri mar y  
series as part of t heir i nfa nt r o uti ne vacci nes. T he c urre nt P n C 3 f or m ulati o n use d i n 1 3 v P n C 
a n d 2 0 v P n C will be use d as direct c o m parat or i n t his st u d y. Data fr o m t his st u d y will hel p 
i nf or m the de vel o p me nt of f ut ure m ulti vale nt p ne u m oc occal c o nj u gate vacci ne ( P C V) 
f or m ulati o ns.
O bjecti ves, E n d p oi nts, a n d Esti m a n ds:
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y:
Pri m ar y:
Pri m ar y:

T o descri be t he safet y 
pr ofile of t he m P n C 
ca n di date a d mi nistere d as a 
2- d ose series i n c hil dre n 
≥1 1 t o ≤1 5 m o nt hs of a ge

Pr o m pte d l ocal reacti o ns 
(re d ness, s welli n g, a n d 
pai n at t he i njecti o n site)

Pr o m pte d s yste mic 
e ve nts ( fe ver, decrease d 
a p petite,
dr o wsi ness/i ncrease d 
slee p, a n d irrita bilit y)

A d verse e ve nts ( A E s)

Seri o us a d verse e ve nts 
(S A Es )
I n partici pa nts recei vi n g at least 1 d ose of
t he st u d y i nter ve nti o n fr o m eac h gr o u p, 
t he perce nta ge of partici pa nts re p orti n g:

Pr o m pte d l ocal reacti o ns wit hi n 
7 da ys after eac h d ose

Pr o m pte d s yste mic e ve nts wit hi n
7 da ys after eac h d ose

A E s fr o m D ose 1 t hr o u g h 1 m o nt h 
after D ose 2

S A Es fr o m D ose 1 t hr o u g h 1 m o nt h 
after D ose 2
Sec o n d ar y:
Sec o n d ar y:
Sec o n d ar y:

T o descri be t he i m m u ne 
res p o nses elicite d b y t he 
m P n C ca n di date

I m m u n o gl o b uli n G (I g G)
co nce ntrati o ns f or t he 
ca n di date ser ot y pe
I n partici pa nts i n c o m plia nce wit h t he ke y 
pr ot oc ol criteria ( e val ua ble partici pa nts)
fr o m eac h gr o u p:

P ne u m oc occal I g G ge o metric mea n 
c o nce ntrati o ns ( G M Cs ) 1 m o nt h after 
D ose 1 a n d 1 m o nt h after D ose 2

Perce nta ges of partici pa nts wit h 
pre defi ne d I g G c o nce ntrati o n 
1 m o nt h after D ose 1 a n d 1 m o nt h 
after D ose 2
 
C CI
C CI
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 1
O bjecti ves
E n d p oi nts
Esti m a n ds

P ne u m oc occal I g G ge o metric mea n 
f ol d rises (G M F Rs ) fr o m bef ore 
D ose 1 t o 1 m o nt h after D ose 1 
a n d fr o m 1 m o nt h after D ose 1 t o 
1 m o nt h after D ose 2

O ps o n o p ha g oc ytic 
acti vit y ( O P A ) titers f or 
t he ca n di date ser ot y pe

P ne u m oc occal O P A ge o metric mea n 
titers (G M Ts ) 1 m o nt h after D ose 1 
a n d 1 m o nt h after D ose 2

P ne u m oc occal O P A G M F Rs fr o m 
bef ore D ose 1 t o 1 m o nt h after D ose 
1 a n d fr o m 1 m o nt h after D ose 1 t o 
1 m o nt h after D ose 2
O ver all Desi g n:
T his is a P hase 2, m ultice nter, ra n d o mize d, o pe n -la bel st u d y t o descri be t he safety a n d 
i m m u n o ge nicity of a n m P n C ca n di date as a 2-d ose series i n healt h y  t o d dlers 1 1 t hr o u g h 
1 5 m o nt hs of a ge. T his st u d y  will be c o n d ucte d at i n vesti gat or sites i n t he E U . 
A p pr o xi matel y  1 0 0 c hil dre n bet wee n 1 1 a n d 1 5 m o nt hs of a ge w h o pre vi o usl y recei ve d t he 
2- d ose P C V 1 0 i nfa nt pri mar y  series as part of t heir r o uti ne vacci nes will be e nr olle d. 
Parti ci pa nts will be e nr olle d a n d ra n d o mize d i n a 1: 1 rati o b y  site-base d ra n d o mizati o n t o 
recei ve eit her t he m P n C ca n di date or t he co ntr ol (m P n C c o ntr ol ) as a 2-d ose series at Visit 1 
a n d Visit 3 (a p pr o xi matel y 8 wee ks a part); partici pa nts will recei ve t he sa me st u d y 
i nter ve nti o n f or b ot h d oses. Partici pa nts will be o bser ve d f or 3 0 mi n utes after eac h d ose. 
Partici pa nts will als o recei ve t heir t o d dler (t hir d) d ose of P C V 1 0 c o nc o mita ntl y at Visit 1.
Ot her r o uti ne c hil d h o o d vacci nes as rec o m me n de d b y  l ocal sta n dar d of care m a y  be 
a d mi nistere d d uri n g st u d y partici pati o n. P r o hi bite d vacci nes are n ot all o we d. L i ve vacci nes 
ma y o nl y be a d mi nistere d c o nc o mita ntl y wit h st u d y i nter ve nti o n at Visit 1 a n d/ or Visit 3 or 
be a d mi nistere d at least 2 8 da ys bef ore or after st u d y i nter ve nti o n a d mi nistrati o n.
Bl o o d sa m ples ( ~ 5 m L) will be c ollecte d at Visit 1 ( pri or t o recei vi n g D ose 1), Visit 2
( 1 m o nt h after D ose 1) , a n d Visit 4 ( 1 m o nt h after D ose 2). A t otal of 1 5 m L of bl o o d will be 
c ollecte d fr o m eac h partic i pa nt d uri n g t heir st u d y partici pati o n.
L ocal reacti o ns at t he st u d y i nter ve nti o n i njecti o n site (re d ness, s welli n g, a n d pai n at t he 
i njecti o n site), s yste mic e ve nts (fe ver, decrease d a p petite, dr o wsi ness/i ncrease d slee p, a n d 
irrita bilit y), a n d use of a nti p yretic/ pai n me dicati o n will be pr o m pte d f or a n d c ollecte d b y  t he 
partici pa nt’s pare nt(s)/le gal g uar dia n i n a n e-diar y , de vice or a p plicati o n, fr o m Da y 1 t hr o u g h 
D a y  7 after eac h d ose ( w here Da y 1 is t he da y of st u d y i nter ve nti o n a d mi nistrati o n).
A E s a n d S A Es will be c ollecte d fr o m t he si g ni n g of t he i nf or me d c o nse nt d oc u me nt (I C D)
t hr o u g h Visit 4 ( 1 m o nt h after D ose 2 ).
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 2
N u m ber of P artici p a nts:
A p pr o xi matel y  1 0 0 partici pa nts (~ 5 0 per gr o u p) will be ra n d o mize d t o recei ve st u d y  
i nter ve nti o n.
St u d y P o p ul ati o n:
K e y  i ncl usi o n a n d e xcl usi o n criteria are liste d bel o w :
Ke y I ncl usi o n Criteri a
Partici pa nts m ust meet t he f oll o wi n g ke y i ncl usi o n criteria t o be eli gi ble f or e nr oll me nt i nt o 
t he st u d y:

T o d dlers ≥1 1 a n d ≤1 5 m o nt hs of a ge at t he ti me of c o nse nt.

Ha ve recei ve d e xactl y 2 i nfa nt d oses of P C V 1 0 acc or di n g t o a l ocal i m m u nizati o n 
sc he d ule.

Healt h y t o d dlers deter mi ne d b y  cli nical assess me nt, i ncl u di n g me dical hist or y a n d 
cli nical j u d g me nt, t o be eli gi ble f or t he st u d y.
Ke y E xcl usi o n Criteri a
Partici pa nts wit h a n y  of t he f oll o wi n g c haracteristics/c o n diti o ns will be e xcl u de d:

Hist or y  of se vere a d verse reacti o n ass ociate d wit h a vacci ne a n d/ or se vere aller gic 
reacti o n (e g, a na p hyl a xis) t o a n y c o m p o ne nt of st u d y i nter ve nti o n, 1 3 v P n C, 2 0 v P n C,
or a n y di p ht heria t o x oi d – c o ntai ni n g vacci ne.

Si g nifica nt ne ur ol o gical dis or der or hist or y  of seiz ure (e xcl u di n g fe brile seiz ure) or 
si g nifica nt sta ble or e v ol vi n g dis or ders s uc h as cere bral pals y, e nce p hal o pat h y, 
h y dr oce p hal us, or ot her si g nifica nt dis or ders.

Maj or k n o w n c o n ge nital mal f or mati o n or seri o us c hr o nic dis or der.

Hist or y  of micr o bi ol o gicall y pr o ve n i n vasi ve disease ca use d b y S p ne u m o ni ae .

Pre vi o us vacci nati o n wit h a n y lice nse d p ne u m oc occal vacci ne ( ot her t ha n t he P C V 1 0 
pri mar y i nfa nt series) or i n vesti gati o nal p ne u m oc occal vacci ne, or pla n ne d recei pt of 
n o nst u d y  p ne u m oc occal vacci ne d uri n g st u d y partici pati o n.
St u d y Ar ms a n d D ur ati o n:
Eac h partici pa nt will partici pate i n t he st u d y  f or a p pr o xi matel y 3 m o nt h s ( Visit 1 t hr o u g h 
Visit 4) .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 3
A 0. 5- m L d os e of m P n C ca n di date or a 0. 5 -m L  d ose of m P n C c o ntr ol will be a d mi nistere d 
i ntra m usc ularly i nt o t he left a nter olateral t hi g h at Visit 1 a n d Visit 3 . P C V 1 0 will be 
a d mi nistere d i nt o t he ri g ht a nter olateral t hi g h at Visit 1.
Ot her r o uti ne c hil d h o o d vacci nes as rec o m me n de d b y  t he l ocal sta n dar d of care m a y  be 
a d mi nistere d d uri n g st u d y partici pati o n. P r o hi bite d vacci nes are n ot all o we d. Li ve vacci nes 
ma y  o nly be a d mi nistere d c o nc o mita ntl y  wit h st u d y i nter ve nti o n at Visit 1 a n d/ or Visit 3 or 
be a d mi nistere d at least 2 8 da ys bef ore or after st u d y i nter ve nti o n a d mi nistrati o n.
T he st u d y i nter ve nti o n ( m P n C ca n di date a n d m P n C c o ntr ol) will be pr o vi de d t o t he sites b y  
t he sp o ns or. P C V 1 0 will be s o urce d l ocally b y  sites a n d sites will be rei m b urse d by t he 
sp o ns or .
St u d y I nter ve nti o n(s)
I nter ve nti o n N a me
C o nj u gate ca n di date 
(
- µg/ m L s us pe nsi o n 
wit h al u mi n u m 
p h os p hate [ Al P O4])
C o ntr ol (
- µg/ m L 
s us pe nsi o n wit h Al P O 4)
P C V 1 0
T y pe
Bi ol o gic
Bi ol o gic
Vacci ne
Use
E x peri me ntal
C o ntr ol
Sta n dar d of care (r o uti ne 
c hil d h o o d vacci ne )
I n vesti g ati o n al 
M e dici n al P r o d uct 
(I M P) or 
N o ni n vesti g ati o n al 
M e dici n al P r o d uct 
(NI M P )/ Au xili ar y 
M e dici n al P r o d uct 
(A x M P )
I M P
I M P
A x M P
D ose F or m ul ati o n
Pref or m ulate d s ol uti o n 
f or si n gle-use i njecti o n
Pref or m ulate d s ol uti o n 
f or si n gle-use i njecti o n
Si n gle -use prefille d 
s yri n ge ( P F S) or i n a vial
( de pe n di n g o n s o urci n g)
U nit D ose Stre n gt h(s)
µ g / m L m P n C
ca n di date
 µ g / m L ca n di date 
c o ntr ol
1 µ g of ser ot y pes 1, 5, 
6 B, 7 F, 9 V, 1 4, a n d 2 3 F, 
a n d 3 µ g of ser ot y pes 4, 
1 8 C, a n d 1 9 F
D os a ge V ol u m e(s)
0. 5 m L
0. 5 m L
0. 5 m L
R o ute of 
A d mi nistr ati o n
I ntra m usc ular i njecti o n 
I ntra m usc ular i njecti o n 
I ntra m usc ular i njecti o n
S o urci n g
Pr o vi de d ce ntrall y b y t he 
s p o ns or
Pr o vi de d ce ntrall y b y 
t he s p o ns or
S o urce d l ocall y
 
C CI
C CI
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 4
St u d y I nter ve nti o n(s)
P ac k a gi n g a n d 
L a beli n g
St u d y i nter ve nti o n will 
be pr o vi de d i n a 
si n gle-use vial. Eac h vial 
will be la bele d as 
re q uire d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n will 
be pr o vi de d i n a vial. 
Eac h vial will be la bele d 
as re q uire d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n will 
be pr o vi de d i n a P F S or 
i n a vial . Eac h P F S or 
vial will be la bele d as 
re q uire d per c o u ntr y 
re q uire me nt.
Si n gle Refere nce S afet y 
D oc u me nt ( S R S D )
I n vesti gat or’s br oc h ure 
(I B)
I B
S u m mar y of pr o d uct 
c haracteristics ( S m P C )
St u d y Ar m(s)
A r m  Title
m P n C ca n di date
m P n C c o ntr ol
D ose Le vel(s)
 µ g m P n C ca n di date per 0. 5 -m L 
d ose
 µ g c o ntr ol per 0. 5 -m L d ose
A r m  Descri pti o n
T his st u d y is a n o pe n -la bel st u d y. 
Partici pa nts will recei ve t he m P n C 
ca n di date at Visit 1 a n d Visit 3 
(a p pr o xi matel y 8 wee ks a part). 
P C V 1 0 will als o be gi ve n at Visit 1.
T his st u d y is a n o pe n -la bel st u d y. 
Partici pa nts will recei ve m P n C c o ntr ol at 
Visit 1 a n d Visit 3 ( a p pr o xi matel y
8 we e ks a part). P C V 1 0 will als o be gi ve n 
at Visit 1.
St atistic al Met h o ds:
T his is a P hase 2 o pe n -la bel descri pti ve st u d y wit h n o f or mal statistical c o m paris o ns pla n ne d . 
T he sa m ple size of t his st u d y  is n ot dri ve n b y a ny f or mal hy p ot hesis test. D escri pti ve 
s u m mar y statistics will be pr o vi de d f or eac h safet y a n d i m m u n o ge nicity e n d p oi nt/esti ma n d .
T he pri mar y  o bjecti ve is t o descri be t he safety pr ofile of t he m P n C ca n di date . T his will 
be d o ne b y s u m mar y statistics (i ncl u di n g c o u nts a n d perce nta ges of partici pa nts a n d t he
ass ociate d 2 -si de d 9 5 % CIs) f or l ocal reacti o ns, s yste mic e ve nts, A Es, a n d S A Es f or eac h
gr o u p.
T he sec o n dar y  o bjecti ve will be t o descri be t he i m m u n o ge nicity of t he m P n C ca n di date . T he
I g G G M Cs, I g G G M F Rs, O P A G M Ts , a n d O P A G M F Rs at eac h a p plica ble ti me p oi nt as 
well as t he c orres p o n di n g 9 5 % CIs f or eac h gr o u p will be pr o vi de d . T he descri pti ve statistics 
(i ncl u di n g c o u nts, perce nta ges , a n d t he ass ociate d 2 -si de d 9 5 % CIs) f or partici pa nts wit h 
pre defi ne d I g G c o nce ntrati o ns of t he ca n di date ser ot y pe will be pr o vi de d f or eac h gr o u p.
 
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 5
Et hic al C o nsi der ati o ns:
Partici pa nts e nr olle d i n t his st u d y  are fr o m c o u ntries w here t he rec o m me n de d i nfa nt P C V
d oes n ot c o ntai n ser oty pe 3. Recei vi n g t he m P n C ca n di date or m P n C c o ntr ol will n ot 
i nterfere wit h t he sta n dar d of care f or t hese partici pa nts a n d has t he p ote ntial t o pr o vi de 
a d diti o nal pr otecti o n.
T h is st u d y will be use d t o s u p p ort t he de vel o p me nt of t he m P n C ca n di date i n f ut ure 
p ne u m oc occal m ulti vale nt c o nj u gate vacci ne s t hat c o ul d p ote ntiall y be nefit a d ults a n d 
c hil dre n.
T he m P n C ca n di date was e val uat e d i n a P hase 1 a d ult st u d y, e x pl ori n g vari o us 
 f or ser oty pe 3 . 
 
 
 
T heref ore, t his m P n C 
ca n di date was selecte d f or f urt her de vel o p me nt, w hic h i ncl u des e val uati o n i n t he pe diatric 
p o p ulati o n. T he data ge nerate d fr o m t his st u d y  will pr o vi de a d diti o nal safet y a n d 
i m m u n o ge nicity data f or f ut ure de vel o p me nt .
T he m P n C c o ntr ol use d i n t his st u d y  is t he ser oty p e 3 
 use d i n t he a p pr o ve d
1 3 v P n C a n d 2 0 v P n C a n d has a n e xte nsi ve safet y hist or y . T he safety pr ofile of m P n C c o ntr ol
is e x pecte d t o be si milar t o 1 3 v P n C a n d 2 0 v P n C .
T he m ost c o m m o n A Es i n i nfa nts a n d t o d dlers after vacci nati o n wit h 1 3 v P n C or 2 0 v P n C are 
pri maril y  relate d t o l ocal reacti o ns (i njecti o n site pai n, re d ness, a n d s welli n g) a n d sys te mic 
e ve nts (fe ver, decrease d a p petite, dr o wsi ness/i ncrease d slee p, a n d irrita bilit y). Safety re vie ws 
of data fr o m t he 5 c o m plete d P hase 3 2 0 v P n C pe diatric (i nfa nts a n d t o d dlers) trials, i n 
a d diti o n t o ot her pe diatric 1 3 v P n C trials, de m o nstrate d a n acce pta ble safet y  pr ofile.
1. 2. Sc he m a
 
C CI
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 6
1. 3. S c he d ule of Acti v ities
T he S o A ta ble pr o vi des a n o ver vie w of t he pr ot oc ol visits a n d pr oce d ures. Refer t o t he St u d y  
Assess me nts A n d Pr oce d ures secti o n of t he pr ot oc ol f or detaile d i nf or mati o n o n eac h 
pr oce d ure a n d assess me nt re q uire d f or c o m plia nce wit h t he pr ot oc ol.
T he i n vesti gat or ma y  sc hed ule visits ( u n pla n ne d visits) i n a d diti o n t o t h ose liste d in t he S o A
ta ble, i n or der t o c o n d uct e val uati o ns or assess me nts re q uire d t o pr otect t he well-bei n g of t he 
partici pa nt .
Visit N u m ber
1
2
3
4
Visit Descri pti o n
D ose 1 Visit
D ose 1 
F oll o w - Up 
Visit
D ose 2 Visit
D ose 2 
F oll o w - Up 
Visit
Visit T y pe
Cli nic Visit
Cli nic Visit
Cli nic Visit
Cli nic Visit
Visit Wi n d o w ( D a ys)
D a y 1
2 8 t o 4 2 D a ys 
After Visit 1
5 6 t o 7 0 D a ys 
after Visit 1
2 8 t o 4 2 D a ys 
After Visit 3
O btai n i nf or me d c o nse nt
X
Assi g n partici pa nt n u m ber via t he 
I R T
X
Rec or d de m o gra p h y
X
Perf or m cli nical assess me nt, 
i ncl u di n g me dical hist or y
X
Rec or d vacci ne hist or y, i ncl u di n g 
pri or P C V 1 0 hist or y
X
Rec or d n o nst u d y vacci nati o ns a n d 
c o nc o mita nt me dicati o ns a
X
X
X
X
O btai n pre vacci nati o n 
t e mperat ure ( meas ure d as 
a p pr o priate f or a ge)
X
X
Re vie w i ncl usi o n a n d e xcl usi o n 
criteria
X
Re vie w t e mp or ar y  dela y criteria
X
X
Assi g n ra n d o mizati o n n u m ber
X
Re vie w c o nti n ue d eli gi bilit y
X
X
O btai n bl o o d sa m pleb
~ 5 m L 
~ 5 m L
~ 5 m L
A d mi nister st u d y i nter ve nti o n 
(m P n C ca n di date or m P n C 
c o ntr ol)
X
X
A d mi nister P C V 1 0
X
If a p plica ble, rec or d 
a d mi nistrati o n of per mitte d 
c o nc o mita nt vacci ne(s) (refer t o 
Secti o n 6. 9 )
X
X
X
X
O bser ve a n d rec or d i m me diate 
reacti o ns f or 3 0 mi n utes after 
st u d y i nter ve nti o n a d mi nistrati o n
X
X
Pr o vi de a partici pa nt c o ntact car d 
t o pare nt or le gal g uar dia n
X
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 7
Visit N u m ber
1
2
3
4
Visit Descri pti o n
D ose 1 Visit
D ose 1 
F oll o w - Up 
Visit
D ose 2 Visit
D ose 2 
F oll o w - Up 
Visit
Visit T y pe
Cli nic Visit
Cli nic Visit
Cli nic Visit
Cli nic Visit
Visit Wi n d o w ( D a ys)
D a y 1
2 8 t o 4 2 D a ys 
After Visit 1
5 6 t o 7 0 D a ys 
after Visit 1
2 8 t o 4 2 D a ys 
After Visit 3
Pr o vi de pare nt(s) or le gal 
g uar dia n wit h a n e -diar y ( de vice 
or a p plicati o n), t her m o meter, a n d 
meas uri n g de vice a n d i nstr uct 
t he m t o c ollect pr o m pte d l ocal 
reacti o ns a n d s yste mic e ve nts c
X
X
(if nee de d)
Re vie w e-diar y d
X -----------------------------------X  
X -----------------------------------X
C ollect e -diar y e
X
Rec or d a n d re p ort A Es a n d S A Es
X ---------------------------------------------------------------------X
a.
Rec or d c o nc o mita nt me dicati o ns use d t o treat S A Es .
b.
Bl o o d sa m ple will be c ollecte d pri or t o a d mi nistrati o n if it is a st u d y i nter ve nti o n a d mi nistrati o n visit.
c.
T he partici pa nt’s pare nt(s)/le gal g uar dia n will rec or d i n a n e -diar y pr o m pte d l ocal reacti o ns a n d s yste mic 
e ve nts occ urri n g wit hi n 7 da ys f oll o wi n g eac h d ose of st u d y i nter ve nti o n. Use of a nti p yretic/ pai n 
me dicati o ns will als o be pr o m pte d f or a n d c ollecte d dail y i n a n e -diar y f or 7 da ys after eac h d ose . T he 
partici pa nt’s pare nt(s)/le gal g uar dia n w ill be i nstr ucte d t o c o ntact t he st u d y staff if t he partici pa nt 
e x perie nces re d ness or s welli n g meas uri n g > 1 4 de vice u nits, se vere pai n at t he st u d y i nter ve nti o n 
i njecti o n site, or a fe ver > 4 0. 0° C ( > 1 0 4. 0° F) or has a n e mer ge nc y r o o m visit or h os pitalizati o n.
d.
Desi g nate d site staff will re vie w e -diar y data f or t he 7 da ys f oll o w i n g eac h d ose t o e val uate partici pa nt 
c o m plia nce a n d re p orte d e ve nts as part of t he o n g oi n g safet y re vie w.
e.
A n y e -diar y de vices gi ve n t o partici pa nts ’ pare nts or le gal g uar dia ns are t o be c ollecte d at Visit 4.
2. I N T R O D U C TI O N
S p ne u m o ni ae ca uses i n vasi ve disease (e g, me ni n gitis, se psis, bactere mic p ne u m o nia) a n d 
n o ni n vasi ve disease (e g, O M, n o n bactere mic p ne u m o nia, si n usitis) ass ociate d wit h a 
si g nifica nt healt hcare b ur de n, m or bi dit y, a n d m ortalit y.1 T he 1 3 -vale nt p ne u m oc occal 
c o nj u gate vacci ne ( Pre v nar 1 3 ; 1 3 v P n C) was lice nse d m ore t ha n a deca de a g o b y t he F D A 
a n d ot her re g ulat or y a ge ncies ar o u n d t he w orl d, i ncl u di n g t he E M A, f or use i n i nfa nts a n d 
y o u n g c hil dre n f or t he pre ve nti o n of p ne u m oc occal disease. 2 ,3 It was s u bse q ue ntl y i n dicate d 
f or pre ve nti o n of p ne u m o nia i n a d ults ≥1 8 y ears of a ge. 1 3 v P n C has bee n i ntr o d uce d i n t o 
NI P s f or pe diatric a n d a d ult p o p ulati o ns w orl d wi de.
Des pite si g nifica nt re d ucti o ns i n p ne u m oc occal disease f oll o wi n g use of 1 3 v P n C, a 
si g nifica nt b ur de n of p ne u m oc occal disease re mai ns.4 T he p ne u m oc occal 2 0 -vale nt c o nj u gate 
vacci ne ( 2 0 v P n C ; Pre v nar 2 0 ® ) was de vel o pe d t o e x pa n d pr otecti o n a gai nst IP D a n d 
p ne u m o nia a n d has bee n a p pr o ve d b y t he F D A a n d E M A f or a d ults ≥1 8 y ears of a ge. It is 
als o bei n g de vel o pe d f or pe diatric patie nts. 2 0 v P n C c o ntai ns t he i de ntical p ol y sacc hari de 
c o nj u gates a n d e xci pie nts as 1 3 v P n C, b ut wit h c o nj u gate p ol ys acc hari des f or 7 a d diti o nal 
ser ot ypes.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 8
B ot h 1 3 v P n C a n d 2 0 v P n C c o ntai n P n C 3, a n d t here is e vi de nce of direct pr otecti o n a gai nst 
I P D a n d p ne u m o nia d ue t o ser ot ype 3. 5 ,6 ,7 H o we ver, ser ot y pe 3 still acc o u nts f or resi d ual 
1 3 v P n C -t ype p ne u m oc occal disease i n c o u ntries t hat ha ve i ntr o d uce d 1 3 v P n C i nt o t heir 
NI P s. Th o u g h t here are a variet y of fact ors t hat c o ntri b ute t o t his, e n ha nc i n g t he i m m u ne 
res p o nse t o ser oty p e 3 ma y  ha ve a n i m pact o n resi d ual disease b ur de n.
2. 1. St u d y R ati o n ale
T he b ur de n of ser ot y pe 3 disease re mai ns a pr o ble m i n c hil dre n. I n E ur o pea n c hil dre n, t he 
V E of 1 3 v P n C a gai nst ser ot y pe 3 I PD was 5 5 % f or f ull y  vacci nate d c hil dre n ( 2 + 1 sc he d ule 
i n i nfa nts).8 H o we ver, wa ni n g V E was o bser ve d i n E n gla n d a n d Wales f or 1 3 v P n C a gai nst 
I P D d ue t o ser oty pe 3 a m o n g ol der c hil dre n 2 t o 9 y ears of a ge, b ut n ot f or t he ot her 1 3 v P n C 
ser ot ypes be y o n d 7 v P n C (e xcl u di n g ser ot y pe 3) .9 F urt her, ser ot y p e 3 is n o w t he m ost 
pre vale nt ser ot y pe ca usi n g I P D a n d O M i n c hil dre n 5 ye ars of a ge i n n u mer o us c o u ntries 
ar o u n d t he w orl d, i ncl u di n g Ger ma n y ( 3 5 % of O M cases i n c hil dre n 5 years of a ge) a n d 
A ustralia ( 2 8 % of I P D cases i n c hil dre n 5 y ears of a ge). 1 0 ,1 1 Effecti ve ness ma y  be i m pacte d 
b y  t he p hys ical pr o perties of t he p ol y sacc hari de ca ps ule t hat are u ni q ue a m o n g m ost ot her 
ser ot ypes as t he p ol ys acc hari de str uct ure facilitates i m m u ne e vasi o n b y  s he d di n g t he ca ps ule, 
t he pri mar y bi n di n g site of ne utralizi n g a nti b o dy. 1 2 M o dificati o n of t he c urre nt f or m ulati o n 
ma y  o verc o me t hese attri b utes t o i n d uce a str o n ger i m m u ne res p o nse t hat c o ul d pr o vi de 
greater pr otecti o n i n vacci nate d p o p ulati o ns.
T he p ur p ose of t he st u d y  is t o descri be t he safety a n d i m m u n o ge nicit y of a n m P n C ca n di date 
as a 2-d ose series i n t o d dlers w h o pre vi o usl y recei ve d P C V 1 0 as a 2-d ose pri mar y  series. T he 
safety a n d i m m u n o ge nicit y  res ults fr o m t his st u d y will c o ntri b ute t o f ut ure de vel o p me nt of 
p ne u m oc occal vacci ne f or m ulati o ns.
2. 2. B ac k gr o u n d
Precli nical st u dies ha ve de m o nstrate d t hat m o dif y i n g t he a p pr oac h t o ma n ufact uri n g ser oty pe 
3 c o nj u gates s u bsta ntiall y i ncreases t he le vels of a nti b o d y  elicite d. T his i ncrease i n i m m u ne 
res p o nse see n i n n o vel P n C 3 ca n di dates, if i nc or p orate d as part of a ne xt -ge nerati o n 
p ne u m oc occal vacci ne, ma y  pr o vi de greater pr otecti o n i n vacci nate d p o p ulati o ns,
partic ularl y i n i nfa nts a n d t o d dlers w h o are at hi g hest ris k f or I P D.4
A P hase 1 st u d y  i n a d ults was c o n d ucte d t o e val uate differe nt f or m ulati o ns t hat i ncl u de d
c ha n ges t o
, a n d/ or
 
T heref ore, t his m P n C 
ca n di date was selecte d f or f urt her de vel o p me nt, w hic h i n cl u des e val uati o n i n t he pe diatric 
p o p ulati o n.
 
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 1 9
2. 2. 1. Cli nic al O ver vie w
T he m P n C ca n di date selecte d f or use i n t his st u d y has m o dificati o ns t o t he 
 t he 
, a n d t he 
w he n c o m pare d t o t he ori gi nal 
ser ot ype f or m ulati o n f o u n d i n 1 3 v P n C a n d 2 0 v P n C . T hese m o dificati o ns ca n i ncrease t he 
i m m u ne res p o nse a n d i m pact c o nj u gate sta bility a n d i m m u n o ge nicity (see t he I B f or details).
2. 3. Be nefit/ Ris k Assess me nt
Partici pa nts will be e nr olle d i n t his st u d y fr o m c o u ntries w here t he rec o m me n de d i nfa nt P C V
d oes n ot c o ntai n ser oty pe 3. Recei vi n g t he m P n C ca n di date or m P n C c o ntr ol will n ot 
i nterfere wit h t he sta n dar d of care f or t hese partici pa nts a n d has t he p ote ntial t o pr o vi de 
a d diti o nal pr otecti o n.
T his st u d y  will be use d t o s u p p ort t he de vel o p me nt of f ut ure p ne u m oc occal m ulti vale nt 
c o nj u gate vacci nes t hat c o ul d p ote ntiall y be nefit a d ults a n d c hil dre n.
T he m P n C c o ntr ol use d i n t his st u d y  is t he ser oty p e 3 c o nj u gate use d i n t he a p pr o ve d
1 3 v P n C a n d 2 0 v P n C a n d ha s a n e xte nsi ve safet y hist or y . T he safety pr ofil e of m P n C c o ntr ol 
is e x pecte d t o be si milar t o 1 3 v P n C a n d 2 0 v P n C.
T he m ost c o m m o n A Es n ote d i n i nfa nts a n d t o d dlers after vacci nati o n wit h 1 3 v P n C a n d 
2 0 v P n C are pri maril y relate d t o l ocal reacti o ns (i njecti o n site pai n, re d ness, a n d s welli n g) 
a n d s yste mic e ve nts (fe ver, decrease d a p petite, dr o wsi ness/i ncrease d slee p, a n d irrita bilit y). 
Safet y  re vie ws of data fr o m t he 5 c o m plete d P hase 3 2 0 v P n C pe diatric (i nfa nts a n d t o d dlers) 
trials, i n a d diti o n t o ot her pe diatric 1 3 v P n C trials, re veale d n o safet y c o ncer ns.
As wit h a n y  vacci ne, a n aller gic reacti o n ca n occ ur. T he aller gic reacti o n ca n var y  fr o m s ki n 
ras h t o s welli n g of t he face or li ps, w heezi n g, a n d/ or s h ort ness of breat h. A se vere aller gic 
reacti o n (a na p hyl actic s h oc k, c olla pse, or s h oc k -li ke state [ h yp ot o nic -h y p ores p o nsi ve 
e pis o de]) ma y als o occ ur. There ma y  als o be a d diti o nal ris ks relate d t o t he vacci nes 
a d mi nistere d i n t he st u d y t hat are n ot k n o w n at t his ti me.
A d diti o nal p ote ntial ris ks of cli nical si g nifica nce are prese nte d i n t he ta ble i n
Secti o n 2. 3. 1 .
M ore detaile d i nf or mati o n a b o ut t he k n o w n a n d e x pecte d be nefits a n d ris ks a n d reas o na bl y 
e x pecte d A Es of t he m P n C ca n di date a n d m P n C c o ntr ol ma y  be f o u n d i n t he I B, w hic h is t he 
S R S D f or t his st u d y . F or P C V 10 , t he S R S D will be t he S m P C .
 
