Assessment of 13-valent Pneumococcal Conjugate Vaccine Effectiveness Among People With HIV in the United States
Conditions: HIV, Pneumonia, Infections, Pneumococcal
Sponsor: Pfizer

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 0 6 Dece m ber  2 0 2 3  
 
P FI Z E R G E N E R A L B U SI N E S S  
C T 2 4 -WI -G L 0 2 -R F 0 2 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy  0 1 -J u n -2 0 2 2   
Pa ge 1  of 4 6  
 
 
N O N -I N T E R V E N TI O N A L ( NI) S T U D Y P R O T O C O L 
St u d y  i nf or m ati o n 
Title  
Assess me nt of 1 3 -vale nt p ne u m oc occal c o nj u gate 
vacci ne effecti ve ness a m o n g pe o ple wit h HI V  i n t he 
U nite d States  
Pr ot oc ol n u m ber  
B 1 8 5 1 2 1 7  
Pr ot oc ol ve rsi o n i de ntifier 
3 . 0 
D ate  
0 6 Dece m b er  2 0 2 3  
Acti ve s u bst a nce  
 
Me dici n al pr o d uct  
Pre v nar 1 3  
Rese arc h q uesti o n a n d 
o bjecti ves  
T he pri mar y o bjecti ves i ncl u de:  
1.  Esti mate v acci ne effecti v e ness ( V E) of 
P C V 1 3 f or i n vasi ve p ne u m oc occal disease 
(I P D) a m o n g pe o pl e li vi n g wit h HI V  
( P L W H) ≥1 8 years of a g e , o verall a n d, if 
feasi ble, at 3, 5, a n d 7 years of f oll o w-u p  
2.  Esti mate V E of P C V 1 3 f or p ne u m oc occal 
p ne u m o nia  a m o n g P L W H ≥1 8 years of a ge, 
o verall a n d, if feasi ble, at 3, 5, a n d 7 years of 
f oll o w-u p  
3.  Esti mate V E  of P C V 1 3 f or all -ca us e 
p ne u m o nia a m o n g P L W H  ≥1 8 years of a ge, 
o verall a n d, if feasi ble, at 3, 5, a n d 7 years of 
f oll o w-u p  
T he sec o n d ar y o bjecti ves  of t his st u d y are t o esti mate : 
1.  Esti mate V E of P C V 1 3 f or p ne u m oc occal 
p ne u m o nia or  p ne u m o nia wit h u ns pecifie d 
ca uses a m o n g P L W H  ≥1 8 years of a ge, 
o verall a n d , if feasi ble, at 3, 5, a n d 7 years of 
f oll o w-u p  
2.  Esti mate V E of P C V 1 3 f or p ne u m o nia wit h 
u ns pecifie d ca uses a m o n g P L W H  ≥1 8 years 
of a ge, o verall a n d , if feasi ble, at 3, 5, a n d 7 
yea rs of f oll o w -u p  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 2  of 4 6  
A ut h or  
, P h D, M P H 
Pfizer, I nc.  
 
 
T his d oc u me nt c o ntai ns c o nfi de ntial i nf or mati o n bel o n gi n g t o Pfizer.  E xce pt as ot her wise a gree d t o i n writi n g, 
b y acce pti n g or re vie wi n g t his d oc u me nt, y o u a gree t o h ol d t his i nf or mati o n i n c o nfi de nce a n d n ot c o p y or 
discl ose it t o ot hers (e x ce pt w here re q uire d b y a p plica ble la w) or use it f or u na ut h orize d p ur p oses.  I n t he e ve nt 
of a n y act ual or s us pecte d breac h of t his o bli gati o n, Pfizer m ust be pr o m ptl y n o tifie d. 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)
P P D
P P D

