A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS
Phase: PHASE2
Conditions: Group B Streptococcus Infections
Sponsor: Pfizer

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1
A P H A S E 1/ 2, R A N D O MI Z E D, P L A C E B O -C O N T R O L L E D, O B S E R V E R -B LI N D E D 
T RI A L T O E V A L U A T E T H E S A F E T Y, T O L E R A BI LI T Y, A N D 
I M M U N O G E NI CI T Y O F A M U L TI V A L E N T G R O U P B S T R E P T O C O C C U S 
V A C CI N E I N H E A L T H Y N O N P R E G N A N T W O M E N A N D P R E G N A N T W O M E N 
1 8 T O 4 0 Y E A R S O F A G E A N D T H EI R I N F A N T S
St u d y I nter ve nti o n N u m ber:
P F - 0 6 7 6 0 8 0 5
S t u d y I nter ve nti o n N a me:
Gr o u p B Stre pt oc occ us 6 -Vale nt 
P ol y sacc hari de C o nj u gate Vacci ne ( G B S 6)
U S I N D N u m ber:
1 7 0 5 8
E u dr a C T N u m ber:
2 0 2 0- 0 0 5 0 7 4- 9 6
Cli nic al Tri als. g o v I D:
N C T 0 3 7 6 5 0 7 3
Pr ot oc ol N u m ber:
C 1 0 9 1 0 0 2
P h ase:
1/ 2
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 nts, y o u a gree t o h ol d t his i nf or mati o n 
i n c o nfi de nce a n d n ot c o p y or discl ose it t o ot hers (e xce pt w here re q uire d b y a p plica ble la w) or use it f or 
u na ut h orize d p ur p oses.  I n t he e ve nt of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfize r m ust be 
pr o m ptl y n otifie d.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2
D oc u me nt Hist or y
D oc u me nt
Versi o n D ate
A me n d me nt 8
2 7 Marc h
2 0 2 3
A me n d me nt 7
2 0 Oct o ber 2 0 2 2
A me n d me nt 6
2 6 A pril 2 0 2 2
A me n d me nt 5
0 3 N o ve m ber 2 0 2 1
A me n d me nt 4
2 5 N o ve m ber 2 0 2 0
A me n d me nt 3
2 7 Ma y  2 0 2 0
A me n d me nt 2
1 8 Se pte m ber 2 0 1 9
A me n d me nt 1
0 4 Fe br uar y  2 0 1 9
Ori gi nal Pr ot oc ol
1 1 Ma y  2 0 1 8
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 
clarificati on letter.
Pr ot oc ol A me n d me nt S u m m ar y of C h a n ges T a ble
A me n d me nt 8 ( 2 7 Marc h 2 0 2 3 )
O ver all R ati o n ale f or t he A me n d me nt: T he t otal n u m ber of partici pa nts e nr olle d fr o m t he 
U nite d States ( U S ) i n S ta ge 3 is 5 4.
T he t otal n u m ber of partici pa nts e nr olle d fr o m t he U S
was i nitiall y  3 6 i n p r ot oc ol ame n d me nt 7. T he n u m ber e nr olle d fr o m t he U S is greater t ha n 
1 0 % a n d is c o nsi dere d a s u bsta ntial c ha n ge. F urt her m ore, beca use of t he a d diti o nal e nr olle d 
partici pa nts fr o m t he U S i n p r ot oc ol ame n d me nt 7 , t he d urati o n of t he st u d y has i ncrease d 
fr o m a p pr o xi matel y 4 8 m o nt hs t o a p pr o xi matel y 6 0 m o nt hs.
Secti o n # a n d N a m e
Descri pti o n of 
C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1. 1 : Bac k gr o u n d a n d 
Rati o nale
Secti o n 2. 2. 5 : St u d y Rati o nale
Secti o n 4. 1 : Di versit y of St u d y 
P o p ulati o n
Secti o n 4. 4 : Sta ge 3
Secti o n 4. 7 : N u m ber of 
P artici pa nts 
Secti o n 4. 7. 3 : Sta ge 3
Secti o n 1 0. 1 : Sa m ple Size 
Deter mi nati o n
Ta ble 1 . E nr oll me nt a n d D ose 
Escalati o n Desi g n

Re vis e d t he 
n u m ber of 
e nr olle d 
partici pa nts i n 
S ta ge 3 t o t he 
c orrect n u m ber 
e nr olle d ( 1 6 2 fr o m 
S o ut h 
Africa/ U nite d 
Ki n g d o m [U K ]
a n d 5 4 fr o m t he 
U S)

T he n u m ber of 
e nr olle d partici pa nts 
fr o m t he U S is 
greater t ha n 1 0 % 
i n dicate d i n pr ot oc ol 
a me n d me nt 7 .

S u bsta ntial
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3
Secti o n # a n d N a m e
Descri pti o n of 
C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Ta ble 2 . Pla n ne d Partici pa nts: 
T otal a n d N u m ber i n Eac h Sta ge 
a n d Gr o u p
Secti o n 4. 6 : D urati o n of t he St u d y 
U p date d t he
d urati o n of t he 
st u d y 

Beca use of t he 
a d diti o n of e nr olle d 
partici pa nts fr o m t he 
U S i n pr ot oc ol 
a me n d me nt 7 , t he 
le n gt h of t he st u d y 
has i ncrease d .

S u bsta ntial
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4
T A B L E O F C O N T E N T S
LI S T O F T A B L E S ................................................................................................................... 1 1
A P P E N DI C E S ......................................................................................................................... 1 2
1. P R O T O C O L  S U M M A RY ................................................................................................... 1 3
1. 1. Bac k gr o u n d a n d Rati o nale ...................................................................................... 1 3
Pri mar y  O bjecti ves: Sta ge 1 ................................................................................. 1 6
Pri mar y  O bjecti ves: Sta ge 2 ................................................................................. 1 6
Pri mar y  O bjecti ves: Sta ge 3 ................................................................................. 1 6
Pri mar y  E n d p oi nts.......................................................................................................... 1 6
Pri mar y  E n d p oi nts: Sta ge 1.................................................................................. 1 6
Pri mar y  Safety E n d p oi nts ( Mater nal Partici pa nts): Sta ges 2 a n d 3 ...................... 1 7
Pri mar y  Safety E n d p oi nts (I nfa nt Partici pa nts): Sta ges 2 a n d 3 ........................... 1 7
St u d y  Desi g n.................................................................................................................. 1 8
Sta ge 1 .................................................................................................................. 1 8
Sta ge 2 .................................................................................................................. 1 9
Sta ge 3 .................................................................................................................. 2 0
I n vesti gati o nal Pr o ducts ................................................................................................. 2 1
Statistical Met h o ds ......................................................................................................... 2 1
1. 2. Sc he d ule of Acti vities ............................................................................................. 2 2
2. I N T R O D U C TI O N ............................................................................................................... 3 0
2. 1. I n dicati o n ................................................................................................................. 3 0
2. 2. Bac k gr o u n d a n d Rati o nale ...................................................................................... 3 0
2. 2. 1. Disease O ver vie w .......................................................................................3 0
2. 2. 2. G B S Disease i n I nfa nts a n d Pre g na nt W o me n ...........................................3 0
2. 2. 3. Rati o nale f or De vel o p me nt of G B S 6 .......................................................... 3 2
2. 2. 3. 1. Mater nal I m m u nizati o n as a n A p pr oac h t o Pre ve nt 
Disease i n I nfa nts a n d Pre g na nt W o me n ........................................... 3 2
2. 2. 3. 2. Mater nal A n ti b o d y a n d Pr otecti o n A gai nst G B S Disease 
i n Infa nts ............................................................................................ 3 2
2. 2. 3. 3. Cli nical E x perie nce Wit h P ol y sacc hari de C o nj u gate 
Vacci nes a n d G B S P ol y sacc hari de C o nj u gate Vacci ne ....................3 3
2. 2. 3. 4. Cli nical E x perie nce Wit h Re peate d D oses of Vacci nes ............3 3
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5
2. 2. 4. Gr o u p B Stre pt oc occ us 6- Vale nt P ol y sacc hari de C o nj u gate Vacci ne ....... 3 4
2. 2. 5. St u d y  Rati o nale........................................................................................... 3 5
3. S T U D Y O BJ E C TI V E S A N D E N D P OI N T S ....................................................................... 3 7
3. 1. Pri mar y  O bjecti ves a n d E n d p oi nts.......................................................................... 3 7
3. 1. 1. Pri mar y  O bjecti ves: Sta ge 1 ....................................................................... 3 7
3. 1. 2. Pri mar y  E n d p oi nts: Sta ge 1........................................................................ 3 7
3. 1. 3. Pri mar y  O bjecti ves: Sta ge 2 ....................................................................... 3 8
3. 1. 4. Pri mar y  O bjecti ves: Sta ge 3 ....................................................................... 3 8
3. 1. 5. Pri mar y  Safety E n d p oi nts ( Mater nal Partici pa nts): Sta ges 2 a n d 3 ............ 3 8
3. 1. 6. Pri mar y  Safety E n d p oi nts (I nfa nt Partici pa nts): Sta ges 2 a n d 3 ................. 3 9
3. 2. Sec o n da r y O bjecti ves a n d E n d p oi nts...................................................................... 3 9
3. 2. 1. Sec o n dar y  O bjecti ves: Sta ge 1 ................................................................... 3 9
3. 2. 2. Sec o n dar y  O bjecti ve: Sta ge 2..................................................................... 3 9
3. 2. 3. Sec o n dar y  O bjecti ve: Sta ge 3..................................................................... 3 9
3. 2. 4. Sec o n dar y  O bjecti ves: Sta ges 2 a n d 3 ........................................................ 3 9
3. 2. 5. Sec o n dar y  E n d p oi nts: Sta ge 1.................................................................... 3 9
3. 2. 6. Sec o n dar y  E n d p oi nts ( Mater nal Partici pa nts): Sta ges 2 a n d 3 ................... 4 0
3. 2. 7. Sec o n dar y  E n d p oi nts (I nfa nt Partici pa nts): Sta ges 2 a n d 3 ........................ 4 0
3. 3. E x pl orat or y  O bjecti ves a n d E n d p oi nts.................................................................... 4 0
3. 3. 1. E x pl orat or y  O bjecti ves: Sta ge 1................................................................. 4 0
3. 3. 2. E x pl orat or y  O bjecti ves: Sta ges 2 a n d 3 ...................................................... 4 0
3. 3. 3. E x pl orat or y  O bjecti ve: Sta ges 1, 2, a n d 3 .................................................. 4 0
3. 3. 4. E x pl orat or y  E n d p oi nts: Sta ge 1.................................................................. 4 1
3. 3. 5. E x pl orat or y  E n d p oi nts ( Mater nal Partici pa nts): Sta ges 2 a n d 3 ................. 4 1
3. 3. 6. E x pl orat or y  E n d p oi nts (Infa nt Partici pa nts): St a ges 2 a n d 3 ...................... 4 1
4. S T U D Y D E SI G N ................................................................................................................. 4 1
4. 1. Di versit y  of St u d y P o p ulati o n................................................................................. 4 2
4. 2. Sta ge 1 ..................................................................................................................... 4 2
4. 3. Sta ge 2 ..................................................................................................................... 4 3
4. 4. Sta ge 3 ..................................................................................................................... 4 4
4. 5. D urati o n of Partici pa nt Partici pati o n ....................................................................... 4 6
4. 6. D urati o n of St u d y .................................................................................................... 4 6
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6
4. 7. N u m ber of Partici pa nts ............................................................................................ 4 6
4. 7. 1. Sta ge 1 ........................................................................................................ 4 6
4. 7. 2. Sta ge 2 ........................................................................................................ 4 6
4. 7. 3. Sta ge 3 ........................................................................................................ 4 6
5. S T U D Y P O P U L A T I ON ...................................................................................................... 4 7
5. 1. I ncl usi o n Criteria – Sta ge 1 ..................................................................................... 4 8
5. 2. I ncl usi o n Criteria – Sta ge 1 B o oster Vacci nati o n ................................................... 4 8
5. 3. E xcl usi o n Criteria – Sta ge 1 .................................................................................... 4 9
5. 4. I ncl usi o n Criteria – Sta ges 2 a n d 3 – Mater nal Partici pa nts ................................... 5 1
5. 5. E xcl usi o n Criteria – Sta ges 2 a n d 3 – Mater nal Partici pa nts .................................. 5 2
5. 6. I ncl usi o n Criteria – I nfa nt Partici pa nts – Sta ges 2 a n d 3 ........................................ 5 4
5. 7. E xcl usi o n Criteria – I nfa nt Partici pa nts – Sta ges 2 a n d 3 ....................................... 5 4
5. 8. Te m p orar y  Dela y Criteria ( Sta ges 1, 2, a n d 3) ....................................................... 5 5
5. 8. 1. Criteria f or Te m p oraril y Dela yi n g V acci ne A d mi nistrati o n 
( Sta ges 1, 2, a n d 3)........................................................................................... 5 5
5. 9. L ifest yle Re q uire me nts ........................................................................................... 5 5
5. 9. 1. C o ntrace pti o n ( Sta ge 1 Partici pa nts O nl y) ................................................. 5 5
5. 1 0. Scree n Fail ures ...................................................................................................... 5 6
5. 1 1. S p o ns or’s Q ualifie d Me dical Pers o n nel ................................................................ 5 6
6. I N V E S TI G A T I O N A L PR O D U C T S ................................................................................... 5 7
6. 1. I n vesti gati o nal Pr o d uct S u p plies ............................................................................. 5 7
6. 1. 1. D osa ge F or m(s) a n d Pac ka gi n g .................................................................. 5 7
6. 1. 2. Pre parati o n a n d Dis pe nsi n g ........................................................................ 5 8
6. 2. All ocati o n t o I n vesti gati o nal Pr o d uct ...................................................................... 5 9
6. 3. Partici pa nt C o m plia nce ........................................................................................... 5 9
6. 4. A d mi nistrati o n ......................................................................................................... 5 9
6. 5. I n vesti gati o nal Pr o d uct St ora ge .............................................................................. 6 0
6. 6. I n vesti gati o nal Pr o d uct Acc o u nta b ilit y................................................................... 6 1
6. 6. 1. Destr ucti o n of I n vesti gati o nal Pr o d uct S u p plies ........................................ 6 1
6. 7. Bli n di n g of t he Site Pers o n nel ................................................................................. 6 1
6. 8. Bli n di n g of t he S p o ns or ........................................................................................... 6 2
6. 9. Brea ki n g t he Bli n d .................................................................................................. 6 2
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7
6. 1 0. C o nc o mita nt Treat me nt(s) ..................................................................................... 6 2
6. 1 0. 1. Pr o hi bite d N o nst u d y  Vacci nes a n d Me dicati o ns D uri n g t he St u d y ......... 6 2
6. 1 0. 1. 1. Sta ge 1 ..................................................................................... 6 2
6. 1 0. 1. 2. Sta ges 2 a n d 3 – Mater nal Partici pa nts
................................... 6 3
6. 1 0. 2. Per mitte d N o nst u d y  Vacci nes a n d Me dicati o ns D uri n g t he St u d y .......... 6 3
6. 1 0. 2. 1. Sta ge 1 ..................................................................................... 6 3
6. 1 0. 2. 2. Sta ges 2 a n d 3 – Mater nal Partici pa nts
................................... 6 4
6. 1 0. 2. 3. Sta ges 2 a n d 3 – I nfa nt Partici pa nts ........................................ 6 4
6. 1 0. 3. Rec or di n g N o nst u d y  Vacci nati o ns a n d C o nc o mita nt Me dicati o ns .......... 6 4
6. 1 0. 3. 1. Sta ge 1 ..................................................................................... 6 4
6. 1 0. 3. 2. Sta ges 2 a n d 3 – Mater nal Partici pa nts
................................... 6 5
6. 1 0. 3. 3. Sta ges 2 a n d 3 – I nfa nt Partici pa nts ........................................ 6 5
7. S T U D Y P R O C E D U R E S ..................................................................................................... 6 5
7. 1. Sta ge 1 St u d y  Pr oce d ures – N o n pre g na nt W o me n ................................................. 6 5
7. 1. 1. Visit 0 – Scree ni n g ( Da y s -7 t o - 2 Pri or t o Vacci nati o n) ........................... 6 5
7. 1. 2. Visit 1 – Vacci nati o n ( Da y  1)..................................................................... 6 6
7. 1. 3. Visit 2 – 2- Wee k F oll o w -U p Visit ( 1 4- 1 7 Da y s After Visit 1) .................. 6 8
7. 1. 4. V isit 3 – 1- M o nt h F oll o w -U p Visit ( 2 8- 4 2 Da y s After Visit 1) ................. 6 8
7. 1. 5. Visit 4 – 6- M o nt h F oll o w -U p Tele p h o ne C o ntact ( 1 6 0 -2 0 0 Da y s
After Visit 1) .................................................................................................... 6 9
7. 1. 6. Visit 5 – Pre -B o oster Scree ni n g ( Da y s -7 t o -2 Pri or t o B o oster 
Vacci nati o n) ..................................................................................................... 6 9
7. 1. 7. Visit 6 – B o oster Vacci nati o n ( A p pr o xi matel y  2 Years After Visit 1) ...... 7 0
7. 1. 8. Visit 7 – 1- M o nt h B o oster Vacci nati o n F oll o w- U p Visit ( 2 8- 4 2 Da y s 
After Visit 6) .................................................................................................... 7 2
7. 1. 9. Visit 8 – 3- M o nt h B o oster Vacci nati o n F oll o w- U p Visit 
( 8 4- 1 2 6 D a y s After Visit 6) ............................................................................. 7 2
7. 1. 1 0. Visit 9 – 6- M o nt h B o oster Vacci nati o n F oll o w -U p Visit 
( 1 6 0- 2 0 0 D a y s After Visit 6)........................................................................... 7 3
7. 1. 1 1. Visit 1 0 – Bl o o d Dra w F oll o w -U p Visit ( 1 4 -1 8 4 Da y s After Visit 
9)...................................................................................................................... 7 3
7. 2. Sta ge 2 a n d 3 St u d y  Pr oce d ures – Mater nal Partici pa nts ........................................ 7 3
7. 2. 1. Visit 0 – Scree ni n g ( Da y s -1 4 t o -2 Pri or t o Vacci nati o n) ......................... 7 4
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8
7. 2. 2. Visit 0 – Rescree ni n g Visit ( Da y s -1 4 t o -2 Pri or t o Vacci nati o n) –
Sta ge 2 Se nti nel -C o h ort Partici pa nts O nl y ......................................................7 5
7. 2. 3. Visit 1 – Vacci nati o n ( Da y  1) Visit............................................................ 7 6
7. 2. 4. Visit 2 – 2- Wee k F oll o w - U p Visit ( 1 4-1 7 Da y s After Visit 1) ..................7 8
7. 2. 5. Visit 3 – 1- M o nt h F oll o w - U p Visit ( 2 8-4 2 Da y s After Visit 1) ................. 7 9
7. 2. 6. Visit 4 – Deli ver y ........................................................................................ 7 9
7. 2. 7. Visit 5 – 1- Wee k P ost deli ver y  F oll o w-U p Tele p h o ne C o ntact 
( 7- 1 0 D a y s After Deli ver y).............................................................................. 8 0
7. 2. 8. Visit 6 – 6- Wee k P ost deli ver y  F oll o w-U p ( 3 5 -4 9 Da y s After 
Deli ver y ).......................................................................................................... 8 1
7. 2. 9. Visit 7 – 1 4- Wee k P ost deli ver y  F oll o w-U p ( 8 0 -1 0 0 Da y s After 
Deli ver y ).......................................................................................................... 8 1
7. 2. 1 0. Visit 8 – 6- M o nt h P ost deli ver y
F oll o w -U p Tele p h o ne C o ntact 
( 1 6 0-2 0 0 Da y s After Deli ver y)........................................................................ 8 1
7. 2. 1 1. Visit 9 – 1 2- M o nt h P ost deli ver y  F oll o w-U p ( 3 6 5 -3 8 5 Da y s After 
Deli ver y ).......................................................................................................... 8 2
7. 3. Sta ge 2 a n d 3 St u d y  Pr oce d ures – I nfa nt Partici pa nts............................................. 8 2
7. 3. 1. Visit 1 – Deli ver y ........................................................................................ 8 2
7. 3. 2. Visit 2 – 1- Wee k P o st deli ver y F oll o w-U p Tele p h o ne C o ntact 
( 7- 1 0 D a y s After Deli ver y).............................................................................. 8 3
7. 3. 3. Visit 3 – 6- Wee k P ost deli ver y  F oll o w-U p ( 3 5 -4 9 Da y s After 
Deli ver y ).......................................................................................................... 8 4
7. 3. 4. Visit 4 – 1 4- Wee k P ost deli ver y  F oll o w-U p ( 8 0 -1 0 0 Da y s After 
Deli ver y ).......................................................................................................... 8 4
7. 3. 5. Visit 5 – 1 8- Wee k P ost deli ver y  F oll o w-U p ( 1 1 9 -1 3 3 Da y s After 
Deli ver y ).......................................................................................................... 8 5
7. 3. 6. Visit 6 – 6- M o nt h P ost deli ver y  F oll o w-U p Tele p h o ne C o ntact 
( 1 6 0-2 0 0 Da y s After Deli ver y)........................................................................ 8 6
7. 3. 7. Visit 7 – 1 2- M o nt h P ost deli ver y  F oll o w-U p ( 3 6 5 -3 8 5 Da y s After 
Deli ver y ).......................................................................................................... 8 6
7. 4. U nsc he d ule d Visit ( Sta ges 1, 2, a n d 3 –
Mater nal Partici pa nts)............................. 8 7
7. 5. Partici pa nt Wit h dra wal ............................................................................................ 8 8
7. 5. 1. Wit h dra wal of C o nse nt ............................................................................... 8 8
7. 6. L ost t o F oll o w -U p ................................................................................................... 8 9
8. A S S E S S M E N T S .................................................................................................................. 9 0
8. 1. Pre g na nc y  Testi n g ( A p plica ble t o Sta ge 1 Partici pa nts O nl y )................................ 9 0
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9
8. 2. Bi ol o gical Sa m ples .................................................................................................. 9 1
8. 3. I m m u n o ge nicit y ...................................................................................................... 9 1
8. 3. 1. G B S A nti b o d y  Testi n g ............................................................................... 9 1
....................................... 9 2
8. 3. 3. Assess me nt of A nti b o d y  Res p o nses t o R o uti ne Pe diatric Vacci nes i n 
I nfa nt Partici pa nts Fr o m S o ut h Africa ( Sta ges 2 a n d 3) .................................. 9 2
................................................................................ 9 2
8. 5. Safet y Para meters .................................................................................................... 9 2
8. 5. 1. Partici pa nt Electr o nic Diar y ....................................................................... 9 3
8. 5. 2. Gra di n g Scale f or Pr o m pte d E ve nts ........................................................... 9 4
8. 5. 2. 1. L ocal Reacti o ns ......................................................................... 9 4
8. 5. 2. 2. S y ste mic E ve nts ........................................................................ 9 5
8. 5. 2. 3. Fe ver .......................................................................................... 9 6
8. 5. 3. L a b orat or y Tests......................................................................................... 9 6
8. 6. Use of A nti p yretic/ Pai n Me dicati o n ........................................................................ 9 7
8. 7. St o p pi n g R ules ........................................................................................................ 9 7
8. 8. Ot her Safet y M o nit ori n g ......................................................................................... 9 9
8. 8. 1. A d verse E ve nts ........................................................................................... 9 9
8. 8. 2. I mme diate A d verse E ve nts ....................................................................... 1 0 0
8. 8. 3. Me dicall y  Atte n de d A d verse E ve nts ........................................................ 1 0 0
8. 8. 4. A d verse E ve nts of S pecial I nterest ........................................................... 1 0 0
8. 8. 5. R o uti ne Me dical Facilit y  Visits a n d Electi ve H os pitalizati o ns N ot 
Ass ociate d Wit h A d verse E ve nts ................................................................... 1 0 0
9. A D V E R S E E V E N T R E P O R TI N G ....................................................................................1 0 1
9. 1. Re q uire me nts ......................................................................................................... 1 0 1
9. 1. 1. A d diti o nal Details o n Rec or di n g A d verse E ve nts o n t he C R F ................. 1 0 3
9. 1. 2. Eliciti n g A d verse E ve nt I nf or mati o n........................................................ 1 0 3
9. 1. 3. Wit h dra wal Fr o m t he St u d y  D ue t o A d verse E ve nts (see als o t he 
Partici pa nt Wit h dra wal Secti o n) .................................................................... 1 0 3
9. 1. 4. Ti me Peri o d a n d Fre q ue nc y  f or C ollecti n g A E/ S A E Inf or mati o n ........... 1 0 3
9. 1. 4. 1. Sta ge 1 ..................................................................................... 1 0 4
9. 1. 4. 2. Sta ges 2 a n d 3 – Mater nal Partici pa nts
................................... 1 0 4
9. 1. 4. 3. Sta ges 2 a n d 3 – I nfa nt Partici pa nts ........................................ 1 0 5
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0
9. 1. 4. 4. Re p orti n g S A Es t o Pfizer Safet y ............................................. 1 0 5
9. 1. 4. 5. 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 ................. 1 0 6
9. 1. 5. F oll o w -u p of A Es a n d S A Es ..................................................................... 1 0 7
9. 1. 6. Ca usalit y  Assess me nt ............................................................................... 1 0 7
9. 1. 7. S p o ns or’s Re p orti n g Re q uire me nts t o Re g ulat or y  A ut h orities................ 1 0 7
9. 2. Defi niti o ns ............................................................................................................. 1 0 8
9. 2. 1. A d verse E ve nts ......................................................................................... 1 0 8
9. 2. 2. A b n or mal Test Fi n di n gs ........................................................................... 1 0 9
9. 2. 3. Seri o us A d verse E ve nts ............................................................................ 1 0 9
9. 2. 4. H os pitalizati o n .......................................................................................... 1 1 0
9. 3. Se verit y  Assess me nt..............................................................................................1 1 1
9. 4. S pecial Sit uati o ns .................................................................................................. 1 1 1
9. 4. 1. Pr ot oc ol -S pecifie d Seri o us A d verse E ve nts ............................................. 1 1 1
9. 4. 2. P ote ntial Cases of Dr u g -I n d uce d Li ver I nj ur y.......................................... 1 1 1
9. 4. 3. E x p os ure t o t he I n vesti gati o nal Pr o d uct 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 ( Sta ge 1 O nl y )........................... 1 1 3
9. 4. 3. 1. E x p os ure D uri n g Pre g na nc y .................................................... 1 1 3
9. 4. 3. 2. E x p os ure D uri n g Breastfee di n g .............................................. 1 1 5
9. 4. 3. 3. Occ u pati o nal E x p os ure ........................................................... 1 1 5
9. 4. 4. Vacci nati o n Err ors .................................................................................... 1 1 5
9. 4. 4. 1. Vacci nati o n Err ors ................................................................... 1 1 5
1 0. D A T A A N A L Y SI S/ S T A TI S TI C A L M E T H O D S ........................................................... 1 1 6
1 0. 1. Sa m ple Size Deter mi nati o n ................................................................................. 1 1 6
1 0. 2. I m m u n o ge nicit y A nal ysis ................................................................................... 1 1 7
1 0. 2. 1. I m m u n o ge nicit y A nal y sis P o p ulati o ns ...................................................1 1 7
1 0. 2. 1. 1. N o n pre g na nt W o me n ( Sta ge 1)............................................. 1 1 8
1 0. 2. 1. 2. Mater nal Partici pa nts ( Sta ges 2 a n d 3) .................................. 1 1 8
1 0. 2. 1. 3. I nfa nt Partici pa nts ( Sta ges 2 a n d 3) ....................................... 1 1 8
1 0. 2. 2. A nal y sis of Im m u n o ge nicit y  E n d p oi nts ................................................. 1 1 9
1 0. 3. Safet y A nal ys is.................................................................................................... 1 1 9
1 0. 3. 1. Safet y P o p ulati o n .................................................................................... 1 2 0
1 0. 3. 1. 1. N o n pre g na nt W o me n ( Sta ge 1) ............................................. 1 2 0
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1
1 0. 3. 1. 2. Mater nal Partici pa nts ( Sta ges 2 a n d 3) .................................. 1 2 0
1 0. 3. 1. 3. I nfa nt Partici pa nts ( Sta ges 2 a n d 3) ....................................... 1 2 0
1 0. 3. 2. A nal y sis of Safet y E n d p oi nts.................................................................. 1 2 1
1 0. 4. A nal y sis Ti mi n g .................................................................................................. 1 2 1
1 0. 5. Data M o nit ori n g C o m mittee ............................................................................... 1 2 2
1 1. Q U A LI T Y C O N T R O L  A N D Q U A LI T Y A S S U R A N C E ............................................... 1 2 3
1 2. D A T A H A N D LI N G A N D R E C O R D K E E PI N G ........................................................... 1 2 3
1 2. 1. Case Re p ort F or ms/ Electr o nic Data Rec or d ....................................................... 1 2 3
1 2. 2. Rec or d Rete nti o n ................................................................................................. 1 2 4
1 3. E T HI C S ............................................................................................................................1 2 4
1 3. 1. I nstit uti o nal Re vie w B oar d/ Et hics C o m mittee .................................................... 1 2 4
1 3. 2. Et hical C o n d uct of t he St u d y .............................................................................. 1 2 5
1 3. 3. Partici pa nt I nf or mati o n a n d C o nse nt ................................................................... 1 2 5
1 3. 4. Re p orti n g of Safet y I ss ues a n d Seri o us Breac hes of t he Pr ot oc ol or I C H 
G C P ......................................................................................................................... 1 2 6
1 4. D E FI NI TI O N O F E N D O F T RI A L ................................................................................. 1 2 6
1 4. 1. E n d of Trial i n All Partici pati n g C o u ntries ......................................................... 1 2 6
1 5. S P O N S O R DI S C O N TI N U A TI O N C RI T E RI A ..............................................................1 2 7
1 6. P U B LI C A TI O N O F S T U D Y R E S U L T S ........................................................................ 1 2 7
1 6. 1. C o m m u nicati o n of Res ults b y  Pfizer .................................................................. 1 2 7
1 6. 2. P u blicati o ns b y  In vesti gat ors .............................................................................. 1 2 8
1 7. P R O T O C O L  A M E N D M EN T HI S T O R Y ....................................................................... 1 3 0
1 8. R E F E R E N C E S ................................................................................................................ 1 4 1
LI S T O F T A B L E S
Ta ble 1.
E nr oll me nt a n d D ose Escalati o n Desi g n .................................................. 4 5
Ta ble 2.
Pla n ne d Partici pa nts: T otal a n d N u m ber i n Eac h Sta ge a n d Gr o u p .........4 7
Ta ble 3.
Tar get C o m p ositi o n of t he G B S 6 F or m ulati o ns I nte n de d f or 
Cli nical E val uati o n ................................................................................... 5 8
Ta ble 4.
L ocal Reacti o n Gra di n g Scale ..................................................................9 4
Ta ble 5.
S y ste mic E ve nt Gra di n g Scale..................................................................9 5
Ta ble 6.
Ra n ges f or Fe ver .......................................................................................9 6
Ta ble 7.
La b orat or y  Tests.......................................................................................9 7
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2
Ta ble 8.
Ti me Peri o d f or C ollecti n g A E/ S A E I nf or mati o n .................................. 1 0 5
Ta ble 9.
Pr o ba bilit y  of O bser vi n g at Least 1 A E b y Ass u me d Tr ue E ve nt 
Rates Wit h Differe nt Sa m ple Sizes ........................................................ 1 1 7
A P P E N DI C E S
A p pe n di x 1. A b bre viati o ns .................................................................................................... 1 4 7
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3
1. P R O T O C O L S U M M A R Y
1. 1. B ac k gr o u n d a n d R ati o n ale
Stre pt oc occ us a g al acti ae , als o k n o w n as gr o u p B stre pt oc occ us ( G B S), is a n e nca ps ulate d, 
gra m -p ositi ve c occ us t hat is ass ociate d wit h l o wer i nte sti nal a n d rect o va gi nal c ol o nizati o n.  
T here are 1 0 ser oty pes of G B S (Ia, I b, II, III, I V, V, VI, VII, VIII, a n d I X) differe ntiate d by 
t he p ol ysacc hari de c o m p ositi o n of t heir ca ps ules.  Alt h o u g h all G B S ser ot y pes ha ve bee n 
f o u n d t o ca use disease, 6 ser ot yp es (Ia, I b, II, III, I V, a n d V) ha ve bee n f o u n d t o ca use o ver 
8 5 % of disease gl o ball y  a n d 9 8 % i n S o ut h Africa, b ut t here is varia bilit y i n t heir gl o bal 
pre vale nce a n d vir ule nce.  G B S disease is m ost fre q ue ntl y f o u n d i n t he ver y y o u n g —
ne w b or ns a n d i nfa nts y o u n ger t ha n 3 m o nt hs of a ge — a n d t he el derl y, es peciall y ol der a d ults 
wit h c o m or bi d c o n diti o ns.  H o we ver, disease d ue t o G B S has bee n re p orte d i n i n di vi d uals of 
all a ges, a n d pre g na nt w o me n ma y be partic ularly s usce pti ble t o G B S disease as well.
A m o n g y o u n g i nfa nts, G B S is a lea di n g ca use of i n vasi ve bacterial i nfecti o n, a si g nifica nt 
ca use of i nfa nt m or bi dit y a n d m ortalit y  gl o bally, a n d t he lea di n g i nfecti o us ca use of 
m or bi dit y  a n d m ortalit y i n i nfa nts i n t he U S.  Seri o us G B S disease, i ncl u di n g se psis, 
me ni n gitis, a n d p ne u m o nia, is ass ociate d wit h m ortalit y rates of 6 % t o 1 4 % i n hi g h -i nc o me
c o u ntries a n d 1 0 % t o 6 0 % i n l o w- a n d mi d dle -i nc o me c o u ntries ( L MI Cs).  Of i nfa nts 
s ur vi vi n g G B S me ni n gitis, o ne st u d y f o u n d mil d t o m o derate ne ur ol o gical se q uelae i n 2 5 %,
a n d 1 9 % s uffere d se vere se q uelae, i ncl u di n g c o g niti ve dela y , cere bral palsy, bli n d ness, or 
heari n g l oss.  Fi ve ser ot y pes (Ia, I b, II, III, a n d V) are m ost fre q ue ntly ass ociate d wit h G B S 
disease i n i nfa nts.  A n ot her ser ot y pe (I V) s h o ws a tre n d of i ncrease d pre vale nce i n certai n 
re gi o ns.  G B S disease i n i nfa nts is ofte n classifie d as early- o nset disease ( E O D), w hic h 
occ urs wit hi n t he first wee k of life, a n d late -o nset disease ( L O D), w hic h occ urs bet wee n 
D a y s 7 a n d 9 0.
T he re p orte d b ur de n of i nfa nt G B S diseas e varies gl o ball y a n d is i nfl ue nce d b y t he i nte nsity 
of t he e pi de mi ol o g y  s ur veilla nce f or t he or ga nis m, as well as b y t he fre q ue nc y of healt hcare 
i nteracti o n.  T his ma y t heref ore lea d t o t he p ote ntial f or u n derre p orti n g, a n d u n der use of 
i ntra part u m a nti bi otic pr o p h yla xis (I A P) t o pre ve nt G B S disease.  I n re gi o ns, s uc h as t he U S, 
w here t here are si g nifica nt eff orts a n d res o urces all ocate d f or u ni versal G B S scree ni n g of 
pre g na nt w o me n a n d use of I A P t o pre ve nt G B S disease, it is n ota ble t hat t he n u m ber of 
cases of E O D decrease d fr o m a hi g h of 1. 7 cases/ 1 0 0 0 li ve birt hs si nce t he early 1 9 9 0s w he n 
rec o m me n dati o ns f or pre ve nti o n were i ntr o d uce d t o 0. 2 1 cases/ 1 0 0 0 li ve birt hs i n 2 0 1 4.  
Des pite decli nes i n pe diatric bacterial me ni n gitis cases i n t he U S bet wee n 2 0 0 3 a n d 2 0 0 7, t he 
i nci de nce i n c hil dre n 2 m o nt hs of a ge was u nc ha n ge d.  T his reflects t he persiste nce of G B S 
L O D, w hic h is t he pri mar y  ca use of bacterial me ni n gitis i n t hat a ge gr o u p.  T he i nci de nce 
was 0. 3 2 cases/ 1 0 0 0 li ve birt hs i n 2 0 1 5.
Vacci nati o n of pre g na nt w o me n has bee n use d gl o ball y  i n t he pre ve nti o n of ne o natal teta n us 
a n d m ore rece ntl y f or pre ve nti o n of pert ussis i n y o u n g i nfa nts, a n d t o pr otect w o me n a n d 
t heir i nfa nts a gai nst i nfl ue nza.  Vacci nati o n wit h teta n us t o x oi d, di p ht heria t o x oi d, a n d 
acell ular pert ussis vacci ne ( T da p) i n pre g na nt w o me n was i ntr o d uce d i n t he U S a n d i n t he 
U K i n res p o nse t o a si g nifica nt u ps ur ge i n pert ussis cases i n all a ge gr o u ps.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4
Mater nal i m m u nizati o n a gai nst i nfl ue nza was rec o m me n de d b y  t he U S A d vis or y C o m mittee 
o n I m m u nizati o n Practices ( A CI P) beca use of t he i ncrease d ris ks of i nfl ue nza a n d relate d 
c o m plicati o ns i n pre g na nt w o me n.  Safet y s ur veilla nce c o n d ucte d t hr o u g h 2 0 1 2 has 
d e m o nstrate d n o u n us ual patter ns of pre g na nc y  c o m plicati o ns or fetal o utc o mes. Se veral 
c o u ntries rec o m me n d t he a d mi nistratio n of T da p d uri n g e ver y  pre g na nc y, i ncl u di n g cl osely 
s pace d pre g na ncies. T he S o ut h Africa n g ui deli nes f or mater nit y care rec o m me n d a ll 
pre g na nt w o me n are gi ve n 3 teta n us t o x oi d i m m u nizati o n d oses d uri n g t he first pre g na nc y 
a n d 2 teta n us t o x oi d i m m u nizati o n b o oster d oses f or t he ne xt 2 s u bse q ue nt pre g na ncies, 
1 i n eac h pre g na nc y, at least 1 ye ar a part.
Pfizer is de vel o pi n g a 6 -vale nt ca ps ular p ol y sacc hari de ( C P S) c o nj u gate vacci ne ( gr o u p B 
stre pt oc occ us 6-vale nt p ol y sacc hari de c o nj u gate vacci ne [ G B S 6]) ai me d at t he pre ve nti o n of 
gr o u p B stre pt oc occal disease d ue t o 6 ser oty pes i n y o u n g i nfa nts b y acti ve i m m u nizati o n of 
pre g na nt w o me n.  G B S 6 has bee n de vel o pe d base d o n Pfizer hist orical e x perie nce wit h 
lice nse d a n d i n vesti gati o nal p ol ysacc hari de c o nj u gate vacci nes a n d p u blis he d/ p u blic data 
wit h ot her i n vesti gati o nal G B S C P S c o nj u gate vacci nes t hat ha ve bee n e val uate d i n cli nical 
trials, i ncl u di n g a tri vale nt (Ia, I b, a n d III) G B S C P S –cr oss -reacti ve material 1 9 7 ( C R M1 9 7) 
c o nj u gate vacci ne i n pre g na nt w o me n.  Precli nical data s h o w t hat G B S 6 i n d uces 
ser ot yp e -s pecific i m m u n o gl o b uli n G (I g G) res p o nses a n d o ps o n o p ha g oc ytic acti vit y ( O P A) 
t hat are pr otecti ve a gai nst a n i nfecti o us c halle n ge i n t he offs pri n g i n a ni mal m o dels.
T his P hase 1/ 2, ra n d o mize d, place b o -c o ntr olle d, o bser ver -bli n de d st u d y  will be t he first 
e val uati o n of t he i n vesti gati o nal G B S 6 i n pre g na nt w o me n.  T his st u d y will be c o n d ucte d 
i n 3 sta ges.  Sta ge 1 will e val uate t he safety, t olera bilit y , a n d i m m u n o ge nicit y of G B S 6 
( 2 0 µ g C P S/ser ot y pe/ d ose) wit h a n d wit h o ut al u mi n u m p h os p hate ( Al P O 4).  T his d ose le vel 
was selecte d b y t he i nter nal re vie w c o m mittee (I R C) after t he re vie w of t he u n b li n de d safety 
data t hr o u g h 1 m o nt h after vacci nati o n i n a n o n g oi n g first- i n-h u ma n ( FI H), P hase 1/ 2, 
ra n d o mize d, place b o-c o ntr olle d, o bser ver -bli n de d st u d y  t hat e val uate d 3 asce n di n g d ose 
le vels ( 5, 1 0, or 2 0 µ g  C P S/ser ot ype/ d ose) of G B S 6 f or m ulate d wit h or wit h o ut Al P O 4 i n 
healt h y  a d ults ( n o n pre g na nt w o me n a n d me n, 1 8 t o 4 9 years of a ge ) i n t he U S ( C 1 0 9 1 0 0 1).  
Sta ge 2 will c o m me nce f oll o wi n g a re vie w of t he 1 - m o nt h p ost vacci nati o n safety data fr o m 
t he P hase 1/ 2 LMI C Sta ge 1 c o h ort a n d 1 -m o nt h p ost vacci nati o n safet y  a n d i m m u n o ge nicity 
data fr o m t he P hase 1/ 2 FI H st u d y ( C 1 0 9 1 0 0 1).  If t he safet y a n d i m m u n o ge nicit y pr ofile is 
dee me d acce pta ble, t he safet y, t olera bilit y , a n d i m m u n o ge nicity of 3 asce n di n g d ose le vels 
(
µ g C P S/ser ot y pe/ d ose ) of G B S 6 f or m ulate d wit h or wit h o ut Al P O4 will be 
assesse d w he n a d mi nistere d as a si n gle d ose t o healt h y  pre g na nt w o me n 1 8 t o 4 0 ye ars of a ge 
d uri n g t heir 2 7 t o 3 6 wee ks of pre g na nc y .  Sta ge 2 will use a se nti nel -c o h ort desi g n wit h 
c o h ort pr o gressi o n (i ncl u di n g pr o gressi o n i nt o e x pa n de d c o h orts) a n d d ose escalati o n ta ki n g 
place after a safet y re vie w.  I n Sta ge 3, a n a d diti o nal c o h ort of healt h y  pre g na nt w o me n will 
be e nr olle d t o recei ve t he selecte d G B S 6 d ose/f or m ulati o n t o pr o vi de a n e x pa n de d safet y a n d 
i m m u n o genicit y data set ( b ot h pre g na nt w o me n a n d t heir i nfa nts) a n d t o s u p p ort pr o gressi o n 
of t he de vel o p me nt of t his vacci ne.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 5
I n A me n d me nt 3, t he gestati o nal a ge of vacci nati o n f or partici pa nt s i n Sta ge 3 is e x pa n di n g 
(fr o m ≥2 7 0/ 7 t o ≤3 5 6/ 7 wee ks ’ gestati o n t o ≥2 4 0/ 7 t o ≤3 5 6/ 7 wee ks ’ gestati o n) t o e na ble 
e x pa n de d e val uati o n of safet y a n d i m m u n o ge nicit y data at t he selecte d d ose, i n t he sec o n d 
a n d t hir d tri mesters of pre g na nc y .
I n A me n d me nt 4, Sta ge 1 partici pa nt s ( n o n pre g na nt w o me n) willi n g a n d eli gi ble t o 
par tici pate will ret ur n t o recei ve a b o oster d ose of G B S 6 a p pr o xi matel y 2 years after t he 
pri mar y  d ose of i n vesti gati o nal pr o d uct, t o e val uate safety a n d i m m u n o ge nicit y f oll o wi n g a 
b o oster d ose of G B S 6 i n S o ut h Africa n w o me n. It is n ot k n o w n if G B S 6 will be re q uire d 
d uri n g eac h pre g na nc y , t h us i nf or mati o n o n t he safet y a n d i m m u ne res p o nse f oll o wi n g a 
b o oster d ose i n differe nt p o p ulati o ns is i m p orta nt. A d diti o nall y , Sta ge 1 partici pa nt s
( n o n pre g na nt w o me n) will pr o vi de a lar ge v ol u me bl o o d dra w t o s u p p ort t he de vel o p me nt 
of a u ni versal G B S vacci ne refere nce sta n dar d assa y .
I n A me n d me nt 5, Sta ge 1 b o oster partici pa nts ( n o n pre g na nt w o me n) will ret ur n f or a n 
a d diti o nal bl o o d dra w at Visit 1 0, w hic h will ta ke place a p pr o xi matel y  1 4 t o 1 8 4 da y s 
after V isit 9. T his a d diti o nal ser u m will f urt her s u p p ort t he de vel o p me nt of a u ni versal 
G B S vacci ne refere nce sta n dar d assa y.
I n A me n d me nt 6, a n a d diti o nal 2 0 0 mater nal partici pa nts will be a d de d t o S ta ge 3. T hese 
partici pa nts will be recr uite d at sites i n t he U S. T he dat a fr o m t hese partici pa nts will 
c o ntri b ute t o t he safety data base t o s u p p ort t he i nitiati o n of t he P hase 3 pr o gra m. T hese data 
will als o e na ble an e val uati o n a n d c o m paris o n of G B S 6 i m m u ne res p o nses a n d place ntal 
a nti b o d y tra nsfer efficie nc y bet wee n mater nal/i nfa nt pairs i n t he U S a n d S o ut h Africa.
F urt her m ore , O P A a nal ysis has bee n re m o ve d as a n e x pl orat or y e n d p oi nt f or S ta ge 1, 
S ta ge 2, a n d Sta ge 3 mater nal a n d i nfa nt partici pa nts . It has als o bee n re m o ve d as a 
sec o n dar y e n d p oi nt f or S ta ge 1 partici pa nts. T his is bei n g re m o ve d beca use data fr o m t he 
sec o n d a n d t hir d i nteri m a nalys es de m o nstrate d r o b ust i m m u ne res p o nses, as meas ure d by 
ser ot yp e -s pecific I g G a n d f u ncti o nal a nti b o d y res p o nse f or ser ot yp e -s pecific O P A after
G B S 6 vacci nati o n . T hes e data s u p p ort t he use of a nti -G B S ca ps ular I g G le vels t o e val uate 
G B S 6 vacci ne pr otecti o n a gai nst i n vasi ve G B S disease. H o we ver, t he l o wer li mit s of 
q ua nti tati o n ( L L O Qs) f or ser ot y pe-s pecific O P As were hi g h, i n dicati n g t hat t he O P A assa ys 
are n ot se nsitive e n o u g h c o m pare d t o I g G, a n d t h us re n der i n g t he O P A assa y u ns uita ble f or 
meas uri n g vacci ne pr otecti o n.
I n A me n d me nt 7, t here will be a re visi o n of t he i nfa nt bl o o d dra w sc he d ule t o re m o ve bl o o d 
dra ws at t he 1 8 -wee k p ost deli ver y  a n d 1 2-m o nt h p ost deli ver y  visits f or i nfa nts b or n t o 
mater nal partici pa nts e nr olle d i n t he U S a n d t he U K Sta ge 3 c o h ort. T he i nfa nt bl o o d dra ws 
at t hese 2 visits are f or t he e x pl orat or y  i m m u n o ge nicit y o bjecti ve t o descri be i m m u ne 
res p o nses t o di p ht heria a n d 1 3- vale nt p ne u m oc occal c o nj u gate vacci ne a d mi nistere d t o i nfa nt 
partici pa nts deli vere d t o mater nal partici pa nts vacci nate d wit h G B S 6, a n d are ali g ne d wit h 
t he S o ut h Africa n pe diatric i m m u nizati o n sc he d ule. T he pe diatric i m m u nizati o n sc he d ules i n 
t he U S a n d t he U K differ a n d are n ot ali g ne d wit h t he 1 8 -wee k p ost deli ver y a n d 1 2 -m o nt h 
p ost deli ver y  st u d y visits. T his e x pl orat or y  a nal ysis will c o nti n ue t o be c o n d ucte d i n Sta ge 2 
a n d Sta ge 3 i nfa nts b or n t o mater nal partici pa nts e nr olle d fr o m S o ut h Africa as ori gi nall y 
pla n ne d.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 6
T he a dj uste d pr o p ose d n u m ber of U S partici pa nts , re d uce d fr o m 2 0 0 t o 3 6, will be s ufficie nt
t o e val uate a n d c o m pare t he G B S 6 place ntal a nti b o d y  tra nsfer efficie nc y bet wee n 
mater nal/i nfa nt pairs i n t he U S a n d S o ut h Africa . T he a me n d me nt t o e xcl usi o n criteria 8 a n d 
1 5 f or t he Sta ge 3 mater nal partici pa nts is clarificati o n te xt t o pr o vi de g ui da nce t o 
i n vesti gati o nal sites, wit h res pect t o c o m plia nce wit h st u d y pr ot oc ol re q uire me nt, a n d will 
facilitate recr uit me nt of s uita ble mater nal partici pa nts f or t he st u d y .
I n A me n d me nt 8, t he t otal n u m ber of partici pa nts e nr olle d fr o m t he U S i n S ta ge 3 will be 
re vise d t o t he c orrect n u m ber e nr olle d ( 1 6 2 fr o m S o ut h Africa/ U K a n d 5 4 fr o m t he U S) .
F urt her m ore, beca use of t he a d diti o nal e nr olle d partici pa nts fr o m t he U S i n pr ot oc ol 
a me n d me nt 7 , t he d urati o n of t he st u d y has i ncrease d fr o m a p pr o xi matel y 4 8 m o nt hs t o 
a p pr o xi matel y 6 0 m o nt hs.
Pri m ar y O bjecti ve s: St a ge 1

T o descri be t he safet y a n d t olera bilit y of vari o us G B S 6 f or m ulati o ns i n health y  
n o n pre g na nt w o me n 1 8 t o 4 0 ye ars of a ge.

T o descri be t he safet y a n d t olera bilit y of a b o oster d ose of G B S 6 w he n a d mi nistere d 
t o healt h y n o n pre g na nt w o me n.
Pri m ar y O bjecti ves: St a ge 2

T o descri be t he safet y a n d t olera bilit y of vari o us G B S 6 f or m ulati o ns whe n 
a d mi nistere d t o healt h y pre g na nt w o me n 1 8 t o 4 0 ye ars of a ge vacci nate d at 
2 7 t o 3 6 wee ks’ gestati o n.

T o assess t he safet y of mater nal i m m u nizati o n i n i nfa nts b or n t o w o me n w h o were 
vacci nate d wit h vari o us G B S 6 f or m ulati o ns d uri n g pre g na nc y.
Pri m ar y O bjecti ves: St a ge 3

T o descri be t he safet y a n d t olera bilit y of 1 selecte d d ose/f or m ulati o n of G B S 6
w he n a d mi nistere d t o healt h y pre g na nt w o me n 1 8 t o 4 0 ye ars of a ge vacci nate d at 
2 4 t o 3 6 wee ks’ gestati o n.

T o assess t he safet y of mater nal i m m u nizati o n i n i nfa nts b or n t o w o me n 
1 8 t o 4 0 ye ars of a ge w h o were vacci nate d wit h 1 selecte d d ose/f or m ulati o n 
d uri n g pre g na nc y .
Pri m ar y E n d p oi nts
Pri m ar y E n d p oi nts: St a ge 1

Pr o p orti o ns of n o n pre g na nt w o me n re p orti n g pr o m pte d l ocal reacti o ns wit hi n 7 da y s 
f oll o wi n g a d mi nistrati o n of t he pri mar y a n d b o oster d oses of i n vesti gati o nal pr o d uct 
( pai n at t he i njecti o n site, re d ness, a n d s welli n g).
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 7

Pr o p orti o ns of n o n pre g na nt w o me n re p orti n g pr o m pte d s y ste mic e ve nts wit hi n 7 da y s 
f oll o wi n g a d mi nistrati o n of t he pri mar y a n d b o oster d oses of i n vesti gati o nal pr o d uct 
(fe ver, na usea/ v o miti n g, diarr hea, hea dac he, fati g ue/tire d ness, m uscle pai n, a n d j oi nt 
pai n).

Pr o p orti o ns of n o n pre g na nt w o me n re p orti n g a d verse e ve nts ( A Es) t hr o u g h 1 m o nt h 
f oll o wi n g a d mi nistrati o n of t he pri mar y a n d b o oster d oses of i n vesti gati o nal pr o d uct.

Pr o p orti o ns of n o n pre g na nt w o me n re p orti n g me dicall y  atte n de d a d verse e ve nts 
( M A Es) a n d seri o us a d verse e ve nts ( S A Es) t hr o u g h 6 m o nt hs f oll o wi n g
a d mi nistrati o n of t he pri mar y  d ose a n d a p pr o xi matel y 7 t o 1 2 m o nt hs f oll o wi n g t he 
b o oster d ose of i n vesti gati o nal pr o d uct.
Pri m ar y S afet y E n d p oi nts ( M ater n al P a rtici p a nts): St a ges 2 a n d 3

Pr o p orti o ns of se nti nel -c o h ort mater nal partici pa nt s ( Sta ge 2 o nl y) wit h cli nical 
la b orat or y a b n or malities f oll o wi n g a d mi nistrati o n of i n vesti gati o nal pr o d uct at t he 
2- wee k f oll o w -u p visit.

Pr o p orti o ns of mater nal partici pa nt s re p orti n g pr o m pte d l ocal reacti o ns wit hi n 7 da y s 
f oll o wi n g a d mi nistrati o n of i n vesti gati o nal pr o d uct ( pai n at t he i njecti o n site, re d ness, 
a n d s welli n g).

Pr o p orti o ns of mater nal partici pa nt s re p orti n g pr o m pte d s yste mic e ve nts wit hi n 
7 da y s f oll o wi n g a d mi nistrati o n of i n vesti gati o nal pr o d uct (fe ver, na usea/ v o miti n g, 
diarr hea, hea dac he, fati g ue/tire d ness, m uscle pai n, a n d j o i nt pai n).

Pr o p orti o ns of mater nal partici pa nt s re p orti n g A Es t hr o u g h 1 m o nt h after 
a d mi nistrati o n of i n vesti gati o nal pr o d uct.

Pr o p orti o ns of mater nal partici pa nt s wit h S A Es, M A Es, a n d o bstetric c o m plicati o ns 
( pre part u m, i ntra part u m, a n d p ost part u m) t hr o u gh o ut t he st u d y  ( Visit 1 t hr o u g h t he 
1 2- m o nt h p ost deli ver y  st u d y visit).

Pr o p orti o ns of mater nal partici pa nt s wit h eac h deli ver y o utc o me (li ve birt h, deli ver y 
m o de).
Pri m ar y S afet y E n d p oi nts (I nf a nt P artici p a nt s): St a ges 2 a n d 3

Pr o p orti o ns of i nfa nt partic i pa nts wit h s pecific birt h o utc o mes.

Pr o p orti o ns of i nfa nt partici pa nt s wit h A Es fr o m birt h t o 6 wee ks of a ge.