C CI
C CI
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 0
2. 3. 1. Ris k Assess me nt
P ote nti al Ris k of Cli nic al Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k
Miti g ati o n Str ate g y
St u d y I nter ve nti o n(s): m P n C c a n di d ate
a n d m P n C c o ntr ol
T he safet y pr ofile of t he m P n C ca n di date
is n ot yet f ull y c haracterize d. L ocal a n d 
s yste mic reacti o ns t o t he i n vesti gati o nal 
ser ot y pe ca n di date ma y occ ur (i njecti o n 
site re d ness, i njecti o n site s welli n g, a n d 
i njecti o n site pai n; fe ver, decrease d 
a p petite, i ncrease d slee p/ dr o wsi ness, a n d
irrita bilit y) f oll o wi n g st u d y i nter ve nti o n.
T he m P n C ca n di date ris ks are u n k n o w n. 
T he p ote ntial ris ks are detaile d i n t he I B.

Eli gi bilit y criteria ha ve bee n selecte d t o e ns ure t hat o nl y 
a p pr o priate partici pa nts are i ncl u de d i n t he st u d y (see
Secti o n 5. 1 a n d Secti o n 5. 2 ).

All st u d y partici pa nts will be o bser ve d f or 3 0 mi n utes after 
st u d y i nter ve nti o n a d mi nistrati o n.

E- diar y a n d A E data will be m o nit ore d b y t he i n vesti gat or 
( or desi g nee) a n d s p o ns or.
C o nc o m it a nt V acci ne: P C V 1 0
T he rele va nt ke y ris ks ass ociate d w it h 
P C V 1 0 i ncl u de l ocal reacti o ns (i njecti o n 
site pai n, re d ness, a n d s welli n g) a n d 
s yste mic e ve nts (fe ver, decrease d a p petite, 
i ncrease d slee p/ dr o wsi ness, a n d 
irrita bilit y). U nc o m m o n e ve nts ca n i ncl u de 
aller gic reacti o ns, w hic h ma y be ass ociate d 
wit h s ki n ras h, face or li p s welli n g, 
w heezi n g, s h ort ness of breat h, or rare 
se vere aller gic reacti o ns (e g, a na p h ylactic 
s h oc k).
T he ris ks are deri ve d fr o m t he relate d 
P C V 1 0 cli nical trials a n d p ost mar keti n g 
data a n d t he cli nical data descri be d i n t he 
P C V 1 0 S m P C .

Eli gi bilit y criteria ha ve bee n selecte d t o e ns ure t hat o nl y 
a p pr o priate partici pa nts are i ncl u de d i n t he st u d y see
Secti o n 5. 1 a n d Secti o n 5. 2 ).

All st u d y partici pa nts will be o bser ve d f or 3 0 mi n utes after 
vacci nati o n.

E- diar y a n d A E data will be m o nit ore d b y t he i n vesti gat or 
( or desi g nee) a n d s p o ns or.
St u d y Pr oce d ures: Ve ni p u nc t ure
Ve ni p u nct ure is re q uire d t o c ollect 
i m m u n o ge nicit y data fr o m partici pa nts.
T here is t he ris k of fai nti n g, a n d pai n, 
s welli n g, br uisi n g, a n d i nfecti o n at t he 
ve ni p u nct ure site.
O nl y q ualifie d n urses, p h ysicia ns, n urse practiti o ners, p h ysicia n 
assista nts, p hle b ot o mists, or me dical assista nts certifie d or 
ot her wise a ut h orize d t o dra w  bl o o d per t he sta n dar ds a n d 
pr oce d ures of t he i n vesti gati ve site, as all o we d b y i nstit uti o nal, 
l ocal, a n d c o u ntr y g ui da nce, will be all o we d t o dra w bl o o d, t o 
mi ni miz e l ocal c o m plicati o ns.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 1
P ote nti al Ris k of Cli nic al Si g nific a nce
S u m m ar y of D at a/ R ati o n ale f or Ris k
Miti g ati o n Str ate g y
Ot her
Partici pa nts a n d t heir care gi vers wi ll be 
re q uire d t o atte n d healt hcare facilities 
d uri n g t he gl o bal S A R S -C o V -2 pa n de mic.
Wit h o ut a p pr o priate s ocial dista nci n g a n d 
P P E, t here is a p ote ntial f or i ncrease d 
e x p os ure t o S A R S -C o V -2.
Pfizer w ill w or k wit h sites t o e ns ure a n a p pr o priate C O VI D-1 9 
pre ve nti o n strate g y.
M o nit ori n g f or cases of C O VI D -1 9 d uri n g t he st u d y as part of t he 
C O VI D -1 9 s ur veilla nce.
 
T)

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 2
2. 3. 2. Be nefit Assess me nt
P artici pa nts i n cli nical st u dies ma y  n ot directl y be nefit fr o m partici pati o n, as cli nical st u dies 
are desi g ne d t o pr o vi de i nf or mati o n a b o ut t he safet y a n d i m m u n o ge nicit y of a n 
i n vesti gati o nal vacci ne . J oi ni n g t his st u d y will be c o ntri b uti n g t o researc h t o hel p ot hers. T h e 
m P n C ca n di date c o ul d be use d i n a f ut ure i n vesti gati o nal e x pa n de d -vale nt P C V . A safe a n d 
i m m u n o ge nic P C V wit h e x pa n de d p ne u m oc occal ser ot y pe c o vera ge w o ul d f ulfill a n u n met 
nee d f or e x pa n de d pr otecti o n a gai nst p ne u m oc occal disease.
2. 3. 3. O ver all Be nefit /Ris k C o ncl usi o n
Partici pa nts e nr olle d i n t his st u d y  are fr o m c o u ntr ies w here t he rec o m me n de d i nfa nt P C V 
pr o vi de d d oes n ot c o ntai n ser ot ype 3. Recei vi n g t he m P n C ca n di date or m P n C c o ntr ol will 
n ot i nterfere wit h sta n dar d of care f or t hese partici pa n ts a n d has t he p ote ntial t o pr o vi de 
a d diti o nal pr otecti o n .
T h is st u d y will be use d t o s u p p ort t he de vel o p me nt of f ut ure p ne u m oc occal m ulti vale nt 
c o nj u gate vacci nes t hat c o ul d p ote ntiall y be nefit a d ults a n d c hil dre n.
C o nsi deri n g t he meas ures t o mi ni mize ris k t o st u d y partici pa nts, t he p ote ntial ris ks i de ntifie d 
i n ass ociati o n wit h t he m P n C ca n di date are j ustifie d b y t he p ote ntial be nefits t hat ma y  be 
aff or de d t o partici pa nts w h o ma y  be at ris k of I PD d ue t o t heir y o u n g a ge .
3. O B J E C TI V E S, E N D P OI N T S, A N D E S TI M A N D S
O bjecti ves
E n d p oi nts
Esti m a n ds
Pri m ar y:
Pri m ar y:
Pri m ar y:

T o descri be t he safet y 
pr ofile of t he m P n C 
ca n di date a d mi nistere d 
as a 2 -d ose series i n 
c hil dre n ≥1 1 t o 
≤1 5 m o nt hs of a ge

Pr o m pte d l ocal reacti o ns 
(re d ness, s welli n g, a n d 
pai n at t he i njecti o n site)

Pr o m pte d s yste mic e ve nts 
(fe ver, decrease d a p petite,
dr o wsi ness/i ncrease d 
slee p, a n d irrita bilit y)

A E s

S A Es
I n partici pa nts recei vi n g at least 1 d ose of t he 
st u d y i nter ve nti o n fr o m eac h gr o u p, t he 
perce nta ge of partici pa nts re p orti n g:

Pr o m pte d l ocal reacti o ns wit hi n 7 da ys 
after eac h d ose

Pr o m pte d s yste mic e ve nts wit hi n 7 da ys 
after eac h d ose

A E s fr o m D ose 1 t hr o u g h 1 m o nt h after 
D ose 2

S A Es fr o m D ose 1 t hr o u g h 1 m o nt h 
after D ose 2
Sec o n d ar y:
Sec o n d ar y:
Sec o n d ar y:

T o descri be t he 
i m m u ne res p o nses 
elicite d b y t he m P n C 
ca n di date

I g G co nce ntrati o ns f or t he 
ca n di date ser ot y pe
I n partici pa nts i n c o m plia nce wit h t he ke y 
pr ot oc ol criteria ( e val ua ble partici pa nts )
fr o m eac h gr o u p:

P ne u m oc occal I g G G M C s 1 m o nt h after 
D ose 1 a n d 1 m o nt h after D ose 2

Perce nta ges of partici pa nts wit h 
pre defi ne d I g G c o nce ntrati o n 1 m o nt h 
after D ose 1 a n d 1 m o nt h after D ose 2
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 3
O bjecti ves
E n d p oi nts
Esti m a n ds

P ne u m oc occal I g G G M F R s fr o m bef ore 
D ose 1 t o 1 m o nt h after D ose 1 a n d fr o m 
1 m o nt h after D ose 1 t o 1 m o nt h after 
D ose 2

O P A titers f or t he 
ca n di date ser ot y pe

P ne u m oc occal O P A G M T s 1 m o nt h 
after D ose 1 a n d 1 m o nt h after D ose 2

P ne u m oc occal O P A G M F R s fr o m 
bef ore D ose 1 t o 1 m o nt h after D ose 1 
a n d fr o m 1 m o nt h after D ose 1 t o 
1 m o nt h after D ose 2
E x pl or at or y :
E x pl or at or y:
E x pl or at or y:

T o be descri be d i n t he S A P

T o be descri be d i n t he S A P
4. S T U D Y D E SI G N
4. 1. O ver all Desi g n
T his is a P hase 2 , m ultice nter, ra n d o mize d, o pe n -la bel st u d y t o descri be t he safety a n d 
i m m u n o ge nicity of a n m P n C ca n di date as a 2-d ose series i n healt h y  t o d dlers 1 1 t hr o u g h 
1 5 m o nt hs of a ge. T his st u d y  will be c o n d ucte d at i n vesti gat or sites i n t he E U. 
A p pr o xi matel y  1 0 0 c hil dre n bet wee n 1 1 a n d 1 5 m o nt hs of a ge w h o pre vi o usl y recei ve d t he 
2- d ose P C V 1 0 i nfa nt pri mar y  series as part of t heir r o uti ne vacci nes will be e nr olle d. 
Partici pa nts will be e nr olle d a n d ra n d o mize d i n a 1: 1 rati o b y  site-base d ra n d o mizati o n t o 
recei ve eit her t he m P n C ca n di date or t he co ntr ol ( m P n C c o ntr ol ) as a 2-d ose series at Visit 1 
a n d Visit 3; partici pa nts will recei ve t he sa me st u d y i nter ve nti o n (eit her m P n C ca n di date or 
m P n C c o ntr ol ) f or b ot h d oses. Partici pa nts will be o bse r ve d f or 3 0 mi n utes after eac h d ose. 
Partici pa nts will als o recei ve t heir t o d dler (t hir d) d ose of P C V 1 0 c o nc o mita ntl y at Visit 1.
Ot her r o uti ne c hil d h o o d vacci nes as rec o m me n de d b y l ocal sta n dar d of care m a y  be 
a d mi nistere d d uri n g st u d y  partici pati o n. Pr o hi bite d vacci nes (see Secti o n 6. 9. 1 ) are n ot 
all o we d. Li ve vacci nes ma y o nly be a d mi nistere d c o nc o mita ntl y  wit h st u d y i nter ve nti o n at 
Visit 1 a n d/ or Visit 3 or be a d mi nistere d at least 2 8 da ys bef ore or after st u d y i nter ve nti o n 
a d mi nistrati o n (see Secti o n 6. 9. 2 ).
O n Da y  1 ( Visit 1), partici pa nts will be assesse d f or eli gi bilit y, ha ve i nf or mati o n c ollecte d, 
i ncl u di n g me dical hist or y a n d vacci ne hist or y, a n d ha ve bl o o d dra w n ( ~ 5 m L ) f or 
i m m u n o ge nicity assess me nts pri or t o rec ei vi n g t heir st u d y i nter ve nti o n a n d P C V 1 0. 
Te m perat ure , meas ure d as a p pr o priate f or t he partici pa nt’s a ge, will be ta ke n, a n d te m p orar y  
dela y  criteria will be re vie we d pri or t o st u dy i nter ve nti o n a d mi nistrati o n. U p o n c o nfir mati o n 
of eli gi bilit y , partici pa nts will be ra n d o mize d t o recei ve D ose 1 of t he m P n C ca n di date or t he 
m P n C c o ntr ol , as well as t heir t o d dler d ose of P C V 1 0 . St u d y  i nter ve nti o n (m P n C ca n di date
or m P n C c o ntr ol ) will be a d mi nistere d i ntra m usc ularl y i nt o t he left a nter olateral t hi g h, w hile 
P C V 1 0 will be a d mi nistere d i ntra m usc ularl y  i nt o t he ri g ht a nter olateral t hi g h. Ot her r o uti ne
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 4
c hil d h o o d vacci nes , if all o we d (see Secti o n 6. 9 ), ma y  be a d mi nistere d at t his visit i nt o a 
differe nt li m b ot her t ha n t he site of t he st u d y  i nter ve nti o n i njecti o n. Partici pa nts will be 
o bser ve d f or 3 0 mi n utes after a d mi nistrati o n of st u d y i nter ve nti o n a n d a n y reacti o ns 
occ urri n g d uri n g t hat ti me will be rec or de d as A Es . T he pare nt(s)/le gal g uar dia n will be 
pr o vi de d wit h a n e -diar y  ( or e-diar y  a p plicati o n), t her m o meter, a n d meas uri n g de vice a n d 
i nstr ucte d t o c ollect pr o m pte d l ocal reacti o ns (re d ness, s welli n g, a n d pai n at t he i njecti o n 
site) a n d pr o m pte d sys te mic e ve nts (fe ver, decrease d a p petite, dr o wsi ness/i ncrease d slee p, 
a n d irrita bilit y) occ urri n g wit hi n 7 da ys after a d mi nistrati o n of st u d y i nter ve nti o n. Use of 
a nti p yretic/ pai n me dicati ons will als o be pr o m pte d f or a n d c ollecte d dail y i n t he e-diar y  f or 
7 da y s after a d mi nistrati o n of st u d y i nter ve nti o n . T he partici pa nt’s pare nt(s)/le gal g uar dia n 
will be i nstr ucte d t o c o ntact t he st u d y staff if t he partici pa nt e x perie nces re d ness or s welli n g 
1 4 cali per u nits (7 c m), se vere pai n at t he st u d y i nter ve nti o n i njecti o n site, or fe ver 
4 0. 0° C ( 1 0 4. 0 °F) or has a n e mer ge nc y  r o o m visit or h os pitalizati o n i n t he 7 da ys after 
vacci nati o n.
At Visit 2 ( 2 8 -4 2 da y s after Visit 1), partici pa nts will ret ur n f or f oll o w- u p a n d bl o o d dra w. 
I nf or mati o n will be c ollecte d fr o m t he partici pa nts’ pare nts/le gal g uar dia ns o n A Es, S A Es, 
a n d e-diar y  f oll o w-u p (as nee de d). C o nc o mita nt me dicati o ns use d t o treat S A Es will be 
rec or de d. I nf or mati o n o n vacci nes a d mi nistere d si nce t he last visit will als o be rec or de d t o 
e ns ure t hat t he partici pa nt di d n ot recei ve pr o hi bite d vacci ne(s) d uri n g t his peri o d. Bl o o d 
( ~ 5 m L ) will be dra w n f or i m m u n o ge nicity assess me nts. Ot her r o uti ne c hil d h o o d vacci nes, 
if all o we d (see Secti o n 6. 9 ), ma y be a d mi nistere d at t his visit. If a p plica ble, re mi n d t he 
pare nt(s)/le gal g uar dia n t o bri n g e -diar y  de vice f or t he ne xt visit.
At Visit 3 ( 5 6 -7 0 da y s after Visit 1), partici pa nts will ret ur n f or D ose 2. Partici pa nts will be 
assesse d f or c o nti n ue d eli gi bilit y  a n d i nf or mati o n will be c ollecte d fr o m t he partici pa nts’ 
pare nts/le gal g uar dia ns o n A Es, i ncl u di n g n o nseri o us A Es a n d S A Es. C o nc o mita nt 
me dicati o ns use d t o treat S A Es will be rec or de d. I nf or mati o n o n vacci nes a d mi nistere d si nce 
t he last visit will als o be rec or de d. Te m perat ure, meas ure d as a p pr o priate f or t he partici pa nt’s 
age, will be ta ke n, a n d te m p orar y  dela y criteria will be re vie we d pri or t o st u d y i nter ve nti o n 
a d mi nistrati o n. Partici pa nts wit h c o nti n ue d eli gi bilit y  will be a d mi nistere d D ose 2 i nt o t he 
left a nter olateral t hi g h, o bser ve d f or 3 0 mi n utes, a n d gi ve n t he sa me i nstr ucti o ns as i n Visit 1.
Ot her r o uti ne c hil d h o o d vacci nes, if all o we d (see Secti o n 6. 9 ), ma y  be a d mi nistere d at t his 
visit i nt o a differe nt li m b ot her t ha n t he site of t he st u d y  i nter ve nti o n i njecti o n.
T he pare nt(s)/le gal g uar dia n will be i nstr ucte d t o c ollect pr o m pte d l ocal reacti o ns a n d 
s yste mic e ve nts occ urri n g wit hi n 7 da ys after a d mi nistrati o n of st u d y i nter ve nti o n usi n g 
t he e-diar y  de vice pr o vi de d at Visit 1 ( or e-diar y  a p plicati o n d o w nl oa de d at Visit 1).
Use of a nti p yr etic/ pai n me dicati o ns will als o be pr o m pte d f or a n d c ollecte d dail y  i n t he 
e-diar y  f or 7 da ys after a d mi nistrati o n of st u d y i nter ve nti o n. T he partici pa nt’s pare nt(s)/le gal 
g uar dia n will be i nstr ucte d t o c o ntact t he st u d y  staff if t he partici pa nt e x perie nces re d ness or 
s welli n g 1 4 cali per u nits, se vere pai n at t he st u d y i nter ve nti o n i njecti o n site, or fe ver 
4 0. 0° C ( 1 0 4. 0 °F) or has a n e mer ge nc y  r o o m visit or h os pitalizati o n.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 5
At Visit 4 ( 2 8- 4 2 d a y s after Visit 3 ), partici pa nts will ret ur n f or f oll o w- u p a n d bl o o d dra w . 
I nf or mati o n will be c ollecte d fr o m t he partici pa nts’ pare nts/le gal g uar dia ns o n A Es, S A Es, 
a n d e-diar y  f oll o w-u p (as nee de d). C o nc o mita nt me dicati o ns use d t o treat S A Es will be 
rec or de d. I nf or mati o n o n vacci nes a d mi nistere d si nce t he last visit will be revie we d . Bl o o d 
( ~ 5 m L ) will be dra w n f or i m m u n o ge nicity assess me nts. Ot her r o uti ne c hil d h o o d vacci nes, 
if all o we d (see Secti o n 6. 9 ), ma y be a d mi nistere d at t his visit. T he e -diar y  de vice will be 
c ollecte d, if a p plica ble.
4. 2. Scie ntific R ati o n ale f or St u d y Desi g n
4. 2. 1. C o u ntr y Selecti o n
T he st u d y  will be c o n d ucte d i n c o u ntries w here P C V 1 0 is part of t he NI P , as P C V 1 0 d oes n ot 
c o ntai n p ne u m oc occal ser ot y pe 3 c o nj u gate .
4. 2. 2. R ati o n ale f or Selecti o n of T o d dler P o p ul ati o n
T o d dlers 1 1 t hr o u g h 1 5 m o nt hs of a ge are t he selecte d p o p ulati o n f or t his st u d y f or se veral 
reas o ns. I nfa nts a n d t o d dlers ha ve p o or i m m u n e res p o nses t o p ol ysacc hari de vacci nes, s uc h 
as P P S V 2 3, beca use t he p ol y sacc hari de a nti ge n elicits a T-i n de pe n de nt i m m u ne res p o nse t hat 
re q uires s pecialize d mar gi nal -z o ne B cells, w hic h d e vel o p after 2 ye ars of a ge. 1 3 C o nj u gati o n 
of a n i m m u n o ge nic pr otei n t o a bacterial ca ps ular p ol y sacc hari de c o n verts t he T- i n de pe n de nt 
p ol y sacc hari de a nti ge n i nt o a T-de pe n de nt a nti ge n ca pa ble of eliciti n g r o b ust a nti b o d y 
res p o nses i n c hil dre n 2 ye ars of a ge. T h us, d ue t o the s pecific li mitati o ns i n t he 
i nfa nt/t o d dler i m m u ne res p o nse t o p ol ysacc hari de a nti ge ns, it is necessar y  t o e val uate t he 
a bilit y of t he m P n C ca n di date t o perf or m as a p ol ysacc hari de c o nj u gate vacci ne i n t his 
p o p ulati o n . 
T he 1 1 t o 1 5 m o nt h s a ge ra n ge ali g ns wit h nati o nal rec o m me n dati o ns f or P C V b o oster d oses 
i n t he rele va nt c o u ntries w here t he st u dy is c o n d ucte d , a n d P C V 1 0 is rec o m me n de d i n t he 
NI P. I m p orta ntl y f or t he o bjecti ves of t he st u dy, P C V 1 0 d oes n ot i ncl u de ser ot y pe 3 .
T heref ore , t o d dlers partici pati n g i n t he st u d y  will be i m m u n ol o gically naï ve t o ser oty pe 3 
vacci nati o n , t h us e na bli n g e val uati o n of pri mar y res p o nses t o t he m P n C st u d y i nter ve nti o n. 
F urt her m ore , the ris k of I P D a n d t he nee d f or its o pti mal pre ve nti o n is t he hi g hest i n t he 
i nfa nt a n d y o u n g c hil d ( ≤4 ye ars of a ge ) a ge gr o u p.4 P ne u m oc occal carria ge rates pea k i n t his 
a ge gr o u p, dri vi n g ser ot y pe 3 disease pre vale nce a n d tra ns missi o n wit hi n t his a ge gr o u p a n d
ol der c hil dre n a n d a d ults. 1 4 T heref ore, i m pr o ve d ser ot ype 3 res p o nses wit h t he p ote ntial f or
decrease d nas o p har y n geal carria g e i n t his p o p ulati o n c o ul d s u bsta ntiall y i m pact t he o verall 
i nci de nce of disease a n d her d i m m u nit y at a p o p ulati o n le vel.  
Fi nall y , ro b ust safet y data fr o m t he a d ult P hase 1 st u d y a n d precli nical st u dies (see 
Secti o n 2. 2 a n d t he I B f or details) s u p p ort t he selecti o n of t his p o p ulati o n i n t his P hase 2
trial.  
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 6
4. 2. 3. R ati o n ale f or C o m p ar at or
T his st u d y  will use a direct c o m parat or, m P n C c o ntr ol , w hic h is t he c urre nt f or m ulati o n f or 
ser ot ype 3 use d i n t he a p pr o ve d 1 3 v P n C a n d 2 0 v P n C vacci nes . T he m P n C c o ntr ol c o ntai ns 
 µg of 
 f or ser oty pe 3 a n d uses
wit h 
 
4. 3. J ustific ati o n f or D ose
T he m P n C ca n di date was e val uate d i n a P hase 1 a d ult st u d y t hat e x pl ore d vari o us 
 f or m P n C 3. 
 
 
 
T heref ore, 
t his m P n C ca n di date was selecte d f or f urt her de vel o p me nt, w hic h i ncl u des e val uati o n i n t he 
pe diatric p o p ulati o n.
T he m P n C ca n di date c o ntai ns  
 µ g/ d ose of ser ot y pe 3 p ol ys acc hari de usi n g t he  
 
 wit h 
.
 
I n d ose-ra n gi n g st u dies 
wit h i n vesti gati o nal vacci nes a n d wit h 1 3 v P n C, i m m u ne res p o nses were at ti mes hi g her, b ut 
n ot c o nsiste ntl y , lea vi n g d ose-res p o nse t o re mai n i n q uesti o n. T he safety pr ofile was 
acce pta ble e ve n at t he hi g hest d oses i n t hese st u dies. 1 5 ,1 6 ,1 7
T he hi g hes t d oses of t he m P n C ca n di date ha ve bee n teste d i n n o ncli nical t o xicit y  st u dies 
(see t he I B f or details). N o si g nifica nt a d verse effects were see n wit h a ni mal data i n rats at 
t he hi g hest d ose ra n ge.
4. 4. E n d of St u d y Defi niti o n
T he e n d of t he st u d y is defi ne d as t he date of t he last visit of t he last partici pa nt i n t he st u d y.
A partici pa nt i s c o nsi dere d t o ha ve c o m plete d t he st u d y if t he y ha ve c o m plete d all peri o ds of 
t he st u d y, i ncl u di n g t he last visit.
5. S T U D Y P O P U L A TI O N
T his st u d y  ca n f ulfill its o bjecti ves o nl y if a p pr o priate partici pa nt s are e nr olle d, i ncl u di n g 
partici pa nts acr oss di verse a n d re prese ntati ve racial a n d et h nic bac k gr o u n ds. If a 
prescree n i n g t o ol is utilize d f or st u dy recr uit me nt p ur p oses , it will i ncl u de c ollecti o n of 
i nf or mati o n t hat reflects t he e nr oll me nt of a di verse partici pa nt p o pulati o n i ncl u di n g, w here 
per mitte d u n der l ocal re g ulati o ns, a ge, se x, race, a n d et h nicit y . T he f oll o wi n g eli gi bilit y 
criteria are desi g ne d t o select partici pa nt s f or w h o m partici pati o n i n t he st u d y  is c o nsi dere d 
a p pr o priate. All rele va nt me dical a n d n o n me d ical c o n diti o ns s h o ul d be ta ke n i nt o 
c o nsi derati o n w he n deci di n g w het her a partic ular partici pa nt is s uita ble f or t his pr ot oc ol.
 
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 7
Pr os pecti ve a p pr o val of pr ot oc ol de viati o ns t o recr uit me nt a n d e nr oll me nt criteria , als o 
k n o w n as pr ot oc ol wai vers or e xe m pti o n s, is n ot per mitte d.
5. 1. I ncl usi o n Criteri a
Partici pa nts are eli gi ble t o be i ncl u de d i n t h is st u d y o nl y if all of t he f oll o wi n g criteria a p ply:
A ge a n d Se x :
1.
T o d dlers ≥1 1 t o ≤1 5 m o nt hs of a ge at t he ti me of c o nse nt .
Dise ase C h ar acteristics:
2.
Ha ve recei ve d e xactl y  2 i nfa nt d oses of P C V 1 0 acc or di n g t o a l ocal i m m u nizati o n 
sc he d ule. D oc u me nte d c o nfir mati o n of P C V 1 0 recei pt will be c ollecte d pri or t o 
ra n d o mizati o n. T he last d ose of P C V 1 0 m ust ha ve bee n a d mi nistere d 5 6 da y s bef ore 
e nr oll me nt i nt o t he st u d y.
Ot her I ncl usi o n Criteri a :
3.
Partici pa nts w h ose pare nt(s)/le gal g uar dia n is willi n g a n d a ble t o c o m pl y wit h all 
sc he d ule d i n-cli nic visits, st u d y sc he d ule, a n d ot her st u d y pr oce d ures, i ncl u di n g bl o o d 
dra ws .
4.
Healt h y t o d dlers deter mi ne d b y  cli nical assess me nt, i ncl u di n g me dical hist or y a n d 
cli nical j u d g me nt, t o be eli gi ble f or t he st u d y.
5.
E x pecte d t o be a vaila ble f or t he d urati o n of t he st u d y  a n d w h ose pare nt(s)/le gal g uar dia n 
ca n be c o ntacte d b y tele p h o ne d uri n g st u d y  partici pati o n.
6.
Partici pa nts w h ose pare nt(s)/le gal g uar dia n is ca pa ble of gi vi n g si g ne d i nf or me d c o nse nt 
as descri be d i n A p pe n di x 1 , w hic h i ncl u des c o m plia nce wit h t he re q uire me nts a n d 
restricti o ns liste d i n t he I C D a n d i n t his pr ot oc ol.
5. 2. E xcl usi o n Criteri a
Partici pa nts are e xcl u de d fr o m t he st u d y  if a n y of t he f oll o wi n g criteria a p pl y:
Me dic al C o n diti o ns:
1.
Hist or y  of se vere a d verse reacti o n ass ociate d wit h a vacci ne a n d/ or se vere aller gic
reacti o n (e g, a na p hyl a xis) t o a n y c o m p o ne nt of t he st u d y i nter ve nti o n, 1 3 v P n C, 2 0 v P n C, 
or a n y di p ht heria t o x oi d -c o ntai ni n g vacci ne.
2.
S i g nifica nt ne ur ol o gical dis or der or hist or y of seiz ure (e xcl u di n g fe brile seiz ure) or 
si g nifica nt sta ble or e v ol vi n g dis or ders s uc h as cere bral pals y, e nce p hal o pat h y, 
h y dr oce p hal us, or ot her si g nifica nt dis or ders.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 8
3.
Maj or k n o w n c o n ge nital malf or mati o n or seri o us c hr o nic dis or der.
4.
Hist or y  of micr o bi ol o gicall y pr o ve n i n vasi ve disease ca use d b y S p ne u m o ni ae.
5.
K n o w n or s us pecte d i m m u n o deficie nc y  or ot her c o n diti o ns ass ociate d wit h
i m m u n os u p pressi o n, i ncl u di n g, b ut n ot li mite d t o, i m m u n o gl o b uli n class/s u bclass
deficie ncies, Di Ge or ge s y n dr o me, ge neralize d mali g na nc y , HI V i nfecti o n, le u ke mia,
l ym p h o ma, or or ga n or b o ne marr o w tra ns pla nt.
6.
Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d blee di n g t ha t w o ul d, i n t he
o pi ni o n of t he i n vesti gat or, c o ntrai n dicate i ntra m usc ular i njecti o n.
7.
C o n ge nital, f u ncti o nal, or s ur gical as ple nia.
8.
Ot her me dical c o n diti o n or la b orat or y  a b n or malit y t hat ma y i ncrease t he ris k of st u d y
partici pati o n or st u d y i nter ve nti o n a d mi nistrati o n or ma y i nterfere wit h t he i nter pretati o n 
of st u d y  res ults a n d, i n t he j u d g me nt of t he i n vesti gat or , w o ul d ma ke t he partici pa nt 
i na p pr o priate f or e ntr y i nt o t his st u d y.
9.
Pre vi o us vacci nati o n wit h a n y  lice nse d p ne u m oc occal vacci ne ( ot her t ha n t he P C V 1 0 
pri mar y  i nfa nt series) or i n vesti gati o nal p ne u m oc occal vacci ne, or pla n ne d recei pt of 
n o nst u d y  p ne u m oc occal vacci ne d uri n g st u d y partici pati o n.
1 0. C urre ntl y  recei ves treat me nt wit h i m m u n os u p pressi ve t hera p y, i ncl u di n g c yt ot o xic a ge nts
or s y ste mic c ortic oster oi ds, or pla n ne d recei pt t hr o u g h t he last bl o o d dra w. If s ys te mic
c ortic oster oi ds ha ve bee n a d mi nistere d s h ort ter m ( 1 4 da y s) f or treat me nt of a n ac ute 
ill ness, partici pa nts s h o ul d n ot be e nr olle d i n t he st u d y u ntil c ortic oster oi d t hera p y has 
bee n disc o nti n ue d f or at least 2 8 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n. 
I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical ( e g, s ki n, e yes, or ears) 
c ortic oster oi ds are per mitte d.
1 1. Recei pt of bl o o d/ pl as ma pr o d ucts or i m m u n o gl o b uli ns (i ncl u di n g he patitis B 
i m m u n o gl o b uli n) or pla n ne d recei pt t hr o u g h t he last pla n ne d bl o o d dra w i n t he st u d y
(t hr o u g h Visit 4).
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:
1 2. Partici pati o n i n ot her st u dies i n v ol vi n g i n vesti gati o nal dr u g(s), i n vesti gati o nal vacci nes, 
or i n vesti gati o nal de vices wit hi n 2 8 da y s pri or t o st u d y e ntr y a n d/ or d uri n g st u d y 
partici pati o n or i ntra uteri ne e x p os ure t o i n vesti gati o nal vacci nes. A n e xce pti o n t o t his is 
a n i n vesti gati o nal vacci ne a ut h orize d b y  the nati o nal re g ulat or y  a ge nc y f or use i n i nfa nts 
or t o d dlers t o pre ve nt pa n de mic disease. Partici pati o n i n p urel y o bser vati o nal st u dies is 
acce pta ble .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 2 9
Di a g n ostic Assess me nts:
N ot a p plica ble.
Ot her E xcl usi o n Criteri a :
1 3. C hil dre n or gra n dc hil dre n w h o are direct desce n da nts of i n vesti gat or site staff or s p o ns or 
a n d s p o ns or dele gate e m pl o y ees directl y i n v ol ve d i n t he c o n d uct of t he st u d y .
5. 3. Lifest yle C o nsi der ati o ns
N ot a p plica ble. N o restricti o ns are re q uire d.
5. 4. Scree n F ail ures
Scree n fail ures are defi ne d as par tici pa nts w h ose pare nts/le gal g uar dia ns ha ve c o nse nte d f or 
t he m t o partici pate i n t he cli nical st u d y b ut are n ot s u bse q ue ntl y ra n d o ml y assi g ne d t o st u d y 
i nter ve nti o n. A mi ni mal set of scree n fail ure i nf or mati o n is re q uire d t o e ns ure tra ns pare nt 
re p orti n g of scree n fail ure partici pa nts t o meet t he C O N S O R T p u blis hi n g re q uire me nts a n d 
t o res p o n d t o q ueries fr o m re g ulat or y a ut h orities. Mi ni mal i nf or mati o n i ncl u des de m o gra p h y, 
scree n fail ure details, eli gi bilit y criteria, a n d a n y S A Es rec or de d fr o m si g ni n g t he i nf or me d 
c o nse nt u ntil t he ti me of deter mi nati o n of scree n fail ures .
I n di vi d uals w h o d o n ot meet t he criteria f or partici pati o n i n t his st u d y (scree n fail ures) ma y 
n ot be rescree ne d.
5. 5. Criteri a f or Te m p or aril y Del a yi n g E nr oll me nt/ R a n d o miz ati o n/ A d mi nistr at i o n of 
St u d y I nter ve nti o n
T he f oll o wi n g c o n diti o ns are te m p orar y or self-li miti n g a n d a partici pa nt ma y be vacci nate d 
o nce t he c o n diti o n (s) has/ha ve res ol ve d , a n d n o ot her e xcl usi o n criteria are met .
T he bl o o d dra ws pri or t o a d mi nistrati o n of st u d y i nter ve ntio n s h o ul d ta ke place o n t he sa me 
da y  as t he a d mi nistrati o n of st u d y i nter ve nti o n.