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 3  of 4 6  
1.  T A B L E O F C O N T E N T S  
1. T A B L E O F C O N T E N T S  .......................................................................................................3  
2. LI S T O F A B B R E VI A TI O N S  ................................................................................................5  
3. R E S P O N SI B L E P A R TI E S  ....................................................................................................7  
4. A B S T R A C T  ...........................................................................................................................8  
5. A M E N D M E N T S A N D U P D A T E S  .....................................................................................1 0  
6. MI L E S T O N E S  .....................................................................................................................1 2  
7. R A TI O N A L E A N D B A C K G R O U N D  ................................................................................1 2  
8. R E S E A R C H Q U E S TI O N A N D O BJ E C TI V E S  .................................................................1 3  
9. R E S E A R C H M E T H O D S  ....................................................................................................1 3  
9. 1. St u d y Desi g n  ...........................................................................................................1 3  
9. 2. Setti n g  ......................................................................................................................1 4  
9. 2. 1. I n cl usi o n Criteria  ........................................................................................1 4  
9. 2. 2. E xcl usi o n Criteria  .......................................................................................1 5  
9. 3. Varia bles  ..................................................................................................................1 7  
9. 4. Data S o urces  ............................................................................................................2 0  
9. 5. St u d y Size  ................................................................................................................2 1  
9. 6. Data Ma n a ge me nt  ...................................................................................................2 2  
9. 7. Data A nal ysis  ..........................................................................................................2 3  
9. 8. Q ualit y C o ntr ol  ........................................................................................................2 5  
9. 9. Li mitati o n s of t he Researc h Met h o ds ......................................................................2 5  
9. 1 0. Ot her As pects  ........................................................................................................2 5  
1 0. P R O T E C TI O N O F H U M A N P A R TI CI P A N T S  ...............................................................2 5  
1 0. 1. Patie nt I nf or mati o n  ................................................................................................2 5  
1 0. 2. Patie nt C o nse nt  ......................................................................................................2 6  
1 0. 3. I nstit uti o nal Re vie w B oar d (I R B)/ Et hics C o m mittee ( E C)  ...................................2 6  
1 0. 4. Et hical C o n d uct of t he St u d y  ................................................................................2 6  
1 1. M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E 
R E A C TI O N S  ......................................................................................................................2 6  
1 2. P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S ........2 6  
1 3. R E F E R E N C E S  ..................................................................................................................2 7  
1 4. LI S T O F T A B L E S  .............................................................................................................2 9  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 4  of 4 6  
1 5. LI S T O F FI G U R E S  ...........................................................................................................2 9  
1 6. A P P E N DI X  ........................................................................................................................2 9  
Ta ble 1. Dia g n osis C o des f or I de ntif yi n g HI V i nf ecti o n  ...............................................2 9  
Ta ble 2. Nati o nal Dr u g C o des f or I d e ntif yi n g HI V A ntiretr o virals (see e x cel) .............2 9  
Ta ble 3. Nati o nal Dr u g C o des a n d C P T ® C o des f or I de ntif yi n g P C V 1 3 Vacci nati o n  .2 9  
Ta ble 5. Dia g n osis C o des f or I de ntif yi n g P ne u m o c occal P ne u m o nia a n d P ne u m o nia wit h 
U ns pecifie d Ca us es  ...................................................................................................3 1  
Ta ble 4. Dia g n osis C o des f or I de ntif yi n g I n v asi ve P ne u m oc occal Dise ase, All -Ca use 
P ne u m o nia, a n d P ne u m oc occal P ne u m o nia  ..............................................................3 2  
Ta ble 6. Nati o nal Dr u g C o des a n d Pr oce d ure C o des f or I de ntif yi n g I m m u n os u p pressi ve 
Me dicati o ns (see e xcel)  .............................................................................................4 1  
Ta ble 7. Nati o nal Dr u g C o des a n d Pr oce d ure C o des f or I de ntif yi n g I nfl ue nza 
Vacci n ati o ns (see e x cel)  ............................................................................................4 1  
Ta ble 8. Nati o nal Dr u g C o des a n d C P T ® C o des f or I de ntif yi n g P P S V 2 3 Vacci nati o n 4 1  
Ta ble 9. C P T ® c o des t o i de ntif y C D 4 la b orat or y t ests  ..................................................4 2  
Ta ble 1 0. C P T ® c o des t o i de ntif y viral l oa d la b orat or y tests  ........................................4 2  
Ta ble 1 1. Dia g n osis C o des f or I d e ntif yi n g All -Ca use P ne u m o nia n ot d ue t o HI V  .......4 3  
Ta ble 1 2. Nati o nal Dr u g C o des a n d C P T ® C o des f or I de ntif yi n g Rec o m bi n a nt Z oster 
Vacci n ati o n  ................................................................................................................4 6  
Ta ble 1 3. Nati o nal Dr u g C o des f or I de ntif yi n g Ca n di diasis A ntif u n gals (see e xcel)  ....4 6  
Ta ble 1 4. Dia g n osis C o des f or I d e ntif yi n g O p p ort u nistic I nfecti o ns (see e x cel)  ..........4 6  
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S  .........................................................4 6  
A N N E X 2. E N C E P P C H E C K LI S T F O R S T U D Y P R O T O C O L S  .........................................4 6  
A N N E X 3. A D DI TI O N A L I N F O R M A TI O N  .........................................................................4 6  
 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 5  of 4 6  
2.  LI S T O F A B B R E VI A TI O N S  
A b bre vi ati o n  
Defi niti o n  
A E  
A d verse e ve nt  
A R T  
A ntiretr o viral t hera p y  
C A P  
C o m m u nit y -ac q uire d p ne u m o nia  
 