Pr o p orti o ns of i nfa nt partici pa nt s wit h S A Es, A Es of s pecial i nterest ( maj or 
c o n ge nital a n o malies, de vel o p me ntal dela y , a n d s us pecte d or c o nfir me d G B S 
i nfecti o n), a n d M A Es t hr o u g h 1 2 m o nt hs of a ge.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 8
St u d y Desi g n
T his is a P hase 1/ 2, ra n d o mize d, place b o- c o ntr olle d, o bser ver - bli n de d trial t o e val uate 
t he safety, t olera bilit y , a n d i m m u n o ge nicity of a m ulti vale nt G B S vacci ne i n healt h y 
n o n pre g na nt w o me n a n d pre g na nt w o me n 1 8 t o 4 0 ye ars of a ge a n d t heir i nfa nts.  A t otal of 
a p pr o xi matel y 6 2 2 partici pa nt s ( 6 6 n o n pre g na nt w o me n a n d 5 5 6 mater nal partici pa nt s a n d 
t heir i nfa nts) will be e nr olle d i n t his st u d y.
St a ge 1
N o n pre g na nt w o me n i n g o o d healt h will be scree ne d, e nr olle d, a n d ra n d o mize d i n a 
1: 1: 1 rati o (a p pr o xi matel y 2 2 partici pa nt s e nr olle d/ gr o u p) t o recei ve place b o (sali ne c o ntr ol) 
or G B S 6 ( 2 0 µ g C P S/ser ot y pe/ d ose) wit h or wit h o ut Al P O 4.  Partici pa nt s will ha ve bl o o d 
dra w n pri or t o vacci nati o n ( Visit 1), 2 wee ks after vacci nati o n ( Visit 2), a n d 1 m o nt h after 
vacci nati o n ( Visit 3).  Electr o nic diaries (e - diaries) will be use d t o c ollect pr o m pte d l ocal 
reacti o n a n d sys te mic e ve nt data f or 7 d a y s after vacci nati o n.  A Es will be c ollecte d t hr o u g h 
1 m o nt h after vacci nati o n ( Visit 3).  I n a d diti o n, M A Es a n d S A Es will be c ollecte d fr o m 
scree ni n g t hr o u g h 6 m o nt hs after vacci nati o n ( Visit 4).
A Pfizer I R C a n d a n e xter nal data m o nit ori n g c o m mittee ( E D M C) will re vie w t he 1 -m o nt h 
p ost vacci nati o n safet y  data ( u n bli n de d) fr o m Sta ge 1 a n d t he 1 -m o nt h safet y a n d 
i m m u n o ge nicity data of t he vari o us G B S 6 f or m ulati o ns fr o m t he FI H P hase 1/ 2 st u d y bef ore 
pr o gressi o n i nt o Sta ge 2.
If a d ose le vel or f or m ulati o n d oes n ot de m o nstrate t he e x pecte d 1-m o nt h i m m u n o ge nicit y 
i n t he FI H P hase 1/ 2 st u d y ( C 1 0 9 1 0 0 1) or acce pta ble safety pr ofile i n Sta ge 1 of t his 
P hase 1/ 2 st u d y, t hat d ose le vel or f or m ulati o n will n ot be e val uate d i n Sta ge 2.
T he st u d y  will pr ocee d t o Sta ge 2 at t he discreti o n of t he IR C i n c o ns ultati o n wit h t he 
E D M C.
Sta ge 1 partici pa nt s ( n o n pre g na nt w o me n) willi n g a n d eli gi ble t o partici pate will ret ur n 
t o recei ve a b o oster d ose of G B S 6 a p pr o xi matel y 2 years after t he pri mar y d ose of 
i n vesti gati o nal pr o d uct. Partici pa nts will ha ve bl o o d dra w n at t he pre b o oster scree ni n g visit 
( Visit 5), pri or t o t he b o oster vacci nati o n ( Visit 6), 1 m o nt h after t he b o oster vacci nati o n 
( Visit 7), 3 m o nt hs after t he b o oster vacci nati o n ( Visit 8), 6 m o nt hs after t he b o oster 
vacci nati o n ( Visit 9) , a n d at t he bl o o d dra w f oll o w-u p visi t after t he b o oster vacci nati o n 
( Visit 1 0).
E- diaries will be use d t o c ollect pr o m pte d l ocal reacti o n a n d sys te mic e ve nt data 
f or 7 da ys after t he b o oster vacci nati o n. A Es will be c ollecte d t hr o u g h 1 m o nt h after 
vacci nati o n ( Visit 7). I n a d diti o n, M A Es a n d S A Es will be c ollecte d fr o m t he b o oster 
vacci nati o n visit ( Visit 6) t hr o u g h a p pr o xi matel y 7 t o 1 2 m o nt hs after t he b o oster vacci nati o n 
( Visit 1 0 ).
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 9
St a ge 2
A p pr o xi matel y  3 6 0 pre g na nt w o me n ( o nce c o nse nte d will be referre d t o as “ mater nal 
partici pa nt s”) will be scree ne d f or ge neral healt h, healt h of t he pre g na nc y, a n d gestati o nal 
a ge.  Sta ge 2 will utilize a se nti nel-c o h ort desi g n, wit h c o h ort pr o gressi o n a n d d ose escalati o n 
ta ki n g place after a safet y re vie w ( data fr o m eac h mater nal par tici pa nt t hr o u g h 1 4 d a y s after 
vacci nati o n) of t he se nti nel c o h ort of partici pa nt s at eac h d ose le vel.  T he first 4 2 eli gi ble 
mater nal partici pa nt s at eac h d ose le vel will be referre d t o as t he se nti nel c o h ort.  Starti n g 
wit h t he l o west d ose le vel, mater na l partici pa nt s will be ra n d o ml y assi g ne d (i n a 1: 1: 1 rati o, 
1 4 partici pa nt s per gr o u p) t o recei ve a si n gle d ose of G B S 6, f or m ulate d wit h or wit h o ut 
Al P O 4, or place b o (sali ne c o ntr ol) wit hi n t he se nti nel c o h ort of a gi ve n d ose le vel.  T he 
e nr oll me nt rate i n t he se nti nel c o h ort will be li mite d t o a ma xi m u m of 5 partici pa nt s per da y.  
A re vie w of t he 1 4 -d a y  safety data i n a se nti nel c o h ort will be c o n d ucte d b y t he Pfizer I R C, 
a n d if dee me d acce pta ble, will tri g ger:

e nr oll me nt i n t he e x pa n de d c o h ort at t hat d os e le vel ( 1: 1: 1 rati o, 2 6 partici pa nt s per 
gr o u p), wit h n o pres pecifie d li mit o n dail y  e nr oll me nt u ntil a p pr o xi matel y 
7 8 a d diti o nal mater nal partici pa nt s are e nr olle d, a n d

e nr oll me nt i n t he se nti nel c o h ort f or t he ne xt hi g her d ose le vel.
E nr oll me nt will pr o cee d t his wa y i n a sta g gere d fas hi o n t hr o u g h t he hi g hest d ose le vel.
T his st u d y  will use st o p pi n g r ules f or t he se nti nel c o h ort, a n d 1 st o p pi n g r ule (seri o us, 
u ne x pecte d A E c o nsi dere d p ossi bl y  relate d t o vacci ne) will als o a p pl y t o t he 
e x pa n de d-c o h ort e nr oll me nt p hase.  St o p pi n g r ules (a n d t he decisi o n t o ter mi nate or restart at 
a gi ve n d ose le vel) ma y be a p plie d i n de pe n de ntl y f or eac h f or m ulati o n at t he discreti o n of t he 
Pfizer I R C i n c o nj u ncti o n wit h t he E D M C.  I t is p ossi ble t hat after a st o p pi n g r ule is met at a 
gi ve n d ose le vel, o ne f or m ulati o n ( wit h or wit h o ut Al P O 4) ma y pr ocee d w hile t he ot her ma y 
n ot.
T he I R C will meet after eac h i nteri m a nal ys is t o re vie w safety a n d i m m u n o ge nicit y data, a n d 
o n a n a d h oc a n d ti mel y  basis t o re vie w safety data if a st o p pi n g r ule is tri g gere d, a n d t o 
ma ke rec o m me n dati o ns f or t he st u d y .  I n a d diti o n, t he E D M C will meet f or re g ular re vie w of 
acc u m ulati n g safet y data a n d f or a d h oc re vie w if a st o p pi n g r ule is met.
At Visit 1, e -diaries will be use d t o c ollect s ys te mic e vent data at baseli ne as well as 
pr o m pte d l ocal reacti o n a n d s y ste mic e ve nt data f or 7 d a y s after vacci nati o n.  In mater nal 
partici pa nt s, t he i n vesti gat or a n d site staff will e ns ure t he acti ve elicitati o n a n d c ollecti o n of 
A Es a n d S A Es t hr o u g h Visit 3.  At 1 wee k f oll o wi n g deli ver y  ( Visit 5), t he partici pa nt will 
be c o ntacte d b y tele p h o ne t o i n q uire a b o ut M A Es a n d S A Es, i ncl u di n g h os pitalizati o ns, si nce 
Visit 3.  At all s u bse q ue nt visits ( Visits 6, 7, 8, a n d 9), o nl y  M A Es a n d S A Es, i ncl u di n g 
h os pitalizati o ns, will be re p orte d.  I n a d diti o n, A Es occ urri n g u p t o 4 8 h o urs after t he Visit 4,
Visit 6 , a n d Visit 9 bl o o d dra ws t hat are relate d t o st u d y  pr oce d ures will als o be re p orte d.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 0
F or i nfa nt partici pa nt s, t he i n vesti gat or a n d site staff will e ns ure t he acti ve elicitati o n a n d 
c ollecti o n of A Es a n d S A Es fr o m birt h ( Visit 1) t hr o u g h Visit 3.  At s u bse q ue nt visits 
( Visits 4, 5, 6, a n d 7), o nl y A Es of s pecial i nterest, M A Es, a n d S A Es, i ncl u di n g 
h os pitalizati o ns, will be re p orte d.  I n a d diti o n, A Es occ urri n g u p t o 4 8 h o urs after t he 
Visit 4, 5, a n d 7 bl o o d dra ws a n d u p t o 4 8 h o urs after t he Visit 4 
 sa m ples 
t hat are relate d t o st u dy pr oce d ures will be re p orte d.
I n mater nal partici pa nt s, bl o o d sa m ples f or i m m u n o ge nicit y assess me nts will be ta ke n at 
D a y 1 ( Visit 1), 2 wee ks ( Visit 2) a n d 1 m o nt h ( Visit 3) after vacci nati o n, at deli ver y  
( Visit 4) ( bl o o d ma y  be c ollecte d fr o m mater nal partici pa nts u p t o 7 2 h o urs after deli ver y ), 
a n d 6 wee ks ( Visit 6) a n d 1 2 m o nt hs ( Visit 9) after deli ver y .
I n i nfa nt par tici pa nts, c or d bl o o d will be c ollecte d at deli ver y ( bl o o d ma y be c ollecte d i n t he 
i nfa nt partici pa nt s u p t o 7 2 h o urs after deli ver y  if c or d bl o o d is u na vaila ble) ( Visit 1) a n d 
bl o o d will be dra w n at 6 a n d 1 4 wee ks of a ge ( Visits 3 a n d 4) f or G B S 6 a nti b o d y
assess me nts. 
 
 
 
 
W he n all Sta ge 2 se nti nel -c o h ort mater nal partici pa nt s a n d t heir i nfa nt partici pa nt s ha ve 
c o m plete d t he deli ver y/ birt h visit, safet y a n d i m m u n o ge nicit y data will be u n bli n de d a n d 
re vie we d, w he n a vaila ble, b y t he I R C f or Pfizer i nf or mati o nal a n d pla n ni n g p ur p oses.
W he n all Sta ge 2
mater nal partici pa nt s a n d t heir i nfa nt partici pa nt s ha ve c o m plete d t he 
deli ver y / birt h visit, safet y a n d i m m u n o ge nicity data will be u n bli n de d b y gr o u p, w he n 
a vaila ble, a n d a nal yz e d a n d re vie we d b y t he Pfizer I R C.  T he fi nal G B S 6 d ose a n d 
f or m ulati o n t o ta ke i nt o Sta ge 3 a n d f urt her de vel o p me nt will be selecte d after t his re vie w.
St a ge 3
A p pr o xi matel y  2 1 6 a d diti o nal mater nal partici pa nt s will be e nr olle d i n Sta ge 3
(a p pr o xi matel y 1 6 2 fr o m S o ut h Africa/ U K a n d 5 4 fr o m t he U S) t o recei ve a si n gle 
d ose/f or m ulati o n of t he selecte d G B S 6 or place b o (sali ne c o ntr ol) i n a 1: 1 rati o. E nr oll me nt 
will be m o nit ore d t o hel p e ns ure distri b uti o n of vacci nati o n acr oss t he gestati o nal a ge ra n ge 
of ≥2 4 0/ 7 t o ≤3 5 6/ 7 wee ks.   T here will be n o d ose escalati o n, n o se nti nel c o h orts, a n d n o 
pla n ne d st o p pi n g r ules.  T he visit sc he d ule, f oll o w -u p, a n d assess me nts f or mater nal 
partici pa nt s a n d t heir i nfa nt partici pa nt s will be si milar t o Sta ge 2.  T he a d diti o nal data fr o m 
Sta ge 3 will c o ntri b ute t o t he safet y data base of mater nal partici pa nt s t o s u p p ort t he desi g n 
t he P hase 3 pr o gra m.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 1
W he n Sta ge 3 mater nal partici pa nt s a n d t heir i nfa nt partici pa nt s ha ve c o m plete d t he 
deli ver y / birt h visit, safet y a n d i m m u n o ge nicity data will be u n bli n de d b y gr o u p, w he n 
a vaila ble, a n d a nal yz e d a n d re vie we d b y t he Pfizer I R C.
I n vesti g ati o n al Pr o d ucts
T he i n vesti gati o nal pr o d ucts are G B S 6, c o m p ose d of C P S of ser ot y pes Ia, Ib, II, III, I V, a n d 
V, i n di vi d uall y  c o nj u gate d t o C R M1 9 7 at d ose le vels of 
µ g C P S/ser ot y pe/ d ose, 
f or m ulate d wit h or wit h o ut Al P O4, or place b o (sali ne c o ntr ol).  At Visit 1, i nvesti gati o nal 
pr o d uct will be a d mi nistere d i ntra m usc ularl y  b y 
, 
prefera bl y of t he n o n d o mi na nt ar m.
St atistic al Met h o ds
Statistical a nal y ses will be descri pti ve i n nat ure.  All safety a n d i m m u n o ge nicit y  data will be 
anal yz e d se paratel y f or n o n pre g na nt w o me n ( Sta ge 1), mater nal partici pa nt s ( Sta ge 2 a n d 
Sta ge 3), a n d t heir i nfa nt partici pa nt s ( Sta ge 2 a n d Sta ge 3).  Safet y a n d i m m u n o ge nicit y data 
fr o m mater nal a n d i nfa nt partici pa nt s i n Sta ge 2 a n d Sta ge 3 will be a nal y ze d se paratel y.
Descri pti ve s u m mar y  statistics will be pr o vi de d f or all data.  F or c o nti n u o us o utc o mes, t he 
s u m mar y statistics i ncl u de n u m ber of partici pa nt s, mea n, sta n dar d de viati o n, me dia n, 
mi ni m u m , a n d ma xi m u m, a n d 2 -si de d 9 5 % c o nfi de nce i nter vals ( CIs) f or t he mea n, as 
nee de d.  F or cate g orical o utc o mes, n u m ber a n d perce nta ge of partici pa nt s i n eac h cate g or y 
a n d 2-si de d 9 5 % CI will be pr o vi de d.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 2
1. 2. Sc he d ule of Acti vities
T he sc he d ule of acti vities 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  Pr oce d ures (Secti o n 7 ) 
a n d Assess me nts (Secti o n 8 ) secti o ns of t he pr ot oc ol f or detaile d i nf or mati o n o n eac h pr oce d ure a n d assess me nt re q uire d f or 
c o m plia nce wit h t he pr ot oc ol.
T he i n vesti gat or ma y  sc he d ule visits ( u n pla n ne d visits) i n a d diti o n t o t h ose liste d o n t he sc he d ule of acti vities 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 .
St a ge 1 – Sc he d ule of Acti vities f or N o n pre g n a nt W o me n
Visit N u m ber
0
1
2
3
4
5
6
7
8
9
1 0
Visit Descri pti o n
Scree ni n g
V acci n ati o n
2- Wee k 
F oll o w - Up 
Visit
1- M o nt h 
F oll o w - Up 
Visit
6- M o nt h 
F oll o w - Up 
Tele p h o ne 
C o nt act
Pre b o oster 
Scree ni n g
B o oster 
V acci n ati o n
1- M o nt h 
B o oster 
V acci n ati o n 
F oll o w - Up 
Visit
3- M o nt h 
B o oster 
V acci n ati o n 
F oll o w - Up 
Visit
6- M o nt h 
B o oster 
V acci n ati o n 
F oll o w - Up 
Visit
Bl o o d 
D r a w
F oll o w -
U p V isit
Visit Wi n d o w ( D a ys) a
D a y - 7 t o 
D a y - 2
Pri or t o 
D a y 1
D a y 1
1 4 -1 7 D a ys 
After Visit 
1
2 8 -4 2 D a ys 
After 
Visit 1
1 6 0 - 2 0 0 D a ys 
After Visit 1
D a y - 7 t o 
D a y - 2
Pri or t o 
Visit 6
~ 2 Ye ars 
After Visit 
1
2 8 -4 2 D a ys 
After Visit 
6
8 4 -1 2 6 D a ys 
After Visit 
6
1 6 0 -2 0 0 D a ys 
After Visit 6
1 4 - 1 8 4
D a ys 
After 
V isit 9
I nf or me d co nse nt
X
X b
X b
De m o gra p h y
X
Me dical hist or y
X
X c
Vital si g ns d
X  
X
X
Meas ure oral te m perat ure
X
P h ysical e xa mi nati o n
X
X
HI V, H B V, a n d H C V testi n g 
( ~ 5-m L bl o o d sa m ple)
X
X
Uri ne pre g na nc y test
X
X
Rec or d n o nst u d y vacci ne 
i nf or mati o n
X  
X  
X  
X
X  
X  
X
Rec or d c o nc o mita nt 
me dicati o n
X  
X  
X  
X  
X e
X  
X  
X  
X e
X e
X e
Re vie w i ncl usi o n a n d 
e xcl usi o n criteria
X
X
Re vie w scree ni n g la b orat or y 
res ults
X
X
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 3
St a ge 1 – Sc he d ule of Acti vities f or N o n pre g n a nt W o me n
Visit N u m ber
0
1
2
3
4
5
6
7
8
9
1 0
Visit Descri pti o n
Scree ni n g
V acci n ati o n
2- Wee k 
F oll o w - Up 
Visit
1- M o nt h 
F oll o w - Up 
Visit
6- M o nt h 
F oll o w - Up 
Tele p h o ne 
C o nt act
Pre b o oster 
Scree ni n g
B o oster 
V acci n ati o n
1- M o nt h 
B o oster 
V acci n ati o n 
F oll o w - Up 
Visit
3- M o nt h 
B o oster 
V acci n ati o n 
F oll o w - Up 
Visit
6- M o nt h 
B o oster 
V acci n ati o n 
F oll o w - Up 
Visit
Bl o o d 
D r a w
F oll o w -
U p V isit
Visit Wi n d o w ( D a ys) a
D a y - 7 t o 
D a y - 2
Pri or t o 
D a y 1
D a y 1
1 4 -1 7 D a ys 
After Visit 
1
2 8 -4 2 D a ys 
After 
Visit 1
1 6 0 - 2 0 0 D a ys 
After Visit 1
D a y - 7 t o 
D a y - 2
Pri or t o 
Visit 6
~ 2 Ye ars 
After Visit 
1
2 8 -4 2 D a ys 
After Visit 
6
8 4 -1 2 6 D a ys 
After Visit 
6
1 6 0 -2 0 0 D a ys 
After Visit 6
1 4 - 1 8 4
D a ys 
After 
V isit 9
C o ntrace pti o n c hec k f
X  
X  
X  
X
X  
X  
X
X  
X
Re vie w te m p orar y dela y 
criteria
X
X
Re vie w c o nti n ue d eli gi bilit y
X  
X  
X
X  
X  
X  
X
X  
X
Assi g n si n gle partici pa nt
i de ntifier
X
Assi g n partici pa nt
ra n d o mizati o n a n d c o ntai ner 
n u m ber
X
Assi g n c o ntai ner n u m ber
X
Bl o o d dra w ( ~ 1 5 m L per 
bl o o d sa m ple) f or 
i m m u n o ge nicit y assess me nt
X  
X  
X
X  
X  
X
X
Lar ge v ol u me bl o o d dra w f or 
de vel o p me nt of a u ni versal 
G B S vacci ne refere nce 
sta n dar d assa y
2 5 m L
1 2 5 m L
1 2 5 m L
1 2 5 m L
1 2 5 m L
1 2 5 m L
A d mi nister i n vesti gati o nal 
pr o d uct
X
X
P ost vacci nati o n o bser vati o n 
( 3 0 mi n utes) a n d assess me nt 
of i m me diate a d verse e ve nts
X
X
Dis pe nse e -diar y, 
t her m o meter, a n d meas uri n g 
de vice h
X
X
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 4
St a ge 1 – Sc he d ule of Acti vities f or N o n pre g n a nt W o me n
Visit N u m ber
0
1
2
3
4
5
6
7
8
9
1 0
Visit Descri pti o n
Scree ni n g
V acci n ati o n
2- Wee k 
F oll o w - Up 
Visit
1- M o nt h 
F oll o w - Up 
Visit
6- M o nt h 
F oll o w - Up 
Tele p h o ne 
C o nt act
Pre b o oster 
Scree ni n g
B o oster 
V acci n ati o n
1- M o nt h 
B o oster 
V acci n ati o n 
F oll o w - Up 
Visit
3- M o nt h 
B o oster 
V acci n ati o n 
F oll o w - Up 
Visit
6- M o nt h 
B o oster 
V acci n ati o n 
F oll o w - Up 
Visit
Bl o o d 
D r a w
F oll o w -
U p V isit
Visit Wi n d o w ( D a ys) a
D a y - 7 t o 
D a y - 2
Pri or t o 
D a y 1
D a y 1
1 4 -1 7 D a ys 
After Visit 
1
2 8 -4 2 D a ys 
After 
Visit 1
1 6 0 - 2 0 0 D a ys 
After Visit 1
D a y - 7 t o 
D a y - 2
Pri or t o 
Visit 6
~ 2 Ye ars 
After Visit 
1
2 8 -4 2 D a ys 
After Visit 
6
8 4 -1 2 6 D a ys 
After Visit 
6
1 6 0 -2 0 0 D a ys 
After Visit 6
1 4 - 1 8 4
D a ys 
After 
V isit 9
Re vie w a n d/ or c ollect e -diar y i
X  
X
X  
X
Rec or d a d verse e ve nts
X  
X  
X  
X
X  
X  
X
Rec or d me dicall y atte n de d 
a d verse e ve nts a n d seri o us 
a d verse e ve nts
X  
X  
X  
X  
X  
X  
X  
X  
X
X  
X
A b bre viati o ns: e -diar y = electr o nic diar y; G B S = gr o u p B stre pt oc occ us; H B V = he patitis B vir us; H C V = he patitis C vir us; HI V = h u ma n i m m u n o de ficie nc y vir us.
a.
Da y relati ve t o t he start of st u d y vacci nati o n ( Da y 1).
b.
O btai n writte n i nf or me d c o nse nt bef ore perf or mi n g a n y st u d y -s pecific pr oce d ures.
c.
Rec or d t he prese nce of c hr o nic c o n diti o ns a n d/ or me dical hist or y of si g nifica nce, i ncl u di n g rele va nt s ur gical pr oce d ures, t ha t ha ve bee n dia g n ose d si nce Visit 1.
d.
Vital si g ns i ncl u de wei g ht, hei g ht, oral te m perat ure, sitti n g bl o o d press ure a n d p ulse rate, a n d res pirat or y rate.
e.
O nl y c o nc o mita nt me dicati o n ta ke n t o treat a n a d verse e ve nt will be rec or de d i n t he case re p ort f or m.
f.
T he c o n trace pti o n c hec k is a n o p p ort u nit y t o c o nfir m t hat c o ntrace pti o n was/is use d c o nsiste ntl y a n d c orrectl y.
h.
Partici pa nt s will rec or d react o ge nicit y e ve nts i n a n e- diar y wit hi n a fi xe d ti me wi n d o w eac h da y f or 7 da ys f o ll o wi n g vacci nati o n.  Re mi n d partici pa nt s t hat st u d y staff ma y 
c o ntact t he m 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.  As k partici pa nt s t o c o ntact t he i n vesti gat or or site staff i m me diatel y if t he y are 
pr o m pte d b y t he e - diar y fr o m Da y 1 t o Da y 7 f oll o wi n g vacci nati o n t o deter mi ne if a n u nsc he d ule d visit is re q uire d.
i.
Desi g nate d site staff will re vie w e- diar y data o nli ne at fre q ue nt i nter vals f or t he 7 da ys f oll o wi n g vacci nati o n t o e val uate partici pa nt c o m plia nce a n d as p art of t he o n g oi n g 
safet y re vie w.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 5
St a ges 2 a n d 3 – Sc he d ule of Acti vities f or M ater n al P artici p a nt s
Visit N u m ber
0
1
2 a
3 a
4
5
6
7
8
9
Visit Descri pti o n
Scree ni n g b V acci n ati o n
2- Wee k 
F oll o w - Up 
Visit b
1- M o nt h 
F oll o w - Up 
Visit
Deli ver y
1- Wee k 
P ost deli v. 
F oll o w - U p
6- Wee k 
P ost deli v. 
F oll o w - U p
1 4 -Wee k 
P ost deli v. 
F oll o w - U p
6- M o nt h 
P ost deli v. 
F oll o w - U p
1 2 -M o nt h 
P ost deli v. 
F oll o w - U p
Visit Wi n d o w ( D a ys)
D a y -1 4 t o 
D a y - 2 Pri
or t o D a y 
1
D a y 1
1 4 -1 7
D a ys After 
Visit 1
2 8 -4 2
D a ys After 
Visit 1
V aries
7- 1 0 D a ys 
After 
Visit 4
3 5 -4 9 D a ys 
After Visit 4
8 0 - 1 0 0 D a ys 
After Visit 4
1 6 0 -2 0 0 D a ys 
After Visit 4
3 6 5 -3 8 5 D a ys 
After Visit 4
T y pe of Visit
Cli nic
Cli nic
Cli nic
Cli nic
H os pit al
P h o ne C all
Cli nic
Cli nic
P h o ne C all
Cli nic
I nf or me d c o nse nt
X
De m o gra p h y
X
Rec or d c urre nt alc o h ol a n d 
t o bacc o usa ge
X
Me dical hist or y i ncl u di n g 
o bstetric a n d gestati o nal hist or y
X
Rec or d L M P a n d E D D
X
Vital si g ns c
X  
X  
X  
X
P h ysical e xa mi nati o n
X
Tar gete d p h ysical e xa mi nati o n
X  
X  
X
X
O bstetric e xa mi nati o n
X  
X  
X  
X
O bstetric ultras o u n d
X
Rec or d n o nst u d y vacci ne 
i nf or mati o n
X  
X  
X  
X  
X
Rec or d c o nc o mita nt me dicati o n
X  
X  
X  
X  
X d
X d
X d
X d
X d
X d
Rec or d use of a nti bi otic 
me dicati o n
X  
X  
X  
X  
X  
X
X
X
X
X
Re vie w eli gi bilit y criteria
X
Re vie w scree ni n g la b orat or y 
res ults
X
Re vie w te m p orar y dela y criteria
X
Re vie w c o nti n ue d eli gi bilit y
X  
X  
X  
X  
X
X
X
X
X
Rec or d s yste mic e ve nts at 
baseli ne i n t he e -diar y
X
Assi g n si n gle partici pa nt
i de ntifier
X
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 6
St a ges 2 a n d 3 – Sc he d ule of Acti vities f or M ater n al P artici p a nt s
Visit N u m ber
0
1
2 a
3 a
4
5
6
7
8
9
Visit Descri pti o n
Scree ni n g b V acci n ati o n
2- Wee k 
F oll o w - Up 
Visit b
1- M o nt h 
F oll o w - Up 
Visit
Deli ver y
1- Wee k 
P ost deli v. 
F oll o w - U p
6- Wee k 
P ost deli v. 
F oll o w - U p
1 4 -Wee k 
P ost deli v. 
F oll o w - U p
6- M o nt h 
P ost deli v. 
F oll o w - U p
1 2 -M o nt h 
P ost deli v. 
F oll o w - U p
Visit Wi n d o w ( D a ys)
D a y -1 4 t o 
D a y - 2 Pri
or t o D a y 
1
D a y 1
1 4 -1 7
D a ys After 
Visit 1
2 8 -4 2
D a ys After 
Visit 1
V aries
7- 1 0 D a ys 
After 
Visit 4
3 5 -4 9 D a ys 
After Visit 4
8 0 - 1 0 0 D a ys 
After Visit 4
1 6 0 -2 0 0 D a ys 
After Visit 4
3 6 5 -3 8 5 D a ys 
After Visit 4
T y pe of Visit
Cli nic
Cli nic
Cli nic
Cli nic
H os pit al
P h o ne C all
Cli nic
Cli nic
P h o ne C all
Cli nic
Assi g n partici pa nt
ra n d o mizati o n a n d c o ntai ner 
n u m ber
X
Bl o o d dra w f or i m m u n o ge nicit y 
assess me nt ( ~ 1 5 m L per bl o o d 
sa m ple)
X  
X  
X
X f
X
X
A d mi nister i n vesti gati o nal 
pr o d uct
X
P ost vacci nati o n o bser vati o n 
( 3 0 mi n utes) a n d assess me nt of 
i m me diate a d verse e ve nts
X
Dis pe nse e -diar y, t her m o meter, 
a n d meas uri n g de vice g
X
Re vie w a n d/ or c ollect e -diar y h
X  
X
Rec or d pre g na nc y o utc o me 
i nf or mati o n
X
Rec or d a d verse e ve nts
X  
X  
X  
X
X i
X i
X i
Rec or d me dicall y atte n de d 
a d verse e ve nts a n d seri o us 
a d verse e ve nts
X  
X  
X  
X  
X  
X
X
X
X
X
Bl o o d dra w f or H B V, H C V, 
HI V, a n d s y p hilis testi n g 
(~ 1 0 m L)
X
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 7
St a ges 2 a n d 3 – Sc he d ule of Acti vities f or M ater n al P artici p a nt s
Visit N u m ber
0
1
2 a
3 a
4
5
6
7
8
9
Visit Descri pti o n
Scree ni n g b V acci n ati o n
2- Wee k 
F oll o w - Up 
Visit b
1- M o nt h 
F oll o w - Up 
Visit
Deli ver y
1- Wee k 
P ost deli v. 
F oll o w - U p
6- Wee k 
P ost deli v. 
F oll o w - U p
1 4 -Wee k 
P ost deli v. 
F oll o w - U p
6- M o nt h 
P ost deli v. 
F oll o w - U p
1 2 -M o nt h 
P ost deli v. 
F oll o w - U p
Visit Wi n d o w ( D a ys)
D a y -1 4 t o 
D a y - 2 Pri
or t o D a y 
1
D a y 1
1 4 -1 7
D a ys After 
Visit 1
2 8 -4 2
D a ys After 
Visit 1
V aries
7- 1 0 D a ys 
After 
Visit 4
3 5 -4 9 D a ys 
After Visit 4
8 0 - 1 0 0 D a ys 
After Visit 4
1 6 0 -2 0 0 D a ys 
After Visit 4
3 6 5 -3 8 5 D a ys 
After Visit 4
T y pe of Visit
Cli nic
Cli nic
Cli nic
Cli nic
H os pit al
P h o ne C all
Cli nic
Cli nic
P h o ne C all
Cli nic
Bl o o d dra w ( ~ 1 0 m L) f or 
he mat ol o g y a n d c he mistr y 
assess me nts ( St a ge 2 se nti nel 
c o h ort o nl y )e
X
X
Uri ne sa m ple f or gl uc ose a n d 
pr otei n testi n g
X  
X
A b bre viati o ns: E D D = esti mate d date of deli ver y; e -diar y = electr o nic diar y; G B S = gr o u p B stre pt oc occ us; H B V = he patitis B vir us; H C V = he patitis C vir us; 
HI V = h u ma n i m m u n o deficie nc y vir us; L M P = last me nstr ual peri o d; P ost deli v. = p ost deli ver y; Vacc. = vacci nati o n.
N ote: If, beca use of a me dical sit uati o n (s uc h as disease o ut brea k or pa n de m ic), st u d y visits ca n n ot be c o n d ucte d i n pers o n at t he st u d y site, visit pr oce d ures 
s h o ul d be c o n d ucte d re m otel y or via tele p h o ne, as is feasi ble.
a.
Visits at 2 w ee ks a n d 1 m o nt h after vacci nati o n will n ot be perf or me d if deli ver y occ urs bef ore t he visits.  I n t hat case, he mat ol o g y , a n d c he mistr y 
assess me nts d ue at t he 2 -wee k visit s h o ul d be c o n d ucte d at t he deli ver y visit.  O nce deli ver y occ urs, t he visit wi n d o ws are calc ulate d base d o n deli ver y date.
b.
If a b n or mal la b orat or y val ues (as defi ne d i n Scree ni n g, Secti o n 7. 2. 1 , a n d i n Secti o n 8. 5. 3 ) are re p orte d at Visit 0/ Visit 2 a n d t he i n vesti gat or belie ves t he 
res ults t o be err o ne ous, t he a b n or mal la b orat or y para meters ma y be reteste d.
c.
Vital si g ns i ncl u de wei g ht, hei g ht ( o nl y re q uire d at Visit 0), oral te m perat ure, sitti n g bl o o d press ure a n d p ulse rate, a n d r es pirator y rate.
d.
O nl y c o nc o mita nt me dicati o n ta ke n t o treat a n a d verse e ve nt w ill be rec or de d i n t he case re p ort f or m.
f.
Bl o o d sa m ple ma y be c ollecte d u p t o 7 2 h o urs after deli ver y.
g.
Partici pa nt s will pr o vi de (i n a n e-diar y) a baseli ne assess me nt of pr o m pte d s yste mic e ve nts pri or t o vacci nati o n a n d partici pa nt s will rec or d (i n a n e-diar y) 
react o ge nicit y e ve nts wit hi n a fi xe d ti me wi n d o w eac h da y f or 7 da ys f oll o wi n g vacci nati o n.  Re mi n d partici pa nt s t hat st u d y staff ma y c o ntact t he m 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.  As k partici pa nt s t o c o ntact t he i n vesti gat or or site staff i m me diatel y if t he y are 
pr o m pte d b y t he e -diar y fr o m Da y 1 t o Da y 7 f oll o wi n g vacci nati 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 7. 4 ).
h.
Desi g nate d site staff will re vie w e diar y data o nli ne at fre q ue nt i nter vals f o r t he 7 da ys f oll o wi n g vacci nati o n t o e val uate partici pa nt c o mplia nce a n d as part 
of t he o n g oi n g safet y re vie w.
i.
O nl y a d verse e ve nts occ urri n g u p t o 4 8 h o urs after eac h bl o o d dra w  t hat are relate d t o st u d y pr oce d ures m ust be rec or de d i n the case re p ort f or m.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 8
St a ges 2 a n d 3 – Sc he d ule of Acti vities f or I nf a nt P artici p a nt s
Visit N u m ber
1
2
3
4
5
6
7
E q ui v ale nt Visit N u m ber 
f or M ater n al P artici p a nt s
4
5
6
7
N/ A
8
9
Visit Descri pti o n
Deli ver y
1- Wee k 
P ost deli ver y 
F oll o w - U p
6- Wee k 
P ost deli ver y 
F oll o w - U p
1 4 -Wee k 
P ost deli ver y 
F oll o w - U p
1 8 -Wee k 
P ost deli ver y 
F oll o w - Up 
6- M o nt h 
P ost deli ver y 
F oll o w - U p
1 2 -M o nt h 
P ost deli ver y 
F oll o w - U p
Visit Wi n d o w ( D a ys)
V aries
7- 1 0 D a ys 
After Visit 1
3 5 -4 9 D a ys After 
Visit 1
8 0 - 1 0 0 D a ys After 
Visit 1
1 1 9 -1 3 3 D a ys After 
Visit 1
1 6 0 -2 0 0 D a ys 
After Visit 1
3 6 5 -3 8 5 D a ys After 
Visit 1
T y pe of Visit
H os pit al
P h o ne C all
Cli nic
Cli nic
Cli nic
P h o ne C all
Cli nic
Assi g n si n gle partici pa nt
i de ntifier
X
Rec or d de m o gra p h y a n d 
a vaila ble birt h i nf or mati o n 
(i ncl u di n g Ballar d sc ore)a
X
Vital si g ns b
X
X
X
X
X
P h ysical e xa mi nati o n
X
X
X
X
X
Rec or d c o nc o mita nt me dicati o n
X
X
X
X c
X c
X c
X c
Rec or d use of a nti bi otic 
me dicati o n
X
X
X
X
X
X
X
Rec or d n o nst u d y vacci ne 
i nf or mati o n
X
X
X
X
X
X
X
Re vie w c o nti n ue d eli gi bilit y
X
X
X
X
X
X
X
Rec or d breastfee di n g 
i nf or mati o n
X
X
X
X
X
X
Bl o o d dra w ( ~ 5 m L per bl o o d 
sa m ple)d
X
X
X
X
Bl o o d dra w U S a n d U K Sta ge 3 
partici pa nts ( ~ 5 m L per bl o o d 
sa m ple)d
X
X
C or d bl o o d sa m ple e
( ~ 1 0 m L) d f or i m m u n o ge nicit y 
assess me nt
X
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Mar c h 2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 2 9
St a ges 2 a n d 3 – Sc he d ule of Acti vities f or I nf a nt P artici p a nt s
Visit N u m ber
1
2
3
4
5
6
7
E q ui v ale nt Visit N u m ber 
f or M ater n al P artici p a nt s
4
5
6
7
N/ A
8
9
Visit Descri pti o n
Deli ver y
1- Wee k 
P ost deli ver y 
F oll o w - U p
6- Wee k 
P ost deli ver y 
F oll o w - U p
1 4 -Wee k 
P ost deli ver y 
F oll o w - U p
1 8 -Wee k 
P ost deli ver y 
F oll o w - Up 
6- M o nt h 
P ost deli ver y 
F oll o w - U p
1 2 -M o nt h 
P ost deli ver y 
F oll o w - U p
Visit Wi n d o w ( D a ys)
V aries
7- 1 0 D a ys 
After Visit 1
3 5 -4 9 D a ys After 
Visit 1
8 0 - 1 0 0 D a ys After 
Visit 1
1 1 9 -1 3 3 D a ys After 
Visit 1
1 6 0 -2 0 0 D a ys 
After Visit 1
3 6 5 -3 8 5 D a ys After 
Visit 1
T y pe of Visit
H os pit al
P h o ne C all
Cli nic
Cli nic
Cli nic
P h o ne C all
Cli nic
Bl o o d s p ot car d c ollecti o n f
X
Rec or d a d verse e ve nts
X
X
X
X g
X g
X g
Rec or d me dicall y atte n de d 
a d verse e ve nts, seri o us a d verse 
e ve nts, a n d a d verse e ve nts of 
s pecial i nterest
X
X
X
X
X
X
X
A b bre viati o ns: G B S = gr o u p B stre pt oc occ us; N/ A = n ot a p plica ble.
N ote: If, beca use of a me dical sit uati o n (s uc h as disease o ut brea k or pa n de mic), st u d y visits ca n n ot be c o n d ucte d i n pers o n a t t he st u d y site, visit pr oce d ures 
s h o ul d be c o n d ucte d re m otel y or via tele p h o ne, as is feasi ble.
a.
If t he Ballar d sc ore is u na vaila ble, it ma y be calc ulate d a n d rec or de d u p t o 7 2 h o urs after deli ver y.
b.
Vital si g ns i ncl u de wei g ht, hei g ht (le n gt h at Visit 1), hea d circ u mfere nce, a xillar y te m perat ure, p ulse rate, a n d res pirat or y rate.
c.
O nl y c o nc o mita nt me dicati o n ta ke n t o treat a n a d verse e ve nt w ill be rec or de d i n t he case re p ort f or m.
d.
All bl o o d v ol u mes are a p pr o xi mate.
e.
If c or d bl o o d is u na vaila ble, t he n a 2. 5-m L b l o o d sa m ple ma y be c ollecte d i n t he i nfa nt partici pa nt s u p t o 7 2 h o urs after deli ver y.
f.
Bl o o d s p ot car d c ollecti o n w ill be perf or me d usi n g c or d bl o o d sa m ple, or bl o o d dra w ( u p t o 7 2 h o urs after deli ver y) if c or d bl oo d u na vaila ble.
g.
O nl y a d verse e ve nts occ urri n g u p t o 4 8 h o urs after eac h bl o o d dra w /s wa b c ollecti o n t hat are relate d t o st u d y pr oce d ures m ust be rec or de d i n t he case re p ort 
f or m.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 0
2. I N T R O D U C TI O N
2. 1. I n dic ati o n
Gr o u p B stre pt oc occ us 6 -vale nt p ol y sacc hari de c o nj u gate vacci ne ( G B S 6) is bei n g de vel o pe d 
f or:

Acti ve i m m u nizati o n t o pre ve nt disease ca use d b y  gr o u p B stre pt oc occ us ( G B S) 
ser ot ypes c o ntai ne d i n t he vacci ne.
2. 2. B ac k gr o u n d a n d R ati o n ale
2. 2. 1. Dise ase O ver vie w
Stre pt oc occ us a g al acti ae , als o k n o w n as G B S, is a n e nca ps ulate d, gra m-p ositi ve c occ us t hat 
is ass ociate d wit h l o wer i ntesti nal a n d rect o va gi nal c ol o nizati o n.  T here are 1 0 ser ot ypes of 
G B S (Ia, I b, II, III, I V, V, VI, VII, VIII, a n d I X) differe ntiate d by t he p ol ys acc hari de 
c o m p ositi o n of t heir ca ps ules.  Alt h o u g h all G B S ser ot y pes ha ve bee n f o u n d t o ca use disease, 
6 ser ot ypes (Ia, I b, II, III,  IV, a n d V) ha ve bee n f o u n d t o ca use o ver 8 5 % of disease gl o ball y 
a n d 9 8 % i n S o ut h Africa, 1 b ut t here is varia bilit y  i n t heir gl o bal pre vale nce a n d vir ule nce.2 ,3  
G B S disease is m ost fre q ue ntl y  f o u n d i n t he ver y yo u n g — ne w b or ns a n d i nfa nts y o u n ger t ha n 
3 m o nt hs of a ge — a n d t he el derl y, es peciall y ol der a d ults wit h c o m or bi d c o n diti o ns. 4 ,5 ,6  
H o we ver, disease d ue t o G B S has bee n re p orte d i n i n di vi d uals of all a ges, a n d pre g na nt 
w o me n ma y  be partic ularl y s usce pti ble t o G B S disease as well.7  A m o n g i nfa nts, G B S ma y  
ca use seri o us disease, i ncl u di n g se psis, me ni n gitis, a n d p ne u m o nia; less c o m m o n 
ma nifestati o ns i ncl u de s ki n a n d s oft tiss ue, b o ne, a n d j oi nt i nfecti o ns. 8  I n pre g na nt w o me n, 
G B S ma y  be ass ociate d wit h asce n di n g i nfecti o ns ra n gi n g fr o m relati vely be ni g n uri nar y  
tract i nfecti o ns t o c h ori oa m ni o nitis ( w hic h ma y res ult i n still birt h or preter m deli ver y) a n d 
p uer peral se psis ( w hic h ma y  be fatal).9  Bactere mia wit h o ut a f oc us, cell ulitis, b o ne a n d j oi nt 
i nfecti o ns, a n d uri nar y tract i nfecti o ns are c o m m o n disease ma nifestati o n of G B S i nfecti o n i n 
ol der n o n pr e g na nt a d ults. 5 ,1 0 ,1 1
2. 2. 2. G B S Dise ase i n I nf a nts a n d Pre g n a nt W o me n
G B S is a lea di n g ca use of i n vasi ve bacterial i nfecti o n i n y o u n g i nfa nts a n d a si g nifica nt ca use 
of i nfa nt m or bi dit y  a n d mortalit y  gl o ball y.5 ,1 2 ,1 3  T he U S Ce nters f or Disease C o ntr ol a n d 
Pre ve nti o n ( C D C) n otes t hat it is a lea di n g i nfecti o us ca use of m or bi dit y a n d m ortalit y i n 
i nfa nts i n t he U S.1 4  Seri o us G B S disease, i ncl u di n g se psis, me ni n gitis, a n d p ne u m o nia, is 
ass ociate d wit h m ortalit y rates of 6 % t o 1 4 % i n hi g h -i nc o me c o u ntries a n d 1 0 % t o 6 0 % i n 
l o w- a n d mi d dle-i nc o me c o u ntries ( L MI Cs).1 3 ,1 5 ,1 6 ,1 7  Of i nfa nts s ur vi vi n g G B S me ni n gitis, 
o ne st u d y  f o u n d mil d t o m o derate ne ur ol o gical se q uelae i n 2 5 %, a n d 1 9 % s uffere d se vere 
se q uelae, i ncl u di n g c o g niti ve dela y, cere bral palsy, bli n d ness, or heari n g l oss. 1 8  Fi ve 
ser ot ypes (Ia, I b, II, III, a n d V) are m ost f re q ue ntl y ass ociate d wit h G B S disease i n i nfa nts.  
A n ot her ser ot y p e (I V) s h o ws a tre n d of i ncrease d pre vale nce i n certai n re gi o ns. 5  G B S 
disease i n i nfa nts is ofte n classifie d as early -o nset disease ( E O D), w hic h occ urs wit hi n t he 
first wee k of life, a n d late-o nset disease ( L O D), w hic h occ urs bet wee n Da ys 7 a n d 9 0. 6  T he 
m ost c o m m o n cli nical s y n dr o me i n E O D is se psis/ bactere mia wit h o ut a f oc us, w hereas L O D 
is m ore li kel y t o be ass ociate d wit h a f oc us,4 ,6 ,1 5 wit h me ni n gitis bei n g m ore c o m m o n i n L O D 
( 2 1 %-5 9 % of L O D cases). 4 ,6 ,1 5
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 1
A d diti o nall y , ser oty pe III a p pears t o be a relati vel y pr o mi ne nt ca use of L O D (ca usi n g 
5 1 %- 6 7 % of L O D), 4 ,6 ,1 5 w hereas t here a p pears t o be greater di versit y of ser ot y pes ca usi n g 
E O D.
T he re p orte d b ur de n of i nfa nt G B S disease varies gl o ball y a n d is i nfl ue nce d b y t he i nte nsity 
of t he e pi de mi ol o g y  s ur veilla nce f or t he or ga nis m, as well as b y t he fre q ue nc y of healt hcare 
i nteracti o n.  T his ma y t heref ore lea d t o t he p ote ntial f or u n derre p orti n g, a n d u n der use of 
i ntra part u m a nti bi otic pr o p h yla xis (I A P) t o pre ve nt G B S disease.1  I n re gi o ns, s uc h as t he 
U S, w here t here are si g nifica nt eff orts a n d res o urces all ocate d f or u ni versal G B S scree ni n g 
of pre g na nt w o me n a n d use of I A P t o pre ve nt G B S disease, it is n ota ble t hat t he n u m ber of 
cases of E O D decrease d fr o m a hi g h of 1. 7 cases/ 1 0 0 0 li ve birt hs si nce t he early 1 9 9 0s w he n 
rec o m me n dati o ns f or pre ve nti o n were i ntr o d uce d t o 0. 2 1 cases/ 1 0 0 0 li ve birt hs i n 2 0 1 4.1 9 ,2 0  
Des pite decli nes i n pe diatric bacterial me ni n gitis cases i n t he U S bet wee n 2 0 0 3 a n d 2 0 0 7, t he 
i nci de nce i n c hil dre n 2 m o nt hs of a ge was u nc ha n ge d.  T his refl ects t he persiste nce of G B S 
L O D, w hic h is t he pri mar y  ca use of bacterial me ni n gitis i n t hat a ge gr o u p.2 1  T he i nci de nce 
was 0. 3 2 cases/ 1 0 0 0 li ve birt hs i n 2 0 1 5.2 0
S o me of t he hi g hest rates of G B S disease a n d hi g hest case fatalit y  rates are f o u n d i n i nfa nt 
p o p ulati o ns i n Africa. 1 ,1 2  S ur veilla nce c o n d ucte d i n S o ut h Africa i n 3 sec o n dar y/ tertiar y 
h os pitals i n J o ha n nes b ur g fr o m N o ve m ber 2 0 1 2 t o Fe br uar y 2 0 1 4 f o u n d t he rate of i nfa nt 
i n vasi ve G B S disease t o be 2. 3 8 cases/ 1 0 0 0 birt hs. 1 5  H u ma n i m m u n o deficie nc y vir us 
( HI V)-e x p ose d i nfa nts ha d a hi g her rate c o m pare d t o u ne x p ose d i nfa nts.  T he o verall case 
fatalit y rate of G B S disease was 1 8 %, a n d m ost deat hs occ urre d wit hi n 4 8 h o urs of 
h os pitalizati o n or birt h.  Me ni n gitis was part of t he cli nical sy n dr o me i n 3 0 % of s ur vi vi n g 
i nfa nts.  F oll o w-u p scree ni n g i n t he st u d y  f o u n d ne ur ol o gical a b n or malities at 3 m o nt hs of 
a ge i n 1 3 % of t he i nfa nts w h o rec o vere d fr o m G B S disease. 1 5  G B S has als o bee n i m plicate d 
as a ca use of still birt h i n c o u ntries wit h fe w res o urces ( u p t o a p pr o xi matel y  1 2 % s u g geste d 
i n o ne re vie w); e val uati o n of G B S as a c o ntri b uti n g fact or i n still birt h is a n acti ve area of 
researc h.2 2  T he rates of G B S disease i n ot her Africa n nati o ns ha ve bee n esti mate d at 
1. 3/ 1 0 0 0 li ve birt hs ( Ga m bia i n 2 0 1 6)2 3 a n d 1. 8/ 1 0 0 0 li ve birt hs ( Mala wi i n 2 0 0 7).2 4  
Beca us e of t he b ur de n of disease a n d its p ote ntiall y  de vastati n g se q uelae, G B S i nfecti o n 
re mai ns a n i m p orta nt p u blic healt h tar get.
G B S disease i n pre g na nt a n d p ost part u m w o me n d oes n ot a p pear t o ha ve bee n re d uce d 
t hr o u g h t he i ntr o d ucti o n of I A P i n t he U S,1 4 as ma y be e x pecte d gi ve n t he s h ort c o urse of 
a d mi nistrati o n d uri n g t he i ntra part u m peri o d o nl y.   In S o ut h Africa, I A P practices var y  
acr oss t he c o u ntr y a n d cases of ne o natal se psis are ge nerall y ma na ge d at sec o n dar y  h os pitals 
i n eac h pr o vi nce.  I A P is n ot base d o n scree ni n g of pre g na nt w o me n t o i de ntif y rect o va gi nal 
c ol o nizati o n at 3 5 t o 3 7 wee ks of gestati o nal a ge ( G A), a n d f or mal g ui deli nes usi n g a cli nical 
ris k- base d a p pr oac h are i m ple me nte d i n s o me i nstit uti o ns (e g, C hris Ha ni Bara g wa nat h 
H os pital i n S o wet o), b ut n ot at ot her i nstit uti o ns.  T he i m pact of I A P o n G B S disease i n 
S o ut h Africa is t heref ore diffic ult t o assess. 2 5
I n ot her c o u ntries, s uc h as i n certai n E ur o pea n c o u ntries, w here i nter ve nti o ns are less wi dely 
use d or a ris k -base d a p pr oac h is use d, t he tre n d i n i nci de nce rates ma y  be u nc han ge d or 
i ncreasi n g sli g htly. 6 ,2 6  Neit her a p pr oac h has eli mi nate d G B S disease i n i nfa nts.   
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 2
F urt her m ore, ma n y c o u ntries ar o u n d t he w orl d d o n ot ha ve t he res o urces t o i m ple me nt I A P.  
E ve n wit h p ote ntial u n derre p orti n g, t he hi g hest rates of G B S disease are f o u n d i n 
L M I Cs,1 5 w here healt hcare access a n d sta n dar ds of pre natal care ma y  var y, or t he res o urces 
f or si g nifica nt pre ve nti ve i nter ve nti o ns are n ot a vaila ble.
2. 2. 3. R ati o n ale f or De vel o p me nt of G B S 6
2. 2. 3. 1. M ater n al
I m m u niz ati o n as a n A p pr o ac h t o Pre ve nt Dise ase i n I nf a nts a n d 
Pre g n a nt W o me n
Vacci nati o n of pre g na nt w o me n has bee n use d gl o ball y  i n t he pre ve nti o n of ne o natal teta n us 
a n d m ore rece ntl y f or pre ve nti o n of pert ussis i n y o u n g i nfa nts, a n d t o pr otect w o me n a n d 
t heir i nfa nts a gai nst i nfl ue nza.2 7 ,2 8  Teta n us t o x oi d vacci ne has bee n use d t o vacci nate 
pre g na nt w o me n i n parts of t he w orl d f or ma n y ye ars as a n effecti ve t o ol t o i n d uce 
i m m u n o gl o b uli n G (I g G) a nti b o dies t hat cr oss t he place nta a n d after birt h pre ve nt ne o natal 
teta n us.2 8  T here is als o i ncreasi n g e x perie nce o n t he safet y, effecti ve ness, a n d acce pta nce of 
i nfl ue nza vacci ne a n d teta n us t o x oi d, di p ht heria t o x oi d, a n d acell ular pert ussis vacci ne 
( T da p) f or use i n pre g na nt w o me n i n vari o us re gi o ns of t he w orl d t o pre ve nt disease i n 
ne w b or ns a n d i nfa nts.  Mater nal i m m u nizati o n a gai nst i nfl ue nza was rec o m me n de d b y t he 
U S A d vis or y  C o m mittee o n Im m u nizati o n Practices ( A CI P) i n 2 0 0 4. 2 9  I n a d diti o n, i n 2 0 0 9, 
beca use of t he i ncrease d ris ks of i nfl ue nza a n d relate d c o m plicati o ns i n pre g na nt w o me n, t he 
A CI P rec o m me n de d t hat pre g na nt w o me n rece i ve b ot h t he i nacti vate d i nfl ue nza A 
H 1 N 1 ( 2 0 0 9) m o n o vale nt vacci ne a n d t he i nacti vate d seas o nal i nfl ue nza vacci ne d uri n g a ny 
sta ge of pre g na nc y.3 0  Safet y  s ur veilla nce c o n d ucte d t hr o u g h 2 0 1 2 has de m o nstrate d n o 
u n us ual patter ns of pre g na nc y  c o m plicati o ns or fetal o utc o mes.3 1  I n t he U S, T da p 
vacci nati o n was i nitiall y  i ntr o d uce d f or u n vacci nate d pre g na nt w o me n, a n d f urt her e x pa n de d 
t o all pre g na ncies i n 2 0 1 2.  T he U K als o i ntr o d uce d a T da p vacci nati o n pr o gra m of pre g na nt 
w o me n; b ot h of t hese meas ures were ta ke n i n res p o nse t o a si g nifica nt u ps u r ge i n pert ussis 
cases i n all a ges.  T o date ( 2 0 1 3), t hese vacci nes ha ve de m o nstrate d a n acce pta ble safet y 
pr ofile wit h si n gle a n d re peat d osi n g. 3 2 ,3 3
2. 2. 3. 2. M ater n al A nti b o d y a n d Pr otecti o n A g ai nst G B S Dise ase i n I nf a nts
D uri n g t he t hir d tri mester of pre g na nc y , o nly I g G a nti b o dies are acti vely tra ns p orte d acr oss 
t he place nta.  T his pr o vi des a mea ns f or pr otecti ve a nti b o d y t o be tra nsferre d fr o m a m ot her 
t o her ne w b or n.3 4  T he efficie nc y  of a nti b o d y tra nsfer de pe n ds o n place ntal i nte grity, 
mater nal t otal I g G, G A at deli ver y , a n d I g G s u bclass (t he 
] 
s u bclass is m ost efficie ntl y tra nsferre d).2 8  Researc hers meas ure d a nti b o d y  i n sera c ollecte d 
at deli ver y fr o m G B S-c ol o nize d m ot hers w h ose i nfa nts ha d de vel o pe d E O D, a n d i n 
G B S -c ol o nize d w o me n w h ose i nfa nts ha d n ot de vel o pe d E O D.  T here was a c orrelati o n 
bet wee n l o w m ater nal a nti b o d y c o nce ntrati o n t o ser ot ype III (as meas ure d i n a n I g G assa y ) 
a n d i nfa nt s usce pti bilit y t o E O D d ue t o ser oty p e III. 3 5  Si nce t he i nitial st u d y, a d diti o nal w or k 
was c o n d ucte d de m o nstrati n g t he c orrelati o n bet wee n ser ot y pe Ia – s pecific a nti– ca ps ular 
p ol y sacc hari de ( C P S) a nti b o d y i n t he m ot her a n d pr otecti o n of t he ba by a gai nst G B S E O D 
d ue t o ser ot y pe Ia, a n d a directi o nal effect wit h t he ser ot y pe V a nti b o d y. 3 6 -3 9  T his s u g gest s 
t hat a nti-C P S a nti b o d y  pr otects a gai nst G B S disease, a mec ha nis m si milar t o t hat e x pl oite d 
a gai nst ot her e nca ps ulate d or ga nis ms, a n d t he a nti b o d y  is tra ns p orte d acr oss t he place nta.  
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 3
T hese fi n di n gs s u p p ort t he bi ol o gical pla usi bilit y  t hat i ncreasi n g t he le vels of mater nal 
a nti-C P S I g G a nti b o d y b y vacci nati o n of pre g na nt w o me n wit h ser ot y pe -s pecific 
p ol y sacc hari de c o nj u gate a nti ge ns will i ncrease t he pr o p orti o n of w o me n wit h p ote ntiall y 
pr otecti ve le vels of I g G a n d will res ult i n place ntal tra nsfer of pr otecti ve a nti b o d y t o a lar ge 
n u m ber of i nfa nts.
2. 2. 3. 3. Cli nic al E x perie nce Wit h P ol ys acc h ari de C o nj u g ate V acci nes a n d G B S 
P ol ys acc h ari de C o nj u g ate V acci ne
T here is si g nifica nt e x perie nce wit h t he use of p ol ysacc hari de c o nj u gate vacci nes t o pre ve nt 
disease d ue t o e nca ps ulate d bacteria i n i nfa nts, c hil dre n, a n d a d ults. 4 0 ,4 1  A n u m ber of 
p ol y sacc hari de c o nj u gate vacci nes ha ve bee n de vel o pe d a n d gl o ball y lice nse d b y Pfizer 
(Hi b TI T E R ® , Me ni n gitec
® , Pre ve nar® , Pre ve nar 1 3® ) a n d ot her vacci ne ma n ufact urers 
(e g, Me n ve o, Act HI B, Hi beri x).  T hese vacci nes ha ve a well -esta blis he d safet y pr ofile a n d 
i n d uce hi g h le vels of f u ncti o nall y acti ve a nti b o dies t hat are pr otecti ve as de m o nstrate d eit her 
t hr o u g h efficac y st u dies or base d o n esta blis he d i m m u ne c orrelates of pr otecti o n.
I n vesti gati o nal G B S p olysacc hari de c o nj u ga te vacci nes ha ve bee n e val uate d i n cli nical trials 
i n pre g na nt w o me n, i ncl u di n g a tri vale nt (Ia, I b, a n d III) G B S C P S– cr oss -reacti ve 
material 1 9 7 ( C R M1 9 7) c o nj u gate vacci ne i n S o ut h Africa.4 2 ,4 3  T hese st u dies de m o nstrate d 
t he acce pta ble safety pr ofile of G B S p ol ysacc hari de c o nj u gate vacci nes, as well as t he 
i n d ucti o n of i m m u ne res p o nses t o t he G B S vacci ne ser oty pes i n t heir i nfa nts.
2. 2. 3. 4. Cli nic al E x perie nce Wit h Re pe ate d D oses of V acci nes
T here is prece de nt f or re peate d d oses of vacci nes t o a u g me nt or s ustai n pr otecti o n a gai nst 
disease i n pre g na nt w o me n. Se veral c o u ntries rec o m me n d t he a d mi nistrati o n of T da p d uri n g 
e ver y pre g na nc y, i ncl u di n g cl osely s pace d pre g na ncies. T he S o ut h Africa n g ui deli nes f or 
mater nit y  care rec o m me n d all pre g na nt w o me n are gi ve n a t otal of 5 pr o perl y  s pace d d oses 
of teta n us t o x oi d i m m u nizati o n t o pr o vi de life -l o n g pr otecti o n a gai nst teta n us. 
T he g ui deli nes rec o m me n d 3 teta n us t o x oi d i m m u nizati o n d oses d uri n g t he first pre g na nc y 
a n d 2 teta n us t o x oi d i m m u nizati o n b o oster d oses f or t he ne xt 2 s u bse q ue nt pre g na ncies, 1 i n 
eac h pre g na nc y, at least 1 ye ar a part. 4 4  P u blis he d data re p ort t hat vacci nati o n wit h T da p 
d uri n g pre g na nc y  is n ot ass ociate d wit h a n i ncrease d ris k of a d verse birt h o utc o mes 4 5 a n d 
s u g gest t hat re petiti ve d osi n g i n a s h ort ti me s pa n i n serial pre g na ncies d oes n ot u nfa v ora bl y 
affect pre g na nc y. I n 1 st u d y, n o a d ver se pre g na nc y, deli ver y, or ne o natal o utc o mes were 
o bser ve d i n ass ociati o n wit h a nte part u m T da p vacci nati o n i n w o me n w h o recei ve d m ore t ha n 
1 a nte part u m T da p vacci nati o n s s pace d i n a 5-ye ar ti me fra me. 4 6
Data are a vaila ble re gar di n g t he b o osti n g of I g G res p o nses fr o m P hase 1 a n d 2 cli nical trials 
of ot her G B S ca n di date vacci nes. I n 1 st u d y, a sec o n d d ose of a n i n vesti gati o nal tri vale nt 
G B S vacci ne, a d m i nistere d 4 t o 6 years after t he first d ose, elicite d a r o b ust i m m u ne res p o nse 
f or eac h vacci ne ser oty pe i n n o n pre g na nt w o me n, i ncl u di n g i n t h ose wit h u n detecta ble 
pre – first d ose a nti-G B S a nti b o d y  le vels. T he a ut h ors s u g gest a s ufficie ntl y  s pace d sec o n d 
vacci ne d ose ma y  be be neficial f or w o me n wit h ver y l o w pree xisti n g a nti b o d y 
c o nce ntrati o ns. 4 7
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 4
I n a n ot her st u dy i n vesti gati n g a differe nt G B S ca n di date vacci ne, a sec o n d d ose of G B S t y pe 
III C P S-teta n us t o x oi d c o nj u gate vacci ne ( G B S III-T T) gi ve n 2 1 m o nt hs after t he first d ose 
rest ore d ty pe III C P S-s pecific I g G a nti b o d y le vels t o t h ose o btai ne d after t he pri mar y 
vacci nati o n. T he a bilit y  of a sec o n d d ose t o a u g me nt t he i m m u ne res p o nse was a p pare nt 
o nl y  i n t he s u bset of healt h y a d ults w h o ha d ver y l o w c o nce ntrati o ns (0. 0 5 µ g/ m L) of 
C P S -s pecific I g G pri or t o vacci nati o n. I n t his gr o u p, t he sec o n d d ose res ulte d i n s pecific I g G 
G M Cs t hat were 3 -f ol d hi g her t ha n t hat o btai ne d after a si n gle d ose.4 8 T hese data s u g gest 
t hat re peat vacci nati o n is safe a n d ma y offer i m m u n ol o gic be nefit.
2. 2. 4. Gr o u p B Stre pt oc occ us 6 -V ale nt P ol ys acc h ari de C o nj u g ate V acci ne
Pfizer is de vel o pi n g a G B S 6 vacci ne ai me d at t he pre ve nti o n of G B S disease d ue t o 
6 ser ot ypes i n y o u n g i nfa nts b y  acti ve i m m u nizati o n of pre g na nt w o me n.
T he G B S 6 ca n di dates are c o m p ose d of p ol ys acc hari des of t he 6 m ost pre vale nt ser ot y pes 
ca usi n g 9 5 % of G B S disease i n i nfa nts, i n di vi d uall y  c o nj ugate d t o t he C R M 1 9 7 carrier 
pr otei n.  T he y  c o ntai n 
µ g C P S/ser ot y pe/ d ose, a n d are f or m ulate d wit h or wit h o ut 
al u mi n u m p h os p hate ( Al P O 4).  Refer t o Ta ble 3 f or f urt her details.  T he ca n di dates ha ve bee n 
de vel o pe d base d o n Pfizer hist orical e x perie nce wit h lice nse d a n d i n vesti gati o nal 
p ol y sacc hari de c o nj u gate vacci nes, p u blis he d/ p u blic data wit h ot her i n vesti gati o nal G B S 
p ol y sacc hari de c o nj u gate vacci nes, a n d data fr o m t he precli nical m o dels of G B S 6. 4 1 ,4 9 -5 7
T he C P S/ser ot y pe/ d ose is wit hi n t he ra n ge cli nicall y  e val uate d i n m o n o vale nt a n d 
m ulti vale nt vacci nes of G B S p ol ysacc hari de c o nj u gate d t o teta n us t o x oi d or C R M
1 9 7.5 0 ,5 8 ,5 9  
T hese i n vesti gati o nal vacci nes ha ve als o bee n e val uate d i n pre g na nt w o me n i n cli nical 
st u dies, wit h n o safet y c o ncer ns i de ntifie d t o date.  Precli nical data s h o w t hat G B S 6 i n d uces 
ser ot yp e -s pecific I g G res p o nses a n d o ps o n o p ha g oc ytic acti vit y ( O P A) t hat are pr otecti ve 
a gai nst a n i nfecti o us c halle n ge i n t he offs pri n g i n a ni mal m o dels.
T he f or m ulati o ns wit h Al P O 4 ma y  offer partic ular a d va nta ges i n i m m u ne res p o nse base d o n 
t heir p ote ntial t o dri ve a n 
a nti b o d y res p o nse, w hic h is t he a ntib o d y  s u bclass 
prefere ntiall y tra ns p orte d acr oss t he place nta. 6 0 ,6 1  T h eref ore, G B S 6 f or m ulate d wit h 
Al P O 4 is bei n g assesse d i n early cli nical de vel o p me nt t o deter mi ne t he o pti mal f or m ulati o n 
t hat i n d uces ma xi mall y pr otecti ve a nti b o d y le vels i n h u ma ns.
A d diti o nal i nf or mati o n f or t his c o m p o u n d ma y  be f o u n d i n t he si n gle reference safet y 
d oc u me nt ( S R S D), w hic h f or t his st u d y  is t he G B S 6 i n vesti gat or’s br oc h ure (I B).
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 5
2. 2. 5. St u d y R ati o n ale
T his P hase 1/ 2, ra n d o mize d, place b o -c o ntr olle d, o bser ver -bli n de d st u d y  will be t he first 
e val uati o n of t he i n vesti gati o nal G B S 6 i n pre g na nt w o me n.  This st u d y  will be c o n d ucte d 
i n 3 sta ges.
Sta ge 1 will e val uate t he safet y, t olera bilit y, a n d i m m u n o ge nicit y of G B S 6 
( 2 0 µ g C P S/ser ot y pe/ d ose) wit h a n d wit h o ut Al P O 4.  T his d ose le vel was selecte d by t he 
i nter nal re vie w c o m mittee (I R C) after t he re vie w of t he u n bli n de d safety data t hr o u g h 
1 m o nt h after vacci nati o n i n a n o n g oi n g first -i n-h u ma n ( FI H), P hase 1/ 2, ra n d o mize d, 
place b o -c o ntr olle d, o bser ver-bli n de d st u d y  t hat e val uate d 3 asce n di n g d ose le vels ( 5, 1 0, or 
2 0 µ g C P S/ser ot y pe/ d ose) of G B S 6 f or m ulate d wit h or wit h o ut Al P O 4 i n healt h y a d ults 
( n o n pre g na nt w o me n a n d me n, 1 8 t o 4 9 years of a ge ) i n t he U S ( St u d y C 1 0 9 1 0 0 1).
Sta ge 2 will c o m me nce f oll o wi n g a re vie w of t he 1 - m o nt h p ost vacci nati o n safety data fr o m 
t he P hase 1/ 2 L M I C Sta ge 1 c o h ort a n d 1 -m o nt h p o st vacci nati o n safet y a n d i m m u n o ge nicity 
data fr o m t he P hase 1/ 2 FI H st u d y ( C 1 0 9 1 0 0 1).  If t he safet y a n d i m m u n o ge nicit y pr ofile is 
dee me d acce pta ble, t he safet y, t olera bilit y , a n d i m m u n o ge nicity of 3 asce n di n g d ose le vels 
(
µ g C P S/ser ot y pe/ d ose ) of G B S 6 f or m ulate d wit h or wit h o ut Al P O 4 will be 
assesse d w he n a d mi nistere d as a si n gle d ose t o healt h y  pre g na nt w o me n 1 8 t o 4 0 ye ars of a ge 
d uri n g t heir 2 7 t o 3 6 wee ks of pre g na nc y .  Of n ote, all 3 d ose le vels ( 
µ g 
C P S/ser ot y pe/ d ose) ma y  n ot be e val uate d d uri n g Sta ge 2 s h o ul d a ny d ose/f or m ulati o n le vel 
be dee me d u nacce pta ble after re vie w of i m m u n o ge nicit y  data fr o m t he P hase 1/ 2 FI H st u d y 
( C 1 0 9 1 0 0 1) a n d t he safet y data fr o m Sta ge 1 of t he C 1 0 9 1 0 0 2 st u d y.
Sta ge 2 will use se nti nel c o h orts t o a ssess safet y t o all o w pr o gressi o n t o t he ne xt hi g her d ose.  
T hese se nti nel c o h orts ser ve as a P hase 1 e val uati o n i n t he st u d y base d o n t he s mall n u m ber 
of partici pa nt s i n t he c o h ort a n d t he f oc us o n safet y, i ncl u di n g safety la b orat or y assess me nts.  
E nr oll me nt of t he re mai ni n g c o h orts ser ves as t he P hase 2 c o m p o ne nt of t he st u d y a n d will 
pr o vi de a n i ncrease d n u m ber of mater nal partici pa nt s f or i m m u n o ge nicit y assess me nt as well 
as e x pa n d t he safet y data set.  Safet y a n d G B S 6 a nti b o d y tra nsfer t o i nfa nts b or n fr o m 
vacci nate d w o me n will be e val uate d.  A si n gle d ose a n d f or m ulati o n f or f urt her e val uati o n i n 
Sta ge 3 of t he st u d y  will be selecte d after re vie w of t he deli ver y safety a n d i m m u n o ge nicit y 
data fr o m mater nal partici pa nt s a n d t heir i nfa nt partici pa nt s.  In Sta ge 3, a n a d diti o nal c o h ort 
of healt h y pre g na nt w o me n will be e nr olle d t o recei ve t he selecte d G B S 6 d ose/f or m ulati o n t o 
pr o vi de a n e x pa n de d safet y  a n d i m m u n o ge nicity data set ( b ot h pre g na nt w o me n a n d t heir 
i nfa nt partici pa nt s) a n d t o s u p p ort pr o gressi on of t he de vel o p me nt of t his vacci ne.
T his st u d y  will descri be t he safety of G B S 6 i n pre g na nt w o me n a n d t heir i nfa nt partici pa nt s.  
It will als o assess t he i m m u n o ge nicity of G B S 6 i n pre g na nt w o me n, t he tra nsfer of 
a ntica ps ular a nti b o d y t o t heir i nfa nt part ici pa nts, a n d t he ki netics of a nti b o d y tra nsfer i n t he 
i nfa nt partici pa nt s. 
 