C urre nt fe brile ill ness ( b o d y  te m perat ure ≥3 8. 0° C [ ≥1 0 0. 4 °F] ) or ot her ac ute ill ness 
wit hi n 4 8 h o urs bef ore st u d y  i nter ve nti o n a d mi nistrati o n.

Recei pt of a n y li ve vacci ne wit hi n 2 8 da y s bef ore st u d y i nter ve nti o n a d mi nistrati o n or 
a ntici pate recei pt of a n y l i ve vacci ne wit hi n 2 8 da ys after st u d y i nter ve nti o n 
a d mi nistrati o n.
o
L ice nse d li ve vacci ne (s) a d mi nistere d o n t he sa me da y  as st u d y i nter ve nti o n at Visit 1 
a n d/ or Visit 3 is/are per mitte d (Secti o n 6. 9. 2 ).
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 0

Recei pt of s h ort -ter m ( < 1 4 da ys) s yste mic c ortic oster oi ds. St u d y i nter ve nti o n 
a d mi nistrati o n s h o ul d be dela y e d u ntil s yste mic c ortic oster oi d use has bee n disc o nti n ue d 
f or at least 2 8 da ys. I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical (s ki n , e yes,
or ears ) c ortic oster oi ds are per mitte d.
6. S T U D Y I N T E R V E N TI O N( S ) A N D C O N C O MI T A N T T HE R A P Y
St u d y  i nter ve nti o ns are all pres pecifie d i n vesti gati o nal a n d n o ni n vesti gati o nal me dici nal 
pr o d ucts, me dical de vices, a n d ot her i nter ve nti o ns (e g, s ur gical a n d be ha vi oral) i nte n de d t o 
be a d mi nistere d t o t he st u d y  partici pa nts d uri n g t he st u d y c o n d uct.
F or t he p ur p oses of t his pr ot oc ol, st u d y i nter ve nti o n refers t o t he m P n C ca n di date a n d t he 
m P n C c o ntr ol . P C V 1 0 is n ot c o nsi dere d t o be a st u d y i nter ve nti o n.
St u d y  i nter ve nti o ns will be pr o vi de d as 2 pref or m ulate d pr o d ucts i n vials, a n d P C V 1 0 ma y  
be pr o vi de d as a P F S or i n a vial , as o utli ne d bel o w:

P F -0 7 8 3 1 6 9 5 s us pe nsi o n f or i njecti o n wit h Al P O 4,  
 µg/ m L , 0. 5-m L  vial ( 
)
( m P n C co ntr ol )

P F -0 7 8 3 1 6 9 5 s us pe nsi o n f or i njecti o n wit h Al P O 4,  
 µg/ m L , 0. 5-m L  vial (
)
( m P n C ca n di date)

P C V 1 0 ( S y nfl ori x) ( P F S or i n a vial )
T he st u d y  i nter ve nti o ns will be pre pare d b y a dj usti n g t he v ol u me e xtracte d fr o m t he 
pref or m ulate d pr o d ucts i n vials t o a d ose of 0. 5 m L. P C V 1 0 will be a d mi nistere d as a 0. 5- m L  
d ose.
6. 1. St u d y I nter ve nti o n(s) A d mi nistere d
St u d y I nter ve nti o n(s)
I nter ve nti o n N a me
m P n C ca n di date 
( 
- µg/ m L s us pe nsi o n 
wit h Al P O 4)
C o ntr ol (
- µg/ m L 
s us pe nsi o n wit h Al P O 4)
P C V 1 0
T y pe
Bi ol o gic
Bi ol o gic
Vacci ne
Use
E x peri me ntal
C o ntr ol
Sta n dar d of care (r o uti ne 
c hil d h o o d vacci ne )
I M P or NI M P/ A x M P
I M P
I M P
A x M P
D ose F o r m ul ati o n
Pref or m ulate d s ol uti o n 
f or si n gle-use i njecti o n
Pref or m ulate d s ol uti o n 
f or si n gle-use i njecti o n
Si n gle -use P F S or i n a 
vial ( de pe n di n g o n 
s o urci n g)
 
C CI
C CI
C CI
C CI
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 1
St u d y I nter ve nti o n(s)
U nit D ose Stre n gt h(s)
µ g / m L m P n C
ca n di date
µ g / m L c o ntr ol
1 µ g of ser ot y pes 1, 5, 
6 B, 7 F, 9 V, 1 4, a n d 2 3 F, 
a n d 3 µ g of ser ot y pes 4, 
1 8 C, a n d 1 9 F
D os a ge V ol u m e(s)
0. 5 m L
0. 5 m L
0. 5 m L
R o ute of A d m i nistr ati o n
I ntra m usc ular i njecti o n 
I ntra m usc ular i njecti o n 
I ntra m usc ular i njecti o n
S o urci n g
Pr o vi de d ce ntrall y b y 
t he s p o ns or
Pr o vi de d ce ntrall y b y t he 
s p o ns or
S o urce d l ocall y
P ac k a gi n g a n d L a beli n g
St u d y i nter ve nti o n will 
be pr o vi de d i n a 
si n gle-use vial. Eac h 
vial will be la bele d as 
re q uire d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n will 
be pr o vi de d i n a vial. 
Eac h vial will be la bele d 
as re q uire d per c o u ntr y 
re q uire me nt.
St u d y i nter ve nti o n will 
be pr o vi de d i n a P F S or 
i n a vial . E ac h P F S or 
vial will be la bele d as 
re q uire d per c o u ntr y 
re q uire me nt.
S R S D
I B
I B
S m P C
St u d y Ar m(s)
A r m  Title
m P n C ca n di date
m P n C c o ntr ol
D ose Le vel (s)
 µ g m P n C ca n di date per 
0. 5 -m L d ose
 µ g c o ntr ol per 0. 5 -m L d ose
A r m  Descri pti o n
T his st u d y is a n o pe n -la bel st u d y. 
Partici pa nts will recei ve t he 
m P n C ca n di date at Visit 1 a n d 
Visit 3 ( a p pr o xi matel y 8 wee ks 
a part). P C V 1 0 will als o be gi ve n 
at Visit 1.
F or ot her r o uti ne vacci nes, refer 
t o Secti o n 6. 9 f or details.
T his st u d y is a n o pe n -la bel st u d y. 
Partici pa nts will recei ve t he m P n C c o ntr ol
at Visit 1 a n d Visit 3 ( a p pr o xi matel y
8 we e ks a part). P C V 1 0 will als o be gi ve n 
at Visit 1.
F or ot her r o uti ne vacci nes, refer t o 
Secti o n 6. 9 f or details.
6. 1. 1. A d mi nistr ati o n
All partici pa nts will be a d mi nistere d eit her t he m P n C ca n di date or m P n C c o ntr ol as assi g ne d 
at Visit 1 a n d Visit 3 . Partici pa nts will als o recei ve t heir t hir d d ose of P C V 1 0 at Visit 1.
St u d y  i nter ve nti o ns will be pr o vi de d b y t he sp o ns or t o t he st u d y sites. A 0. 5-m L  d ose of t he 
m P n C ca n di date or m P n C c o ntr ol will be a d mi nistere d i ntra m usc ularl y i n t he left 
a nter olateral t hi g h b y a q ualifie d site staff me m ber at Visit 1 a n d Visit 3. T he descri pti o n of 
t he m P n C ca n di date or m P n C c o ntr ol ca n be f o u n d i n t he IP M.
P C V 1 0 will be s o urce d l ocall y by sites a n d sites will be rei m b urse d b y t he s p o ns or . P C V 1 0 
will be a d mi nistere d i ntra m usc ularl y i n t he ri g ht a nter olateral t hi g h b y a q ualifie d staff 
me m ber at Visit 1 .
 
C CI
C CI
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 2
A n y  c o nc o mita nt vacci nes re q uire d b y l ocal rec o m me n dati o ns a n d per mitte d b y t he pr ot oc ol 
ma y  be a d mi nistere d d uri n g st u d y  partici pati o n (see Secti o n 6. 9 f or details).
Sta n dar d vacci nati o n practices m ust be o bser ve d, a n d vacci ne m ust n ot b e i njecte d i nt o bl o o d 
vessels. A p pr o priate me dicati o n a n d ot her s u p p orti ve meas ures f or ma na ge me nt of a n ac ute 
h y perse nsiti vit y  reacti o n m ust be a vaila ble i n acc or da nce wit h l ocal g ui deli nes f or sta n dar d 
i m m u nizati o n practices.
A d mi nistrati o n of st u d y i nter ve nti o ns will be perf or me d b y  a n a p pr o priatel y q ualifie d, 
trai ne d, a n d vacci ne-e x perie nce d me m ber of t he st u d y staff (e g, p hys icia n, n urse, p h ysicia n’s 
assista nt, n urse practiti o ner, p har macist, or me dical assista nt) as all o we d b y l ocal, state, a n d 
i nstit uti o nal g ui da nce.
St u d y  i nter ve nti o n a d mi nistrati o n details will be rec or de d o n t he C R F.
6. 1. 2. Me dic al De vices (if P C V 1 0 Is S u p plie d i n P F S s)
1.
I n t his st u dy, t he me dical de vices bei n g de pl o ye d are t he P F Ss c o ntai ni n g P C V 1 0.
2.
I nstr ucti o ns f or me dical de vice use are pr o vi de d i n t he pac ka ge i nsert.
3.
All me dical de vice deficie ncies (i ncl u di n g malf u ncti o ns of t he de vice, use err or, a n d 
i na de q uate la beli n g) m ust be detecte d, d oc u me nte d, a n d re p orte d by t he st u d y pers o n nel 
t hr o u g h o ut t he st u dy. Please refer t o Secti o n 8. 4. 9 f or details.
6. 2. Pre p ar ati o n , H a n dli n g , St or a ge , a n d Acc o u nt a bilit y
1.
T he i n vesti gat or or desi g nee m ust c o nfir m t hat a p pr o priate c o n diti o ns (e g, te m perat ure) 
ha ve bee n mai ntai ne d d uri n g tra nsit f or all st u d y  i nter ve nti o ns recei ve d a n d a n y 
discre pa ncies are re p orte d a n d res ol ve d bef ore use of t he st u d y  i nter ve nti o n.
2.
O nl y  partici pa nts e nr olle d i n t he st u d y ma y recei ve st u dy i nter ve nti o n a n d o nl y  
a ut h orize d site staff ma y  s u p pl y, pre pare, a n d/or a d mi nister st u d y  i nter ve nti o n.
3.
All st u d y  i nter ve nti o ns m ust be st ore d i n a sec ure, e n vir o n me ntall y  c o ntr olle d, a n d 
m o nit ore d ( ma n ual or a ut o mate d rec or di n g) area i n acc or da nce wit h the la bele d st ora ge 
c o n diti o ns wit h access li mite d t o t he i n vesti gat or a n d a ut h orize d site staff. At a mi ni m u m, 
dail y  mi ni m u m a n d ma xi m u m te m perat ures f or all site st ora ge l ocati o ns m ust be 
d oc u me nte d a n d a vaila ble u p o n re q uest. Data f or n o n w or ki n g da y s m ust i n dicate t he 
mi ni m u m a n d ma xi m u m te m perat ures si nce pre vi o usl y  d oc u me nte d u p o n ret ur n t o 
b usi ness.
4.
A n y  e xc ursi o ns fr o m t he st u d y i nter ve nti o n la bel st ora ge c o n diti o ns s h o ul d be re p orte d t o 
Pfizer u p o n disc o ver y  al o n g wit h acti o ns ta ke n. T he site s h o ul d acti vel y p urs ue o pti o ns 
f or ret ur ni n g t he st u dy i nter ve nti o n t o la bele d st ora ge c o n diti o ns, as s o o n as p ossi ble. 
O nce a n e xc ursi o n is i de ntifie d, t he st u d y  i nter ve nti o n m ust be q uara nti ne d a n d n ot use d 
u ntil Pfizer pr o vi des per missi o n t o use t he st u d y  i nterve nti o n. S pecific details re gar di n g 
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 3
t he e xc ursi o n defi niti o n a n d i nf or mati o n t o re p ort f or eac h e xc ursi o n will be pr o vi de d t o 
t he site i n t he IP M.
5.
A n y  st ora ge c o n diti o ns state d i n t he S R S D will be s u perse de d b y t he st ora ge c o n diti o ns 
state d o n t he la bel.
6.
S t u d y i nter ve nti o ns s h o ul d be st ore d i n t heir ori gi nal c o ntai ners.
7.
T he i n vesti gat or, i nstit uti o n, hea d of t he me dical i nstit uti o n ( w here a p plica ble), or 
a ut h orize d site staff is res p o nsi ble f or st u d y i nter ve nti o n acc o u nta bilit y, rec o nciliati o n, 
a n d rec or d m ai nte na nce (ie, recei pt, rec o nciliati o n, a n d fi nal dis p ositi o n rec or ds) , s uc h as 
t he IP A L or s p o ns or -a p pr o ve d e q ui vale nt . All st u d y i nter ve nti o ns will be acc o u nte d f or 
usi n g a st u d y i nter ve nti o n acc o u nta bilit y f or m/rec or d.
8.
F urt her g ui da nce a n d i nf or mati o n f or t he fi nal dis p ositi o n of u n use d st u d y i nter ve nti o ns 
are pr o vi de d i n t he IP M.
All destr ucti o n m ust be a de q uatel y d oc u me nte d. If destr ucti o n is 
a ut h orize d t o ta ke place at t he i n vesti gat or site, t he i n vesti gat or m ust e ns ure t hat t he 
materials are destr o y e d i n c o m plia nce wit h a p plica ble e n vir o n me ntal re g ulati o ns, 
i nstit uti o nal p olic y, a n d a n y s pecial i nstr ucti o ns pr o vi de d b y Pfizer.
U p o n i de ntificati o n of a pr o d uct c o m plai nt, n otif y t he s p o ns or w it hi n 1 b usi ness da y  of 
disc o ver y as descri be d i n t he IP M.
6. 2. 1. Pr e p ar ati o n a n d Dis pe nsi n g
See t he I P M
f or i nstr ucti o ns o n h o w t o pre pare t he st u d y i nter ve nti o n f or a d mi nistrati o n. 
St u d y  i nter ve nti o n s h o ul d be pre pare d a n d dis pe nse d b y a n a p pr o priately q ualifie d a n d 
e x perie nce d me m ber of t he st u d y  staff (e g, p h ysicia n, nurse, p h ys icia n’s assista nt, n urse 
practiti o ner, p har mac y  assista nt/tec h nicia n, or p har macist) as all o we d b y l ocal, state, a n d 
i nstit uti o nal g ui da nce. A sec o n d staff me m ber will verif y  t he dis pe nsi n g.
T he st u d y  i nter ve nti o n will be pre pare d b y q ualifie d site pers o n nel acc or di n g t o t he I P M.
6. 3. Assi g n me nt t o St u d y I nter ve nti o n
St u d y  i nter ve nti o n will be dis pe nse d at t he st u d y visits s u m marize d i n t he S o A .
All ocati o n (ra n d o mizati o n) of partici pa nts t o i nter ve nti o n gr o u ps will pr ocee d t hr o u g h t he 
use of a n I R T s ys te m (I W R). T he site pers o n nel (st u d y c o or di nat or or s pecifie d desi g nee) 
will be re q uire d t o e nter or select i nf or mati o n i ncl u di n g b ut n ot li mite d t o t he user’s I D a n d 
pass w or d, t he pr ot oc ol n u m ber, a n d t he partici pa nt n u m ber.
T he st u d y  i nter ve nti o n t o be dis pe nse d t o t he partici pa nt will be assi g ne d usi n g a n I R T 
s yste m. T he I RT s ys te m will pr o vi de a c o nfir mati o n re p ort c o ntai ni n g t he partici pa nt 
n u m ber , t he ra n d o mizati o n n u m ber, a n d D U or c o ntai ner n u m ber assi g ne d. T he c o nfir mati o n 
re p ort m ust be st ore d i n t he site’s files. T he site will rec or d t he st u dy i nter ve nti o n assi g n me nt 
o n t he a p plica ble C R F, if re q uire d.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 4
T his is a n o pe n -la bel st u d y. T he i n vesti gat or’s k n o wle d ge of t he vacci ne assi g n me nt m ust n ot 
i nfl ue nce the decisi o n t o e nr oll a partic ular partici pa nt or affect t he or der i n w hic h 
partici pa nts are e nr olle d. P ote ntial bias will be re d uce d b y ce ntral ra n d o mizati o n.
T he st u d y -s pecific IR T refere nce ma n ual a n d I P M will pr o vi de t he c o ntact i nf or mati o n a n d 
f urt her details o n t he use of t he I R T s y ste m.
6. 4. Bli n di n g
T his is a n o pe n -la bel st u d y.
6. 4. 1. Bli n di n g of P artici p a nts
Partici pa nts ’ care gi vers will be u n bli n de d t o t he partici pa nt’s assi g ne d st u d y i nter ve nti o n.
6. 4. 2. Bli n di n g of Site Pers o n nel
I n vesti gat ors a n d ot her site staff will be u n bli n de d t o partici pa nts’ assi g ne d st u d y  
i nter ve nti o n.
6. 4. 3. Bli n di n g of t he S p o ns or
S p o ns or staff will be u n bli n de d t o partici pa nts’ assi g ne d st u d y  i nter ve nti o n. All la b orat or y  
testi n g pers o n nel perf or mi n g ser ol o g y assa ys will re mai n bli n de d t o st u d y i nter ve nti o n 
assi g ne d/recei ve d t hr o u g h o ut t he st u d y .
As t his is a n o pe n- la bel st u d y, t he s p o ns or ma y c o n d uct u n bli n de d re vie ws of t he data d uri n g 
t he c o urse of t he st u d y f or t he p ur p ose of safety assess me nt a n d/ or s u p p orti n g cli nical 
de vel o p me nt.
6. 5. St u d y I nt er ve nti o n C o m pli a nce
W he n partici pa nts are d ose d at t he site, t he y  will recei ve st u d y i nter ve nti o n directl y fr o m t he 
i n vesti gat or or desi g nee, u n der me dical s u per visi o n. T he date a n d ti me of eac h d ose 
a d mi nistere d i n t he cli nic will be rec or de d i n t he s o urce d oc u me nts a n d rec or de d i n t he C R F. 
T he d ose of st u d y i nter ve nti o n a n d st u d y partici pa nt i de ntificati o n will be c o nfir me d at t he 
ti me of d osi n g by a me m ber of t he st u d y site staff ot her t ha n t he pers o n a d mi nisteri n g t he 
st u d y i nter ve nti o n.
T he site w ill c o m plete t he re q uire d d osa ge Pre parati o n Rec or d l ocate d i n t he IP M. T he use of 
t he Pre parati o n Rec or d is re q uire d. T he use of alter nati ve pre parati o n rec or ds m ust be 
a p pr o ve d b y t he sp o ns or’s cli nical researc h p har macist pri or t o its use.
6. 6. D ose M o dific a ti o n
N ot a p plica ble. D ose m o dificati o n is n ot per mitte d d uri n g t he st u d y .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 5
6. 7. C o nti n ue d Access t o St u d y I nter ve nti o n A fter t he E n d of t he St u d y
N o st u d y i nter ve nti o n will be pr o vi de d t o partici pa nts at t he e n d of t heir st u d y partici pati o n.
6. 8. Tre at me nt of O ver d os e
F or t his st u d y , a n y d ose of st u d y i nter ve nti o n greater t ha n 0. 5 m L wit hi n a 2 4 - h o ur ti me 
peri o d will be c o nsi dere d a n o ver d ose.
T here is n o s pecific treat me nt f or a n o ver d ose.
I n t he e ve nt of a n o ver d ose, t he i n vesti gat or s h o ul d:
1.
C o ntact t he st u d y me dical m o nit or wit hi n 2 4 h o urs.
2.
Cl osel y  m o nit or t he partici pa nt f or a ny A Es/ S A Es as me dicall y a p pr o priate a n d f oll o w u p
u ntil res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, or t he partici pa nt is l ost t o 
f oll o w-u p (as defi ne d i n Secti o n 7. 3 ).
3.
D oc u me nt t he q ua ntit y of t he e xcess d ose as well as t he d urati o n of t he o ver d ose i n t he 
C R F.
4.
O ver d ose is re p orta ble t o Pfizer Safet y  o nl y w he n ass oci ate d wit h a n S A E.
Decisi o ns re gar di n g d ose i nterr u pti o ns or m o dificati o ns will be ma de b y  t he i n vesti gat or i n 
c o ns ultati o n wit h t he st u d y me dical m o nit or as nee de d base d o n t he cli nical e val uati o n of t he 
partici pa nt.
6. 9. Pri or a n d C o nc o mit a nt T her a p y
T he na me a n d date of a d mi nistrati o n f or all n o nst u d y  vacci nati o ns recei ve d fr o m 2 8 da y s 
pri or t o Visit 1 t hr o u g h Visit 4 will be c ollecte d a n d rec or de d i n t he C R F.
Me dicati o ns ta ke n t o treat S A Es fr o m t he ti me of si g ni n g of t he I C D t hr o u g h Visit 4 will be 
rec or de d i n t he C R F.
6. 9. 1. Pr o hi bite d D uri n g t he St u d y

Recei pt of a n y i n vesti gati o nal vacci nes, dr u gs, or me dical de vices is pr o hi bite d d uri n g 
st u d y partici pati o n.

Recei pt of n o nst u d y  p ne u m oc occal vacci ne is pr o hi bite d d uri n g st u d y partici pati o n.

Recei pt of me ni n g oc occal c o nj u gate vacci ne is pr o hi bite d d uri n g st u d y partici pati o n.

Recei pt of bl o o d/ plas ma pr o d ucts, i m m u n o gl o b uli ns, a n d/ or i m m u n os u p pressi ve t hera p y 
(i ncl u di n g a ≥1 4- d a y  c o urse of sys te mic c ortic oster oi ds) is pr o hi bite d d uri n g st u d y 
partici pati o n .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 6
6. 9. 2. Per mitte d C o nc o mit a nt V acci nes a n d Tre at me nts

Recei pt of ot her lice nse d n o nst u d y  vacci nes as rec o m me n de d b y l ocal sta n dar d of care
(e xce pt p ne u m oc occal a n d me ni n g oc occal vacci nes descri be d a b o ve) is per mitte d. L i ve 
vacci ne (s) m ust be a d mi n istere d c o nc o mita ntly wit h st u d y  i nter ve nti o n at Visit 1 a n d/ or 
Visit 3, or at least 2 8 da ys bef ore or after st u d y i nter ve nti o n a d mi nistrati o n.
o
Lice nse d i nacti vate d i nfl ue nza vacci ne m a y  be gi ve n at a n y ti me t hr o u g h o ut st u d y  
partici pati o n, per official l ocal rec o m me n dati o ns/re g ulati o ns.

Prescri pti o n a n d n o n prescri pti o n me dicati o ns, vita mi ns, mi nerals, a n d her bal re me dies 
are per mitte d d uri n g partici pati o n i n t he st u d y .

T he use of pr o p h yl actic a nti p yretic/ pai n me dicati o n, w hile per mitte d, is n ot
rec o m me n de d o n t he da y of st u d y i nter ve nti o n a d mi nistrati o n ( bef ore or after 
a d mi nistrati o n of st u d y i nter ve nti o n ). If sy m pt o ms de vel o p, t he use of a nti p y retic/ pai n 
me dicati o n is all o we d.

T o pical a nest hetic at t he site of bl o o d dra w is per mitte d.

I n hale d/ne b ulize d, t o pical (e g, s ki n, e y es, ears), or l ocalize d i njecti o ns of c ortic oster oi ds 
(e g, i ntra- artic ular or i ntra b ursal a d mi nistrati o n) are per mitte d d uri n g st u d y partici pati o n.

If me dically necessar y  (e g, d uri n g a pa n de mic), a C O VI D -1 9 vacci ne, or teta n us vacci ne 
re q uire d f oll o wi n g w o u n d care, ma y be gi ve n d uri n g t he st u dy, wit h prefere nce f or 
7 da y s after st u d y i nter ve nti o n a d mi nistrati o n, if feasi ble.
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L
7. 1. Disc o nti n u ati o n of St u d y I nter ve nti o n
It ma y be necessar y f or a partici pa nt t o per ma ne ntl y disc o nti n ue st u d y i nter ve nti o n. Reas o ns 
f or per ma ne nt disc o nti n uati o n of st u d y  i nter ve nti o n i ncl u de t he f oll o wi n g:

Ref use d f urt her st u d y pr oce d ures;

L ost t o f oll o w - u p;

Deat h;

St u d y  ter mi nate d b y s p o ns or;

A E;

P h y sicia n decisi o n;

Pr ot oc ol de viati o n;

Scree n fail ure;
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 7

Wit h dra wal b y  pare nt/le gal g uar dia n;

Vacci nati o n err or wit h o ut ass ociate d A E;

N o l o n ger meets eli gi bilit y  criteria;

Ot her.
Disc o nti n uati o n of st u d y i nter ve nti o n d oes n ot re p rese nt wit h dra wal fr o m t he st u d y. If st u d y 
i nter ve nti o n is per ma ne ntl y disc o nti n ue d, t he partici pa nt s h o ul d re mai n i n t he st u d y t o be 
e val uate d f or safety f oll o w - u p. See t he S o A f or data t o be c ollecte d at t he ti me of 
disc o nti n uati o n of st u d y  i nter ve nti o n a n d f oll o w-u p f or a n y  f urt her e val uati o ns t hat nee d t o 
be c o m plete d.
I n t he e ve nt of disc o nti n uati o n of st u d y i nter ve nti o n, it m ust be d oc u me nte d o n t he 
a p pr o priate C R F/i n t he me dical rec or ds w het her t he partici pa nt is disc o nti n ui n g f urt her 
recei pt of st u dy i nter ve nti o n or als o fr o m st u d y  pr oce d ures, f urt her st u d y f oll o w-u p, a n d/ or 
f ut ure c ollecti o n of a d diti o nal i nf or mati o n.
7. 2. P artici p a nt Disc o nti n u ati o n/ Wit h dr a w al F r o m t he St u d y
A partici pa nt ma y  wit h dra w fr o m t he st u d y at a ny ti me at their o w n re q uest . Reas o ns f or 
disc o nti n uati o n fr o m t he st u d y  i ncl u de t he f oll o wi n g:

Ref use d f urt her st u d y pr oce d ures;

L ost t o f oll o w - u p;

Deat h;

St u d y  ter mi nate d b y s p o ns or;

A E;

P h y sicia n decisi o n;

Pr ot oc ol de viati o n;

Scree n fail ure;

Wit h dra wal b y  pare nt/le gal g uar dia n;

Vacci nati o n err or wit h o ut ass ociate d A E;

N o l o n ger meets eli gi bilit y  criteria;

Ot her.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 8
If a partici pa nt’s pare nt(s)/le gal g uar dia n wit h dra ws t he partici pa nt fr o m t he st u d y , t he
pare nt(s)/le gal g uar d ia n ma y  re q uest destr ucti o n of a n y re mai ni n g sa m ples ta ke n a n d n ot 
teste d, a n d the i n vesti gat or m ust d oc u me nt a n y  s uc h re q uests i n t he site st u d y rec or ds a n d 
n otif y  t he s p o ns or acc or di n gly.
If t he partici pa nt’s pare nt(s)/le gal g uar dia n wit h dra ws t he partici pant fr o m t he st u d y a n d als o 
wit h dra ws c o nse nt (see Secti o n 7. 2. 1 ) f or discl os ure of f ut ure i nf or mati o n, n o f urt her 
e val uati o ns will be perf or me d a n d n o a d diti o nal data will be c ollecte d. T he s p o ns or ma y  
retai n a n d c o nti n ue t o use a ny data c ollecte d bef ore s uc h wit h dra wal of c o nse nt.
7. 2. 1. Wit h dr a w al of C o nse nt
A p artici pa nt w h ose pare nt(s)/le gal g uar dia n re q uests t o disc o nti n ue recei pt of stu d y  
i nter ve nti o n will re mai n i n t he st u d y  a n d m ust c o nti n ue t o be f oll o we d f or pr ot oc ol-s pecifie d 
f oll o w-u p pr oce d ures. T he o nl y  e xce pti o n t o t his is w he n a partici pa nt ’s pare nt(s)/le gal 
g uar dia n s pecifically wit h dra ws c o nse nt f or a n y f urt her c o ntact wit h t he m or pers o ns 
pre vi o usl y  a ut h orize d b y t he partici pa nt t o pr o vi de t his i nf or mati o n. A p artici pa nt ’s 
pare nt(s)/le gal g uar dia n s h o ul d n otif y t he i n vesti gat or i n writi n g of t he decisi o n t o wit h dra w 
c o nse nt fr o m f ut ure f oll o w -u p, w he ne ver p ossi ble. T he wit h d ra wal of c o nse nt s h o ul d be 
e x plai ne d i n detail i n t he me dical rec or ds b y t he i n vesti gat or, as t o w het her t he wit h dra wal is 
o nl y  fr o m f urt her recei pt of st u d y i nter ve nti o n or als o fr o m st u d y  pr oce d ures a n d/ or p ostd ose
st u d y f oll o w-u p a n d e ntere d o n t he a p pr o priate C R F pa ge. I n t he e ve nt t hat vital stat us 
( w het her t he partici pa nt is ali ve or dea d) is bei n g meas ure d, p u blicly a vaila ble i nf or mati o n 
s h o ul d be use d t o deter mi ne vital stat us o nl y as a p pr o priately directe d i n acc or da nce wit h 
l ocal la w.
7. 3. L ost t o F ol l o w- U p
A partici pa nt will be c o nsi dere d l ost t o f oll o w- u p if t he partici pa nt re peate dl y fails t o ret ur n 
f or sc he d ule d visits a n d t he partici pa nt’s pare nt(s)/le gal g uar dia n is u na ble t o be c o ntacte d by 
t he st u d y site.
T he f oll o wi n g acti o n s m ust be ta ke n if a partici pa nt fails t o ret ur n t o t he cli nic f or a re q uire d 
st u d y visit:

T he site m ust atte m pt t o c o ntact t he partici pa nt’ s pare nt(s)/le gal g uar dia n a n d resc he d ule 
t he misse d visit as s o o n as p ossi ble. Co u nsel t he partici pa nt ’s pare nt(s) or le gal g uar dia n
o n t he i m p orta nce of mai ntai ni n g t he assi g ne d visit sc he d ule, a n d ascertai n w het her t he 
partici pa nt ’s pare nt(s)/ g uar dia n wis hes f or t he partici pa nt t o c o nti n ue i n t he st u d y a n d/ or 
w het her t he partici pa nt s h o ul d c o nti n ue i n t he st u d y ;

Bef o re a partici pa nt is dee me d l ost t o f oll o w-u p, t he i n vesti gat or or desi g nee m ust ma ke 
e ver y eff ort t o re gai n c o ntact wit h t he partici pa nt’s pare nt(s)/le gal g uar dia n ( w here 
p ossi ble, 3 tele p h o ne calls a n d, if necessar y , a certifie d letter t o t he partici pa nt’s last 
k n o w n maili n g a d dress or l ocal e q ui vale nt met h o ds). T hese c o ntact atte m pts s h o ul d be 
d oc u me nte d i n t he partici pa nt’s me dical rec or d ;
0
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 3 9