C A P iT A  
T he C o m m u nit y -Ac q uire d P ne u m o nia I m m u nizati o n 
Trial i n A d ults  
CI  
C o nfi de nce i nter val  
CI O M S  
C o u ncil f or I nter nati o nal Or ga nizati o ns of M e dical 
Scie nces  
C P T  
C urre nt pr oce d ural ter mi n ol o g y ®  
C S F  
Cere br os pi nal fl ui d  
E C  
Et hics C o m mittee  
E M A  
E ur o pea n Me dici nes A ge nc y  
E N Ce P P  
E ur o pea n Net w or k of C e ntres f or 
P har mac oe pi de mi ol o g y a n d P har mac o vi gila nce  
F D A  
F o o d a n d Dr u g A d mi nistrati o n  
G E P  
G o o d E pi de mi ol o gical Practice  
G P P  
G o o d P har mac o e pi de mi ol o g y Practices  
H C P C S  
Healt hcare C o m m o n Pr oce d ure C o di n g S yste m  
HI P A A  
Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y A ct  
HI V  
H u ma n i m m u n o deficie nc y vir us  
H R  
Hazar d rati o  
I C D-9 -C M  
I nter nati o nal Classificati o n of Diseases, Ni nt h Re visi o n, 
Cli nical M o dificati o n  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 6  of 4 6  
A b bre vi ati o n  
Defi niti o n  
I C D-1 0 -C M  
I nter nati o nal Classificati o n of Diseases, T e nt h Re visi o n, 
Cli nical M o dificati o n  
I C D-9 -P C S  
I nter nati o nal Classificati o n of Diseases, Ni nt h Re visi o n, 
Pr oce d ure C o di n g  S yste m  
I C D-1 0 -P C S  
I nter nati o nal Classificati o n of Diseases, T e nt h Re visi o n, 
Pr oce d ure C o di n g S yste m  
I E A 
I nter nati o nal E pi de mi ol o gical Ass ociati o n 
I P D 
I n v asi ve p ne u m oc occal disease 
I R B 
 
I nstit uti o nal re vie w b o ar d 
I S P O R 
I nter nati o nal S ociet y f or P har mac oec o n o mics a n d 
O utc o mes Researc h  
N D C  
Nati o nal Dr u g C o de  
P C V  
P ne u m oc occal c o nj u gate vacci ne  
P C V 1 3  
1 3 -vale nt p ne u m oc occal c o nj u gate vacci ne  
P C V 1 5  
1 5 -vale nt p ne u m oc occal c o nj u gate vacci ne  
P C V 2 0  
2 0 -vale nt p ne u m oc occal c o nj u gate vacci ne  
P P S V 2 3  
2 3 -vale nt p ne u m oc occal p ol ysacc hari de vacci ne  
P L W H  
Pe o ple li vi n g wit h HI V  
R Z V  
Rec o m bi na nt z oster vacci ne  
S VI  
S ocial V ul nera bilit y I n de x  
V E  
Vacci n e effecti ve n ess  
V T  
Vacci n e -t y pe 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 7  of 4 6  
3.  R E S P O N SI B L E P A R TI E S  
Pri nci p al I n vesti g at or (s) of t he Pr ot oc ol  
 
N a m e, D e gree(s) 
J o b Title  
Affili ati o n  
A d dress  
, 
P har m D  
, U S 
 
Pfizer, I nc  
5 0 0 Arc ola R oa d 
C olle ge ville, P A 
1 9 4 2 6  
 
 
 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)
P P D
P P D
P P D

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 8  of 4 6  
4.  A B S T R A C T  
Title  
Assess me nt of P C V 1 3 vacci ne effecti ve ness a m o n g pe o ple wit h HI V  
R ati o n ale a n d 
b ack gr o u n d   
Pe o ple li vi n g wit h HI V ( P L W H) are at i ncrease d ris k of p ne u m oc occal 
i nfecti o ns. A rece nt meta-a nal ysis s h o ws t hat i n t he era of a d v a nce d 
a ntiretr o viral t hera p y, t he i nci de nce of i n v asi ve p n e u m oc occal disease (I P D) 
i n P L W H is a p pr oxi matel y 3 0 ti mes hi g her w he n c o m pare d wit h t he g e neral 
p o p ulati o n [ 1]. E ve n wit h ti mel y a n d effecti ve treat me nt, t he case fatalit y 
rate of I P D is at least 8 % i n P L W H [ 2] a n d u p t o 2 5 % of P L W H e x p erie n ce 
rec urrent e pis o des of I P D i n t he s u bse q ue nt 1 2 m o nt hs [ 3].  
 