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 6
I n A me n d me nt 3, t he gestati o nal a ge of vacci nati o n f or partici pa nt s i n Sta ge 3 is e x pa n di n g 
(fr o m ≥2 7 0/ 7 t o ≤3 5 6/ 7 wee ks ’ gestati o n t o ≥2 4 0/ 7 t o ≤3 5 6/ 7 wee ks ’ gestati o n) t o e na ble 
e x pa n de d e val uati o n of safet y a n d i m m u n o ge nicit y data at t he selecte d d ose, i n t he sec o n d 
a n d t hir d tri mesters of pre g na nc y .
I n A me n d me nt 4, Sta ge 1 partici pa nt s ( n o n pre g na nt w o me n) willi n g a n d eli gi ble t o 
partici pate will ret ur n t o recei ve a b o oster d ose of G B S 6 a p pr o xi matel y  2 years after t he 
pri mar y  d ose of i n vesti gati o nal pr o d uct, t o e val uate safety a n d i m m u n o ge nicit y f oll o wi n g a 
b o oster d ose of G B S 6 i n S o ut h Africa n w o me n. It is n ot k n o w n if G B S 6 will be re q uire d 
d uri n g eac h pre g na nc y , t h us i nf or mati o n o n t he safet y a n d i m m u ne res p o nse f oll o wi n g a 
b o oster d ose i n differe nt p o p ulati o ns is i m p orta nt. A d diti o nall y , Sta ge 1 partici pa nt s
( n o n pre g na nt w o me n) will pr o vi de a lar ge v ol u me bl o o d dra w t o s u p p ort t he de vel o p me nt of 
a u ni versal G B S vacci ne refere nce sta n dar d assa y .
I n A me n d me nt 5, Sta ge 1 b o oster partici pa nts ( n o n pre g na nt w o me n) will ret ur n f or a n 
a d diti o nal bl o o d dra w at V isit 1 0, w hic h will ta ke place a p pr o xi matel y  1 4 t o 18 4 da y s 
after V isit 9. T his a d diti o nal ser u m will f urt her s u p p ort t he de vel o p me nt of a u ni versal 
G B S vacci ne refere nce sta n dar d assa y .
I n A me n d me nt 6, a n a d diti o nal 2 0 0 mater nal partici pa nts will be a d de d t o S ta ge 3. T hese 
partici pa nts will be recr uite d at sites i n t he U S. T he data fr o m t hese partici pa nts will 
c o ntri b ute t o t he safet y data base t o s u p p ort t he i nitiati o n of t he P hase 3 pr o gra m. T hese data 
will als o e na ble a n e val uati o n a n d c o m paris o n of G B S 6 i m m u ne res p o nses a n d place ntal 
a nti b o d y tra nsfer efficie nc y bet wee n mater nal/i nfa nt pairs i n t he U S a n d S o ut h Africa. 
F urt her m ore , O P A a nal ysis has bee n re m o ve d as a n e x pl orat or y e n d p oi nt f or S ta ge 1, 
S ta ge 2, a n d S ta ge 3 mater nal a n d i nfa nt partici pa nts . It has als o bee n re m o ve d as a 
sec o n dar y e n d poi nt f or S ta ge 1 partici pa nts. T his is bei n g re m o ve d beca use data fr o m t he 
sec o n d a n d t hir d i nteri m a nalys es de m o nstrate d r o b ust i m m u ne res p o nses, as meas ure d by 
ser ot yp e -s pecific I g G a n d f u ncti o nal a nti b o d y res p o nse f or ser ot yp e -s pecific O P A after
G B S 6 v acci nati o n. T hese data s u p p ort t he use of a nti -G B S ca ps ular I g G le vels t o e val uate 
G B S 6 vacci ne pr otecti o n a gai nst i n vasi ve G B S disease. H o we ver, t he l o wer li mit s of 
q ua nti tati o n ( L L O Qs) f or ser ot y pe-s pecific O P As were hi g h, i n dicati n g t hat t he O P A assa ys 
are n ot se nsiti ve e n o u g h c o m pare d t o I g G, a n d t h us re n der i n g t he O P A assa y u ns uita ble f or 
meas uri n g vacci ne pr otecti o n.
I n A me n d me nt 7, t here will be a re visi o n of t he i nfa nt bl o o d dra w sc he d ule t o re m o ve bl o o d 
dra ws at t he 1 8 -wee k p ost deli ver y  a n d 1 2-m o nt h p ost deli ver y  visits f or i nfa nts b or n t o 
mater nal partici pa nts e nr olle d i n t he U S a n d t he U K Sta ge 3 c o h ort. T he i nfa n t bl o o d dra ws 
at t hese 2 visits are f or t he e x pl orat or y  i m m u n o ge nicit y o bjecti ve t o descri be i m m u ne 
res p o nses t o di p ht heria a n d 1 3-vale nt p ne u m oc occal c o nj u gate vacci ne a d mi nistere d t o i nfa nt 
partici pa nts deli vere d t o mater nal partici pa nts vacci nate d wit h G B S 6, a n d are ali g ne d wit h 
t he S o ut h Africa n pe diatric i m m u nizati o n sc he d ule. T he pe diatric i m m u nizati o n sc he d ules i n 
t he U S a n d t he U K differ a n d are n ot ali g ne d wit h t he 1 8-wee k p ost deli ver y a n d 1 2 -m o nt h 
p ost deli ver y  st u d y visits. T his e x pl orat or y  a nalys is will c o nti n ue t o be c o n d ucte d i n Sta ge 2 
a n d Sta ge 3 i nfa nts b or n t o mater nal partici pa nts e nr olle d fr o m S o ut h Africa as ori gi nall y 
pla n ne d. 
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 7
T he a dj uste d pr o p ose d n u m ber of U S partici pa nts , re d uce d fr o m 2 0 0 t o 3 6, will be s ufficie nt
t o e val uate a n d c o m pare t he G B S 6 place ntal a nti b o d y  tra nsfer efficie nc y bet wee n 
mater nal/i nfa nt pairs i n t he U S a n d S o ut h Africa . T he a me n d me nt t o e xcl usi o n criteria 8 a n d 
1 5 f or t he Sta ge 3 mater nal partici pa nts is clarificati o n te xt t o pr o vi de g ui da nce t o 
i n vesti gati o nal sites, wit h res pect t o c o m plia nce wit h st u d y pr ot oc ol re q uire me nt, a n d will 
facilitate recr uit me nt of s uita ble mater nal partici pa nts f or t he st u d y.
Data fr o m t his st u d y  will be use d t o pr o gress t he de vel o p me nt of t his vacci ne i nt o P hase 3.
I n A me n d me nt 8, t he t otal n u m ber of partici pa nts e nr olle d fr o m t he U S i n S ta ge 3 will be 
re vise d t o t he c orrect n u m ber e nr olle d ( 1 6 2 fr o m S o ut h Africa/ U K a n d 5 4 fr o m t he U S). 
F urt her m ore, beca use of t he a d diti o nal e nr olle d partici pa nts fr o m t he U S i n pr ot oc ol 
a me n d me nt 7 , t he d urati o n of t he st u d y has i ncrease d fr o m a p pr o xi matel y 4 8 m o nt hs t o 
a p pr o xi matel y 6 0 m o nt hs.
3. S T U D Y O B J E C TI V E S A N D E N D P OI N T S
3. 1. Pri m ar y O bjecti ves a n d E n d p oi nts
3. 1. 1. Pri m ar y O bjecti ve s: St a ge 1

T o descri be t he safet y a n d t olera bilit y of vari o us G B S6 f or m ulati o ns i n healt h y 
n o n pre g na nt w o me n 1 8 t o 4 0 ye ars of a ge.

T o descri be t he safet y a n d t olera bilit y of a b o oster d ose of G B S 6 w he n a d mi nistere d 
t o healt h y n o n pre g na nt w o me n.
3. 1. 2. Pri m ar y E n d p oi nts: St a ge 1

Pr o p orti o ns of n o n pre g na nt w o me n re p orti n g pr o m p te d l ocal reacti o ns wit hi n 7 da y s 
f oll o wi n g a d mi nistrati o n of t he pri mar y a n d b o oster d oses of i n vesti gati o nal pr o d uct 
( pai n at t he i njecti o n site, re d ness, a n d s welli n g).

Pr o p orti o ns of n o n pre g na nt w o me n re p orti n g pr o m pte d s y ste mic e ve nts wit hi n 7 da y s 
f oll o wi n g a d mi nistrati o n of t he pri mar y a n d b o oster d oses of i n vesti gati o nal pr o d uct 
(fe ver, na usea/ v o miti n g, diarr hea, hea dac he, fati g ue/tire d ness, m uscle pai n, a n d j oi nt 
pai n).

Pr o p orti o ns of n o n pre g na nt w o me n re p orti n g a d verse e ve nts ( A Es) t hr o u g h 1 m o nt h
f oll o wi n g a d mi nistrati o n of t he pri mar y a n d b o oster d oses of i n vesti gati o nal pr o d uct.

Pr o p orti o ns of n o n pre g na nt w o me n re p orti n g me dicall y  atte n de d a d verse e ve nts 
( M A Es) a n d seri o us a d verse e ve nts ( S A Es) t hr o u g h 6 m o nt hs f oll o wi n g
a d mi nistrati o n of t he pr i mar y d ose a n d a p pr o xi matel y 7 t o 1 2 m o nt hs f oll o wi n g 
t he b o oster d ose of i n vesti gati o nal pr o d uct.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 8
3. 1. 3. Pri m ar y O bjecti ves: St a ge 2

T o descri be t he safet y a n d t olera bilit y of vari o us G B S 6 f or m ulati o ns w he n 
a d mi nistere d t o healt h y pre g na nt w o me n 1 8 t o 4 0 ye ars of a ge vacci nate d at 
2 7 t o 3 6 wee ks’ gestati o n.

T o assess t he safet y of mater nal i m m u nizati o n i n i nfa nt partici pa nt s b or n t o w o me n 
w h o were vacci nate d wit h vari o us G B S 6 f or m ulati o ns d uri n g pre g na nc y.
3. 1. 4. Pri m ar y O bjecti ves: St a ge 3

T o descri be t he safet y a n d tolera bilit y  of 1 selecte d d ose/f or m ulati o n of G B S 6 w he n 
a d mi nistere d t o healt h y pre g na nt w o me n 1 8 t o 4 0 ye ars of a ge vacci nate d at 2 4 t o 
3 6 wee ks’ gestati o n.

T o assess t he safet y of mater nal i m m u nizati o n i n i nfa nt partici pa nt s b or n t o w o me n 
1 8 t o 4 0 ye ars of a ge w h o were vacci nate d wit h 1 selecte d d ose/f or m ulati o n d uri n g 
pre g na nc y .
3. 1. 5. Pri m ar y S afet y E n d p oi nts ( M ater n al P a rtici p a nts): St a ges 2 a n d 3

Pr o p orti o ns of se nti nel -c o h ort mater nal partici pa nt s ( Sta ge 2 o nl y) wit h cli nical 
la b orat or y a b n or malities f oll o wi n g a d mi nistrati o n of i n vesti gati o nal pr o d uct at t he 
2- wee k f oll o w -u p visit.

Pr o p orti o ns of mater nal partici pa nt s re p orti n g pr o m pte d l ocal reacti o ns wit hi n 7 da y s 
f oll o wi n g a d mi nistrati o n of i n vesti gati o nal pr o d uct ( pai n at t he i njecti o n site, re d ness, 
a n d s welli n g).

Pr o p orti o ns of mater nal partici pa nt s re p orti n g pr o m pte d s yste mic e ve nts wit hi n 
7 da y s f oll o wi n g a d mi nistrati o n of i n vesti gati o nal pr o d uct (fe ver, na usea/ v o miti n g, 
diarr hea, hea dac he, fati g ue/tire d ness, m uscle pai n, a n d j oi nt pai n).

Pr o p orti o ns of mater nal partici pa nt s re p orti n g A Es t hr o u g h 1 m o nt h after 
a d mi nistrati o n of i n vesti gati o nal pr o d uct.

Pr o p orti o ns of mater nal partici pa nt s wit h S A Es, M A Es, a n d o bstetric c o m plicati o ns 
( pre part u m, i ntra part u m, a n d p ost part u m) t hr o u g h o ut t he stu d y  ( Visit 1 t hr o u g h t he 
1 2- m o nt h p ost deli ver y  st u d y visit).

Pr o p orti o ns of mater nal partici pa nt s wit h eac h deli ver y o utc o me (li ve birt h, deli ver y 
m o de).
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 3 9
3. 1. 6. Pri m ar y S afet y E n d p oi nts (I nf a nt P artici p a nt s): St a ges 2 a n d 3

Pr o p orti o ns of i nfa nt partici pa nt s wit h s pecific birt h o utc o mes.

Pr o p orti o ns of i nfa nt partici pa nt s wit h A Es fr o m birt h t o 6 wee ks of a ge.

Pr o p orti o ns of i nfa nt partici pa nt s wit h S A Es, A Es of s pecial i nterest ( maj or 
c o n ge nital a n o malies, de vel o p me ntal dela y , a n d s us pecte d or c o nfir me d 
G B S i nfecti o n), a n d M A Es t hr o u g h 1 2 m o nt hs of a ge.
3. 2. Sec o n d ar y O bjecti ves a n d E n d p oi nts
3. 2. 1. Sec o n d ar y O bjecti ve s: St a ge 1

T o descri be t he i m m u n o ge nicit y  of vari o us G B S 6 f or m ulati o ns w he n a d mi nistere d t o 
healt h y  n o n pre g na nt w o me n.

T o descri be t he i m m u n o ge nicit y of a b o ost er d ose of G B S 6 w he n a d mi nistere d t o 
healt h y  n o n pre g na nt w o me n.
3. 2. 2. Sec o n d ar y O bjecti ve: St a ge 2

T o descri be t he i m m u n o ge nicit y  of vari o us G B S 6 f or m ulati o ns w he n a d mi nistere d t o 
healt h y  pre g na nt w o me n.
3. 2. 3. Sec o n d ar y O bjecti ve: St a ge 3

T o descri be t he i m m u n o ge nicit y of 1 selecte d d ose le vel/f or m ulati o n of G B S 6 w he n 
a d mi nistere d t o healt h y pre g na nt w o me n.
3. 2. 4. Sec o n d ar y O bjecti ves: St a ges 2 a n d 3

T o descri be G B S 6 a nti b o d y le vels i n i nfa nt partici pa nts deli vere d t o mater nal 
partici pa nt s vacci nate d wit h G B S 6.

T o assess plac e ntal tra nsfer of a nti b o d y fr o m mater nal partici pa nt s vacci nate d wit h 
G B S 6 t o t heir i nfa nt partici pa nt s.
3. 2. 5. Sec o n d ar y E n d p oi nts: St a ge 1

G B S ser ot y pe -s pecific I g G ge o metric mea n c o nce ntrati o ns ( G M Cs) 1 m o nt h after 
vacci nati o n i n n o n pre g na nt w o me n.

G B S ser ot y p e-s pecific I g G ge o metric mea n c o nce ntrati o ns ( G M Cs) meas ure d bef ore 
a n d 1 m o nt h, 3 m o nt hs , a n d 6 m o nt hs after a b o oster vacci nati o n i n n o n pre g n a nt 
w o me n.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 0
3. 2. 6. Sec o n d ar y E n d p oi nts ( M ater n al P artici p a nt s): St a ges 2 a n d 3

G B S ser ot y pe -s pecific I g G G M Cs meas ure d at 2 wee ks a n d 1 m o nt h after vacci nati o n 
a n d at deli ver y i n mater nal partici pa nt s.

G B S ser ot y pe -s pecific O P A ge o metric mea n titers ( G M Ts ) meas ure d 1 m o nt h after 
vacci nati o n a n d at deli ver y  i n mater nal partici pa nt s.
3. 2. 7. Sec o n d ar y E n d p oi nts (I nf a nt P artici p a nt s): St a ges 2 a n d 3

G B S ser ot y pe -s pecific I g G G M Cs i n i nfa nt partici pa nt s meas ure d at birt h.

G B S ser ot y pe -s pecific O P A G M Ts i n i nfa nt partici pa nt s meas ure d at birt h.
3. 3. E x pl or at or y O bjecti ves a n d E n d p oi nts
3. 3. 1. E x pl or at or y O bjecti ves: St a ge 1
3. 3. 2. E x pl or at or y O bjecti ves: St a ges 2 a n d 3
3. 3. 3. E x pl or at or y O bjecti ve: St a ges 1, 2, a n d 3
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 1
3. 3. 4. E x pl or at or y E n d p oi nts: St a ge 1
3. 3. 5. E x pl or at or y E n d p oi nts ( M ater n al P a rtici p a nts): St a ges 2 a n d 3
3. 3. 6. E x pl or at or y E n d p oi nts (I nf a nt P artici p a nt s): St a ges 2 a n d 3
4. S T U D Y D E SI G N
T his is a P hase 1/ 2, ra n d o mize d, place b o- c o ntr olle d, o bser ver -bli n de d st u d y  t o e val uate t he 
safety, t olera bilit y, a n d i m m u n o ge nicit y of a m ulti vale nt G B S vacci ne i n healt h y 1 8 - t o 
4 0- ye ar -ol d n o n pre g na nt w o me n as well as pre g na nt w o me n a n d t heir i nfa nts.  Partici pa nt s 
i n Sta ge 2 will be vacci nate d bet wee n 2 7 0/ 7 a n d 3 5 6/ 7 wee ks’ gestati o n a n d partici pa nt s i n 
Sta ge 3 will be vacci nate d bet wee n 2 4 0/ 7 a n d 3 5 6/ 7 wee ks’ gestati o n.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 2
4. 1. Di versit y of St u d y P o p ul ati o n
T his st u d y has alrea d y c o m plete d e nr oll me nt i n S o ut h Africa / U K a n d a n a d diti o nal
5 4 partici pa nts will be e nr olle d i n t he U S, w here t he di versit y strate g y will i ncl u de 
hi g h -perf or mi n g sites wit h t he p ote ntial t o s u p p ort t he recr uit me nt of di verse p o p ulati o ns.  
T he di versit y  strate g y f or t his st u d y will i ncl u de t he f oll o wi n g:

Selecti n g sites t hat ha ve access t o di verse partici pa nts wit hi n t heir l ocale s.

E d ucati n g sites a b o ut t he i m p orta nce of i ncreasi n g di versit y  o n cli nical trials a n d 
Pfizer ’s c o m mit me nt.

I n vesti gat or site recr uit me nt pla ns t hat are c ocreate d wit h a n d i ncl u de di verse 
recr uit me nt t o ols a n d i nf or mati o n t o s u p p ort e nr oll me nt.

Real -w orl d data are use d t o tar get o utreac h a n d p ote ntial referri n g p h y sicia ns.

C o nti n ual m o nit ori n g of di verse e nr oll me nt t o i de ntif y a d diti o nal o p p ort u nities t o 
i ncl u de di verse p o p ulati o ns.
4. 2. St a ge 1
N o n pre g na nt w o me n i n g o o d healt h will be scree ne d, e nr olle d, a n d ra n d o mize d i n a 
1: 1: 1 rati o (a p pr o xi matel y 2 2 partici pa nt s e nr olle d/ gr o u p) t o recei ve place b o (sali ne c o ntr ol) 
or G B S 6 ( 2 0 µ g  C P S/ser ot ype/ d ose) wit h or wit h o ut Al P O 4.  Partici pa nt s will ha ve bl o o d 
dra w n pri or t o vacci nati o n ( Visit 1), 2 wee ks after vacci nati o n ( Visit 2), a n d 1 m o nt h after 
vacci nati o n ( Visit 3).  E -diaries will be use d t o c ollect pr o m pte d l ocal reacti o n a n d s yste mic 
e ve nt data f or 7 d a y s after vacci nati o n.  A Es will be c ollecte d t hr o u g h 1 m o nt h after 
vacci nati o n ( Visit 3).  I n a d diti o n, M A Es a n d S A Es will be c ollecte d fr o m scree ni n g t hr o u g h 
6 m o nt hs after vacci nati o n ( Visit 4).  A Pfizer I R C a n d a n e xter nal data m o nit ori n g 
c o m mittee ( E D M C) will re vie w t he 1 -m o nt h p ost vacci nati o n safet y data ( u n bli n de d) fr o m 
Sta ge 1 a n d t he 1 -m o nt h safet y a n d i m m u n o ge nicit y data fr o m t he vari o us G B S 6
f or m ulati o ns fr o m t he FI H P hase 1/ 2 st u d y bef ore pr o gressi on i nt o Sta ge 2.
If a d ose le vel or f or m ulati o n d oes n ot de m o nstrate t he e x pecte d 1-m o nt h i m m u n o ge nicit y 
i n t he FI H P hase 1/ 2 st u d y ( C 1 0 9 1 0 0 1) or acce pta ble safety pr ofile i n Sta ge 1 of t his 
P hase 1/ 2 st u d y, t hat d ose le vel or f or m ulati o n will n ot be e val uate d i n Sta ge 2.
T he st u d y  will pr ocee d t o Sta ge 2 at t he discreti o n of t he IR C i n c o ns ultati o n wit h t he 
E D M C.
Sta ge 1 partici pa nt s ( n o n pre g na nt w o me n) willi n g a n d eli gi ble t o partici pate will ret ur n t o 
recei ve a b o oster d ose of G B S 6 a p pr o xi matel y 2 years after t he pri mar y d ose of 
i n vesti gati o nal pr o d uct. Partici pa nt s will ha ve bl o o d dra w n at t he pre b o oster scree ni n g visit, 
pri or t o t he b o oster vacci nati o n ( Visit 6), 1 m o nt h after t he b o oster vacci nati o n ( Visit 7), 
3 m o nt hs after t he b o oster vacci nati o n ( V isit 8), 6 m o nt hs after t he b o oster vacci nati o n 
( Visit 9), a n d at t he b l o o d dra w f oll o w-u p visit after t he b o oster vacci nati o n ( Visit 1 0) .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 3
E- diaries will be use d t o c ollect pr o m pte d l ocal reacti o n a n d s ys te mic e ve nt data f or 7 da ys 
after t he b o oster vacci nati o n. A Es will be c ollecte d t hr o u g h 1 m o nt h after vacci nati o n 
( Visit 7). I n a d diti o n, M A Es a n d S A Es will be c ollecte d fr o m t he b o oster vacci nati o n visit 
( Visit 6) t hr o u g h a p pr o xi matel y 7 t o 1 2 m o nt hs after t he b o oster vacci nati o n ( Visit 1 0 ).
4. 3. St a ge 2
Sta ge 2 will utilize a se nti nel -c o h ort desi g n, wit h c o h ort pr o gressi o n a n d d ose escalati o n 
ta ki n g place after a safet y re vie w ( data fr o m eac h mater nal partici pa nt t hr o u g h 1 4 d a y s after 
vacci nati o n) of t he se nti nel c o h ort of partici pa nt s at eac h d ose le vel (see Ta ble 1 ).  U p o n 
pr o vi di n g i nf or me d c o nse nt, pre g na nt w o me n will be e nr olle d a n d scree ne d f or ge neral 
healt h, healt h of t he pre g na nc y , a n d G A.  Pre g na nt w o me n, o nce c o nse nte d, will be referre d 
t o as “ mater nal partici pa nt s.” T he first 4 2 eli gi ble mater nal partici pa nt s at eac h d ose le vel 
will be referre d t o as t he se nti nel c o h ort.  Starti n g wit h t he l o west d ose le vel, mater nal 
partici pa nt s will be ran d o ml y  assi g ne d ( 1: 1: 1 rati o, 1 4 partici pa nt s per gr o u p) t o recei ve a 
si n gle d ose of G B S 6, f or m ulate d wit h or wit h o ut Al P O 4, or place b o (sali ne c o ntr ol) wit hi n 
t he se nti nel c o h ort of a gi ve n d ose le vel.  T he e nr oll me nt rate i n t he se nti nel c o h ort will be 
li mite d t o a ma xi m u m of 5 partici pa nt s per da y.  A re vie w of t he 1 4-d a y  safet y data i n a 
se nti nel c o h ort will be c o n d ucte d by t he Pfizer I R C, a n d if dee me d acce pta ble, will tri g ger :

e nr oll me nt i n t he e x pa n de d c o h ort at t hat d ose le vel ( 1: 1: 1 rati o, 2 6 parti ci pa nts per 
gr o u p), wit h n o pres pecifie d li mit o n dail y  e nr oll me nt u ntil a p pr o xi matel y 
7 8 a d diti o nal mater nal partici pa nts are e nr olle d (see Ta ble 2 ), a n d

e nr oll me nt i n t he se nti nel c o h ort f or t he ne xt hi g her d ose le vel (see Ta ble 2 ).
E nr oll me nt will pr ocee d t his wa y  i n a sta g gere d fas hi o n t hr o u g h t he hi g hest d ose le vel.  
A p pr o xi matel y  3 6 0 mater nal partici pa nt s are pla n ne d t o be e nr olle d i nt o Sta ge 2.
T his st u d y  will use st o p pi n g r ules f or t he se nti nel c o h ort, a n d 1 st o p pi n g r ule (seri ous, 
u ne x pecte d A E c o nsi dere d p ossi bl y  relate d t o vacci ne) will als o a p pl y t o t he 
e x pa n de d-c o h ort e nr oll me nt p hase.  St o p pi n g r ules (a n d t he decisi o n t o ter mi nate or restart at 
a gi ve n d ose le vel) ma y be a p plie d i n de pe n de ntl y f or eac h f or m ulati o n at t he discreti o n of t he 
Pfizer I R C i n c o nj u ncti o n wit h t he E D M C rec o m me n dati o ns (t heref ore, it is p ossi ble t hat 
after a st o p pi n g r ule is met at a gi ve n d ose le vel, o ne f or m ulati o n [ wit h or wit h o ut Al P O 4] 
ma y  pr ocee d w hile t he ot her ma y n ot).
T he I R C will meet after eac h i nteri m a nal ys is t o re vie w safety a n d i m m u n o ge nicit y data, 
a n d o n a n a d h oc a n d ti mel y  basis t o re vie w safety data if a st o p pi n g r ule is tri g gere d, a n d 
t o ma ke rec o m me n dati o ns f or t he st u d y.  I n a d diti o n t o t he a d h oc meeti n gs c o n ve ne d i n t he 
case a st o p pi n g r ule is met, t he E D M C will als o meet peri o dically t o c o n d uct r o uti ne re vie ws 
of safet y data.
W he n all Sta ge 2 se nti nel -c o h ort mater nal partici pa nt s a n d t heir i nfa nt partici pa nt s ha ve 
c o m plete d t he deli ver y/ birt h visit, safet y a n d i m m u n o ge nicit y data will be u n bli n de d a n d 
re vie we d, w he n a vaila ble, b y t he I R C f or Pfizer i nf or mati o nal a n d pla n ni n g p ur p oses.
F or details of s p o ns or bli n di n g, refer t o Secti o n 6. 8 .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 4
W he n all Sta ge 2
mater nal partici pa nt s a n d t heir i nfa nt partici pa nt s ha ve c o m plete d t he 
deli ver y / birt h visit, safet y a n d i m m u n o ge nicity data will be u n bli n de d b y gr o u p, w he n 
a vaila ble, a nal yze d, a n d re vie we d b y t he Pfizer I R C.  T he fi nal G B S 6 d ose a n d f or m ulati o n 
t o ta ke i nt o Sta ge 3 a n d f urt her de vel o p me nt will be selecte d after t his re vie w.  F or details of 
s p o ns or bli n di n g, refer t o Secti o n 6. 8 .
4. 4. St a ge 3
A p pr o xi matel y  2 1 6 a d diti o nal mater nal partici pa nt s will be e nr olle d i nt o Sta ge 3
(a p pr o xi matel y 1 6 2 fr o m S o ut h Africa/ U K a n d 5 4 fr o m t he U S) t o recei ve a si n gle 
d ose/f or m ulati o n of t he selecte d G B S 6 or place b o (sali ne c o ntr ol) i n a 1: 1 rati o.  E nr oll me nt 
will be m o nit ore d t o hel p e ns ure distri b uti o n of vacci nati o n acr oss t he gestati o nal a ge ra n ge 
of ≥2 4 0/ 7 t o ≤3 5 6/ 7 wee ks.  T here will be n o d ose escalati o n, n o se nti nel c o h orts, a n d n o 
pla n ne d st o p pi n g r ules.  T he visit sc he d ule, f oll o w- u p, a n d assess me nts f or mater nal 
partici pa nt s a n d t heir i nfa nt partici pa nt s will be si milar t o t h ose i n Sta ge 2.  T he a d diti o nal 
data fr o m Sta ge 3 will c o ntri b ute t o t he saf et y data base of mater nal partici pa nts t o s u p p ort 
t he desi g n of t he P hase 3 pr o gra m.
W he n Sta ge 3 mater nal partici pa nt s a n d t heir i nfa nt partici pa nt s ha ve c o m plete d t he 
deli ver y / birt h visit, safet y a n d i m m u n o ge nicity data will be u n bli n de d b y gr o u p, w he n 
a vaila ble, a n d a nal yz e d a n d re vie we d b y t he Pfizer I R C.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 5
T a ble 1.
E nr oll me nt a n d D ose Esc al ati o n Desi g n
D ose Esc al ati o n
St a ge 1
N o n pre g n a nt 
W o m e n
St a ge 1 S afet y D at a Re vie w b y Pfizer I R C a n d E D M C a
St a ge 2
M ater n al P artici p a nt s
St a ge 2 S afet y a n d I m m u n o ge nicit y Re vie w/ D ose Selecti o n
St a ge 3
M ater n al 
P artici p a nt s
L o west D ose
- G B S 6 l o west d ose 
wit h Al P O 4
- G B S 6 l o west d ose 
wit h o ut Al P O 4
- Place b o 
(sali ne c o ntr ol) 
E nr oll 
se nti nel 
c o h ort 
( n = 4 2)
1 4 -Da y  
safet y 
re vie w b y 
I R C
C o m plete 
e nr oll me nt of 
e x pa n de d b
c o h ort( n = 7 8)
E nr oll a n d 
vacci nate
( n =2 1 6
G B S 6 selecte d c
or place b o 
(sali ne)
Mi d dle D ose
- G B S 6 mi d dle 
d ose w it h Al P O4
- G B S 6 mi d dle 
d ose w it h o ut Al P O4
- Place b o 
(sali ne c o ntr ol)
E nr oll 
se nti nel 
c o h ort b
( n = 4 2)
1 4 -Da y  
safet y 
re vie w 
b y I R C
C o m plete e nr oll me nt 
of e x pa n de d c o h ort b
( n = 7 8)
Hi g hest D ose
- G B S 6 hi g hest 
d ose w it h Al P O4
- G B S 6 hi g hest 
d ose w it h o ut Al P O4
- Place b o 
(sali ne c o ntr ol)
E nr oll a n d 
vacci nate d
( n = 6 6)
E nr oll 
se nti nel 
c o h ort b
( n = 4 2)
1 4 -D a y  
safet y 
re vie w 
b y I R C
C o m plete 
e nr oll me nt of 
e x pa n de d c o h ort 
( n = 7 8)
A b bre viati o ns: Al P O 4 = al u mi n u m p h os p hate; C P S = ca ps ular p ol ysacc hari de; E D M C = e xter nal data m o nit ori n g c o m mittee; FI H = first -i n-h u ma n; 
I R C = i nter nal re vie w c o m mittee.
a.
Safet y a n d i m m u n o ge nicit y data at t he 1 -m o nt h p ost vacci nati o n ti me p oi nt fr o m t he U S FI H P hase 1/ 2 st u d y ( C 1 0 9 1 0 0 1) will als o be i ncl u de d i n t he re vie w.
b.
T he 1 4 -da y safet y re vie w b y t he I R C will tri g ger e nr oll me nt of t he e x pa n de d c o h ort (at t he sa me d ose le vel) a n d se nti nel c o h ort (f or t he ne xt d ose le vel).
c.
O ne of t he 6 G B S 6 d ose le vels wit h or wit h o ut Al P O 4.
d.
N o n pre g na nt w o me n will recei ve t he 2 0 - µ g C P S/ser ot y pe/ d ose ( wit h or wit h o ut Al P O4) of G B S 6. Sta ge 1 partici pa nt s ( n o n pre g na nt w o me n) willi n g a n d eli gi ble t o 
partici pate will ret ur n t o rece i ve a b o oster d ose of G B S 6 ( 2 0 µ g C P S/ser ot y pe/ d ose wit h Al P O4) a p pr o xi matel y 2 years after t he pri mar y d ose of i n vesti gati o nal pr o d uct.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 6
4. 5. D ur ati o n of P artici p a nt P artici p 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 mately 6 t o 1 2 m o nt hs f or Sta ge 1 
( n o n pre g na nt w o me n) a n d u p t o 1 6 m o nt hs f or Sta ges 2 a n d 3 ( pre g na nt w o me n a n d t heir 
i nfa nt partici pa nt s). Sta ge 1 partici pa nt s ( n o n pre g na nt w o me n) willi n g a n d eli gi ble t o 
partici pate will ret ur n t o recei ve a b o oster d ose of G B S 6 a p pr o xi matel y  2 years after t he 
pri mar y  d ose of i n vesti gati o nal pr o d uct a n d will partici pate f or a d diti o nal v isits t hr o u g h 
a p pr o xi matel y 1 2 m o nt hs.
4. 6. D ur ati o n of St u d y
T he st u d y d urati o n will be a p pr o xi matel y  6 0 m o nt hs.
4. 7. N u m ber of P artici p a nts
Refer t o Ta ble 2 bel o w f or a detaile d descri pti o n of t he n u m ber of partici pa nt s per sta ge a n d 
d ose/f or m ulati o n gr o u p.  Partici pa nt s w h o wit h dra w or are wit h dra w n fr o m t he st u d y after 
ra n d o mizati o n will n ot be re place d, re gar dless of t he reas o n f or wit h dra wal.  A t otal of 
a p pr o xi matel y 6 4 2 partici pa nt s ( 6 6 n o n pre g na nt w o me n a n d 5 7 6 mater nal partici pa nt s an d 
t heir i nfa nt partici pa nt s) will be e nr olle d i n t his st u d y b y ce ntral ra n d o mizati o n.
4. 7. 1. St a ge 1
A p pr o xi matel y  6 6 partici pa nt s ( n o n pre g na nt w o me n) will be e nr olle d i nt o Sta ge 1, 
2 2 partici pa nt s at eac h f or m ulati o n of G B S 6 ( wit h/ wit h o ut Al P O4) a n d 2 2 partici pa nt s i n 
t he place b o gr o u p. Sta ge 1 partici pa nt s ( n o n pre g na nt w o me n) will recei ve a b o oster d ose 
of G B S 6 ( 2 0 µ g C P S/ser ot y pe/ d ose wit h Al P O 4) a p pr o xi matel y 2 years after i nitial 
i n vesti gati o nal pr o d uct a d mi nistrati o n.
4. 7. 2. St a ge 2
A p pr o xi matel y  3 6 0 mater nal partici pa nt s will be e nr olle d i nt o Sta ge 2.  T he first 
4 2 partici pa nt s wit hi n a d ose le vel (l o w, mi d dle, hi g h) will c o m p ose t he se nti nel c o h ort 
wit h 1 4 partici pa nt s at eac h d ose/f or m ulati o n a n d 1 4 partici pa nt s i n t he place b o gr o u p.  
T he e nr oll me nt rate i n eac h of t he se nti nel c o h orts will be li mite d t o a ma xi m u m of 
5 partici pa nt s per da y.  F urt her e nr oll me nt will be e x pa n de d at eac h d ose le vel u ntil 
7 8 a d diti o nal partici pa nt s are e nr olle d (e x pa n de d c o h ort).
4. 7. 3. St a ge 3
A p pr o xi matel y  2 1 6 mater nal partici pa nt s will be e nr olle d i nt o Sta ge 3 (a p pr o xi matel y 
1 6 2 fr o m S o ut h Africa/ U K a n d 5 4 fr o m t he U S), 1 0 8 at t he selecte d G B S 6 d ose/f or m ulati o n 
a n d 1 0 8 i n t he place b o gr o u p. E nr oll me nt will be m o nit ore d t o hel p e ns ure distri b uti o n of 
vacci nati o n acr oss t he gestati o nal a ge ra n ge of ≥2 4 0/ 7 t o ≤3 5 6/ 7 wee ks.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 7
T a ble 2.
Pl a n ne d P artici p a nts: T ot al a n d N u m ber i n E ac h St a ge a n d Gr o u p
St a ge 1 D ose/ F or m ul ati o n Gr o u p a
T ot al
( 1: 1: 1)
Hi g hest 
D ose b
G B S 6 ( 2 0 µ g C P S/ser ot y pe/ d ose) w it h Al P O4
2 2
G B S 6 ( 2 0 µ g C P S/ser ot y pe/ d ose) w it h o ut Al P O4
2 2
Place b o (sali ne c o ntr ol)
2 2
St a ge 2 D ose/ F or m ul ati o n Gr o u ps
Se nti nel 
( 1: 1: 1)
E x p a n de d 
( 1: 1: 1)
T ot al
L o west 
D ose
G B S 6 l o west d ose wit h Al P O 4
1 4 
2 6
4 0
G B S 6 l o west d ose wit h o ut Al P O 4
1 4 
2 6
4 0
Place b o (sali ne c o ntr ol)
1 4 
2 6
4 0 c
Mi d dle 
D ose
G B S 6 mi d dle d ose w it h Al P O4
1 4 
2 6
4 0
G B S 6 mi d dle d ose wit h o ut Al P O 4
1 4 
2 6
4 0
Place b o (sali ne c o ntr ol)
1 4 
2 6
4 0 c
Hi g hest 
D ose
G B S 6 hi g hest d ose wit h Al P O 4
1 4 
2 6
4 0
G B S 6 hi g hest d ose wit h o ut Al P O 4
1 4 
2 6
4 0
Place b o (sali ne c o ntr ol)
1 4 
2 6
4 0 c
St a ge 3 D ose/ F or m ul ati o n Gr o u p
T ot al ( 1: 1)
Selecte d
D ose
Selecte d G B S 6 d ose/f or m ulati o n
1 0 8
Place b o (sali ne c o ntr ol)
1 0 8
A b bre viati o ns: Al P O 4 = al u mi n u m p h os p hate; C P S = ca ps ular p ol ysacc hari de; FI H = first -i n-h u ma n.
a.
Sta ge 1 partici pa nt s ( n o n pre g na nt w o me n) willi n g a n d eli gi ble t o partici pate w ill ret ur n t o recei ve a 
b o oster d ose of G B S 6 ( 2 0 µ g C P S/ser ot y pe/ d ose wit h Al P O 4) a p pr o xi matel y 2 years after t he pri mar y 
d ose of i n vesti gati o nal pr o d uct.
b.
O ne h u n dre d f o ur healt h y a d ults ( males a n d fe males) 1 8 t o 4 9 years of  a ge ha ve recei ve d t hi s d ose le vel 
( ~ 5 2/f or m ulati o n wit h/ wit h o ut Al P O4) i n t he U S FI H P hase 1/ 2 st u d y ( C 1 0 9 1 0 0 1).
c.
A p pr o xi matel y 1 2 0 pre g na nt c o ntr ol partici pa nt s recei vi n g place b o (sali ne c o ntr ol) i n t otal i n Sta ge 2.
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 p o p ulati o n i ncl u di n g, w here per mitte d 
u n der l ocal re g ulati o ns, a ge, se x, race, a n d et h nicit y . T he f oll o wi n g eli gi bilit y  criteria are 
desi g ne d t o select partici pa nt s f or w h o m partici pati o n i n t he st u d y is c o nsi dere d a p pr o priate.  
All rele va nt me dical a n d n o n me dical c o n diti o ns s h o ul d be ta ke n i nt o c o nsi derati o n w he n 
deci di n g w het her a partic ular partici pa nt is s uita ble f or t his pr ot oc ol.
Pr os pecti ve a p pr o val of pr ot oc ol de viati o ns t o recr uit me nt a n d e nr oll me nt criteria, als o 
k n o w n as pr ot oc ol wai vers or e xe m pti o ns, is n ot per mitte d.
Pfizer will re vie w eli gi bilit y  criteria verifie d b y t he i n vesti gat or or q ualifie d desi g nee t o 
c o nfir m t hat partici pa nts meet st u d y  eli gibilit y  criteria bef ore t he y are e nr olle d i nt o t he st u d y. 
T he e nr oll me nt a p pr o val pr ocess will be i nitiate d f or a partici pa nt after a n i nf or me d c o nse nt 
d oc u me nt has bee n si g ne d a n d t he i n vesti gat or or q ualifie d desi g nee has assesse d t he 
partici pa nt as eli g i ble. T he e nr oll me nt a p pr o val will be base d o n re vie w of C R F/s y ste m data.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 8
5. 1. I ncl usi o n Criteri a – St a ge 1
Partici pa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y:
1.
E vi de nce of a pers o nall y  si g ne d a n d date d i nf or me d c onse nt d oc u me nt (I C D) i n dicati n g 
t hat t he partici pa nt has bee n i nf or me d of all perti ne nt as pects of t he st u d y.
2.
Willi n g a n d a ble t o c o m pl y  wit h sc he d ule d visits, i n vesti gati o nal pla n, la b orat or y tests, 
a n d ot her st u d y pr oce d ures, i ncl u di n g c o m pleti o n of t he e-diar y  fr o m Da y 1 t o 
D a y 7 f oll o wi n g a d mi nistrati o n of i n vesti gati o nal pr o d uct.
3.
Healt h y n o n pre g n a nt fe males ≥1 8 t o ≤4 0 y ears of a ge at e nr oll me nt w h o are deter mi ne d 
b y  me dical hist or y, p h ysical e xa mi nati o n, a n d cli nical j u d g me nt of t he i n vesti gat or t o be 
eli gi ble f or i ncl usi o n i n t he st u d y .
4.
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 o ca n be c o ntacte d b y 
tele p h o ne d uri n g st u dy partici pati o n.
5.
Ne gati ve uri ne pre g na nc y  test at Visit 1 ( pri or t o vacci nati o n).
Fe male partici pa nt s of n o nc hil d beari n g p ote ntial m ust meet at least 1 of t he f oll o wi n g 
criteria:
a.
Ac hie ve d p ost me n o pa usal stat us, defi ne d as f oll o ws: cessati o n of re g ular me nses f or 
at least 1 2 c o nsec uti ve m o nt hs wit h n o alter nati ve pat h ol o gical or p h y si ol o gical 
ca use; stat us ma y be c o nfir me d wit h a ser u m f ollicle -sti m ulati n g h or m o ne ( F S H) 
le vel c o nfir mi n g t he p ost me n o pa usal state;
b.
Ha ve u n der g o ne a d oc u me nte d h y sterect o m y a n d/ or bilateral o o p h orect o m y;
c.
Ha ve me dicall y  c o nfir me d o varia n fail ure.
All ot her fe male partici pa nt s (i ncl u di n g fe male partici pa nt s wit h t u bal li gati o ns) are 
c o nsi dere d t o be of c hil d beari n g p ote ntial.
6.
D oc u me nte d ne gati ve HI V, he patitis C vir us ( H C V), a n d ac ute or c hr o nic he patitis B 
vir us ( H B V) i nfecti o n at scree ni n g.
5. 2. I ncl usi o n Criteri a – St a ge 1 B o ost er V acci n ati o n
Partici pa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y:
1.
E vi de nce of a pers o nall y  si g ne d a n d date d i nf or me d c o nse nt d oc u me nt (I C D) i n dicati n g 
t hat t he partici pa nt has bee n i nf or me d of all perti ne nt a s pects f or t he b o oster vacci nati o n 
a n d s u bse q ue nt visits.
2.
Partici pa nt m ust ha ve recei ve d i n vesti gati o nal pr o d uct at Visit 1.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 4 9
3.
Willi n g a n d a ble t o c o m pl y  wit h sc he d ule d visits, i n vesti gati o nal pla n, la b orat or y tests, 
a n d ot her st u d y pr oce d ures, i ncl u di n g c o m pleti o n of t he e -diar y  fr o m Da y 1 t o 
D a y 7 f oll o wi n g b o oster vacci nati o n wit h G B S 6.
4.
Partici pa nt c o nti n ues t o meet all Sta ge 1 i ncl usi o n criteria a n d n o ne of t he Sta ge 1 
e xcl usi o n criteria (e xce pt e xcl usi o n criterio n 1 1) .
5.
Healt h y n o n pre g na nt fe male deter mi n e d b y m e dical hist or y, p h ysical e xa mi nati o n, a n d 
cli nical j u d g me nt of t he i n vesti gat or t o be eli gi ble f or b o oster vacci nati o n a n d recei ve d 
i n vesti gati o nal pr o d uct at Visit 1.
6.
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 o ca n be c o ntacte d by 
tele p h o ne d uri n g st u dy partici pati o n.
7.
Ne gati ve uri ne pre g na nc y  test at Visit 6 ( pri or t o vacci nati o n).
Fe male partici pa nt s of n o nc hil d beari n g p ote ntial m ust meet at least 1 of t he f oll o wi n g 
criteria:
a.
Ac hie ve d p ost me n o pa usal stat us, defi ne d as f oll o ws: cessati o n of re g ular me nses f or 
at least 1 2 c o nsec uti ve m o nt hs wit h n o alter nati ve pat h ol o gical or p h y si ol o gical 
ca use; stat us ma y be c o nfir me d wit h a ser u m f ollicle-sti m ulati n g h or m o ne ( F S H) 
le vel c o nfir mi n g t he p ost me n o pa usal state;
b.
Ha ve u n der g o ne a d oc u me nte d h y sterect o m y a n d/ or bilateral o o p h orect o m y;
c.
Ha ve me dicall y  c o nfir me d o varia n fail ure.
All ot her fe male partici pa nt s (i ncl u di n g fe male partici pa nt s wit h t u bal li gati o ns) are 
c o nsi dere d t o be of c hil d beari n g p ote ntial.
8.
D oc u me nte d ne gati ve HI V, he patitis C vir us ( H C V), a n d ac ute or c hr o nic he patitis B 
vir us ( H B V) i nfecti o n at scree ni n g.
5. 3. E xcl usi o n Criteri a – St a ge 1
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:
1.
I n vesti gat or site staff me m bers directly i n v ol ve d i n t he c o n d uct of t he st u d y  a n d t heir 
fa mil y me m bers, site staff me m bers ot her wise s u per vise d b y t he i n vesti gat or, or 
partici pa nt s w h o are Pfizer e m pl o yees, i ncl u di n g t heir fa mil y me m bers, directl y i n v ol ve d 
i n t he c o n d uct of t he st u d y.
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), vacci nes, or me dical 
de vices wit hi n 2 8 d a 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.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 0
3.
Ot her me dical or ps y c hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he past year) or acti ve 
s uici dal i deati o n or be ha vi or or la b orat or y a b n or malit y t hat ma y i ncrease t he ris k 
ass ociate d wit h st u d y partici pati o n or i n vesti gati o nal pr o d uct a d mi nistrati o n or ma y
i nterfere wit h t he i nter pretati o n of st u d y res ults a n d, i n t he j u d g me nt of t he i n vesti gat or, 
w o ul d ma ke t he partici pa nt i na p pr o priate f or e ntr y i nt o t his st u d y.
4.
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 h yl a xis) t o a n y c o m p o ne nt of t he i n vesti gati o nal pr o d uct or a n y 
di p ht heria t o x oi d – c o ntai ni n g or C R M 1 9 7-c o ntai ni n g vacci ne.
5.
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 G B S (S a g al acti ae ).
6.
I m m u n oc o m pr o mise d partici pa nt s wit h k n o w n or s us pecte d i m m u n o deficie nc y.
7.
Partici pa nt s w h o recei ve 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 ys te mic c ortic oster oi ds, e g, f or ca ncer or a n a ut oi m m u ne disease, or pla n ne d 
recei pt t hr o u g h t he 1- m o nt h p ost vacci nati o n bl o o d dra w.  If s yste mic c ortic oster oi ds ha ve 
bee n a d mi nistere d s h ort ter m ( 1 4 d a y s) f or treat me nt of a n ac ute ill ness, partici pa nt s 
s h o ul d n ot be e nr olle d i nt o 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 3 0 d a y s bef ore i n vesti gati onal pr o d uct a d mi nistrati o n.  I n hale d/ ne b ulize d, 
i ntra-artic ular, i ntra b ursal, or t o pical (s ki n or e y es) c ortic oster oi ds are per mitte d.
8.
Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d blee di n g t hat w o ul d i n t he 
o pi ni o n of t he i n vesti gat or c o ntrai n dicate i ntra m usc ular i njecti o n.
9.
A n y  k n o w n or s us pecte d a ut oi m m u ne or ne ur oi nfla m mat or y disease (refer t o t he st u d y 
refere nce ma n ual [ S R M]).
1 0. C urre nt alc o h ol a b use or illicit dr u g use.
1 1. Pre vi o us vacci nati o n wit h a n y  lice nse d or i n vesti gati o nal G B S vacci ne ( other t ha n G B S 6 
recei ve d as a pri mar y vacci nati o n at Visit 1), or pla n ne d recei pt d uri n g t he partici pa nt ’s 
partici pati o n i n t he st u d y  (t hr o u g h t he last bl o o d dra w).
1 2. Vacci nati o n wit h di p ht heria- or C R M 1 9 7-c o ntai ni n g vacci ne(s) fr o m 6 m o nt hs bef ore 
i n vesti gatio nal pr o d uct a d mi nistrati o n.
1 3. Recei pt or pla n ne d recei pt of bl o o d/ plas ma pr o d ucts or i m m u n o gl o b uli n, fr o m 6 0 d a y s 
bef ore i n vesti gati o nal pr o d uct a d mi nistrati o n t hr o u g h t he 1 -m o nt h p ost vacci nati o n bl o o d 
dra w.
1 4. Fe male partici pa nt s w h o are breastfee di n g.
1 5. Partic i pa nts of c hil d beari n g p ote ntial w h o are u n willi n g or u na ble t o use a hi g hly 
effecti ve met h o d of c o ntrace pti o n as o utli ne d i n t his pr ot oc ol f or at least 3 m o nt hs 
after a d mi nistrati o n of t he i n vesti gati o nal pr o d uct.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 1
5. 4. I ncl usi o n Criteri a – St a ges 2 a n d 3 – M at er n al P artici p a nts
Partici pa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y:
1.
E vi de nce of 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 has bee n 
i nf or me d of all perti ne nt as pects of t he st u dy.
2.
Wil li n g a n d a ble t o c o m pl y wit h sc he d ule d visits, i n vesti gati o nal pla n, la b orat or y tests, 
a n d ot her st u d y pr oce d ures i ncl u di n g c o m pleti o n of t he e -diar y  fr o m Da y 1 t o 
D a y 7 f oll o wi n g a d mi nistrati o n of i n vesti gati o nal pr o d uct.
3.
Healt h y fe males ≥1 8 a n d ≤4 0 ye ars of a ge w h o are ≥2 7 0/ 7 ( Sta ge 2) or ≥2 4 0/ 7 ( Sta ge 3) 
t o ≤3 5 6/ 7 wee ks’ gestati o n o n t he da y  of pla n ne d vacci nati o n, wit h a n u nc o m plicate d, 
si n glet o n pre g na nc y, a n d at n o i ncrease d ris k f or c o m plicati o ns a n d n o si g nifica nt fetal 
a b n or malities o bser ve d o n ultras o u n d perf or me d at a n y  ti me pri or t o st u d y e ntr y a n d/ or at 
t he scree ni n g visit.
Gestati o nal a ge ( G A) will be d oc u me nte d base d o n o ne of t he f oll o wi n g c o m p osite 
criteria base d o n ti mi n g a n d a vaila bilit y  of data o n t he last me nstr ual peri o d ( LM P), 
ultras o u n d, a n d p h ys ical e xa mi nati o n.  T he earliest ultras o u n d data a vaila ble d uri n g 
t he c urre nt pre g na nc y s h o ul d be use d t o esta blis h G A:
a.
First - Tri mester D at a A v ail a ble ( data o btai ne d at ≤1 3 6/ 7 wee ks):

T he date of t he first da y  of t he re p orte d L M P ma y be use d t o esta blis h t he G A if 
c orr o b orate d b y a first -tri mester ultras o u n d.