S h o ul d t he partici pa nt ’s pare nt(s)/le gal g uar dia n c o nti n ue t o be u nreac ha ble, t he 
partici pa nt will be c o nsi dere d t o ha ve wit h dra w n fr o m t he st u d y .
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S
8. 1. A d mi nistr ati ve Pr oce d ures
T he i n vesti gat or ( or a n a p pr o priate dele gate at t he i n vesti gat or site) m ust o btai n a si g ne d a n d 
date d I C D bef ore perf or mi n g a n y  st u d y-s pecific pr oce d ures.
T he date of birt h will be c ollecte d t o criticall y  e val uate t he i m m u ne res p o nse a n d safet y 
pr ofile b y a ge.
St u d y  pr oce d ures a n d t heir ti mi n g are s u m marize d i n t he S o A . Pr ot oc ol wai vers or 
e xe m pti o ns are n ot all o we d.
A d here nce t o t he st u d y  desi g n re q uire me nts, i ncl u di n g t h ose s pecifie d i n t he S o A , is esse ntial 
a n d re q uire d f or st u d y c o n d uct.
All scree ni n g e val uati o ns m ust be c o m plete d a n d re vie we d t o c o nfir m t hat p ote ntial 
partici pa nts meet all eli gi bi lit y criteria. T he i n vesti gat or will mai ntai n a scree ni n g l o g t o 
rec or d details of all partici pa nts scree ne d a n d t o c o nfir m eli gi bilit y or rec or d reas o ns f or 
scree ni n g fail ure, as a p plica ble.
E ver y  eff ort s h o ul d be ma de t o e ns ure t hat pr ot oc ol-re q uire d tests a n d pr oce d ures are 
c o m plete d as descri be d. H o we ver, it is a ntici pate d t hat fr o m ti me t o ti me t here ma y  be 
circ u msta nces o utsi de t he c o ntr ol of t he i n vesti gat or t hat ma ke it u nfeasi ble t o perf or m t he 
test. In t hese cases, t he i n vesti gat or m ust ta ke all s te ps necessar y t o e ns ure t he safety a n d 
well -bei n g of t he partici pa nt . W he n a pr ot oc ol-re q uire d test ca n n ot be perf or me d, t he 
i n vesti gat or will d oc u me nt t he reas o n f or t he misse d test a n d a ny c orrecti ve a n d pre ve nti ve 
acti o ns t hat t he y ha ve ta ke n t o e ns ure t hat re q uire d pr ocesses are a d here d t o as s o o n as 
p ossi ble. T he st u d y  tea m m ust be i nf or me d of t hese i nci de nts i n a ti mel y ma n ner. F or 
sa m ples bei n g c ollecte d a n d s hi p pe d, detaile d c ollecti o n, pr ocessi n g, st ora ge, a n d s hi p me nt 
i nstr ucti o ns a n d c o ntact i nf or mati o n will be pr o vi de d t o t he i n vesti gat or site pri or t o i nitiati o n 
of t he st u d y .
T he t otal bl o o d sa m pli n g v ol u me f or i n di vi d ual partici pa nt s i n t his st u d y is a p pr o xi matel y 
1 5 m L .
8. 2. Effic ac y a n d/ or I m m u n o ge nicit y Assess me nts
Bl o o d will be c ollecte d bef ore D ose 1 ( Visit 1), a p pr o xi matel y  1 m o nt h after D ose 1 
( Visit 2), a n d a p pr o xi matel y 1 m o nt h after D ose 2 ( Visit 4) t o assess i m m u n o ge nicit y.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 0
I m m u ne Res p o nses
Ser ot y pe 3 O P A titers a n d I g G c o nce ntrati o ns will be meas ure d i n sera c ollecte d at Visits 1,
2 , a n d 4.
Sera c ollecte d fr o m all partici pa nts ma y  be use d f or a d diti o nal testi n g t o better u n dersta n d t he 
i m m u ne res p o nses of t he ca n di date bei n g st u die d i n t his pr ot oc ol, t o i nf or m t he de vel o p me nt 
of ot her pr o d ucts, a n d/ or f or vacci ne -relate d assa y w or k s u p p orti n g vacci ne pr o gra ms.
A d diti o n al I m m u n o ge nicit y Assess me nts
Ot her e x pl orat or y  i m m u n ol o gical assa ys (e g, a nti b o d y vali dity, differe ntiati o n of I g Gs ) ma y 
be perf or me d if a d diti o nal sera are a vaila ble.
N o cell ular assa y s will be perf or me d.
8. 2. 1. Bi ol o gic al S a m ples
Bl o o d sa m ples will be use d o nl y f or scie ntific researc h. Eac h sa m ple will be la bele d wit h a 
c o de s o t hat t he la b orat or y a n al yst testi n g t he sa m ples will n ot k n o w t he partici pa nt’s 
i de ntit y, st u d y visit, or st u d y c o h ort ass ociate d wit h t he sa m ple. Sa m ples t hat re mai n after 
perf or mi n g assa ys o utli ne d i n t he pr ot oc ol ma y be st ore d b y  Pfizer. U nless a ti me li mitati o n 
is re q uire d by l ocal re g ulati o ns or et hical re q uire me nts, t he sa m ples will be st ore d f or u p t o 
1 5 y ears after t he e n d of t he st u d y a n d t hen destr o ye d. If all o we d b y t he I C D, st ore d sa m ples 
ma y  be use d f or a d diti o nal testi n g t o better u n dersta n d t he i m m u ne res p o nses t o t he 
vacci ne(s) u n der st u d y  i n t his pr ot oc ol, t o i nf or m t he de vel o p me nt of ot her vacci nes or 
vacci ne -relate d pr o d ucts, a n d/ or f or vacci ne-relate d assa y w or k s u p p orti n g vacci ne pr o gra ms.
N o testi n g of t he partici pa nt’s ge netic material will be perf or me d.
T he partici pa nt ’s pare nt(s)/le gal g uar dia n m a y  re q uest t hat t he partici pa nt’s sa m ples, if still 
i de ntifia ble, be destr oye d at a n y ti me; h o we ver, a n y data alrea d y c ollecte d fr o m t h ose 
sa m ples will still be use d f or t his researc h. T he bi ol o gical sa m ples ma y be s hare d wit h ot her 
researc hers as l o n g as c o nfi de ntialit y is mai ntai ne d, a n d n o testi n g of t he partici pa nt’s ge netic 
material is perf or me d.
8. 3. S afet y Assess me nts
Pla n ne d ti me p oi nts f or all safet y  assess me nts are pr o vi de d i n t he S o A . U nsc he d ule d safety 
meas ure me nts m a y  be o btai ne d at a n y ti me d uri n g t he st u d y t o assess a n y percei ve d safet y 
iss ues.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 1
8. 3. 1. Cli nic al Ass ess me nt
A cli nical assess me nt, i ncl u di n g me dical a n d vacci ne hist or y, will be perf or me d o n all 
partici pa nts pri or t o recei pt of st u d y  i nter ve nti o n a d mi nistrati o n at Visit 1 t o deter mi ne 
partici pa nt eli gi bilit y  a n d t o esta blis h a cli nical baseli ne. Si g nifica nt me dical hist or y  a n d 
si g nifica nt fi n di n gs fr o m a n y p h ysical e xa mi nati o n (if perf or me d) will be rec or de d as 
me dical hist or y  i n t he C R F.
I n vesti gat ors s h o ul d pa y s pecial atte nti o n t o cli nical si g ns relate d t o pre vi o us seri o us 
ill nesses.
P h y sical exa mi nati o n fi n di n gs c ollecte d d uri n g t he st u d y  will be c o nsi dere d s o urce rec or d 
a n d will n ot be re q uire d t o be re p orte d, u nless ot her wise n ote d. A ny u nt o war d p h ys ical 
e xa mi nati o n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d meet t he
defi niti o n of a n A E or S A E (A p pe n di x 2 ) m ust be re p orte d acc or di n g t o t he pr ocesses i n
Secti o ns 8. 4. 1 t o 8. 4. 3 .
8. 3. 1. 1. Te m per at ure
B o d y t e m perat ure meas ure d as a p pr o priate f or a ge will be assesse d at eac h visit w he n st u d y 
i nter ve nti o n will be a d mi nistere d.
A n y  u nt o war d te m perat ure fi n di n gs t hat are i de ntified d uri n g t he acti ve c ollecti o n peri o d a n d 
meet t he defi niti o n of a n A E or S A E ( A p pe n di x 2 ) m ust be re p orte d acc or di n g t o t he 
pr ocesses i n Secti o ns 8. 4. 1 t o 8. 4. 3 .
8. 3. 1. 2. P ost i njecti o n O bser v ati o n
T he partici pa nt will be o bser ve d f or 3 0 mi n utes after eac h d ose , a n d a n y reacti o ns occ urri n g 
d uri n g t hat ti me will be rec or de d as A Es.
8. 3. 2. Cli nic al S afet y L a b or at or y Assess me nts
Cli nical safet y  la b orat or y assess me nts will n ot be c ollecte d i n t his st u d y.
8. 3. 3. P artic i p a nt Electr o nic Di ar y
Partici pa nts’ pare nt(s)/le gal g uar dia n s will be as ke d t o m o nit or a n d rec or d l ocal reacti o ns a n d 
s yste mic e ve nts after st u d y i nter ve nti o n a d mi nistrati o n ( Da y 1 t hr o u g h Da y 7, w here Da y 1 is 
t he da y of st u d y i nter ve nti o n a d mi nistrati o n) usi n g a n e-diar y  t hr o u g h a n a p plicati o n i nstalle d 
o n a pr o visi o ne d de vice or o n t he partici pa nt’s pare nt(s)/le gal g uar dia n’s o w n pers o nal 
de vice. T his all o ws rec or di n g of t hese assess me nts o nl y  wit hi n a fi xe d ti me wi n d o w, t h us 
pr o vi di n g t he acc urate re pr ese ntati o n of t he partici pa nt’s e x perie nce. Data re p orte d i n t he 
e-diar y  will be tra nsferre d electr o nicall y t o t he e-diar y  ve n d or, w here t he y will be a vaila ble 
f or re vie w by i n vesti gat ors, t heir a p pr o priatel y q ualifie d desi g nees, a n d s p o ns or staff at all 
ti mes via a n i nter net-base d p ortal. At i nter vals a gree d t o b y t he ve n d or a n d Pfizer, t hese data 
will be tra nsferre d electr o nicall y  t o Pfizer f or a nal ysis a n d re p orti n g.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 2
T he dail y  e-diar y  data will n ot be ca pt ure d i n t he C R F. H o we ver, if a partici pa nt is 
wi t h dra w n beca use of pr o m pte d e ve nts re p orte d i n t he e-diar y , t he e ve nt(s) s h o ul d be 
rec or de d o n t he A E pa ge of t he C R F, re gar dless of w het her t he i n vesti gat or c o nsi ders t he 
e ve nt(s) t o be cli nicall y si g nifica nt.
T he i n vesti gat or or desi g nee m ust o btai n st o p dates f or a n y l ocal reacti o ns a n d s pecific 
s yste mic e ve nts t hat were o n g oi n g o n t he last da y t hat t he e-diar y  was c o m plete d. T he st o p 
dates s h o ul d be e ntere d i n t he C R F.
I n vesti gat ors ( or a n a p pr o priatel y q ualifie d desi g nee) are re q uire d t o re vie w t he e- di ar y data 
o nli ne at fre q ue nt i nter vals ( dail y  is o pti mal) t o e val uate partici pa nt c o m plia nce a n d re p orte d 
e ve nts as part of t he o n g oi n g safet y re vie w.
8. 3. 3. 1. Gr a di n g Sc al e f or Pr o m pte d E ve nts
T he gra di n g scales use d i n t his st u d y  t o assess pr o m pte d e ve nts as desc ri be d bel o w are base d 
o n c o nce pts o utli ne d i n t he F D A C B E R g ui deli nes o n t o xicit y  gra di n g scales f or healt h y 
a d ults 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, 1 8 b ut ha ve bee n 
a da pte d f or a p plica bilit y t o healt h y i nfa nts.
8. 3. 3. 1. 1. L oc al Re acti o ns
F or t he first 7 da y s f oll o wi n g eac h d ose fr o m Da y 1 t hr o u g h Da y 7, w here Da y 1 is t he da y 
of st u d y i nter ve nti o n a d mi nistrati o n, t he partici pa nt’s pare nt(s)/le gal g uar dia n will be as ke d 
t o assess re d ness, s welli n g, a n d pai n at t he st u d y i nter ve nti o n i njecti o n site (left a nter olateral 
t hi g h) a n d t o rec or d t he s ym pt o ms i n t he e -diar y  i n t he e ve ni n g. Re d ness a n d s welli n g will be 
meas ure d a n d rec or de d i n meas uri n g de vice (cali per) u nits (ra n ge: 1 t o 1 4; a n e ntr y  i n t he 
e-diar y  of 1 5 will de n ote > 1 4), a n d t he n cate g orize d d uri n g a nalys is as mil d, m o derate, or 
se vere base d o n t he gra di n g scale i n Ta ble 1 . Meas uri n g de vice u nits ca n be c o n verte d t o 
ce nti meters acc or di n g t o t he f oll o wi n g scale: 1 meas uri n g de vice u nit = 0. 5 c m. Pai n at t he 
vacci ne i njecti o n site will be assesse d b y t he partici pa nt’s pare nt(s)/le gal g uar dia n as mil d, 
m o derate, or se vere acc or di n g t o t he gra di n g scale i n Ta ble 1 . T he partici pa nt’s 
pare nt(s)/le gal g uar dia n will be pr o m pte d t o c o ntact t he i n vesti gat or if t he partici pa nt 
e x perie nces a se vere ( Gra de 3) or a b o ve l ocal reacti o n t o assess t he reacti o n a n d perf or m a n 
u nsc he d ule d assess me nt or visit as a p pr o priate.
O nl y  a n i n vesti gat or is a ble t o classif y a partici pa nt’s l ocal reacti o n as Gra de 4, after p h ysical 
e xa mi nati o n of t he partici pa nt or d oc u me ntati o n fr o m a n ot her me dicall y q ualifie d s o urce 
(e g, e mer ge nc y r o o m or h os pital rec or d). If a partici pa nt e x perie nces a Gra de 4 l ocal 
reacti o n, t he i n vesti gat or m ust i m me diatel y n otif y t he s p o ns or. Site staff will e d ucate t he 
partici pa nt’s pare nt(s)/le gal g uar dia n re gar di n g si g ns a n d s ym pt o ms t hat w o ul d pr o m pt site 
c o ntact.
T he pr oce d ure f or n otificati o n of t he s p o ns or is pr o vi de d i n t he I S F or e q ui vale nt.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 3
T a ble 1.
Gr a di n g Sc ales f or L oc al Re acti o ns
Mil d
Gr a de 1
M o der ate
Gr a de 2
Se vere
Gr a de 3 a
Gr a de 4 b
Re d ness
1 t o 4 meas uri n g 
de vice u nits
=
0 t o 2 . 0 c m
5 t o 1 4 cali per u nits
( or meas uri n g 
de vice u nits)
=
2. 0 t o 7. 0 c m
> 1 4 cali per u nits
( or meas uri n g 
de vice u nits)
=
7 c m
Necr osis or 
e xf oliati ve 
der matitis
S welli n g
1 t o 4 meas uri n g 
de vice u nits
=
0 t o 2. 0 c m
5 t o 1 4 cali per u nits
( or meas uri n g 
de vice u nits)
=
2. 0 t o 7. 0 c m
> 1 4 cali per u nits
( or meas uri n g 
de vice u nits)
=
7 c m
Necr osis
Pai n at i njecti o n site
(te n der ness)
H urts if ge ntl y 
t o uc he d (e g, 
w hi m pers, wi nces,
pr otests, or 
wit h dra ws)
H urts if ge ntl y 
t o uc he d, wit h cr yi n g
Ca uses li mitati o n of 
li m b m o ve me nt
E m er ge nc y r o o m 
visit or 
h os pitalizati o n f or 
se vere i njecti o n site 
pai n (te n der ness) at 
i njecti o n site
N ote: If t he size of t he re d ness a n d/ or s welli n g falls bet wee n 2 meas uri n g de vice u nits, t he hi g her meas uri n g 
de vice u nit n u m ber will be rec or de d i n t he e -diar y.
a. 
P are nts/le gal g uar dia n s of  partici pa nts e x perie nci n g Gra de 3 l ocal reacti o ns are re q uire d t o c o ntact t he 
i n vesti gat or site. I n t he e ve nt t hat t he partici pa nt’s pare nt(s)/le gal g uar dia n d oes n ot call, t he i n vesti gat or 
will call t he partici pa nt ’s pare nt(s)/le gal g uar dia n. A n u nsc he d ule d visit ma y be re q uire d.
b.
Gra de 4 assess me nt s h o ul d be ma de b y t he i n vesti gat or; Gra de 4 l ocal reacti o ns will n ot be c ollecte d i n 
t he e-diar y b ut will be c ollecte d as A Es o n t h e C R F. T he i nte nsit y of t he l ocal reacti o n s h o ul d be gra de d 
usi n g t he A E i nte nsit y gra di n g scale i n Secti o n 1 0. 2. 3 .
8. 3. 3. 1. 2. S yste mic E v e nts – S y m pt o ms a n d Fe ver
8. 3. 3. 1. 2. 1. S y m pt o ms
F or t he first 7 da y s f oll o wi n g eac h d ose fr o m Da y 1 t hr o u g h Da y 7, w here Da y  1 is t he da y 
of st u d y  i nter ve nti o n a d mi nistrati o n, t he partici pa nt’s pare nt(s)/le gal g uar dia n will be as ke d 
t o assess decrease d a p petite, dr o wsiness/i ncrease d slee p, a n d irrita bilit y  a n d t o rec or d t he 
s ym pt o ms i n t he e -diar y  (i n a pr o visi o ne d de vice or a p plicati o n o n a pers o nal de vice) i n t he 
e ve ni n g. T he s y m pt o ms will be assesse d b y t he partici pa nt’s pare nt(s)/le gal g uar dia n as mil d, 
m o derate, or se vere acc or di n g t o t he gra di n g scale i n Ta ble 2 .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 4
T he partici pa nt’s pare nt(s)/le gal g uar dia n will als o be i nstr ucte d t o c o ntact site staff if t he 
partici pa nt e x perie n ces a n y p ossi ble Gra de 4 pr o m pte d s yste mic e ve nt (ie, e mer ge nc y r o o m 
visit or h os pitalizati o n f or se vere decrease d a p petite, se vere dr o wsi ness/i ncrease d slee p, or 
se vere irrita bilit y) wit hi n 7 da ys after d ose a d mi nistrati o n . St u d y staff ma y als o c o ntact t he 
partici pa nt’s pare nt(s)/le gal g uar dia n t o o btai n a d diti o nal i nf or mati o n o n Gra de 3 e ve nts 
e ntere d i nt o t he e -diar y .
O nl y  a n i n vesti gat or is a ble t o classif y a partici pa nt’s s yste mic e ve nt as Gra de 4, after
p h y sical e xa mi nati o n of t he partici pa nt or d oc u me ntati o n fr o m a n ot her me dicall y q ualifie d
s o urce (e g, e mer ge nc y r o o m or h os pital rec or d) or tele p h o ne c o ntact wit h t he partici pa nt’s
pare nt(s)/le gal g uar dia n. If a partici pa nt e x perie nces a Gra de 4 s ys te mic e ve nt, t he
i n vesti gat or m ust i m me diatel y n otif y t he s p o ns or.
T he pr oce d ure f or n otificati o n of t he s p o ns or is pr o vi de d i n t he I S F or e q ui vale nt.
T a ble 2.
Gr a di n g Sc ales f or S yste mic E ve nts
Mil d
Gr a de 1
M o der ate
Gr a de 2
Se vere
Gr a de 3
Gr a de 4 a
Decrease d a p petite 
(l oss of a p petite)
Decrease d i nterest 
i n eati n g
Decrease d oral
i nta ke
Ref usal t o fee d
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere decrease d 
a p petite (l oss of 
a p petite)
Dr o w si ness 
(i ncrease d slee p)
I ncrease d or
pr ol o n ge d slee pi n g
b o uts
Sli g htl y s u b d ue d,
i nterferi n g wit h
dail y acti vit y
Disa bli n g, n ot
i ntereste d i n us ual
dail y acti vit y
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere dr o w si ness 
(i ncrease d slee p)
Irrita bilit y 
(f ussi ness) 
(s y n o n y m o us wit h 
restless slee p; 
decrease d s lee p)
Easil y c o ns ola ble
Re q uiri n g i ncrease d
atte nti o n
I nc o ns ola ble; cr yi n g
ca n n ot be c o mf orte d
E m er ge nc y r o o m visit 
or h os pitalizati o n f or 
se vere irrita bilit y 
(f ussi ness)
a.
Gra de 4 assess me nt s h o ul d be ma de b y t he i n vesti gat or; Gra de 4 s yste mic e ve nts will n ot be c ollecte d i n 
t he e-diar y b ut will be c ollecte d as A Es o n t he C R F. T he i nte nsit y of t he s yste mic e ve nt s h o ul d be gra de d 
usi n g t he A E i nte nsit y gra di n g scale i n Secti o n 1 0. 2. 3 .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 5
8. 3. 3. 1. 2. 2. Fe ver
I n or der t o rec or d i nf or mati o n o n fe ver, a di gital t her m o meter will be gi ve n t o t he 
partici pa nt ’s pare nt(s)/le gal g uar dia n wit h i nstr ucti o ns o n h o w t o meas ure a xillar y
te m perat ure at h o me. Te m perat ure will be c ollecte d i n t he e ve ni n g, daily, f or 7 da ys 
f oll o wi n g eac h d ose ( Da ys 1 t hr o u g h 7, w here Da y  1 is t he da y of st u d y i nter ve nti o n 
a d mi nistrati o n ) a n d at a n y ti me d uri n g t he 7 da ys t hat fe ver is s us pecte d. Fe ver is defi ne d as a 
te m perat ure of ≥3 8. 0 °C ( ≥1 0 0. 4 °F). T he hi g hest te m perat ure f or eac h da y  will be rec or de d i n 
t he e-diar y . In t he e ve nt of a fe ver o n Da y  7, te m perat ure will be c ollecte d dail y  u ntil fe ver 
has res ol ve d ( 1 da y  of te m perat ure less t ha n 3 8. 0°C [ 1 0 0. 4 °F]) i n or der t o c ollect a st o p date 
i n t he C R F.
A partici pa nt’s pare nt(s)/le gal g uar dia n will be pr o m pte d t o c o ntact t he i n vesti gat or if t he 
partici pa nt e x perie nces a te m perat ure 4 0. 0° C ( 1 0 4. 0° F) t o assess t he fe ver a n d perf or m a n 
u nsc he d ule d assess me nt, as a p plica ble (see u nsc he d ule d assess me nts i n Secti o n 8. 1 0. 5 ). 
St u d y  staff ma y als o c o ntact t he partici pa nt’s pare nt(s)/le gal g uar dia n t o o btai n a d diti o nal 
i nf or mati o n if a te m perat ure of 3 8. 9 °C ( 1 0 2. 0 °F) is e ntere d i nt o a n e -diar y . Te m perat ure 
will be meas ure d a n d rec or de d t o 1 deci mal place a n d t he n gr o u pe d i nt o ra n ges f or t he 
a nal ys is; see Ta ble 3.
T a ble 3.
R a n ges f or Fe ver
≥3 8. 0 °C t o 3 8. 4 °C
3 8. 4 °C t o 3 8. 9 ° C
> 3 8. 9 °C t o 4 0. 0 ° Ca
4 0. 0 ° Ca
N ote: Fe ver is defi ne d as a te m perat ure of ≥3 8. 0 °C.
a.
Partici pa nts re p orti n g a fe ver 1 0 4 . 0°F ( 4 0. 0 ° C) will be pr o m pte d t o c o ntact t he st u d y site.
8. 3. 3. 1. 3. Use of A nti p yretic/ P ai n Me dic ati o n
T he partici pa nt’s pare nt(s)/le gal g uar dia n will be as ke d t o rec or d t he use of a nti p y retic/ pai n 
me dicati o n ( y es/ n o) i n t he e -diar y  (i n a pr o visi o ne d de vice or a p plicati o n o n a pers o nal 
de vice) i n t he e ve ni n g, dail y , f or 7 da ys after eac h d ose of st u d y i nter ve nti o n. T he use of 
pr o p h y lactic a nti p yretic/ pai n me dicati o n, w hile per mitte d, is n ot rec o m me n de d o n t he da y 
of st u d y i nter ve nti o n a d mi nistrati o n ( bef ore or after st u d y i nter ve nti o n a d mi nistrati o n). If 
s ym pt o ms de vel o p, t he use of a nti p y retic/ pai n me dicati o n is all o we d.
8. 4. A d verse E ve nts , Seri o us A d verse E ve nts , a n d Ot her S afet y Re p orti n g
T he defi niti o ns of a n A E a n d a n S A E ca n be f o u n d i n A p pe n di x 2 .
A Es ma y  arise fr o m sy m pt o ms or ot her c o m plai nts re p orte d t o t he i n vesti gat or b y  t he 
partici pa nt ( or , w he n a p pr o priate, b y a care gi ver, s urr o gate, or t he partici pa nt's le gally 
a ut h orize d re prese ntati ve), or t he y  ma y arise fr o m cli nical fi n di n gs of t he in vesti gat or or 
ot her healt hcare pr o vi ders (cli nical si g ns, test res ults, etc).
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 6
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detecti n g, d oc u me nti n g, a n d 
rec or di n g e ve nts t hat meet t he defi niti o n of a n A E or S A E a n d re mai n res p o nsi ble t o p urs ue 
a n d o btai n a de q uate i nf or mati o n b ot h t o deter mi ne t h e o utc o me a n d t o assess w het her t he 
e ve nt meets t he criteria f or classificati o n as a n S A E or ca use d t he partici pa nt t o disc o nti n ue 
t he st u d y i nter ve nti o n (see Secti o n 7. 1 ).
D uri n g t he acti ve c ollecti o n peri o d as descri be d i n Secti o n 8. 4. 1, e ac h partici pa nt’s 
pare nt (s)/le gal g uar dia n will be q uesti o ne d a b o ut t he occ urre nce of A Es i n a n o nlea di n g 
ma n ner .
I n a d diti o n, t he i n vesti gat or ma y be re q ueste d b y Pfizer Safety t o o btai n s pecific f oll o w -u p 
i nf or mati o n i n a n e x pe dite d fas hi o n.
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y f or C ollecti n g A E a n d S A E I nf or m ati o n
T he ti me peri o d f or acti vel y  eliciti n g a n d c ollecti n g A Es a n d S A Es (“acti ve c ollecti o n 
peri o d”) f or eac h partici pa nt be gi ns fr o m t he ti me t he partici pa nt ’s pare nt(s)/le gal g uar dia n 
pr o vi des i nf or me d c o nse nt, w hic h is o btai ne d bef ore t he partici pa nt ’s partici pati o n i n t he 
st u d y (ie, bef ore u n der g oi n g a ny st u d y- relate d pr oce d ure a n d/ or recei vi n g st u d y 
i nter ve nti o n), t hr o u g h a n d i ncl u di n g Visit 4.
F oll o w -u p b y  t he i n vesti gat or c o nti n ues t hr o u g h o ut t he acti ve c ollecti o n peri o d a n d u ntil t he 
A E or S A E or its se q uelae res ol ve or sta bilize at a le vel acce pta ble t o t he i n vesti gat or.
W he n a cli nicall y  i m p orta nt A E re mai ns o n g oi n g at t he e n d of t he acti ve c ollecti o n peri o d, 
f oll o w-u p b y  t he i n vesti gat or c o nti n ues u ntil t he A E or S A E or its se q uelae res ol ve or 
sta bilize at a le vel acce pta ble t o t he i n vesti gat or a n d Pfizer c o nc urs wit h t hat assess me nt.
F or partici pa nts w h o are scree n fail ures, t he acti ve c ollecti o n peri o d e n ds w he n scree n fail ure 
stat us is deter mi ne d.
If t he partici pa nt wit h dra ws fr o m t he st u d y a n d als o wit h dra ws c o nse nt f or t he c ollecti o n of 
f ut ure i nf or mati o n, t he acti ve c ollecti o n peri o d e n ds w he n c o nse nt is wit h dra w n.
If a partici pa nt per ma ne ntl y disc o nti n ues or te m p oraril y disc o nti n ues st u d y i nter ve nti o n 
beca use of a n A E or S A E, t he A E or S A E m ust b e rec or de d o n t he C R F a n d t he S A E 
re p orte d via t he P S S A .
I n vesti gat ors are n ot o bli gate d t o acti vely see k i nf or mati o n o n A E s or S A E s after t he 
partici pa nt has c o ncl u de d st u d y partici pati o n. H o we ver, if t he i n vesti gat or lear ns of a n y S A E, 
i ncl u di n g a deat h, at a n y ti me after a partici pa nt has c o m plete d t he st u d y, a n d t he y c o nsi der 
t he e ve nt t o be reas o na bl y relate d t o t he st u dy i nter ve nti o n, t he i n vesti gat or m ust pr o m ptl y  
re p ort t he S A E t o Pfizer via t he P S S A .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 7
8. 4. 1. 1. Re p orti n g S A Es t o Pfizer S afet y
All S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d as descri be d i n 
Secti o n 8. 4. 1 are re p orte d t o Pfizer Safet y via t he P S S A i m me diatel y u p o n a ware ness a n d 
u n der n o circ u msta nce s h o ul d t his e xcee d 2 4 h o urs, as i n dicate d i n A p pe n di x 2 . T he 
i n vesti gat or will s u b mit a n y u p date d S A E data t o t he s p o ns or wit hi n 2 4 h o urs of it s bei n g 
a vaila ble.
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F
All n o nseri o us A Es a n d S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d , 
w hic h be gi ns after o btai ni n g i nf or me d c o nse nt as descri be d i n Secti o n 8. 4. 1 , will be rec or de d 
o n t he A E secti o n of t he C R F.
T he i n vesti gat or is t o rec or d o n t he C R F all directl y o bser ve d a n d all s p o nta ne o usl y re p orte d 
A Es a n d S A Es re p orte d b y  t he partici pa nt.
As part of o n g oi n g safet y re vie ws c o n d ucte d b y t he s p o ns or, a n y n o nseri o us A E t hat is 
deter mi ne d b y t he s p o ns or t o be seri o us will be re p orte d b y  t he s p o ns or as a n S A E. T o assist 
i n t he deter mi nati o n of case seri o us ness, f urt her i nf or mati o n ma y be re q ueste d fr o m t he 
i n vesti gat or t o pr o vi de clarit y a n d u n dersta n di n g of t he e ve nt i n t he c o nte xt of t he cli nical 
st u d y.
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es
T he met h o d of rec or di n g, e val uati n g, a n d assessi n g ca usalit y  of A Es a n d S A Es a n d t he 
pr oce d ures f or c o m pleti n g a n d tra ns mitti n g S A E re p orts are pr o vi de d i n A p pe n di x 2 .
Care will be ta ke n n ot t o i ntr o d uce bi as w he n detecti n g A Es a n d/ or S A Es. O pe n -e n de d a n d 
n o nlea di n g ver bal q uesti o ni n g of t he partici pa nt’s pare nt(s)/le gal g uar dia n is t he preferre d 
met h o d t o i n q uire a b o ut A E occ urre nces.
8. 4. 3. F oll o w - Up of A Es a n d S A Es
After t he i nitial A E or S A E re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y f oll o w eac h 
partici pa nt at s u bse q ue nt visits/c o ntacts. F or eac h e ve nt, t he i n vesti gat or m ust p urs ue a n d 
o btai n a de q uate i nf or mati o n u ntil res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, 
or t he partici pa n t is l ost t o f oll o w-u p (as defi ne d i n Secti o n 7. 3 ).
I n ge neral, f oll o w-u p i nf or mati o n will i ncl u de a descri pti o n of t he e ve nt i n s ufficie nt detail t o 
all o w f or a c o m plete me dical assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of 
p ossi ble ca usalit y . A ny 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 n t deat h, a s u m mar y  of a vaila ble 
a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o Pfizer Safet y.
F urt her i nf or mati o n o n f oll o w -u p pr oce d ures is pr o vi de d i n A p pe n di x 2 .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 8
8. 4. 4. Re g ul at or y Re p orti n g Re q uire me nts f or S A Es
Pr o m pt n otificati o n b y  t he i n vesti gat or t o t he s p o ns or of an S A E is esse ntial s o t hat le gal 
o bli gati o ns a n d et hical res p o nsi bilities t o war d t he safet y of partici pa nts a n d t he safet y of a 
st u d y i nter ve nti o n u n der cli nical i n vesti gati o n are met.
T he s p o ns or has a le gal res p o nsi bilit y  t o n otif y b ot h t he l ocal re g ulat or y a ut h orit y a n d ot her 
re g ulat or y a ge ncies a b o ut t he safety of a st u d y i nter ve nti o n u n der cli nical i n vesti gati o n. T he 
s p o ns or will c o m pl y wit h c o u ntr y-s pecific re g ulat or y re q uire me nts relati ng t o safet y 
re p orti n g t o t he re g ulat or y a ut h ority, I R B s/ E Cs, a n d i n vesti gat ors.
I n vesti gat or safet y re p orts m ust be pre pare d f or S U S A Rs acc or di n g t o l ocal re g ulat or y 
re q uire me nts a n d s p o ns or p olic y a n d f or war de d t o i n vesti gat ors as necessar y.
A n i n vesti gat or w h o recei ves S U S A R s or ot her s pecific safet y i nf or mati o n (e g, s u m mar y or 
listi n g of S A Es) fr o m t he s p o ns or will re vie w a n d t he n file it al o n g wit h t he S R S D (s) f or t he 
st u d y a n d will n otif y t he I R B/ E C, if a p pr o priate acc or di n g t o l ocal re q uire me nts.
8. 4. 5. E n vir o n me nt al E x p os ure, E x p os ure D uri n g Pre g n a nc y or Bre astfee di n g, a n d 
Occ u p ati o n al E x p os ure
E n vir o n me ntal e x p os ure occ urs w he n a pers o n n ot e nr olle d i n t he st u d y as a partici pa nt 
recei ves u n pla n ne d direct c o ntact wit h or e x p os ure t o t he st u d y i nter ve nti o n. S uc h e x p os ure 
ma y  or ma y n ot lea d t o t he occ urre nce of a n A E or S A E. Pers o ns at ris k f or e n vir o n me ntal 
e x p os ure i ncl u de healt hcare pr o vi ders, fa mil y me m bers, a n d ot hers w h o ma y be e x p ose d . A n
e n vir o n me ntal e x p os ure ma y i ncl u de E D P, E D B , a n d occ u pati o nal e x p os ure.
A n y  s uc h ex p os ure s t o t he st u d y i nter ve nti on u n der st u d y  are re p orta ble t o Pfizer Safet y 
wit hi n 2 4 h o urs of i n vesti gat or a ware ness.
8. 4. 5. 1. E x p os ure D uri n g Pre g n a nc y
A n E D P  occ urs if:

A fe male n o n partici pa nt is f o u n d t o be pre g na nt w hile bei n g e x p ose d or ha vi n g bee n 
e x p ose d t o st u d y i nter ve nti o n beca use of e n vir o n me ntal e x p os ure. Bel o w are e xa m ples of 
e n vir o n me ntal E D P :
o
A fe male fa mil y  me m ber or healt hcare pr o vi der re p orts t hat s he is pre g na nt after 
ha vi n g bee n e x p ose d t o t he st u d y  i nterve nti o n b y i njecti o n, i n halati o n, or s ki n 
c o ntact .
o
A male fa mil y me m ber or healt hcare pr o vi der w h o has bee n e x p ose d t o t he st u d y  
i nter ve nti o n b y i njecti o n, i n halati o n, or s ki n c o ntact t he n i nse mi nates his fe male 
part ner pri or t o or ar o u n d t he ti me of c o nce pti o n .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 4 9
T he i n vesti gat or m ust re p ort E D P t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nitial i nf or mati o n s u b mitte d 
s h o ul d i ncl u de t he a ntici pate d date of deli ver y (see bel o w f or i nfor mati o n relate d t o 
ter mi nati o n of pre g na nc y).