I nter nati o nal g ui deli nes rec o m me n d p ne u m oc occal vacci nati o n f or 
i m m u n oc o m pr o mise d i n di vi d uals [ 4] a n d pre vi o us researc h has s h o w n t h at 
t he p ne u m oc occal c o nj u g ate vacci ne ( P C V) is safe a n d i m m u n o ge nic i n 
P L W H [ 5-8] . St u dies ha v e assesse d t he cli nical efficac y/effecti ve ness of 
P C V i n a d ults, b ut patie nts wit h i m m u n oc o m pr o misi n g c o n diti o ns or 
treat me nts were eit her e x cl u de d fr o m t he st u dies, or vacci n e effecti ve n ess 
( V E) esti mates w ere calc ulate d o verall a n d n ot s p ecificall y a m o n g P L W H or 
a m o n g pe o ple wit h ot her i m m u n oc o m pr o misi n g c o n diti o ns [ 9, 1 0].  
 
Gi ve n t he lac k of P C V 1 3 V E data i n i m m u n oc o m pr o mise d a d ults, t his st u d y 
was desi g ne d t o esti mate P C V 1 3 V E a gai nst p ne u m oc occal disease i n 
P L W H a ge d ≥1 8 years, o verall a n d, if feasi ble, at 3, 5, a n d 7 years after 
vacci nati o n.  
Rese arc h 
o bjectives   
T he pri mar y o bje cti ves i ncl u de:  
1.  Esti mate v acci ne effecti v e ness ( V E) of P C V 1 3 f or i n vasi ve 
p ne u m oc occal disease (I P D)  a m o n g pe o ple li vi n g wit h HI V  ( P L W H) 
≥1 8 years of a ge , o verall a n d, if feasi ble, at 3, 5, a n d 7 years of 
f oll o w-u p  
2.  Esti mate V E of P C V 1 3 f or p ne u m oc occal p ne u m o nia  a m o n g P L W H 
≥1 8 years of a ge, o verall a n d, if feasi ble, at 3, 5, a n d 7 years of 
f oll o w-u p  
3.  Esti mate V E  of P C V 1 3 f or all -ca us e p ne u m o nia a m o n g P L W H  ≥1 8 
years of a ge, o verall a n d, if feasi ble, at 3, 5, a n d 7 years of f oll o w -u p  
T he sec o n d ar y o bjecti ves  of t his st u d y are t o : 
1.  Esti mate V E of P C V 1 3 f or p ne u m oc occal p ne u m o nia or  p ne u m o nia 
wit h u ns pecifie d ca uses a m o n g P L W H  ≥1 8 years of a ge, o verall a n d , 
if feasi ble, at 3, 5, a n d 7 years of f oll o w -u p  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 9  of 4 6  
2.  Esti mate V E of P C V 1 3 f or p ne u m o nia wit h u ns pecifie d ca us es 
a m o n g P L W H ≥1 8 years of a ge, o verall a n d, if feasi ble, at 3, 5, a n d 7 
years of f oll o w -u p  
Desi g n   
T h e V E st u d y will be a retr os pecti ve c o h ort st u d y usi n g healt h care 
a d mi nistrati ve clai ms  a n d la b orat or y dat a.  
P o p ul ati o n  
P L W H will be i de ntifie d usi n g a d mi nistrati ve clai ms a n d i ncl u de i n di vi d uals 
wit h at least o ne i n patie nt I nter nati o nal Classificati o n of Diseases, Ni nt h 
Re visi o n, Cli nical M o dificati o n (I C D -9 -C M) or I nter nati o nal Classificati o n 
of Diseases, T e nt h Re visi o n, Cli nical M o dificati o n (I C D -1 0 -C M) c o d e 
relate d t o HI V or at least 2 o ut patie nt I C D-9 -C M or I C D -1 0 -C M c o d es 
relate d t o HI V at least 3 0 da ys, b ut n o m ore t ha n 7 3 0 da ys a part, d uri n g  
Ja n uar y 1, 2 0 1 4 a n d Dece m ber 3 1, 2 0 2 1. P L W H are re q uire d t o ha ve at least 
si x m o nt hs of c o nti n u o us e nr oll me nt i n o ne or m ore healt h pla ns a n d 
p har mac y b e nefits after t heir first HI V-relat e d I C D-9 -C M or I C D -1 0 -C M . 
T hese si x m o nt hs of c o nti n u o us e nr oll me nt will be c o nsi dere d t he baseli ne 
peri o d, d uri n g w hic h bas eli ne c o vari ates i ncl u di n g de m o gra p hics, 
c o m or bi dities, a n d pre ve ntati ve care will be meas ure d. T he e n d of t he st u d y 
will occ ur o n t he last dat e t hat a d mi nistrati ve clai ms data will be a vaila ble, 
Se pte m ber 3 0, 2 0 2 2.  
 