If t here is a discre pa nc y of 7 da y s bet wee n t he L M P- deter mi ne d G A a n d a 
first-tri mester ultras o u n d O R t he LM P is u ncertai n/ u n k n o w n, t he n t he G A s h o ul d 
be deter mi ne d usi n g t he first -tri mester ultras o u n d.
b.
Sec o n d- Tri mester D at a A v ail a ble ( data o btai ne d at 1 4 0/ 7 t o 2 7 6/ 7 wee ks):

T he date of t he first da y  of t he re p orte d L M P ma y be use d t o esta blis h t he G A if 
c orr o b orate d b y a sec o n d -tri mester ultras o u n d or a p h ysical e xa mi nati o n 
i ncl udi n g f u n dal hei g ht.

If t here is a discre pa nc y of 1 0 da y s bet wee n t he L M P-deter mi ne d G A a n d t he 
sec o n d-tri mester ultras o u n d O R if t he LM P is u ncertai n/ u n k n o w n, t he n t he G A 
s h o ul d be deter mi ne d usi n g t he sec o n d-tri mester ultras o u n d.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 2
c.
T hir d -Tri mester D at a A v ail a ble ( data o btai ne d at ≥2 8 wee ks):

T he date of t he first da y  of t he re p orte d L M P ma y be use d t o esta blis h t he G A if 
c orr o b orate d b y a t hir d -tri mester ultras o u n d.

If t here is a discre pa nc y of 2 1 da y s bet wee n t he L M P-deter mi ne d G A a n d t he 
t hir d-tri mester ultras o u n d O R if t he LM P is u ncertai n/ u n k n o w n, t he n t he G A 
s h o ul d be deter mi ne d usi n g t he t hir d-tri mester ultras o u n d.
4.
Pre g na nt partici pa nt s m ust be recei vi n g pre natal sta n dar d of care at t he cli nics/ p h ysicia n 
offices/ h os pital net w or k affiliate d wit h t he cli nical st u d y site.
5.
Deter mi ne d b y me dical hist or y , p h ysical e xa mi nati o n, scree ni n g la b orat or y assess me nt, 
a n d cli nical j u d g me nt t o be a p pr o priate f or i ncl usi o n i n t he st u d y .
6.
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 , ca n be c o ntacte d by t elep h o ne 
d uri n g st u d y partici pati o n, a n d e x pecte d t o gi ve i nf or me d c o nse nt f or t heir i nfa nt 
partici pa nt t o partici pate i n t he st u d y.
7.
D oc u me nte d ne gati ve HI V a nti b o d y , H B V s urface a nti ge n, H C V a nti b o d y, a n d s yp hilis 
tests at scree ni n g.
5. 5. E xcl usi o n Criteri a – St a ges 2 a n d 3 – M ater n al P artici p a nts
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:
1.
I n vesti gat or site staff me m bers directly i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir 
fa mil y me m bers, site staff me m bers ot her wise s u per vise d b y t he i n vesti gat or, or 
partici pa nt s w h o are Pfizer e m pl o yees, i ncl u di n g t heir fa mil y me m bers, directl y i n v ol ve d
i n t he c o n d uct of t he st u d y.
2.
Partici pa nt s w h ose u n b or n ba b y ha ve bee n fat here d b y i n vesti gati o nal site staff me m bers 
directl y  i n v ol ve d i n t he c o n d uct of t he st u d y or t heir fa mily me m bers, site staff me m bers 
ot her wise s u per vise d b y t he i n vesti gat or, or Pfi zer e m pl o yees directl y i n v ol ve d i n t he 
c o n d uct of t he st u d y.
3.
F or St a ge 2 se nti nel-c o h ort p artici p a nt s o nl y, la b orat or y test res ults at t he scree ni n g 
visit o utsi de t he n or mal refere nce ra n ge f or pre g na nt w o me n acc or di n g t o t heir tri mester 
i n pre g na nc y.
4.
Part ici 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), vacci nes, or me dical 
de vices wit hi n 2 8 d a 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.
5.
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 h yl a xis) t o a n y c o m p o ne nt of t he i n vesti gati o nal pr o d uct or a n y relate d 
vacci ne.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 3
6.
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 G B S (S a g al acti ae ), or 
hist or y  of a n i nfa nt wit h G B S disease.
7.
C urre nt alc o h ol a b use or illicit dr u g use.
8.
Pre pre g na nc y  bo d y  mass i n de x ( B MI) of ≥4 0 k g/ m 2. If pre pre g na nc y B MI is n ot 
a vaila ble, t he B MI at t he ti me of t he first o bstetric visit d uri n g t he c urre nt pre g na nc y  ma y 
be use d .
9.
Cli nical hist or y  of pri mar y ge nital her pes si m ple x vir us ( H S V) i nfecti o n d uri n g t he 
c urre nt pre g na nc y.
1 0. Partici pa nt s wit h k n o w n or s us pecte d i m m u n o deficie nc y.
1 1. Partici pa nt s w h o recei ve 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 ys te mic c ortic oster oi ds, e g, f or ca ncer or a n a ut oi m m u ne disease, or pla n ne d 
recei pt t hr o u g h t he p ost vacci nati o n bl o o d dra w.  If s yste 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 nt s s h o ul d 
n ot be e nr olle d i nt o 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 3 0 d a y s bef ore i n vesti gati o nal pr o d uct a d mi nistrati o n.  In hale d/ ne b ulize d, 
i ntra-artic ular, i ntra b ursal, or t o pical (s ki n or e y es) c ortic oster oi ds are per mitte d.
1 2. Ot her me dical or ps y c hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he past y ear) or acti ve 
s uici dal i deati o n or be ha vi or or la b orat or y a b n or malit y t hat ma y i ncrease t he ris k 
ass ociate d wit h st u d y partici pati o n or i n vesti gati o nal pr o d uct a d mi nistrati o n or ma y  
i nterfere wit h t he i nter pretati o n of st u d y res ults a n d, i n t he j u d g me nt of t he i n vesti gat or, 
w o ul d ma ke t he partici pa nt i na p pr o priate f or e ntr y i nt o t his st u d y.
1 3. Blee di n g diat hesis or c o n diti o n ass ociate d wit h pr ol o n ge d blee di n g t hat w o ul d i n t he 
o pi ni o n of t he i n vesti gat or c o ntrai n dicate i ntra m usc ular i njecti o n.
1 4. Pre vi o us vacci nati o n wit h a n y  lice nse d or i n vesti gati o nal G B S vacci ne, or pla n ne d 
recei pt d uri n g st u dy partici pati o n.
1 5. Vacci nati o n wit h di p ht heria- or C R M 1 9 7-c o ntai ni n g vacci ne, fr o m 6 m o nt hs bef ore 
i n vesti gati o nal pr o d uct a d mi nistrati o n. Li ce nse d T da p ma y be gi ve n as per local 
rec o m me n dati o n f or i m m u nizati o n i n pre g na nt w o me n, pr o vi de d t hat it is a d mi nistere d at 
a mi ni m u m 1 5 da ys bef ore or after st u dy vacci nati o n (see te m p orar y dela y c o n diti o ns i n 
t he pr ot oc ol , Secti o n 5. 8. 1 ).
1 6. Recei pt of bl o o d/ plas ma pr o d ucts or i m m u n o gl o b uli n, fr o m 6 0 da y s bef ore 
i n vesti gati o nal pr o d uct a d mi nistrati o n, or pla n ne d recei pt t hr o u g h deli ver y, wit h 
1 e xce pti o n, a nti-D i m m u n o gl o b uli n (e g, R h o G A M), w hic h ca n be gi ve n at a n y ti me.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 4
1 7. A pri or hist or y  of or c urre nt pre g na nc y c o m plicati o ns or a b n or malities t hat will i ncrease 
t he ris k ass ociate d wit h t he partici pa nt ’s partici pati o n i n, a n d c o m pleti o n of, t he st u d y, 
i ncl u di n g b ut n ot li mite d t o t he f oll o wi n g (refer t o t he S R M) f or f urt her details):

Gestati o nal h y perte nsi o n or preecla m psia -ecla m psia

Place ntal a b n or malit y

P ol y h y dra m ni os or oli g o h y dra m ni os

Si g nifica nt blee di n g or bl o o d cl otti n g dis or der

Gestati o nal dia betes

A n y  si g ns of pre mat ure la b or wit h t he c urre nt pre g na nc y

Pri or still birt h or ne o natal deat h, pri or l o w -birt h -wei g ht or preter m deli ver y , pri or 
hist or y  of at least 3 miscarria ges, pri or pre g na ncies n u m beri n g greater t ha n 5, or 
pre vi o us i nfa nt wit h a k n o w n ge netic dis o r der or maj or c o n ge nital a n o mal y

C o nfir me d G B S bacteri uria d uri n g t he c urre nt pre g na nc y
1 8.
Maj or ill ness of t he m ot her or c o n diti o ns of t he fet us t hat, i n t he i n vesti gat or’s j u d g me nt, 
will s u bsta ntiall y  i ncrease t he ris k ass ociate d wit h t he partici pa nt ’s partici pati o n i n, a n d 
c o m pleti o n of, t he st u d y or c o ul d precl u de t he e val uati o n of t he partici pa nt ’s res p o nse.
1 9. A n y  k n o w n or s us pecte d a ut oi m m u ne or ne ur oi nfla m mat or y disease (refer t o t he S R M).
5. 6. I ncl usi o n Criteri a – I nf a nt P artici p a nts – St a ges 2 a n d 3
Partici pa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y:
1.
E vi de nce of a si g ne d a n d date d I C D si g ne d b y t he pare nt(s).
T he mater nal partici pa nt m ust partici pate i n t he i nf or me d c o nse nt pr ocess a n d si g n a n d 
date a n I C D f or herself a n d her fet us/i nfa nt pri or t o t he mater nal partici pa nt ’s ta ki n g part 
i n t he st u d y.  I nf or me d c o nse nt will be o btai ne d fr o m t he fat her of t he fet us/i nfa nt if 
ma n date d b y l ocal re q uire me nts.
2.
Pare nt(s) willi n g a n d a ble t o c o m pl y  wit h sc he d ule d visits, i n vesti gati o nal pla n, 
la b orat or y tests, a n d ot her st u d y pr oce d ures.
5. 7. E xcl usi o n Criteri a – I nf a nt P artici p a nt s – St a ges 2 a n d 3
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:
1.
I nfa nt w h o is a direct desce n da nt (e g, c hil d or gra n dc hil d) of t he st u d y pers o n nel.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 5
5. 8. Te m p or ar y Del a y Criteri a ( St a ges 1, 2, a n d 3)
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 
pre vacci nati o n i m m u n o ge nicit y  bl o o d dra w a n d vacci nati o n s h o ul d ta ke place o n t he sa me 
da y  ( Visit 1 a n d Visit 6 [ Sta ge 1 o nly] ).
5. 8. 1. Criteri a f or Te m p or aril y Del a yi n g V acci ne A d mi nistr ati o n ( St a ges 1, 2, a n d 3)

C urre nt fe brile ill ness ( b o d y  te m perature ≥3 8° C [ ≥1 0 0. 4° F]) or ot her ac ute ill ness 
wit hi n 4 8 h o urs bef ore i n vesti gati o nal pr o d uct a d mi nistrati o n.

Recei pt of a n y i nacti vate d vacci ne wit hi n 1 4 da y s a n d a n y li ve vacci ne wit hi n 2 8 da y s 
bef ore i n vesti gati o nal pr o d uct a d mi nistrati o n.

Recei pt of s h ort-ter m (1 4 da y s) s yste mic c ortic oster oi ds.  I n vesti gati o nal pr o d uct 
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 3 0 da y s.  I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or 
t o pical (s ki n or e yes) c ortic oster oi ds are per mitte d.
5. 9. Lifest yle Re q uire me nts
5. 9. 1. C o ntr ace pti o n ( St a ge 1 P artici p a nt s O nl y)
All fe male partici pa nt s w h o are of c hil d beari n g p ote ntial a n d are se x uall y acti ve wit h 1 or 
m ore me m bers of t he o p p osite se x m ust a gree t o use a hi g hl y  effecti ve met h o d of 
c o ntrace pti o n c o nsiste ntl y a n d c orrectl y f or at least 3 m o nt hs after a d mi nistrati o n of 
i n vesti gati o nal pr o d uct.  T he i n vesti gat or or his or her desi g nee, i n c o ns ultati o n wit h t he 
partici pa nt , will c o nfir m t hat t he partici pa nt has selecte d a n a p pr o priate met h o d of 
c o ntrace pti o n f or t he i n di vi d ual partici pa nt fr o m t he per mitte d list of c o ntrace pti o n met h o ds 
(see bel o w) a n d will c o nfir m t hat t he partici pa nt has bee n i nstr ucte d i n its c o nsiste nt a n d 
c orrect use.  At ti me p oi nts i n dicate d i n t he sc he d ule of acti vities, t he i n vesti gat or or desi g nee 
will i nf or m t he partici pa nt of t he nee d t o use hi g hl y  effecti ve c o ntrace pti o n c o nsiste ntl y a n d 
c orrectl y a n d d oc u me nt t he c o n versati o n a n d t he partici pa nt ’s affir mati o n i n t he part ici pa nt’s 
c hart (partici pa nt s nee d t o affir m t heir c o nsiste nt a n d c orrect use of at least 1 of t he selecte d 
met h o ds of c o ntrace pti o n) c o nsi deri n g t hat t heir ris k f or pre g na nc y  ma y ha ve c ha n ge d si nce 
t he last visit.  In a d diti o n, t he i n vesti gat or or desi g ne e will i nstr uct t he partici pa nt t o call 
i m me diatel y if t he selecte d c o ntrace pti o n met h o d is disc o nti n ue d or if pre g na nc y is k n o w n or 
s us pecte d i n t he partici pa nt or t he part ner.
Hi g hl y effecti ve met h o ds of c o ntrace pti o n are t h ose t hat, al o ne or i n c o m bi nat i o n, res ult i n a 
fail ure rate of less t ha n 1 % per ye ar w he n use d c o nsiste ntl y a n d c orrectl y (ie, perfect use) a n d 
i ncl u de t he f oll o wi n g:
1.
Esta blis he d use of h or m o nal met h o ds of c o ntrace pti o n ass ociate d wit h i n hi biti o n of 
o v ulati o n (e g, oral, i nserte d, i njec te d, i m pla nte d, tra ns der mal), pr o vi de d t he partici pa nt
pla ns t o re mai n o n t he sa me treat me nt t hr o u g h o ut t he e ntire st u d y  a n d has bee n usi n g t hat 
h or m o nal c o ntrace pti ve f or a n a de q uate peri o d of ti me t o e ns ure effecti ve ness.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 6
2.
C orrectl y place d c o p per -c o ntai ni n g i ntra uteri ne de vice (I U D).
3.
Male c o n d o m or fe male c o n d o m use d WI T H a se parate s per mici de pr o d uct (ie, f oa m, gel, 
fil m, crea m, or s u p p osit or y).  F or c o u ntries w here s per mici de is n ot a vaila ble or c o n d o m 
pl us s per mici de is n ot acce pte d as hi g hl y effecti ve c o ntrace pti o n, t his o pti o n is n ot 
a p pr o priate.
4.
Male sterilizati o n wit h a bse nce of s per m i n t he p ost vasect o m y  ejac ulate.
5.
Bilateral t u bal li gati o n/ bilateral sal pi n gect o m y or bilateral t u bal occl usi ve pr oce d ure 
( pr o vi de d t hat occl usi o n has bee n c o nfir me d i n acc or da nce wit h t he de vice’s la bel).
5. 1 0. Scree n F ail ures
Scree n fail ures are defi ne d as partici pa nts w h o c o nse nt t o partici pate i n t he cli nical st u d y  b ut 
are n ot s u bse q ue ntl y ra n d o ml y assi g ne d t o st u d y i nter ve nti o n. I n di vi d uals w h o d o n ot meet 
t he criteria f or partici pati o n i n t his st u d y  (scree n fail ure) ma y be rescree ne d u n der a differe nt 
partici pa nt n u m ber if t he y later meet eli gi bilit y  criteria.
5. 1 1. S p o ns or’s Q u alifie d Me dic al Pers o n nel
T he c o ntact i nf or mati o n f or t he s p o ns or's a p pr o priatel y  q ualifie d me dical pers o n nel 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.
T o facilitate access t o a p pr o priatel y q ualifie d me dical pers o n nel o n st u d y- relate d me dical 
q uesti o ns or pr o ble ms, partici pa nt s are pr o vi de d wit h a c o ntact car d.  T he c o ntact car d 
c o ntai ns, at a mi ni m u m, pr ot oc ol a n d i n vesti gati o nal pr o d uct i de ntifiers, partici pa nt st u d y 
n u m bers, c o ntact i nf or mati o n f or t he i n vesti gat or site, a n d c o ntact details f or a c o ntact ce nter 
i n t he e ve nt t hat t he i n vesti gat or site staff ca n n ot be reac he d t o pr o vi de a d vice o n a me dical 
q uesti o n or pr o ble m ori gi nati n g fr o m a n ot her healt hcare pr ofessi o nal n ot i n v ol ve d i n t he 
partici pa nt ’s partici pati o n i n t he st u d y.  T he c o ntact n u m ber ca n als o be use d b y i n vesti gat or 
staff if t hey are see ki n g a d vice o n me dical q uesti o ns or pr o ble ms; h o we ver, it s h o ul d be use d 
o nl y  i n t he e ve nt t hat t he esta blis he d c o m m u nicati o n pat h wa ys bet wee n t he i n vesti gat or site 
a n d t he st u d y tea m are n ot a vaila ble.  It is t heref ore i nte n de d t o a u g me nt, b ut 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 i n vesti gat or site a n d t he st u d y tea m f or 
a d vice o n me dical q uesti o ns or pr o ble ms t hat ma y arise d uri n g t he st u d y.  T he c o ntact 
n u m ber is n ot i nte n de d f or use b y t he partici pa nt directl y , a n d if a partici pa nt calls t hat 
n u m ber, he or s he will be directe d bac k t o t he i n vesti gat or site.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 7
6. I N V E S TI G A TI O N A L P R O D U C T S
F or t he p ur p oses of t his st u d y , a n d per I nter nati o nal C o u ncil f or Har m o nisati o n6 2 (IC H) 
g ui deli nes, i n vesti gati o nal pr o d uct is defi ne d as a p har mace utical f or m of a n acti ve 
i n gre die nt or place b o bei n g teste d or use d as a refere nce/c o m parat or i n a cli nical trial, 
i ncl u di n g a pr o d uct wit h a mar keti n g a ut h orizati o n w he n use d or asse m ble d (f or m ulate d or 
pac ka ge d) i n a wa y  differe nt fr o m t he a p pr o ve d f or m, or w he n use d f or a n u na p pr o ve d 
i n dicati o n, or w he n use d t o gai n f urt her i nf or mati o n a b o ut a n a p pr o ve d use (IC H E 6 1. 3 3).
F or t his st u d y , t he i n vesti gati o nal pr o d uct(s) are G B S 6 (c o ntai ni n g
µ g 
C P S/ser ot y pe/ d ose, eac h f or m ulate d wit h or wit h o ut Al P O 4) a n d place b o (sali ne c o ntr ol).  
Partici pa nt s will recei ve 1 d ose of eit her G B S 6, wit h or wit h o ut Al P O 4, or place b o (sali ne 
c o ntr ol) at Visit 1 a d mi nistere d i ntra m usc ularl y b y 
, 
prefera bl y of t he n o n d o mi na nt ar m.  T he d ose le vel/f or m ulati o n recei ve d b y eac h partici pa nt
will be base d o n w hic h sta ge of t he st u d y t he partici pa nt will be e nr olle d i n (see Ta ble 1 ).
I n St a ge 1, 1 d ose le vel ( 2 0 µ g C P S/ser ot y pe/ d ose), wit h or wit h o ut Al P O 4, will be use d. 
T he b o oster vacci nati o n f or Sta ge 1 will be 1 d ose le vel ( 2 0 µ g C P S/ser ot y pe/ d ose wit h 
Al P O 4).  I n St a ge 2, u p t o 6 d ose le vel/ f or m ulati o ns of G B S 6 m a y  be use d ( 3 d ose le vels, 
eac h f or m ulate d wit h or wit h o ut Al P O 4).  T he n u m ber of d ose le vel/f or m ulati o ns e val uate d 
i n Sta ge 2 will be i nfl ue nce d b y  safety a n d i m m u n o ge nicit y data fr o m t he U S FI H 
P hase 1/ 2 st u d y ( C 1 0 9 1 00 1).  I n St a ge 3, 1 d ose le vel/f or m ulati o n will be e val uate d after a 
re vie w of safety a n d i m m u n o ge nicit y data fr o m Sta ge 2.
See Ta ble 3 f or m ore i nf or mati o n o n t he i n vesti gati o nal pr o d uct d ose le vel/f or m ulati o n 
gr o u ps.
6. 1. I n vesti g ati o n al Pr o d uct S u p plies
G B S 6 a n d place b o (sali ne c o ntr ol) will be pr o vi de d b y  t he s p o ns or t o eac h st u d y site.
St u d y  vacci nes will be pac ke d a n d la bele d as i n vesti gati o nal pr o d uct i n acc or da nce wit h 
c urre nt g ui deli nes a n d a p plica ble l ocal a n d le gal re g ulat or y  re q uire me nts.  T he f or m ulati o n 
of t he i n vesti gati o nal pr o d ucts is descri be d bel o w.
6. 1. 1. D os a ge F or m(s) a n d P ac k a gi n g
G B S 6 is c o m p ose d of ser ot ypes Ia, I b, II, III, I V, a n d V C P S
 
  T here are 3 d ose le vels (
 
), eac h f or m ulate d eit her wit h 
Al P O 4, 
, or wit h o ut Al P O4.  See Ta ble 3 f or 
f urt her details.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI
C CI
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 8
T a ble 3. 
T ar get C o m p ositi o n of t he G B S 6 F or m ul ati o ns I nte n de d f or Cli nic al 
E v al u ati o n
G B S 6 f or m ulate d wit h or wit h o ut Al P O4 is s u p plie d as a sterile preser vati ve-free s ol uti o n 
( wit h o ut Al P O4) or s us pe nsi o n ( wit h Al P O4) 
 
T he place b o will be a sterile n or mal sali ne s ol uti o n f or i njecti o n ( 0. 9 % s o di u m c hl ori de 
i njecti o n, i n a 0. 5-m L  d ose) a n d will be pr o vi de d b y t he s p o ns or t o eac h st u d y site.  T he 
place b o will be pac ka ge d wit hi n cart o ns la bele d b y  Pfizer or its desi g nee i n acc or da nce wit h 
c urre nt g ui deli nes a n d a p plica ble l ocal a n d le gal re g ulat or y  re q uire me nts.
6. 1. 2. Pre p ar ati o n a n d Dis pe nsi n g
I n vesti gati o nal pr o d uct pre parati o n a n d d osi n g i nf or mati o n will be pr o vi de d i n t he 
i n vesti gati o nal pr o d uct ma n ual (I P M).
G B S 6 a n d place b o will be pre pare d b y q ualifie d u n bli n de d site pers o n nel acc or di n g t o t he 
I P M.  T he i n vesti gati o nal pr o d uct will be a d ministere d b y q ualifie d u n bli n de d site pers o n nel 
w h o kee p t he partici pa nt s bli n de d, beca use of t he differe nce i n i n vesti gati o nal pr o d uct 
a p peara nce, ie, cl o u d y f or G B S 6 wit h Al P O 4 vers us clear f or G B S 6 wit h o ut Al P O 4 a n d 
place b o (sali ne c o ntr ol).
T he i n vesti g ati o nal pr o d uct will be assi g ne d usi n g a n i nteracti ve res p o nse tec h n ol o g y  (IR T) 
dr u g ma na ge me nt s ys te m at Visit 1.  T he IR T s ys te m will assi g n partici pa nt s a u ni q ue 
c o ntai ner n u m ber fr o m t he s yste m, w hic h will be pri nte d o n t he cart o n a n d t he vial wit hi n t he 
cart o n.  Q ualifie d u n bli n de d pers o n nel will dis pe nse t he assi g ne d i n vesti gati o nal pr o d uct f or 
pre parati o n a n d a d mi nistrati o n.
Please refer t o t he I P M f or i nstr ucti o ns o n h o w t o pre pare t he i n vesti gati o nal pr o d uct f or 
a d mi nistrati o n.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 5 9
6. 2. All oc ati o n t o I n vest i g ati o n al Pr o d uct
All ocati o n (ra n d o mizati o n) of partici pa nt s t o i n vesti gati o nal pr o d uct gr o u ps will pr ocee d 
t hr o u g h t he use of a n I RT s y ste m (i nteracti ve We b-base d res p o nse [I W R]).  T he u n bli n de d 
dis pe nsi n g pers o n nel 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 de ntificati o n (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 u n bli n de d dis pe nser will t he n be pr o vi de d wit h a ra n d o mizati o n n u m ber, 
i n vesti gati o nal pr o d uct assi g n me nt, a n d c o ntai ner n u m ber w he n i n vesti gati o nal pr o d uct is 
bei n g s u p plie d via t he I RT s y ste 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, ra n d o mizati o n n u m ber, a n d 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 retai ne d b y  t he u n bli n de d dis pe nser i n t he u n bli n de d site 
files.
T he st u d y -s pecific IR T q uic k refere nce g ui de will pr o vi de t he c o ntact i nf or mati o n a n d 
f urt her details o n t he use of t he IR T s y ste m.
Sta ge 1 partici pa nt s a n d mater nal partici pa nt s ( Sta ges 2 a n d 3) wi ll be all ocate d t o a n 
i n vesti gati o nal pr o d uct gr o u p as descri be d a b o ve.  Infa nts (i nfa nt partici pa nt s) of t he 
mater nal partici pa nt s will be assi g ne d a partici pa nt n u m ber at birt h. Si nce t he b o oster 
vacci nati o n f or Sta ge 1 partici pa nt s is o pe n la bel , t he IR T s ys te m will be use d t o all ocate 
t he c o ntai ner n u m ber.
6. 3. P artici p a nt C o m pli a nce
All d oses of i n vesti gati o nal pr o d uct will be a d mi nistere d b y  t he a p pr o priatel y desi g nate d 
st u d y staff at t he i n vesti gat or site.
6. 4. A d mi nistr ati o n
Sta n dar d vacci nati o n practices m u st be o bser ve d, a n d vacci ne m ust n ot be i njecte d i nt o bl o o d 
vessels.  A p pr o priate me dicati o n a n d ot her s u p p orti ve meas ures f or ma na ge me nt of a n ac ute 
h y perse nsiti vit y  reacti o n s h o ul d be a vaila ble i n acc or da nce wit h l ocal g ui deli nes f or sta n dar d 
i m m u nizati o n practices.
Pr e parati o n a n d a d mi nistrati o n of i n vesti gati o nal pr o d ucts s h o ul d 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 h y sicia 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.
I n vesti gati o nal pr o d uct a d mi nistrati o n details will be rec or de d o n t he case re p ort f or m ( C R F).
I n Sta ge 1, partici pa nt s will recei ve 1 d ose of eit her G B S 6, f or m ulate d wit h or wit h o ut 
Al P O 4, or place b o (sali ne c o ntr ol) at Visit 1 i n acc or da nce wit h t he st u d y’s sc he d ule of 
acti vities.  All ret ur ni n g partici pa nt s i n Sta ge 1 will als o recei ve 1 d ose of G B S 6 ( 2 0 µg 
C P S/ser ot y pe/ d ose wit h Al P O 4) at Visit 6 i n acc or da nce wit h t he st u d y ’s sc he d ule of 
acti vities. Sta ge 2 partici pa nt s will recei ve 1 of 3 p ossi ble d ose le vels of G B S 6, f or m ulate d 
wit h or wit h o ut Al P O 4, or place b o (sali ne c o ntr ol) at Visit 1 i n acc or da nce wit h t he st u d y’s 
sc he d ule of acti vities.  
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 0
I n Sta ge 3, part ici pa nts will recei ve 1 selecte d d ose/f or m ulati o n of eit her G B S 6 or place b o 
(sali ne c o ntr ol) at Visit 1 i n acc or da nce wit h t he st u d y’s sc he d ule of acti vities.
G B S 6 or place b o (sali ne c o ntr ol) s h o ul d be a d mi nistere d i ntra m usc ularl y b y 
 
, prefera bly of t he n o n d o mi na nt ar m.
6. 5. I n vesti g ati o n al Pr o d uct St or a ge
T he i n vesti gat or or desi g nee m ust c o nfir m a p pr o priate te m perat ure c o n diti o ns 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 dy i nter ve nti o n .
St u d y  i nter ve nti o ns s h o ul d be st ore d i n t heir ori gi nal c o ntai ners.
I n vesti gati o nal pr o d uct will be s hi p pe d at + 2°C t o + 8 °C t o eac h st u d y site after re q uire d 
re g ulat or y a n d le gal d oc u me nts ha ve bee n recei ve d b y t he s p o ns or.  U p o n recei pt at t he st u d y 
site, t he i n vesti gati o nal pr o d uct s h o ul d be i m me diatel y tra nsferre d t o a + 2°C t o + 8 °C 
te m perat ure-m o nit ore d refri gerat or f or st ora ge.
O nl y  partici pa nts e nr olle d i n t he st u d y ma y recei ve st u d y i nter ve nti o n a n d o nl y a ut h orize d 
site staff ma y s u p pl y or a d mi nister st u d y i nter ve nti o n. All st u d y  i nter ve nti o ns m ust be st ore d 
i n a sec ure, e n vir o n me ntall y c o ntr olle d, a n d m o nit ore d ( ma n ual or a ut o mate d rec or di n g) area 
i n acc or da nce wit h t he la bele d st ora ge c o n diti o ns wit h access li mite d t o t he i n vesti gat or a n d 
a ut h orize d site staff. 
A n y  stora ge c o n diti o ns state d i n t he S R S D ( G B S 6 I B) 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 pr o d uct la bel.
Site s y ste ms m ust be ca pa ble of meas uri n g a n d d oc u me nti n g (f or e xa m ple, via a l o g), 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 
(as a p plica ble, i ncl u di n g fr oze n, refri gerate d, a n d/ or r o o m-te m perat ure pr o d ucts).  T his 
s h o ul d be ca pt ure d fr o m t he ti me of i n vesti gati o nal pr o d uct recei pt t hr o u g h o ut t he st u d y.  
E ve n f or c o nti n u o us -m o nit ori n g s ys te ms, a lo g or site pr oce d ure t hat e ns ures acti ve 
e val uati o n f or e xc ursi o ns s h o ul d be a vaila ble.  T he i nte nt is t o e ns ure t hat t he mi ni m u m a n d 
ma xi m u m te m perat ure is c hec ke d eac h b usi ness da y t o c o nfir m t hat n o e xc ursi o n occ urre d 
si nce t he last e val uati o n a n d t o pro vi de t he site wit h t he ca pa bilit y  t o st ore or vie w t he 
mi ni m u m/ ma xi m u m te m perat ure f or all n o n w or ki n g da ys u p o n ret ur n t o n or mal o perati o ns.  
T he o perati o n of t he te m perat ure m o nit ori n g de vice a n d st ora ge u nit (f or e xa m ple, 
refri gerat or), as a p plica ble, sh o ul d be re g ularl y  i ns pecte d t o e ns ure t he y are mai ntai ne d i n 
w or ki n g or der.
A n y  e xc ursi o ns fr o m t he pr o d uct 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 a n y 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 retur ni n g 
t he st u d y i nter ve nti o n t o t he st ora ge c o n diti o ns descri be d i n t he la beli n g, as s o o n as p ossi ble.  
Recei pt of materials, d o or o pe ni n g a n d cl osi n g, a n d ot her r o uti ne ha n dli n g o perati o ns w here 
t he pr o d ucts are briefly o ut of t he te m perat ure ra n ge descr i be d i n t he la beli n g are n ot 
c o nsi dere d e xc ursi o ns.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 1
O nce a n e xc ursi o n is i de ntifie d, t he i n vesti gati o nal pr o d uct 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 i n vesti gati o nal pr o d uct.  It will n ot be c o nsi dere d 
a pr ot oc ol de v iati o n if Pfizer a p pr o ves t he use of t he i n vesti gati o nal pr o d uct after t he 
te m perat ure e xc ursi o n.  Use of t he i n vesti gati o nal pr o d uct pri or t o Pfizer a p pr o val will be 
c o nsi dere d a pr ot oc ol de viati o n.  S pecific details re gar di n g i nf or mati o n t he site s h o ul d re p ort 
f or eac h e xc ursi o n will be pr o vi de d t o t he site i n t he I PM.
6. 6. I n vesti g ati o n al Pr o d uct Acc o u nt a bilit y
T he i n vesti gat or, i nstit uti o n, or t he hea d of t he me dical i nstit uti o n ( w here a p plica ble) is 
res p o nsi ble f or st u dy i nter ve nti o n acc o u nta bilit y , rec o nciliati o n, a n d rec or d mai nte na nce 
(ie, recei pt, rec o nciliati o n, a n d fi nal dis p ositi o n rec or ds), s uc h as t he I P A L or 
s p o ns or-a p pr o ve d e q ui vale nt. All i n vesti gati o nal pr o d ucts will be acc o u nte d f or usi n g a dr u g 
acc o u nta bilit y f or m/rec or d.
6. 6. 1. Destr ucti o n of I n ve sti g ati o n al Pr o d uct S u p plies
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 I PM. 
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 s ite, t he i n vesti gat or m ust e ns ure t hat t he materials 
are destr o ye d i n c o m plia nce wit h a p plica ble e n vir o n me ntal re g ulati o ns, i nstit uti o nal p olic y , 
a n d a n y s pecial i nstr ucti o ns pr o vi de d b y Pfizer .
U p o n i de ntificati o n of a pr o d uct c o m plai nt, n otif y t he s p o ns o r wit hi n 1 b usi ness da y of 
disc o ver y .
6. 7. Bli n di n g of t he Site Pers o n nel
T his is a n o bser ver -bli n de d st u d y , as t he a p peara nce of G B S 6 a n d place b o will n ot be 
matc he d.  T he st u d y staff dis pe nsi n g a n d a d mi nisteri n g t he vacci ne will be u n bli n de d, b ut 
all ot her st u d y  pers o n nel, i ncl u di n g t he pri nci pal i n vesti gat or, a n d t he partici pa nt , will be 
bli n de d.  T he pri nci pal i n vesti gat or will assi g n t he res p o nsi bilit y  of u n bli n de d dis pe nser a n d 
u n bli n de d a d mi nistrat or t o pers o ns w h o will n ot partici pate i n t he e val uati o n o f a ny st u d y 
partici pa nt .  M ore t ha n 1 u n bli n de d dis pe nser/a d mi nistrat or ma y  be assi g ne d.  A me m ber of 
t he st u d y site staff, or cli nic p har mac y  s h o ul d f ulfill t his r ole.  C o ntact bet wee n t he u n bli n de d 
dis pe nser/a d mi nistrat or a n d st u d y  partici pa nt s s h o ul d be ke pt t o a mi ni m u m.  T he 
i n vesti gat or, st u dy c o or di nat or, a n d a n y site staff ot her t ha n t he u n bli n de d 
dis pe nser/a d mi nistrat or m ust n ot be all o we d t o k n o w t he i n vesti gati o nal pr o d uct assi g ne d t o 
a n y st u d y partici pa nt a n d m ust n ot be all o we d t o se e t he i n vesti gati o nal pr o d uct c o ntai ners.
T he b o oster vacci nati o n at Visit 6 f or Sta ge 1 partici pa nt s will be o pe n la bel.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 2
6. 8. Bli n di n g of t he S p o ns or
I n eac h sta ge of t he st u dy, s p o ns or st u d y  tea m me m bers will re mai n bli n de d t o vacci ne 
assi g n me nt of all partic i pa nts e nr olle d i n t hat sta ge, f oll o wi n g t he pri nci ples o utli ne d i n 
I C H E 9 g ui deli ne o n Statistical Pri nci ples f or Cli nical Trials, Secti o n 2. 3. 1, 6 2 u ntil t he 
pla n ne d i nteri m a nal ys es i n t hat sta ge.  F o ur u n bli n de d i nteri m a nal ys es are pla n ne d i n t he 
st u d y (refer t o Secti o n 1 0. 4 ).  F or t he sec o n d i nteri m a nal y sis, t he st u d y tea m will o nl y be 
u n bli n de d f or t he se nti nel -c o h ort data a n d will re mai n bli n de d f or all e x pa n de d c o h orts.  
I n a n e ve nt t hat u n bli n de d res ults nee d t o be s u b mitte d f or re g ulat or y c o m m u nicati o ns pri or 
t o st u d y tea m u n bli n di n g, eff orts will be ma de t o e ns ure st u d y tea m me m bers i n v ol ve d i n 
partici pa nt assess me nts are bli n de d.
Certai n s p o ns or pers o n nel n ot directl y  i n v ol ve d i n t he c o n d uct of t he st u d y will re vie w 
u n bli n de d data as defi ne d i n a n I RC c harter per Pfizer sta n dar d o perati n g pr oce d ures ( S O Ps).  
U n bli n de d s p o ns or pers o n nel w h o are n ot part of t he st u d y  tea m will be assi g ne d t o assess 
w het her a st o p pi n g r ule is tri g gere d f or o n g oi n g safet y re vie w as well as t o w or k wit h a n 
i n de pe n de nt statistical tea m ce nter f or I R C re vie w acti vities.  L a b orat or y pers o n nel 
perf or mi n g t he i m m u n ol o gic assa y s will re mai n bli n de d t o vacci ne assi g ne d/recei ve d 
t hr o u g h o ut t he st u dy.
T he b o oster vacci nati o n at Visit 6 f or Sta ge 1 partici pa nt s will be o pe n la bel.
6. 9. Bre a ki n g t he Bli n d
T he st u d y  will be partici pa nt a n d i n vesti gat or bli n de d, e xce pt f or t he o pe n -la bel b o oster 
vacci nati o n gi ve n at Visit 6 f or Sta ge 1 partici pa nt s.
At t he i nitiati o n of t he st u d y , t he i n vesti gat or site will be i nstr ucte d o n t he met h o d f or 
brea ki n g t he bli n d.  T he met h o d will be a n electr o nic pr ocess.  Bli n di n g c o des s h o ul d be 
br o ke n o nl y i n e xce pti o nal circ u msta nces w he n k n o wle d ge of t he act ual treat m e nt c o de is 
a bs ol utel y esse ntial f or f urt her ma na ge me nt of t he partici pa nt .  I n vesti gat ors are e nc o ura ge d 
t o disc uss wit h a me m ber of t he st u d y tea m if t he y belie ve t hat u n bli n di n g is necessar y.  
W he n t he bli n di n g c o de is br o ke n, t he reas o n m ust be f ull y  doc u me nte d a n d e ntere d o n t he 
C R F.
6. 1 0. C o nc o mit a nt Tre at me nt(s)
6. 1 0. 1. Pr o hi bite d N o nst u d y V acci nes a n d Me dic ati o ns D uri n g t he St u d y
6. 1 0. 1. 1. St a ge 1

I n vesti gati o nal vacci nes, dr u gs, or me dical de vices are pr o hi bite d d uri n g t he c o urse of 
t he st u d y.

N o nst u d y  di p ht heria- a n d C R M 1 9 7-c o ntai ni n g vacci nes, bl o o d/ plas ma pr o d ucts or 
i m m u n o gl o b uli ns, a n d i m m u n os u p pressi ve t hera p y are pr o hi bite d d uri n g t he c o urse 
of t he st u d y .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 3

Ot her n o nst u d y  vacci nes ma y n ot be gi ve n c o nc o mita ntl y wit h t he i n vesti gati o nal 
pr o d uct or wit hi n 1 4 da ys after i n vesti gati o nal pr o d uct a d mi nistrati o n (e xce pt d uri n g 
a n o ut brea k or pa n de mic sit uati o n).
6. 1 0. 1. 2. St a ges 2 a n d 3 – M ater n al P artici p a nt s

I n vesti gati o nal vacci nes, dr u gs, or me dical de vices are pr o hi bite d d uri n g t he c o urse of 
t he st u d y.

N o nst u d y  di p ht heria- a n d C R M 1 9 7-c o ntai ni n g vacci nes, bl o o d/ plas ma pr o d ucts or 
i m m u n o gl o b uli ns (e xce pt a nti- D i m m u n o gl o b uli n, e g, R h o G A M, w hic h ca n be gi ve n 
at a n y ti me), a n d i m m u n os u p pressi ve t hera p y are pr o hi bite d d uri n g t he c o urse of t he 
st u d y.

Ot her n o nst u d y  vacci nes ma y n ot be give n c o nc o mita ntl y  wit h t he i n vesti gati o nal 
pr o d uct or wit hi n 1 4 da ys after i n vesti gati o nal pr o d uct a d mi nistrati o n (e xce pt d uri n g 
a n o ut brea k or pa n de mic sit uati o n).
6. 1 0. 2. Per mitte d N o nst u d y V acci nes a n d Me dic ati o ns D uri n g t he St u d y
6. 1 0. 2. 1. St a ge 1

Lice nse d i nfl ue nza vac ci ne ma y be gi ve n d uri n g t he st u d y starti n g 1 5 d a y s after 
i n vesti gati o nal pr o d uct a d mi nistrati o n.  If me dicall y necessar y (e g, pa n de mic), 
i nfl ue nza vacci ne ma y be gi ve n at a ny ti me.

I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical (s ki n or e y es) c ortic oster oi ds 
are per mitte d.

T he use of a nti p yr etics a n d ot her pai n me dicati o n t o treat s y m pt o ms ass ociate d wit h 
i n vesti gati o nal pr o d uct a d mi nistrati o n is per mitte d d uri n g partici pa nt 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 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  pri or t o vacci nati o n or t he da y of t he i n vesti gati o nal pr o d uct 
a d mi nistrati o n.

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 c o nc o mita ntl y wit h G B S 6 or place b o (sali ne c o ntr ol ) 
b ut m ust be a d mi nistere d i n a differe nt li m b.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 4
6. 1 0. 2. 2. St a ges 2 a n d 3 – M ater n al P artici p a nt s

Lice nse d i nfl ue nza vacci ne, teta n us vacci nes , a n d teta n us di pht heria vacci nes ma y  be 
gi ve n d uri n g t he st u d y starti n g 1 5 d a y s after i n vesti gati o nal pr o d uct a d mi nistrati o n as 
per l ocal rec o m me n dati o n f or i m m u nizati o n i n pre g na nt w o me n.  If me dicall y  
necessar y  (e g, pa n de mic), i nfl ue nza vacci ne ma y  be gi ve n at a ny ti me.

I n hale d/ ne b ulize d, i ntra-artic ular, i ntra b ursal, or t o pical (s ki n or e yes) c ortic oster oi ds 
are per mitte d.

T he use of a nti p yr etics a n d ot her pai n me dicati o n t o treat s y m pt o ms ass ociate d wit h 
i n vesti gati o nal pr o d uct a d mi nistrati o n is per mitte d d uri n g partici pa nt 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 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  pri or t o vacci nati o n or t he da y of t he i n vesti gati o nal pr o d uct 
a d mi nistrati o n.

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 c o nc o mitantl y  wit h G B S 6 or place b o (sali ne c o ntr ol) 
b ut m ust be a d mi nistere d i n a differe nt li m b.
T he sta n dar d of care f or pre ve nti o n of G B S disease i n i nfa nts will be a p plica ble t o all 
pre g na nt w o me n e nr olle d i n t he st u d y  i n acc or da nce wit h l ocal rec o m me n dati o ns/ gui deli nes.
6. 1 0. 2. 3. St a ges 2 a n d 3 – I nf a nt P artici p a nts

A n y  r o uti ne vacci nati o n gi ve n as part of t he nati o nal rec o m me n de d vacci nati o n 
sc he d ule f or i nfa nts will be a d mi nistere d.
6. 1 0. 3. Rec or di n g N o nst u d y V acci n ati o ns a n d C o nc o mit a nt Me dic ati o ns
6. 1 0. 3. 1. St a ge 1
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 t he ti me of 
si g ni n g of t he I C D t o Visit 3 ( 1-m o nt h f oll o w -u p visit) will be c ollecte d a n d rec or de d i n t he 
C R F. F or partici pa nt s recei vi n g t he b o oster vacci nati o n, 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 t he ti me of si g ni n g of t he IC D ( Visit 5) t o Visit 7 
( 1-m o nt h b o oster vacci nati o n f oll o w - u p) will be c ollecte d a n d rec or de d i n t he C R F.
A n y  me dicati o ns ta ke n fr o m t he si g ni n g of I C D t hr o u g h Visit 3 ( 1-m o nt h f oll o w-u p visit) 
will be rec or de d i n t he C R F.  A d diti o nall y , a ny m e dicati o n ta ke n t o treat A Es fr o m t he 
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. F or partici pa nt s recei vi n g 
t he b o oster vacci nati o n, me dicati o ns ta ke n fr o m t he si g ni n g of I CD ( Visit 5) t hr o u g h Visit 7 
( 1-m o nt h b o oster vacci nati o n f oll o w - u p) will be c ollecte d a n d rec or de d i n t he C R F. 
A d diti o nall y , a ny me dicati o n ta ke n t o treat A Es fr o m t he si g ni n g of t he I C D ( Visit 5) t hr o u g h 
Visit 1 0 will be rec or de d i n t he C R F.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 5
6. 1 0. 3. 2. St a ges 2 a n d 3 – M ater n al P artici p a nt s
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 t he ti me of 
si g ni n g of t he I C D t o Visit 4 ( deli ver y) will be c ollecte d a n d rec or de d i n t he C R F.
A n y  me dicati o ns ta ke n fr o m t he si g ni n g of t he I C D t hr o u g h Visit 3 ( 1-m o nt h f oll o w -u p visit) 
will be rec or de d i n t he C R F.  A nti bi otic treat me nt ta ke n fr o m t he si g ni n g of t he I C D t o 
Visit 9 ( 1 2-m o nt h p ost deli ver y  f oll o w-u p) will be rec or de d.  A d diti o nall y , a n y me dicati o n 
ta ke n t o treat A Es fr o m t he si g ni ng of t he I CD t hr o u g h Visit 9 will be rec or de d i n t he C R F.
6. 1 0. 3. 3. St a ges 2 a n d 3 – I nf a nt P artici p a nts
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 
Visit 1 ( birt h) t o Visit 7 ( 1 2-m o nt h p ost deli ver y  f oll o w-u p) will be c ollecte d a n d rec or de d 
i n t he C R F.
A n y  me dicati o ns ta ke n fr o m Visit 1 ( birt h) t hr o u g h Visit 3 ( 6-wee k p ost deli ver y  f oll o w-u p) 
will be rec or de d i n t he C R F.  A nti bi otic treat me nt ta ke n fr o m birt h t o Visit 7 ( 1 2-m o nt h 
p ost deli ver y  f oll o w- u p) will be rec or de d.  A d diti o nall y, a ny m e dicati o n ta ke n t o treat A Es 
fr o m birt h t hr o u g h Visit 7 will be rec or de d i n t he C R F.
7. S T U D Y P R O C E D U R E S
T he sc he d ule of pr oce d ures is s u m marize d i n t he sc he d ule of acti vities.  T he da y of 
vacci nati o n is c o nsi dere d Da y  1.
7. 1. St a ge 1 St u d y Pr oce d ures – N o n pre g n a nt W o me n
If, beca use of a me dical sit uati o n (s uc h as disease o ut brea k or pa n de mic), st u d y visits ca n n ot 
be c o n d ucte d i n pers o n at t he st u d y site, visit pr oce d ures s h o ul d be c o n d ucte d re m otel y  or via 
tele p h o ne, as is feasi ble.
7. 1. 1. Visit 0 – Scree ni n g ( D a ys - 7 t o - 2 Pri or t o V acci n ati o n)
Partici pa nt s will be scree ne d fr o m 2 t o 7 d a y s pri or t o a d mi nistrati o n of t he i n vesti gati o nal 
pr o d uct t o c o nfir m t hat t he y  meet eli gi bilit y (all of t he i ncl usi o n a n d n o ne of t he e xcl usi o n) 
criteria f or t he st u d y.
If t he partici pa nt is f o u n d i neli gi ble f or t he st u d y o n t he basis of la b orat or y assess me nt, t he 
i n vesti gat or ma y a d vise t he partici pa nt of t he res ults b y  tele p h o ne, a n d t he partici pa nt will 
be wit h dra w n fr o m f urt her partici pati o n i n t he st u d y.  All eli gi ble partici pa nt s ( wit h o ut 
la b orat or y a b n or malities) will pr ocee d t o Visit 1.
T he f oll o wi n g pr oce d ures will be perf or me d:

O btai n writte n i nf or me d c o nse nt bef ore perf or mi n g a n y st u d y- s pecific pr oce d ures.

Assi g n a si n gle partici pa nt i de ntifier usi n g t he I RT s y ste m.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 6

O btai n a n d rec or d t he partici pa nt de m o gra p h y (i ncl u di n g date of birt h, se x, race, a n d 
et h nicit y).  T he c o m plete date of birt h ( 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.

O btai n a n d rec or d a n y m e dical hist or y of cli nical si g nifica nce.

Perf or m p h ys ical e xa mi nati o n e val uati n g a ny cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g b o d y  s yste ms: ge neral a p peara nce; s ki n; hea d, e yes, ears, n ose, 
a n d t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ne ur ol o gical; a n d 
l ym p h n o des.  A b n or mal res ults m ust be rec or de d o n s o urce d oc u me nts a n d t he 
p h y sical e xa mi nati o n pa ge of t he C R F.

Meas ure vital si g ns, i ncl u di n g wei g ht, hei g ht, oral te m perat ure, sitti n g bl o o d press ure 
a n d pulse rate, a n d res pirat or y  rate.

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 (see Secti o n 5 ).

O btai n a bl o o d sa m ple (a p pr o xi matel y  5 m L) f or HI V, H B V, a n d H C V testi n g.  
Partici pa nt s testi n g p ositi ve f or HI V, ac ute or c hr o nic H B V, or H C V will n ot be 
eli gi ble f or ra n d o mizati o n.

C o m plete t he s o urce d oc u me nts.

Rec or d n o nst u d y vacci nati o ns a n d me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 1. 2. Visit 1 – V acci n ati o n ( D a y 1)

E ns ure 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, meets n o ne of t he 
partici pa nt wit h dra wal criteria a s descri be d i n Secti o n 7. 5 , a n d meets n o ne of t he 
te m p orar y dela y criteria as descri be d i n Secti o n 5. 8 .

Re vie w scree ni n g la b orat or y  res ults.

Pri or t o vacci nati o n, meas ure vital si g ns, i ncl u di n g wei g ht, hei g ht, oral te m perat ure, 
sitti n g bl o o d press ure a n d p ulse rate, a n d res pirat or y rate.

Pri or t o vacci nati o n, perf or m a uri ne pre g na nc y  test f or fe male partici pa nt s of 
c hil d beari n g p ote ntial.

Pri or t o vacci nati o n, c ollect a bl o o d sa m ple of a p pr o xi matel y  1 5 m L  f or 
i m m u n o ge nicity assess me nts.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 7

 

 
 Refer t o t he S R M f or f urt her details.

Verif y  u n dersta n din g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or 
c o ntrace pti o n.

A bli n de d site staff me m ber will use t he I R T s ys te m t o o btai n t he partici pa nt ’s 
ra n d o mizati o n n u m ber.  A n u n bli n de d site staff me m ber will use t he I R T t o assi g n 
i n vesti gati o nal pr o d uct c o ntai ner n u m ber a n d will pre pare t he i n vesti gati o nal pr o d uct 
a n d deli ver it t o t he i n vesti gati o nal pr o d uct a d mi nistrat or.  Please refer t o t he I PM
f or 
f urt her i nstr ucti o n o n t his pr ocess.

T he u n bli n de d a d mi nistrat or a d mi nisters a si n gle 
 
, prefera bly of t he n o n d o mi na nt ar m.

Bli n de d site staff m ust o bser ve t he partici pa nt f or at least 3 0 mi n utes after 
i n vesti gati o nal pr o d uct a d mi nistrati o n f or a n y ac ute reacti o ns.  Rec or d a n y ac ute 
reacti o ns i n the partici pa nt ’s s o urce d oc u me nts a n d o n t he A E pa ge of t he C R F, a n d 
o n a n S A E f or m as a p plica ble.

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns a n d a di gital t her m o meter f or 
rec or di n g dail y te m perat ures a n d pr o vi de i nstr ucti o ns o n t heir use.

Iss ue the partici pa nt a n e -diar y  a n d pr o vi de i nstr ucti o ns o n its c o m pleti o n.  As k t he 
partici pa nt t o c o m plete t he e-diar y  fr o m Da y 1 t o Da y 7, wit h Da y 1 bei n g t he da y  of 
vacci nati o n.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diately if pr o m pte d b y  
t he e-diar y  fr o m Da y 1 t o Da y 7 f oll o wi n g vacci nati o n t o deter mi ne if a n u nsc he d ule d 
visit is re q uire d (e g, re d ness or s welli n g at t he i njecti o n site meas uri n g ≥2 1 meas uri n g 
de vice u nits [ ≥1 0. 5 c m]).

Re mi n d partici pa nt s t hat st u d y staff ma y c o ntact t he m 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 .

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dically atte n de d 
e ve nt (e g, e mer ge nc y r o o m) or h os pitalizati o n occ urs.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

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 as descri be d i n 
Secti o n 6. 1 0. 3 .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 8

Rec or d A Es as descri b e d i n Secti o n 8. 8 a n d Secti o n 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 a n u n bli n de d site 
staff me m ber u p dates t he i n vesti gati o nal pr o d uct acc o u nta bilit y rec or ds.

Desi g nate d site staff will re vie w e -diar y  data o nli ne at fre q ue nt i nter vals f or t he 
7 da y s f oll o wi n g vacci nati o n t o e val uate partici pa nt c o m plia nce a n d as part of t he 
o n g oi n g safet y re vie w.
7. 1. 3. Visit 2 – 2- Wee k F oll o w- U p Visit ( 1 4- 1 7 D a ys After Visit 1)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or 
c o ntrace pti o n.

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 5 m L  f or i m m u n o ge nicity assess me nts.

 

Re vie w t he partici pa nt ’s e-diar y  data a n d c ollect t he e-diar y .  C ollect st o p dates of 
a n y e-diar y  e ve nts o n g oi n g o n t he last da y t hat t he e-diar y  was c o m plete d a n d rec or d 
st o p dates i n t he C R F.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d n o nst u d y  vacci nati o ns a n d me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

T he i n vesti gat o r or a n a ut h orize d desi g nee c o m pletes t he C R F.
7. 1. 4. Visit 3 – 1- M o nt h F oll o w -U p Visit ( 2 8- 4 2 D a ys After Visit 1)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or 
c o ntrace pti o n.

C ollect a bl o o d sa m ple of a p pr o x i matel y 1 5 m L  f or i m m u n o ge nicity assess me nts.

 
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 6 9

  Refer t o 
t he S R M f or f urt her details.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

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 as descri be d i n 
Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 1. 5. Visit 4 – 6 -M o nt h F oll o w - Up Tele p h o ne C o nt act ( 1 6 0 -2 0 0 D a ys After Visit 1)
T he 6 - m o nt h tele p h o ne c o ntact s h o ul d be atte m pte d f or all partici pa nt s w h o ha ve recei ve d 
vacci nati o n, u nless t he y  ha ve wit h dra w n c o nse nt.  T he f oll o wi n g pr oce d ures will be 
perf or me d:

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or 
c o ntrace pti o n.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

R ec or d c o nc o mita nt me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .  O nl y c o nc o mita nt 
me dicati o n ta ke n t o treat a n A E will be rec or de d i n t he C R F.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 1. 6. Visit 5 – Pre -B o oster Scree ni n g ( D a ys -7 t o -2 Pri or t o B o oster V acci n ati o n)
Partici pa nt s will be scree ne d fr o m 2 t o 7 d a y s pri or t o t he b o oster vacci nati o n t o c o nfir m t hat 
t he y meet eli gi bilit y (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) f or t he 
b o oster vacci nati o n.
If t he partici pa nt is f o u n d i neli gi ble o n t he basis of la b orat or y  assess me nt, t he i n vesti gat or 
ma y  ad vise t he partici pa nt of t he res ults b y  tele p h o ne, a n d t he partici pa nt will be wit h dra w n 
fr o m f urt her partici pati o n i n t he st u d y.  All eli gi ble partici pa nt s ( wit h o ut la b orat or y 
a b n or malities) will pr ocee d t o Visit 6.
T he f oll o wi n g pr oce d ures will be perf or me d:

O btai n writte n i nf or me d c o nse nt bef ore perf or mi n g a n y st u d y- s pecific pr oce d ures.

Rec or d t he prese nce of c hr o nic c o n diti o ns a n d/ or me dical hist or y  of si g nifica nce, 
i ncl u di n g rele va nt s ur gical pr oce d ures, t hat ha ve bee n dia g n ose d si nce Visit 1.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 0

Pe rf or m p hys ical e xa mi nati o n e val uati n g a ny cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g b o d y  s yste ms: ge neral a p peara nce; s ki n; hea d, e yes, ears, n ose, 
a n d t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ne ur ol o gical; a n d 
l ym p h n o d es.  A b n or mal res ults m ust be rec or de d o n s o urce d oc u me nts a n d t he 
p h y sical e xa mi nati o n pa ge of t he C R F.