If E D P occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, t he i n vesti gat or m ust re p ort 
i nf or mati o n t o Pfizer Safet y via t he P S S A . Si nce t he e x p os ure i nf or mati o n d oes n ot 
pertai n t o t he partici pa nt e nr olle d i n t h e st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; 
h o we ver, a c o p y of t he c o m plete d re p ort is mai ntai ne d i n t he I SF .

F oll o w -u p is c o n d ucte d t o o btai n ge neral i nf or mati o n o n t he pre g na nc y  a n d its o utc o me 
f or all E D P re p orts wit h a n u n k n o w n o utc o me. T he i n vesti gat or will f oll o w t he 
pre g na nc y  u ntil c o m pleti o n ( or u ntil pre g na nc y ter mi nati o n) a n d n otif y Pfizer Safety of 
t he o utc o me as a f oll o w-u p t o t he i nitial re p ort. I n t he case of a li ve birt h, t he str uct ural 
i nte grity of t he ne o nate ca n be assesse d at t he t i me of birt h. I n t he e ve nt of a ter mi nati o n, 
t he reas o n(s) f or ter mi nati o n s h o ul d be s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural 
i nte grity of t he ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual i ns pecti o n ( u nless 
pre pr oce d ure test fi n di n gs ar e c o ncl usi ve f or a c o n ge nital a n o mal y a n d t he fi n di n gs are 
re p orte d).
A b n or mal pre g na nc y  o utc o mes are c o nsi dere d S A Es. If t he o utc o me of t he pre g na nc y meets 
t he criteria f or a n S A E (ie, ect o pic pre g na nc y, s p o nta ne o us a b orti o n, i ntra uteri ne fetal 
de mise, ne o natal deat h, or c o n ge nital a n o mal y i n a li ve -b or n ba b y, a ter mi nate d fet us, a n 
i ntra uteri ne fetal de mise, or a ne o natal deat h), t he i n vesti gat or s h o ul d f oll o w t he pr oce d ures 
f or re p orti n g S A Es. A d diti o nal i nf or mati o n a b o ut pre g na nc y o utc o mes t hat are re p orte d t o 
Pfizer Safet y  as S A Es f oll o ws:

S p o nta ne o us a b orti o n , i ncl u di n g miscarria ge a n d misse d a b orti o n , s h o ul d be re p orte d as 
a n S A E;

Ne o natal deat hs t hat occ ur wit hi n 1 m o nt h of birt h s h o ul d be re p orte d, wit h o ut re gar d t o 
ca usalit y, as S A Es. I n a d diti o n, i nfa nt deat hs after 1 m o nt h s h o ul d be re p orte d as S A Es 
w he n t he i n vesti gat or assesses t he i nfa nt deat h as relate d or p ossi bl y  relate d t o e x p os ure 
t o t he st u d y i nter ve nti o n.
A d diti o nal i nf or mati o n re gar di n g t he E D P ma y  be re q ueste d b y t he s p o ns or. F urt her 
foll o w - u p of birt h o utc o mes will be ha n dle d o n a case-b y -case basis (e g, f oll o w- u p o n 
preter m i nfa nts t o i de ntif y de vel o p me ntal dela y s). I n t he case of pater nal e x p os ure, t he 
i n vesti gat or will pr o vi de t he partici pa nt wit h t he Pre g na nt Part ner Release of I nfor mati o n 
F or m t o deli ver t o his part ner. T he i n vesti gat or m ust d oc u me nt i n t he s o urce d oc u me nts t hat 
t he partici pa nt was gi ve n t he Pre g na nt Part ner Release of I nf or mati o n F or m t o pr o vi de t o his 
part ner.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 0
8. 4. 5. 2. E x p os ure D uri n g Bre astfee di n g
A n E D B occ urs if:

A fe m ale n o n partici pa nt is f o u n d t o be breastfee di n g w hile bei n g e x p ose d or ha vi n g 
bee n e x p ose d t o st u d y i nter ve nti o n (ie, e n vir o n me ntal e x p os ure). A n e xa m ple of 
e n vir o n me ntal E D B is a fe male fa mily me m ber or healt hcare pr o vi der w h o re p orts t hat 
s he is breastfee di n g after ha vi n g bee n e x p ose d t o t he st u d y  i nter ve nti o n b y i njecti o n, 
i n halati o n, or s ki n c o ntact.
T he i n vesti gat or m ust re p ort E D B t o Pfizer Safet y wit hi n 2 4 h o urs of t he i n vesti gat or’s 
a ware ness, irres pecti ve of w het her a n S A E has occ urre d. T he i nf or mati o n m ust be re p orte d 
via t he P S S A . W he n E D B occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, t he e x p os ure 
i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d i n t he st u d y, s o t he i nf or mati o n is n ot 
rec or de d o n a C R F. H o we ver, a c o py of t he c o m plete d re p ort is mai ntai ne d i n t he I SF.
A n E D B re p ort is n ot create d w he n a Pfizer dr u g s pecifically a p pr o ve d f or use i n 
breastfee di n g w o me n (e g, vita mi ns) is a d mi nistere d i n acc or d a nce wit h a ut h orize d use. 
H o we ver, if t he i nfa nt e x perie nces a n S A E ass ociate d wit h s uc h a dr u g, t he S A E is re p orte d 
t o get her wit h t he E D B .
8. 4. 5. 3. Occ u p ati o n al E x p os ure
T he i n vesti gat or m ust re p ort a n y i nsta nce of occ u pati o nal e x p os ure t o Pfizer Safety wit hi n 
2 4 h o urs of t he i n vesti gat or’s a ware ness via t he P S S A , re gar dless of w het her t here is a n 
ass ociate d S A E. Si nce t he i nf or mati o n a b o ut t he occ u pati o nal e x p os ure d oes n ot pertai n t o a 
partici pa nt e nr olle d i n t he st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; h o we ver, a c o p y 
of t he c o m plete d re p ort is mai ntai ne d i n t he I SF .
8. 4. 6. C ar di o v asc ul ar a n d De at h E ve nts
N ot a p plica ble.
8. 4. 7. Dise ase -Rel ate d E ve nts a n d/ or Dise ase -Rel ate d O utc o mes N ot Q u alif yi n g as A Es 
or S A Es
N ot a p plica ble.
8. 4. 8. A d verse E ve nts of S peci al I nterest
N ot a p plica ble.
8. 4. 8. 1. L ac k of Effic ac y
T he i n vesti gat or m ust re p ort si g ns, s ym pt o ms, a n d/ or cli nical se q uelae res ulti n g fr o m lac k of 
efficac y. Lac k of efficac y or fail ure of e x pecte d p har mac ol o gical acti o n is re p orta ble t o 
Pfizer Safet y  o nly if ass ociate d wit h a n S A E.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 1
8. 4. 9. Me dic al De vice Deficie ncies
Me dical de vices bei n g pr o vi de d f or
use i n t his st u d y  are t h ose liste d i n Secti o n 6. 1. 2 . I n or der 
t o f ulfill re g ulat or y re p orti n g o bli gati o ns w orl d wi de, t he i n vestigat or is res p o nsi ble f or t he 
detecti o n a n d d oc u me ntati o n of e ve nts meeti n g t he defi niti o ns of de vice deficie nc y t hat occ ur 
d uri n g t he st u d y wit h s uc h de vices.
T he defi niti o n of a m e dical d e vice deficie nc y ca n be f o u n d i n A p pe n di x 5 .
N ote: A Es a n d/ or S A Es t hat are ass ociate d wit h a me dical de vice deficie nc y will f oll o w t he 
sa me pr ocesses as ot her A Es or S A Es, as o utli ne d i n Secti o ns 8. 4. 1 t hr o u g h 8. 4. 4 a n d 
A p pe n di x 2 of t he pr ot oc ol .
8. 4. 9. 1. Ti me Peri o d f or Detecti n g Me dic al De vice Deficie ncies
Me dical de vice deficie ncies t hat res ult i n a n i nci de nt will be d etecte d, d oc u me nte d, a n d 
re p orte d d uri n g all peri o ds of t he st u d y i n w hic h t he me dical de vice is use d.
I m p orta ntl y, re p orta ble de vice deficie ncies are n ot li mite d t o pr o ble ms wit h t he de vice itself 
b ut als o i ncl u de i nc orrect or i m pr o per use of t he de vice a n d e ve n i nte nti o nal mis use, etc.
If t he i n vesti gat or lear ns of a n y de vice deficie nc y at a n y ti me after a partici pa nt has bee n 
disc har ge d fr o m t he st u d y, a n d s uc h deficie nc y is c o nsi dere d reas o na bl y relate d t o a me dical 
de vice pr o vi de d f or t he st u d y , t he i nvesti gat or will pr o m ptl y  n otif y t he s p o ns or.
T he met h o d of d oc u me nti n g m e dical d e vice deficie ncies is pr o vi de d i n A p pe n di x 5 .
8. 4. 9. 2. F oll o w -U p of Me dic al De vice Deficie ncies
F oll o w - u p a p plies t o all partici pa nts, i ncl u di n g t h ose w h o disc o nti n ue st u d y  i nter ve nti o n.
T he i n vesti gat or is res p o nsi ble f or e ns uri n g t hat f oll o w-u p i ncl u des a n y s u p ple me ntal 
i n vesti gati o ns as i n dicate d t o el uci date t he nat ure a n d/ or ca usalit y of t he deficie nc y .
Ne w or u p date d i nf or mati o n will be rec or de d o n a f oll o w- u p f or m wit h all c ha n ges si g ne d 
a n d date d b y t he i n vesti gat or.
8. 4. 9. 3. Pr o m pt Re p orti n g of De vice Deficie ncies t o t he S p o ns or
W he n a de vice deficie nc y  occ urs:
1.
T he i n vesti gat or n otifies t he s p o ns or b y  tele p h o ne or e mail wit hi n 1 b usi ness da y  of 
deter mi ni n g t hat t he i nci de nt meets t he pr ot oc ol defi niti o n of a me dical de vice 
deficie nc y .
2.
T he de vice deficie nc y  m ust be rec or de d o n t he Me dical De vice C o m plai nt f or m al o n g 
wit h a n y  ass ociate d A E (eit her seri o us or n o nseri o us) w he n a p plica ble .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 2
3. If a n A E (eit her seri o us or n o nseri o us) ass ociate d wit h t he de vice deficie nc y occ urs , t he n 
t he A E m ust be e ntere d i nt o t he A E secti o n of t he C R F.
4.
If a n S A E ass ociate d wit h t he de vice deficie nc y is br o u g ht t o t he atte nti o n of t he 
i nvesti gat or, t he in vesti gat or m ust i m me diatel y  n otif y Pfizer Safet y of t he S A E (see 
Secti o n 8. 4. 1. 1 ). All rele va nt details relate d t o t he r ole of t he de vice i n t he e ve nt m ust be 
re p orte d via t he P S S A as o utli ne d i n Secti o ns 8. 4. 1. 1 a n d 8. 4. 1. 2 . T he sa me S A E 
i nf or mati o n m ust be pr o vi de d o n t he Me dical De vice C o m plai nt f or m.
T he s p o ns or will be t he c o ntact f or t he recei pt of de vice deficie nc y  i nf or mati o n.
8. 4. 9. 4. Re g ul at or y Re p orti n g Re q uire m e nts f or De vice Deficie ncies
T he i n vesti gat or will pr o m ptl y  re p ort all de vice deficie ncies occ urri n g wit h a n y  me dical 
de vice pr o vi de d f or use i n t he st u d y  i n or der f or t he s p o ns or t o f ulfill t he le gal res p o nsi bilit y 
t o n otif y a p pr o priate re g ulat or y a ut h orities a n d ot her e ntities a b o ut certai n safety i nf or mati o n 
relati n g t o me dical de vices bei n g use d i n cli nical st u dies.
T he i n vesti gat or, or res p o nsi ble pers o n acc or di n g t o l ocal re q uire me nts (e g, t he hea d of t he 
me dical i nstit uti o n), will c o m pl y  wit h t he a p plica ble l ocal re g ulat or y re q uire me nts relati n g t o 
t he re p orti n g of de vice deficie ncies t o t he I R B/ E C.
8. 4. 1 0. V acci n ati o n Err ors
Vacci nati o n err ors ma y res ult fr o m t he a d mi nistrati o n or c o ns u m pti o n of t he st u d y 
i nter ve nti o n b y  t he wr o n g partici pa nt , or at t he wr o n g ti me, or at t he wr o n g d osa ge stre n gt h.
Vacci nati o n err ors are rec or de d a n d re p orte d as f oll o ws:
Rec or de d o n t he 
V acci n ati o n Err or P a ge 
of t he C R F
Rec or de d o n t he 
A d verse E ve nt P a ge 
of t he C R F
Re p orte d o n t he P S S A t o 
Pfizer S afet y Wit hi n 
2 4 H o urs of A w are ness
All vacci nati o n err ors
(re gar dless of w het her 
ass ociate d wit h a n A E)
A n y  A E or S A E ass ociate d 
wit h t he vacci nati o n err or
O nl y  if ass ociate d wit h a n 
S A E
Vacci nati o n err ors i ncl u de:

Vacci nati o n err ors i n v ol vi n g partici pa nt e x p os ure t o t he st u d y i nter ve nti o n;

P ote ntial vacci nati o n err ors or uses o utsi de of w hat is f oresee n i n t he pr ot oc ol t hat d o or 
d o n ot i n v ol ve t he st u d y partici pa nt .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 3
Ot her e xa m ples i ncl u de, b ut are n ot li mite d t o:

T he a d mi nistrati o n of e x pire d st u d y  i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect st u d y  i nter ve nti o n;

T he a d mi nistrati o n of a n i nc orrect d osa ge;

T he a d mi nistrati o n of st u d y  i nter ve nti o n t hat has u n der g o ne te m perat ure e xc ursi o n fr o m 
t he s pecifie d st ora ge ra n ge, u nless it is deter mi ne d b y t he s p o ns or t hat t he st u d y 
i nter ve nti o n u n der q uesti o n is acce pta ble f or use.
W het her or n ot t he vacci nati o n err or is acc o m pa nie d b y a n A E, as deter mi ne d b y t he 
i n vesti gat or, suc h vacci nati o n err ors occ urri n g t o a st u d y partici pa nt are rec or de d o n t he 
vacci nati o n err or pa ge of t he C R F, w hic h is a s pecific versi o n of t he A E pa ge , a n d, if 
a p plica ble, a n y ass ociate d seri o us a n d n o nseri o us A E(s) are rec or de d o n t he A E pa ge of t he 
C R F .
I n t he e ve nt of a vacci nati o n d osi n g err or, t he s p o ns or s h o ul d be n otifie d wit hi n 2 4 h o urs .
Vacci nati o n err ors s h o ul d be re p orte d t o Pfizer Safet y  wit hi n 2 4 h o urs via t he P S S A o nl y  
w he n ass ociate d wit h a n S A E.
8. 5. P h ar m ac o ki netics
P har mac o ki netic para meters are n ot e val uate d i n t his st u d y .
8. 6. Ge netics
8. 6. 1. S pecifie d Ge netics
S pecifie d g e netic a nal ys es are n ot e val uate d i n t his st u d y .
8. 6. 2. Ret ai ne d Rese arc h S a m ples f or Ge netics
N ot a p plica ble.
8. 7. Bi o m ar kers
Bi o mar kers are n ot e val uate d i n t his st u d y .
8. 8. I m m u n o ge nicit y Assess me nts
I m m u n o ge nicity assess me nts are descri be d i n Secti o n 8. 2 .
8. 9. H e alt h Ec o n o mics
Healt h ec o n o mics/ me dical res o urce utilizati o n a n d healt h ec o n o mics para meters are n ot 
e val uate d i n t his st u d y.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 4
8. 1 0. St u d y Pr oce d ures
Bef ore e nr oll me nt a n d bef ore a n y st u d y- relate d pr oce d ures are perf or me d, v ol u ntar y, writte n, 
st u d y-s pecific i nf or me d c o nse nt will be o btai ne d fr o m t he partici pa nt’s pare nt(s)/le gal 
g uar dia n. Eac h si g nat ure o n t he I C D m ust be pers o nall y  date d b y t he si g nat or y. T he 
i n vesti gat or or t heir desi g nee will als o si g n t he I CD. A c o p y of t he si g ne d a n d date d I C D 
m ust be gi ve n t o t he partici pa nt’s pare nt(s)/le gal g uar dia n. T he s o urce data m ust reflect t hat 
t he i nf or me d c o nse nt was o btai ne d bef ore partici pati o n i n t he st u d y.
T he ti mi n g of visit pr oce d ures (ie, pri or t o ra n d o mizati o n a n d after ra n d o mizati o n) m ust 
be mai ntai ne d; h o we ver, t here is fle xi bilit y  i n t he or der i n w hic h t he pr oce d ures ca n be 
c o n d ucte d at eac h visit. T he IC D m ust be si g ne d pri or t o t he start of a n y st u d y  pr oce d ure.
8. 1 0. 1. Visit 1 – D ose 1 ( D a y 1)
Pri or t o r a n d o miz ati o n:

O btai n a pers o nall y  si g ne d a n d date d I C D i n dicati n g t hat t he partici pa nt’s pare nt(s)/le gal 
g uar dia n has bee n i nf or me d of all perti ne nt as pects of t he st u d y  bef ore perf or mi n g a n y 
st u d y-s pecific pr oce d ures.

Assi g n a partici pa nt n u m ber via t he I R T.

O btai n a n d rec or d t he partici pa nt’s de m o gra p hic i nf or mati o n (i ncl u di n g date of birt h, se x, 
race, a n d et h nicity). T he c o m plete date of birt h (ie, D D -M M M -Y Y Y Y) will be c ollecte d 
t o criticall y e val uate t he i m m u ne res p o nse a n d safet y pr ofile b y a ge.

Perf or m a cli nical assess me nt. If t he cli nical assess me nt i n dicates t hat a p h y sical 
e xa mi nati o n is necessar y t o c o m pre he nsi vel y e val uate t he partici pa nt, perf or m a p h ys ical 
e xa mi nati o n a n d rec or d a n y fi n di n gs i n t he s o urce d oc u me nts a n d, if si g nifica nt, rec or d 
s uc h fi n di n gs o n t he me dical hist or y C R F.

Meas ure a n d rec or d t he partici pa nt’s pre vacci nati o n b o d y  te m perat ure usi n g a met h o d 
a p pr o priate f or t he a ge of t he t o d dler, acc or di n g t o r o uti ne l ocal practice (° C).

Rec or d recei pt of 2 i nfa nt d oses of P C V 1 0 ( pri or t o 1 1 m o nt hs of a ge), i ncl u di n g dates 
gi ve n.

Rec or d n o nst u d y vacci nati o ns gi ve n u p t o 2 8 da ys pri or t o st u d y i nter ve nti o n 
a d mi nistrati o n, i n s o urce d oc u me nts a n d i n t he C R F, if a p plica ble. ( Refer t o Secti o n 6. 9
f or acce pta ble c o nc o mita nt vacci nes a n d pr o hi bite d vacci nes.)

E ns ure a n d d oc u me nt t hat all of t he i ncl usi o n criteria a n d n o ne of t he e xcl usi o n criteria 
are met.

Assi g n a ra n d o mizati o n n u m ber a n d a st u d y i nter ve nti o n c o ntai ner n u m ber via t he I R T. 
T his m ust be t he last ste p bef ore pr ocee di n g. A site staff me m ber will pre pare t he st u d y 
i nter ve nti o n acc or di n g t o t he IP M .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 5
After r a n d o miz ati o n:

Re vie w te m p orar y  dela y criteria.

C ollect a p pr o xi matel y  5 m L  of bl o o d pri or t o st u d y  i nter ve nti o n a d mi nistrati o n.

A d mi nister a si n gle 0. 5 -m L  i njecti o n of t he assi g ne d st u d y i nter ve nti o n i nt o t he left 
a nter olateral t hi g h (see Secti o n 8. 1 ).

A d mi nister t he t hir d (t o d dler) d ose of P C V 1 0 i nt o t he ri g ht a nter olateral t hi g h (see 
Secti o n 8. 1 ).

If all o we d, a d mi nister r o uti ne pe diatric vacci nati o ns i nt o a li m b ot her t ha n t he site of 
st u d y i nter ve nti o n (m P n C ca n di date or m P n C c o ntr ol ) i njecti o n a n d ca pt ure all details of 
c o nc o mita nt vacci ne gi ve n o n t he sa me da y  as st u d y i nter ve nti o n, i ncl u di n g t he na me, 
date of a d mi nistrati o n, a n d site of a d mi nistrati o n, o n t he C R F (see Secti o n 6. 9 ).
After st u d y i nter ve nti o n a d mi nistr ati o n:

Site staff will o bser ve t he partici pa nt f or 3 0 mi n utes after a d mi nistrati o n of st u d y  
i nter ve nti o n f or a ny reacti o ns. Rec or d a ny ac ute reacti o ns (i ncl u di n g ti me of o nset) i n t he 
partici pa nt’s s o urce d oc u me nts a n d o n t he A E pa ge of t he C R F, a n d via t he P S S A , as 
a p plica ble.

Rec or d c o nc o mita nt me dicati o ns use d t o treat S A Es, if a p plica ble.

Rec or d A Es a n d S A Es as descri be d i n Secti o n 8. 4 .

E x plai n t he e -diar y  tec h n ol o gies a vaila ble f or t his st u d y (Secti o n 8. 3. 3 ) a n d assist t he 
partici pa nt ’s pare nt(s)/le gal g uar dia n i n d o w nl oa di n g t he st u d y a p plicati o n o nt o t he 
partici pa nt’s pare nt(s)/le gal g uar dia n’s o w n de vice or iss ue a pr o visi o ne d de vice, if 
re q uire d. Pr o vi de i nstr ucti o ns o n t he e-diar y ’s use a n d c o m pleti o n a n d as k t he 
partici pa nt ’s pare nt(s)/le gal g uar dia n t o c om plete t he e -diar y  fr o m Da y 1 t hr o u g h Da y 7, 
wit h Da y  1 bei n g t he da y of st u d y i nter ve nti o n a d mi nistrati o n.

Iss ue t he partici pa nt’s pare nt(s)/le gal g uar dia n a meas uri n g de vice t o meas ure i njecti o n 
site reacti o ns a n d a di gital t her m o meter a n d pr o vi de i nstr ucti o ns o n t heir use.

As k t he partici pa nt ’s pare nt(s)/le gal g uar dia n t o c o ntact t he i n vesti gat or site staff or 
i n vesti gat or as s o o n as p ossi ble d uri n g t he 7-d a y  p osta d mi nistrati o n peri o d if t he 
partici pa nt has re d ness a n d/ or s welli n g at t he i njecti o n site m eas uri n g >1 4 meas uri n g 
de vice u nits ( 7 c m) or se vere i njecti o n site pai n (ca uses li mitati o n of li m b m o ve me nt ) t o 
deter mi ne if a n u nsc he d ule d visit is re q uire d (refer t o Secti o n 8. 1 0. 5 ).
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 6

As k t he partici pa nt ’s pare nt(s) or le gal g uar dia n t o c o ntact t he i n vesti gat or site staff or 
i n vesti gat or as s o o n as p ossi ble if t he partici pa nt e x perie nces a fe ver ≥1 0 4° F ( ≥4 0. 0° C) 
fr o m Da y 1 t hr o u g h Da y  7 after st u d y i nter ve nti o n a d mi nistrati o n ( w here Da y 1 is t he 
da y  of a d mi nistrati o n) t o deter mi ne if a n u nsc he d ule d visit is re q uire d (see 
Secti o n 8. 1 0. 5 ).

As k t he partici pa nt ’s pare nt(s)/le gal g uar dia n t o c o ntact t he site staff or i n vesti gat or 
i m me diatel y if a ny si g nifica nt ill ness or me dical e ve nt (e g, e mer ge nc y  r o o m visit or 
h os pitalizati o n) occ urs t o t he partici pa nt.

Pr o vi de t he partici pa nt’s pare nt(s)/le gal g uar dia n wit h t he partici pa nt c o ntact car d 
c o ntai ni n g t he st u d y a n d i n vesti gat or i nf or mati o n .

I nf or m t he partici pa nt’s pare nt(s)/le gal g uar dia n t hat t he use of pr o p hyl actic 
a nti p yretic/ pai n me dicati o n, w hile per mitte d, is n ot rec o m me n de d o n t he da y of st u d y 
i nter ve nti o n a d mi nistrati o n ( bef ore or after st u d y i nter ve nti o n a d mi nistrati o n). If 
s ym pt o ms de vel o p, t he use of a nti p y retic/ pai n me dicati o n is all o we d.

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R F a n d t he s o urce d oc u me nts 
a n d u p dates t he st u d y i nter ve nti o n acc o u nta bilit y rec or ds .

T he i n vesti gat or or a p pr o priatel y  q ualifie d desi g nee re vie ws t he e-diar y  data o nli ne at 
fre q ue nt i nter vals ( dail y i s o pti mal) f or t he 7 da ys ( Da y 1 is t he da y of st u d y i nter ve nti o n 
a d mi nistrati o n) f oll o wi n g a d mi nistrati o n t o e val uate partici pa nt c o m plia nce a n d as part of 
t he o n g oi n g safety re vie w .
8. 1 0. 2. Visit 2 – D ose 1 F oll o w -U p Visit ( 2 8 - 4 2 Da ys Af ter Visit 1)

E ns ure a n d d oc u me nt t hat t he partici pa nt c o nti n ues t o be eli gi ble f or t he st u d y  
(see Secti o n 7. 1 a n d Secti o n 7. 2 f or partici pa nt disc o nti n uati o n/ wit h dra wal).

Rec or d n o nst u d y vacci nati o ns si nce t he last visit i n t he s o urce d oc u me nts a n d i n t he C R F, 
if a p plica ble, as descri be d i n Secti o n 6. 9 .

Re vie w t he partici pa nt’s e -diar y  data. C ollect st o p dates of a ny e-diar y e ve nts (l ocal 
reacti o ns or sys te mic e ve nts) o n g oi n g o n t he last da y t hat t he e-diar y  was c o m plete d a n d 
rec or d st o p dates i n t he C R F.

Deter mi ne if a n y A Es (i ncl u di n g n o nseri o us A Es a n d S A Es) ha ve occ urre d si nce t he 
pre vi o us visit, f oll o w u p o n a n y  pre vi o usl y re p orte d e ve nts t o deter mi ne t he o utc o me 
(ie, rec or d st o p dates or c o nfir m if t he y are still c o nti n ui n g), a n d rec or d s uc h A Es as 
descri be d i n Secti o n 8. 4 .

Rec or d c o nc o mita nt me dicati o ns use d t o treat S A Es.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 7

C ollect a p pr o xi matel y 5 m L of bl o o d f or i m m u n o ge nicit y assess me nts.

If all o we d, a d mi nister r o uti ne pe diatric vacci nati o ns a n d ca pt ure all details of 
c o nc o mita nt vacci n e(s), i ncl u di n g t he na me, date of a d mi nistrati o n, a n d site of 
a d mi nistrati o n, o n t he C R F ( see Secti o n 6. 9 ).

Re mi n d t he pare nt(s)/le gal g uar dia n t o bri n g bac k t he e-diar y  de vice f or t he ne xt visit, if 
a p plica ble.

C o nfir m w het her t he partici pa nt’s pare nt(s)/le gal g uar dia n still p ossess es t he partici pa nt 
c o ntact car d c o ntai ni n g t he st u d y  a n d i n vesti gat or i nf or mati o n. Pr o vi de a partici pa nt 
c o ntact car d, if nee de d.

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

Re mi n d t he partici pa nt’s pare nt(s)/le gal g uar dia n t o c o ntact t he i n vesti gat or or 
i n vesti gat or site staff as s o o n as p ossi ble if a ny si g ni fica nt ill ness or me dical e ve nt 
(e g, e mer ge nc y r o o m visit or h os pitalizati o n) occ urs d uri n g t he st u d y peri o d.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R F a n d t he s o urce d oc u me nts.
8. 1 0. 3. Visit 3 – D ose 2 ( 5 6- 7 0 D a ys A fter Visit 1/ D ose 1)

E ns ure a n d d oc u me nt t hat t he partici pa nt c o nti n ues t o be eli gi ble f or t he st u d y  
(see Secti o n 7. 1 a n d Secti o n 7. 2 f or partici pa nt disc o nti n uati o n/ wit h dra wal).

Rec or d n o nst u d y vacci nati o ns si nce t he last visit, if a p plica ble, as descri be d i n 
Secti o n 6. 9 .

If a p plica ble, collect st o p dates of a n y  D ose 1 e-diar y  e ve nts (l ocal reacti o ns or s yste mic 
e ve nts) o n g oi n g o n t he last da y  t hat t he D ose 1 e-diar y  was c o m plete d a n d rec or d st o p 
dates i n t he C R F.

Deter mi ne if a n y A Es (i ncl u di n g n o nseri o us A Es a n d S A Es) ha ve occ urre d si nce t he 
pre vi o us visit, f oll o w u p o n a n y  pre vi o usly re p orte d e ve nts t o deter mi ne t he o utc o me 
(ie, rec or d st o p dates or c o nfir m if t he y are still c o nti n ui n g), a n d rec or d s uc h A Es as 
descri be d i n Secti o n 8. 4 .

Rec or d c o nc o mita nt me dicati o ns use d t o treat S A Es.

Meas ure a n d rec or d t he partici pa nt’s pre vacci nati o n b o d y  te m perat ure usi n g a met h o d 
a p pr o priate f or t he a ge of t he t o d dler , acc or di n g t o r o uti ne l ocal practice (° C).

Re vie w te m p orar y  dela y criteria.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 8

A d mi nister a si n gle 0. 5 -m L  i njecti o n of t he assi g ne d st u d y i nter ve nti o n i nt o t he left 
a nter olateral t hi g h (see Secti o n 6. 1 ).

If all o we d, a d mi nister r o uti ne pe diatric vacci nati o ns i nt o a li m b ot her t ha n t he site of t he
st u d y i nter ve nti o n i njecti o n a n d ca pt ure all details of t he c o nc o mita nt vacci ne gi ve n o n 
t he sa me da y as st u d y i nter ve nti o n a d mi nistrati o n, i ncl u di n g t he na me, date of
a d mi nistrati o n, a n d site of a d mi nistrati o n, o n t he C R F (see Secti o n 6. 9 ).
After st u d y i nter ve nti o n a d mi nistr ati o n:

Site staff will o bser ve t he partici pa nt f or 3 0 mi n utes after a d mi nistrati o n of st u d y  
i nter ve nti o n f or a ny reacti o ns. Rec or d a ny ac ute reacti o ns (i ncl u di n g ti me of o nset) i n t he 
partici pa nt’s s o urce d oc u me nts a n d o n t he A E pa ge of t he C R F, a n d via t he P S S A , as 
a p plica ble.