D at a s o urce  
Healt h care a d mi nistrati v e clai ms a n d la b orat or y d ata will be pr o vi de d b y 
K o m o d o Healt h. K o m o d o Healt h uses artificial i ntelli ge nce a n d dat a 
a nal ytics t o c o m bi ne a n d li n k patie nt -le vel i nf or mati o n fr o m m ore t ha n 1 5 0 
pa yers i n t he U nite d Stat es, i ncl u di n g M e dicare, Me dicai d, a n d C o m merci al 
pla ns. C urre ntl y, K o m o d o Healt h has patie nt -l e vel data o n a p pr o xi matel y 
3 2 5 milli o n i n di vi d uals a n d t hese data i ncl u de i n p atie nt a n d o ut patie nt 
clai ms, p har mac y dis pe nsi n g clai ms, pr o vi der s pecialt y clai ms, a n d m ortalit y 
inf or mati o n.   
 
D at a a n alyses   
C o x pr o p orti o nal hazar ds m o dels will be use d t o esti mate t he hazar d rati o 
( H R) f or eac h o ut c o me c o m pari n g vacci n ate d P L W H wit h u n vacci nate d ( n o 
P C V 1 3)  P L W H. T o e x pl ore p ote ntial c ha n g es i n V E o ver ti me, H Rs will 
als o be ge nerate d d uri n g s pecific ti me peri o ds ( 0 -3, 3 -5, 5 -7 years) usi n g 
piece wise C o x re gressi o n m o dels, if t here is a de q u ate sa m ple size.  All 
m o dels will be a dj uste d f or ti me -fi xe d a n d ti me-v ar yi n g c o variates of 
i nterest usi n g i n verse pr o ba bilit y of treat me nt wei g hti n g.  
V E will be calc ulat e d as 1 mi n us t he esti mate d H R f or eac h o ut c o me.  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 0  of 4 6  
5.  A M E N D M E N T S A N D U P D A T E S  
 
V ersi o n 
I de ntifier 
D ate  
A me n d me nt 
T y pe    
(s u bst a nti al or 
a d mi nistr ati ve)  
 Pr ot oc ol 
Secti o n(s) 
C h a n ge d  
S u m m ar y of 
A me n d me nt(s)  
Re as o n  
2. 0  
0 2 A u g ust 2 0 2 3  
S u bsta ntial  
9. 1 St u d y Desi g n  
1. I n di vi d uals m ust n o w 
ha ve  at least o ne 
i n patie nt or at least t w o 
o ut patie nt HI V -relate d 
I C D-9 -C M a n d I C D -1 0 -
C M c o des occ urri n g at 
least 3 0 da ys b ut n o 
m ore t ha n 7 3 0 da ys 
a part 
2.  St u d y f oll o w -u p will 
n o w be gi n 9 0 da ys after 
i n de x date 
1.  Li miti n g t he ti me bet wee n 
o ut patie nt HI V dia g n osis 
c o des decreases 
misclassificati o n of HI V 
i nfecti o n i n a d mi nistrati ve 
clai ms data 
 
2. Starti n g f oll o w -u p 9 0 da ys 
after i n de x decreases t he 
li keli h o o d t hat o utc o me 
e ve nts occ urre d bef ore a n d/ or 
tri g gere d a n HI V dia g n osis 
9. 3 Varia bles  
1.  A d de d ti me -var yi n g 
c o variate f or a n n ual 
HI V viral l oa d testi n g  
 
2.  A d de d ti me -var yi n g 
c o variate f or a n n ual 
C D 4 cell c o u nt testi n g  
 
3.  A d de d ti me -var yi n g 
c o variate f or res pirat or y 
vir us seas o n  
 
4.  A d de d a n alter nate 
defi niti o n f or o ut patie nt 
ca n di diasis i nfecti o n 
(I C D-9 -C M or I C D -1 0 -
C M c o de a n d a ntif u n gal 
treat me nt wit hi n 7 da ys 
 