Meas ure vital si g ns, i ncl u di n g wei g ht, hei g ht, oral te m perat ure, sitti n g bl o o d press ure 
a n d p ulse rate, a n d res pirat or y rate.

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 (see Secti o n 5 ).

O btai n a bl o o d sa m ple (a p pr o xi matel y  5 m L) f or HI V, H B V, a n d H C V testi n g.  
Partici pa nt s testi n g p ositi ve f or HI V, ac ute or c hr o nic H B V, or H C V will be 
wit h dra w n fr o m f urt her partici pati o n i n t he st u d y .

C ollect a n a d diti o nal bl o o d sa m ple of a p pr o xi matel y  2 5 m L .

C o m plete t he s o urce d oc u me nts.

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 as descri be d i n 
Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 1. 7. Visit 6 – B o oster V acci n ati o n ( A p pr o xi m atel y 2 Y e ars A fter Visit 1)

E ns ure t hat t he partici pa nt is eli gi ble f or t he b o oster vacci nati o n a n d meets n o ne of 
t he te m p orar y dela y criteria as descri be d i n Secti o n 5. 8 .

Re vie w scree ni n g la b orat or y  res ults.

Pri or t o vacci nati o n, meas ure oral te m perat ure.

Pri or t o vacci nati o n, perf or m a uri ne pre g na nc y  test f or fe male partici pa nt s of 
c hil d beari n g p ote ntial.

Pri or t o vacci nati o n, c ollect a bl o o d sa m ple of a p pr o xi matel y  1 4 0 m L.

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or 
c o ntrace pti on.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 1

Use t he I R T t o assi g n i n vesti gati o nal pr o d uct c o ntai ner n u m ber a n d pre pare a n d 
a d mi nister a si n gle 
 
, prefera bly of t he n o n d o mi na nt ar m. Please refer t o t he I P M f or f urt her 
i nstr ucti o n on t his pr ocess.

Site staff m ust o bser ve t he partici pa nt f or at least 3 0 mi n utes after i n vesti gati o nal 
pr o d uct a d mi nistrati o n f or a n y ac ute reacti o ns.  Rec or d a n y ac ute reacti o ns i n t he 
partici pa nt ’s s o urce d oc u me nts a n d o n t he A E pa ge of t he C R F, a n d o n a n S A E f or m 
as a p plica ble.

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns a n d a di gital t her m o meter f or 
rec or di n g dail y te m perat ures a n d pr o vi de i nstr ucti o ns o n t heir use.

Iss ue t he partici pa nt a n e -diar y  a n d pr o vi de i nstr ucti o ns o n its c o m pleti o n.  As k t he 
partici pa nt t o c o m plete t he e-diar y  fr o m Da y 1 t o Da y 7, wit h Da y 1 bei n g t he da y  of 
vacci nati o n.

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diately if pr o m pte d b y 
t he e-diar y  fr o m Da y 1 t o Da y 7 f oll o wi n g vacci nati o n t o deter mine if a n u nsc he d ule d 
visit is re q uire d (e g, re d ness or s welli n g at t he i njecti o n site meas uri n g ≥2 1 meas uri n g 
de vice u nits [ ≥1 0. 5 c m]).

Re mi n d partici pa nt s t hat st u d y staff ma y c o ntact t he m 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 h e e-diar y .

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dically atte n de d 
e ve nt (e g, e mer ge nc y r o o m) or h os pitalizati o n occ urs.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

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 as descri be d i n 
Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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 u p dates t he 
i n vesti gati o nal pr o d uct acc o u nta bilit y rec or ds.

Desi g nate d site staff will re vie w e -diar y  data o nli ne at fre q ue nt i nter vals f or t he 
7 da y s f oll o wi n g vacci nati o n t o e val uate partici pa nt c o m plia nce a n d as part of t he 
o n g oi n g safet y re vie w.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 2
7. 1. 8. Visit 7 – 1- M o nt h B o oster V acci n ati o n F oll o w -U p Visit ( 2 8- 4 2 D a ys After Visit 6)

E ns ure 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 a n d meets n o ne of t he 
part ici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or 
c o ntrace pti o n.

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 4 0 m L .

Re vie w t he partici pa nt ’s e-diar y  data a n d c ollect t he e-diar y .  C ollect st o p dates of 
a n y e-diar y  e ve nts o n g oi n g o n t he last da y t hat t he e-diar y  was c o m plete d a n d rec or d 
st o p dates i n t he C R F.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

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 as descri be d i n 
Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 1. 9. Visit 8 – 3- M o nt h B o oster V acci n ati o n F oll o w -U p Visit ( 8 4- 1 2 6 D a ys After Visit 
6)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or 
c o ntrace pti o n.

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 4 0 m L.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d c o nc o mita nt me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 . O nl y  c o nc o mita nt 
me dicati o n ta ke n t o treat a n A E will be rec or de d i n t he C R F.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 3
7. 1. 1 0. Visit 9 – 6- M o nt h B o oster V acci n ati o n F oll o w -U p Visit ( 1 6 0- 2 0 0 D a ys After 
Visit 6)

E ns ure t hat t he partici pa nt c o nti n ues t o b e eli gi ble f or t he st u d y a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or 
c o ntrace pti o n.

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 4 0 m L.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d c o nc o mita nt me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 . O nl y  c o nc o mita nt 
me dicati o n s ta ke n t o treat a n A E will be rec or de d i n t he C R F.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

T he i n vesti gat o r or a n a ut h orize d desi g nee c o m pletes t he C R F.
7. 1. 1 1. Visit 1 0 – Bl o o d D r a w F oll o w -U p Visit ( 1 4 - 1 8 4 D a ys After Visit 9 )

O btai n writte n i nf or me d c o nse nt bef ore perf or mi n g a n y st u d y- s pecific pr oce d ures.

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Verif y  u n dersta n di n g of a n d c o m plia nce wit h pr ot oc ol re q uire me nts f or 
c o ntrace pti o n.

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 2 5 m L .

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d c o nc o mita nt me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .  O nl y c o nc o mita nt 
me dicati o ns ta ke n t o treat a n A E will be rec or de d i n t he C R F.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 2. St a ge 2 a n d 3 St u d y Pr oce d ures – M ater n al P a rtici p a nts
If, beca use of a me dical sit uati o n (s uc h as disease o ut brea k or pa n de mic), st u d y visits ca n n ot 
be c o n d ucte d i n pers o n at t he st u d y site, visit pr oce d ures s h o ul d be c o n d ucte d re m otel y  or via 
tele p h o ne, as is feasi ble.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 4
7. 2. 1. Visit 0 – Scree ni n g ( D a ys -1 4 t o -2 Pri or t o V acci n ati o n)
Partici pa nt s will be scree ne d fr o m 2 t o 1 4 d a y s prior t o a d mi nistrati o n of t he i n vesti gati o nal 
pr o d uct t o c o nfir m t hat t he y  meet eli gi bilit y (all of t he i ncl usi o n a n d n o ne of t he e xcl usi o n) 
criteria f or t he st u d y.
F or St a ge 2 se nti nel-c o h ort p artici p a nts o nl y: I n t he 1 4-d a y  scree ni n g peri o d, retesti n g of 
the scree ni n g bl o o d/c he mistr y  la b orat or y para meters will be all o we d at t he discreti o n of t he 
i n vesti gat or if t he i n vesti gat or belie ves t he res ults t o be err o ne o us.  I n t his circ u msta nce, 
partici pa nt s will ret ur n f or a sec o n d scree ni n g visit wit hi n t he 1 4- day s cree ni n g peri o d t o 
ree val uate t he scree ni n g la b orat or y para meters (see Secti o n 7. 2. 2 ).
If t he partici pa nt is f o u n d i neli gi ble f or t he st u d y o n t he basis of scree ni n g la b orat or y 
assess me nt a n d re peat testi n g is n ot warra nte d, t he i n vesti gat or ma y  a d vise t he partici pa nt of 
t he res ults b y tele p h o ne, a n d t he partici pa nt will be wit h dra w n fr o m f urt her partici pati o n i n 
t he st u d y.  All eli gi ble partici pa nts will pr ocee d t o Visit 1.
T he f oll o wi n g pr oce d ures will be perf or me d:

O btai n writte n i nf or me d c o nse nt bef ore perf or mi n g a n y st u d y- s pecific pr oce d ures.

Assi g n a si n gle partici pa nt i de ntifier usi n g t he I RT s y ste m.

O b tai n a n d rec or d t he partici pa nt de m o gra p h y (i ncl u di n g date of birt h, se x, race, a n d 
et h nicit y).  T he c o m plete date of birt h ( 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.

O btai n a n d rec or d c urre nt alc o h ol a n d t o bacc o usa ge.

O btai n a n d rec or d a n y m e dical a n d o bstetric hist or y of cli nical si g nifica nce i ncl u di n g 
hist or y  fr o m pri or a n d c urre nt pre g na nc y(ies).  Refer t o t he S R M f or f urt her details.

Rec or d t he last n or mal me nstr ual peri o d ( L M P) a n d esti mate d date of deli ver y  
( E D D).

Meas ure vital si g ns, i ncl u di n g wei g ht, hei g ht, oral te m perat ure, sitti n g bl o o d press ure 
a n d p ulse rate, a n d res pirat or y rate.

Perf or m p h ys ical e xa mi nati o n e val uati n g a ny cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g b o d y s yste ms: ge neral a p peara nce; s ki n; hea d, e yes, ears, n ose, 
a n d t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ne ur ol o gical; a n d 
l ym p h n o des.  A b n or mal res ults m ust be rec or de d o n s o urce d oc u me nts a n d t he 
p h y sical e xa mi nati o n pa ge of t he C R F.

Perf or m o bstetric e xa mi nati o n i ncl u di n g b ut n ot li mite d t o scars fr o m pre vi o us 
deli veries, f u n dal hei g ht, fetal heart t o nes, a n d fetal m o ve me nt.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 5

Perf or m o bstetric ultras o u n d a n d / or rec or d fi n di n gs t o c o nfir m si n glet o n pre g na nc y 
a n d r ule o ut fetal a b n or malities.

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 (see Secti o n 5 ).

O btai n bl o o d sa m ple (a p pr o xi matel y  1 0 m L) f or H B V, H C V, HI V, a n d sy p hilis 
testi n g.  Partici pa nt s testi n g p ositi ve f or HI V, ac ute or c hr o nic H B V, H C V, or 
s yp hilis will n ot be eli gi ble f or ra n d o mizati o n.

Sta ge 2 se nti nel c o h ort o nl y: O btai n a bl o o d sa m ple (ap pr o xi matel y  1 0 m L) f or 
he mat ol o g y  a n d bl o o d c he mistr y assess me nts.  T he f oll o wi n g para meters will be 
assesse d:
o
He mat ol o g y : he m o gl o bi n, he mat ocrit, re d bl o o d cell ( R B C) c o u nt, w hite bl o o d 
cell ( W B C) c o u nt wit h differe ntial, a n d platelets.
o
Bl o o d c he mistries : ala ni ne a mi n otra nsferase ( A L T), as partate a mi n otra nsferase 
( A S T), al kali ne p h os p hatase, t otal bilir u bi n, bl o o d urea nitr o ge n ( B U N), a n d 
creati ni ne.

O btai n uri ne sa m ple f or gl uc ose a n d pr otei n testi n g ( uri ne di pstic k).

C o m plete t he s o urce d oc u me nts.

Rec or d n o nst u d y  vacci nati o ns a n d me dicati o ns (i ncl u di n g a nti bi otic me dicati o ns) as 
descri be d i n Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 2. 2. Visit 0 – Rescree ni n g Visit ( D a ys -1 4 t o -2 Pri or t o V acci n ati o n) – St a ge 2 
Se nti nel -C o h ort P a rtici p a nts O nl y
If a b n or mal bl o o d/c he mistr y la b orat or y para meters are re porte d at Visit 0 a n d t he 
i n vesti gat or belie ves t he res ults t o be err o ne o us, a sec o n d scree ni n g visit ma y be c o n d ucte d.  
T he f oll o wi n g i nf or mati o n will be c ollecte d a n d t he f oll o wi n g assess me nts will be ma de at a 
rescree ni n g visit:

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 (see Secti o n 5 ).

O btai n a bl o o d sa m ple (a p pr o xi matel y  1 0 m L) f or a nalys is of he mat ol o g y a n d bl o o d 
c he mistr y assess me nts (see Secti o n 8. 5. 3 ).  Retest o nl y a b n or mal lab orat or y 
para meters fr o m Visit 0.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 6

C o m plete t he s o urce d oc u me nts.

Rec or d n o nst u d y vacci nati o ns a n d me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
If t he partici pa nt is s u bse q ue ntl y f o u n d i neli gi ble f or t he st u d y o n t he basis of he mat ol o g y 
a n d/ or bl o o d c he mistr y la b orat ory assess me nt, t he i n vesti gat or ma y  a d vise t he partici pa nt of 
t he res ults b y tele p h o ne, a n d t he partici pa nt will be wit h dra w n fr o m f urt her partici pati o n i n 
t he st u d y.  All eli gi ble partici pa nts will pr ocee d t o Visit 1.
7. 2. 3. Visit 1 – V acci n ati o n ( D a y 1) Visit

Re vie w la b orat or y  res ults.

E ns ure 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, meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 , a n d meets n o ne of t he 
te m p orar y dela y criteria as descri be d i n Secti o n 5. 8 .

Pri or t o vacci nati o n, meas ure vital si g ns, i ncl u di n g wei g ht, oral te m perat ure, sitti n g 
bl o o d press ure a n d p ulse rate, a n d res pirat or y  rate.

Perf or m a tar gete d p h ys ical e xa mi nati o n, e val uati n g a ny cli nicall y si g nifica nt 
a b n or malities base d o n hist or y  a n d t he partici pa nt ’s self-re p orte d sy m pt o ms or 
c o m plai nts si nce t he last visit.  A b n or mal res ults, i ncl u di n g t h ose t hat i n dicate 
w orse ni n g of me dical hist or y c o n diti o ns, m ust be rec or de d o n s o urce d oc u me nts 
a n d t he A E C R F ( wit h rec or di n g of ti me relati ve t o vacci nati o n) as a p pr o priate.

Perf or m o bstetric e xa mi nati o n i ncl u di n g b ut n ot li mite d t o f u n dal hei g ht, fetal heart 
t o nes, a n d fetal m o ve me nt.

O btai n uri ne sa m ple f or gl uc ose a n d pr otei n testi n g ( uri ne di pstic k).

Iss ue t he partici pa nt a n e -diar y  a n d pr o vi de i nstr ucti o ns o n its c o m pleti o n.  E ns ure 
t hat t he partici pa nt rec or ds a baseli ne assess me nt of pr o m pte d sys te mic e ve nts i n t he 
e-diar y  pri or t o vacci nati o n.

Pri or t o vacci nati o n, c ollect a bl o o d sa m ple of a p pr o xi matel y  1 5 m L f or 
i m m un o ge nicit y assess me nts.

 

 
 Refer t o the S R M f or f urt her details.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 7

A bli n de d site staff me m ber will use t he I R T s ys te m t o o btai n t he partici pa nt ’s 
ra n d o mizati o n n u m ber.  A n u n bli n de d site staff me m ber will use t he I R T t o assi g n 
i n vesti gati o nal pr o d uct c o ntai ner n u m ber a n d will pre pare t he i n vesti gati o nal pr o d uct 
a n d deli ver it t o t he i n vesti gati o nal pr o d uct a d mi nistrat or.  Please refer t o t he I PM
f or 
f urt her i nstr ucti o n o n t his pr ocess.

T he u n bli n de d a d mi nistrat or a d mi nisters a si n gle 
 
, prefera bly of t he n o n d o mi na nt ar m.

Bli n de d site staff m ust o bser ve t he partici pa nt f or at least 3 0 mi n utes after 
i n vesti gati o nal pr o d uct a d mi nistrati o n f or a n y ac ute reacti o ns.  Rec or d a n y ac ute 
reacti o ns i n t he partici pa nt ’s s o urce d oc u me nts a n d on t he A E pa ge of t he C R F, 
a n d o n a n S A E f or m as a p plica ble.

Iss ue a meas uri n g de vice t o meas ure l ocal reacti o ns a n d a di gital t her m o meter f or 
rec or di n g dail y te m perat ures a n d pr o vi de i nstr ucti o ns o n t heir use.

As k t he partici pa nt t o c o m plete t he e-diar y  fro m Da y 1 t o Da y  7 ( Da y 1 is t he da y  of 
vacci nati o n).

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or i m me diately if pr o m pte d b y 
t he e-diar y  fr o m Da y 1 t o Da y 7 f oll o wi n g vacci nati o n t o deter mi ne if a n u nsc he d ule d 
visit is re q uire d (e g, re d nes s or s welli n g at t he i njecti o n site meas uri n g ≥2 1 meas uri n g 
de vice u nits [ ≥1 0. 5 c m]).

Re mi n d partici pa nt s t hat st u d y staff ma y c o ntact t he m 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 .

As k t he partici pa nt t o c o ntact t he site staff or i n vesti gat or if a me dically atte n de d 
e ve nt (e g, e mer ge nc y r o o m) or h os pitalizati o n occ urs.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

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 (i ncl u di n g a nti bi otic 
me dicati o ns) as descri be d i n Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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 a n u n bli n de d site 
staff me m ber u p dates t he i n vesti gati o nal pr o d uct acc o u nta bilit y rec or ds.

Desi g nate d site staff will re v ie w e-diar y  data o nli ne at fre q ue nt i nter vals f or t he 
7 da y s f oll o wi n g vacci nati o n t o e val uate partici pa nt c o m plia nce a n d as part of t he 
o n g oi n g safet y re vie w.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 8
7. 2. 4. Visit 2 – 2- Wee k F oll o w- U p Visit ( 1 4- 1 7 D a ys After Visit 1)
If deli ver y occ urs bef ore t his visit, t his visit will n ot be c o n d ucte d; h o we ver, t he 
he m at ol o g y a n d c he mistr y assess me nts pl a n ne d t o be c ollecte d at t his visit s h o ul d be 
c o n d ucte d at t he deli ver y visit, if p ossi ble.  F or t he ot her pr oce d ures t o be c o n d ucte d at 
deli ver y, see Secti o n 7. 2. 6 .

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Meas ure vital si g ns, i ncl u di n g wei g ht, oral te m perat ure, sitti n g bl o o d press ure a n d 
p ulse rate, a n d res pirat or y  rate.

Perf or m a tar gete d p h ys ical e xa mi nati o n, e val uati n g a ny cli nicall y si g nifica nt 
a b n or malities base d o n hist or y  a n d t he partici pa nt ’s self-re p orte d sy m pt o ms or 
c o m plai nts si nce t he last visit.  A b n or mal res ults, i ncl u di n g t h ose t hat i n dicate 
w orse ni n g of me dical hist or y  c o n diti o ns, m ust be rec or de d o n s o urce d oc u me nts 
a n d t he A E C R F ( wit h rec or di n g of ti me relati ve t o vacci nati o n) as a p pr o priate.

Perf or m o bstetric e xa mi nati o n i ncl u di n g b ut n ot li mite d t o f u n dal hei g ht, fetal heart 
t o nes, a n d fetal m o ve me nt.

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 5 m L f or i m m u n o ge nicity assess me nts.

St a ge 2 se nti nel c o h ort o nl y: O btai n a bl o o d sa m ple (a p pr o xi matel y  1 0 m L) f or 
he mat ol o g y  a n d bl o o d c he mistr y assess me nts.  T he f oll o wi n g para meters will be 
assesse d:
o
He mat ol o g y : he m o gl o bi n, he mat ocrit, R B C c o u nt, W B C c o u nt wit h differe ntial, 
a n d platelets.
o
Bl o o d c he mistries: A L T, A S T, al kali ne p h os p hatase, t otal bilir u bi n, B U N, a n d 
creati ni ne.
o
Retesti n g of a b n or mal la b orat or y  para meters will be all o we d at t he discreti on of 
t he i n vesti gat or if t he i n vesti gat or belie ves t he res ults t o be err o ne o us.

Re vie w t he partici pa nt ’s e-diar y  data a n d c ollect t he e-diar y .  C ollect st o p dates of 
a n y e-diar y  e ve nts o n g oi n g o n t he last da y t hat t he e-diar y  was c o m plete d a n d rec or d 
st o p dates i n t he C R F.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

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 (i ncl u di n g a nti bi otic 
me dicati o ns) as descri be d i n Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 7 9
7. 2. 5. Visit 3 – 1- M o nt h F oll o w -U p Visit ( 2 8- 4 2 D a ys After Visit 1)
If deli ver y occ urs bef ore t his visit, ple ase c o n d uct t he deli ver y visit i nste a d.  F or 
pr oce d ures t o be c o n d ucte d at deli ver y, see Secti o n 7. 2. 6 .

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Meas ure vital si g ns, i ncl u di n g wei g ht, oral te m perat ure, sitti n g bl o o d press ure a n d 
p ulse rate, a n d res pirat or y  rate.

Perf or m a tar gete d p h ys ical e xa mi nati o n, e val uati n g a ny cli nicall y si g nifica nt 
a b n or malities base d o n hist or y  a n d t he partici pa nt ’s self-re p orte d sy m pt o ms or 
c o m plai nts si nce t he last visit.  A b n or mal res ults, i ncl u di n g t h ose t hat i n dicate 
w orse ni n g of me d ical hist or y c o n diti o ns, m ust be rec or de d o n s o urce d oc u me nts 
a n d t he A E C R F ( wit h rec or di n g of ti me relati ve t o vacci nati o n) as a p pr o priate.

Perf or m o bstetric e xa mi nati o n i ncl u di n g b ut n ot li mite d t o f u n dal hei g ht, fetal heart 
t o nes, a n d fetal m o ve me nt.

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 5 m L f or i m m u n o ge nicity assess me nts.

 

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d n o nst u d y vacci nati o ns a n d me dicati o ns (i ncl u di n g a nti bi otic me dicati o ns) as 
descri be d i n Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 2. 6. Visit 4 – Deli ver y

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Rec or d n o nst u d y vacci nati o ns, a n y me dicati o n ta ke n t o treat A Es, a n d a nti bi otic 
me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 5 m L f or i m m u n o ge nicity assess me nts.  
T he bl o o d sa m ple ma y  be c ollecte d u p t o 7 2 h o urs after deli ver y.  Refer t o t he S R M 
f or bl o o d sa m ple c ollecti o n g ui deli nes.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 0

 
 
 Refer t o t he S R M f or f urt her 
details.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

Rec or d pre g na nc y  o utc o me i nf or mati o n.

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.
7. 2. 7. Visit 5 – 1- Wee k P ost deli ver y F oll o w -U p Tele p h o ne C o nt act ( 7 - 1 0 D a ys After 
Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .  T his tele p h o ne c o ntact 
s h o ul d be perf or me d by 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 
site staff.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d a n y me dicati o n ta ke n t o treat A Es a n d a nti bi otic me dicati o ns as descri be d i n 
Secti o n 6. 1 0. 3 .

Rec or d A Es as descr i be d i n Secti o n 8. 8 a n d Secti o n 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.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 1
7. 2. 8. Visit 6 – 6- Wee k P ost deli ver y F oll o w -U p ( 3 5 -4 9 D a ys After Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partic i pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Perf or m a tar gete d p h ys ical e xa mi nati o n, e val uati n g a ny cli nicall y si g nifica nt 
a b n or malities base d o n hist or y  a n d t he partici pa nt ’s self-re p orte d sy m pt o ms or 
c o m plai nts si nce t he last visit.  A b n or mal res ults, i ncl u di n g t h ose t hat i n dicate 
w orse ni n g of me d ical hist or y c o n diti o ns, m ust be rec or de d o n s o urce d oc u me nts a n d 
t he A E C R F ( wit h rec or di n g of ti me relati ve t o vacci nati o n) as a p pr o priate.

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 5 m L f or i m m u n o ge nicity assess me nts.

  Refer t o 
t he S R M f or f urt her details.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d a n y me dicati o n ta ke n t o treat A Es a n d a nti bi otic me dicati o ns as descri be d i n 
Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a nd Secti o n 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.
7. 2. 9. Visit 7 – 1 4- Wee k P ost deli ver y F oll o w -U p ( 8 0 -1 0 0 D a ys A fter Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d a n y me dicati o n ta ke n t o treat A Es a n d a nti bi otic me dicati o ns as descri be d i n 
Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 2. 1 0. Visit 8 – 6- M o nt h P ost deli ver y F oll o w -U p Tele p h o ne C o nt act ( 1 6 0 -2 0 0 D a ys 
After Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

C o m plete t he partici pa nt ’s s o urce d oc u me nts.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 2

Rec or d a n y me dicati o n ta ke n t o treat A Es a n d a nti bi otic me dicati o ns as descri be d i n 
Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 2. 1 1. Visit 9 – 1 2- M o nt h P ost deli ver y F oll o w -U p ( 3 6 5 -3 8 5 D a ys After Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

C ollect a bl o o d sa m ple of a p pr o xi matel y  1 5 m L f or i m m u n o ge nicity assess me nts.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d a n y me dicati o n ta ke n t o treat A Es a n d a nti bi otic me dicati o ns as descri be d i n 
Secti o n 6. 1 0. 3 .

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 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.
7. 3. St a ge 2 a n d 3 St u d y Pr oce d ures – I nf a nt P artici p a nts
If, beca use of a me dical sit uati o n (s uc h as disease o ut brea k or pa n de mic), st u d y visits ca n n ot 
be c o n d ucte d i n pers o n at t he st u d y site, visit pr oce d ures s h o ul d be c o n d ucte d re m otel y  or via 
tele p h o ne, as is feasi ble.
7. 3. 1. Visit 1 – Deli ver y

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Assi g n a si n gle partici pa nt i de ntifier.

Rec or d de m o gra p h y (i ncl u di n g date of birt h, se x, race, a n d et h nicit y) a n d a vaila ble 
birt h i nf or mati o n, i ncl u di n g b ut n ot li mite d t o i nfa nt partici pa nt vital stat us (li ve, 
still birt h, ne o natal deat h), a p peara nce, p ulse, gri mace, acti vit y, a n d res pirati o n 
( A p gar) sc ore, birt h le n gt h, birt h wei g ht, hea d circ u mfere nce, a n d Ballar d sc ore. If 
t he Ballar d sc ore is u na vaila ble, it ma y be calc ulate d a n d rec or de d u p t o 7 2 h o urs 
after deli ver y.  T he c o m plete date of birt h ( d d-m m m -y y y y) will be c ollecte d t o 
criticall y e val uate t he a nti b o d y le vels a n d safety pr ofile b y a ge.

Rec or d a vaila ble vital si g ns, i ncl u di n g a xillar y  te m perat ure, p ulse rate, a n d 
res pirat or y rate.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 3

Rec or d p h ys ical e xa mi nati o n e val uati n g a n y cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g a vaila ble b o d y  sys te ms: ge neral a p peara nce; s ki n; hea d, e yes, 
ears, n ose, a n d t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; 
ge nit o uri nar y ; bac k; ne ur ol o gical; a n d l y m p h n o des.  A b n or mal res ults m ust be 
rec or de d o n s o urce d oc u me nts a n d t he p h ysical e xa mi nati o n pa ge of t he C R F.

C ollect a c or d bl o o d sa m ple of a p pr o xi matel y  1 0 m L f or i m m u n o ge nicity 
assess me nts.  If c or d bl o o d is u na vaila ble, a b l o o d sa m ple of a p pr o xi matel y 2. 5 m L 
ma y  be c ollecte d i n t he i nfa nt partici pa nt s u p t o 7 2 h o urs after deli ver y.  Refer t o t he 
S R M f or bl o o d sa m ple c ollecti o n g ui deli nes.

Bl o o d s p ot car d c ollecti o n will be perf or me d usi n g t he c or d bl o o d sa m ple, or bl o o d 
dra w ( u p t o 7 2 h o urs after deli ver y) if c or d bl o o d is u na vaila ble.  Refer t o t he S R M 
f or f urt her details.

  Refer t o t he 
S R M f or f urt her details.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

R ec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

Rec or d n o nst u d y vacci nes a n d c o nc o mita nt me dicati o ns (i ncl u di n g a nti bi otic 
me dicati o ns) as descri be d i n Secti o n 6. 1 0. 3 .

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.
7. 3. 2. Visit 2 – 1 -Wee k P ost deli ver y F oll o w - Up Tele p h o ne C o nt act ( 7 - 1 0 D a ys After 
Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

C ollect a n d rec or d breastfee di n g i nf or mati o n.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

Rec or d n o nst u d y vacci nes a n d c o nc o mita nt me dicati o ns (i ncl u di n g a nti bi otic 
me dicati o ns) as descri be d i n Secti o n 6. 1 0. 3 .

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.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 4
7. 3. 3. Visit 3 – 6- Wee k P ost deli ver y F oll o w -U p ( 3 5 -4 9 D a ys After Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Meas ure vital si g ns, i ncl u di n g wei g ht, hei g ht, hea d circ u mfere nce, a xillar y 
te m perat ure, p ulse rate, a n d res pirat or y rate.

Perf or m p h ys ical e xa mi nati o n e val uati n g a ny cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g b o d y  s yste ms: ge neral a p peara nce; s ki n; hea d, e yes, ears, n ose, 
a n d t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ge nit o uri nar y; bac k; 
ne ur ol o gical; a n d l y m p h n o des.  A b n or mal res ults m ust be rec or de d o n s o urce 
d oc u me nts a n d t he p h ys ical e xa mi nati o n pa ge of t he C R F.

C ollect a bl o o d sa m ple of a p pr o xi matel y  5 m L f or i m m u n o ge nicity assess me nts.  
Refer t o t he S R M f or bl o o d sa m ple c ollecti o n g ui deli nes.

  Refer t o t he 
S R M f or f urt her details.

C ollect a n d rec or d breastfee di n g i nf or mati o n.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

Rec or d n o nst u d y vacci nes a n d c o nc o mita nt me dicati o ns (i ncl u di n g a nti bi otic 
me dicati o ns) as descri be d i n Secti o n 6. 1 0. 3 .

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.
7. 3. 4. Visit 4 – 1 4 -Wee k P ost deli ver y F oll o w - Up ( 8 0 -1 0 0 D a ys After Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Meas ure vital si g ns, i ncl u di n g wei g ht, hei g ht, hea d circ u mfere nce, a xillar y 
te m perat ure, p ulse rate, a n d res pirat or y rate.

Perf or m p h ys ical e xa mi nati o n e val uati n g a n y cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g b o d y  s yste ms: ge neral a p peara nce; s ki n; hea d, e yes, ears, n ose, 
a n d t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ge nit o uri nar y; bac k; 
ne ur ol o gical; a n d l y m p h n o des.  A b n o r mal res ults m ust be rec or de d o n s o urce 
d oc u me nts a n d t he p h ys ical e xa mi nati o n pa ge of t he C R F.

C ollect a bl o o d sa m ple of a p pr o xi matel y  5 m L f or i m m u n o ge nicity assess me nts.  
Refer t o t he S R M f or bl o o d sa m ple c ollecti o n g ui deli nes.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 5

  Refer t o t he 
S R M f or f urt her details.

C ollect a n d rec or d breastfee di n g i nf or mati o n.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

Rec or d n o nst u d y vacci nes, a n y  me dicati o n t o ta ke n treat A Es, a n d a nti bi otic 
me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .

T he i n vesti gat or or a n a u t h orize d desi g nee c o m pletes t he C R F.
7. 3. 5. Visit 5 – 1 8- Wee k P ost deli ver y F oll o w -U p ( 1 1 9 -1 3 3 D a ys After Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Meas ure vital si g ns, i ncl u di n g wei g ht, hei g ht, hea d circ u mfere nce, a xillar y 
te m perat ure, p ulse rate, a n d res pirat or y rate.

Perf or m p h ys ical e xa mi nati o n e val uati n g a ny cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g b o d y  s yste ms: ge neral a p peara nce; s ki n; hea d, e yes, ears, n ose, 
a n d t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ge nit o uri nar y; bac k ; 
ne ur ol o gical; a n d l y m p h n o des.  A b n or mal res ults m ust be rec or de d o n s o urce 
d oc u me nts a n d t he p h ys ical e xa mi nati o n pa ge of t he C R F.

C ollect a bl o o d sa m ple of a p pr o xi matel y  5 m L f or assess me nt of a nti b o dy res p o nses 
t o r o uti ne pe diatric vacci nes ( not re q ui re d f or i nfa nts b or n t o U S a n d U K Sta ge 3
partici pa nts) .  Refer t o t he S R M f or bl o o d sa m ple c ollecti o n g ui deli nes.

C ollect a n d rec or d breastfee di n g i nf or mati o n.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

R ec or d n o nst u d y vacci nes, a n y me dicati o n ta ke n t o treat A Es, a n d a nti bi otic 
me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .

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.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 6
7. 3. 6. Visit 6 – 6- M o nt h P ost deli ver y F oll o w -U p Tele p h o ne C o nt act ( 1 6 0 -2 0 0 D a ys After 
Deli ver y)

E ns ure 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 a n d meets n o ne of t he 
partici pa nt wit h dra w al criteria as descri be d i n Secti o n 7. 5 .

C ollect a n d rec or d breastfee di n g i nf or mati o n.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

Rec or d n o nst u d y vacci nes, a n y me dicati o n ta ke n t o treat A Es, a n d a nti bi otic 
me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .

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.
7. 3. 7. Visit 7 – 1 2- M o nt h P ost deli ver y F oll o w -U p ( 3 6 5 -3 8 5 D a ys After Deli ver y)

E ns ure t hat t he partici pa nt c o nti n ues t o be eli gi ble f or t he st u dy a n d meets n o ne of t he 
partici pa nt wit h dra wal criteria as descri be d i n Secti o n 7. 5 .

Meas ure vital si g ns, i ncl u di n g we i ght, hei g ht, hea d circ u mfere nce, a xillar y 
te m perat ure, p ulse rate, a n d res pirat or y rate.

Perf or m p h ys ical e xa mi nati o n e val uati n g a ny cli nicall y si g nifica nt a b n or malities 
wit hi n t he f oll o wi n g b o d y  s yste ms: ge neral a p peara nce; s ki n; hea d, e yes, ears, n ose, 
a n d t hr oat; heart; l u n gs; a b d o me n; m usc ul os keletal; e xtre mities; ge nit o uri nar y; bac k; 
ne ur ol o gical; a n d l y m p h n o des.  A b n or mal res ults m ust be rec or de d o n s o urce 
d oc u me nts a n d t he p h ys ical e xa mi nati o n pa ge of t he C R F.

C ollect a bl o o d sa m ple of a p pr o xi matel y 5 m L f or assess me nt of a nti b o d y res p o nses 
t o r o uti ne pe diatric vacci nes ( not re q uire d f or i nfa nts b or n t o U S a n d U K Sta ge 3 
partici pa nts) .  Refer t o t he S R M f or bl o o d sa m ple c ollecti o n g ui deli nes.

C ollect a n d rec or d breastfee di n g i nf or mati o n.

C o m plete t he partici pa nt ’s s o urce d oc u me nts.

Rec or d A Es as descri be d i n Secti o n 8. 8 a n d Secti o n 9 .

Rec or d n o nst u d y vacci nes, a n y me dicati o n ta ke n t o treat A Es, a n d a nti bi otic 
me dicati o ns as descri be d i n Secti o n 6. 1 0. 3 .

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.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 7
7. 4. U nsc he d ule d Visit ( St a ges 1, 2, a n d 3 – M ater n al P artici p a nt s)
If t he partici pa nt re p orts re d ness or s welli n g at t he i njecti o n site meas uri n g ≥2 1 meas uri n g 
de vice u nits ( ≥1 0. 5 c m), fe ver ≥3 9. 0° C ( ≥1 0 2. 1° F), or se vere i njecti o n site pai n, se vere 
na usea/ v o miti n g, se vere diarr hea, se vere hea dac he, se vere fati g ue/tire d ness, se vere m uscle 
pai n, or se vere j oi nt pai 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 
partici pa nt a n d 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 site staff t o 
assess if a n u nsc he d ule d visit is re q uire d.  A site visit m ust be sc he d ule d as s o o n as p ossi ble 
t o assess t he e xte nt of t he reacti o n u nless:

T he partici pa nt is u na ble t o atte n d t he u nsc he d ule d visit.

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 partici pa nt rec or de d a n i nc orrect val ue i n t he e-diar y  (c o nfir mati o n of a n e-diar y  
data e ntr y  err or).

T he i n vesti gat or 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 C R F a n d i n t he partici pa nt ’s s o urce 
d oc u me ntati o n.
If t he partici pa nt is u na ble t o atte n d t he u nsc he d ule d visit, a n y o n g oi n g reacti o ns m ust be 
assesse d at t he ne xt sc he d ule d visit.
T he reacti o ns s h o ul d be assesse d b y  t he i n vesti gat or or a me dicall y q ualifie d me m ber of t he 
st u d y staff s uc h as a st u d y p h ysicia 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 oral te m perat ure.

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 a n y i njecti o n site pai n t hat is prese nt i n acc or da nce wit h t he gra di n g scale 
pr o vi de d i n Secti o n 8. 5. 2 .

Assess f or l y m p ha de n o pat h y  ass ociate d wit h a ny prese nt l ocal reacti o n.

Assess a n y s ys te mic e ve nts ( na usea/ v o miti n g, diarr hea, hea dac he, fati g ue, m uscle 
pai n, or j oi nt pai n) t hat are prese nt i n acc or da nce wit h t he gra di n g scale pr o vi de d i n 
Secti o n 8. 5. 2 .
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 pa ge of t he 
C R F.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 8
Partici pa nt s will als o be i nstr ucte d t o c o ntact site staff if t he y e x perie nce a n y p ossi ble 
Gra de 4 pr o m pte d s y ste mic e ve nt (ie, e mer ge nc y r o o m visit or h os pitalizati o n f or hea dac he, 
fati g ue, m uscle pai n, j oi nt pai n, etc.) wit hi n 7 d a y s after vacci nati o n.  St u d y staff ma y c o ntact 
t he partici pa nt t o o btai n a d diti o nal i nf or mati o n o n Gra de 3 e ve nts e ntere d i nt o t he e -diar y .  
Lastl y, partici pa nt s will be i nstr ucte d t o c o ntact t he 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 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.
7. 5. P artic i p a nt Wit h dr a w al
A n i n vesti gat or a n d/ or s p o ns or ca n wit h dra w a partici pa nt fr o m t he st u d y if dee me d 
a p pr o priate.  I n a d diti o n, if a partici pa nt fails t o c o nti n ue t o meet t he i ncl usi o n criteria, ne w 
i nf or mati o n bec o mes a vaila ble t hat w o ul d e xcl u de t he parti ci pa nt, or t he partici pa nt de vel o ps 
a c o n diti o n or sit uati o n t hat w o ul d meet e xcl usi o n criteria (e xce pt e xcl usi o n criteria 1 1 a n d 
1 2 [ Sta ge 1] a n d e xcl usi o n criteria 1 4 a n d 1 5 [ Sta ges 2 a n d 3] after Visit 1 relati n g t o G B S 6), 
t he partici pa nt m a y  be c o nsi dere d f or wit h dra wal.  Infa nt partici pa nt s b or n fr o m vacci nate d 
mater nal partici pa nt s ma y be c o nsi dere d f or wit h dra wal fr o m st u d y pr oce d ures f or a n y 
me dical c o n diti o n(s) t hat, i n t he o pi ni o n of t he i n vesti gat or, w o ul d c o ntrai n dicate bl o o d 
sa m pli n g.
Reas o ns w h y  a partici pa nt ma y  disc o nti n ue or be wit h dra w n fr o m t he st u d y i ncl u de, b ut are 
n ot li mite d t o, fail ure t o meet e ntra nce criteria (scree ni n g fail ure), A E, deat h, pre g na nc y  
( Sta ge 1 partici pa nt s o nl y), pr ot oc ol vi olati o n, l ost t o f oll o w- u p, n o l o n ger willin g t o 
partici pate i n t he st u d y, st u d y  ter mi nate d by s p o ns or, i n vesti gat or decli ne d f urt her st u d y 
partici pati o n, or a n y ot her reas o n.  Partici pa nt s w h o ha ve recei ve d t he i n vesti gati o nal pr o d uct 
will n ot be re place d re gar dless of t he reas o n f or wit h dra wal.
7. 5. 1.
W it h dr a w al of C o nse nt
After i n vesti gati o nal pr o d uct a d mi nistrati o n at Visit 1 a n d Visit 6 ( Sta ge 1 o nl y ), partici pa nt s 
( n o n pre g na nt w o me n i n Sta ge 1; mater nal partici pa nt s, a n d pare nts of i nfa nt partici pa nt s b or n 
t o mater nal partici pa nt s i n Sta ges 2 a n d 3) w h o re q uest t o disc o nti n ue f urt her st u d y  
pr oce d ures (e g, bl o o d dra ws) at u pc o mi n g visits will be as ke d t o re mai n i n t he st u d y f or 
pr ot oc ol -s pecifie d safet y f oll o w-u p pr oce d ures.  T he o nl y  e xce pti o n t o t his is w he n a 
partici pa nt or pare nt s pecificall y  wit h dra ws c o nse nt f or a n y f urt her c o ntact wit h hi m or her 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 .  It is per missi ble 
t hat Visit 4 a n d Visit 1 0 ( Sta ge 1 partici pa nt s), Visit 9 ( Sta ge 2 a n d 3 mater nal partici pa nt s), 
a n d Visit 7 ( Sta ge 2 a n d 3 i nfa nt partici pa nt s) be c o n d ucte d via tele p h o ne c o ntact f or 
partici pa nt s w h o are sta yi n g i n t he st u d y f or pr ot oc ol-s pecifie d safety f oll o w- u p pr oce d ures 
o nl y .  Partici pa nt s s h o ul d n otif y t he i n vesti gat or i n writi n g of t he decisi o n t o wit h dra w 
c o nse nt fr o m f ut ure f oll o w -u p, w he ne ver p ossi ble.  T he wit h dra wal of c o nse nt s h o ul d be 
e x plai ne d i n detail i n t he me dical rec or ds b y t he i n vesti gat or, as t o w het her t he wit h dra wal is 
o nl y  fr o m f urt her st u dy pr oce d ures (e g, bl o o d dra ws) a n d / or p ost v acci nati o n st u d y safety 
f oll o w- u p, a n d e ntere d o n t he a p pr o priate C R F pa ge. I n t he e ve nt t hat vital stat us ( w het her 
t he partici pa nt is ali ve or dea d) is bei n g meas ure d, p u blicl y a vaila ble i nf or mati o n s h o ul d be 
use d t o deter mi ne vital stat us o nl y  as a p pr o priatel y directe d i n acc or da nce wit h l ocal la w.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 8 9
7. 6. L ost t o F oll o w - U p
A partici pa nt will be c o nsi dere d l ost t o f oll o w -u p if s he re peate dl y fails t o ret ur n f or 
sc he d ule d visits a n d is u na ble t o be c o ntacte d by t he st u d y  site.
T he f oll o wi n g acti o ns m ust be ta ke n if a partici pa nt fails t o ret ur n t o t he cli nic f or a re q uire d 
st u d y visit:

T he site m ust atte m pt t o c o ntact t he partici pa nt as s o o n as p ossi ble t o resc he d ule t he 
misse d visit, c o u nsel t he partici pa nt o n t he i m p orta nce of mai ntai ni n g t he assi g ne d 
visit sc he d ule, a n d ascertai n w het her or n ot t he partici pa nt wis hes t o a n d/ or s h o ul d 
c o nti n ue i n t he st u d y;

Bef ore a partici pa nt is dee me d l ost t o f oll o w- u p, t he i n vesti gat or or desi g nee m ust 
ma ke e ver y  eff ort t o re gai n c o ntact wit h t he partici pa nt ( w here p ossi ble, ma ke 
3 tele p h o ne calls a n d, if necessar y, se n d a certifie d letter t o t he partici pa nt ’s last 
k n o w n maili n g a d dress or l ocal e q ui vale nt met h o ds).  T hese c o ntact atte m pts s h o ul d 
be d oc u me nte d i n t he partici pa nt ’s me dical rec or d;

S h o ul d t he partici pa nt c o nti n ue t o be u nreac ha ble, s he will be c o nsi dere d t o ha ve 
wit h dra w n fr o m t he st u d y.
Partici pa nt s ma y wit h dra w fr o m t he st u d y at a n y t i me at t heir o w n re q uest, or t he y m a y be 
wit h dra w n at a n y ti me at t he discreti o n of t he i n vesti gat or or s p o ns or f or safet y (see als o t he 
Wit h dra wal Fr o m t he St u d y  D ue t o A d verse E ve nts secti o n) or be ha vi oral reas o ns, or t he 
i na bilit y of t he partici pa nt t o c o m pl y wit h t he pr ot oc ol-re q uire d sc he d ule of st u d y visits or 
pr oce d ures at a gi ve n st u d y  site.
If a partici pa nt d oes n ot ret ur n f or a sc he d ule d visit, e ver y  eff ort s h o ul d be ma de t o c o ntact 
t he partici pa nt /partici pa nt ’s pare nt.  All atte m pts t o c o ntact t he partici pa nt / pare nt a n d 
i nf or mati o n recei ve d d uri n g c o ntact atte m pts m ust be d oc u me nte d i n t he partici pa nt ’s 
me dical rec or d.  I n a n y ci rc u msta nce, e ver y eff ort s h o ul d be ma de t o d oc u me nt partici pa nt
o utc o me , if p ossi ble.  T he i n vesti gat or s h o ul d i n q uire a b o ut t he reas o n f or wit h dra wal, 
re q uest t hat t he partici pa nt ret ur n f or a fi nal visit, if a p plica ble, a n d f oll o w u p wit h t he 
partici pa nt re gar di n g a ny u nres ol ve d A Es.
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 discl os ure of 
f ut ure i nf or mati o n, n o f urt her e val uati o ns s h o ul d be perf or me d, a n d n o a d diti o nal data s h o ul d 
be c ollecte d.  T he s p o ns or ma y  retai n a n d c o nti n ue t o use a n y data c ollecte d bef ore s uc h 
wit h dra wal of c o nse nt.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 0
8. A S S E S S M E N T S
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 sc he d ule of acti vities.  Pr ot oc ol 
wai vers or e xe m pti o ns are n ot all o we d.
Safet y  iss ues s h o ul d be disc usse d wit h t he s p o ns or i m me diatel y u p o n occ urre nce or 
a ware ness t o deter mi ne w het h er t he partici pa nt s h o ul d c o nti n ue or disc o nti n ue st u d y  
i nter ve nti o n.
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 sc he d ule of 
acti vities, is esse ntial a n d re q uire d f or st u dy c o n d uct.
All scree ni n g e val uati o ns m ust be c o m ple te d a n d re vie we d t o c o nfir m t hat p ote ntial 
partici pa nts meet all eli gi bilit y  criteria. T he i n vesti gat or will mai ntai n a scree ni n g l o g t o 
rec or d details of all partici pa nts scree ne d a n d t o c o nfir m eli gi bilit y or rec or d reas o ns f or 
scree ni n g fail ure, as a p plica ble.
E ver y  eff ort s h o ul d be ma de t o e ns ure t hat t he 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 of t he c o ntr ol of t he i n vesti gat or t hat ma y  ma ke it u nfeasi ble t o 
perf or m t he test.  I n t hese cases , t he i n vesti gat or m ust ta ke all ste ps necessar y t o e ns ure t he 
safety a n d well -bei n g of t he partici pa nt .  W he n a pr ot oc ol-re q uire d test ca n n ot be perf or me d, 
t he i n vesti gat or will d oc u me nt t he reas o n f or the misse d test a n d a n y  c orrecti ve a n d 
pre ve nti ve acti o ns t hat he or s he has ta ke n t o e ns ure t hat re q uire d pr ocesses are a d here d t o as 
s o o n as p ossi ble.  T he st u d y tea m m ust be i nf or me d of t hese i nci de nts i n a ti mel y ma n ner.
F or sa m ples bei n g c ollecte d a n d s hi p pe d, detaile d c ollecti o n, pr ocessi n g, st ora ge, a n d 
s hi p me nt i nstr ucti o ns a n d c o ntact i nf or mati o n will be pr o vi de d t o t he i n vesti gat or site pri or 
t o i nitiati o n of t he st u d y.
8. 1. Pre g n a nc y Testi n g ( A p plic a ble t o St a ge 1 P artici p a nt s O nl y)
F or fe male partici pa nt s of c hil d beari n g p ote ntial, a uri ne pre g na nc y test, wit h se nsiti vit y of at 
least 2 5 mI U/ m L , will be perf or me d i m me diatel y bef ore a d mi nistrati o n of i n vesti gati o nal 
pr o d uct.  A ne gati ve pre g na nc y  test res ult is re q uire d bef ore t he partici pa nt ma y recei ve t he 
i n vesti gati o nal pr o d uct.  Pre g na nc y tests will als o be d o ne w he ne ver 1 me nstr ual c y cle is 
misse d d uri n g t he acti ve treat me nt peri o d ( or w he n p ote ntial pre g na nc y  is ot her wise 
s us pecte d).  Pre g na nc y tests ma y als o be re peate d if re q ueste d by i ns tit uti o nal re vie w b oar ds 
(IR Bs)/et hics c o m mittees ( E Cs) or if re q uire d b y  l ocal re g ulati o ns.  I n t he case of a p ositi ve 
c o nfir me d pre g na nc y, t he partici pa nt will be wit h dra w n fr o m a d mi nistrati o n of 
i n vesti gati o nal pr o d uct a n d fr o m t he st u d y.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 1
I n t he case of a p ositi ve c o nfir me d pre g na nc y  after a d mi nistrati o n of i n vesti gati o nal pr o d uct, 
t he partici pa nt m a y  re mai n i n t he st u d y f or bl o o d sa m ple c ollecti o ns a n d safet y m o nit ori n g.
8. 2. Bi ol o gic al S a m ples
Ser u m 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  pers o n nel 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.  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 quire d b y  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 ye ars after t he e n d of t he st u d y a n d t he n destr o ye d.  
If all o we d by t he I CD, 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 po 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 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 (part ici pa nt’s pare nt) ma y re q uest t hat her sa m ples (c hil d’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. I m m u n o ge nicit y
Pfizer will be res p o nsi ble f or all i m m u n o ge nicit y  assa ys.  I m m u n o ge nicit y assa ys will be 
perf or me d at Pfizer Vacci ne Res earc h & De vel o p me nt La b orat or y l ocate d at 4 0 1 N ort h 
Mi d dlet o w n R oa d, Pearl Ri ver, N Y 1 0 9 6 5
a n d/ or at a facilit y desi g nate d b y Pfizer.
8. 3. 1. G B S A nti b o d y Testi n g
Sera c ollecte d fr o m n o n pre g na nt w o me n ( Sta ge 1) a n d mater nal partici pa nt s ( Sta ges 2 a n d 3) 
t hr o u g h o ut t he st u dy a n d fr o m i nfa nt partici pa nt s will be assa ye d f or G B S 6 ser ot yp e -s pecific 
a ntica ps ular a nti b o dies.  Sa m ple c ollecti o n, pr ocessi n g, st ora ge, a n d s hi p pi n g i nf or mati o n 
ca n be f o u n d i n t he S R M or e q ui vale nt ma n ual.  O P A re s ults f or t he 6 ser ot ypes (Ia, I b, II, 
III, I V, a n d V) will be deter mi ne d i n st u d y partici pa nt s’ bl o o d sa m ple s c ollecte d at 
pres pecifie d ti me p oi nts .  Res ults will be re p orte d as O P A titers.  C o nce ntrati o ns of 
a ntica ps ular I g G f or t he 6 ser ot ypes (Ia, I b, II, III, IV, a n d V) will be deter mi ne d i n all 
partici pa nt s f or eac h bl o o d sa m ple b y direct L u mi ne x i m m u n oassa y ( d LI A) a n d re p orte d as 
I g G c o nce ntrati o ns. 
 