Rec or d c o nc o mita nt me dicati o ns use d t o treat S A Es, if a p plica ble.

Rec or d A Es a n d S A Es as descri be d i n Secti o n 8. 4 .

A ssist t he partici pa nt’s pare nt(s)/le gal g uar dia n i n red o w nl oa di n g t he st u d y a p plicati o n 
o nt o t he partici pa nt’s pare nt(s)/le gal g uar dia n’s o w n de vice or reiss ue a pr o visi o ne d 
de vice, if re q uire d. Pr o vi de i nstr ucti o ns o n t he e -diar y ’s use a n d c o m pleti o n a nd as k t he 
partici pa nt’s pare nt(s)/le gal g uar dia n t o c o m plete t he e -diar y  fr o m Da y 1 t hr o u g h Da y 7, 
wit h Da y  1 bei n g t he da y of st u d y i nter ve nti o n a d mi nistrati o n (see Secti o n 8. 3. 3 ).

C o nfir m if t he pare nt(s)/le gal g uar dia n still p ossesses t he meas uri n g de vice a n d di gital 
t her m o meter. Reiss ue a n d pr o vi de i nstr ucti o ns o n t heir use , if nee de d.

As k t he partici pa nt’s pare nt(s)/le gal g uar dia n t o c o ntact t he i n vesti gat or site staff or 
i n vesti gat or as s o o n as p ossi ble d uri n g t he 7-d a y  p osta d mi nistrati o n peri o d if t he 
partici pa nt has re d ness a n d/ or s welli n g at t he i njecti o n site meas uri n g 1 4 meas uri n g 
de vice u nits ( 7 c m) or se vere i njecti o n site pai n (ca uses li mitati o n of li m b m o ve me nt) t o 
deter mi ne if a n u nsc he d ule d visit is re q uire d (refer t o Secti o n 8. 1 0. 5 ).

As k t he partici pa nt’s pare nt(s) /le gal g uar dia n t o c o ntact t he i n vesti gat or site staff or 
i n vesti gat or as s o o n as p ossi ble if t he partici pa nt e x perie nces a fe ver ≥1 0 4° F ( ≥4 0. 0° C) 
fr o m Da y 1 t hr o u g h Da y  7 after st u d y i nterve nti o n a d mi nistrati o n ( w here Da y  1 is t he 
da y  of a d mi nistrati o n) t o deter mi ne if a n u nsc he d ule d visit is re q uire d (see 
Secti o n 8. 1 0. 5 ).

As k t he partici pa nt’s pare nt(s)/le gal g uar dia n t o c o ntact t he site staff or i n vesti gat or 
i m me diatel y if a ny si g nifica nt ill ness or me dical e ve nt (e g, e mer ge nc y  r o o m visit or 
h os pitalizati o n) occ urs t o t he partici pa nt.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 5 9

C o nfir m w het her t he partici pa nt’s pare nt(s)/le gal g uar dia n still p ossesses t he partici pa nt 
c o ntact car d c o ntai ni n g t he st u d y  a n d i n vesti gat or i nf or mati o n. Pr o vi de a partici pa nt 
c o ntact car d , if nee de d.

Sc he d ule a n a p p oi nt me nt f or t he partici pa nt t o ret ur n f or t he ne xt st u d y  visit.

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R F a n d t he s o urce d oc u me nts 
a n d u p dates t he st u d y i nter ve nti o n acc o u nta bilit y rec or ds.

T he i n vesti gat or or a p pr o priatel y  q ualifie d desi g nee re vie ws t he e-diar y  data o nli ne at 
fre q ue nt i nter vals ( daily i s o pti mal) f or t he 7 da ys ( Da y 1 is t he da y of st u d y i nter ve nti o n 
a d mi nistrati o n) f oll o wi n g a d mi nistrati o n t o e val uate partici pa nt c o m plia nce a n d as part of 
t he o n g oi n g safety re vie w.
8. 1 0. 4. Visit 4 – D ose 2 F oll o w -U p Visit ( 2 8 - 4 2 Da ys A fter Visit 3)

Re c or d n o nst u d y vacci nati o ns si nce t he last visit, if a p plica ble, as descri be d i n 
Secti o n 6. 9 .

Re vie w t he partici pa nt’s e -diar y  data. C ollect st o p dates of a n y e-diar y  e ve nts (l ocal 
reacti o ns or sys te mic e ve nts) o n g oi n g o n t he last da y t hat t he e-diar y  was c o m plete d a n d 
rec or d st o p dates i n t he C R F.

Deter mi ne if a n y A Es (i ncl u di n g n o nseri o us A Es a n d S A Es) ha ve occ urre d si nce t he 
pre vi o u s visit, f oll o w u p o n a n y pre vi o usly re p orte d e ve nts t o deter mi ne t he o utc o me 
(ie, rec or d st o p dates or c o nfir m if t he y are still c o nti n ui n g), a n d rec or d s uc h A Es as 
descri be d i n Secti o n 8. 4 .

C ollect t he e-diar y  de vice, if a p plica ble.

Rec or d c o nc o mita nt me dicati o ns use d t o treat S A Es.

C ollect a p pr o xi matel y  5 m L of bl o o d f or i m m u n o ge nicit y assess me nts.

If all o we d, a d mi nister r outi ne pe diatric vacci nati o ns a n d ca pt ure all details of t he 
c o nc o mita nt vacci ne(s), i ncl u di n g t he na me, date of a d mi nistrati o n, a n d site of 
a d mi nistrati o n, o n t he C R F (s ee Secti o n 6. 9 ).

T he i n vesti gat or or a n a ut h orize d desi g nee c o m pletes t he C R F a n d t he s o urce d oc u me nts.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 0
8. 1 0. 5. U nsc he d ule d Visits
If t he partici pa nt’s pare nt(s)/le gal g uar dia n re p orts re d ness or s welli n g at t he i njecti o n 
site m eas uri n g 1 4 meas uri n g de vice u nits ( 7. 0 c m) or se vere i njecti o n site pai n 
(Secti o n 8. 3. 3. 1. 1 ), or a te m perat ure 4 0° C (1 0 4. 0 °F) (Secti o n 8. 3. 3. 1. 2. 2 ) d uri n g t he 
7 da y s f oll o wi n g st u d y i nter ve nti o n a d mi nistrati o n, a tele p h o ne c o ntact m ust occ ur as s o o n as 
p ossi ble bet wee n t he i n vesti gat or or me dicall y q ualifie d desi g nee a n d t he partici pa nt ’s 
pare nt(s)/le gal g uar dia n t o assess if a n u nsc he d ule d i n vesti gator site visit is re q uire d. N ote 
t hat f or a fe ver 4 0. 0° C, t he partici pa nt’s pare nt(s)/le gal g uar dia n s h o ul d be i nstr ucte d n ot t o 
dela y  see ki n g me dical care, as a p pr o priate, w hile arra n gi n g f or a n u nsc he d ule d visit if 
a p plica ble. A site visit s h o ul d be sc he d ule d as s o o n as p ossi ble t o assess t he e xte nt of t he 
i njecti o n site reacti o n u nless a ny of t he f oll o wi n g is tr ue:

T he partici pa nt is u na ble t o atte n d t he u nsc he d ule d visit.

T he reacti o n is n o l o n ger prese nt at t he ti me of t he tele p h o ne c o ntact.

T he partic i pa nt’s pare nt(s)/le gal g uar dia n rec or de d a n i nc orrect val ue i n t he e-diar y  
(c o nfir mati o n of a n e-diar y  data e ntr y err or).

T he PI  or a ut h orize d desi g nee deter mi ne d it was n ot nee de d.
T his tele p h o ne c o ntact will be rec or de d i n t he partici pa nt’s s o urce d oc u m e ntati o n a n d t he 
C R F. If t he partici pa nt is u na ble t o atte n d t he u nsc he d ule d visit, or t he PI  or a ut h orize d 
desi g nee deter mi ne d it was n ot nee de d, a n y  o n g oi n g reacti o ns m ust be assesse d at t he ne xt 
st u d y visit. D uri n g t he u nsc he d ule d visit, t he reacti o ns sh o ul d be assesse d b y t he i n vesti gat or 
or a me dicall y q ualifie d me m ber of t he st u d y staff, s uc h as a st u d y p h ys icia n or a st u d y 
n urse, as a p plica ble t o t he i n vesti gat or’s l ocal practice, w h o will:

Meas ure b o d y  te m perat ure, as a p pr o priate f or t he a ge of t he t o d dler, acc or di n g t o r o uti ne 
l ocal practice (°F/ ° C).

Meas ure mi ni m u m a n d ma xi m u m dia meters of re d ness (if prese nt).

Meas ure mi ni m u m a n d ma xi m u m dia meters of s welli n g (if prese nt).

Assess i njecti o n site pai n (if prese nt) i n acc or da nce wit h t he gra des pr o vi de d i n 
Secti o n 8. 3. 3. 1. 1 .

Assess f or ot her fi n di n gs ass ociate d wit h t he reacti o n a n d rec or d o n t he A E pa ge of t he 
C R F, if a p pr o priate.
T he i n vesti gat or or a n a ut h orize d desi g nee will c o m plete t he u nsc he d ule d visit assess me nt 
pa ge of t he C R F.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 1
T he partici pa nt’s pare nt(s)/le gal g uar dia n will als o be i nstr ucte d t o c o ntact i n vesti gat or site 
staff if t he partici pa nt e x perie nces a ny e m er ge nc y r o o m visit or h os pitalizati o n f or decrease d 
a p petite, dr o wsi ness/i ncrease d slee p, irrita bilit y , or l ocal reacti o n wit hi n 7 da ys after
a d mi nistrati o n of st u d y i nter ve nti o n.
T he partici pa nt’s pare nt(s)/le gal g uar dia n will als o be i nstr ucte d t o c o ntact t he i n vesti gat or 
site t o re p ort a ny si g nifica nt ill ness, me dical e ve nt, or h os pitalizati o n t hat occ urs d uri n g t he 
st u d y peri o d. T he i n vesti gat or site s h o ul d deter mi ne if a n u nsc he d ule d visit t o f urt her
e val uate t he e ve nt is warra nte d i n all s uc h cases.
A d diti o nall y , st u d y staff ma y c o ntact t he partici pa nt’s pare nt(s)/le gal g uar dia n t o o btai n 
a d diti o nal i nf or mati o n o n Gra de 3 e ve nts e ntere d i nt o t he e- diar y .
9. S T A TI S TI C A L C O N SI D E R A TI O N S
Met h o d ol o g y f or s u m mar y  a n d statistical a nalys es of t he data c ollecte d i n t his st u d y is 
descri be d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or. T he 
S A P ma y  m o dif y w hat is o utli ne d i n t he pr ot oc ol w here a p pr o priate; h o we ver, a ny maj or 
m o dificati o ns of t he pri mar y  e n d p oi nt defi niti o ns or t heir a nalys es will als o be reflecte d i n a 
pr ot oc ol a me n d me nt.
9. 1. St atistic al H y p ot hesis
T here is n o f or mal statistical h y p ot hesis testi n g pla n ne d f or t his st u d y .
9. 1. 1. Esti m a n ds
T he esti ma n ds c orres p o n di n g t o t he pri mar y  a n d sec o n dar y o bjecti ves are descri be d i n t he
ta ble i n Secti o n 3 . T he esti ma n ds t o e val uate t he i m m u n o ge nicity o bjecti ves will be base d o n
t he e val ua ble i m m u n o ge nicit y p o p ulati o ns (see Secti o n 9. 2 f or defi niti o n). T he esti ma n ds
esti mate t he st u d y i nter ve nti o n effect i n t he h yp ot hetical setti n g w here partici pa nts f oll o w t he
st u d y sc he d ules a n d pr ot oc ol re q uire me nts as directe d. Missi n g ser ol o g y res ults will n ot be
i m p ute d.
I n t he safety pri mar y  o bjecti ve e val uati o ns, missi n g e-diar y  data will n ot be i m p ute d. A 
partial A E start date (e g, missi n g da y , missi n g b ot h m o nt h a n d da y) will be i m p ute d b y
assi g ni n g t he earliest p ossi ble start date usi n g all a vaila ble i nf or mati o n (e g, st o p date of A E,
date of st u d y  i nter ve nti o n a d mi nistrati o n fr o m t he sa me partici pa nt) f oll o wi n g t he Pfizer 
sta n dar ds f or ha n dli n g i nc o m plete A E start date. A n A E wit h a c o m pletely missi n g start date 
is n ot all o we d i n t he data c ollecti o n. N o ot her missi n g i nf or mati o n will be i m p ute d i n t he 
safety a nal ysis.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 2
9. 2. A n al ysis Sets
F or p ur p oses of a nal y sis, t he f oll o wi n g a nal ys is sets are defi ne d:
P artici p a nt A n al ysis Set
Descri pti o n
E nr olle d
All partici pa nts w h ose pare nts/le gal g uar dia n s si g n t he IC D.
Ra n d o mize d
All partici pa nts w h o are assi g ne d a ra n d o mizati o n n u m ber i n 
t he IR T s ys te m.
D ose 1 eval ua ble 
i m m u n o ge nicity
All ra n d o mize d partici pa nts w h o
1.
a re eli gi ble,
2.
recei ve t he first d ose of st u d y i nter ve nti o n t o w hic h t he y  
are ra n d o ml y assi g ne d,
3.
ha ve at least 1 vali d i m m u n o ge nicit y res ult fr o m t he 
bl o o d sa m ple c ollecte d wit hi n a n a p pr o priate wi n d o w 
1 m o nt h after D ose 1 , a n d
4.
ha ve n o ot her maj or pr ot oc ol de viati o ns as deter mi ne d b y 
t he cli nicia n u p t o t he 1 -m o nt h p o st– D ose 1 visit .
D ose 2 eval ua ble 
i m m u n o ge nicity
All ra n d o mize d partici pa nts w h o
1.
are eli gi ble,
2.
recei ve b ot h d oses of st u d y i nter ve nti o n t o w hic h t he y are 
ra n d o ml y assi g ne d,
3.
ha ve at least 1 vali d i m m u n o ge nicit y res ult fr o m t he 
bl o o d sa m ple c ollecte d wit hi n a n a p pr o priate wi n d o w 
1 m o nt h after D ose 2, a n d
4.
ha ve n o ot her maj or pr ot oc ol de viati o ns as deter mi ne d b y 
t he cli nicia n.
mI T T
All ra n d o mize d partici pa nts w h o recei ve t he st u d y
i nter ve nti o n wit h at least 1 vali d i m m u n o ge nicit y res ult
1 m o nt h after D ose 1 a n d/ or 1 m o nt h after D ose 2 .
Safet y
All partici pa nts w h o recei ve at least 1 d ose of st u d y 
i nter ve nti o n.
9. 3. St atistic al A n al yses
T he S A P will be de vel o pe d a n d fi nalize d bef ore a n y of t he pla n ne d a nal ys es (Secti o n 9. 4. 1 )
are pe rf or me d a n d will descri be t he a nal ys es a n d pr oce d ures f or acc o u nti n g f or missi n g, 
u n use d, a n d s p uri o us data. T his secti o n is a s u m mar y  of t he pla n ne d statistical a nal ys es of t he 
pri mar y  a n d sec o n dar y e n d p oi nts.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 3
9. 3. 1. Ge ner al C o nsi der ati o ns
I n ge neral, t he st u d y data will be s u m marize d b y st u d y i nter ve nti o n gr o u ps. CIs f or all 
e n d p oi nts i n t he statistical a nal ysis will be prese nte d as 2-si de d at t he 9 5 % le vel.
F or all t he i m m u n o ge nicit y  e n d p oi nts, t he a nal ysis will be pri maril y base d o n t he e val ua ble 
i m m u n o ge nicity p o p ulati o n s. A n a d diti o nal a nalys is will be perf or me d base d o n t he mIT T
p o p ulati o n if t here is a lar ge e n o u g h differe nce i n t he n u m ber of part ici pa nts i ncl u de d
bet wee n t he mI T T a n d t he e val ua ble i m m u n o ge nicit y  p o p ulati o ns. Partici pa nts will be
s u m marize d acc or di n g t o t he st u d y i nter ve nti o n gr o u p t o w hic h t he y were ra n d o mize d.
Missi n g la b orat or y  res ults will n ot be i m p ute d.
T he safet y a nal ys es are base d o n t he safet y p o p ulati o n. Partici pa nts will be s u m marize d 
acc or di n g t o t he st u d y i nter ve nti o ns t he y  recei ve d.
9. 3. 1. 1. A n al yses f or Bi n ar y D at a
Descri pti ve statistics f or cate g orical varia bles (e g, pr o p orti o ns) are t he perce nta ge ( %), t he 
n u merat or ( n) a n d de n o mi nat or ( N) use d i n t he perce nta ge calc ulati o n, a n d t he 2- si de d 9 5 % 
CI s, w here a p plica ble.
T he e xact 9 5 % CI f or bi nar y  e n d p oi nts f or eac h gr o u p will be c o m p ute d usi n g t he 
F distri b uti o n ( Cl o p per -Pears o n).
9. 3. 1. 2. A n al yses f or C o nti n u o us D at a
U nless ot her wise s tate d, descri pti ve statistics f or c o nti n u o us varia bles are n, mea n, me dia n,
sta n dar d de viati o n, mi ni m u m, a n d ma xi m u m.
Assa y  res ults a b o ve t he L L O Q will be re p orte d, b ut res ults t hat are bel o w t he L L O Q, or 
B L Qs, will be set t o 0. 5 × L L O Q i n t he calc ulati o n of G M Cs a n d set t o L L O Q i n t he a nal ys is 
of f ol d rises .
9. 3. 1. 3. Ge o metric Me a ns
T he ge o metric mea n f or eac h gr o u p will be calc ulate d as t he mea n of t he l o garit h micall y  
tra nsf or me d assa y res ults a n d t he n e x p o ne ntiati n g the mea n. T he 2 -si de d 9 5 % CI will be 
o btai ne d b y  e x p o ne ntiati n g t he CI f or t he mea n of t he l o garit h micall y tra nsf or me d assa y 
res ults base d o n t he St u de nt t distri b uti o n.
9. 3. 1. 4. Ge o metric Me a n F ol d Rises
T he G M F R f or eac h gr o u p is defi ne d as t he ge o metric mea n of t he f ol d rises i n t he assa y
res ults fr o m 1 ti me p oi nt t o a later ti me p oi nt. O nl y data fr o m partici pa nts wit h n o n missi n g 
assa y res ults at b ot h ti me p oi nts will be i ncl u de d i n t he G M F R calc ulati o n .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 4
T he G M F R will be calc ulate d as t he mea n differe nce of l o garit h micall y tra nsf or me d assa y 
res ults (later ti me p oi nt - earlier ti me p oi nt ) a n d e x p o ne ntiati n g t he mea n differe nce. T he 
2- si de d 9 5 % CI will be o btai ne d b y e x p o ne ntiati n g t he li mits of t he CI f or t he mea n 
differe nce of t he l o garit h micall y  tra nsf or me d assa y res ults base d o n t he St u de nt 
t distri b uti o n.
9. 3. 1. 5. Re verse C u m ul ati ve Distri b uti o n C ur ves
E m pirical R C D Cs f or I g G c o nce ntrati o ns a n d O P A titers will be pl otte d as a ste p f u ncti o n of 
t he pr o p orti o n of partici pa nts wit h t he assa y res ult e q ual t o or e xcee di ng a s pecifie d val ue 
o ver t he f ull ra n ge of t he o bser ve d assa y  res ults.
9. 3. 2. Pri m ar y E n d p oi nt(s) / Esti m a n d(s) A n al ysis
O bjecti ves
E n d p oi nts a n d Esti m a n ds
St atistics
Safet y a

Perce nta ge of partici pa nts wit h pr o m pte d 
l ocal reacti o ns (re d ness, s welli n g, a n d pai n 
at t he i njecti o n site) wit hi n 7 da y s after 
eac h d ose i n eac h gr o u p

Perce nta ge of partici pa nts wit h pr o m pte d
s yste mic e ve nts (fe ver, decrease d a p petite, 
dr o wsi ness/i ncrease d slee p , a n d irrita bilit y) 
wit hi n 7 da y s after eac h d ose i n eac h gr o u p

Descri pti ve 
s u m mar y statistics 
f or partici pa nts 
wit h eac h l ocal 
reacti o n/s yste mic
e ve nt wit hi n 
7 da y s after eac h 
d ose , b y  se verity 
le vel

Perce nta ge of partici pa nts wit h A Es fr o m 
D ose 1 t hr o u g h 1 m o nt h after D ose 2

Descri pti ve 
s u m mar y statistics

Perce nta ge of partici pa nts wit h S A Es fr o m 
D ose 1 t hr o u g h 1 m o nt h after D ose 2

Descri pti ve 
s u m mar y statistics
a.
A n y relate d A Es starti n g wit hi n 7 da ys after eac h d ose, a n d c ollecte d b y t he A E C R F, t hat are 
c o nsi dere d l ocal reacti o ns or s yste mic e ve nts will be c o ns oli date d wit h e-diar y data a n d i ncl u de d i n t he 
c orres p o n di n g s u m mar y f or l ocal reacti o ns or s yste mic e ve nts.
9. 3. 3. Sec o n d ar y E n d p oi nt(s) / Esti m a n d(s) A n al ysis
O bjecti ves
E n d p oi nt s a n d Esti m a n d s
St atistics
I m m u n o ge nicity

P ne u m oc occal I g G G M Cs 1 m o nt h after 
D ose 1 a n d 1 m o nt h after D ose 2

G M C s a n d 2-si de d 
9 5 % CI s

Perce nta ges of partici pa nts wit h pre defi ne d 
I g G c o nce ntrati o ns 1 m o nt h after D ose 1 
a n d 1 m o nt h after D ose 2

Descri pti ve 
s u m mar y statistics
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 5
O bjecti ves
E n d p oi nt s a n d Esti m a n d s
St atistics

P ne u m oc occal I g G G M F Rs fr o m bef ore 
D ose 1 t o 1 m o nt h after D ose 1 a n d fr o m 
1 m o nt h after D ose 1 t o 1 m o nt h after 
D ose 2

G M F Rs a n d 
2- si de d 9 5 % CIs

P ne u m oc occal O P A G M Ts 1 m o nt h after 
D ose 1 a n d 1 m o nt h after D ose 2

G M T s a n d 2-si de d 
9 5 % CI s

P ne u m oc occal O P A G M F Rs fr o m bef ore 
D ose 1 t o 1 m o nt h after D ose 1 a n d fr o m 
1 m o nt h after D ose 1 t o 1 m o nt h after 
D ose 2

Descri pti ve 
s u m mar y statistics
9. 3. 4. E x pl or at or y E n d p oi nt(s) A n al ysis
T he a nal ys es o n t he e x pl orat or y  e n d p oi nts 
 
will be pr o vi de d i n t he S A P.
9. 4. I nteri m A n al yses
N o i nteri m a nal ys is will be c o n d ucte d f or t his st u d y. As t his is a n o pe n-la bel st u d y, t he 
s p o ns or ma y c o n d uct u n bli n de d re vie ws of t he data d uri n g t he c o urse of t he st u d y f or t he 
p ur p ose of safet y assess me nt a n d/ or f or s u p p orti n g cli nical de vel o p me nt.
9. 4. 1. A n al ysis Ti mi n g
Statistical a nal y ses m a y  be carrie d o ut as s pecifie d bel o w:

A nal y sis of safet y data t hr o u g h Visit 2 ( 1 m o nt h after D ose 1 );

A nal y sis of im m u n o ge nicit y  data of I g G a n d O P A res ults t hr o u g h Visit 2 ( 1 m o nt h after 
D ose 1 ), w he n a vaila ble, f or 1 or m ore i m m u n o ge nicit y e n d p oi nts;

F i nal a nalys is of safet y a n d i m m u n o ge nicity , i ncl u di n g c o m plete I g G a n d O P A res ults 
a vaila ble after t he c o m pleti o n of t he st u d y .
I m m u n o ge nicity data re vie ws b y t he s p o ns or ma y be c o n d ucte d at a n y ti me t he data are 
a vaila ble t o ai d i n decisi o n- ma ki n g f or t he s p o ns or pr o gra ms.
Certai n a nal ys es ma y be c o m bi ne d if t he data bec o me a vaila ble ar o u n d t he sa me ti me.
A d diti o nal a nal yses ma y be c o n d ucte d or c o m bi ne d if re q uire d f or re g ulat or y p ur p oses or f or 
f urt her cli nical e val uati o n of t he st u d y i nter ve nti o n.
 
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 6
9. 5. S a m ple Size Deter mi n ati o n
T he sa m ple size of t his st u d y  is n ot dri ve n b y a ny f or mal hy p ot hesis test. I t is deter mi ne d 
pri maril y  base d o n t he c o nsi derati o n of pr o vi di n g i nitial i nf or mati o n o n t he i m m u ne 
res p o nses i n d uce d by t he m P n C ca n di date a n d t he c orres p o n di n g safet y pr ofiles i n or der t o 
s u p p ort a decisi o n f or f urt her cli nical de vel o p me nt.
T he safety pri mar y  o bjecti ve i ncl u des t he e n d p oi nts f or A Es, l ocal reacti o ns, a n d s yste mic 
e ve nts. Ta ble 4 s h o ws t he bi n o mial pr o ba bilit y of detecti n g at least 1 A E. T he n u m ber of
partici pa nts i n eac h st u d y gr o u p is 5 0 , w hic h pr o vi des a > 92 % c ha nce of o bser vi n g at least
1 e ve nt i n a gr o u p, ass u mi n g a tr ue e ve nt rate of at least 5 %.
T a ble 4.
Pr o b a bilit y of Detecti n g at Le ast 1 A d verse E ve nt
S a m ple Size per Gr o u p
Tr ue R ate of A Es
Pr o b a bilit y of O bser vi n g at Le ast 1 A E
5 0
2. 0 %
6 3. 6 %
3. 0 %
7 8. 2 %
4. 0 %
8 7. 0 %
5. 0 %
9 2. 3 %
6. 0 %
9 5. 5 %
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 7
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L C O N SI D E R A TI O N S
1 0. 1. A p pe n di x 1: Re g ul at or y, Et hic al, a n d St u d y O versi g ht C o nsi der ati o ns
1 0. 1. 1. Re g ul at or y a n d Et hic al C o nsi der ati o ns
T his st u d y  will be c o n d ucte d i n acc or da nce wit h t he pr ot oc ol a n d wit h t he f oll o wi n g:

C o nse ns us et hical pri nci ples deri ve d fr o m i nter nat i o nal g ui deli nes, i ncl u di n g t he 
Declarati o n of Helsi n ki a n d CI O M S I nter nati o nal Et hical G ui deli nes ;

A p plica ble I C H G C P g ui deli nes ;

A p plica ble la ws a n d re g ulati o ns , i ncl u di n g a p plica ble pri vac y la ws.
T he pr ot oc ol, pr ot oc ol a me n d me nts, I C D, S R S D(s) , a n d ot her rele va nt d oc u me nts (e g, 
a d vertise me nts) m ust be re vie we d a n d a p pr o ve d b y t he s p o ns or, s u b mitte d t o a n IR B/ E C b y  
t he i n vesti gat or, a n d re vie we d a n d a p pr o ve d b y t he I R B/ E C bef ore t he st u d y  is i nitiate d.
A n y  a me n d me nts t o t he pr ot oc ol will re q uire I RB/ E C a p pr o val bef ore i m ple me ntati o n of 
c ha n ges ma de t o t he st u d y desi g n, e xce pt f or c ha n ges necessar y  t o eli mi nate a n i m me diate 
hazar d t o st u d y  partici pa nts.
Pr ot oc ols a n d a n y s u bsta ntial a me n d me nts t o t he pr ot oc ol will re q uire healt h a ut h orit y  
a p pr o val pri or t o i nitiati o n , e xce pt f or c ha n ges necessar y  t o eli mi nate a n i m me diate hazar d t o 
st u d y partici pa nts.
T he i n vesti gat or will be res p o nsi ble f or t he f oll o wi n g:

Pr o vi di n g writte n s u m maries of t he stat us of t he st u d y  t o t he I R B/ E C a n n uall y or m ore 
fre q ue ntl y i n acc or da nce wit h t he re q uire me nts, p olicies, a n d pr oce d ures esta blis he d b y 
t he IR B/ E C ;

N otif y i n g t he I R B/ E C of S A Es or ot her si g nifica nt safety fi n di n gs as re q uire d b y I RB/ E C 
pr oce d ures ;

Pr o vi di n g o versi g ht of t he c o n d uct of t he st u d y at t he site a n d a d here nce t o re q uire me nts 
of 2 1 C F R, I C H G C P g ui deli nes, t he I R B/ E C, E ur o pea n re g ulati o n 5 3 6/ 2 0 1 4 f or cli nical 
st u dies, E ur o pea n M D R 2 0 1 7/ 7 4 5 f or cli nical de vice researc h, a n d all ot her a p plica ble 
l ocal re g ulati o ns.
1 0. 1. 1. 1. Re p orti n g of S afet y Iss ues a n d Seri o us Bre a c hes of t he Pr ot oc ol or I C H G C P
I n t he e ve nt of a ny pr o hi biti o n or restricti o n i m p ose d (ie, cli nical h ol d) b y a n a p plica ble 
re g ulat or y a ut h ority i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n t hat mi g ht i nfl ue nce t he eval uati o n of t he be nefits a n d ris ks of t he st u d y 
i nter ve nti o n, Pfizer s h o ul d be i nf or me d i m me diatel y.
 