5.  C ha n ge d pa y or 
cate g ories 
1.  Mi ni mize c o nf o u n di n g d ue t o 
differe nt HI V care see ki n g 
patter ns a m o n g P C V 1 3 
vacci nate d a n d u n vacci nate d 
i n di vi d uals 
 
2.  Mi ni mize c o nf o u n di n g d ue t o 
differe nt HI V care see ki n g 
patter ns a m o n g P C V 1 3 
vacci nate d a n d u n vacci nate d 
i n di vi d uals 
 
3.  Mi ni mize c o nf o u n di n g d ue t o 
i ncrease d ris k f or res pirat or y 
vir us i nfecti o ns d uri n g fall 
a n d wi nter m o nt hs 
 
4.  I ncrease s pecificit y of 
ca n di diasis i nfecti o ns wit hi n 
a d mi nistrati ve clai ms 
 
5.  Re vise d pa y or cate g ories 
matc h  act ual pa y or cate g ories 
i n data pr o vi de d b y K o m o d o  
 
9. 5 St u d y size  
A d de d ‘ T otal n u m ber of 
e ve nts' c ol u m ns t o Ta bles 2 
a n d 3  
De m o nstrates t hat t he st u d y has 
s ufficie nt statistical p o wer f or 
I P D a n d all-ca use p ne u m o nia 
o utc o mes  
9. 7 Data a nal ysis  
Restrict e d  stratifie d a nal ysis 
b y i n de x year t o first 3 years 
of f oll o w -u p  
D ue t o p ossi ble wa ni n g of t he V E 
a n d differe nt le n gt hs of f oll o w -u p 
b y i n de x year, V E stratificati o n 
b y year of HI V dia g n osis will be 
restricte d t o t he first 3 years of 
f oll o w-u p.  
A p pe n di x  
1.  A d de d A p pe n di x Ta ble 
9 f or C D 4 cell c o u nt 
la b orat or y C P T c o des 
A d de d A p pe n di x Ta ble 9 , 1 0, a n d 
1 3 as ne w varia bles are n o w 
i nclu de d   
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 1  of 4 6  
2.  A d de d A p pe n di x Ta ble 
1 0 f or HI V viral l oa d 
la b orat or y C P T c o des 
3.  A d de d A p pe n di x Ta ble 
1 3 f or ca n di diasis 
a ntif u n gal N D Cs 
3. 0  
2 1 N o ve m ber 
2 0 2 3  
S u bsta ntial  
9. 1 St u d y Desi g n  
1.   Re m o ve d re q uire me nt 
f or si x m o nt hs of 
c o nti n u o us e nr oll me nt 
bef ore me m bers’ first 
HI V -relate d I C D-9 -C M 
or I C D -1 0 -C M c o de  
 
2.  St u d y f oll o w -u p be gi ns 
si x m o nt hs after t he first 
HI V -relate d I C D-9 -C M 
or I C D -1 0 -C M c o de  
A nal ysis will i ncl u de i nci de nt a n d 
pre vale nt  HI V cases d uri n g 2 0 1 4 -
2 0 2 1, rat her t ha n o nl y i ncl u di n g 
i nci de nt cases d uri n g 2 0 1 5-2 0 2 1  
9. 2. 1 I ncl usi o n 
criteria 
1. Re m o ve d criteri o n f or 
si x m o nt hs of 
c o nti n u o us e nr oll me nt 
bef ore first HI V -relate d 
I C D-9 -C M or I C D -1 0 -
C M c o de  
2. Re q uire at least si x 
m o nt hs of c o nti n u o us 
e nr oll me nt after t he first 
HI V -relate d I C D-9 -C M 
or I C D -1 0 -C M c o de 
i nstea d of 9 0 da ys. 
A nal ysis will i ncl u de i nci de nt a n d 
pre vale nt HI V cases d uri n g 2 0 1 4 -
2 0 2 1, rat her t ha n o nl y i ncl u di n g 
i nci de nt cases d uri n g 2 0 1 5-2 0 2 1  
9. 2. 2 E x cl usi o n 
criteria 
Re m o ve d e xcl usi o n f or 
i n di vi d uals wit h e vi de nce of 
A R T t hera p y d uri n g 
baseli ne peri o d  
A nal ysis will i ncl u de i nci de nt a n d 
pre vale nt HI V cases d uri n g 2 0 1 4 -
2 0 2 1, rat her t ha n o nl y i ncl u di n g 
i nci de nt cases d uri n g 2 0 1 5-2 0 2 1  
9. 3  Varia bles  
1.  A d de d a d diti o nal 
o p p ort u nistic i nfecti o ns 
t o c o variates meas ure d 
d uri n g baseli ne a n d 
f oll o w-u p  
2.  Re m o ve d s pecific 
ne gati ve c o ntr ol 
e x p os ure a n d ne gati ve 
c o ntr ol o utc o mes fr o m 
ta ble 
1. C o ntr ol f or p ote ntial 
c o nf o u n di n g d ue t o a n y 
o p p ort u nistic i nfecti o n  
 