 
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 2
8. 3. 3. Assess me nt of A nti b o d y Res p o nses t o R o uti ne Pe di atric V acci nes i n I nf a nt 
P artici p a nts F r o m S o ut h Afric a ( St a ges 2 a n d 3)
Sera fr o m t he 1 8 -wee k a n d 1 2 -m o nt h bl o o d dra ws i n i nfa nt partici pa nt s will be assa ye d f or 
a nti b o dies t o
 
 
8. 5. S afet y P ar a meters
Safet y  para meters will be assesse d as descri be d i n t he sc he d ule of acti vities, Secti o n 7 , a n d 
bel o w. U nsc he d ule d cli nical la b orat or y meas ure me nts ma y  be o btai ne d at a n y ti me d uri n g 
t he st u d y t o assess a n y percei ve d safet y iss ues.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 3
A me dical hist or y  a n d p h ysical e xa mi nati o n will be perf or me d o n all n o n pre g na nt w o me n 
a n d mater nal partici pa nt s, t o esta blis h a baseli ne.  Si g nifica nt me dical hist or y  a n d 
o bser vati o ns fr o m t he p h ysical e xa mi nati o n will be d oc u me nte d i n t he C R F.
T he safet y para meters i ncl u de e -diar y  re p orts of l ocal reacti o ns a n d sys te mic e ve nts t hat 
occ ur i n t he 7 d a y s after i n vesti gati o nal pr o d uct a d mi nistrati o n.  T hese pr os pecti vel y 
c ollecte d occ urre nces of l ocal reacti o ns a n d s ys te mic e ve nts are gra de d as descri be d i n 
Secti o n 8. 5. 2 .
Ac ute reacti o ns wit hi n t he first 3 0 mi n utes after i n vesti gati o nal pr o d uct a d mi nistrati o n will 
be assesse d a n d d oc u me nte d i n t he A E C R F.
I n a d diti o n, A Es, M A Es, a n d S A Es are c ollecte d, rec or de d, a n d re p orte d as defi ne d i n 
Secti o n 9 .
8. 5. 1. P artici p a nt Electr o nic Di ar y
T he pa rtici pa nt will be as ke d t o m o nit or a n d rec or d l ocal reacti o ns, s yste mic e ve nts, 
i ncl u di n g fe ver, a n d a nti p yretics/ pai n me dicati o n use d t o pre ve nt a n d/ or treat s ym pt o ms, 
wit hi n a fi xe d ti me wi n d o w eac h da y  f or 7 d a y s f oll o wi n g vacci nati o n ( w here Da y 1 is t he 
da y  of vacci nati o n) o n a s yste m t hat uses a pers o nal di gital assista nt ( P D A) or ot her 
tec h n ol o g y.  I n Sta ges 2 a n d 3, a baseli ne assess me nt ( na usea/ v o miti n g, diarr hea, hea dac he, 
fati g ue/tire d ness, m uscle pai n, or j oi nt pai n o ver t he pre vi o us m o nt h) pri or t o vacci nati o n 
will be rec or de d i n t he e -diar y .  T his s yste m, hereafter referre d t o as t he partici pa nt ’s e-diar y , 
all o ws rec or di n g of t hese assess me nts o nl y wit hi n a fi xe d ti me wi n d o w, t h us pr o vi di n g t he 
acc urate re prese ntati o n of t he partici pa nt ’s e x perie nce at t hat ti me.  Data o n l ocal reacti o ns, 
s yste mic e ve nts, a n d a nti p yretics/ pai n me dicati o n use d t o pre ve nt a n d/ or treat s ym pt o ms 
re p orte d o n t he e-diar y  will be tra nsferre d electr o nicall y t o t he e-diar y  ve n d or, w here t he y 
will be a vaila ble f or re vie w b y i n vesti gat ors, t heir q ualifie d desi g nees, a n d s p o ns or staff at all 
ti mes via a n i nter net-base d p ortal.  At i nter vals a gree d t o b y t he ve n d or a n d Pfizer, t hese data 
will be tra nsferre d electr o nicall y  t o Pfizer f or a nal ysis a n d re p orti n g.  T hese data d o n ot nee d 
t o be re p orte d by t he i n vesti gat or i n t he C R F.  H o we ver, if a partici pa nt wit h dra ws 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 eve nt(s) t o be cli nicall y  
si g nifica nt.
I n vesti gat ors ( or 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-diar y  data 
o nli ne t o e val uate partici pa nt c o m plia nce a n d as part of t he o n g oi n g safet y re vie w 
(see St o p pi n g R ules i n Secti o n 8. 7 ).
T he i n vesti gat or or desi g nee m ust c o ntact t he partici pa nt i n or der t o o btai n st o p dates f or a ny 
reacti o ns o n g oi n g o n t he last da y t hat the e -diar y  was c o m plete d.  T he st o p dates s h o ul d be 
d oc u me nte d i n t he s o urce d oc u me nts a n d t he i nf or mati o n e ntere d i n t he C R F.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 4
8. 5. 2. Gr a di n g Sc ale 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 A Es as descri be d bel o w are base d o n c o nce pts 
o u tli ne d i n t he F o o d a n d Dr u g A d mi nistrati o n ( F D A) Ce nter f or Bi ol o gics E val uati o n a n d 
Researc h ( C B E R) g ui deli nes o n t o xicit y  gra di n g scales f or healt hy a d ult v ol u nteers e nr olle d 
i n pre ve nti ve vacci ne cli nical trials.6 3
8. 5. 2. 1. L oc al Re acti o ns
Fr o m Da y 1 t o Da y 7, w here Da y  1 is t he da y of vacci nati o n, partici pa nt s will be as ke d t o 
assess pai n at t he i njecti o n site, re d ness, a n d s welli n g a n d t o rec or d t he s y m pt o ms i n t he 
e-diar y  i n t he e ve ni n g.  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 u nits (ra n ge: 1 t o 2 1 +), a n d t he n cate g orize d d uri n g a 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 4 bel o w.  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 by t he partici pa nt 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 4 bel o w.  A partici pa nt wit h a se vere ( Gra de 3 or 
a b o ve) l ocal reacti o n will be pr o m pte d t o c o ntact t he i n vesti gat or t o perf or m a n u nsc he d ule d 
visit a n d assess t he reacti o n.
O nl y  a n i n vesti gat or ca n classif y a partici pa nt ’s l ocal reacti o n 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, i n t he case of pai n at t he i njecti o n site o nl y, 
tele p h o ne c o ntact wit h t he partici pa nt .  If a partici pa nt e x perie nces a Gra de 4 l ocal reacti o n, 
t he i n vesti gat or m ust i m me diatel y n otif y t he s p o ns or.  Site staff will e d ucate t he partici pa nt
re gar di n g si g ns a n d sy m pt o ms t hat w o ul d pr o m pt si te 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 st u d y  d oc u me ntati o n.
If a l ocal reacti o n persists be yo n d t he e n d of t he e -diar y  peri o d f oll o wi n g vacci nati o n, t he 
partici pa nt will be re q ueste d t o re p ort t hat i nf or mati o n a n d/ or a n y  ne w A Es t hat de vel o p t o 
t he i n vesti gat or.  T he i n vesti gat or will e nter t his a d diti o nal i nf or mati o n i n t he C R F.
T a ble 4.
L oc al Re acti o n Gr a di n g Sc ale
Mil d
( Gr a de 1)
M o der ate
( Gr a de 2)
Se vere ( Gr a de 3)a
Gr a de 4 b
P ai n at 
i njecti o n site
D oes n ot i nterfere 
wit h acti vit y
Re peate d use of n o n narc otic 
pai n relie ver 2 4 h o urs or 
i nterferes wit h acti vit y
A n y use of narc otic 
pai n relie ver or pre ve nts 
dail y acti vit y c
E m er ge nc y 
r o o m visit or 
h os pitalizati o n
Er yt he m a/
Re d ness
2. 5 c m t o 5. 0 c m
( 5 t o 1 0 meas uri n g 
de vice u nits)
5. 0 c m t o 1 0. 0 c m ( 1 1 t o 
2 0 meas uri n g de vice u nits)
1 0 c m ( ≥2 1 meas uri n g 
de vice u nits)
Necr osis or 
e xf oliati ve 
der matitis
I n d ur ati o n/
S welli n g
2. 5 c m t o 5. 0 c m 
( 5 t o 1 0 meas uri n g 
de vice u nits)
5. 0 c m t o 1 0. 0 c m ( 1 1 t o 
2 0 meas uri n g de vice u nits)
1 0 c m ( ≥2 1 meas uri n g 
de vi ce u nits)
Necr osis
a.
Partici pa nt s e x perie nci n g ≥Gra de 3 l ocal reacti o ns are t o be see n b y t he st u d y site.
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 will n ot be c ollecte d i n t he electr o nic 
diar y b ut will be rec or de d as a n A E o n t he case re p ort f or m.
c.
Pre ve nts dail y acti vit y, ie, res ults i n misse d da y s of w or k or sc h o ol or is ot her wise i nca pacitati n g or 
i ncl u des use of narc otics f or a nal gesia.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 5
8. 5. 2. 2. S yste mic E ve nts
I n Sta ges 2 a n d 3, pri or t o vacci nati o n, o n Da y  1, a baseli ne assess me nt ( na usea/ v o miti n g, 
diarr hea, hea dac he, fati g ue/tire d ness, m uscle pa i n, a n d j oi nt pai n o ver t he pre vi o us m o nt h) 
will be rec or de d i n t he e -diar y .  Fr o m Da y 1 t o Da y 7, w here Da y  1 is t he da y of vacci nati o n, 
partici pa nt s will be as ke d t o assess na usea/ v o miti n g, diarr hea, hea dac he, fati g ue/tire d ness, 
m uscle pai n, a n d j oi nt pa i n 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.  T he 
s ym pt o ms will be assesse d b y  t he partici pa nt 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 5 bel o w.  Partici pa nt s will als o be i nstr ucte d t o c o ntact site staff if t he y 
e x perie nce a n y p ossi ble Gra de 4 pr o m pte d s y ste mic e ve nt (ie, e mer ge nc y r o o m visit or 
h os pitalizati o n f or na usea/ v o mi ti n g, diarr hea, hea dac he, fati g ue/tire d ness, m uscle pai n, or 
j oi nt pai n) wit hi n 7 da y s after vacci nati o n.  St u d y staff ma y als o c o ntact t he partici pa nt t o 
o btai n a d diti o nal i nf or mati o n o n 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 .  If 
a partici pa nt e x perie nces a Gra de 4 s yste mic e ve nt, t he i n vesti gat or m ust i m me diatel y n otif y 
t he s p o ns or.  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 st u d y 
d oc u me ntati o n.
F urt her, if a s ys te mic e ve nt persists be yo n d t he e n d of t he e -diar y  perio d f oll o wi n g 
vacci nati o n, t he partici pa nt will be re q ueste d t o re p ort t hat i nf or mati o n a n d/ or a n y  ne w A Es 
t hat de vel o p t o t he i n vesti gat or.  T he i n vesti gat or will e nter t his a d diti o nal i nf or mati o n i n t he 
C R F.
T a ble 5.
S yste mic E ve nt Gr a di n g Sc ale
Mil d
( Gr a de 1)
M o der ate
( Gr a de 2)
Se vere ( Gr a de 3) a
Gr a de 4 b
N a use a/ V o miti n g
N o i nterfere nce wit h 
acti vit y or 1 - 2 ti mes i n 
2 4 h o urs
S o m e i nterfere nce 
wit h acti vit y or 
> 2 ti mes i n 2 4 h o urs
Pre ve nts dail y 
acti vit y, re q uires 
I V h y drati o n
E m er ge nc y r o o m 
visit or 
h os pitalizati o n f or 
h y p ote nsi ve s h oc k
Di arr he a
2- 3 l o ose st o ols i n 
2 4 h o urs
4- 5 l o ose st o ols i n 
2 4 h o urs
≥6 l o ose st o ols i n 
2 4 h o urs
E m er ge nc y r o o m 
visit or 
h os pitalizati o n
He a d ac he
N o i nterfere nce wit h 
acti vit y
Re peate d use of 
n o n narc otic pai n 
relie ver > 2 4 h o urs or 
s o me i nterfere nce 
wit h acti vit y 
Si g nifica nt; a n y use 
of narc otic pai n 
relie ver or pre ve nts 
dail y acti vit y c
E m er ge nc y r o o m 
visit or 
h os pitalizati o n
F ati g ue/ Tire d ness
N o i nterfere nce wit h 
acti vit y
S o m e i nterfere nce 
wit h acti vit y
Si g nifica nt; pre ve nts 
dail y acti vit y c
E m er ge nc y r o o m 
visit or 
h os pitalizati o n
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 6
T a ble 5.
S yste mic E ve nt Gr a di n g Sc ale
Mil d
( Gr a de 1)
M o der ate
( Gr a de 2)
Se vere ( Gr a de 3) a
Gr a de 4 b
M uscle p ai n
N o i nterfere nce wit h 
acti vit y
S o m e i nterfere nce 
wit h acti vit y
Si g nifica nt; pre ve nts 
dail y acti vit y c
E m er ge nc y r o o m 
visit or 
h os pitalizati o n
J oi nt p ai n
N o i nterfere nce wit h 
acti vit y
S o m e i nterfere nce 
wit h acti vit y
Si g nifica nt; pre ve nts 
dail y acti vit y c
E m er ge nc y r o o m 
visit or 
h os pitalizati o n
A b bre viati o n: I V = i ntra ve n o us.
a.
Partici pa nt s e x perie nci n g ≥Gra de 3 s yste mic e ve nts are t o be see n b y t he st u d y site.
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 will n ot be c ollecte d i n t he electr o nic 
diar y b ut w ill be c ollecte d as a n A E o n t he case re p ort f or m.
c.
Pre ve nts dail y r o uti ne acti vit y, ie, res ults i n misse d da ys of w or k or sc h o ol or is ot her w ise i nca pacitati n g 
or i ncl u des use of narc otics f or a nal gesia.
8. 5. 2. 3. 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
wit h i nstr ucti o ns o n h o w t o meas ure oral te m perat ure at h o me.  Te m perat ure will be 
c ollecte d i n t he e ve ni n g dail y f or 7 d a y s f oll o wi n g vacci nati o n ( w here Da y 1 is t he da y of 
vacci nati o n) a n d at a n y ti me d uri n g t he 7 d a y s t hat fe ver is s us pecte d.  Fe ver is defi ne d as a n 
oral te m perat ure of ≥3 8. 0° C ( ≥1 0 0. 4° F).  T he hi g hest te m perat ure f or eac h da y will be 
rec or de d i n t he e-diar y .  I n 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 wit h a fe ver 4 0. 0° C (1 0 4. 0° F) will be pr o m pte d t o 
c o ntact t he i n vesti gat or t o assess t he fe ver a n d perf or m a n u nsc he d ule d visit as a p pr o priate.  
St u d y  staff m ust als o c o ntact t he partici pa nt t o o btai n a d diti o nal i nf or mati o n if a te m perat ure 
of ≥3 9° C ( ≥1 0 2. 1° F) is e ntere d i nt o a n e -d iar 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 acc or di n g t o Ta ble 6 bel o w:
T a ble 6.
R a n ges f or Fe ver
3 8. 0 °C t o 3 8. 4 °C ( 1 0 0. 4 °F t o 1 0 1. 1 °F)
3 8. 5 °C t o 3 8. 9 °C ( 1 0 1. 2 °F t o 1 0 2. 0 °F)
3 9. 0 °C t o 4 0. 0 °C ( 1 0 2. 1 °F t o 1 0 4. 0 °F)
4 0. 0 °C ( 1 0 4. 0 °F)
If a fe ver persists be yo n d t he e n d of t he e- diar y  peri o d f oll o wi n g vacci nati o n, t he partici pa nt
will be re q ueste d t o re p ort t hat i nf or mati o n a n d/ or a n y  ne w A Es t hat de vel o p t o t he 
i n vesti gat or.  T he i n vesti gat or will e nter t his a d diti o nal i nf or mati o n i n t he C R F.
8. 5. 3. L a b or at or y Tests
F or St a ge 2 se nti nel-c o h ort p artici p a nt s, t he safet y la b orator y  tests i n Ta ble 7 will be
perf or me d at ti mes defi ne d i n t he sc he d ule of acti vities a n d Secti o n 7 of t he pr ot oc ol.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 7
T a ble 7.
L a b or at or y Tests
H e m at ol o g y
C he mistr y
H e m o gl o bi n
H e m at ocrit
R B C c o u nt
Platelet c o u nt
W B C c o u nt
T otal ne utr o p hils ( A bs)
E osi n o p hils ( A bs)
M o n oc ytes ( A bs)
Bas o p hils ( A bs)
L y m p h oc ytes ( A bs)
B U N a n d creati ni ne
A S T, A L T
T otal bilir u bi n
Al kali ne p h os p hatase
A b bre viati o ns: A bs = a bs ol ute; A L T = ala ni ne a mi n otra nsferase; A S T = as partate a mi n otra nsferase; 
B U N = bl o o d urea nitr o ge n; R B C = re d bl o o d cell; W B C = w hite bl o o d cell.
A t o xicit y  gra di n g scale a da pte d f or use i n pre g na nt w o me n will be use d t o gra de la b orat or y 
test a b n or malities.6 4  Please ref er t o t he S R M f or f urt her details.
If a b n or mal la b orat or y para meters are re p orte d at scree ni n g ( Visit 0) or Visit 2 a n d t he 
i n vesti gat or belie ves t he res ults t o be err o ne o us, t he a b n or mal la b orat or y para meters ma y be 
reteste d.
8. 6. Use of A nti p yretic/ P ai n Me dic ati o n
Fr o m Da y  1 t o Da y 7, w here Da y 1 is t he da y of vacci nati o n, t he partici pa nt will be as ke d t o 
rec or d t he use of a nti p yretic a n d/ or pai n me dicati o n i n t he e-diar y  i n t he e ve ni n g.
8. 7. St o p pi n g R ules
Safet y  will be e val uate d acc or di n g t o t he st o p pi n g r ules defi ne d bel o w.  St o p pi n g r ules 
will be i n effect a n d a p pl y as detaile d bel o w t o partici pa nt s e nr olle d i n se nti nel c o h orts 
(se nti nel-c o h ort st o p pi n g r ules 1 t o 8) a n d partici pa nt s e nr olle d i n eit her se nti nel or e x pa n de d 
c o h orts (st o p pi n g r ule 9) a n d wil l a p pl y o nly t o G B S 6 -vacci nate d partici pa nt s.  “ D ose le vel” 
refers t o t he gr o u p c o m p ose d of partici pa nt s recei vi n g eit her f or m ulati o n ( wit h, a n d wit h o ut 
Al P O 4) at t he s pecifie d d ose of p ol ysacc hari de.  E-diar y  data c o nfir me d t o be e ntere d b y t he 
partici pa n t i n err or will n ot c o ntri b ute t o war d a st o p pi n g r ule.
If it is s us pecte d t hat a st o p pi n g r ule has bee n met base d o n bli n de d safet y assess me nt, t he 
s p o ns or’s desi g nate d u n bli n de d pers o n nel (a n d t heir bac k u p desi g nees) will see k t o verif y 
w het her a st o p pi n g r ule has bee n met base d o n u n bli n de d ra n d o mizati o n i nf or mati o n.  D uri n g 
t his verificati o n pr ocess, t he i n vesti gati o nal sites will be i nstr ucte d b y t he s p o ns or n ot t o 
a d mi nister a n y f urt her i n vesti gati o nal pr o d uct.  If t he u n bli n de d s p o ns or pers o n nel deter mi ne 
t hat a st o p pi n g r ule has n ot bee n met, t he n t he s p o ns or will n otif y i n vesti gati o nal sites t hat 
a d mi nistrati o n of t he i n vesti gati o nal pr o d uct ma y c o nti n ue acc or di n g t o t he cli nical trial 
pr ot oc ol.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 8
I n t he e ve nt t hat t he u n bli n de d s p o ns or pers o n nel c o nfir m t hat a st o p pi n g r ule is met, 
e nr oll me nt a n d a d mi nistrati o n of t he i n vesti gati o nal pr o d uct at t hat d ose le vel will n ot 
c o nti n ue u ntil t he IR C has re vie we d all safet y data a n d pr o vi de d rec o m me n dati o ns t o t he 
E D M C.  T he E D M C will re vie w t he safet y data a n d I RC rec o m me n dati o ns a n d a gree or 
pr o vi de a n alter nate rec o m me n dati o n (t o be detaile d i n t he I R C a n d E D M C c harters).  
Alt h o u g h e nr oll me nt a n d vacci nati o n acti vities at t hat d ose le vel will st o p u ntil I R C a n d 
E D M C re vie w is c o m plete a n d t he iss ue is res ol ve d, all ot her r o uti ne st u d y c o n d uct acti vities 
s uc h as o n g oi n g data e ntr y, re p orti n g of A Es, partici pa nt e-diar y  c o m pleti o n, partici pa nt
f oll o w-u p i ncl u di n g bl o o d dra ws, etc., m ust c o nti n ue d uri n g t his ti me.
Alt h o u g h b ot h f or m ulati o ns ( wit h a n d wit h o ut Al P O 4) at a gi ve n d ose le vel will be e val uate d 
f or c o ntri b uti o n t o st o p pi n g r ules t o get her, it is p ossi ble t hat t he rec o m me n dati o ns ma y 
i ncl u de halti n g or c o nti n ui n g e nr oll me nt wit h eit her or b ot h f or m ulati o ns at a gi ve n d ose 
le vel.
A st o p pi n g r ule will be c o nsi dere d t o ha ve bee n met if a n y of t he f oll o wi n g occ ur i n a 
se nti nel c o h ort:
1.
If a ny G B S 6 -vacci nate d partici pa nt i n a se nti nel c o h ort de vel o ps a n S A E wit hi n 3 0 da y s 
f oll o wi n g vacci nati o n f or w hic h t here is n o ot her clear attri b uta ble ca use, or if t he 
i n vesti gat or deter mi nes t hat t he S A E is relate d t o vacci nati o n.
2.
If a ny G B S 6 -vacci nate d partici pa nt i n a se nti nel c o h ort of a gi ve n d ose le vel e x perie nces 
a pr o m pte d l ocal reacti o n or s yste mic e ve nt c o nsi dere d relate d t o vacci nati o n t hat res ults 
i n a n e mer ge ncy r o o m visit, or a l ocal e q ui vale nt t o t his t y pe of visit, or has l ocal necr osis 
or e xf oliati ve der matitis ( Gra de 4 e ve nt) wit hi n 7 da ys f oll o wi n g vacci nati o n, or a 
Gra de 4 la b orat or y  a b n or malit y at or bef ore t he 2- wee k p ost vacci nati o n visit.
3.
If ≥6 G B S 6 -v a cci nate d partici pa nt s i n a se nti nel c o h ort of a gi ve n d ose le vel 
( 2 8 partici pa nt s i n t otal recei ve a G B S 6 d ose/se nti nel c o h ort) e x perie nce t he sa me 
Gra de 3 l ocal reacti o n or s yste mic e ve nt (see Ta ble 4 a n d Ta ble 5 ) wit hi n 7 da y s 
f oll o wi n g vacci nati o n, n ot attri b uta ble t o a n y ot her ca use, i ncl u di n g:

L ocal re d ness

L ocal s welli n g

L oca l pai n

Hea dac he

Fati g ue

J oi nt pai n

M uscle pai n

Na usea/ v o miti n g

Diarr hea
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 9 9
4.
If ≥2 G B S 6 -vacci nate d partici pa nt s i n a se nti nel c o h ort of a gi ve n d ose le vel 
( 2 8 partici pa nt s i n t otal recei ve a G B S 6 d ose/se nti nel c o h ort) e x perie nce t he sa me or 
si milar Gra de 3 u ns olicite d A E wit hi n 7 d a y s f oll o wi n g vacci nati o n, or la b orat or y 
a b n or malit y at or bef ore t he 2-wee k p ost vacci nati o n visit, n ot attri b uta ble t o a n y  ot her 
ca use.
5.
If ≥2 G B S 6 -vacci nate d partici pa nt s i n a se nti nel c o h ort of a gi ve n d ose le vel 
( 2 8 part ici pa nts i n t otal recei ve a G B S 6 d ose/se nti nel c o h ort) e x perie nce fe ver ≥3 9. 0 °C 
(≥1 0 2. 1° F) f or ≥2 c o nsec uti ve da ys wit hi n 7 da y s f oll o wi n g vacci nati o n, f or w hic h t here 
is n o ot her clear attri b uta ble ca use.
6.
If a ny G B S 6 -vacci nate d partici pa nt i n t he se nti nel c o h ort of a gi ve n d ose le vel 
( 2 8 partici pa nt s i n t otal recei ve a G B S 6 d ose/se nti nel c o h ort) e x perie nces a c o nfir me d 
fe ver 4 0. 0° C ( 1 0 4. 0 °F) f or 1 dail y meas ure me nt wit hi n 7 da y s f oll o wi n g vacci nati o n, 
f or w hic h t here is n o ot her clear attri b uta ble ca use.
7.
If ≥2 G B S 6 -vacci nate d partici pa nt s i n a se nti nel c o h ort of a gi ve n d ose le vel 
( 2 8 partici pa nt s i n t otal recei ve a G B S 6 d ose/se nti nel c o h ort) e x perie nce pre mat ure la b or 
or pre mat ure r u pt ure of me m bra nes wit hi n 1 4 da y s after vacci nati o n.
8.
If a ny G B S 6 -vacci na te d partici pa nt i n a se nti nel c o h ort of a gi ve n d ose le vel e x perie nces 
se vere va gi nal blee di n g (e g, partial a br u pti o n), se vere preecla m psia, ecla m psia, H E L LP 
( he m ol ysis, ele vate d li ver e nz ymes, a n d l o w platelet c o u nt) s y n dr o me, or life -t hreate ni n g 
se q uelae of preecla m psia (e g, p ul m o nar y  e de ma), still birt h, or fetal l oss wit hi n 1 4 da y s 
after vacci nati o n.  Refer t o t he S R M f or f urt her details.
I n a d diti o n, a st o p pi n g r ule will be c o nsi dere d t o ha ve bee n met if t he f oll o wi n g occ urs i n 
eit her a se nti nel or a n e x pa n de d c o h ort:
9.
If a ny G B S 6 -vacci nate d partici pa nt (i n eit her a se nti nel or a n e x pa n de d c o h ort) de vel o ps 
a n S A E d uri n g partici pati o n i n t he st u d y  f oll o wi n g vacci nati o n f or w hic h t he i n vesti gat or 
deter mi nes t hat t he S A E is relate d t o vacci nati o n.
8. 8. Ot her S afet y M o nit ori n g
8. 8. 1. A d verse E ve nts
A Es a n d S A Es re p orte d o utsi de of t he e- diar y  are rec or de d a n d re p orte d as descri be d i n 
Secti o n 9 .
A E s ma y arise fr o m sy m pt o ms or ot her c o m plai nts re p orte d t o t he i n vesti gat or b y  t he 
partici pa nt ( or, w he n a p pr o priate, b y a care gi ver, s urr o gate, or t he partici pa nt's le gall y 
a ut h orize d re prese ntati ve), or t he y  ma y arise fr o m cli nical fi n di n gs of t he in vesti gat or or 
ot her healt hcare pr o vi ders (cli nical si g ns, test res ults, etc.).
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 0
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detecti n g, d oc u me nti n g, a n d 
rec or di n g e ve nts t hat meet t he defi niti o n of a n A E or S A E a n d re mai n res p o nsi ble t o p urs ue 
a n d o btai n a de q uate i nf or mati o n b ot h t o deter mi ne t he o utc o me a n d t o assess w het her t he 
e ve nt meets t he criteria f or classificati o n as a n S A E or ca use d t he partici pa nt t o disc o nti n ue 
t he st u d y i nter ve nti o n (see Secti o n 7. 5 ).
D uri n g t he acti ve c ollecti o n peri o d as descri be d i n Secti o n 9. 1. 4 , eac h partici pa nt/ pare nt/le gal 
g uar dia n/le gall y a ut h orize d re prese ntati ve 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 P fizer 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. 8. 2. I m me di ate A d verse E ve nts
I m me diate A Es, defi ne d as A Es occ urri n g wit hi n t he first 3 0 mi n utes after i n vesti gati o nal 
pr o d uct a d mi nistrati o n, will be assesse d a n d d oc u me nte d i n t he A E C R F.  T he ti me of o nset 
will be rec or de d f or a n y A Es t hat occ ur o n t he sa me da y  as i n vesti gati o nal pr o d uct 
a d mi nistrati o n.
8. 8. 3. Me dic all y Atte n de d A d verse E ve nts
M A Es will be assesse d fr o m scree ni n g f or all partici pa nt s u p t o Visit 4 ( Sta ge 1) f or 
n o n pre g na nt partici pa nt s, u p t o Visit 9 f or mater nal partici pa nt s ( Sta ges 2 a n d 3), a n d u p t o 
Visit 7 f or i nfa nt partici pa nt s ( Sta ges 2 a n d 3). I n a d diti o n, f or partici pa nt s recei vi n g t he 
b o oster vacci nati o n i n Sta ge 1, M A Es will be assesse d fr o m Visit 5 t o Visit 1 0.
A n M A E is defi ne d as a n o nseri o us A E t hat res ults i n a n e val uati o n at a me dical facilit y.
8. 8. 4. A d verse E ve nts of S peci al I nterest
De vel o p me ntal dela y , maj or c o n ge nital dis or ders, a n d s us pecte d or c o nfir me d G B S disease 
i n i nfa nt partici pa nt s will be re p orte d fr o m deli ver y t hr o u g h t he e n d of t he st u d y ( 1 2-m o nt h 
p ost deli ver y visit).
8. 8. 5. R o uti ne Me dic al F acilit y Visits a n d Electi ve H os pit aliz ati o ns N ot Ass oci ate d Wit h 
A d verse E ve nts
R o uti ne visits t o me dical facilities a n d electi ve h os pitalizati o ns n ot ass oc iate d wit h a n A E 
(ie, healt hcare visits f or pre ve nti ve care, or f or r o uti ne p h y sical e xa mi nati o ns) will n ot be 
c ollecte d.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 1
9. A D V E R S E E V E N T R E P O R T I N G
F or mater nal -i m m u nizati o n cli nical st u dies c o n d ucte d i n pre g na nt w o me n, data o n t he 
e x p os ure d uri n g pre g na nc y ( E D P) as well as pre g na nc y o utc o me are c ollecte d a n d a nalyz e d 
i n t he cli nical data base.  F or t hese st u dies, i n ge neral, E D P cases are n ot re p orta ble u nless 
ass ociate d wit h S A Es/ n o nseri o us A Es.  F or t his st u d y , t his will be a p plica ble t o mater nal 
partici pa n ts e nr olle d i nt o Sta ges 2 a n d 3.
T he ter m “ partici pa nt ” i n t his secti o n refers t o ( 1) n o n pre g na nt partici pa nt s; ( 2) t he mater nal 
partici pa nt a n d her fet us; a n d after deli ver y  ( 3) t he mater nal partici pa nt a n d ( 4) t he i nfa nt 
partici pa nt .
9. 1. Re q uire me nts
T he ta b le bel o w s u m marizes t he re q uire me nts f or rec or di n g safety e ve nts o n t he C R F a n d f or 
re p orti n g safet y e ve nts o n t he Vacci ne Seri o us A d verse E ve nt ( S A E) Re p ort i n g F or m t o 
Pfizer Safet y .  T hese re q uire me nts are deli neate d f or 3 t ypes of e ve nts: ( 1) S A Es; 
( 2) n o nseri o us A Es; a n d ( 3) e x p os ure t o t he i n vesti gati o nal pr o d uct u n der st u d y  d uri n g 
pre g na nc y  (f or Sta ge 1 partici pa nt s o nl y), a n d occ u pati o nal e x p os ure.
S afet y E ve nt
Rec or de d o n t he C R F
Re p orte d o n t he V acci ne S A E 
Re p orti n g F or m t o Pfizer S afet y 
Wit hi n 2 4
H o urs of A w are ness
St a ge 1 p artici p a nt s
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 i n vesti gati o nal 
pr o d uct 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
All (re gar dless of w het her 
ass ociate d wit h a n A E), e xce pt 
occ u p ati o n al e x p os ure
E x p os ure d uri n g pre g na nc y, 
e x p os ure via breastfee di n g, 
occ u pati o nal e x p os ure (re gar dless 
of w het her ass ociate d wit h a n A E)
St a ges 2 a n d 3 ( mater n al a n d i nf a nt p artici p a nt s)
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 i n vesti gati o nal 
pr o d uct u n der st u d y via 
occ u pati o nal e x p os ure
N o ne
Occ u pati o nal e x p os ure (re gar dless 
of w het her ass ociate d wit h a n A E)
All o bser ve d or v ol u nteere d e ve nts re gar dless of i n vesti gati o nal pr o d uct gr o u p or s us pecte d 
ca usal relati o ns hi p t o t he i n vesti gati o nal pr o d uct(s) will be re p orte d as descri be d i n t he 
f oll o wi n g para gra p hs.
E ve nts liste d i n t he ta ble a b o ve t hat re q uire re p orti n g t o Pfizer Safet y o n t he Vacci ne S A E 
Re p orti n g F or m wit hi n 2 4 h o urs of a ware ness of t he e ve nt b y t he i n vesti gat or are t o be 
re p orte d re g ar dless of w het her t he e ve nt is deter mi ne d b y t he i n vesti g at or t o be rel ate d 
t o a n i n vesti g ati o n al pr o d uct u n der st u d y.  In partic ular, if t he S A E is fatal or 
life-t hreate ni n g, n otificati o n t o Pfizer Safet y m ust be ma de i m me diately, irres pecti ve of t he 
e xte nt of a vaila ble e ve nt i nf or mati o n.  T his ti me fra me als o a p plies t o a d diti o nal ne w 
(f oll o w-u p) i nf or mati o n o n pre vi o usl y  f or war de d re p orts.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 2
I n t he rare sit uati o n t hat t he i n vesti gat or d oes n ot bec o me i m me diately a ware of t he 
occ urre nce of a n e ve nt, t he i n vesti gat or m ust re p ort t he e ve nt wit hi n 2 4 h o urs after lear ni n g 
of it a n d d oc u me nt t he ti me of his/ her first a ware ness of t he e ve nt.
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 b ot h t o 
deter mi ne t he o utc o me a n d t o assess w het her it meets t he criteria f or classificati o n as a n S A E 
(see t he Seri o us A d verse E ve nts secti o n, Secti o n 9. 2. 3 ).  I n a d diti o n, t he i n vesti gat or ma y be 
re q ueste d by Pfizer Safet y t o o btai n s pecific f oll o w -u p i nf or mati o n i n a n e x pe dite d fas hi o n.  
T his i nf or mati o n is m ore detaile d t ha n t hat rec or de d o n t he C R F.  I n ge neral, t his will i 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 usality.  A n y i nf or mati o n rele va nt t o 
t he e ve nt, s uc h as c o nc o mita nt me dicati o ns a n d ill nesses, m ust be pr o vi de d.  In t he case of 
a partici pa nt deat h, a s u m mar y  of a vaila ble a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as 
p ossi ble t o Pfizer Safet y .  A n y perti ne nt a d diti o nal i nf or mati o n m ust be re p orte d o n t he 
Vacci ne S A E Re p orti n g F or m ; a d diti o nal s o urce d oc u me nts (e g, me dical rec or ds, C R F, 
la b orat or y data) are t o be se nt t o Pfizer Safet y O N L Y u p o n re q uest.
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 clarity 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.
T he i n vesti gat or m ust c o ntact t he Pfizer st u d y  p h ysicia n directly as s o o n as p ossi ble after 
bec o mi n g a ware of:

A se vere A E occ urri n g wit hi n 7 da y s after vacci nati o n i n t he se nti nel c o h ort 
( Sta ge 2).

A n S A E occ urri n g wit hi n 3 0 da y s after vacci nati o n i n t he se nti nel c o h ort ( Sta ge 2).

Pre mat ure la b or or pre mat ure r u pt ure of me m bra nes wit hi n 1 4 da y s after vacci nati o n 
i n t he se nti nel c o h orts ( Sta ge 2).

Se vere va gi nal blee di n g (e g, partial a br u pti o n), se vere preecla m psia, ecla m psia, 
H E L L P ( he m ol y sis, ele vate d li ver e nzy m es, a n d l o w platelet c o u nt) s y n dr o me, or 
life-t hreate ni n g se q uelae of preecla m psia (e g, p ul m o nar y e de ma), still birt h, or fetal 
l oss wit hi n 1 4 da ys after vacci nati o n, i n t he se nti nel c o h orts ( Sta ge 2).

A n S A E occ urri n g d uri n g t he st u d y f oll o wi n g vacci nati o n f or w hic h t he i n vesti gat or 
deter mi nes t hat t he S A E is relate d t o vacci nati o n ( Sta ge 2 se nti nel or e x pa n de d 
c o h ort).
A d diti o nal i nf or mati o n re gar di n g s uc h e ve nts a n d t he re p orti n g re q uire me nts ca n be f o u n d i n 
t he S R M or e q ui vale nt.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 3
T he i n vesti gat or m ust c o ntact t he Pfizer st u d y  p h ysicia n directly as s o o n as p ossi ble after 
bec o mi n g a ware of a n A E of s pecial i nterest.  T his n otificati o n d oes n ot re place a n y of t he 
sta n dar d A E re p orti n g re q uire me nts as descri be d a b o ve.  A d diti o nal i nf or mati o n is i ncl u de d 
i n t he S R M.
9. 1. 1. A d d iti o n al Det ails o n Rec or di n g A d verse E ve nts o n t he C R F
All e ve nts detaile d i n t he ta ble a b o ve will be rec or de d o n t he A E pa ge(s) of t he C R F.  I t 
s h o ul d be n ote d t hat t he Vacci ne S A E Re p orti n g F or m f or re p orti n g of S A E i nf or mati o n is 
n ot t he sa me as t he A E pa ge of t he C R F.  W he n t he sa me data are c ollecte d, t he f or ms m ust 
be c o m plete d i n a c o nsiste nt ma n ner.  A Es s h o ul d be rec or de d usi n g c o ncise me dical 
ter mi n ol o g y a n d t he sa me A E ter m s h o ul d be used o n b ot h t he C R F a n d t he Vacci ne S A E 
Re p orti n g F or m f or re p orti n g of S A E i nf or mati o n.
9. 1. 2. Eliciti n g A d verse E ve nt I nf or m ati o n
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 Es a n d all A Es s p o nta ne o usl y 
re p orte d by t he st u d y partici pa nt / pare nt(s).  I n a d diti o n, eac h st u d y partici pa nt / pare nt(s) 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.
9. 1. 3. Wit h dr a w al Fr o m t he St u d y D ue t o A d verse E ve nts (see als o t he P a rtici p a nt
Wit h dr a w al
S ecti o n)
Wit h dra wal d ue t o A Es s h o ul d be disti n g uis he d fr o m wit h dra wal d ue t o ot her ca uses, 
acc or di n g t o t he defi niti o n of A E n ote d bel o w, a n d rec or de d o n t he C R F.
W he n a partici pa nt wit h dra w s fr o m t he st u dy beca use of a n S A E, t he S A E m ust be rec or de d 
o n t he C R F a n d re p orte d, as a p pr o priate, o n t he Vacci ne S A E Re p orti n g F or m , i n acc or da nce 
wit h t he Re q uire me nts secti o n, Secti o n 9. 1 , a b o ve.
9. 1. 4. Ti me Peri o d a n d Fre q ue nc y f or C ollecti n g A E/ 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 n o n pre g na nt partici pa nt be gi ns fr o m t he ti me t he partici pa nt pr o vi des 
i nf or me d c o nse nt, w hic h is o btai ne d bef ore t he partici pa nt ’s partici pati o n i n t he st u d y 
(ie, bef ore u n der g oi n g a n y st u d y-relate d pr oce d ure a n d/ or recei vi n g st u d y i nter ve nti o n), 
t hr o u g h a n d i ncl u di ng Visit 3, a n d fr o m Visit 5 t o Visit 7. Bet wee n Visit 3 a n d Visit 4, 
a n d bet wee n Visit 7 a n d Visit 1 0 , o nl y S A Es (i ncl u di n g h os pitalizati o ns) a n d M A Es will 
be re p orte d.
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 mater nal partici pa nt i ncl u di n g her fet us be gi ns fr o m t he ti me t he mater nal 
partici pa nt pr o vi des i nf or me d c o nse nt, w hic h is o btai ne d bef ore t he partici pa nt ’s 
partici pati o n i n t he st u d y  (ie, bef ore u n der g oi n g a n y st u d y-relate d pr oce d ure a nd/ or recei vi n g 
st u d y i nter ve nti o n), t hr o u g h a n d i ncl u di n g a mi ni m u m of 2 8 cale n dar da ys (e xce pt as 
i n dicate d bel o w) after t he last a d mi nistrati o n of t he st u d y i nter ve nti o n.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 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 a n d after 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.
F or partici pa nt s 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 w s 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 orarily disc o nti n ues st u d y i nter ve nti o n 
beca use of a n A E or S A E, t he A E or S A E m ust be rec or de d o n t he C R F a n d t he S A E 
re p orte d usi n g t he Vacci ne S A E Re p orti n g F or m .
I n vesti gat ors are n ot o bli gate d t o acti vely see k A Es or S A Es after t he partici pa nt has 
c o ncl u de d st u d y partici pati o n.  H o we ver, if t he i n vesti gat or le ar 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 he/s he c o nsi ders t he e ve nt 
t o be reas o na bl y relate d t o t he st u d y i nter ve nti o n, t he i n vesti gat or m ust pr o m ptl y re p ort t he 
S A E t o Pfizer usi n g t he Vacci ne S A E Re p orti n g F or m .
9. 1. 4. 1. St a ge 1
T he i n vesti gat or a n d site staff will e ns ure t he acti ve elicitati o n a n d c ollecti o n of A Es a n d 
S A Es t hr o u g h Visit 3.  At M o nt h 6 ( Visit 4), t he partici pa nt will be c o ntacte d b y  tele p h o ne 
t o i n q uire a b o ut M A Es a n d S A Es, i ncl u di n g h os pitalizati o ns si nce Visit 3. F or partici pa nt s 
recei vi n g t he b o oster vacci nati o n, site staff will e ns ure t he acti ve elicitati o n a n d c ollecti o n of 
A Es a n d S A Es fr o m Visit 5 t o Visit 7. At Visit 8 ( 3 - mo nt h b o oster v acci nati o n foll o w -u p 
v isit), Visit 9 ( 6 - mo nt h b o oster v acci nati o n foll o w - u p visit), a n d Visit 1 0 (b l o o d dra w
f oll o w-u p visit) , M A Es a n d S A Es (i ncl u di n g h os pitalizati o ns) si nce t he pre vi o us visit will be 
rec or de d.
I m me diate A Es will be re p orte d as detaile d i n Secti o n 8. 8. 2 .
9. 1. 4. 2. St a ges 2 a n d 3 – M ater n al P artici p a nt s
I n t his st u dy, t he i n vesti gat or a n d site staff will e ns ure t he acti ve elic itati o n a n d c ollecti o n of 
A Es a n d S A Es t hr o u g h Visit 3.  At 1 wee k f oll o wi n g deli ver y  ( Visit 5), t he partici pa nt will 
be c o ntacte d b y tele p h o ne t o i n q uire a b o ut M A Es a n d S A Es, i ncl u di n g h os pitalizati o ns, si nce 
Visit 3.  At all s u bse q ue nt visits ( Visits 6, 7, 8, a n d 9), o nl y M A Es a n d S A Es, i ncl u di n g 
h os pitalizati o ns, will be re p orte d.
I m me diate A Es will be re p orte d as detaile d i n Secti o n 8. 8. 2 .
I n a d diti o n, A Es occ urri n g u p t o 4 8 h o urs after t he Visit 4, Visit 6, a n d Visit 9 bl o o d dra ws 
t hat are relate d t o st u dy pr oce d ures m ust be re p orte d i n t he C R F .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 5
9. 1. 4. 3. St a ges 2 a n d 3 – I nf a nt P ar tici p a nts
T he i n vesti gat or a n d site staff will e ns ure t he acti ve elicitati o n a n d c ollecti o n of A Es a n d 
S A Es fr o m birt h ( Visit 1) t hr o u g h Visit 3.  At s u bse q ue nt visits ( Visit 4, Visit 5, Visit 6, a n d 
Visit 7), o nl y  A Es of s pecial i nterest, M A Es, a n d S A Es, i ncl u di n g h os pitalizati o ns, will be 
re p orte d.
I n a d diti o n, A Es occ urri n g u p t o 4 8 h o urs after t he Visit 4, 5, a n d 7 bl o o d dra ws t hat are 
relate d t o st u dy pr oce d ures m ust be re p orte d i n t he C R F.  I n a d diti o n, A Es occ urri n g u p t o 
4 8 h o urs after t he Visit 4
 t hat are relate d t o st u d y pr oce d ures 
m ust be re p orte d i n t he C R F.
Refer t o Ta ble 8 f or a s u m mar y of A E/ S A E c ollecti o n.
T a ble 8. 
Ti me Peri o d f or C ollecti n g A E/ S A E I nf or m ati o n
S afet y E ve nt
St a ge 1
St a ges 2 a n d 3
M ater n al P artici p a nt
St a ges 2 a n d 3
I nf a nt P artici p a nt
N o nseri o us A E
C o nse nt – Visit 3
Visit 5 – Visit 7
C o nse nt – Visit 3
Visit 1 ( birt h) – Visit 3
S A E
C o nse nt – Visit 4
Visit 5 – Visit 1 0
C o nse nt – Visit 9
Visit 1 – Visit 7
M A E
C o nse nt – Visit 4
Visit 5 – Visit 1 0
C o nse nt – Visit 9
Visit 1 – Visit 7
A E of s pecial i nterest
N/ A
N/ A
Visit 1 – Visit 7
I m me diate A E
Wit hi n 3 0
mi n utes of I P 
a d mi nistrati o n
Wit hi n 3 0
mi n utes of I P 
a d mi nistrati o n
N/ A
A E relate d t o st u d y 
pr oce d ure
N ot a p plica ble a
Visit 4, Visit 6, a n d Visit 9 
( u p t o 48 h o urs after bl o o d 
dr a w )
Visit 4, Visit 5, a n d Visit 7 
( u p t o 4 8 h o urs after bl o o d 
dr a w /s wa b c ollecti o n)
A b bre viati o ns: I P = i n vesti gati o nal pr o d uct; M A E = me dicall y atte n de d a d verse e ve nt; N/ A = n ot a p plica ble.
a.
St u d y pr oce d ures will o nl y be perf or me d i n Sta ge 1 d uri n g t he sta n dar d A E/ S A E re p orti n g peri o d , t h us 
A E s relate d t o st u d y pr oce d ures are n ot a p plica ble.  T heref ore, d uri n g Sta ge 1, t hese e ve nt s will be 
re p orte d as per sta n dar d A E re p orti n g re q uire me nts detaile d i n Secti o n 9. 1. 4. 1 .
9. 1. 4. 4. 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 9. 1. 4 are re p orte d t o Pfizer Safet y o n t he Vacci ne S A E Re p orti n g F or m , i m me diately 
u p o n a ware ness a n d u n der n o circ u msta nce s h o ul d t his e xcee d 2 4 h o urs , a n d t he E x p os ure 
D uri n g Pre g na nc y S u p ple me ntal F or m ( Sta ge 1 partici pa nt s o nl y ), if a p plica ble. 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 bei n g 
a vaila ble.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 6
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 ncl u di n g miscarria ge a n d misse d a b orti o n, i ntra uteri ne fetal de mise, 
ne o natal deat h [ defi ne d as t h ose deat hs t hat occ ur wit hi n 1 m o nt h of birt h], or c o n ge nital 
a n o mal y [ defi ne d as str uct ural or f u ncti onal a n o malies (e g, meta b olic dis or ders) t hat occ ur 
d uri n g i ntra uteri ne life a n d ca n be i de ntifie d pre natall y , at birt h or later i n life]).6 5  T hese 
S A Es ca n occ ur 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 n d rec or d 
t his i nf or mati o n i n t he C R F.  I n a d diti o n, i nfa nt deat hs after 1 m o nt h of a ge s h o ul d be 
re p orte d as S A Es a n d rec or de d i n t he C R F.
F urt her f oll o w -u p ma y  be re q ueste d b y t he s p o ns or a n d 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 nt partici pa nt s t o i de ntif y de vel o p me ntal dela ys).
S A Es occ urri n g i n a parti ci pa nt after t he acti ve c ollecti o n peri o d has e n de d are re p orte d t o 
Pfizer Safet y  if t he i n vesti gat or bec o mes a ware of t he m; at a mi ni m u m, all S A Es t hat t he 
i n vesti gat or belie ves ha ve at least a reas o na ble p ossi bilit y of bei n g relate d t o i n vesti gati o nal 
pr o d uct m ust be re p orte d t o Pfizer Safet y .
T he sa me is a p plie d f or t h ose S A Es after t he acti ve c ollecti o n peri o d has e n de d s h o ul d t he y  
occ ur t o t he fet us.  I n a d diti o n, i nfa nt deat hs t hat occ ur after 1 2 m o nt hs of a ge s h o ul d be 
re p orte d as S A Es w he n t he i n vesti gat or belie ves t he deat h has at least a reas o na ble p ossi bilit y 
of bei n g relate d t o i n vesti gati o nal pr o d uct.
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 a n d after t he acti ve c ollecti o n peri o d a n d 
u ntil t he e ve nt 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.
9. 1. 4. 5. 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 A Es/ 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 9. 1. 4 , 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.
T he i n vesti gat or o btai ns 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 st u d y 
partici pa nt s.  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).  I n t he case of a li ve birt h, t he str uct ural i nte grit y of t he ne o nate ca n be assesse d 
at t he ti me of birt h.  I n t he e ve nt of a ter mi nati o n, t he reas o n(s) f or ter mi nati o n s h o ul d be 
s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural i nte grity of t he ter mi nate d fet us s h o ul d be 
assesse d b y gr oss vis ual i ns pecti o n ( u nless pre pr oce d ure test fi n di n gs are c o ncl usi ve f or a 
c o n ge nital a n o mal y a n d t he fi n di n gs are re p orte d).
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 7
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 ncl u di n g miscarria ge a n d misse d a b orti o n, i ntra uteri ne fetal de mise, 
ne o natal deat h [ defi ne d as t h ose deat hs t hat occ ur wit hi n 1 m o nt h of birt 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 rec or d t his i nf or mati o n i n t he C R F.  I n a d diti o n, i nfa nt deat hs 
after 1 m o nt h of a ge s h o ul d be rec or de d i n t he C R F as S A Es.
9. 1. 5. F oll o w - u p of A Es a n d S A Es
After t he i nitial A E or S A E r e 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 h e partici pa nt is l ost t o f oll o w- u p (as defi ne d i n Secti o n 7. 5. 1 ).
I n ge neral, f oll o w-u p i nf or mati o n will i ncl u de a descri pti o n of t he e ve nt i n s ufficie nt detail 
t o all o w f or a c o m plete me dical assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of 
p ossi ble ca usalit y . A n y i nf or mati o n rele va nt t o t he e ve nt, s uc h as c o nc o mita nt me dicati o ns 
a n d ill nesses, m ust be pr o vi de d. I n t he case of a partici pa nt deat h, a s u m mar y of a vaila ble 
a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o Pfizer Safet y.
9. 1. 6. C a us alit y Assess me nt
T he i n vesti gat or’s assess me nt of ca usalit y m ust be pr o vi de d f or all A Es (seri o us a n d 
n o nseri o us); t he i n vesti gat or m ust rec or d t he ca usal relati o ns hi p o n t he C R F, a n d re p ort 
s uc h a n assess me nt i n acc or da nce wit h t he S A E re p orti n g re q uire me nts, if a p plica ble.  A n 
i n vesti gat or’s ca usality assess me nt is t he deter mi nati o n of w het her t here e xists a reas o na ble 
p ossi bilit y  t hat t he i n vesti gati o nal pr o d uct ca use d or c o ntri b ute d t o a n A E; ge nerally, t he 
facts (e vi de nce) or ar g u me nts t o s u g gest a ca usal relati o ns hi p s h o ul d be pr o vi de d.  If t he 
i n vesti gat or d oes n ot k n o w w het her or n ot t he i n vesti gati o nal pr o d uct ca use d t he e ve nt, the n 
t he e ve nt will be ha n dle d as “relate d t o i n vesti gati o nal pr o d uct” f or re p orti n g p ur p oses, as 
defi ne d b y t he s p o ns or.  If t he i n vesti gat or's ca usalit y assess me nt is “ u n k n o w n b ut n ot 
relate d” t o i n vesti gati o nal pr o d uct, t his s h o ul d be clearly d oc u me nte d o n st u d y  rec or ds.
I n a d diti o n, if t he i n vesti gat or deter mi nes t hat a n S A E is ass ociate d wit h st u d y pr oce d ures, 
t he i n vesti gat or m ust rec or d t his ca usal relati o ns hi p i n t he s o urce d oc u me nts a n d C R F, a n d 
re p ort s uc h a n assess me nt i n t he de dicate d secti o n of t he Vacci ne S A E Re p orti n g F or m a n d 
i n acc or da nce wit h t he S A E re p orti n g re q uire me nts.
9. 1. 7. S p o ns or’s Re p orti n g Re q uire me nts t o Re g ul at or y A ut h orities
A E re p orti n g, i ncl u di n g s us pecte d u ne x pecte d seri o us a d verse reacti o ns, will be carrie d o ut 
i n acc or da nce wit h a p plica ble l ocal re g ulati o ns.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 8
9. 2. Defi niti o ns
9. 2. 1. A d verse E ve nts
A n A E is a n y u nt o war d me dical occ urre nce i n a st u d y partici pa nt a d mi nistere d a pr o d uct or 
me dical de vice; t he e ve nt nee d n ot necessaril y ha ve a ca usal relati o ns hi p wit h t he treat me nt 
or usa ge.  E xa m p les of A Es i ncl u de, b ut are n ot li mite d t o:

A b n or mal test fi n di n gs;

Cli nicall y  si g nifica nt si g ns a n d s ym pt o ms;

C ha n ges i n p h ys ical e xa mi nati o n fi n di n gs;

H y perse nsiti vit y ;

Pr o gressi o n/ w orse ni n g of u n derl yi n g disease;

Dr u g a b use;

Dr u g de pe n de nc y .
A d diti o nall y, A Es ma y i ncl u de si g ns a n d s y m pt o ms res ulti n g fr o m:

Dr u g o ver d ose;

Dr u g wit h dra wal;

Dr u g mis use; 

Dr u g i nteracti o ns;

E xtra vasati o n;

E D P ( Sta ge 1 partici pa nts o nl y );

E x p os ure via breastfee di n g ( Sta ge 1 partici pa nts o nl y );

Vacci nati o n err or;

Occ u pati o nal e x p os ure.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 0 9
9. 2. 2. A b n or m al Test Fi n di n gs
A b n or mal o bjecti ve test fi n di n gs s h o ul d be rec or de d as A Es w he n a n y of t he f oll o wi n g 
c o n diti o ns are met:

Test res ult is ass ociate d wit h acc o m pa n yi n g s y m pt o ms; a n d/ or

Test res ult re q uires a d diti o nal dia g n ostic testi n g or me d ical/s ur gical i nter ve nti o n; 
a n d/ or

Test res ult lea ds t o a c ha n ge i n st u d y d osi n g ( 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;  a n d/ or

Test res ult is c o nsi dere d t o be a n A E b y t he i n vesti gat or or s p o ns or.
Merel y re peati n g a n a b n or mal test, i n t he a bse nce of a n y of t he a b o ve c o n diti o ns, d oes n ot 
c o nstit ute a n A E.  A n y a b n or mal test res ult t hat is deter mi ne d t o be a n err or d oes n ot re q uire 
rec or di n g as a n A E.
9. 2. 3. Seri o us A d verse E ve nts
A n S A E is a n y  u nt o war d me dical occ urre nce at a n y d ose t hat:

Res ults i n deat h;

Is life-t hreate ni n g (i m me diate ris k of deat h);

Re q uires i n patie nt h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n;

Res ults i n persist e nt or si g nifica nt disa bilit y/i nca pacit y (s u bsta ntial disr u pti o n of t he 
a bilit y t o c o n d uct n or mal life f u ncti o ns);

Res ults i n c o n ge nital a n o mal y/ birt h defect;
Or t hat is c o nsi dere d t o be:

A n i m p orta nt me dical e ve nt.
Me dical a n d scie ntific j u d g me nt is e xerc ise d i n deter mi ni n g w het her a n e ve nt is a n i m p orta nt 
me dical e ve nt.  A n i m p orta nt me dical e ve nt ma y  n ot be i m me diatel y life-t hreate ni n g a n d/ or 
res ult i n deat h or h os pitalizati o n.  H o we ver, if it is deter mi ne d t hat t he e ve nt ma y je o par dize 
t he partici pa nt o r ma y re q uire i nter ve nti o n t o pre ve nt o ne of t he ot her A E o utc o mes, t he 
i m p orta nt me dical e ve nt s h o ul d be re p orte d as seri o us.
E xa m ples of s uc h e ve nts are i nte nsi ve treat me nt i n a n e mer ge nc y  r o o m or at h o me f or 
aller gic br o nc h os pas m; bl o o d d y scrasias or c on v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n; 
or de vel o p me nt of dr u g de pe n de nc y  or dr u g a b use.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 0
9. 2. 4. H os pit aliz ati o n
H os pitalizati o n is defi ne d as a n y i nitial a d missi o n (e ve n less t ha n 2 4 h o urs) i n a h os pital or 
e q ui vale nt healt hcare facilit y, or a n y pr ol o n gati o n of a n e xisti n g a d missi o n.  A d missi o n als o 
i ncl u des tra nsfer wit hi n t he h os pital t o a n ac ute/i nte nsi ve care u nit (e g, fr o m t he ps yc hiatric 
wi n g t o a me dical fl o or, me dical fl o or t o a c or o nar y  care u nit, or ne ur ol o gical fl o or t o a 
t u berc ul osis unit).  A n e mer ge nc y  r o o m visit d oes n ot necessaril y c o nstit ute a h os pitalizati o n; 
h o we ver, t he e ve nt lea di n g t o t he e mer ge nc y  r o o m visit is assesse d f or me dical i m p orta nce.
H os pitalizati o n d oes n ot i ncl u de t he f oll o wi n g:

Re ha bilitati o n facilities;

H os pice facilities;

Res pite care (e g, care gi ver relief);

S kille d n ursi n g facilities;

N ursi n g h o mes;

Sa me -d a y  s ur geries (as o ut patie nt/sa me-d a y /a m b ulat or y pr oce d ures).
H os pitalizati o n or pr ol o n gati o n of h os pitalizati o n i n t he a bse nce of a preci pitati n g cli nical 
A E is n ot i n itself a n S A E.  E xa m ples i ncl u de:

A d missi o n f or treat me nt of a pree xisti n g c o n diti o n n ot ass ociate d wit h t he 
de vel o p me nt of a ne w A E or wit h a w orse ni n g of t he pree xisti n g c o n diti o n 
(e g, f or w or k u p of a persiste nt pretreat me nt la b orat or y a b n or malit y);

S ocial a d missi o n (e g, partici pa nt has n o place t o slee p);

A d mi nistrati ve a d missi o n (e g, f or ye arl y p h ys ical e xa mi nati o n);

Pr ot oc ol -s pecifie d a d missi o n d uri n g a st u dy (e g, f or a pr oce d ure re q uire d b y t he st u d y 
pr ot oc ol);

O pti o nal a d missi o n n ot ass ociate d wit h a preci pitati n g cli nical A E (e g, f or electi ve 
c os metic s ur ger y);

H os pitalizati o n f or o bser vati o n wit h o ut a me dical A E;

Pre pla n ne d treat me nts or s ur gical pr oce d ures, i ncl u di n g va gi nal deli ver y  pr oce d ures 
a n d cesarea n deli veries.  T hese s h o ul d be n ote d i n t he baseli ne d oc u me ntati o n f or t he 
e ntire pr ot oc ol a n d/ or f or t he i n di vi d ual partici pa nt .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 1
Dia g n ostic a n d t hera pe utic n o ni n vasi ve a n d i n vasi ve pr oce d ures, s uc h as s ur ger y , s h o ul d 
n ot be re p orte d as S A Es.  H o we ver, t he me dical c o n diti o n f or w hic h t he pr oce d ure was 
perf or me d s h o ul d be re p orte d if it meets t he defi niti o n of a n S A E.  F or e xa m ple, a n ac ute 
a p pe n dicitis t hat be gi ns d uri n g t he re p orti n g peri o d s h o ul d be re p orte d if t he S A E 
re q uire me nts are met, a n d t he res ulti n g a p pe n dect o m y s h o ul d be rec orde d as treat me nt of 
t he A E.
9. 3. Se verit y Assess me nt
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:
MI L D
D oes n ot i nterfere wit h partici pa nts’ us ual f u ncti o n.
M O D E R A T E
I nterferes t o s o me e xte nt wit h partici pa nts’ us ual f u ncti o n.
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.
N ote t he disti ncti o n bet wee n t he se verit y a n d t he seri o us ness of a n A E.  A se vere e ve nt is n ot 
necessaril y  a n S A E.  F or e xa m ple, a hea dac he ma y be se vere (i nterferes si g nifica ntl y wit h 
t he partici pa nt's us ual f u ncti o n) b ut w o ul d n ot be classifie d as seri o u s u nless it met o ne of t he 
criteria f or S A Es, liste d a b o ve.  A se verit y  assess me nt will be c ollecte d o n t he A E C R F f or 
all A Es.
9. 4. S peci al Sit u ati o ns
9. 4. 1. Pr ot oc ol -S pecifie d Seri o us A d verse E ve nts
T here are n o pr ot oc ol -s pecifie d S A Es i n t his st u d y.  All S A Es will be re p orte d t o Pfizer 
Safet y  b y t he i n vesti gat or as descri be d i n pre vi o us secti o ns a n d will be ha n dle d as S A Es 
i n t he safety data base.
9. 4. 2. P ote nti al C ases of Dr u g -I n d uce d Li ver I nj ur y
H u ma ns e x p ose d t o a dr u g w h o s h o w n o si g n of li ver i nj ur y  (as deter mi ne d b y ele vati o ns i n 
tra nsa mi nases) are ter me d “t olerat ors,” w hile t h ose w h o s h o w tra nsie nt li ver i nj ur y, b ut a da pt 
are ter me d “a da pt ors .”  I n s o me partici pa nts, tra nsa mi nase ele vati o ns are a har bi n ger of a 
m ore seri o us p ote ntial o utc o me.  T hese partici pa nts fail t o a da pt a n d t heref ore are 
"s usce pti ble" t o pr o gressi ve a n d seri o us li ver i nj ur y, c o m m o nl y referre d t o as dr u g -i n d uce d 
li ver i nj ur y ( DI LI).  Partici pa nts w h o e x perie nce a tra nsa mi nase ele vati o n a b o ve 3 ti mes t he 
u p per li mit of n or mal ( × U L N) s h o ul d be m o n it ore d m ore fre q ue ntl y t o deter mi ne if t he y are 
a n “a da pt or” or are “s usce pti ble.”
Li ver f u ncti o n tests ( L F Ts) 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 f or partici pa nts e nr olle d i n Sta ge 1 or t he e x pa n de d c o h orts f or Sta ge 2 a n d Sta ge 3.  
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 y m pt o ms, s uc h L F T res ults s h o ul d be ma na ge d a n d f oll o we d as 
descri be d bel o w.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 2
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 otal bilir u bi n ( T bili ) 
ele vati o ns (2 × U L N) b y  se veral da ys or wee ks.  T he i ncrease i n T bili t ypicall y  occ urs 
w hile A S T/ A L T is/are still ele vate d a b o ve 3 × U L N (ie, A S T/ A L T a n d T bili val ues will be 
ele vate d wit hi n t he sa me la b orat o r y sa m ple).  I n rare i nsta nces, b y t he ti me T bili ele vati o ns 
are detecte d, A S T/ A L T val ues mi g ht ha ve decrease d.  T his occ urre nce is still re gar de d as a 
p ote ntial DI LI.  T heref ore, a b n or mal ele vati o ns i n eit her A S T O R A L T i n a d diti o n t o T bili 
t hat meet t he criteria o utli ne d 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 y s be c o nsi dere d i m p orta nt me dical e ve nts, e ve n bef ore all 
ot her p ossi ble ca uses of li ver i nj ur y  ha ve bee n e xcl u de d.
T he t hres h ol d of la b orat or y a b n or malities f or a p ote ntial DI LI case de pe n ds o n t he 
partici pa nt’s i n di vi d ual baseli ne val ues a n d u n derl yi n g c o n diti o ns.  Partici pa nts w h o prese nt 
wit h t he f oll o wi n g la b orat or y  a b n or malities s h o ul d be e val uate d f urt her as p ote ntial DI LI 
( Hy’s la w) cases t o defi niti vel y deter mi ne t he eti ol o g y of t he a b n or mal la b orat or y val ues:

Partici pa nts wit h A S T/ A L T a n d T bili baseli ne val ues wit hi n t he n or mal ra n ge w h o 
s u bse q ue ntl y prese nt wit h A S T O R A LT val ues 3 × U L N A N D a T bili val ue 
2 × U L N wit h n o e vi de nce of he m ol ys is a n d a n al kali ne p h os p hatase val ue 
2 × U L N or n ot a vaila ble;

F or partici pa nts wit h baseli ne A S T O R A L T O R T bili val ues a b o ve t he U L N, t he 
f oll o wi n g t hres h ol d val ues are use d i n t he defi niti o n me nti o ne d a b o ve, as nee de d, 
de pe n di n g o n w hic h val ue s 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 bili a b o ve t he n or mal ra n ge: T bili le vel i ncrease d fr o m 
baseli ne val ue b y a n a m o u nt of at least 1 × U L N o r if t he val ue reac hes 3 × U L N 
( w hic he ver is s maller).
Rises i n A S T/ A L T a n d T bili se parate d by m ore t ha n a fe w wee ks s h o ul d be assesse d 
i n di vi d uall y base d o n cli nical j u d g me nt; a n y case where u ncertai nt y  re mai ns as t o w het her it 
re prese nts a p ote ntial H y’s la w case s h o ul d be re vie we d wit h t he s p o ns or.
T he partici pa nt s h o ul d ret ur n t o t he i n vesti gat or site a n d be e val uate d as s o o n as p ossi ble, 
prefera bl y wit hi n 4 8 h o urs fr o m a ware ness of t h e a b n or mal res ults.  T his e val uati o n s h o ul d 
i ncl u de la b orat or y tests, detaile d hist or y, a n d p h ysical assess me nt.
I n a d diti o n t o re peati n g meas ure me nts of A S T a n d A LT a n d T bili , la b orat or y tests s h o ul d 
i ncl u de al b u mi n, creati ne ki nase ( C K), direct a n d i n direct bilir u bi n, ga m ma-gl uta m yl  
tra nsferase ( G G T), pr ot hr o m bi n ti me ( P T)/i nter nati o nal n or malize d rati o (I N R), t otal bile 
aci ds, al kali ne p h os p hatase, a n d aceta mi n o p he n dr u g a n d/ or pr otei n a d d uct le vels.  
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 pa rate 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 
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 3
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 matio n, s uc h as re vie w of et ha n ol, aceta mi n o p he n (eit her b y 
itself or as a c of or m ulate d pr o d uct i n prescri pti o n or o ver-t he-c o u nter me dicati o ns) , 
recreati o nal dr u g, 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 ory 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 a n d li ver i ma gi n g 
(e g, biliar y tract) ma y be warra nte d.
All cases de m o nstrate d o n re peat testi n g as meeti n g t he la b orat or y  criteria of A S T/ A LT a n d 
T bili ele vati o n defi ne d a b o ve s h o ul d be c o nsi dere d p ote ntial DI LI ( H y ’s la w) cases if n o 
ot her reas o n f or t he L F T a b n or malit ies 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 a b n or m alities.
A p ote ntial DI LI ( H y ’s la w) case bec o mes a c o nfir me d case o nl y 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.
9. 4. 3. E x p os ure t o t he I n vesti g ati o n al Pr o d uct 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 ( St a ge 1 O nl y)
E x p os u re t o t he i n vesti gati o nal pr o d uct u n der st u d y d uri n g pre g na nc y or breastfee di n g 
(a p plica ble o nly t o Sta ge 1 partici pa nt s) a n d occ u pati o nal e x p os ure (a p plica ble t o 
partici pa nt s i n all st u d y sta ges) are re p orta ble t o Pfizer Safety wit hi n 2 4 h o urs of i n vesti gat or 
a ware ness.  Refer t o Secti o n 9. 1 f or f urt her details.
9. 4. 3. 1. E x p os ure D uri n g Pre g n a nc y
E D P s h o ul d be re p orte d f or all partici pa nt s i n Sta ge 1 a n d f or all w o me n i n Sta ges 2 a n d 3 
after deli ver y a n d bef ore t he e n d of t he st u d y ( Visit 9).
F or b ot h u na p pr o ve d/ u nlice nse d pr o d ucts a n d f or mar kete d pr o d ucts, a n E D P occ urs if:

A fe male bec o mes, or is f o u n d t o be, pre g na nt eit her w hile recei vi n g or ha vi n g bee n 
e x p ose d (e g, beca use of treat me nt or e n vir o n me ntal e x p os ure) t o t he i n vesti gati o nal 
pr o d uct; or t he fe male bec o mes or is f o u n d t o be pre g na nt after disc o nti n ui n g a n d/ or 
bei n g e x p ose d t o t he i n vesti gati o nal pr o d uct;
o
A n e xa m ple of e n vir o n me ntal e x p os ure w o ul d be a case i n v ol vi n g direct c o ntact 
wit h a Pfizer pr o d uct i n a pre g na nt w o ma n (e g, a n urse re p orts t hat s he is pre g na nt 
a n d has bee n e x p ose d t o c he m ot hera pe utic pr o d ucts).