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

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 6 9
T he i n vesti gat or m ust e ns ure t hat eac h st u d y  partici pa nt’s pare nt(s)/le gal g uar dia n is f ull y 
i nf or me d a b o ut t he nat ure a n d o bjecti ves of t he st u d y, t he s hari n g of data relate d t o t he st u d y, 
a n d p ossi ble ris ks ass ociate d wit h partici pati o n, i ncl u di n g t he ri s ks ass ociate d wit h t he 
pr ocessi n g of t he partici pa nt’s pers o nal data.
T he partici pa nt’s pare nt(s)/le gal g uar dia n m ust be i nf or me d t hat t he partici pa nt’s pers o nal 
st u d y-relate d data will be use d b y t he s p o ns or i n acc or da nce wit h l ocal data pr otecti o n 
la w. T he le vel of discl os ure m ust als o be e x plai ne d t o t he partici pa nt’s pare nt(s)/le gal 
g uar dia n.
T he partici pa nt’s pare nt(s)/le gal g uar dia n m ust be i nf or me d t hat t he partici pa nt’s me dical 
rec or ds ma y be e xa mi ne d b y Cli nical Q uality Ass ura nce a u dit ors or ot her a ut h orize d 
pers o n nel a p p oi nte d b y t he s p o ns or, b y a p pr o priate I R B/ E C me m bers, a n d b y  i ns pect ors 
fr o m re g ulat or y a ut h orities.
T he i n vesti gat or f urt her m ust e ns ure t hat eac h st u d y  partici pa nt’s pare nt(s)/le gal g uar dia n
is f ull y i nf or me d a b o ut t heir ri g ht t o access a n d c orrect t heir c hil d’s pers o nal data a n d t o 
wit h dra w c o nse nt f or t he pr ocessi n g of t heir c hil d’s pers o nal data , kee pi n g i n mi n d t he 
pri vac y  ri g hts t hat ma y restrict access of ol der a d olesce nts’ me dical rec or ds b y  t heir 
pare nt(s)/le gal g uar dia n i n certai n re gi o ns.
T he s o urce d oc u me ntati o n m ust i ncl u de a state me nt t hat writte n i nf or me d c o nse nt was 
o btai ne d bef ore t he partici pa nt was e nr olle d i n t he st u d y  a n d t he date t he writte n 
c o nse nt/asse nt was o btai ne d. T he a ut h orize d pers o n o btai ni n g t he i nf or me d c o nse nt m ust als o 
si g n t he I C D.
T he partici p ants ’ pare nts/le gal g uar dia ns m ust be rec o nse nte d t o t he m ost c urre nt versi o n of 
t he IC D(s) d uri n g t heir partici pati o n i n t he st u d y as re q uire d per l ocal re g ulati o ns .
A c o p y of t he I C D(s) , if writte n, m ust be pr o vi de d t o t he pare nt(s)/le gal g uar dia n a n d t he 
partici pa nt.
1 0. 1. 4. D at a Pr otecti o n
All parties will c o m pl y  wit h all a p plica ble la ws, i ncl u di n g la ws re gar di n g t he i m ple me ntati o n 
of or ga nizati o nal a n d tec h nical meas ures t o e ns ure pr otecti o n of partici pa nt data.
Partici pa nts’ pers o nal data will be st ore d at t he st u d y  site i n e ncr ypte d electr o nic a n d/ or pa per 
f or m a n d will be pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o e ns ure t hat o nl y  
a ut h orize d st u d y staff ha ve access. T he st u 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 will be res p o nsi ble f or 
deter mi ni n g w het her a pers o nal data brea c 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.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 0
T o pr otect t he ri g hts a n d free d o ms of partici pa nts wit h re gar d t o t he pr ocessi n g of pers o nal 
data, partici pa nts will be assi g ne d a si n gle, partici pa nt -s pecific n u merical c o de. A n y 
partici pa nt rec or ds or data sets t hat are tra nsferre d t o t he s p o ns or will c o ntai n t he n u merical 
c o de; partici pa nt na mes will n ot be tra nsferre d. All ot her i de ntifia ble data tra nsferre d t o t he 
s p o ns or will be i de ntifie d b y t his si n gle, partici pa nt -s pecific c o de. T he st u d y site will 
mai ntai n a c o nfi de ntial list of partici pa nt s w h o partici pate d i n t he st u d y, li n ki n g eac h 
partici pa nt ’s n u merical c o de t o t heir act ual i de ntit y a n d me dical rec or d I D. I n case of data 
tra nsfer, t he s p o ns or will pr otect t he c o nfi de ntialit y of partici pa nts’ pers o nal data c o nsiste nt 
wit h t he c li nical st u d y a gree me nt a n d a p plica ble pri vac y  la ws.
I nf or mati o n tec h n ol o g y s yste ms use d t o c ollect, pr ocess, a n d st ore st u d y-relate d data are 
sec ure d by t ec h nical a n d or ga niza ti o nal sec urity meas ures desi g ne d t o pr otect s uc h data 
a gai nst acci de ntal or u nla wf ul l oss, alterati o n, or u na ut h orize d discl os ure or access.
T he s p o ns or mai ntai ns S O P s o n h o w t o res p o n d i n t he e ve nt of u na ut h orize d access, use, or 
discl os ure of s p o ns or i n f or mati o n or s yste ms.
1 0. 1. 5. C o m mittees Str uct ure
1 0. 1. 5. 1. D at a M o nit ori n g C o m mittee
T his st u d y  will n ot use an E D M C.
1 0. 1. 6. Disse mi n ati o n of Cli nic al St u d y D at a
Pfizer f ulfills its c o m mit me nt t o p u blicl y  discl ose cli nical st u d y res ults t hr o u g h p osti n g t he 
res ults of st u dies o n w w w.cli nicaltrials. g o v ( Cli nical Trials. g o v), t he E u dra C T / C TIS , a n d/ or 
w w w. pfizer.c o m, a n d ot her p u blic re gistries a n d we bsites i n acc or da nce wit h a p plica ble l ocal 
la ws/re g ulati o ns. I n a d diti o n, Pfizer re p orts st u d y res ults o utsi de of t he re q uire me nts of l ocal 
la ws/re g ulati o ns p urs ua nt t o its S O Ps.
I n all cases, st u dy res ults are re p orte d b y Pfizer i n a n o bjecti ve, acc urate, bala nce d, a n d 
c o m plete ma n ner a n d are re p orte d re gar dless of t he o utc o me of t he st u d y or t he c o u ntr y i n 
w hic h t he st u d y  was c o n d ucte d.
w w w.cli nicaltrials. g o v
Pfizer p osts cli nical trial res ults o n w w w.cli nicaltrials. g o v f or Pfizer-s p o ns ore d i nter ve nti o nal 
st u dies (c o n d ucte d i n patie nts) t hat e val uate t he safet y a n d/ or efficac y of a pr o d uct, 
re gar dless of t he ge o gra p hical l ocati o n i n w hic h t he st u d y is c o n d ucte d. T hese r es ults are 
s u b mitte d f or p osti n g i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y U S la w.
E u dra C T / C TIS
Pfizer p osts cli nical trial res ults o n E u dra C T / C TIS f or Pfizer-s p o ns ore d i nter ve nti o nal st u dies 
i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y E U re q uire me nts.
0
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 1
w w w. pfizer.c o m
Pfizer p osts C S R sy n o p ses a n d plai n-la n g ua ge st u d y res ults s u m maries o n w w w. pfizer.c o m 
f or Pfizer-s p o ns ore d i nter ve nti o nal st u dies at t he sa me ti me t he c orres p o n di n g st u d y res ults 
are p oste d t o w w w.cli nicaltrials. g o v. C S R s y n o pses will ha ve pers o nall y  i de ntifia ble 
i nf or mati o n a n o ny m ize d.
D oc u me nts wit hi n mar keti n g a p plicati o ns
Pfizer c o m plies wit h a p plica ble l ocal la ws/re g ulati o ns t o p u blis h cli nical d oc u me nts i ncl u de d 
i n mar keti n g a p plicati o ns. Cli nical d oc u me nts i ncl u de s u m mar y d oc u me nts a n d C S Rs 
i ncl u di n g t he pr ot oc ol a n d pr ot oc ol a me n d me nts, sa m ple C R Fs, a n d S A P s. Cli nical 
d oc u me nts will ha ve pers o nall y  i de ntifia ble i nf or mati o n a n o n ymize d.
Data shari n g
Pfizer pr o vi des researc hers sec ure access t o partici pa nt -le vel data or f ull C S Rs f or t he 
p ur p oses of “ b o na -fi de scie ntific researc h” t hat c o ntri b utes t o t he scie ntific u n dersta n di n g of 
t he disease, tar get, or c o m p o u n d class. Pfizer will ma ke data fr o m t hese trials a vaila ble 
1 8 m o nt hs after st u d y  c o m pleti o n. Partici pa nt -le vel data will be a n o ny m ize d i n acc or da nce 
wit h a p plica ble pri vac y  la ws a n d re g ulati o ns. C S Rs will ha ve pers o nall y i de ntifia ble 
i nf or mati o n a n o n y m ize d.
Data re q uests are c o nsi dere d fr o m q ualifie d researc hers wit h t he a p pr o priate c o m pete ncies t o 
perf or m t he pr o p ose d a nal y ses. Researc h tea ms m ust i ncl u de a bi ostatisticia n. Data will n ot 
be pr o vi de d t o a p plica nts wit h si g nifica nt c o nflicts of i nterest, i ncl u di n g i n di vi d uals 
re q uesti n g access f or c o m mercial/c o m petiti ve or le gal p ur p oses.
1 0. 1. 7. D at a Q u alit y Ass ur a nce
All partici pa nt data relati n g t o t he st u d y will be rec or de d o n pri nte d or electr o ni c C R F u nless 
tra ns mitte d t o t he s p o ns or or desi g nee electr o nicall y (e g, la b orat or y data). T he i n vesti gat or is 
res p o nsi ble f or verif yi n g t hat data e ntries are acc urate a n d c orrect b y p h ysicall y or 
electr o nicall y si g ni n g t he C R F.
G ui da nce o n c o m pleti o n of C R Fs will be pr o vi de d i n t he C R F C o m pleti o n Re q uire me nts 
d oc u me nt .
T he i n vesti gat or m ust e ns ure t hat t he C R Fs are sec urel y st ore d at t he st u d y site i n e ncr y pte d 
electr o nic a n d/ or pa per f or m a n d are pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o 
pre ve nt ac cess b y u na ut h orize d t hir d parties.
Q T L s are pre defi ne d para meters t hat are m o nit ore d d uri n g t he st u d y . I m p orta nt de viati o ns 
fr o m t he Q T Ls a n d a n y re me dial acti o ns ta ke n will be s u m marize d i n t he C S R .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 2
T he i n vesti gat or m ust per mit st u d y -relate d m o nit ori n g, a u dits, I R B/ E C re vie w, a n d 
re g ulat or y a ge nc y i ns pecti o ns a n d pr o vi de direct access t o s o urce rec or ds a n d d oc u me nts.
T his verificati o n ma y  als o occ ur after st u d y c o m pleti o n. It is i m p orta nt t hat t he 
i n vesti gat or(s) a n d t heir rele va nt pers o n nel are a vaila ble d uri n g t he m o nit ori n g visits a n d 
p ossi ble a u dits or i ns pecti o ns a n d t hat s ufficie nt ti me is de v ote d t o t he pr ocess.
M o nit ori n g details descri bi n g strate g y , i ncl u di n g defi niti o n of st u d y-critical data ite ms a n d 
pr ocesses (e g, ris k-base d i nitiati ves i n o perati o ns a n d q ualit y s uc h as ris k m a na ge me nt a n d 
m iti gati o n strate gies a n d anal yt ical ris k- base d m o nit ori n g), met h o ds, res p o nsi bilities , a n d 
re q uire me nts, i ncl u di n g ha n dli n g of n o nc o m plia nce iss ues a n d m o nit ori n g tec h ni q ues 
(ce ntral, virt ual , or o n-site m o nit ori n g), are pr o vi de d i n t he data ma na ge me nt pla n a n d 
m o nit ori n g p la n mai ntai ne d a n d utilize d b y  t he s p o ns or or desi g nee.
T he s p o ns or or desi g nee is res p o nsi ble f or t he data ma na ge me nt of t his st u d y , i ncl u di n g 
q ualit y  c hec ki n g of t he data.
Rec or ds a n d d oc u me nts, i ncl u di n g si g ne d I C D s, pertai ni n g t o t he c o n d uct of t his st u d y m ust 
be retai ne d b y t he i n vesti gat or f or 1 5 ye ars after st u d y c o m pleti o n u nless l ocal re g ulati o ns or 
i nstit uti o nal p olicies re q uire a l o n ger rete nti o n peri o d. N o rec or ds ma y be destr o ye d d uri n g 
t he rete nti o n peri o d wit h o ut t he writte n a p pr o val of t he s p o ns or. N o rec or ds ma y be 
tra nsferre d t o a n ot her l ocati o n or part y wit h o ut writte n n otificati o n t o t he s p o ns or. T he 
i n vesti gat or m ust e ns ure t hat t he rec or ds c o nti n ue t o be st ore d sec urel y f or as l o n g as t he y are 
mai ntai ne d.
W he n partici pa nt data are t o be delete d, t he i n vesti gat or will e ns ure t hat all c o pies of s uc h 
data are pr o m ptl y  a n d irre v oca bly delete d fr o m all s yste ms.
T he i n vest i gat or(s) will n otif y t he s p o ns or or its a ge nts i m me diatel y of a n y re g ulat or y 
i ns pecti o n n otificati o n i n relati o n t o t he st u d y . F urt her m ore, t he i n vesti gat or will c o o perate 
wit h t he s p o ns or or its a ge nts t o pre pare t he i n vesti gat or site f or t he i ns pecti o n a n d will all o w 
t he s p o ns or or its a ge nt, w he ne ver feasi ble, t o be prese nt d uri n g t he i ns pecti o n. T he 
i n vesti gat or site a n d i n vesti gat or will pr o m ptl y res ol ve a n y discre pa ncies t hat are i de ntifie d 
bet wee n t he st u d y data a n d t he partici pa nt ’s me dical rec or ds. T he i n vesti gat or will pr o m ptl y 
pr o vi de c o pies of t he i ns pecti o n fi n di n gs t o t he s p o ns or or its a ge nt. Bef ore res p o nse 
s u b missi o n t o t he re g ulat or y a ut h orities, t he i n vesti gat or will pr o vi de t he s p o ns or or its 
a ge nts wit h a n o p p ort u nit y t o re vie w a n d c o m m e nt o n res p o nses t o a n y s uc h fi n di n gs.
1 0. 1. 8. S o urce D oc u me nts
S o urce d oc u me nts pr o vi de e vi de nce f or t he e xiste nce of t he partici pa nt a n d s u bsta ntiate t he 
i nte grity of t he data c ollecte d. S o urce d oc u me nt s are file d at t he i n vesti gat or site.
Data re p orte d o n t he C R F or e ntere d i n t he e C R F t hat are fr o m s o urce d oc u me nts m ust 
be c o nsiste nt wit h t he s o urce d oc u me nts or t he discre pa ncies m ust be e x plai ne d. T he 
i n vesti gat or ma y nee d t o re q uest pre vi o us me dical rec or ds or tra nsfer rec or ds, de pe n di n g 
o n t he st u d y. Als o, c urre nt me dical rec or ds m ust be a vaila ble.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 3
Defi niti o n of w hat c o nstit utes a s o urce d oc u me nt a n d its ori gi n ca n be f o u n d i n t he S o urce 
D oc u me nt L ocat or , w hic h is mai ntai ne d b y t he sites a n d ca n be f o u n d i n t he IS F .
Descri pti o n of t he use of t he c o m p uterize d s yste m is d oc u me nte d i n t he data ma na ge me nt 
pla n , w hic h is mai ntai ne d b y t he s p o ns or.
T he i n vesti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce rec or d) t hat s u p p orts t he 
i nf or mati o n e ntere d i n t he C R F.
T he s p o ns or or desi g nee will perf or m m o nit ori n g t o c o nfir m t hat data e ntere d i nt o t he C R F 
b y  a ut h orize d site pers o n nel are acc urate, c o m plete, a n d verifia ble fr o m s o urce d oc u me nts; 
t hat t he safety a n d ri g hts of partici pa nts are bei n g pr otecte d; a n d t hat t he st u d y is bei n g 
c o n d ucte d i n acc or da nce wit h t he c urre ntl y a p pr o ve d pr ot oc ol a n d a n y ot her st u d y  
a gree me nts, IC H G C P g ui deli nes , a n d all a p plica ble re g ulat or y re q uire me nts.
1 0. 1. 9. Use of Me dic al Rec or ds
T here ma y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are re q ueste d b y 
Pfizer Safet y , w here et hicall y a n d scie ntificall y j ustifie d a n d per mitte d b y l ocal re g ulati o ns, 
t o e ns ure partici pa nt safet y.
D ue t o t he p ote ntial f or a partici pa nt t o be rei de ntifie d fr o m t heir me dical rec or ds, t he 
f oll o wi n g acti o ns m ust be ta ke n w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or 
desi g nee:

T he i n vesti gat or or site staff m ust re dact pers o nal i nf or mati o n fr o m t he me dical rec or d. 
T he pers o nal i nf or mati o n i ncl u des, b ut is n ot li mite d t o, t he f oll o wi n g: partici pa nt na mes 
or i nitials , partici pa nt dates (e g, birt h date, date of h os pital a d missi o n/ disc har ge, date of 
deat h), partici pa nt I D n u m bers (e g, S ocial Sec urit y n u m ber, healt h i ns ura nce n u m ber, 
me dical rec or d n u m ber, h os pital/i nstit uti o n i de ntifier), p artici pa nt l ocati o n i nf or mati o n
(e g, street a d dress, cit y, c o u ntr y, p ostal c o de, I P a d dress), a n d partici pa nt c o ntact 
i nf or mati o n (e g, tele p h o ne/fa x n u m ber, e mail a d dress).

Eac h me dical rec or d m ust be tra ns mitte d t o t he s p o ns or or s p o ns or desi g nee usi n g 
s yste ms wit h tec h nical a n d or ga nizati o nal sec urit y meas ures t o e ns ure t he pr otecti o n of 
pers o nal data (e g, Fl ore nce is t he preferre d sys te m if a vaila ble).

T here ma y  be u n pla n ne d sit uati o ns w here t he s p o ns or ma y re q uest me dical rec or ds 
(e g, s hari n g me dical rec or ds s o t hat t he s p o ns or ca n pr o vi de st u d y-relate d a d vice t o t he 
i n vesti gat or). T he me dical rec or ds s h o ul d be s u b mitte d acc or di n g t o t he pr oce d ure 
descri be d a b o ve.
1 0. 1. 1 0. St u d y a n d Site St art a n d Cl os ure
T he st u d y  start date is t he date of t he first partici pa nt’s first visit.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 4
T he s p o ns or desi g nee reser ves t he ri g ht t o cl ose t he st u d y  site or ter mi nate t he st u d y at a n y 
ti me f or a ny reas o n at t he s ole discreti o n of t he s p o ns or , i ncl u di n g ( b ut n ot li mite d t o) 
re g ulat or y a ut h ority decisi o n, c ha n ge i n o pi ni o n of t he I R B/ E C , or c ha n ge i n be nefit-ris k 
assess me nt . St u d y  sites will be cl ose d u p o n st u d y c o m pleti o n. A st u d y site is c o nsi dere d 
cl ose d w he n all re q uire d d oc u me nts a n d st u d y  s u p plies ha ve bee n c ollecte d a n d a st u d y-site 
cl os ure visit has bee n perf or me d.
T he i n vesti gat or ma y  i nitiate st u d y-site cl os ure at a n y ti me u p o n n otificati o n t o t he s p o ns or 
or desi g nee/ C R O if re q ueste d t o d o s o b y  t he res p o nsi ble IR B/ E C or if s uc h ter mi nati o n is 
re q uire d t o pr otect t he healt h of st u d y partici pa nts.
Reas o ns f or t he earl y cl os ure of a st u d y site b y t he s p o ns or ma y i ncl u de b ut are n ot li mite d 
t o:

Fail ure of t he i n vesti gat or t o c o m pl y  wit h t he pr ot oc ol, t he re q uire me nts of t he IR B/ E C 
or l ocal healt h a ut h orities, t he s p o ns or’s pr oce d ures, or t he IC H G C P g ui deli nes ;

I na de q uate recr uit me nt of partici pa nts b y t he i n vesti gat or;

Disc o nti n uati o n of f urt her st u d y  i nter ve nti o n de vel o p me nt.
If t he st u dy is pre mat urel y ter mi nate d or s us pe n de d, t he s p o ns or s hall pr o m ptl y i nf or m t he 
in vesti gat ors, t he E Cs /IR Bs, t he re g ulat or y  a ut h orities, a n d a n y C R O (s) use d i n t he st u d y 
of t he reas o n f or ter mi nati o n or s us pe nsi o n, as s pecifie d b y t he a p plica ble re g ulat or y 
re q uire me nts. T he in vesti gat or s hall pr o m ptl y  i nf or m t he partici pa nt a n d s h o ul d ass ure 
a p pr o priate partici pa nt t hera p y a n d/ or f oll o w- u p.
St u d y  ter mi nati o n is als o pr o vi de d f or i n t he cli nical st u d y a gree me nt. If t here is a n y c o nflict 
bet wee n t he c o ntract a n d t his pr ot oc ol, t he c o ntract will c o ntr ol as t o ter mi nati o n ri g hts.
1 0. 1. 1 1. P u blic ati o n P olic y
F or m ultice nter trials, t he pri mar y  p u blicati o n will be a joi nt p u blicati o n de vel o pe d b y t he 
in vesti gat or a n d Pfizer re p orti n g t he pri mar y e n d p oi nt(s) of t he st u d y c o veri n g all st u d y sites . 
T he i n vesti gat or a grees t o refer t o t he pri mar y  p u blicati o n i n a n y s u bse q ue nt p u blicati o ns. 
Pfizer will n ot pr o vi de a n y fi na ncial c o m pe nsati o n f or t he i n vesti gat or’s partici pati o n i n t he 
pre parati o n of t he pri mar y c o n gress a bstract, p oster, prese ntati o n, or pri mar y ma n uscri pt f or 
t he st u d y.
I n vesti gat ors are free t o p u blis h i n di vi d ual ce nter res ults t hat t he y dee m t o be cli nicall y  
mea ni n gf ul after p u blicati o n of t he o verall res ults of t he st u d y  or 1 2 m o nt hs after pri mar y 
c o m pleti o n date or st u d y c o m pleti o n at all sites, w hic he ver occ urs first, s u bject t o t he ot her 
re q uire me nts descri be d i n t his secti o n.
 

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

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

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 7 7
E ve nts N O T Meeti n g t he A E Defi niti o n

E ve nts t hat, i n t he cli nical j u d g me nt of t he i n vesti gat or, are 1) c o nsiste nt wit h n or mal 
gr o wt h a n d de vel o p me nt a n d 2) d o n ot differ si g nifica ntl y  i n fre q ue nc y or se verity 
fr o m e x pecte d, are n ot ge nerally t o be c o nsi dere d A Es. E xa m ples ma y i ncl u de, b ut are 
n ot li mite d t o, teet hi n g, c o ntact dia per ras h, s pitti n g u p, c olic, or t y pical 
f ussi ness/cr yi n g i n i nfa nts a n d c hil dre n.

A n y  cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs or ot her a b n or mal safety 
assess me nts t hat are ass ociate d wit h t he u n derl yi n g disease, u nless j u d ge d b y  t he 
i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he partici pa nt’s c o n diti o n.

T he disease/ dis or der bei n g st u die d or e x pecte d pr o gressi o n, si g ns, or s y m pt o ms of t he 
disease/ dis or der bei n g st u die d, u nless m ore se vere t ha n e x pecte d f or t he partici pa nt’s 
c o n diti o n.

Me dical or s ur gical pr oce d ure (e g, e n d osc o p y, a p pe n dect o my): t he c o n diti o n t hat lea ds 
t o t he pr oce d ure is t he A E.

Sit uati o ns i n w hic h a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).

A ntici pate d da y -t o-d a y  fl uct uati o ns of pree xisti n g disease(s) or c o n diti o n(s) prese nt or 
detecte d at t he start of t he st u d y  t hat d o n ot w orse n.
1 0. 2. 2. Defi niti o n of a n S A E
A n S A E is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at a n y d ose , meets o ne 
or m ore of t he criteri a liste d bel o w:
a.
Res ults i n de at h
b.
Is life-t hre ate ni n g

T he ter m “life-t hreate ni n g” i n t he defi niti o n of “seri o us” refers t o a n e ve nt i n w hic h 
t he partici pa nt was at ris k of deat h at t he ti me of t he e ve nt. It d oes n ot refer t o a n 
e ve nt t hat h y p ot heticall y mi g ht ha ve ca use d deat h if it were m ore se vere.
c.
Re q uires i n p atie nt h os pit aliz ati o n or pr ol o n g ati o n of e xisti n g h os pit aliz ati o n

I n ge neral, h os pitalizati o n si g nifies t hat t he partici pa nt has bee n a d mitte d ( us uall y 
i n v ol vi n g at least a n o verni g ht sta y ) at t he h os pital or e mer ge nc y war d f or 
o bser vati o n a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he 
p h y sicia n’s office or o ut patie nt setti n g. C o m plicati o ns t hat occ ur d uri n g 
h os pitalizati o n are A Es . If a c o m plicati o n pr ol o n gs h os pitalizati o n or f ulfills a n y 
ot her seri o us criteria, t he e ve nt is seri o us. W he n i n d o u bt as t o w het her 
“ h os pitalizati o n” occ urre d or was necessar y , t he A E s h o ul d be c o nsi dere d seri o us.
 

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

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

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 0

W he n a n A E
or S A E occ urs, it is t he res p o nsi bilit y  of t he i n vesti gat or t o re vie w all 
d oc u me ntati o n (e g, h os pital pr o gress n otes, la b orat or y  re p orts, a n d dia g n ostic re p orts) 
relate d t o t he e ve nt.

T he i n vesti gat or will t he n rec or d all rele va nt A E or S A E i nf or mati o n i n t he C R F.

It is n ot acce pta ble f or t he i n vesti gat or t o se n d p h ot oc o pies of t he partici pa nt’s me dical 
rec or ds t o Pfizer Safet y  i n lie u of c o m pleti o n of t he P S S A / A E or S A E C R F pa ge.

T here ma y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are re q ueste d 
b y  Pfizer Safet y . I n t his case, all partici pa nt i de ntifiers, wit h t he e xce pti o n of t he 
partici pa nt n u m ber, will be re dacte d o n t he c o pies of t h e me dical rec or ds bef ore 
s u b missi o n t o Pfizer Safet y . Refer t o Secti o n 1 0. 1. 9 f or acti o ns t hat m ust be ta ke n 
w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or desi g nee.

T he i n vesti gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n si g ns, 
s ym pt o m s, a n d/ or ot her cli nical i nf or mati o n. W he ne ver p ossi ble, t he dia g n osis 
( n ot t he i n di vi d ual si g ns/s ym pt o ms) will be d oc u me nte d as t he A E or S A E.
Assess me nt of I nte nsit y
T he i n vesti gat or will ma ke a n assess me nt of i nte nsit y f or eac h A E a n d S A E re p orte d 
d uri n g t he st u d y a n d assi g n it t o 1 of t he f oll o wi n g cate g ories:

Mil d: A t y pe of A E t hat is us uall y tra nsie nt a n d ma y re q uire o nl y mi ni mal treat me nt or 
t hera pe utic i nter ve nti o n. T he e ve nt d oes n ot ge nerall y i nterfere wit h us ual A D L .

M o derate: A t y pe of A E t hat is us uall y  alle viate d wit h a d diti o nal s pecific t hera pe utic 
i nter ve nti o n. T he e ve nt i nterferes wit h us ual A D L, ca usi n g disc o mf ort , b ut p oses n o 
si g nifica nt or per ma ne nt ris k of har m t o t he researc h partici pa nt.

Se vere: A t y pe of A E t hat i n terr u pts us ual A D L, or si g nifica ntl y  affects cli nical stat us, 
or ma y  re q uire i nte nsi ve t hera pe utic i nter ve nti o n.
G R A D E
If re q uire d o n t he A E pa ge of t he C R F, t he i n vesti gat or will use t he 
a djecti ves MI L D, M O D E R A T E, or S E V E R E t o descri be t he ma xi m u m 
i nte nsit y of t he A E. F or p ur p oses of c o nsiste nc y , t hese i nte nsit y gra des are 
defi ne d as f oll o ws:
1
MI L D
D oes n ot i nterfere wit h partici pa nt ’s us ual 
f u ncti o n.
2
M O D E R A T E
I nterferes t o s o me e xte nt wit h partici pa nt ’s us ual 
f u ncti o n.
3
S E V E R E
I nterferes si g nifica ntly wit h partici pa nt ’s us ual 
f u ncti o n.
A n e ve nt is defi ne d as “seri o us” w he n it meets at least 1 of t he pre defi ne d o utc o mes as 
descri be d i n t he defi niti o n of a n S A E, N O T w he n it is rate d as se vere.
 

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

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 2
F oll o w - Up of A Es a n d S A Es

T he i n vesti gat or is o bli gate d t o perf or m or a rra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uati o ns, as me dicall y i n dicate d or as re q ueste d b y t he 
s p o ns or, t o el uci date t he nat ure a n d/ or ca usality of t he A E or S A E as f ull y as p ossi ble.
T his ma y  i ncl u de a d diti o nal la b orat or y tests or i n vesti gati o ns, hist o pat h ol o gical 
e xa mi nati o ns, or c o ns ultati o n wit h ot her healt hcare pr o vi ders .

If a partici pa nt dies d uri n g partici pati o n i n t he st u d y or d uri n g a rec o g nize d f oll o w- u p 
peri o d, t he i n vesti gat or will pr o vi de Pfizer Safet y  wit h a c o p y of a n y p ost m orte m 
fi n di n gs, i ncl u di n g hist o pat h ol o g y.

Ne w or u p date d i nf or mati o n will be rec or de d i n t he ori gi nall y  s u b mitte d d oc u me nts.

T he i n vesti gat or will s u b mit a n y  u p date d S A E data t o t he s p o ns or wit hi n 2 4 h o urs of 
recei pt of t he i nf or mati o n.
1 0. 2. 4. Re p orti n g of S A Es
S A E Re p orti n g t o Pfizer S afet y vi a a n Electr o nic D C T

T he pri mar y  mec ha nis m f or re p orti n g a n S A E t o Pfizer Safet y will be t he electr o nic 
D C T (e g, e S A E or P S S A).

If t he electr o nic sys te m is u na vaila ble, t he n t he site will use t he pa per S A E re p ort f or m 
(see ne xt secti o n) t o re p ort t he e ve nt wit hi n 2 4 h o urs.

T he site will e nter t he S A E data i nt o t he electr o nic D C T (e g, e S A E or P S S A) or pa per 
f or m (as a p plica ble) as so o n as t he data bec o me a vaila ble.

After t he st u d y is c o m plete d at a gi ve n site, t he electr o nic D C T will be ta ke n off -li ne t o 
pre ve nt t he e ntr y  of ne w data or c ha n ges t o e xisti n g data.

If a site recei ves a re p ort of a ne w S A E fr o m a st u d y partici pa nt or recei ves u p date d 
data o n a pre vi o usl y  re p orte d S A E after t he electr o nic D C T has bee n ta ke n off -li ne, 
t he n t he site ca n re p ort t his i nf or mati o n o n a pa per S A E f or m (see ne xt secti o n) or t o 
Pfizer Safet y  b y tele p h o ne.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 3
S A E Re p orti n g t o Pfizer S afet y vi a t he V acci ne S A E Re p ort i n g F or m

Facsi mile tra ns missi o n of t he Vacci ne S A E Re p ort i n g F or m is o ne of t he preferre d 
met h o d s t o tra ns mit t his i nf or mati o n t o Pfizer Safet y .

I n circ u msta nces w he n t he facsi mile is n ot w or ki n g, a n alter nati ve met h o d s h o ul d be 
use d, e g, sec ure d ( Tra ns p ort La y er Sec urit y) or pass w or d -pr otecte d e mail. If n o ne of 
t hese met h o ds ca n be use d, n otificati o n b y  tele p h o ne is acce pta ble wit h a c o p y of t he 
Vacci ne S A E Re p ort i n g F or m se nt by o ver ni g ht mail or c o urier ser vice.

I nitial n otificati o n via tele p h o ne d oes n ot re place t he nee d f or t he i n vesti gat or t o 
c o m plete a n d si g n t he Vacci ne S A E Re p ort i n g F or m pa ges wit hi n t he desi g nate d 
re p orti n g ti me fra mes.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 4
1 0. 3. A p pe n di x 3 : Li ver S afet y: S u g geste d Acti o ns a n d F oll o w-U p Assess me nts
P ote nti al C ases of Dr u g -I n d uce d Li ver I nj ur y
H u ma ns e x p ose d t o a dr u g w h o s h o w n o si g n of li ver i nj ur y  (as deter mi ne d b y ele vati o ns i n 
tra nsa mi nases) are ter me d “t olerat ors,” w hile t h ose w h o s h o w tra nsie nt li ver i nj ur y b ut a da pt 
are ter me d “ a da pt ors.” I n s o me partici pa nt s, tra nsa mi nase ele vati o ns are a har bi n ger of a 
m ore seri o us p ote ntial o utc o me. T hese partici pa nt s fail t o a da pt a n d t heref ore are 
“s usce pti ble” t o pr o gressi ve a n d seri o us li ver i nj ur y, c o m m o nl y referre d t o as DI LI. 
Partici pa nt s w h o e x perie nce a tra nsa mi nase ele vati o n a b o ve 3 × U L N s h o ul d be m o nit ore d 
m ore fre q ue ntl y  t o deter mi ne if t he y are “a da pt or s” or are “s usce pti ble.”
L F T s are n ot re q uire d as a r o uti ne safet y m o nit ori n g pr oce d ure i n t his st u d y. H o we ver, s h o ul d 
a n i n vesti gat or dee m it necessar y  t o assess L F Ts beca use a partici pa nt prese nts wit h cli nical 
si g ns/s ym pt o ms, s uc h L F T  res ults s h o ul d be ma na ge d a n d f oll o we d as descri be d bel o w.
I n t he maj orit y of DI LI cases, ele vati o ns i n A S T a n d/ or A L T prece de T b ili ele vati o ns 
(2 × U L N) b y s e veral da ys or wee ks. T he i ncrease i n T b ili t ypicall y occ urs w hile A S T/ A L T 
is/are still ele vate d a b o ve 3 × U L N (ie, A S T/ A L T a n d T b ili val ues will be ele vate d wit hi n 
t he sa me la borat or y sa m ple). I n rare i nsta nces, b y t he ti me T b ili ele vati o ns are detecte d, 
A S T/ A L T val ues mi g ht ha ve decrease d. T his occ urre nce is still re gar de d as a p ote ntial DI LI. 
T heref ore, a b n or mal ele vati o ns i n eit her A S T O R A L T i n a d diti o n t o T b ili t hat meet t he 
criteria o utli ne d bel o w are c o nsi dere d p ote ntial DI LI (assesse d per H y ’s la w criteria) cases
a n d s h o ul d al wa ys be c o nsi dere d i m p orta nt me dical e ve nts, e ve n bef ore all ot her p ossi ble 
ca uses of li ver i nj ur y ha ve bee n e xcl u de d.
T he t hres h ol d of la b orat or y  a b n or malities f or a p ote ntial DI LI case de pe n ds o n t he 
partici pa nt ’s i n di vi d ual baseli ne val ues a n d u n derl yi n g c o n diti o ns. Partici pa nt s w h o prese nt 
wit h t he f oll o wi n g la b orat or y  a b n or malities s h o ul d be e val uate d f urt her as p ote ntial DI LI 
( Hy ’s la w) cases t o defi niti vel y deter mi ne t he eti ol o g y of t he a b n or mal la b orat or y val ues:

Partici pa nt s wit h A S T/ A L T a n d T b ili baseli ne val ues wit hi n t he n or mal ra n ge w h o 
s u bse q ue ntl y prese nt wit h A S T O R A LT val ues ≥3 × U L N A N D a T b ili val ue ≥2 × U L N 
wit h n o e vi de nce of he m ol y sis a n d a n al kali ne p h os p hatase val ue 2 × U L N or n ot 
a vaila ble.