2. St u d y tea m w o ul d li ke t o 
e x pl ore a d diti o nal ne gati ve 
c o ntr ol e x p os ures a n d 
o utc o mes i n a nal yses be y o n d 
S hi n gri x a n d ca n di diasis  
A p pe n di x  
A d de d a d diti o nal I C D -9 -
C M a n d I C D -1 0 -C M c o des 
f or o p p ort u nistic i nfecti o ns 
Pr o vi de d dia g n osis c o des t o 
i de ntif y a d diti o nal o p p ort u nistic 
i nfecti o ns  
 
 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 2  of 4 6  
6.  MI L E S T O N E S  
Milest o ne  
Pl a n ne d d ate  
Start of data c ollecti o n  
0 6 Marc h 2 0 2 3  
E n d of data c ollecti o n   
3 0 Oct o ber 2 0 2 4  
Fi nal st u d y re p ort  
3 0 Oct o ber 2 0 2 4  
7.  R A TI O N A L E A N D B A C K G R O U N D  
H u ma n i m m u n o deficie nc y vir us  ( HI V) i nf ecti o n lea ds t o e xte nsi ve defects i n t he i m m u ne 
s yste m,i ncl u di n g t he pr o gressi ve de pleti o n a n d d ysf u ncti o n of C D 4 +  T cells, pert ur bati o n of t he B 
cell c o m part me nt wit h re d uce d resti n g me m or y B cells, a n d s u b o pti mal h u m oral i m m u ne res p o nses 
[ 1 1-1 4] . Pe o ple li vi n g wit h HI V ( P L W H) are at i n creas e d ris k of p n e u m oc occal i nfecti o ns. W hile 
a ntiretr oviral t hera p y ( A R T) ca n rest ore t he i m m u ne s yste m a n d c o nse q u e ntl y l o wer t he ris k of 
p ne u m oc occal i nfecti o ns [ 2, 1 5], t he b ur d e n of p ne u m oc occal i nfecti o ns persists i n P L W H [ 1 6, 1 7]. 
A rece nt meta -a nal ysis s h o ws t hat i n t he era of a d va nce d A R T, t he i n ci de nce rat e of i n vasi ve 
p ne u m oc occal disease (I P D) i n P L W H is a p pr o xi matel y 3 0 ti mes hi g her w he n c o m pare d wit h t he 
ge neral p o p ulati o n [ 1]. E ve n wit h ti mel y a n d effecti ve treat me nt, t he case fatalit y rate of I P D is at 
least 8 % i n P L W H [ 2]. U p t o 2 5 % of P L W H e x p erie nce rec urre nt e pis o des of I P D i n t he s u bse q ue nt 
1 2 m o nt hs [ 3].  
 
I nter nati o nal g ui deli nes r ec o m me n d p ne u m oc occal vacci nati o n f or i m mu n o c o m pr o mise d i n di vi d uals 
[ 4]. I n t he U nite d States, o ne d ose of 1 3 -v ale nt p n e u m oc occal c o nj u gate vacci ne ( P C V 1 3) h as bee n 
rec o m me n de d t o P L W H si nce 2 0 1 2 [ 1 8]. C urre ntl y, t he C D C rec o m me n ds 2 0-vale nt p ne u m oc occal 
c o nj u gate vacci ne ( P C V 2 0) al o ne or 1 5 -vale nt p ne u m oc occal c o nj u gate vacci ne ( P C V 1 5) f oll o we d 
b y p ne u m oc occal p ol ysacc hari d e vacci ne ( P P S V 2 3) f or a d ults a g e d 1 9 -6 4 years  wit h certai n 
u n derl yi n g me dical c o n diti o ns, i ncl u di n g HI V i nfecti o n, a n d f or all a d ults a ge d ≥6 5 years  [ 1 9].  
 