A male has bee n e x p ose d (e g, beca use of treat me nt or e n vir o n me ntal e x p os ure) t o t he 
i n vesti gati o nal pr o d uct pri or t o or ar o u n d t he ti me of c o nce pti o n a n d/ or is e x p ose d 
d uri n g his part ner’s pre g na nc y .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 4
If a partici pa nt bec o mes or is f o u n d t o be pre g na nt d uri n g t he partici pa nt ’s treat me nt wit h t he 
i n vesti gati o nal pr o d uct, t he i n vesti gat or m ust re p ort t his i nf or mati o n t o Pfizer Safet y o n t he 
Vacci ne S A E Re p orti n g F or m a n d a n E D P s u p ple me ntal f or m, re gar dless of w het her a n S A E 
has occ urre d.   I n ad diti o n, t he i n vesti gat or m ust s u b mit i nf or mati o n re gar di n g e n vir o n me ntal 
e x p os ure t o a Pfizer pr o d uct i n a pre g na nt w o ma n (e g, a partici pa nt re p orts t hat s he is 
pre g na nt a n d has bee n e x p ose d t o a c y t ot o xic pr o d uct b y i n halati o n or s pilla ge) t o Pfizer 
Safe t y usi n g t he E D P s u p ple me ntal f or m.  T his m ust be d o ne irres pecti ve of w het her a n A E 
has occ urre d a n d wit hi n 2 4 h o urs of a ware ness of t he e x p os ure.  T he i nf or mati o n s u b mitte d 
s h o ul d i ncl u de t he a ntici pate d date of deli ver y (see bel o w f or i nf or mati o n related t o 
ter mi nati o n of pre g na nc y).
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 E D P s u p ple me ntal f or m.  I n t he case of a li ve birt h, t he str uct ural 
i nte grity of t he ne o nate ca n be assesse d at t he ti me of birt h.  I n t he e ve nt of a ter mi nati o n, 
t he reas o n(s) f or ter mi nati o n s h o ul d be s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural 
i nte grity of t he ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual i ns pecti o n ( u nless 
pre pr oce d ure test fi n di n gs are c o ncl usi ve f or a c o n ge nital a n o mal y a n d t he fi n di n gs are 
re p orte d).
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 onatal 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 Safety as S A Es 
f oll o ws:

S p o nta ne o us a b orti o n i ncl u des miscarria ge a n d misse d a b orti o n;

Ne o natal dea t 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 i n vesti gati o nal pr o d uct.
A d diti o nal i nf or mati o n re gar di n g t he E D P ma y  be re q ueste d b y t he s p o ns or.  F urt her 
f oll o w- u p of birt h o utc o mes will be ha n dle d o n a case-b y -case basis (e g, f oll o w- u p o n 
preter m i nfa nt partici pa nt s t o i de ntif y de vel o p me ntal dela y s).  I n t he case of pater nal 
e x p os ure, t he i n vesti gat or will pr o vi de t he partici pa nt wit h t he Pre g na nt Part ner Release of 
I nf or mati o n F or m t o deli ver t o his part ner.  T he i n vesti gat or m ust d oc u me nt i n t he s o urce 
d oc u me nts t hat t he partici pa nt was gi ve n t he Pre g na nt Part ner Release of I nf or mati o n F or m 
t o pr o vi de t o his part ner.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 5
9. 4. 3. 2. E x p os ure D uri n g Bre astfee di n g
E x p os ure d uri n g breastfee di n g re p orts are n ot e x pecte d f or mater nal partici pa nt s w h o 
breastfee d a c hil d deli vere d d uri n g t he st u d y .
Sce nari os of e x p os ure d uri n g breastfee di n g m ust be re p orte d, irres pecti ve of t he prese nce of 
a n ass ociate d S A E, 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, usi n g t he 
Vacci ne S A E Re p orti n g F or m .  A n e x p os ure d uri n g breastfee di n g re p ort is n ot create d w he n 
a Pfizer dr u g s pecificall y a p pr o ve d f or use i n breastfee di n g w o me n (e g, vita mi ns) is 
a d mi nistere d i n acc or d wit h a ut h orize d use.  H o we ver, if t he i nfa nt partici pa nt e x perie nces a n 
S A E ass ociate d wit h s uc h a dr u g’s a d mi nistrati o n, t he S A E is re p orte d t o get her wit h t he 
e x p os ure d uri n g breastfee di n g.
9. 4. 3. 3. Occ u p ati o n al E x p os ure
A n occ u pati o nal e x p os ure occ urs w he n, d uri n g t he perf or ma nce of j o b d uties, a pers o n 
( w het her a healt hcare pr ofessi o nal or ot her wise) gets i n u n pla n ne d direct c o ntact with t he 
pr o d uct, w hic h ma y  or ma y n ot lea d t o t he occ urre nce of a n A E.
A n occ u pati o nal e x p os ure is re p orte d 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, usi n g t he Vacci ne S A E Re p orti n g F or m , re gar dless of w het her t here is a n 
ass ociate d S A E.  Si nce t he i nf or mati o n d oes n ot pertai n t o a partici pa nt e nr olle d i n t he st u d y, 
t he i nf or mati o n is n ot rec or de d o n a C R F; h o we ver, a c o py of t he c o m plete d Vacci ne S A E 
Re p orti n g F or m is mai ntai ne d i n t he i n vesti gat or site file.
9. 4. 4. V acci n ati o n Err ors
Ot her e x p os ures t o t he i n vesti gati o nal pr o d uct u n der st u d y  m a y occ ur i n cli nical trial setti n gs, 
s uc h as vacci nati o n err ors.
S afet y E ve nt
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
Re p orte d o n t he V acci ne S A E 
Re p orti n g F or m t o Pfizer S afet y 
Wit hi n 2 4
H o ur s of A w are ness
Vacci nati o n err ors
All (re gar dless of w het her 
ass ociate d wit h a n A E)
O nl y if ass ociate d wit h a n S A E
9. 4. 4. 1. 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 i n vesti gati o nal 
pr o d uct 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 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 i n vesti gati o nal pr o d uct;

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 partici pati n g partici pa nt .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 6
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 i n vesti gati o nal pr o d uct;

T he a d mi nistrati o n of a n i nc orrect i n vesti gati o nal pr o d uct;

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 i n vesti gati o nal pr o d uct 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 i n vesti gati o nal pr o d uct u n der q uesti o n is acce pta ble f or use.
S uc h va cci nati o n err ors occ urri n g t o a st u d y partici pa nt are t o be ca pt ure d o n t he vacci nati o n 
err or pa ge of t he C R F, w hic h is a s pecific versi o n of t he A E pa ge.
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 i m me diatel y .
W het her or n o t t he vacci nati o n err or is acc o m pa nie d b y a n A E, as deter mi ne d b y t he 
i n vesti gat or, t he vacci nati o n err or is rec or de d o n t he vacci nati o n err or pa ge of t he C R F a n d, 
if a p plica ble, a ny ass ociate d A E(s), seri o us a n d n o nseri o us, are rec or de d o n a n A E pa ge of 
the C R F.
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 o n a Vacci ne S A E 
Re p orti n g F or m o nl y w he n ass oci ate d wit h a n S A E .
1 0. D A T A A N A L Y SI S/ S T A TI S TI C A L M E T H O D 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 hi s st u d y is 
descri be d here a n d a d diti o nal details will be d oc u me nte d i n t he statistical a nal y sis pla n 
( 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 nal yses will als o be reflecte d i n a pr ot oc ol a me n d me nt.
All a nal y ses f or b ot h i m m u n o ge nicity a n d safet y data will be descri pti ve i n nat ure.
1 0. 1. S a m ple Size Deter mi n ati o n
T his is a P hase 1/ 2 ra n d o mize d, place b o- c o ntr olle d, o bser ver-bli n de d st u d y t o assess safet y, 
t olera bilit y, a n d i m m u n o ge nicit y of G B S 6 i n healt h y n o n pre g na nt as well as pre g na nt w o me n 
a n d t heir i nfa nt partici pa nt s.  T he st u d y c o nsists of 3 sta ges.  T he sa m ple sizes at eac h sta ge 
are n ot dri ve n b y a n y s pecific h y p ot hesis testi n g.
A p pr o xi matel y  6 6 n o n pre g na nt w o me n will be e nr olle d at Sta ge 1, 2 2 partici pa nt s per gr o u p 
t o recei ve place b o (sali ne c o ntr ol) or G B S 6 ( 2 0 µ g C P S/ser ot y pe/ d ose) wit h or wit h o ut 
Al P O 4. Partici pa nt s i n Sta ge 1 will als o recei ve a b o oster d ose of G B S 6 ( 2 0 µ g 
C P S/ser ot y pe/ d ose wit h Al P O 4) a p pr o xi matel y 2 years after t he i nitial d ose of i n vesti gati o nal 
pr o d uct. Sa m ple size f or t he partici pa nt s recei vi n g G B S 6 b o oster d ose is de pe n de nt u p o n t he 
n u m ber of partici pa nt s pr o vi di n g c o nse nt t o c o nti n ue i n t he st u d y.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 7
A p pr o xi matel y  3 6 0 pre g na nt w o me n will be e nr olle d at Sta ge 2, 4 0 partici pa nt s at eac h 
G B S 6 d ose/f or m ulati o n a n d a t otal of 1 2 0 partici pa nt s i n t he place b o gr o u p.  Refer t o Ta ble 2
f or a detaile d descri pti o n of t he n u m ber of partici pa nt s per gr o u p.  A p pr o xi matel y 
2 1 6 pre g na nt w o me n will be e nr olle d at Sta ge 3 (a p pr o xi matel y 1 6 2 fr o m S o ut h Africa/ U K 
a n d 5 4 fr o m t he U S), 1 0 8 partici pa nt s at t he selecte d G B S 6 d ose/f or m ulati o n 
a n d 1 0 8 partici pa nt s i n t he place b o gr o u p. E nr oll me nt will be m o nit ore d t o hel p e ns ure 
distri b uti o n of vacci nati o n acr oss t he gestati o nal a ge ra n ge of ≥2 4 0/ 7 t o ≤3 5 6/ 7 wee ks.
Ta ble 9 s h o ws t he pr o babilit y  of o bser vi n g at least 1 A E f or a gi ve n tr ue e ve nt rate of a 
partic ular A E, f or vari o us sa m ple sizes.  F or e xa m ple, if t he tr ue A E rate is 1 0 %, wit h 
1 4 partici pa nt s i n eac h d ose/f or m ulati o n gr o u p, t here is 7 7 % pr o ba bilit y of o bser vi n g at least 
1 A E.
T a ble 9.
Pr o b a bilit y of O bser vi n g at Le ast 1 A E b y Ass u me d Tr ue E ve nt R ates 
Wit h Differe nt S a m ple Sizes
S a m ple Size 
( N)
Ass u me d Tr ue E ve nt R ate of a n A E
1. 0 % 
2. 0 % 
2. 5 % 
3. 0 % 
5. 0 %
1 0. 0 %
1 4
0. 1 3
0. 2 5
0. 3 0
0. 3 5
0. 5 1
0. 7 7
2 2
0. 2 0
0. 3 6
0. 4 3
0. 4 9
0. 6 8
0. 9 0
2 8
0. 2 5
0. 4 3
0. 5 1
0. 5 7
0. 7 6
0. 9 5
4 0
0. 3 3
0. 5 5
0. 6 4
0. 7 0
0. 8 7
0. 9 9
4 4
0. 3 6
0. 5 9
0. 6 7
0. 7 4
0. 9 0
0. 9 9
8 0
0. 5 5 
0. 8 0 
0. 8 7 
0. 9 1 
0. 9 8
0. 9 9
1 2 0
0. 7 0 
0. 9 1 
0. 9 5 
0. 9 7
0. 9 9
0. 9 9
2 4 0
0. 9 1 
0. 9 9
0. 9 9
0. 9 9
0. 9 9
0. 9 9
3 4 8 
0. 9 7
> 0. 9 9 
0. 9 9  
0. 9 9  
0. 9 9  
0. 9 9 
A b bre viati o ns: Al P O 4 = al u mi n u m p h os p hate; C P S = ca ps ular p ol ysacc hari de.
N ote: I n Sta ge 1, 4 4 n o n pre g na nt w o me n are pla n ne d t o be vacci nate d wit h G B S 6 ( 2 0 µ g 
C P S/ser ot y pe/ d ose) wit h or wit h o ut Al P O 4 ( 2 2/f or m ulati o n).  I n eac h se nti nel c o h ort of Sta ge 2, 28 mater nal 
partici pa nt s are pla n ne d t o be vacci nate d wit h eac h d ose of G B S6 wit h or w it h o ut Al P O4 ( 1 4/f or m ulati o n).  
I n Sta ge 2, a t otal of 8 0 mater nal partici pa nt s are pla n ne d t o be vacci nate d wit h eac h d ose of G B S 6 wit h or 
wit h o ut Al P O 4 ( 4 0/f or m ulati o n), a n d a t otal of 2 4 0 mater nal partici pa nt s are t o be vacci nate d wit h a n y d ose 
of G B S 6 wit h or w it h o ut Al P O4 ( 1 2 0/f or m ulati o n).  I n t he e ntire st u d y, 3 4 8 ma ter nal partici pa nt s are t o be 
vacci nate d w it h a n y d ose of G B S 6.
1 0. 2. I m m u n o ge nicit y A n al ysis
I m m u n o ge nicity data will be a nal yz e d se paratel y f or n o n pre g na nt w o me n ( Sta ge 1), mat er nal 
partici pa nt s ( Sta ges 2 a n d 3), a n d t heir i nfa nt partici pa nt s ( Sta ges 2 a n d 3).
1 0. 2. 1. I m m u n o ge nicit y A n al ysis P o p ul ati o ns
F or t he i m m u n o ge nicit y a nal ys es, 2 a nal ysis p o p ulati o ns will be defi ne d se parately f or 
n o n pre g na nt w o me n, mater nal partici pa nt s, a n d t heir i nfa nt partici pa nt s: e val ua ble 
i m m u n o ge nicity a n d m o difie d i nte nt t o treat ( mI T T) p o p ulati o ns.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 8
F or t he i m m u n o ge nicit y a nal ys es, n o n pre g na nt a n d mater nal partici pa nt s will be a nal yze d 
acc or di n g t o t he i n vesti gati o nal pr o d uct recei ve d f or t he e val ua ble i m m u n o ge nicit y  
p o p ulati o n a n d t he i n vesti gati o nal pr o d uct as ra n d o mize d f or t he mI T T p o p ulati o n.  I nfa nt 
partici pa nt s will be a nalyze d acc or di n g t o t he i n vesti gati o nal p r o d uct recei ve d b y t heir 
m ot hers ( mater nal partici pa nt s) f or t he e val ua ble i m m u n o ge nicity p o p ulati o n a n d t he 
i n vesti gati o nal pr o d uct assi g ne d t o t heir m ot hers ( mater nal partici pa nt s) f or t he mIT T 
p o p ulati o n.  T he e val ua ble i m m u n o ge nicit y p o p ulati o n is c o ns i dere d t o be t he pri mar y 
p o p ulati o n f or t he i m m u n o ge nicit y  a nalys es.
1 0. 2. 1. 1. N o n pre g n a nt W o me n ( St a ge 1)
T o be i ncl u de d i n t he e val ua ble i m m u n o ge nicit y p o p ulati o n of pri mar y vacci nati o n, i n 
ge neral , a Sta ge 1 partici pa nt m ust ha ve bee n eli gi ble f or t he st u d y, ha ve recei ve d G B S 6 or 
place b o as ra n d o mize d, ha ve ha d bl o o d dra w n wit hi n t he s pecifie d ti me fra mes, ha ve ha d at 
least 1 vali d a n d deter mi nate assa y  res ult f or t he pr o p ose d a nalys is, a n d ha ve ha d n o ot her 
maj or pr ot oc ol vi olati o ns.  T o be i ncl u de d i n t he mI T T p o p ulati o n, a Sta ge 1 partici pa nt m ust 
be ra n d o mize d a n d ha ve ha d at least 1 vali d a n d deter mi nate assa y  res ult relate d t o t he 
pr o p ose d a nal ys is.
T o be i ncl u de d i n t he e val ua ble i m m u n o ge nicit y p o p ulati o n of b o oster vacci nati o n, i n 
ge neral , a Sta ge 1 partici pa nt m ust ha ve bee n eli gi ble f or t he st u d y, ha ve recei ve d a b o oster 
d ose of G B S 6, ha ve ha d bl o o d dra w n wit hi n t he s pecifie d ti me fra mes, ha ve ha d at least 
1 vali d a n d deter mi nate assa y  res ult f or t he pr o p ose d a nalys is, a n d ha ve ha d n o ot her maj or 
pr ot oc ol vi olati o ns.  T o be i ncl u de d i n t he mI T T p o p ulati o n, a Sta ge 1 partici pa nt m ust ha ve 
at least 1 vali d a n d deter mi nate assa y  res ult relate d t o t he pr o p ose d a nalys is.
1 0. 2. 1. 2. M ater n al P artici p a nt s ( St a ges 2 a n d 3)
Si milarl y , t o be i ncl u de d i n t he e val ua ble i m mu n o ge nicit y  p o p ulati o n, a mater nal partici pa nt
fr o m Sta ge 2 or 3 m ust ha ve bee n eli gi ble f or t he st u d y , ha ve recei ve d G B S 6 or place b o as 
ra n d o mize d, ha ve ha d bl o o d dra w n wit hi n t he s pecifie d ti me fra mes, ha ve at least 1 vali d a n d 
deter mi nate assa y  res ult for t he pr o p ose d a nal ys is, a n d ha ve n o ot her maj or pr ot oc ol 
vi olati o ns.  T o be i ncl u de d i n t he mI T T p o p ulati o n, a mater nal partici pa nt fr o m Sta ge 2 or 
3 m ust be ra n d o mize d a n d ha ve at least 1 vali d a n d deter mi nate assa y  res ult relate d t o t he 
pr o p ose d a nal ys is.
1 0. 2. 1. 3. I nf a nt P artici p a nt s ( St a ges 2 a n d 3)
T o be i ncl u de d i n t he e val ua ble i m m u n o ge nicit y p o p ulati o n, a n i nfa nt partici pa nt fr o m 
Sta ge 2 or 3 m ust ha ve bee n eli gi ble f or t he st u d y, t he i nfa nt partici pa nt ’s m ot her m ust ha ve 
recei ve d G B S 6 or place b o as ra n d o mi ze d, a n d t he i nfa nt partici pa nt m ust ha ve ha d bl o o d 
dra w n wit hi n t he s pecifie d ti me fra mes, ha ve at least 1 vali d a n d deter mi nate assa y  res ult f or 
t he pr o p ose d a nal ysis, a n d ha ve n o ot her maj or pr ot oc ol vi olati o ns.  T o be i ncl u de d i n t he 
mI T T p o p ulati o n, t he i nfa nt partici pa nt ’s m ot her m ust be ra n d o mize d, a n d t he i nfa nt 
partici pa nt m ust ha ve at least 1 vali d a n d deter mi nate assa y  res ult relate d t o t he pr o p ose d 
a nal ys is.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 1 9
1 0. 2. 2. A n al ysis of I m m u n o ge nicit y E n d p oi nts
I m m u n o ge nicity e n d p oi nts are sec o n dar y or e x pl orat o r y i n t he st u d y as liste d i n Secti o n 3. 2
a n d Secti o n 3. 3 . Descri pti ve s u m mar y  statistics will be pr o vi de d f or all i m m u n o ge nicity 
e n d p oi nts.  N o f or mal bet wee n -gr o u p c o m paris o n will be ma de.
Descri pti ve e val uati o ns i ncl u de G B S 6 ser oty pe -s pecific I g G G M Cs a n d O P A G M Ts 
meas ure d at pres pecifie d ti me p oi nts a n d will be s u m marize d b y  vacci ne gr o u p.
G B S 6 ser oty pe -s pecific I g G c o nce ntrati o ns will be l o garit h micall y tra nsf or me d f or a nal ysis.  
F or eac h ser ot y pe, G M Cs will be calc ulate d at all bl o o d dra w visits.  T w o ( 2) -side d 9 5 % 
c o nfi de nce i nter vals ( CIs) f or t he G M Cs will be c o nstr ucte d b y bac k tra nsf or mati o n of t he 
CI s f or t he mea n of t he l o garit h micall y tra nsf or me d assa y res ults c o m p ute d usi n g St u de nt’s 
t distri b uti o n.
O P A G M Ts a n d t he c orres p o n di n g 2 -si de d 9 5 % CIs f or t he G B S 6 ser oty p e-s pecific O P A 
titers will be c o m p ute d usi n g si milar met h o ds t o t h ose f or I g G c o nce ntrati o ns.
T he pr o p orti o ns of partici pa nt s ac hie vi n g defi ne d G B S 6 ser oty pe -s pecific I g G c o nce ntrati o ns 
a n d O P A titers will be s u m marize d descri pti vel y  at pres pecifie d ti me p oi nts as c o u nts a n d 
perce nta ges wit h 2 -si de d 9 5 % e xact CIs b y vacci ne gr o u p.
 
 
 
 
All of t he bi nar y  e n d p oi nts will be descri pti vel y s u m marize d wit h 2-si de d e xact 9 5 % CIs 
usi n g t he Cl o p per -Pears o n met h o d.
Re verse c u m ulati ve distri b uti o n c ur ves ( R C D Cs) f or c o m bi nati o n of pres pecifie d ti me p oi nts 
a n d vacci ne gr o u ps will be ge nerate d f or eac h G B S 6 ser ot ype.  A d diti o nall y , a nti b o d y 
res p o nse li ne pl ot of ge o metric mea ns a n d t he ass ociate d 9 5 % CIs will be prese nte d at eac h 
a nal ys is ti me p oi nt b y vacci ne gr o u p a n d ser oty pe.
Detaile d a nal y ses of all t he i m m u n o ge nicity e n d p oi nts i ncl u di n g a d diti o nal e x pl orat or y 
a nal ys es a n d gra p hical dis pla y s will be descri be d i n t he S A P.
1 0. 3. S afet y A n al ysis
Safet y  data will be a nalyze d se paratel y f or n o n pre g na nt w o me n ( Sta ge 1), mater nal 
partici pa nt s ( Sta ges 2 a n d 3), a n d t heir i nfa nt partic i pa nts ( Sta ges 2 a n d 3).
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 0
1 0. 3. 1. S afet y P o p ul ati o n
A safet y p o p ulati o n will be defi ne d se paratel y f or n o n pre g na nt w o me n, mater nal partici pa nt s, 
a n d t heir i nfa nt partici pa nt s.
F or t he safet y a nal yses, n o n pre g na nt a n d mater nal partici pa nt s will be a nalyze d acc or di n g t o 
t he i n vesti gati o nal pr o d uct recei ve d a n d i nfa nt partici pa nt s will be a nal yze d acc or di n g t o t he 
i n vesti gati o nal pr o d uct t heir m ot hers ( mater nal partici pa nt s) recei ve d.
1 0. 3. 1. 1. N o n pre g n a nt W o me n ( St a ge 1)
All Sta ge 1 partici pa nt s recei vi n g a pri mar y d ose of G B S 6 or place b o will be i ncl u de d i n t he 
safety p o p ulati o n of pri mar y  vacci nati o n.
All Sta ge 1 partici pa nt s recei vi n g a b o oster d ose of G B S 6 will be i ncl u de d i n t he b o oster 
safety p o p ulati o n.
1 0. 3. 1. 2. M ater n al P artici p a nt s ( St a ges 2 a n d 3)
All mater nal partici pa nt s fr o m Sta ges 2 or 3 recei vi n g a d ose of G B S 6 or place b o will be 
i ncl u de d i n t he safet y p o p ulati o n.
1 0. 3. 1. 3. I nf a nt P artici p a nt s ( St a ges 2 a n d 3)
All i nfa nt partici pa nt s w h o are e nr olle d i n t he st u d y will be i ncl u de d i n t he safety p o p ulati o n .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 1
1 0. 3. 2. A n al ysis of S afet y E n d p oi nts
T he safet y e n d p oi nts as liste d i n Secti o n 3. 1 are pri mar y i n t he st u d y a n d t heir a nalys es are 
base d o n t he safet y p o p ulati o n.
T he safet y a nal ys es f or Sta ge 1 n o n pre g na nt w o me n a n d mater nal partici pa nt s fr o m 
Sta ges 2 a n d 3 are descri pti ve e val uati o ns of l ocal reacti o ns, s ys te mic e ve nts, A Es, 
M A Es,
a n d S A Es b y vacci ne gr o u p.  I n a d diti o n, cli nical la b orat or y a b n or malities, deli ver y 
o utc o mes, a n d o bstetric c o m plicati o ns f or mater nal partici pa nt s fr o m Sta ges 2 a n d 3 will be 
s u m marize d b y vacci ne gr o u p.  T he safety a nal ys es f or i nfa nt partici pa nt s fr o m Sta ges 2 a n d 
3 are descri pti ve e val uati o ns of birt h o utc o m es, A Es, M A Es, A Es of s pecial i nterest, a n d 
S A Es.  A Es will be cate g orize d acc or di n g t o t he Me dical Dicti o nar y  f or Re g ulat or y 
Acti vities ( Me d D R A).
Descri pti ve s u m mar y  statistics f or c o nti n u o us o utc o mes will i ncl u de n u m ber of partici pa nt s, 
mea n, sta n dar d de viati o n, me dia n, mi ni m u m, a n d ma xi m u m a n d 2 -si de d 9 5 % CIs f or t he 
mea n, as nee de d.  F or cate g orical o utc o mes, n u m ber a n d perce nta ge of partici pa nt s i n eac h 
cate g or y a n d 2-si de d 9 5 % e xact CIs usi n g Cl o p per- Pears o n met h o d will be pr o vi de d.
1 0. 4. A n al ysis Ti mi n g
I n a d diti o n t o t he pla n ne d safet y data re vie w w hile t he st u d y is o n g oi n g, 4 i nteri m a nal yses 
are pla n ne d f or t his st u d y.
T he first i nteri m a nal ys is will be perf or me d w he n 1- m o nt h p ost vacci nati o n safety data fr o m 
all partici pa nt s e nr olle d i n Sta ge 1 are a vail a ble.  Sta ge 2 of t he st u d y  will be i nitiate d base d 
o n res ults fr o m t he first i nteri m a nal ys is as well as t h ose fr o m t he 1-m o nt h p ost vacci nati o n 
safety a n d i m m u n o ge nicit y  data of 3 differe nt d ose le vels of G B S 6 f or m ulate d wit h or 
wit h o ut Al P O 4 fr o m t he prior U S FI H P hase 1/ 2 st u d y ( C 1 0 9 1 0 0 1).  B ot h t he IR C a n d 
E D M C will re vie w all t he a vaila ble u n bli n de d data a n d t he I R C i n c o ns ultati o n wit h t he 
E D M C will ma ke rec o m me n dati o ns re gar di n g t he st u d y  pr ocee di n g t o Sta ge 2.  F or details of 
s p o ns or bli n di n g, refer t o Secti o n 6. 8 .
T he sec o n d i nteri m a nal ysis will be perf or me d w he n deli ver y/ birt h safet y a n d 
i m m u n o ge nicity data fr o m all mater nal partici pa nt s i n t he se nti nel c o h orts a n d t heir i nfa nt 
partici pa nt s i n Sta ge 2 are a vaila ble.  Safet y a n d i m m u n o ge nicit y data fr o m all mater nal 
se nti nel-c o h ort st u d y partici pa nt s a n d t heir i nfa nts will be i ncl u de d i n t he a nal ysis.  
T he sec o n d i nteri m a nal ysis is bei n g c o n d ucte d f or i nter nal pla n ni n g p ur p oses o nl y .  T hese 
u n bli n de d data will be re vie we d b y t he I R C.  F or details of s p o ns or bli n di n g, refer t o 
Secti o n 6. 8 .
T he t hir d i nteri m a nal ys is will be perf or me d w he n deli ver y/ birt h safety a n d i m m u n o ge nicit y 
data fr o m all mater nal partici pa nt s a n d t heir i nfa nt partici pa nt s i n Sta ge 2 are a vaila ble.  All 
a vaila ble safet y a n d i m m u n o ge nicit y data fr o m al l st u d y partici pa nt s will be i ncl u de d i n t he 
a nal ys is.  T he pri mar y o bjecti ve of t he t hir d i nteri m a nal ysis is t o select a d ose a n d 
f or m ulati o n f or Sta ge 3.  T hese u n bli n de d data will be re vie we d by t he I R C.  
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 2
T he fi nal G B S 6 d ose a n d f or m ulati o n t o ta ke i n t o Sta ge 3 a n d f urt her de vel o p me nt will be 
selecte d after t his re vie w.  F or details of s p o ns or bli n di n g, refer t o Secti o n 6. 8 .
T he f o urt h i nteri m a nal y sis will be perf or me d w he n deli ver y/ birt h safety a n d 
i m m u n o ge nicity data fr o m all mater nal partici pa nt s a n d t heir i nfa nt partici pa nt s i n 
Sta ge 3 are a vaila ble.  All a vaila ble safet y a n d i m m u n o ge nicity data fr o m all st u d y  
partici pa nt s will be i ncl u de d i n t he a nalys is.  T he pri mar y o bjecti ve of t he f o urt h i nteri m 
a nal ys is is t o s u p p ort i nter nal de vel o p me nt decisi o ns a n d p ote ntial re g ulat or y a ge nc y 
i nteracti o ns f or t he pr o gra m.  T hese u n bli n de d data will be re vie we d by t he I R C.  F or det ails 
of s p o ns or bli n di n g, refer t o Secti o n 6. 8 .
N o m ulti plicit y  a dj ust me nts will be a p plie d f or t hese assess me nts.
After t he c o m pleti o n of t he 1 2 -m o nt h p ost deli ver y / birt h f oll o w-u p visit f or partici pa nt s i n 
Sta ge 3, a cli nical st u d y  re p ort ( C S R) i ncl u di n g all u n bli n de d safety a n d i m m u n o ge nicit y 
data gat here d fr o m all partici pa nt s fr o m eac h of t he 3 sta ges will be iss ue d.  Safet y a n d 
i m m u n o ge nicit y data fr o m mater nal a n d i nfa nt partici pa nt s i n Sta ges 2 a n d 3 will be a nal yz e d 
se paratel y.
Safet y  a n d i m m u n o ge nicit y data fr o m i nfa nt partici pa nt s w h o are b or n t o mater nal 
partici pa nt s recei vi n g t he sa me vacci ne d ose/f or m ulati o n or place b o i n Sta ges 2 a n d 3 will 
be a nal yz e d se parately.
I m m u n o ge nicity data fr o m Sta ge 3 will als o be a nal yze d se paratel y b y c o u ntr y ( U S/ U K, 
S o ut h Africa).
1 0. 5. D at a M o nit ori n g C o m mittee
T his st u d y  will use b ot h a n IR C a n d a n E D M C .
T he E D M C will be res p o nsi ble f or o n g oi n g m o nit ori n g of t he safet y  of partici pa nt s i n t he 
st u d y acc or di n g t o t he c harter, as well as t he a nalysis res ults wit h t he safet y data c ut off at 
1 m o nt h after vacci nati o n f or partici pa nt s fr o m Sta ge 1 as descri be d i n Secti o n 1 0. 4 a b o ve.  
T he E D M C will als o meet f or a n a d h oc safet y re vie w s h o ul d e nr oll me nt of Sta ge 
2 partici pa nt s be halte d, t o revie w t he I RC rec o m me n dati o n a n d ma ke a rec o m me n dati o n 
bef ore e nr oll me nt ma y  be restarte d, t he pr ot oc ol m o difie d, or e nr oll me nt ter mi nate d.
T he rec o m me n dati o ns ma de b y t he E D M C t o alter t he c o n d uct of t he st u d y will be f or war de d 
t o Pfizer f or fi nal decisi o n.  Pfizer will f or war d s uc h decisi o ns, w hic h ma y i ncl u de 
s u m maries of a g gre gate a nalys es of e n d p oi nt e ve nts a n d of safet y data t hat are n ot e n d p oi nts, 
t o re g ulat or y a ut h orities, as a p pr o priate.
T he E D M C will n ot partici pate i n t he Sta ge 2 d ose -escalati o n p r ocesses b ut will partici pate 
i n t he st o p pi n g r ule a n d o verall safet y data re vie w pr ocesses, i n li ne wit h t he re mit of t he 
E D M C c harter.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 3
1 1. Q U A LI T Y C O N T R O L A N D Q U A LI T Y A S S U R A N C E
Pfizer or its a ge nt will c o n d uct peri o dic m o nit ori n g visits d uri n g st u d y c o n d uct t o e ns ure t hat 
t he pr ot oc ol a n d G o o d Cli nical Practices ( G C Ps ) are bei n g f oll o we d.  T he m o nit ors ma y  
re vie w s o urce d oc u me nts t o c o nfir m t hat t he data rec or de d o n C R Fs are acc urate.  T he 
i n vesti gat or a n d i nstit uti o n will all o w Pfizer m o nit ors/a u dit ors or its a ge nts a n d a p pr o priate 
re g ulat or y a ut h orities direct access t o s o urce d oc u me nts t o perf or m t his verificati o n.  T his 
verificati o n ma y  als o occ ur after st u d y c o m pleti o n.
D uri n g st u d y c o n d uct a n d/ or after st u d y c o m pleti o n, t he i n vesti gat or site ma y be s u bje ct t o 
re vie w by t he I RB/ E C, a n d/ or t o q ualit y  ass ura nce a u dits perf or me d b y Pfizer, or c o m pa nies 
w or ki n g wit h or o n be half of Pfizer, a n d/ or t o i ns pecti o n b y  a p pr o priate re g ulat or y 
a ut h orities.
T he i n vesti gat or(s) will n otif y  Pfizer 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 Pfizer 
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 Pfizer 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 ny 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 Pfizer 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 Pfizer or its a ge nts wit h a n o p p ort u nit y  t o re vie w 
a n d c o m me nt o n res p o nses t o a n y  s uc h fi n di n gs.
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.
1 2. D A T A H A N D LI N G A N D R E C O R D K E E PI N G
1 2. 1. C ase Re p ort F or ms/ Electr o nic D at a Rec or d
As use d i n t his pr ot oc ol, t he ter m C R F s h o ul d be u n derst o o d t o refer t o eit her a pa per f or m or 
a n electr o nic data rec or d or b ot h, de pe n di n g o n t he data c ollecti o n met h o d use d i n t his st u d y .
A C R F is re q uire d a n d s h o ul d be c o m plete d f or eac h i ncl u de d partici pa nt .  T he c o m plete d 
ori gi nal C R Fs are t he s ole pr o pert y of Pfizer a n d s h o ul d n ot be ma de a vaila ble i n a n y f or m 
t o t hir d parties, e xce pt f or a ut h orize d re prese ntati ves of Pfizer or a p pr o priate re g ulat or y 
a ut h orities, wit h o ut writte n per missi o n fr o m Pfizer.
T he i n vesti gat or s hall e ns ure t hat t he C R Fs are sec urel y st ore d at t he st u d y site i n e ncr y pte d 
electr o nic a n d/ or pa per f or m a n d will be pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m t o 
pre ve nt access b y u na u t h orize d t hir d parties.
T he i n vesti gat or has ulti mate res p o nsi bilit y  f or t he c ollecti o n a n d re p orti n g of all cli nical, 
safety, a n d la b orat or y data e ntere d o n t he C R Fs a n d a n y ot her data c ollecti o n f or ms (s o urce 
d oc u me nts) a n d e ns uri n g t hat t he y are acc urate, a ut he ntic/ ori gi nal, a ttri b uta ble, c o m plete, 
c o nsiste nt, le gi ble, ti mel y (c o nte m p ora ne o us), e n d uri n g, a n d a vaila ble w he n re q uire d.  
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 4
T he C R Fs m ust be si g ne d b y  t he i n vesti gat or or b y a n a ut h orize d staff me m ber t o attest t hat 
t he data c o ntai ne d o n t he C R Fs are tr ue.  A ny c orrect i o ns t o e ntries ma de i n t he C R Fs or 
s o urce d oc u me nts m ust be date d, i nitiale d, a n d e x plai ne d (if necessar y) a n d s h o ul d n ot 
o bsc ure t he ori gi nal e ntr y .
I n m ost cases, t he s o urce d oc u me nts are t he h os pital or t he p hys icia n’s c hart.  In t hese cases, 
data c oll ecte d o n t he C R Fs m ust matc h t h ose c harts.
I n s o me cases, t he C R F ma y als o ser ve as t he s o urce d oc u me nt.  I n t hese cases, a d oc u me nt 
s h o ul d be a vaila ble at t he i n vesti gat or site a n d at Pfizer t hat clearly i de ntifies t h ose data t hat 
will be rec or de d o n t he C R F, a n d f or w hic h t he C R F will sta n d as t he s o urce d oc u me nt.
1 2. 2. Rec or d Rete nti o n
T o e na ble e val uati o ns a n d/ or i ns pecti o ns/a u dits fr o m re g ulat or y a ut h orities or Pfizer, t he 
i n vesti gat or a grees t o kee p rec or ds, i ncl u di n g t he i de ntit y of all partici pati n g parti ci pa nts 
(s ufficie nt i nf or mati o n t o li n k rec or ds, e g, C R Fs a n d h os pital rec or ds), all ori gi nal si g ne d 
I C Ds, c o pies of all C R Fs, safety re p orti n g f or ms, s o urce d oc u me nts, detaile d rec or ds of 
treat me nt dis p ositi o n, a n d a de q uate d oc u me ntati o n of rele va nt c orres p o n de nce (e g, letters, 
meeti n g mi n utes, a n d tele p h o ne call re p orts).  T he rec or ds s h o ul d be retai ne d b y t he 
i n vesti gat or acc or di n g t o t he IC H g ui deli nes, acc or di n g t o l ocal re g ulati o ns, or as s pecifie d i n 
t he cli nical st u d y a gree me nt ( C S A), w hic he ver is lo n ger.  T he i n vesti gat or m ust e ns ure t hat 
t he rec or ds c o nti n ue t o be st ore d sec urely f or s o l o n g as t he y  are retai ne d.
If t he i n vesti gat or bec o mes u na ble f or a ny reas o n t o c o nti n ue t o retai n st u d y rec or ds f or t he 
re q uire d peri o d (e g, retire me nt, rel ocati o n), Pfizer s h o ul d be pr os pecti vely n otifie d.  
T he st u d y  rec or ds m ust be tra nsferre d t o a desi g nee acce pta ble t o Pfizer, s uc h as a n ot her 
i n vesti gat or, a n ot her i nstit uti o n, or a n i n de pe n de nt t hir d part y arra n ge d b y Pfizer.
I n vesti gat or rec or ds m ust be ke pt for a mi ni m u m of 1 5 ye ars after c o m pleti o n or 
disc o nti n uati o n of t he st u d y or f or l o n ger if re q uire d b y  a p plica ble l ocal re g ulati o ns.
T he i n vesti gat or m ust o btai n Pfizer's writte n per missi o n bef ore dis p osi n g of a n y rec or ds, 
e ve n if rete nti o n re q uire me nts ha ve bee n met.
1 3. E T HI C S
1 3. 1. I nstit uti o n al Re vie w B o ar d/ Et hics C o m mittee
It is t he res p o nsi bilit y of t he i n vesti gat or t o ha ve pr os pecti ve a p pr o val of t he st u d y pr ot oc ol, 
pr ot oc ol a me n d me nts, I C Ds, a n d ot her rele va nt d oc u me nts, e g, recr uit me nt a d vertise me nts, if 
a p plica ble, fr o m t he I R B/ E C.  All c orres p o n de nce wit h t he IR B/ E C s h o ul d be retai ne d i n t he 
i n vesti gat or file.  C o pies of IR B/ E C a p pr o vals s h o ul d be f or war de d t o Pfizer.
T he o nl y  circ u msta nce i n w hic h a n a me n d me nt ma y be i nitiate d pri or t o I R B/ E C a p pr o val is 
w here t he c ha n ge is necessar y  t o eli mi nate a p pare nt i m me diate hazar ds t o t he partici pa nt s.  
I n t hat e ve nt, t he i n vesti gat or m ust n otif y t he I R B/ E C a n d Pfizer i n writi n g i m me diatel y after 
t he i m ple me ntati o n.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 5
1 3. 2. Et hic al C o n d uct of t he St u d y
T he st u d y  will be c o nd ucte d i n acc or da nce wit h t he pr ot oc ol, le gal a n d re g ulat or y  
re q uire me nts, a n d t he ge neral pri nci ples set f ort h i n t he Inter nati o nal Et hical G ui deli nes f or 
Bi o me dical Researc h I n v ol vi n g H u ma n S u bjects ( C o u ncil f or I nter nati o nal Or ga nizati o ns of 
Me dical Sci e nces 2 0 0 2), t he IC H G ui deli ne f or G C P, a n d t he Declarati o n of Helsi n ki.
1 3. 3. P artici p a nt I nf or m ati o n a n d C o nse nt
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 pers o nal data.  
S uc h meas ures will i ncl u de o mitti n g partici pa nt na mes or ot her directl y i de ntifia ble data i n 
a n y re p orts, p u blicati o ns, or ot her discl os ures, e xce pt w here re q uire d b y a p plica ble la ws.
T he pers o nal data will be st ore d at t he st u d y site i n e ncr 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 s hall be res p o nsi ble 
f or deter mi ni n g w het her a pers o nal data breac h has i n fact occ urre d a n d, if s o, pr o vi di n g 
br eac h n otificati o ns as re q uire d b y la w.
T o pr otect t he ri g hts a n d free d o ms of nat ural pers o ns wit h re gar d t o t he pr ocessi n g of 
pers o nal data, w he n st u d y  data are c o m pile d f or tra nsfer t o Pfizer a n d ot her a ut h orize d 
parties, partici pa nt na mes will be re m o ve d a n d will be re place d b y a si n gle, s pecific, 
n u merical c o de, base d o n a n u m beri n g s ys te m defi ne d b y Pfizer.  All ot her i de ntifia ble 
data tra nsferre d t o Pfizer or ot her a ut h orize d parties will be i de ntifie d b y t his si n gle, 
partici pa nt -s pecific c o de.  T he i nvesti gat or 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 his 
or her act ual i de ntit y .  I n case of data tra nsfer, Pfizer will mai ntai n hi g h sta n dar ds of 
c o nfi de ntialit y a n d pr otecti o n of partici pa nt s’ pers o nal data c o nsiste nt wit h t he C S A a n d 
a p plica ble pri vac y la ws.  T he IC Ds a n d a n y  partici pa nt recr uit me nt materials m ust be i n 
c o m plia nce wit h I C H G C P, l ocal re g ulat or y  re q uire me nts, a n d le gal re q uire me nts, i ncl u di n g 
a p plica ble pri vac y la ws.
T he I C Ds use d d uri n g t he i nf or me d c o nse nt pr ocess a n d a n y  partici pa nt recr uit me nt materials 
m ust be re vie we d a n d a p pr o ve d b y Pfizer, a p pr o ve d b y t he I R B/ E C bef ore use, a n d a vaila ble 
f or i ns pecti o n.
T he i n vesti gat or m ust e ns ure t hat eac h st u d y  partici pa nt , or pare nt(s) if a mi n or, is f ull y 
i nf or me d a b o ut t he nat ure a n d o bjecti ves of t he st u d y, t he s hari n g of data relati n g t o t he 
st u d y, a n d p ossi ble ris ks ass ociate d wit h partici pati o n, i ncl u di n g t he ris ks ass ociate d wit h t he 
pr ocessi n g of t he partici pa nt ’s pers o nal data.  T he i n vesti gat or f urt her m ust e ns ure t hat eac h 
st u d y partici pa nt , or pare nt(s) if a mi n or, is f ull y i nf or me d a b o ut his or her ri g ht t o access a n d 
c orrect his or her pers o nal data a n d t o wit h dra w c o nse nt f or t he pr ocessi n g of his or her 
pers o nal data.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 6
W he ne ver c o nse nt is o btai ne d fr o m a partici pa nt ’s pare nt(s), t he partici pa nt ’s asse nt 
(affir mati ve a gree me nt) m ust s u bse q ue ntl y be o btai ne d w he n t he partici pa nt has t he ca pacit y  
t o pr o vi de asse nt, as deter mi ne d b y t he I RB/ E C.  If t he i n vesti gat or deter mi nes t hat a 
partici pa nt ’s decisi o nal ca pacity is s o li mite d t hat he or s he ca n n ot reas o na bl y  be c o ns ulte d, 
t he n, as per mitte d by t he I R B/ E C a n d c o nsiste nt wit h l ocal re g ulat or y a n d le gal re q uire me nts, 
t he partici pa nt ’s asse nt ma y be wai ve d wit h s o urce d oc u me ntati o n of t he reas o n asse nt was 
n ot o btai ne d.  If t he st u d y  partici pa nt d oes n ot pr o vi de his or her o w n c o nse nt, t he s o urce 
d oc u me nts m ust rec or d w h y  t he partici pa nt di d n ot pr o vi de c o nse nt (e g, mi n or, decisi o nall y  
i m paire d a d ult), h o w t he i n vesti gat or deter mi ne d t hat t he pers o n si g ni n g t he c o nse nt was t he 
partici pa nt ’s le gally acce pta ble re prese ntati ve, t he c o nse nt si g ner’s relati o ns hi p t o t he st u d y  
partici pa nt (e g, pare nt, s p o use), a n d t hat t he partici pa nt ’s asse nt was o btai ne d or wai ve d.  
If asse nt is o btai ne d ver ball y, it m ust be d oc u me nte d i n t he s o urce d oc u me nts.
T he i n vesti gat or, or a pers o n desi g nate d b y t he i n vesti gat or, will o btai n writte n i nf or me d 
c o nse nt fr o m eac h partici pa nt bef ore a n y st u d y- s pecific acti vit y is perf or me d.  
T he i n vesti gat or will retai n t he ori gi nal of eac h partici pa nt 's si g ne d c o nse nt.
Bef o re a ny st u d y- s pecific acti vit y is perf or me d, t he i n vesti gat or, or a pers o n desi g nate d b y 
t he i n vesti gat or, will o btai n writte n i nf or me d c o nse nt fr o m eac h mater nal partici pa nt .  T his 
will i ncl u de writte n i nf or me d c o nse nt f or t he m ot her a n d t he fet us d uri n g t he pre g na nc y a n d 
t he i nfa nt partici pa nt ’s c o nti n uati o n i n t he st u d y after deli ver y.  I nf or me d c o nse nt will be 
o btai ne d fr o m t he fat her of t he fet us/i nfa nt partici pa nt if ma n date d by l ocal re q uire me nts.
1 3. 4. Re p orti n g of S afet y Iss ues a n d Seri o us Bre ac hes of t h e Pr ot oc ol or I C H G C P
I n t he e ve nt of a ny pr o hi biti o n or restricti o n i m p ose d (ie, cli nical h ol d) b y a n a p plica ble 
re g ulat or y a ut h ority i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n t hat mi g ht i nfl ue nce t he e val uati o n of the be nefits a n d ris ks of t he i n vesti gati o nal 
pr o d uct, Pfizer s h o ul d be i nf or me d i m me diatel y.
I n a d diti o n, t he i n vesti gat or will i nf or m Pfizer i m me diatel y of a n y ur ge nt 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 I C H G C P t hat t he i n vesti gat or bec o mes a ware 
of.
1 4. D E FI NI TI O N O F E N D O F T RI A L
1 4. 1. E n d of Tri al i n All P artici p ati n g C o u ntries
E n d of trial i n all partici pati n g c o u ntries is defi ne d as t he last v isit of t he last partici pa nt .
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 7
1 5. S P O N S O R DI S C O N TI N U A T I O N C RI T E RI A
Pre mat ure ter mi nati o n of t his st u d y  ma y occ ur beca use of a re g ulat or y a ut h orit y decisi o n, 
c ha n ge i n o pi ni o n of t he I R B/ E C, or i n vesti gati o nal pr o d uct safet y  pr o ble ms, or at t he 
discreti o n of Pf izer.  I n a d diti o n, Pfizer retai ns t he ri g ht t o disc o nti n ue de vel o p me nt of 
G B S 6 at a n y ti me.
If a st u dy is pre mat urel y ter mi nate d, Pfizer will pr o m ptl y n otif y t he i n vesti gat or.  After 
n otificati o n, t he i n vesti gat or m ust c o ntact all partici pati n g partici pa n ts a n d t he h os pital 
p har mac y  (if a p plica ble) wit hi n 3 0 da ys.  As directe d b y Pfizer, all st u d y materials m ust 
be c ollecte d a n d all C R Fs c o m plete d t o t he greatest e xte nt p ossi ble.
1 6. P U B LI C A TI O N O F S T U D Y R E S U L T S
1 6. 1. C o m m u nic ati o n of Res ults b y Pfizer
Pfizer f ulfil ls its c o m mit me nt t o p u blicl y discl ose cli nical trial 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 ur o pea n Cli nical Trials 
Data base ( E u dra C T), a n d/ or w w w. pfizer.c o m, a n d ot her p u blic re gistries i n acc o r 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 nd ucte d i n patie nts) t hat e val uate t he safet y  a n d/ or efficac y of a Pfizer 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 res ults are 
s u b mitte d f or p osti n g i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y U S la w.
E u dra C T
Pfizer p osts cli nical trial res ults o n E u dra C T f or Pfizer -s p o ns ore d i nter ve nti o nal st u dies i n 
acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y  E U re q uire me nts.
w w w. pfizer.c o m
Pfizer p osts p u blic discl os ure s y n o pses (cli nical st u d y re p ort s yn o pses i n w hic h a n y  data t hat 
c o ul d be use d t o i de ntif y  i n di vi d ual partici pa nts ha ve bee n re m o ve d) 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.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 8
D oc u me nts wit hi n mar keti n g a ut h orizati o n pac ka ges/s u b missi o ns
Pfizer c o m plies wit h t he E ur o pea n U ni o n P olic y  0 0 7 0, t he pr oacti ve p u blicati o n of cli nical 
data t o t he E M A we bsite.  Cli nical data, u n der P hase 1 of t his p olic y , i ncl u des cli nical 
o ver vie ws, cli nical s u m maries, C S Rs, a n d a p pe n dices c o ntai ni 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 statistical met h o ds.  Cli nical data, u n der P hase 2 of t his 
p olic y , i ncl u des t he p u blis hi n g of i n di vi d ual partici pa nt data.  P olic y 0 0 7 0 a p plies t o ne w 
mar keti n g a ut h orizati o n a p plicati o ns s u b mitte d via t he ce ntralize d pr oce d ure si nce 
0 1 Ja n uar y 2 0 1 5 a n d a p plicati o ns f or li ne e xte nsi o ns a n d f or ne w i n dicati o ns s u b mitte d via 
t he ce ntralize d pr oce d ure si nce 0 1 J ul y 2 0 1 5.
Data S hari n g
Pfizer pr o vi des researc hers se c ure access t o patie 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 a vaila ble data fr o m t hese trials 
2 4 m o nt hs afte r st u d y c o m pleti o n.  Patie nt-le vel data will be a n o ny m ize d i n acc or da nce wit h 
a p plica ble pri vac y la ws a n d re g ulati o ns.  C S Rs will ha ve pers o nally i de ntifia ble i nf or mati o n 
re dacte d.
Data re q uests are c o nsi dere d fr o m q ualifie d researc hers wit h t he a p pr o priate c o m pete ncies t o 
perf or m t he pr o p ose d a nal yses.  Researc h tea ms m ust i ncl u de a bi ostatisticia n.  Data will n ot 
be pr o vi de d t o a p plica nts wit h si g nifica nt c o nflicts of i nterest, i ncl u di n g i n di vi d uals 
re q uesti n g access f or c o m mercial/c o m petiti ve or le gal p ur p oses.
1 6. 2. P u blic ati o ns b y I n vesti g at ors
Pfizer s u p p orts t he e xercise of aca de mic free d o m a n d has n o o bjecti o n t o p u blicati o n b y  
t he pri nci pal i n vesti gat or ( PI) of t he res ults of t he st u d y  base d o n i nf or mati o n c ollecte d or 
ge nerate d b y t he PI, w het h er or n ot t he res ults are fa v ora ble t o t he Pfizer pr o d uct.  H o we ver, 
t o e ns ure a gai nst i na d verte nt discl os ure of c o nfi de ntial i nf or mati o n or u n pr otecte d 
i n ve nti o ns, 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 o t her ty pe of discl os ure of t he res ults of t he st u d y (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.
T he i n vesti gat or will pr o vi de a n y  p u blicati o n t o Pfizer at least 3 0 d a y s bef ore it is s u b mitte d 
f or p u blicati o n or ot her wise discl ose d.  If a ny pate nt acti o n is re q uire d t o pr otect i ntellect ual 
pr o pert y ri g hts, t he i n vesti gat or a grees t o dela y  t he discl os ure f or a peri o d n ot t o e xcee d a n 
a d diti o nal 6 0 da y s.
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 nfide ntial 
i nf or mati o n bef ore discl os ure, e xce pt f or a ny st u d y - or Pfizer pr o d uct -relate d i nf or mati o n 
necessar y  t o 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.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 2 9
If t he st u dy is part of a m ultice nter st u d y, t he i n vesti gat or a gr ees t hat t he first p u blicati o n is 
t o be a j oi nt p u blicati o n c o veri n g all i n vesti gat or sites, a n d t hat a ny s u bse q ue nt p u blicati o ns 
b y  t he PI will refere nce t hat pri mar y p u blicati o n.  H o we ver, if a j oi nt ma n uscri pt has n ot 
bee n s u b mitte d f or p u blicati o n wit h i n 1 2 m o nt hs of c o m pleti o n or ter mi nati o n of t he st u d y  
at all partici pati n g sites, t he i n vesti gat or is free t o p u blis h se paratel y, s u bject t o t he ot her 
re q uire me nts of t his secti o n.
F or all p u blicati o ns relati n g t o t he st u d y, t he i nstit uti o n 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 Secti o n II - “ Et hical 
C o nsi derati o ns i n t he C o n d uct a n d Re p orti n g of Researc h” of t he U nif or m Re q uire me nts f or 
Ma n uscri pts S u b mitte d t o Bi o me dical J o ur nals, htt p:// w w w.ic mje. or g/i n de x. ht ml #a ut h ors hi p, 
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.
P u blicati o n of st u d y  res ults is als o pr o vi de d f or i n t he C S A bet wee n Pfizer a n d t he 
i nstit uti o n.  In t his secti o n e ntitle d P u blicati o ns b y  In vesti gat ors, t he defi ne d ter ms s hall 
ha ve t he mea ni n gs gi ve n t o t he m i n t he C S A.
If t here is a ny c o nflict bet wee n t he C S A a n d a n y attac h me nts t o it, t he ter ms of t he C S A 
c o ntr ol.  If t here is a n y c o nflict bet wee n t his pr ot oc ol a n d t he C S A, t his pr ot oc ol will c o ntr ol 
as t o a n y iss ue re gar di n g treat me nt of st u d y partici pa nt s, a n d t he C S A will c o ntr ol as t o all 
ot her iss ues.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 0
1 7. P R O T O C O L A M E N D M E N T HI S T O R Y
T he Pr ot oc ol A me n d me nt S u m mar y  of C ha n ges Ta ble f or t he c urre nt a me n d me nt is l ocate d 
directl y  bef ore t he ta ble of c o nte nts.  The pr ot oc ol a me n d me nt s u m mar y  of c ha n ges ta bles 
f or past a me n d me nt(s) ca n be f o u n d bel o w:
A m e n d me nt 7 (2 0 Oct 2 0 2 2)
Secti o n # a n d N a m e
Descri pti o n of 
C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 1. 1 : Pr ot oc ol S u m mar y
Secti o n 1. 2 : Sc he d ule of 
Acti vities
Secti o n 2. 2. 5 : St u d y Rati o nale
Secti o n 3. 3. 2 : E x pl orat or y 
O bjecti ves: Sta ges 2 a n d 3
Secti o n 3. 3. 6 : E x pl orat or y 
E n d p oi nts (I nfa nt Partici pa nts): 
Sta ges 2 a n d 3
Secti o n 7. 3. 5 : Visit 5 – 1 8 -Wee k 
P ost deli ver y F oll o w -U p 
( 1 1 9-1 3 3 Da ys After Deli ver y)
Secti o n 7. 3. 7 : Visit 7 – 1 2 -M o nt h 
P ost deli ver y F oll o w -U p 
( 3 6 5-3 8 5 Da ys After Deli ver y)
Secti o n 8. 3. 3 : Assess me nt of 
A nti b o d y Res p o nses t o R o uti ne 
Pe diatric Vacci nes i n I nfa nt 
Partici pa nts Fr o m S o ut h Africa 
( Sta ges 2 a n d 3)

Re vise d t he i nfa nt 
bl o o d dra w  
sc he d ule f or t he 
U S a n d U K Sta ge 
3 partici pa nts 

T he pe diatric 
i m m u nizati o n 
sc he d ules i n t he U S 
a n d U K differ wit h 
res pect t o 
a d mi nistrati o n of 
di p ht heria a n d 
1 3 -vale nt 
p ne u m oc o ccal 
c o nj u gate vacci ne. 
T he re vise d i nfa nt 
bl o o d sc he d ule has 
c ha n ge d t o be i n li ne 
wit h t his pe diatric 
i m m u nizati o n 
sc he d ule.