F or partici pa nt s wit h baseli ne A S T O R A L T O R T b ili val ues a b o ve t he U L N, t he 
f oll o wi n g t hres h ol d val ues are use d i n t he defi niti o n me nti o ne d a b o ve, as nee de d, 
de pe n di n g o n w hic h val ues are a b o ve t he U L N at baseli ne:
o
Pree xisti n g A S T or A L T baseli ne val ues a b o ve t he n or mal ra n ge: A S T or A L T val ues 
≥2 ti mes t he baseli ne val ues A N D ≥3 × U L N; or ≥8 × U L N ( w hic he ver is s maller).
o
Pree xisti n g val ues of T b ili a b o ve t he n or mal ra n ge: T b ili le vel i ncrease d fr o m 
baseli ne val ue b y a n a m o u nt of ≥1 × U L N or if t he val ue reac hes ≥3 × U L N 
( w hic he ver is s maller).
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 5
Rises i n A S T/ A L T a n d T b ili se parate d b y m ore t ha n a fe w wee ks s h o ul d be assesse d 
i n di vi d uall y based o n cli nical j u d g me nt; a n y case w here u ncertai nt y re mai ns as t o w het her it 
re prese nts a p ote ntial H y’s la w case s h o ul d be re vie we d wit h t he s p o ns or.
T he partici pa nt s h o ul d ret ur n t o t he i n vesti gat or site a n d be e val uate d as s o o n as p ossi ble, 
prefera bl y wi t hi n 4 8 h o urs fr o m a ware ness of t he a b n or mal res ults. T his e val uati o n s h o ul d 
i ncl u de la b orat or y tests, detaile d hist or y, a n d p hys ical assess me nt.
I n a d diti o n t o re peati n g meas ure me nts of A S T  a n d A L T a n d T b ili f or s us pecte d H y’s la w
cases , a d diti o nal la b orat or y tests s h o ul d i ncl u de al b u mi n, C K, direct a n d i n direct bilir u bi n, 
G G T , P T/IN R, e osi n o p hils ( %), a n d al kali ne p h os p hatase. C o nsi derati o n s h o ul d als o be 
gi ve n t o dra wi n g a se parate t u be of cl otte d bl o o d a n d a n a ntic oa g ulate d t u be of bl o o d f or 
f urt her testi n g, as nee de d, f or f urt her c o nte m p ora ne o us a nal ys es at t he ti me of t he rec o g nize d 
i nitial a b n or malities t o deter mi ne eti ol o g y. A detaile d hist or y, i ncl u di n g rele va nt i nf or mati o n, 
s uc h as re vie w of et ha n ol, aceta mi n o p he n/ paraceta m ol (eit her by itsel f or as a c of or m ulate d 
pr o d uct i n prescri pti o n or o ver -t he-c o u nter me dicati o ns), recreati o nal dr u g, or s u p ple me nt 
( her bal) use a n d c o ns u m pti o n, fa mil y hist or y, se x ual hist or y, tra vel hist or y, hist or y of c o ntact 
wit h a ja u n dice d pers o n, s ur ger y, bl o o d tra nsf usi o n, hist or y of li ver or aller gic disease, a n d 
p ote ntial occ u pati o nal e x p os ure t o c he micals, s h o ul d be c ollecte d. F urt her testi n g f or ac ute 
he patitis A, B, C, D, a n d E i nfecti o n , t otal bile aci ds, li ver i ma gi n g (e g, biliar y tract), a n d 
c ollecti o n of ser u m sa m ple s f or aceta mi n o p he n/ paraceta m ol dr u g a n d/ or pr otei n a d d uct 
le vels ma y  be warra nte d.
All cases de m o nstrate d o n re peat testi n g as meeti n g t he la b orat or y  criteria of A S T/ A L T a n d 
T b ili ele vati o n defi ne d a b o ve s h o ul d be c o nsi dere d p ote ntial DI LI ( H y’s la w) cases if n o 
ot her reas o n f or t he L F T  a b n or malities has yet bee n f o u n d. S uc h p ote nti al DI LI ( H y’s l a w) 
c ases are t o be re p orte d as S A Es, irres pecti ve of a v ail a bilit y of all t he res ults of t he 
i n vesti g ati o ns perf or me d t o deter mi ne eti ol o g y of t he L F T ab n or m alities.
A p ote ntial DI LI ( H y ’s la w) case bec o mes a c o nfir me d case o nly after all res ults of 
reas o na ble i n vesti gati o ns ha ve bee n recei ve d a n d ha ve e xcl u de d a n alter nati ve eti ol o g y.
0
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 6
1 0. 4. A p pe n di x 4 : Ki d ne y S afet y M o nit ori n g G ui deli nes
1 0. 4. 1. L a b or at or y Assess me n t of C h a n ge i n Ki d ne y F u ncti o n a n d Detecti o n of Ki d ne y 
I nj ur y
Sta n dar d ki d ne y  safet y m o nit ori n g re q uires assess me nt of baseli ne a n d p ost baseli ne Screat 
meas ure me nt t o esti mate ki d ne y  f u ncti o n [ Screat-base d e G F R] or creati ni ne cleara nce 
[e Cr Cl]). Baseli ne an d p ost baseli ne Sc y s ma kes it feasi ble t o disti n g uis h A KI fr o m ot her 
ca uses of Screat i ncrease. If Screat i ncrease is c o nfir me d after baseli ne, t he n refle x 
meas ure me nt of Sc y s is i n dicate d (f or a d ult a n d f or pe diatric partici pa nts). Screat a n d refle x 
Sc y s val ues are nee de d t o esti mate t he c o m bi ne d Screat- S c y s e G F R calc ulati o n t o ascertai n 
w het her e G F R c ha n ge fr o m baseli ne is c o m para ble f or 2 0 2 1 C K D -E PI  e G F R Screat-o nl y  
a n d f or 2 0 2 1 C K D -E PI  e G F R c o m bi ne d Screat pl us Sc ys (f or a d ult partici pa nts o nl y).
Re gar dless of w het her ki d ne y  f u ncti o n m o nit ori n g tests are re q uire d as a r o uti ne safety 
m o nit ori n g pr oce d ure i n t he st u d y , if t he i n vesti gat or or s p o ns or dee ms it necessar y t o f urt her 
assess ki d ne y safet y a n d q ua ntif y ki d ne y f u ncti o n, t he n t hese test res ults s h o ul d be ma na ge d 
a n d f oll o we d per sta n dar d of care.
1 0. 4. 2. A ge -S pecific Ki d ne y F u ncti o n C alc ul ati o n Rec o m me n d ati o ns
1 0. 4. 2. 1. I nf a nts ( 1 M o nt h t o 2 Y e ars) a n d Ne o n ates ( 1 M o nt h) —
Sc h w artz E q u ati o n
e G F R ( m L/ mi n/ 1. 7 3 m 2) = 0. 4 1 3 × ( Ht/ Screat)
Ht i n cm ; Screat i n m g/ d L.
1 0. 4. 3. A d verse E ve nt Gr a di n g f or Ki d ne y S afet y L a b or at or y A b n or m alities
A E gra di n g f or decli ne i n ki d ne y  f u ncti o n (ie, e G F R or e Cr Cl) will be acc or di n g t o K DI G O
criteria.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 7
1 0. 5. A p pe n di x 5 : A Es, A D Es, S A Es, S A D Es, U S A D Es, a n d De vice Deficie ncies:
Defi niti o n s a n d Pr oce d ures f or Rec or di n g, E v al u ati n g, F oll o w - Up, a n d Re p orti n g i n 
Me dic al De vice St u dies
Defi niti o ns of a Me dic al De vice Deficie nc y
T he defi niti o ns a n d pr oce d ures detaile d i n t his a p pe n di x are i n acc or da nce wit h I S O 1 4 1 5 5 
a n d t he E ur o pea n M D R 2 0 1 7/ 7 4 5 f or cli nical de vice researc h (if a p plica ble).
B ot h t he i n vesti gat or a n d t he s p o ns or will c o m pl y  wit h all l ocal re p orti n g re q uire me nts f or 
me dical de vices.
T he detecti o n a n d d oc u me ntati o n pr oce d ures descri be d i n t his pr ot oc ol a p pl y  t o all s p o ns or 
me dical d e vices pr o vi de d f or use i n t he st u d y (see Secti o n 6. 1. 2 f or t he list of s p o ns or 
me dical de vices).
1 0. 5. 1. Defi niti o n of A E a n d A D E
A E a n d A D E Defi niti o n

A n A E is defi ne d i n A p pe n di x 2 (Secti o n 1 0. 2. 1 ).

A n A D E is defi ne d as a n A E relate d t o t he use of a n i n vesti gati o nal me dical de vice. 
T his defi niti o n i ncl u des a n y  A Es res ulti n g fr o m i ns ufficie nt or i na de q uate i nstr ucti o ns 
f or use, de pl oy m e nt, i m pla ntati o n, i nstallati o n, or o perati o n, or a n y  malf u ncti o n of t he 
i n vesti gati o nal me dical de vice as well as a ny e ve nt res ulti n g fr o m use err or or fr o m 
i nte nti o nal mis use of t he i n vesti gati o nal me dical de vice.
1 0. 5. 2. Defi niti o n of S A E, S A D E, a n d U S A D E
S A E Defi niti o n

A n S A E is defi ne d i n A p pe n di x 2 (Secti o n 1 0. 2. 2 ).
S A D E Defi niti o n

A n S A D E is defi ne d as a n A D E t hat has res ulte d i n a n y  of t he c o nse q ue nces 
c haracteristic of a n S A E.

A n y  de vice deficie nc y t hat mi g ht ha ve le d t o a n S A E if a p pr o priate acti o n ha d n ot bee n 
ta ke n, i nter ve nti o n ha d n ot occ urre d, or circ u msta nces ha d bee n less f ort u nate.
U S A D E Defi niti o n

A U S A D E (als o i de ntifie d as U A D E i n U S Re g ulati o n 2 1 C F R 8 1 3. 3) is a n S A D E t hat
b y  its nat ure, i nci de nce, se verity, or o utc o me has n ot bee n i de ntifie d i n t he c urre nt 
versi o n of t he ris k a nal y sis ma na ge me nt file.
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 8
1 0. 5. 3. Defi niti o n of De vice Deficie nc y
De vice Deficie nc y Defi niti o n

A de vice deficie nc y  is a n i na de q uac y of a me dical de vice wit h res pect t o its i de ntit y , 
q ualit y , d ura bility, relia bilit y , safety, or perf or ma nce. De vice deficie ncies i ncl u de 
malf u ncti o ns, use err ors, a n d i na de q uate i nf or mati o n s u p plie d b y  t he ma n ufact urer.
1 0. 5. 4. Rec or di n g/ Re p orti n g a n d F oll o w -U p of Me dic al De vice Def icie ncies
De vice Deficie nc y Rec or di n g

W he n a de vice deficie nc y  occ urs, it is t he res p o nsi bilit y of t he i n vesti gat or t o re vie w 
all d oc u me ntati o n (e g, h os pital pr o gress n otes, la b orat or y  re p orts, a n d dia g n ostic 
re p orts) relate d t o t he e ve nt.

T he i n vesti gat or will t he n rec or d all rele va nt de vice deficie nc y i nf or mati o n i n t he 
partici pa nt’s me dical rec or ds, i n acc or da nce wit h t he i n vesti gat or’s n or mal cli nical 
practice a n d will als o ca pt ure t he re q uire d i nf or mati o n o n t he Me dical De vice 
C o m plai nt f or m.

It is n ot acce pta ble f or t he i n vesti gat or t o se n d p h ot oc o pies of t he partici pa nt’s me dical 
rec or ds t o Pfizer Safet y i n lie u of f oll o wi n g t he re p orti n g pr ocess descri be d i n t he 
Me dical De vice C o m plai nt f or m.

T here ma y  be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are re q ueste d 
b y  Pfizer Safety. I n t his case, all partici pa nt i de ntifiers, wit h t he e xce pti o n of t he 
partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he me dical rec or ds bef ore 
s u b missi o n t o Pfizer Safet y. Refer t o Secti o n 1 0. 1. 9 f or acti o ns t hat m ust be ta ke n 
w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or desi g nee.

If t he i n vesti gat or deter mi nes t hat t he me dical de vice deficie nc y ma y ha ve i nj ure d t he 
partici pa nt (ie, t he me dical de vice deficie nc y  is ass ociate d wit h a n A E or S A E), t he n 
t he i n vesti gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n si g ns, 
s ym pt o ms, a n d/ or ot her cli nical i nf or mati o n. W he ne ver p ossi ble, t he dia g n osis will be 
d oc u me nte d i n t he partici pa nt’s me dical rec or d a n d rec or de d as t he A E or S A E rat her 
t ha n t he i n di vi d ual si g ns/s ym pt o ms. Re q uire me nts f or rec or di n g a n d re p orti n g a n A E 
or S A E are pr o vi de d i n A p pe n di x 2 (Secti o n 1 0. 2. 3 ).

F or de vice deficie ncies, it is ver y  i m p orta nt t hat t he i n vesti gat or descri be a n y 
c orrecti ve or re me dial acti o ns ta ke n t o pre ve nt rec urre nce of t he i nci de nt.

A re me dial acti o n is a n y actio n ot her t ha n r o uti ne mai nte na nce or ser vici n g of a 
me dical de vice w here s uc h acti o n is necessar y  t o pre ve nt rec urre nce of a de vice 
deficie nc y . T his i ncl u des a n y a me n d me nt t o t he de vice desi g n t o pre ve nt rec urre nce.
0
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 8 9
Assess me nt of C a us alit y Occ urri n g i n C o nj u ncti o n Wit h a Me dic al De vice Deficie nc y

If a n A E or S A E has occ urre d i n c o nj u ncti o n wit h a me dical de vice deficie nc y, t he 
i n vesti gat or m ust assess t he relati o ns hi p bet wee n eac h occ urre nce of t he A E or S A E 
a n d t he me dical de vice deficie nc y. T he i n vesti gat or will use cli nical j u d g me nt t o 
deter mi ne t he relati o ns hi p.

A “reas o na ble p ossi bilit y” of a relati o ns hi p c o n ve ys t hat t here are facts, e vi de nce, 
a n d/ or ar g u me nts t o s u g gest a ca usal relati o ns hi p, rat her t ha n a relati o ns hi p ca n n ot be 
r ule d o ut.

Alter na ti ve ca uses, s uc h as u n derlyi n g disease(s), c o nc o mita nt t hera p y, a n d ot her ris k 
fact ors, as well as t he te m p oral relati o ns hi p of t he e ve nt t o st u d y i nter ve nti o n 
a d mi nistrati o n will be c o nsi dere d a n d i n vesti gate d.

T he i n vesti gat or will als o c o ns ult t he I B i n t heir assess me nt.

F or eac h de vice deficie nc y , t he i n vesti gat or m ust d oc u me nt i n t he me dical n otes t hat 
t he y ha ve re vie we d t he de vice deficie nc y a n d ha ve pr o vi de d a n assess me nt of 
ca usalit y.

T here ma y  be sit uati o ns i n w hic h a n S A E has occ urre d a n d t he i n vesti gat or has 
mi ni mal i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o t he s p o ns or. H o we ver, it is ver y  
i m p orta nt t hat t he i n vesti gat or al wa ys ma ke a n assess me nt of ca usalit y f or e ver y e ve nt 
bef ore t he i nitial tra ns missi o n of t he S A E data t o t he s p o ns or.

T he i n vesti gat or ma y  c ha n ge t heir o pi ni o n of ca usalit y i n li g ht of f oll o w-u p 
i nf or mati o n a n d se n d a n S A E f oll o w-u p re p ort wit h t he u p date d ca usalit y  assess me nt.

T he ca usalit y  assess me nt is o ne of t he criteria use d w he n deter mi ni n g re g ulat or y 
re p orti n g re q uire me nts.
F oll o w - U p of Me dic al De vice Deficie nc y

T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uati o ns, as me dicall y  i n dicate d or as re q ueste d b y t he 
s p o ns or, t o el uci date t he nat ure a n d/ or ca usality of t he de vice deficie nc y  as f ull y as 
p ossi ble. T his ma y  i ncl u de a d diti o nal la b orat or y tests or i n vesti gati o ns, 
hist o pat h ol o gical e xa mi nati o ns, or c o ns ultati o n wit h ot her healt hcare pr o vi ders.

Ne w or u p date d i nf or mati o n re gar di n g t he n at ure of t he de vice deficie nc y  will be 
rec or de d i n t he ori gi nally c o m plete d Me dical De vice C o m plai nt f or m.

Ne w or u p date d i nf or mati o n re gar di n g a n y S A E t hat was p ote ntiall y ass ociate d wit h 
t he me dical de vice deficie nc y will be s u b mitte d t o Pfizer Safet y via P S S A wit hi n 
2 4 h o urs of recei pt of t he i nf or mati o n, acc or di n g t o t he re q uire me nts pr o vi de d i n 
A p pe n di x 2 .
 

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

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 1
1 0. 6. A p pe n di x 6 : A b bre vi ati o ns
T he f oll o wi n g is a list of a b bre viati o ns t hat ma y be use d i n t he pr ot oc ol.
A b bre vi ati o n
Ter m
7 v P n C
7 -vale nt p ne u m oc occal c o nj u gate vacci ne
1 3 v P n C
1 3 -vale nt p ne u m oc occal c o nj u gate vacci ne
2 0 v P n C
2 0 -vale nt p ne u m oc occal c o nj u gate vacci ne
A D E
a d verse de vice effect
A D L
acti vit y/acti vities of daily li vi n g
A E
a d verse e ve nt
A KI
ac ute ki d ne y i nj ur y
Al P O 4
al u mi n u m p h os p hate
A L T
ala ni ne a mi n otra nsferase
A S T
as partate a mi n otra nsferase
A x M P
a u xiliar y me dici nal pr o d uct
B L Q
bel o w t he li mit of q ua nti tati o n
C 5a
c o m ple me nt c o m p o ne nt 5a
C B E R
Ce nter f or Bi ol o gics E val uati o n a n d Researc h ( U nite d States)
C F R
C o de of Fe deral Re g ulati o ns ( U nite d States)
CI
c o nfi de nce i nter val
CI O M S
C o u ncil f or I nter nati o nal Or ga nizati o ns of Me dical Scie nces
C K
creati ne ki nase
C K D -E PI
C hr o nic Ki d ne y  Disease E pi de mi ol o g y C olla b orati o n
C O N S O R T
C o ns oli date d Sta n dar ds of Re p orti n g Trials
C O VI D -1 9
c or o na vir us disease 2 0 1 9
C R F
case re p ort f or m
C R O
c o ntract researc h or ga nizati o n
C S R
cli nical st u d y re p ort
C T
cli nical trial
C TI S
Cli nical Trial I nf or mati o n S y ste m
D C T
data c ollecti o n t o ol
DI LI
dr u g -i n d uce d li ver i nj ur y
D U
dis pe nsa ble u nit
E C
et hics c o m mittee
E C C
e mer ge nc y c o ntact car d
E C G
electr ocar di o gra m
e Cr Cl
esti mate d creati ni ne cleara nce
e C R F
electr o nic case re p ort f or m
E D B
e x p os ure d uri n g breastfee di n g
e-diar y
electr o nic diar y
E D M C
exter nal d ata m o nit ori n g co m mittee
 
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 2
A b bre vi ati o n
Ter m
E D P
e x p os ure d uri n g pre g na nc y
e G F R
esti mate d gl o mer ular filtrati o n rate
E M A
E ur o pea n Me dici nes A ge nc y
e S A E
electr o nic seri o us a d verse e ve nt
E U
E ur o pea n U ni o n
E u dra C T
E ur o pea n U ni o n Dr u g Re g ulati n g A ut h orities Cli nical Trials 
( E ur o pea n Cli nical Trials Data base)
F D A
F o o d a n d Dr u g A d mi nistrati o n ( U nite d States)
G C P
G o o d Cli nical Practice
G G T
ga m ma -gl uta m y l tra nsferase
G M C
ge o metric mea n c o nce ntrati o n
G M F R
ge o metric mea n f ol d rise
G M T
ge o metric mea n titer
HI P A A
Healt h I ns ura nce P orta bilit y  a n d Acc o u nta bilit y Act
HI V
h u ma n i m m u n o deficie nc y vir us
Ht
hei g ht
I B
i n vesti gat or’s br oc h ure
I C D
i nf or me d c o nse nt d oc u me nt
I C H
I nter nati o nal C o u ncil f or Har m o nisati o n of Tec h nical Re q uire me nts 
f or P har mace uticals f or H u ma n Use
I D
i de ntificati o n
I g G
i m m u n o gl o b uli n G
I M P
i n vesti gati o nal me dici nal pr o d uct
I ND
i n vesti gati o nal ne w dr u g
I N R
i nter nati o nal n or malize d rati o
I P
Inter net P r ot oc ol
I P A L
in vesti gati o nal p r o d uct acc o u nta bilit y lo g
I P D
i n vasi ve p ne u m oc occal disease
I P M
i n vesti gati o nal pr o d uct ma n ual
I RB
i nstit uti o nal re vie w b oar d
I R T
i nteracti ve res p o nse tec h n ol o g y
I SF
i n vesti gat or site file
I S O
I nter nati o nal Or ga nizati o n f or Sta n dar dizati o n
I W R
i nteracti ve We b-base d res p o nse
K DI G O
Ki d ne y  Disease: I mpr o vi n g Gl o bal O utc o mes
L F T
li ver f u ncti o n test
L L O Q
l o wer li mit of q ua ntitati o n
M D R
me dical de vice re g ulati o n
mI T T
m o difie d i nte nt -t o-treat
m P n C
m o n o vale nt p ne u m oc occal c o nj u gate
m P n C 3
m o n o vale nt p ne u m oc occal ser ot y pe 3 c o nj u gate
M QI
me dicall y  q ualifie d i n di vi d ual
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 3
A b bre vi ati o n
Ter m
N/ A
n ot a p plica ble
NI M P
n o ni n vesti gati o nal me dici nal pr o d uct
NI P
nati o nal i m m u nizati o n pr o gra m
O M
otitis me dia
O P A
o ps o n o p ha g oc y tic acti vit y
P C V
p ne u m oc occal c o nj u gate vacci ne
P C V 1 0
1 0 -vale nt p ne u m oc occal c o nj u gate vacci ne
P C V 1 5
1 5 -vale nt p ne u m oc occal c o nj u gate vacci ne
P F S
prefille d s yri n ge
PI
pri nci pal i n vesti gat or
P n C 3
p ne u m oc occal ser ot y pe 3 c o nj u gate
P P E
pers o nal pr otecti ve e q ui p me nt
P P S V 2 3
2 3 -vale nt p ne u m oc occal p ol y sacc hari de vacci ne
P S S A
Pfizer's Seri o us A d verse E ve nt S u b missi o n Assista nt
P T
pr ot hr o m bi n ti me
Q T L
q ualit y  t olera nce li mit
R C D C
re verse c u m ulati ve distri b uti o n c ur ve
S A D E
seri o us a d verse de vice effect
S A E
seri o us a d verse e ve nt
S A P
statistical a nal ysis pla n
S A R S -C o V -2
se vere ac ute res pirat or y s yn dr o me c or o na vir us 2
Scr eat
ser u m creati ni ne
Sc y s
ser u m c ystati n C
S m P C
su m mar y  of p r o d uct characteristics
S o A
sc he d ule of acti vities
S O P
sta n dar d o perati n g pr oce d ure
S R S D
si n gle refere nce safety d oc u me nt
S U S A R
s us pecte d u ne x pecte d seri o us a d verse reacti o n
T B D
t o be deter mi ne d
T bili
t otal bilir u bi n
U A D E
u na ntici pate d a d verse de vice effect
U L N
u p per li mit of n or mal
U S
U nite d States
U S A D E
u na ntici pate d seri o us a d verse de vice effect
V E
vacci ne efficac y
 
C CI
C CI

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 4
1 1. R E F E R E N C E S
1
T heilac ker C, Fletc her M A, J o dar L , et al. P C V 1 3 vacci nati o n of a d ults a gai nst 
p ne u m oc occal disease: w hat we ha ve lear ne d fr o m t he C o m m u nit y -Ac q uire d 
P ne u m o nia I m m u nizati o n Trial i n A d ults ( C A Pi T A) [ p u blis he d errat u m a p pears i n
Micr o or ga nis ms. 2 0 2 2; 1 0( 5 ): 10 1 8] . Micr o or ga nis ms. 2 0 2 2; 1 0( 1): 1 2 7.
2
Rei nert R R, Para dis o P, Fritzell B. A d va nces i n p ne u m oc occal vacci nes: t he 1 3 -vale nt 
p ne u m oc occal c o nj u gate vacci ne recei ve d mar ket a ut h orizati o n i n E ur o pe. E x pert Re v 
Vacci nes. 2 0 1 0; 9( 3): 2 2 9 -3 6.
3
C D C. L ice ns ure of a 1 3-vale nt p ne u m oc occal c o nj u gate vacci ne ( P C V 1 3) a n d 
rec o m me n dati o ns f or use a m o n g c hil dre n – A d vis or y  C o m mittee o n I m m u nizati o n 
Practices ( A C I P), 2 0 1 0. M M W R M or b M ortal W kl y Re p. 2 0 1 0; 5 9( 9): 2 5 8- 61. A vaila ble 
fr o m: htt ps://stac ks.c dc. g o v/ vie w/c dc/ 7 4 4 7 . Accesse d: 2 8 A pr 2 0 2 3.
4
N u orti J P, W hit ne y  C G. Pre ve nti o n of p ne u m oc occal disease a m o n g i nfa nts a n d 
c hil dre n - use of 1 3 - vale nt p ne u m oc occal c o nj u gate vacci ne a n d 2 3-vale nt 
p ne u m oc occal p ol y sacc hari de vacci ne - rec o m me n dati o ns of t he A d vis or y C o m mittee 
o n I m m u nizati o n Practices ( A CI P). M M W R Rec o m m Re p. 2 0 1 0; 5 9( R R -1 1): 1 - 1 8.
5
B o nte n MJ M, H uijts S M, B ol ke n baas M, et al. P ol ysacc hari de c o nj u gate vacci ne a gai nst 
p ne u m oc occal p ne u m o nia i n a d ul ts. N E n gl J Me d. 2 0 1 5; 3 7 2 ( 1 2): 1 1 1 4-2 5.
6
Ba x ter R, A u kes L, Pelt o n SI, et al. I mpact of t he 1 3 -vale nt p ne u m oc occal c o nj u gate 
vacci ne o n i n vasi ve p ne u m oc occal disease after i ntr o d ucti o n i nt o r o uti ne pe diatric use. 
J Pe diatric I nfect Dis S oc. 2 0 2 1; 1 0( 2): 1 4 1- 5 0.
7
Mc La u g hli n J M , Jia n g Q, Gess ner BD , et al. P ne u m oc occal c o nj u gate vacci ne a gai nst 
ser ot yp e 3 p ne u m oc occal p ne u m o nia i n a d ults: a s yste matic re vie w a n d p o ole d a nalys is. 
Vacci ne. 2 0 1 9; 3 7( 4 3): 6 3 1 0 - 6.
8
Sa v ulesc u C, Kriz o va P, Sl ot ve d H C, et al. Effecti ve ness of 1 3 - vale nt p ne u m oc occal 
c o nj u gate vacci ne o n i n vasi ve p ne u m oc occal disease i n t he E ur o pea n U ni o n: res ults of 
s pI Dnet m ultice ntre st u d y . P oster prese nte d at: E S PID 3 6t h A n n ual Meeti n g; 2 8 M a y  t o 
0 2 J u n 2 0 1 8; Mal m ö, S we de n.
9
A n dre ws N, Ke nt A, A mi n -C h o w d h ur y  Z, et al. Effecti ve ness of t he se ve n-vale nt a n d 
t hirtee n- vale nt p ne u m oc occal c o nj u gate vacci nes i n E n gla n d: the i n direct c o h ort desi g n, 
2 0 0 6- 2 0 1 8. Vacci ne. 2 0 1 9; 3 7 ( 3 2): 4 4 9 1- 8. D OI : 1 0. 1 0 1 6/j. vacci ne. 2 0 1 9. 0 6. 0 7 1.
1 0
I m ö hl M, Per niciar o S,
B usse A, et al. Bacterial s pectr u m of sp o nta ne o usl y ru pt ure d 
o titis m e dia i n a 7 -y ear, lo n git u di nal, m ultice nter, epi de mi ol o gical cr oss-secti o nal st u d y 
i n Ger ma ny. Fr o nt Me d ( La usa n ne). 2 0 2 1; 8: 6 7 5 2 2 5 . D OI: 1 0. 3 3 8 9/f me d. 2 0 2 1. 6 7 5 2 2 5 .
 

P F -0 7 8 3 1 6 9 5 
Pr ot oc ol C 4 8 0 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 1 , 1 5 Se pte m ber 2 0 2 3
P FI Z E R C O N FI D E N TI A L
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4 A pril 2 0 2 3)
T M F D oc I D: 1 6 4. 0 1
Pa ge 9 5
1 1
Pe n ni n gt o n K, E n ha nce d I n vasi ve P ne u m oc occal Disease S ur veilla nce W or ki n g Gr o u p,
C o m m u nica ble Diseases Net w or k A ustralia . I n vasi ve p ne u m oc occal d isease 
sur veilla nce, 1 J ul y  t o 3 0 Se pte m ber 2 0 1 9. C o m m u n Dis Intell. 2 0 2 0; 4 4. A vaila ble 
fr o m: 
htt ps:// w w w 1. healt h. g o v.a u/i nter net/ mai n/ p u blis hi n g. nsf/ C o nte nt/ A D 2 D F 7 4 8 7 5 3 A F D E
1 C A 2 5 8 4 E 2 0 0 8 0 0 9 B A/ $ File/i n vasi ve _ p ne u m oc occal _ disease _s ur veilla nce _ 1 _j ul y _t o _
3 0 _se pte m ber _ 2 0 1 9. p df . Accesse d: 1 1 Se p 2 0 2 3. D OI: 1 0. 3 3 3 2 1/c di. 2 0 2 0. 4 4. 4 0.
1 2
C h oi E H, Z ha n g F, L u Y -J, et al. Ca ps ular p ol y sacc hari de ( C P S) release b y ser ot ype 3 
p ne u m oc occal strai ns re d uces t he pr otecti ve effect of a nti -t ype 3 C P S a nti b o dies. Cli n 
Vacci ne I m m u n ol. 2 0 1 6; 2 3( 2): 1 6 2 - 7.
1 3
B u g y a Z, Prec hl J , Szé nási T , et al. M ulti ple le vels of im m u n ol o gical m e m or y a n d their 
ass ociati o n wit h v acci nati o n. Vacci nes ( Basel) . 2 0 2 1 ;9 ( 2): 1 7 4. D OI: 
1 0. 3 3 9 0/ vacci nes 9 0 2 0 1 7 4.
1 4
Neal E F G , C ha n J, N g uye n C D , et al. Fact ors ass ociate d wit h p ne u m oc occal 
nas o p har y n geal carria ge: a s yste matic re vie w. P L O S Gl o b P u blic Healt h.
2 0 2 2; 2( 4):e 0 0 0 0 3 2 7. d oi: 1 0. 1 3 7 1/j o ur nal. p g p h. 0 0 0 0 3 2 7.
1 5
L o de H, Sc h m oele -T h o ma B, Gr u ber W, et al. D ose -ra n gi n g st u dy of a si n gle i njecti o n 
of p ne u m oc occal c o nj u gate vacci ne ( 1 ×, 2 ×, or 4 ×) i n healt h y s u bjects a ge d 7 0 ye ars 
or ol der. Vacci ne. 2 0 1 1; 2 9( 3 1): 4 9 4 0 - 6. D OI : 1 0. 1 0 1 6/j. vacci ne. 2 0 1 1. 0 4. 1 3 2.
1 6
Jac ks o n LA, El Sa hl y H M, Ge or ge S, et al. Ra n d o mize d cli nical trial of a si n gle vers us a 
d o u ble d ose of 1 3 -vale nt p ne u m oc occal c o nj u gate vacci ne i n a d ults 5 5 t hr o u g h 7 4 ye ars 
of a ge pre vi o usl y  vaccinate d wit h 2 3 -vale nt p ne u m oc occal p ol ys acc hari de vacci ne. 
Vacci ne. 2 0 1 8; 3 6( 5): 6 0 6 - 1 4. D OI: 1 0. 1 0 1 6/j. vacci ne. 2 0 1 7. 1 2. 0 6 1.
1 7
R u p p R, H urle y  D, Gra ys o n S, et al. A d ose ra n gi n g st u dy of 2 differe nt f or m ulati o ns of 
1 5 -vale nt p ne u m oc occal c o nj u gate vacci ne ( P C V 1 5) i n healt h y  i nfa nts. H u m Vacci n 
I m m u n ot her. 2 0 1 9; 1 5( 3): 5 4 9- 5 9. D OI : 1 0. 1 0 8 0/ 2 1 6 4 5 5 1 5. 2 0 1 9. 1 5 6 8 1 5 9.
1 8
F D A. G ui da nce f or i n d ustr y : t o xicit y gra di n g scale f or healt h y a d ult a n d a d olesce nt 
v ol u nteers e nr olle d i n pre ve nti ve vacci ne cli nical trials. R oc k vill e, M D: Ce nter f or 
Bi ol o gics E val uati o n a n d Researc h; Se p 2 0 0 7.
 

D o c u m e nt A p pr o v al R e c or d
D o c u m e nt N a m e:
D o c u m e nt Titl e:
Si g n e d B y:
D at e( G M T)
Si g ni n g C a p a cit y
 
P P D