S u bsta ntial
Secti o n 1 : Pr ot oc ol S u m mar y
Secti o n 2. 2. 5 : St u d y Rati o nale
Secti o n 4. 1 : Di versit y of St u d y 
P o p ulati o n
Secti o n 4. 4 : Sta ge 3
Secti o n 4. 7 : N u m ber of 
Partici pa nts
Secti o n 4. 7. 3 : Sta ge 3
Secti o n 1 0. 1 : Sa m ple Size 
Deter mi nati o n

A me n de d U S 
partici pa nt 
n u m ber fr o m 
2 0 0 t o 3 6

T he a dj uste d 
pr o p ose d n u m ber of 
partici pa nts will be 
s ufficie nt t o e val uate 
a n d c o m pare t he 
G B S 6 place ntal 
a nti b o d y tra nsfer 
efficie nc y bet wee n 
mater nal/i nfa nt pairs 
i n t he U S a n d S o ut h 
Africa.

S u bsta ntial
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 1
Secti o n # a n d N a m e
Descri pti o n of 
C h a n ge
Brief R ati o n ale
S u bst a nti al or 
N o ns u bst a nti al
Secti o n 5. 5 : E xcl usi o n Criteria –
Sta ges 2 a n d 3 – Mater nal 
Partici pa nts

A me n de d 
e xcl usi o n criteri o n 
8 t o use B MI of 
≥4 0 k g/ m 2 fr o m 
pre pre g na nc y. 
If pre pre g na nc y 
B MI is n ot 
a vaila ble, t he B MI 
at t he ti me of t he 
first o bstetric visit 
d uri n g t he c urre nt 
pre g na nc y ma y be 
use d. 

T his clarificati o n 
wa s a d de d t o e ns ure 
e nr ollme nt of 
healt h y pre g na nt 
w o me n w h o are at 
n o i ncrease d ris k of 
pre g na nc y 
c o m plicati o ns a n d 
will facilitate 
recr uit me nt of 
s uita ble mater nal 
partici pa nts f or t he 
st u d y. I nc or p orate d 
t he Pr ot oc ol 
A d mi nistrati ve 
C ha n ge Letter fr o m 
Se pte m ber 2 0 2 2.

N o ns u bsta ntial
Secti o n 5. 5 : E xcl usi o n Criteria –
Sta ges 2 a n d 3 – Mater nal 
Partici pa nts
Secti o n 6. 1 0. 2. 2 : Sta ges 2 a n d 3 –
Mater nal Partici pa nts

Clarifie d 
e xcl usi o n criteri o n 
1 5 re gar di n g 
partici pa nts’ 
recei pt of lice nse d 
T da p vacci nati o ns

T his c ha n ge has 
bee n ma de t o 
i mpr o ve clarit y a n d 
pr o vi de g ui da nce t o 
i n vesti gati o nal sites. 
I nc or p orate d t he 
Pr ot oc ol 
A d mi nistrati ve 
C ha n ge Letter fr o m 
Se pte m ber 2 0 2 2.

N o ns u bsta ntial
A m e n d me nt 6 ( 2 6 A pr 2 0 2 2)
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n 1. 1 : Bac k gr o u n d a n d 
Rati o nale
Secti o n 4. 1 : Di versit y of St u d y 
P o p ulati o n
Secti o n 4. 4 : Sta ge 3
Secti o n 4. 7 : N u m ber of 
Partici pa nts
Secti o n 4. 7. 3 : Sta ge 3
Ta ble 1 : E nr oll me nt a n d D ose 
Escalati o n Desi g n

A d de d 2 0 0 mater nal partici pa nts t o be 
e nr olle d fr o m t he U S i nt o Sta ge 3.

Data fr o m 
a d d iti o nal 
partici pa nts will 
c o ntri b ute t o t he 
safet y data base of 
mater nal 
partici pa nts t o 
s u p p ort t he 
i nitiati o n of t he 
P hase 3 pr o gra m.

Data w ill e na ble a 
better e val uati o n 
a n d c o m paris o n of 
G B S 6 place ntal 
a nti b o d y tra nsfer 
efficie nc y bet wee n 
mater nal/i nfa n t 
pairs i n t he U S a n d 
S o ut h Africa.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 2
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n 3. 2. 5 : Sec o n dar y 
E n d p oi nts: Sta ge 1
Secti o n 3. 2. 6 : Sec o n dar y 
E n d p oi nts ( Mater nal Partici pa nts): 
Sta ges 2 a n d 3
Secti o n 3. 3. 4 : E x pl orat or y 
E n d p oi nts: Sta ge 1
Secti o n 3. 3. 5 : E x pl orat or y 
E n d p oi nts ( Mater nal Partici pa nts): 
Sta ges 2 a n d 3
Secti o n 3. 3. 6 : E x pl orat or y 
E n d p oi nts (I nfa nt Partici pa nts): 
Sta ges 2 a n d 3
Secti o n 8. 3. 1 : G B S A nti b o d y 
Testi n g

Re m o val of O P A a nal ysis as a n e x pl orat or y 
e n d p oi nt f or Sta ge 1 n o n pre g na nt w o me n, 
a n d Sta ge 2 a n d Sta ge 3 m ater nal a n d i nfa nt 
partici pa nts.

Re m o val of O P A a nal ysis as a sec o n dar y 
e n d p oi nt f or Sta ge 1 n o n pre g na nt w o me n.

Data fr o m t he 
sec o n d a n d t hir d 
i nteri m a nal yses 
de m o nstrate d r o b ust 
i m m u ne res p o nses, 
as meas ure d b y 
ser ot y pe-s pecific 
I g G a n d f u ncti o nal 
a nti b o d y res p o nse
f or ser ot y pe-
s pecific O P A after 
G B S 6 vacci nati o n. 
T hese data s u p p ort 
t he use of a nti-G B S 
ca ps ular I g G le vels 
t o e val uate G B S 6 
vacci ne pr otecti o n 
a gai nst i n vasi ve 
G B S disease. 
H o w e ver, t he l o wer 
li mits of 
q ua ntitati o n 
( L L O Qs) f or 
ser ot y pe-s pecific 
O P As we re hi g h, 
i n dicati n g t hat t he 
O P A assa ys are n ot 
se nsiti ve e n o u g h 
c o m pare d t o I g G, 
a n d t h us re n deri n g 
t he O P A assa y 
u ns uita ble f or 
meas uri n g vacci ne 
pr otecti o n.
Secti o n 1. 1 : Sta ge 3
Secti o n 4. 4 : Sta ge 3

U p date d t he f o urt h i nteri m a nal ysis t hat will 
be perf or me d w he n all Sta ge 3 mater nal 
partici pa nts a n d t heir i nfa nts ha ve c o m plete d 
t he deli ver y/ birt h visit a n d a pr otecti ve 
t hres h ol d, o nce i de ntifie d, will be base d o n 
i nfa nt I g G at birt h.

T his c ha n ge was 
i mple me nte d i n 
pr ot oc ol 
a me n d me nt 4, b ut 
t hese secti o ns were 
misse d i n err or.
Secti o n 1. 1 : Statistical Met h o ds
Secti o n 1 0. 2 : I m m u n o ge nicit y 
A nal ysis
Secti o n 1 0. 4 : A nal ysis Ti mi n g

Safet y a n d i m m u n o ge nicit y data fr o m 
mater nal a n d i nfa nt partici pa nts fr o m Sta ge 2 
a n d 3 w ill be a nal yze d se paratel y.

T his w ill e na ble 
se parate a nal ysis of 
mater nal a n d i nfa nt 
partici pa nts i n 
Sta ge 2 a n d Sta ge 3.
Secti o n 1. 2 : Sc he d ule of Acti vities
Secti o n 7. 1. 1 1 : Visit 1 0 – Bl o o d 
Dra w  F oll o w-u p Visit ( 1 4 -1 8 4 
D a y s After Visit 9)

U p date d refere nce t o t he I C D f or b o oster 
partici pa nts.

A d diti o n of I C D 
re q uire me nts t hat 
were misse d at 
pr ot oc ol 
a me n d me nt 5 f or 
c o nsiste nc y acr oss 
t he pr ot oc ol.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 3
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n 5. 1 0 : Scree n Fail ures

A d diti o n of t he secti o n t o i ncl u de s pecifics 
f or scree n fail ures.

Secti o n has bee n 
a d de d t o clarif y t he 
pr ot oc ol.
Secti o n 7. 2. 1 : Visit 0 – Scree ni n g 
( Da ys -1 4 t o -2 Pri or t o 
Vacci nati o n)

U p date d w or di n g t o clarif y t he reas o n f or 
ultras o u n d at scree ni n g.

A d diti o nal 
i nf or mati o n a d de d 
f or pr ot oc ol 
clarificati o n.
Secti o n 1 0. 4 : A nal ysis Ti mi n g

I m m u n o ge nicit y data fr o m Sta ge 3 w ill als o 
be a nal yze d se paratel y b y c o u ntr y. ( U S/ U K, 
S o ut h Africa).

Se parate a nal ysis b y 
c o u ntr y will all o w 
t he a nal ysis of 
tra ns place ntal 
tra nsfer rati os 
bet w ee n U S a n d 
S o ut h Africa n 
m o t her-i nfa nt pairs.
Title Pa ge

U p date of t he Cli nical Trials. g o v I D fr o m 
N C T 0 1 1 9 3 9 2 0 t o N C T 0 3 7 6 5 0 7 3.

T he 
Cli nical Trials. g o v 
I D N C T 0 1 1 9 3 9 2 0 is 
n ot a p plica ble t o 
t his G B S 6 st u d y; 
t he I D has bee n 
c orrecte d t o 
N C T 0 3 7 6 5 0 7 3.
A m e n d me nt 5 (0 3 N o v 2 0 2 1)
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
Pr ot oc ol S u m mar y
Secti o n 1. 2 : Sc he d ule of Acti vities
Secti o n 3. 1. 2 : Pri mar y E n d p oi nts: 
Sta ge 1
Secti o n 4. 1 : Sta ge 1
Secti o n 4. 5 : D urati o n of 
Partici pa nt Partici pati o n
Secti o n 7. 1. 1 1 : Visit 1 0 – Bl o o d 
Dra w  F oll o w-u p Visit 
( 1 4-1 8 4 Da ys After Visit 9)
Secti o n 9. 1. 4. 1 : Sta ge 1
Secti o n 9. 1. 4. 3 : Sta ges 2 a n d 3 –
I nfa nt Partici pa nts

A d de d a n a d diti o nal bl o o d dra w visit f or 
Sta ge 1 c o h ort b o oster partici pa nts.

T he a d diti o nal 
bl o o d dra w  visit f or 
t he Sta ge 1 c o h ort 
b o oster will pr o vi de 
a d diti o nal ser u m t o 
s u p p ort t he 
de vel o p me nt of a 
u ni versal refere nce 
sta n dar d assa y, 
w hic h is nee de d t o 
i nf or m a p ote ntial 
s urr o gate of 
pr otecti o n f or 
G B S 6.
Title Pa ge

A d de d t he E u dra C T N u m ber.

A d diti o n of t he 
E u dra C T N u m ber 
beca use of t he 
a d diti o n of a U K 
site f or Sta ge 3.  
I nc or p orati n g t he 
Pr ot oc ol 
A d mi nistrati ve 
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 4
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
C ha n ge Letter fr o m 
A u g ust 2 0 2 1.
Secti o n 5 : St u d y P o p ulati o n
Secti o n 5. 1 : I ncl usi o n Criteria –
Sta ge 1
Secti o n 5. 2 : I ncl usi o n Criteria –
Sta ge 1 B o oster Vacci nati o n
Secti o n 5. 3 : E xcl usi o n Criteria –
Sta ge 1
Secti o n 5. 4 : I ncl usi o n Criteria –
Sta ges 2 a n d 3 – Mater nal 
Partici pa nts
Secti o n 5. 5 : E xcl usi o n Criteria –
Sta ges 2 a n d 3 – Mater nal 
Partici pa nts
Secti o n 5. 6 : I ncl usi o n Criteria –
I nfa nt Partici pa nts – Sta ges 2 
a n d 3
Secti o n 5. 7 : E xcl usi o n Criteria –
I nfa nt Partici pa nts – Sta ges 2 
a n d 3
Secti o n 6. 5 : I n vesti gati o nal 
Pr o d uct St ora ge
Secti o n 6. 6 : I n vesti gati o nal 
Pr o d uct Acc o u nta bilit y
Secti o n 6. 6. 1 : Destr ucti o n of 
I n vesti gati o nal Pr o d uct S u p plies
Secti o n 7. 5. 1 : Wit h dra wal of 
C o nse nt
Secti o n 8 : Assess me nts
S ecti o n 8. 5 : Safet y Para meters
Secti o n 8. 8. 1 : A d verse E ve nts
Secti o n 9. 1. 4 : Ti me Peri o d a n d 
Fre q ue nc y f or C ollecti n g A E/ S A E 
I nf or mati o n
Secti o n 9. 1. 4. 4 : Re p orti n g S A Es t o 
Pfizer Safet y
Secti o n 9. 1. 4. 5 : 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
Secti o n 9. 1. 5 : F oll o w-u p of A Es 
a n d S A Es
Secti o n 1 7 : Pr ot oc ol A me n d me nt 
Hist or y

U p date d w or di n g t o matc h t he ne w pr ot oc ol 
te mplate.

Pr ot oc ol te m plate 
c ha n ges.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 5
A m e n d me nt 4 ( 2 5 N o v 2 0 2 0)
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n 1: I ntr o d ucti o n

A d de d bac k gr o u n d i nf or mati o n o n 
cli nical e x perie nce wit h re peate d 
d osi n g

A d de d t hat Sta ge 1 partici pa nt s 
( n o n pre g na nt w o me n) willi n g a n d 
eli gi ble t o partici pate will ret ur n t o 
recei ve a b o oster d ose of G B S 6

U p date d t he o bjecti ves a n d 
ass ociate d a nal yses t o be 
perf or me d f or Sta ge 1 partici pa nt s 
( n o n pre g na nt w o me n) ret ur ni n g f or 
t he b o oster vacci nati o n

U p date d t he eli gi bilit y a n d 
te mp orar y dela y criteria f or Sta ge 1 
partici pa nt s ( n o n pre g na nt w o me n) 
ret ur ni n g f or t he b o oster 
vacci nati o n

U p date d t h e I n vesti gati o nal 
Pr o d ucts secti o n t o i ncl u de details 
of t he b o oster vacci nati o n, 
n o nst u d y vacci nati o ns, a n d 
c o nc o mita nt me dicati o ns f or Sta ge 
1 partici pa nt s ( n o n pre g na nt 
w o me n) ret ur ni n g f or t he b o oster 
vacci nati o n

U p date d t he safet y m o nit ori n g a n d 
a d verse e ve nt ( A E) re p orti n g 
pr oce d ures f or Sta ge 1 partici pa nt s 
( n o n pre g na nt w o me n) ret ur ni n g f or 
t he b o oster vacci nati o n

U p date d “ Cli nical Trial ( C T) 
Seri o us A d verse E ve nt ( S A E) 
Re p ort F or m” t o “ Vacci ne S A E 
Re p orti n g F or m” t hr o u g h o ut 
Secti o n 9

U p date d t he f o urt h i nteri m a nal ysis 
t hat will be perf or me d w he n all 
Sta ge 3 mater nal partici pa nt s a n d 
t heir i nfa nts ha ve c o m plete d t he 
deli ver y/ birt h visit a n d as a 
pr otecti ve t hres h ol d

A d de d t hat Sta ge 1 
partici pa nt s ( n o n pre g na nt 
w o me n) willi n g a n d 
eli gi b le t o partici pate will 
ret ur n t o recei ve a b o oster 
d ose of G B S 6 a n d pr o vi de 
a d diti o nal ser u m t o s u p p ort 
t he de vel o p me nt of a 
u ni versal refere nce 
sta n dar d assa y, w hic h is 
nee de d t o i nf or m a 
p ote ntial s urr o gate of 
pr otecti o n f or t he G B S 6 
vacci ne

U p date d t he f o urt h i nteri m 
a nal ysis t hat will be 
perf or me d w he n all Sta ge 3 
mater nal partici pa nt s a n d 
t heir i nfa nts ha ve 
c o m plete d t he 
deli ver y/ birt h visit a n d as a 
pr otecti ve t hres h ol d, o nce 
i de ntifie d, will be base d o n 
i nfa nt I g G at birt h. T he 
i nteri m a nal ysis is bei n g 
m o difie d t o be i n li ne wit h 
t his strate g y.
Secti o n 2: St u d y O bjecti ves a n d 
E n d p oi nts
Secti o n 3: St u d y Desi g n
Secti o n 4: Partici pa nt Eli gi bilit y 
Criteria
Secti o n 5: I n vesti gati o nal Pr o d ucts
Secti o n 6: St u d y Pr oce d ures
Secti o n 7: Assess me nts
Secti o n 8: A d verse E ve nt 
Re p orti n g
Secti o n 9: Data A nal ysis/ Statistical 
Met h o ds
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 6
A m e n d me nt 3 ( 2 7 M a y
2 0 2 0)
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n 2: St u d y O bjecti ves a n d 
E n d p oi nts

T he gestati o nal a ge of vacci nati o n 
f or partici pa nt s i n Sta ge 3 has bee n 
c ha n ge d fr o m ≥2 7 0/ 7 t o 
≤3 5 6/ 7 we e ks’ g estati o n t o 
≥2 4 0/ 7 t o ≤3 5 6/ 7 we e ks ’
gestati o n

T he t hir d i nteri m a nal ysis has bee n 
u p date d a n d w ill be perf or me d 
w he n all Sta ge 2 mater nal 
partici pa nt s a n d t heir i nfa nts ha ve 
c o m plete d t he deli ver y/ birt h visit .

E nr oll me nt will be m o nit ore d t o 
hel p e ns ure distri b uti o n of 
vacci nati o n acr oss t he gestati o nal 
a ge ra n ge of ≥2 4 0/ 7 t o 
≤3 5 6/ 7 we e ks

Te xt w as a d de d t o Secti o n 6. 2 a n d 
Secti o n 6. 3 a n d t he sc he d ule of 
acti vities ( Sta ges 2 a n d 3) t o clarif y 
t hat st u d y visits ca n be c o n d ucte d 
b y tele p h o ne i n t he e ve nt of a 
disease o ut brea k or pa n de mic

T he te xt i n Secti o n 6. 3. 1 a n d t he 
sc he d ule of acti vities was u p date d 

T he gestati o nal a ge of 
vacci nati o n f or partici pa nt s 
i n Sta ge 3 has bee n 
c ha n ge d fr o m ≥2 7 0/ 7 t o 
≤3 5 6/ 7 wee ks’ gestati o n t o 
≥2 4 0/ 7 t o ≤3 5 6/ 7 we e ks’ 
gestati o n, t o e na ble 
e val uati o n of safet y a n d 
i m m u n o ge nicit y at earlier 
gestati o nal a ges (sec o n d 
tri mester)

T he t hir d i nteri m a nal ysis 
has bee n u p date d a n d w ill 
be perf or me d w he n all 
Sta ge 2 mater nal 
partici pa nts a n d t heir 
i nfa nts ha ve c o m plete d t he 
deli ver y/ birt h visit, as a 
pr otecti ve t hres h ol d, o nce 
i de ntifie d, will be base d o n 
i nfa nt I g G at birt h. T he 
i nteri m a nal ysis is bei n g 
m o difie d t o be i n li ne wit h 
t his strate g y
Secti o n 3: St u d y Desi g n
Secti o n 4: Partici pa nt Eli gi bilit y 
Criteria
Secti o n 6: St u d y Pr oce d ures
Secti o n 7: Assess me nts
Secti o n 9: Data A nal ysis/ Statistical 
Met h o ds
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 7
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n 1 5: P u blicati o n of St u d y 
Res ults
t o all o w sites t o calc ulate a n d 
rec or d t he Ballar d sc ore u p t o 7 2 
h o urs after deli ver y. T his will 
all o w i nf or mati o n t o be o btai ne d if 
u na vaila ble at deli ver y. 
I nc or p orate d t he Pr ot oc ol 
A d mi nistrati ve C ha n ge Letter fr o m 
N o ve m ber 2 0 1 9

A d de d e dit orial c ha n ges i n Secti o n 
7 a n d Secti o n 1 5. 1 t o i m pr o ve 
clarit y

E nr oll me nt will be 
m o nit ore d t o hel p e ns ure 
distri b uti o n of vacci nati o n 
acr oss t he gestati o nal a ge 
ra n ge of ≥2 4 0/ 7 t o 
≤3 5 6/ 7 we e ks, t o e na ble 
e x pa n de d e val uati o n of 
safet y a n d im m u n o ge nicit y 
data at t he selecte d d ose, i n 
t he sec o n d a n d t hir d 
tri mester of pre g na nc y

Te xt w as a d de d t o 
Secti o n 6. 2 a n d Secti o n 6. 3 
a n d t he sc he d ule of 
acti vities ( Sta ges 2 a n d 3) 
t o clarif y t hat st u d y visits 
ca n be c o n d ucte d b y 
tele p h o ne i n t he e ve nt of a 
disease o ut brea k or 
pa n de mic. T his will all o w 
f or a p pr o priate safet y 
f oll o w-u p per pr ot oc ol 
re q uire me nts. I nc or p orate d 
t he Pr ot oc ol 
A d mi nistrati ve C ha n ge 
Letter fr o m Marc h 2 0 2 0
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 8
A m e n d me nt 2 ( 1 8 Se p 2 0 1 9)
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
Secti o n 6: St u d y Pr oce d ures

U p date d t he te xt i n 
Secti o n 6. 2. 6 a n d t he sc he d ule of 
acti vities t o all o w sites  
 
 

U p date d t he st u d y pr oce d ures 
secti o n f or i nfa nt partici pa nt s 
( Secti o n 6. 3) t o i ncl u de a d diti o nal 
b o d y s yste ms t o be e val uate d f or 
t he p h ysical e xa mi nati o n, per 
re g ulat or y fee d bac k

U p date d Secti o n 6. 3. 1 t o all o w f or 
t he c ollecti o n of deli ver y visit 
i nf or mati o n fr o m a vaila ble s o urces

U p date d t he ti me wi n d o w  f or t he 
dail y diar y c ollect i o n ( Secti o n 
7. 5. 1 a n d t he sc he d ule of 
acti vities), si nce t he ti me wi n d o w 
o pe ns i n t he after n o o n ( n ot t he 
e ve ni n g)

U p date d te xt i n t he sc he d ule of 
acti vities, Secti o n 8. 1. 4. 2, a n d 
Ta ble 8 t o clarif y t hat a d verse 
e ve nts ( A Es) relate d t o st u d y 
pr oce d ures occ urri n g u p t o 4 8 
h o urs after t he bl o o d dra w  at Visit 
4 s h o ul d als o be re p orte d i n t he 
case re p ort f or m ( C R F)

U p date d t he te xt i n 
Secti o n 6. 2. 6 a n d t he 
sc he d ule of acti vities t o 
all o w sites t o 
 
 
 
 
I nc or p orate d t he Pr ot oc ol 
A d mi nistrati ve C ha n ge 
Letter fr o m J ul y 2 0 1 9

U p date d t he st u d y 
pr oce d ures secti o n f or 
i nfa nt partici pa nt s ( Secti o n 
6. 3) t o i ncl u de a d diti o nal 
b o d y s yste ms t o be 
e val uate d f or t he p h ysical 
e xa mi nati o n, per re g ulat or y 
fee d bac k. I nc or p orate d t he 
Pr ot oc ol A d mi nistrati ve 
C ha n ge Letter fr o m A pril 
2 0 1 9

U p date d Secti o n 6. 3. 1 t o 
all o w f or t he c ollecti o n of 
deli ver y visit i nf or mati o n 
fr o m a vaila ble s o urces.
I nc or p orate d t he Pr ot oc ol 
A d mi nistrati ve C ha n ge 
Letter fr o m A u g ust 2 0 1 9

U p date d t he ti me wi n d o w  
f or t he dail y diar y 
c ollecti o n ( Secti o n 7. 5. 1 
a n d t he sc he d ule of 
acti vities) si nce t he ti me 
wi n d o w  o pe ns i n t he 
after n o o n ( n ot t he 
e ve ni n g). I nc or p orate d t he 
Pr ot oc ol A d mi nistrati ve 
C ha n ge Letter fr o m A pril 
2 0 1 9

U p date d te xt i n t he 
sc he d ule of acti vities, 
Secti o n 8. 1. 4. 2, a n d 
Ta ble 8 t o clarif y t hat 
a d verse e ve nts ( A Es) 
relate d t o st u d y pr oce d ures 
occ urri n g u p t o 4 8 h o urs 
after t he bl o o d dra w at 
Visit 4 s h o ul d als o be 
re p orte d i n t he case re p ort 
Secti o n 7: Assess me nts
Secti o n 8: A d verse E ve nt 
Re p orti n g
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 3 9
Secti o n # a n d N a m e
Descri pti o n of C h a n ge
Brief R ati o n ale
f or m ( C R F). I nc or p orate d 
t he Pr ot oc ol 
A d mi nistrati ve C ha n ge 
Letter fr o m J ul y 2 0 1 9
A m e n d me nt 1 ( 0 4 Fe b 2 0 1 9)
Secti o n # a n d N a m e
Descri pti o n of c h a n ge
Brief R ati o n ale
Secti o n 2: St u d y O bjecti ves a n d 
E n d p oi nts

A d de d e dit orial c ha n ges 
t hr o u g h o ut t he d oc u me nt t o 
i mpr o ve clarit y a n d t o fi x 
t yp o gra p hical err ors

Pr o vi de d clarificati o n o n t he 
ti mi n g of i nter nal re vie w 
c o m mittee (I R C) re vie ws i n 
t he Pr ot oc ol S u m mar y a n d 
Secti o n 3. 2

U p date d t he e x pl orat or y 
o bjecti ve ( Secti o n 2. 3. 2) t o 
be i n li ne wit h t he e x pecte d 
d urati o n of c o vera ge a gai nst 
i n vasi ve G B S disease i n 
i nfa nts, w hic h is 3 m o nt hs

Ma de c ha n ges re gar di n g t he 
c ollecti o n of c o nc o mita nt 
me dicati o ns t o t he sc he d ule 
of acti vities a n d t he 
Pr oce d ures secti o n t o e ns ure 
c o nsiste nc y wit h Secti o n 
5. 1 0. 3

Ma de c ha n ges t o t he 
sc he d ule of acti vities a n d 
t he Pr oce d ures secti o n f or 
mater nal partici pa nt s t o o nl y 
meas ure hei g ht at t he 
scree ni n g visit

U p date d t he e x pl orat or y 
o bjecti ve ( Secti o n 2. 3. 2) t o 
be i n li ne wit h t he e x pecte d 
d urati o n of c o vera ge 
a gai nst i n vasi ve G B S 
disease i n i nfa nts, w hic h is 
3 m o nt hs. T he 1 2 -m o nt h 
ti me p oi nt has bee n 
r e mo ve d as it is e x pecte d 
t hat passi vel y ac q uire d 
mater nal a nti b o dies will n o 
l o n ger be detecta ble. 
A p plica ble e n d p oi nts f or 
t his o bjecti ve were 
r e mo ve d i n Secti o n 2. 3. 6

Ma de c ha n ges t o t he 
sc he d ule of acti vities an d 
t he Pr oce d ures secti o n f or 
mater nal partici pa nt s t o 
o nl y meas ure hei g ht at t he 
scree ni n g visit, si nce 
hei g ht is n ot e x pecte d t o 
c ha n ge si g nifica ntl y d uri n g 
t he st u d y

A d de d a state me nt 
c o nfir mi n g t he rati o nale f or 
t he c ollecti o n of date of 
Secti o n 3: St u d y Desi g n
Secti o n 5: I n vesti gati o nal Pr o d ucts
Secti o n 6: St u d y Pr oce d ures
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 0
Secti o n # a n d N a m e
Descri pti o n of c h a n ge
Brief R ati o n ale
Secti o n 9: Data A nal ysis/ Statistical 
Met h o ds

U p date d all te m perat ure 
refere nces t o ° C (° F) per 
l ocal practice

A d de d a state me nt 
c o nfir mi n g t he rati o nale f or 
t he c ollecti o n of date of 
birt h t o t he Pr oce d ures 
secti o n ( Secti o n 6)

U p date d Secti o n 6. 5. 1 t o 
acc o m m o date l ocal 
re q uire me nts f or partici pa nt s 
w h o are l ost t o f oll o w -u p
birt h t o t he P r oce d ures 
secti o n ( Secti o n 6)

U p date d Secti o ns 5. 8 a n d 
9. 4 t o i ncl u de a n a d diti o nal 
i nteri m a nal ysis t hat was 
a d de d f or i nter nal pla n ni n g 
p ur p oses
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 1
1 8. R E F E R E N C E S
1.
E d m o n d K M, K ortsali o u da ki C, Sc ott S, et al. Gr o u p B stre pt oc occal disease i n i nfa nts 
a ge d y o u n ger t ha n 3 m o nt hs: s y ste matic re vie w a n d meta-a nal ys is. L a ncet . 
2 0 1 2; 3 7 9( 9 8 1 5): 5 4 7 -5 5 6. 
2.
Ma dzi v ha n dila M, A dria n P V, C utla n d C L , K u wa n da L, Sc hra g SJ, Ma d hi S A. 
Ser ot y pe distri b uti o n a n d i n vasi ve p ote ntial of gr o u p B stre pt oc occ us is olates ca usi n g 
disease i n i nfa nts a n d c ol o nizi n g mater nal ne w b or n d y a ds. P L o S O ne . 
2 0 1 1; 6( 3):e 1 7 8 6 1.
3.
Meli n P, Ef strati o u A. Gr o u p B stre pt oc occal e pi de mi ol o g y a n d vacci ne nee ds i n 
de vel o pe d c o u ntries. V acci ne . 2 0 1 3; 3 1( S u p pl 4): D 3 1-D 4 2.
4.
P hares C R, L y nfiel d R, Farle y  M M, et al. E pi de mi ol o g y of i n vasi ve gr o u p B 
stre pt oc occal disease i n t he U nite d States, 1 9 9 9-2 0 0 5. J A MA . 2 0 0 8; 2 9 9( 1 7): 2 0 5 6- 2 0 6 5.
5.
S k off T H, Farle y  M M, Petit S, et al. Increasi n g b ur de n of i n vasi ve gr o u p B 
stre pt oc occal disease i n n o n pre g na nt a d ults, 1 9 9 0- 2 0 0 7. Cli n I nfect Dis . 
2 0 0 9; 4 9( 1): 8 5 -9 2.
6. 
La ma g ni T L, Kes his hia n C, Efstrati o u A, et al. E mer gi n g tre n ds i n t he e pi de mi ol o g y of 
i n vasi ve gr o u p B stre pt oc occal disease i n E n gla n d a n d Wales, 1 9 9 1-2 0 1 0. Cli n I nfect 
Dis . 2 0 1 3; 5 7( 5): 6 8 2- 6 8 8.
7.
De utsc her M, Le wis M, Zell E R, Ta y l or T H Jr, Va n Be ne de n C, Sc hra g S; f or t he 
Acti ve Bacterial C ore S ur veilla nce Tea m. I nci d e nce a n d se verit y of i n vasi ve 
Stre pt oc occ us p ne u m o ni ae , gr o u p A Stre pt oc occ us , a n d gr o u p B Stre pt oc occ us
i nfecti o ns a m o n g pre g na nt a n d p ost part u m w o me n. Cli n I nfect Dis . 
2 0 1 1; 5 3( 2): 1 1 4 - 1 2 3.
8.
E d war ds M S, Nizet V, Ba ker CJ.  Gr o u p B stre pt oc occal i nfecti o ns. I n: Wils o n C B, 
Nizet V, Mal d o na d o Y E, et al, e ds.  Re mi n gt o n a n d Klei n’s I nfecti o us Diseases of t he 
Fet us a n d Ne w b or n I nfa nt.  8t h E diti o n. A mster da m, t he Net herla n ds: Else vier; 
2 0 1 6: 4 1 1 - 4 5 6.  htt p:// nizetla b. ucs d.e d u/ P u blicati o ns/ R K 2 0 1 5-G B S. p df. Accesse d
2 7 Ma y  2 0 2 0.
9.
Ba ker CJ. T he s pectr u m of peri natal gr o u p B stre pt oc occal disease. V acci ne . 
2 0 1 3; 3 1( S u p pl 4): D 3 -D 6.
1 0.
S mit h E M, K ha n M A, Rei n g ol d A, Watt J P. Gr o u p B stre pt oc occ us i nfecti o ns of s oft 
tiss ue a n d b o ne i n Calif or nia a d ults, 1 9 9 5- 2 0 1 2. E pi de mi ol I n fect. 
2 0 1 5; 1 4 3( 1 5): 3 3 4 3 -3 3 5 0.
1 1.
Nataraja n P, P oretz D M. T he i ncreasi n g t hreat of gr o u p B Stre pt oc occ us i nfecti o n i n 
a d ults [a bstract 7 3 8]. O pe n F or u m I nfect Dis . 2 0 1 4; 1( S u p pl 1): S 2 0 8-S 2 0 9.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 2
1 2.
Le D oare K, Heat h P T. A n o ver vie w of gl o bal G B S e pi de mi ol o g y . V acci ne . 
2 0 1 3; 3 1( S u p pl 4): D 7 -D 1 2.
1 3.
J o hri A K, Lata H, Ya da v P, et al. E pi de mi ol o g y  of gr o u p B Stre pt oc occ us i n de vel o pi n g 
c o u ntries. V acci ne . 2 0 1 3; 3 1( S u p pl 4): D 4 3-D 4 5.
1 4.
Vera ni J R, Mc Gee L, Sc hra g SJ. Pre ve nti o n of peri natal gr o u p B stre pt oc occal disease --
re vise d g ui deli nes fr o m C D C, 2 0 1 0. M M W R Rec o m m Re p . 2 0 1 0; 5 9( R R-1 0): 1 - 3 6.
1 5.
Da n g or Z, Lala S G, C utla n d C L , et al. B ur de n of i n vasi ve gr o u p B Stre pt oc occ us 
disease a n d earl y ne ur ol o gical se q uelae i n S o ut h Africa n i nfa nts. P L o S O ne . 
2 0 1 5; 1 0( 4):e 0 1 2 3 0 1 4.
1 6.
E d war ds M S, G o ni k B. Pre ve nti n g t he br oa d s pectr u m of peri natal m or bi dit y  a n d 
m ortalit y  t hr o u g h gr o u p B stre pt oc occal vacci nati o n. 
V acci ne . 2 0 1 3; 3 1( S u p pl 4): D 6 6 -D 7 1.
1 7.
Ri vera L, Saez -Ll ore ns X, Feris -I glesias J, et al. I nci de nce a n d ser ot ype distri b uti o n of 
i n vasi ve gr o u p B stre pt oc occal disease i n y o u n g i nfa nts: a m ulti -c o u ntr y o bser vati o nal 
st u d y. B M C Pe di atr . 2 0 1 5; 1 5: 1 4 3.
1 8.
Li bster R, E d war ds K M, Le ve nt F, et al. L o n g-t er m o utc o mes of gr o u p B stre pt oc occal 
me ni n gitis. Pe di atrics . 2 0 1 2; 1 3 0( 1):e 8- 1 5.
1 9.
Sc hra g SJ, Z y wic ki S, Farle y  M M, et al.  Gr o u p B stre pt oc occal disease i n t he era of 
i ntra part u m a nti bi otic pr o p h yla xis.  N E n gl J Me d . 2 0 0 0; 3 4 2( 1): 1 5- 2 0.
2 0.
Ce nters f or Disease Pre ve nti o n a n d C o ntr ol. Acti ve Bacterial C ore S ur veilla nce ( A B Cs) 
Re p ort. E mer gi n g I nfecti o ns Pr o gra m Net w or k, Gr o u p B Stre pt oc occ us, 2 0 1 5.
2 1.
T hi g pe n M C, W hit ne y  C G, Mess o n nier N E, et al; f or t he E mer gi n g I nfecti o ns Pr o gra ms 
Net w or k. Bacterial me ni n gitis i n t he U nite d States, 1 9 9 8-2 0 0 7. N E n gl J Me d . 
2 0 1 1; 3 6 4( 2 1): 2 0 1 6 -2 0 2 5.
2 2.
Na n C, Da n g or Z, C utla n d C L , E d war ds M S, Ma d hi S A, C u n ni n gt o n M C. Mater nal 
gr o u p B Stre pt oc occ us -relate d still birt h: a s yste matic re vie w. Br J O bstet Gy n aec ol . 
2 0 1 5; 1 2 2( 1 1): 1 4 3 7 -1 4 4 5.
2 3.
Le D oare K, Jarj u S, Dar b oe S, et al. Ris k fact ors f or gr o u p B stre pt oc occ us 
c ol o nisati o n a n d disease i n Ga m bia n w o me n a n d t heir i nfa nts. 
J I nfect. 2 0 1 6; 7 2( 3): 2 8 3 -2 9 4.
2 4.
Gra y  KJ, Be n nett S L, Fre nc h N, P hiri AJ, Gra ha m S M. In vasi ve gr o u p B stre pt oc occal 
i nfecti o n i n i nfa nts, Mala wi. E mer g I nfect Dis . 2 0 0 7; 1 3( 2): 2 2 3- 2 2 9.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 3
2 5.
Q ua n V, Vera ni J R, C o he n C, et al. I n vasi ve gr o u p B stre pt oc occal disease i n S o ut h 
Africa: i m p orta nce of s ur veilla nce met h o d ol o g y . Pl o S O ne . 2 0 1 6; 1 1( 4):e 0 1 5 2 5 2 4. d oi: 
1 0. 1 3 7 1/j o ur nal. p o ne. 0 1 5 2 5 2 4.
2 6.
Be k ker V, Bijls ma M W, va n de Bee k D, K uij pers T W, va n der E n de A.  I nci de nce of 
i n vasi ve gr o u p B stre pt oc occal disease a n d pat h o ge n ge n oty pe distri b uti o n i n ne w b or n 
ba bies i n t he Net herla n ds o ver 2 5 years: a nati o n wi de s ur veilla nce st u d y.  L a ncet I nfect 
Di s. 2 0 1 4; 1 4( 1 1): 1 0 8 3- 1 0 8 9.
2 7.
S wa m y  G K, Bei gi R H. Mater nal be nefits of i m m u nizati o n d uri n g pre g na nc y.  V acci ne . 
2 0 1 5; 3 3( 4 7): 6 4 3 6 -6 4 4 0.
2 8.
E n gl u n d J A. T he i nfl ue nce of mater nal i m m u nizati o n o n i nfa nt i m m u ne res p o nses. 
J C o m p P at h ol . 2 0 0 7; 1 3 7( S u p pl 1): S 1 6-S 1 9.
2 9.
Har per S A, F u k u da K, U y e ki T M, C o x NJ, Bri d ges C B. Ce nters f or Disease C o ntr ol 
a n d Pre ve nti o n ( C D C) A d vis or y  C o m mittee o n I m m u nizati o n Practices ( A CIP). 
Pre ve nti o n a n d c o ntr ol of i nfl ue nza: 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) [errat u m a p pears i n M M W R Rec o m m Re p . 
2 0 0 4; 5 3( 3 2): 7 4 3]. M M W R Rec o m m Re p . 2 0 0 4; 5 3( R R-6): 1 - 4 0. U p date a p pears i n 
M M W R Rec o m m Re p .  2 0 0 5; 5 4( R R-8): 1 - 4 0.
3 0.
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. Use of i nfl ue nza A ( H 1 N 1) 2 0 0 9 
m o n o vale nt 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 C I P), 2 0 0 9. M M W R Rec o m m Re p . 2 0 0 9; 5 8( R R-1 0): 1 - 8.
3 1.
M or o P L , Te p per N K, Gr o hs k o pf L A, Vell ozzi C, Br o der K. Safet y of seas o nal 
i nfl ue nza a n d i nfl ue nza A ( H 1 N 1) 2 0 0 9 m o n o vale nt vacci nes i n pre g na nc y. Ex pert Rev 
V acci nes . 2 0 1 2; 1 1( 8): 9 1 1- 9 2 1.
3 2.
Li n dse y  B, Ka m p ma n n B, J o nes C. Mater nal i m m u nizati o n as a strate g y t o decrease 
s usce pti bilit y t o i nfecti o n i n ne w b or n i nfa nts. C urr O pi n I nfect Dis.
2 0 1 3; 2 6( 3): 2 4 8 -2 5 3.
3 3.
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n. U p date d rec o m me n dati o ns f or use of 
teta n us t o x oi d, re d uce d di p ht heria t o x oi d, a n d acell ular pert ussis vacci ne ( T da p) i n 
pre g na nt w o me n --A d vis or y  C o m mittee o n I m m u nizati o n Practices ( A CIP), 2 0 1 2. 
M M W R M or b M ort al Wkly Re p . 2 0 1 3; 6 2( 7): 1 3 1-1 3 5.
3 4.
Pal meira P, Q ui nell o C, Sil veira -Lessa A L, Za g o C A, Car neir o -Sa m pai o M. I g G 
place ntal tra nsfer i n healt h y a n d pat h ol o gical p re g na ncies. Cli n Dev I m m u n ol . 
2 0 1 2; 2 0 1 2: 9 8 5 6 4 6.
3 5.
Ba ker CJ, Kas per D L. C orrelati o n of mater nal a nti b o d y  deficie nc y wit h s usce pti bilit y t o 
ne o natal gr o u p B stre pt oc occal i nfecti o n. N E n gl J Me d . 1 9 7 6; 2 9 4( 1 4): 7 5 3- 7 5 6.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 4
3 6.
Ba ker CJ, Care y  VJ, Re nc h M A, et al. Maternal a nti b o d y  at deli ver y pr otects ne o nates 
fr o m early o nset gr o u p B stre pt oc occal disease. J I nfect Dis. 2 0 1 4; 2 0 9( 5): 7 8 1-7 8 8.
3 7.
Ba ker CJ, E d war ds M S, Kas per D L. R ole of a nti b o d y  t o nati ve ty pe III p ol ysacc hari de 
of gr o u p B Stre pt oc occ us i n i nfa nt i nfecti o n. Pe di atrics . 1 9 8 1; 6 8( 4): 5 4 4- 5 4 9.
3 8.
Li n F Y C, P hili ps J B III, Azi mi P H, et al. Le vel of mater nal a nti b o d y re q uire d t o pr otect 
ne o nates a gai nst earl y- o nset disease ca use d b y  gr o u p B stre pt oc occ us ty pe Ia: a 
m ultice nter, ser oe pi de mi ol o g y  st u d y. J I nfect Dis. 2 0 0 1; 1 8 4( 8): 1 0 2 2-1 0 2 8.
3 9.
Li n F Y C, Weis ma n L E, Azi mi P H, et al. Le vel of mater nal I g G a nti -gr o u p B 
stre pt oc occ us ty pe III a nti b o d y c orrelate d wit h pr otecti o n of ne o nates a gai nst 
earl y- o nset disease ca use d b y  t his pat h o ge n. J I nfect Dis. 2 0 0 4; 1 9 0( 5): 9 2 8- 9 3 4.
4 0.
Pic hi c her o M E. Pr otei n carriers of c o nj u gate vacci nes: c haracteristics, de vel o p me nt, 
a n d cli nical trials. H u m V acci n I m m u n ot her . 2 0 1 3; 9( 1 2): 2 5 0 5- 2 5 2 3.
4 1.
Gr u ber W C, Sc ott D A, E mi ni E A. De vel o p me nt a n d cli nical e val uati o n of Pre v nar 1 3, 
a 1 3-vale nt p ne u m oc occal C R M 1 9 7 c o nj u gate vacci ne. A n n N Y Ac a d Sci. 
2 0 1 2; 1 2 6 3( 1): 1 5 -2 6.
4 2.
Ma d hi S A, C utla n d C L , J ose L, et al. Safet y a n d i m m u n o ge nicit y of a n i n vesti gati o nal 
mater nal tri vale nt gr o u p B stre pt oc occ us vacci ne i n healt h y  w o me n a n d t heir i nfa nts: a 
ra n d o mise d p hase 1 b/ 2 trial. L a ncet I nfect Dis . 2 0 1 6; 1 6( 8): 9 2 3- 9 3 4.
4 3.
H e y der ma n R S, Ma d hi S A, Fre nc h N, et al. Gr o u p B stre pt oc occ us vacci nati o n i n 
pre g na nt w o me n wit h or wit h o ut HI V i n Africa: a n o n -ra n d o mise d p hase 2, o pe n-la bel, 
m ultice ntre trial. L a ncet I nfect Dis . 2 0 1 6; 1 6( 5):5 4 6- 5 5 5.
4 4.
Nati o nal De part me nt of Healt h, S o ut h Africa. G ui deli nes f or Mater nit y Care i n S o ut h 
Africa. A Ma n ual f or Cli nics, C o m m u nit y  Healt h Ce ntres a n d District H os pitals. 4t h e d. 
Pret oria: N D o H, 2 0 1 5: 1 7 2
4 5.
La yt o n J B, B utler A M, Li D, et al. Pre natal T da p i m m u nizati o n a n d ris k of mater nal a n d 
ne w b or n a d verse e ve nts. V acci ne 2 0 1 7; 3 5( 3 3): 4 0 7 2 - 8.
4 6.
M or ga n J L,  Ba g gari S R, McI ntire D D, et al. Pre g na nc y o utc o mes after a nte part u m 
teta n us, di p ht heria, a n d acell ular pert ussis vacci nati o n. O bstet Gy nec ol
2 0 1 5; 1 2 5( 6): 1 4 3 3 - 8.
4 7.
Ler o u x -R oels G, Be bia Z, Maes C, et al. Safet y a n d i m m u n o ge nicit y of a sec o n d d ose 
of a n i n vesti gati o nal mater nal tri vale nt gr o u p B stre pt oc occ us vacci ne i n n o n pre g na nt 
w o me n 4 -6 y ears after a first d ose: res ults fr o m a p hase 2 trial. C li n I nfect Dis
2 0 2 0; 7 0( 1 2): 2 5 7 0 - 9.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 5
4 8.
Pa oletti L C, Re nc h M A, Kas per D L, et al. Effects of al u m a dj u va nt or a b o oster d ose o n 
i m m u n o ge nicity d uri n g cli nical trials of gr o u p B stre pt oc occal t y pe III c o nj u gate 
vacci nes. I nfect I m m u n 2 0 0 1; 6 9( 1 1): 6 6 9 6 - 7 0 1.
4 9.
Kas per D L, Pa oletti L C, Wessels M R, et al. I m m u ne res p o nse t o t y pe III gr o u p B 
stre pt oc occal p ol ysacc hari de-teta n us t o x oi d c o nj u gate vacci ne. J Cli n I nvest . 
1 9 9 6; 9 8( 1 0): 2 3 0 8 - 2 3 1 4.
5 0.
Heat h P T. A n u p date o n vacci nati o n a gai nst gr o u p B stre pt oc occ us. Ex pert Rev
V acci nes. 2 0 1 1; 1 0( 5): 6 8 5 - 6 9 4.
5 1.
Ba ker CJ, Re nc h M A, Fer na n dez M, Pa oletti L C, Kas per D L, E d war ds M S. Safet y  a n d 
i m m u n o ge nicity of a bi vale nt gr o u p B stre pt oc occal c o nj u gate vacci ne f or ser ot y pes II 
a n d III. J I nfect Dis. 2 0 0 3; 1 8 8( 1): 6 6-7 3.
5 2.
Ba ker CJ, Re nc h M A, Pa oletti L C, E d war ds M S. D ose -res p o nse t o t ype V gr o u p B 
stre pt oc occal p ol ysacc hari de-teta n us t o x oi d c o nj u gate vacci ne i n healt h y a d ults. 
V acci ne . 2 0 0 7; 2 5( 1): 5 5- 6 3.
5 3.
E d war ds M S, La ne HJ, Hillier S L , Re nc h M A, Ba ker CJ. Persiste nce of f u ncti o nal 
a nti b o dies t o gr o u p B stre pt oc occal ca ps ular p olysacc hari des f oll o wi n g i m m u nizati o n 
wit h gl yc oc o nj u gate vacci nes. V acci ne. 2 0 1 2; 3 0( 2 8): 4 1 2 3 - 4 1 2 6.
5 4.
Nisse n M, Mars hall H, Ric h m o n d P, et al. A ra n d o mize d p hase I  st u d y of t he safety a n d 
i m m u n o ge nicit y of t hree asce n di n g d ose le vels of a 3 a nti ge n St a p hyl oc occ us a ure us
vacci ne ( S A 3 A g) i n healt h y  a d ults. V acci ne . 2 0 1 5; 3 3( 1 5): 1 8 4 6- 1 8 5 4.
5 5.
Ba ker CJ, Pa oletti L C, Wessels M R, et al. Safet y a n d i m m u n o ge nicit y of ca ps ular 
p ol y sacc hari de-teta n us t o x oi d c o nj u gate vacci nes f or gr o u p B stre pt oc occal t y pes Ia a n d 
I b. J I nfect Dis. 1 9 9 9; 1 7 9( 1): 1 4 2-1 5 0.
5 6.
C he n V L , A vci F Y, Kas per D L. A mater nal vacci ne a gai nst gr o u p B Stre pt oc occ us : 
past, prese nt, a n d f ut ure. V acci ne . 2 0 1 3; 3 1( S u p pl 4): D 1 3 D 1 9.
5 7.
C utla n d C L , C u n ni n gt o n M, Ol u g b osi M, et al. Less o ns lear nt fr o m e nr ol me nt a n d 
f oll o w u p of pre g na nt w o me n a n d t heir i nfa nts i n cli nical trials i n S o ut h Africa, a 
l o w-mi d dle i nc o me c o u ntr y . V acci ne . 2 0 1 5; 3 3( 4 7): 6 4 0 6- 6 4 1 2.
5 8.
Ma d hi S, C utla n d C, J ose L , et al. Mater nal gr o u p B stre pt oc occ us vacci nati o n results i n 
place ntal a nti b o d y tra nsfer wit h o ut i nterferi n g wit h res p o nse t o r o uti ne i nfa nt 
vacci nati o n [a bstract E S PI D- 0 2 7 4]. E ur o pea n S ociet y  f or Pae diatric I nfecti o us 
Diseases; 2 0 1 4; D u bli n, Irela n d.
5 9.
Ler o u x - R oels G, Maes C, Wille ke ns J, et al. I de ntificati on of f or m ulati o ns a n d vacci ne 
sc he d ules of a tri vale nt gr o u p B stre pt oc occ us vacci ne f or f urt her de vel o p me nt i n 
n o n- pre g na nt a n d pre g na nt w o me n [a bstract 1 1 1 0]. O pe n F or u m I nfect Dis . 
2 0 1 4; 1( S u p pl 1): S 3 2 9.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 6
6 0.
Male k A, Sa ger R, Za k her A, Sc h nei der H. Tra ns p ort
of i m m u n o gl o b uli n G a n d its 
s u bclasses acr oss t he i n vitr o-perf use d h u ma n place nta. A m J O bst Gy nec ol.
1 9 9 5; 1 7 3( 3, Pt 1): 7 6 0 - 7 6 7.
6 1.
W u ori maa T, Ka y ht y H, Ler o y O, Es k ola J. T olera bilit y  a n d i m m u n o ge nicit y of a n 
1 1- vale nt p ne u m oc occal c o nj u gate vacci ne i n a d ults. 
V acci ne . 2 0 0 1; 1 9( 1 5 1 6): 1 8 6 3 - 1 8 6 9.
6 2.
I nter nati o nal C o nfere nce o n Har m o nisati o n. Statistical Pri nci ples f or Cli nical Trials. 
I C H Har m o nise d Tri partite G ui deli ne E 9, Fe br uar y 1 9 9 8.
6 3.
F o o d a n d Dr u g A d mi nistrati o n, Ce nter f or Bi ol o gics E val uati o n a n d Researc h . 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. G ui da nce f or I n d ustr y , Se pte m ber 2 0 0 7.
6 4.
S heffiel d J S, M u n oz F M, Bei gi R H, et al. Researc h o n vacci nes d uri n g pre g na nc y : 
refere nce val ues f or vital si g ns a n d la b orat or y  assess me nts. 
V acci ne . 2 0 1 3;( 3 1): 4 2 6 4 - 4 2 7 3.
6 5.
W orl d Healt h Or ga nizati o n. C o n ge nital a n o malies.  
htt p:// w w w. w h o.i nt/t o pics/c o n ge nital _a n o malies/e n/. Accesse d 0 8 Ma y  2 0 1 8.
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 7
A p pe n di x 1. 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 m a y  be use d i n t he pr ot oc ol.
A b bre vi ati o n
Ter m
A CI P
A d vis or y  C o m mittee o n I m m u nizati o n Practices
A E
a d verse e ve nt
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 p gar
a p peara nce, p ulse, gri mace, acti vit y , a n d res pirati o n
A S T
as partate a mi n otra nsferase
B MI
b o d y  mass i n de x
B U N
bl o o d urea nitr o ge n
C B E R
Ce nter f or Bi ol o gics E val uati o n a n d Researc h
C D C
Ce nters f or Disease C o ntr ol a n d Pre ve nti o n ( U nite d States)
CI
c o nfi de nce i nter val
C K
creati ne ki nase
C P S
ca ps ular p ol ys acc hari de
C R F
case re p ort f or m
C R M 1 9 7
cr oss -reacti ve material 1 9 7
C S A
cli nical st u d y a gree me nt
C S R
cli nical st u d y re p ort
C T
cli nical trial
DI LI
dr u g -i n d uce d li ver i nj ur y
d L I A
direct L u mi ne x i m m u n oassa y
E C
et hics c o m mittee
E D D
esti mate d deli ver y date
e-diar y
electr o nic diar y
E D M C
e xter nal data m o nit ori n g c o m mittee
E D P
e x p os ure d uri n g pre g na nc y
E M A
E ur o pea n Me dici nes A ge nc y
E O D
earl y -o nset disease
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 Trial s 
( 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)
FI H
first-i n-h u ma n
F S H
f ollicle-sti m ulati n g h or m o ne
G A
gestati o nal a ge
G B S
gr o u p B stre pt oc occ us
G B S 6
gr o u p B stre pt oc occ us 6 -vale nt p ol y sacc hari de c o nj u gate vacci ne
G B S III -T T
gr o u p B stre pt oc occ us t y pe III ca ps ular p ol ys acc hari de-teta n us 
t o x oi d c o nj u gate vacci ne
G C P
G o o d Cli nical Practice
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 8
A b bre vi ati o n
Ter m
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 T
ge o metric mea n titer
H B V
he patitis B vir us
H C V
he patitis C vir us
H E L L P
he m ol y sis, ele vate d li ver e nz ymes, a n d l o w platelet c o u nt
HI V
h u ma n i m m u n o deficie nc y vir us
H S V
her pes si m ple x vir us
I A P
i ntra part u m a nti bi otic pr o p h yla xis
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 ND
i n vesti gati o nal ne w dr u g a p plicati o n
I N R
i nter nati o nal n or malize d rati o
I P A L
I n vesti gati o nal Pr o d uct Acc o u nta bilit y  L o g
I P M
i n vesti gati o nal pr o d uct ma n ual
I RB
i nstit uti o nal re vie w b oar d
I R C
i nter nal re vie w c o m mittee
I R T
i nteracti ve res p o nse tec h n ol o g y
I UD
i ntra uteri ne de vice
I W R
i nteracti ve We b-base d res p o nse
L F T
li ver f u ncti o n test
L M I C
l o w- a n d mi d dle -i nc o me c o u ntr y
L M P
last me nstr ual peri o d
L O D
late-o nset disease
M A E
me dicall y  atte n de d a d verse e ve nt
Me d D R A
Me dical Dicti o nar y  f or Re g ulat or y Acti vities
mI T T
m o difie d i nte nt -t o-treat
N/ A
n ot a p plica ble
O P A
o ps o n o p ha g oc y tic acti vit y
P D A
pers o nal di gital assista nt
PI
pri nci pal i n vesti gat or
P T
pr ot hr o m bi n ti me
R B C
re d bl o o d cell
R C D C
re verse c u m ulati ve distri b uti o n c ur ve
S A E
seri o us a d verse e ve nt
S A P
statistical a nal ysis pla n
S O P
sta n dar d o perati n g pr oce d ure
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
C CI
C CI

P F -0 6 7 6 0 8 0 5 ( Gr o u p B Stre pt oc occ us 6 -Vale nt P ol ysacc hari de C o nj u gate Vacci ne [G B S 6 ])
Pr ot oc ol C 1 0 9 1 0 0 2
Fi nal Pr ot oc ol A me n d me nt 8 , 2 7 Marc h
2 0 2 3
P FI Z E R C O N FI D E N TI A L
Pa ge 1 4 9
A b bre vi ati o n
Ter m
S R M
st u d y refere nce ma n ual
S R S D
si n gle refere nce safety d oc u me nt
T b ili
t otal bilir u bi n
T da p
teta n us t o x oi d, di p ht heria t o x oi d, a n d acell ular pert ussis vacci ne
U K
U nite d Ki n g d o m
U L N
u p per li mit of n or mal
U S
U nite d States
W B C
w hite bl o o d cell
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)

D o c u m e nt A p pr o v al R e c or d
D o c u m e nt N a m e:
D o c u m e nt Titl e:
Si g n e d B y:
D at e( G M T)
Si g ni n g C a p a cit y
0 9 0 1 7 7 e 1 9 d 0 5 4 c 7 9\ A p pr o v e d\ A p pr o v e d O n: 2 8- M ar- 2 0 2 3 0 0: 5 2 ( G M T)
P P D