Pre vi o us researc h h as s h o w n t hat P C V 1 3 is safe a n d i m m u n o ge nic i n a d ults, i ncl u di n g P L W H [ 5-8] . 
A fe w st u dies als o ass esse d t he cli nical efficac y/effecti ve ness of a P C V i n a d ults. I n a lar ge, 
ra n d o mize d, pla ce b o-c o ntr olle d cli nical trial ( C A Pi T A) of o ver 8 4, 0 0 0 D utc h a d ults a ge d ≥6 5 years , 
P C V 1 3 s h o we d  effic ac y a gai nst b ot h vacci ne -t y pe ( V T) I P D (V E 7 5 %; 9 5 % c o nfi de n ce i nter val 
[ CI]: 4 1 % t o 9 1 %) a n d V T n o n -bactere mic p ne u m oc occal c o m m u nit y -ac q uire d p ne u m o nia ( C A P) 
( V E 4 5 %; 9 5 % CI: 1 4 %-6 5 %) [ 9]. P CV 1 3 efficac y persiste d t hr o u g h o ut t he cli nical trial ( mea n 
f oll o w-u p: 4 years) [ 9]. A p o p ulati o n-base d , test ne gati ve desi g n, s ur veilla nce st u d y re p orte d a 
P C V 1 3 V E of 7 3 % ( 9 5 % CI: 1 3 % -9 2 %) a g ai nst V T C A P i n h os pitalize d a d ults a ge d ≥6 5 years [ 1 0]. 
I n a cli nical trial c o n d u ct e d i n HI V-i nf ecte d a d ults i n Mala wi rece ntl y h os pitalize d wit h p ne u m o nia, 
t w o d oses of P C V 7 de m o nstrate d s u bsta ntial pr otecti o n a gai nst rec urre nt p n e u m oc occal i nfecti o n 
ca use d b y vacci ne s er ot y pes or ser ot y pe 6 A ( V E 7 4 %; 9 5 % CI: 3 0 % -9 0 %) [ 3], alt h o u g h t here was 
n o pr otecti o n a gai nst m ortalit y .   
 
Alt h o u g h t he C A Pi T A st u d y pr o vi des i m p orta nt i nf or mati o n o n P C V 1 3 V E i n a d ults, patie nts wit h 
a n y i m m u n oc o m pr o misi n g c o n diti o n or treat me nt were e xcl u de d fr o m t he st u d y. I n c o ntrast t o 
C A Pi T A, t he st u d y b y Mc La u g hli n et al. i ncl u de d i m m u n oc o m pr o mise d a d ults; h o we ver, P C V 1 3 
V E was r e p orte d f or t he e ntire st u d y p o p ulati o n [ 1 0]. T h us, t here is a lac k of data o n P C V 1 3 V E 
s pecific t o i m m u n oc o m pr o mise d a d ults. I n t h e a bse nce of s uc h data, i n a C D C c ost -effecti veness  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 3  of 4 6  
m o del, it was ass u me d t hat P C V 1 3 V E i n i m m u n oc o m pr o mise d a d ults was 2 5 % ( 9 5 % CI: 1 4 % -
3 0 %) a gai nst V T I P D a n d 1 5 % ( 9 5 % CI: 5 % -2 2 %) a g ai nst V T p n e u m o nia, b ot h of w hic h are 
a p pr o xi matel y o ne t hir d of t he V E meas ure d i n healt h y a d ults/a d ults wit h c hr o nic me dical c o n diti o ns 
[ 2 0, 2 1].  
 
T here h as b ee n a l o n gsta n di n g rec o m me n dati o n f or p ne u m oc occal vacci nati o n f or P L W H i n t he 
U nite d States. P C V 1 3 was rec o m me n de d f or P L W H i n 2 0 1 2 a n d t he u pta ke i n P L W H is hi g her 
c o m pare d wit h i n di vi d uals wit h ot her ris k c o n diti o ns [ 2 2, 2 3]; t his all o ws us t o e xa mi ne P C V 1 3  V E  
i n t he P L W H p o p ulati o n o ver ti me. Gi ve n t he lac k of P C V 1 3 V E data i n i m m u n oc o m pr o mise d 
a d ults, t his st u d y was desi g ne d t o esti mate P C V 1 3 V E a gai nst p ne u m oc occal disease i n P L W H a g e d 
≥1 8 years, o verall a n d, if feasi ble, at 3, 5, a n d 7 years after vacci nati o n. I n a d diti o n t o I P D a n d 
p ne u m oc occal p ne u m o ni a, we will i ncl u de all -ca use p ne u m o nia as a dise as e e n d p oi nt i n t he 
a nal ysis, beca us e S . p ne u m o ni ae is t he m ost c o m m o n bacterial ca use of all-ca use p n e u m o nia [ 2 4].    
     
8.  R E S E A R C H Q U E S TI O N A N D O B J E C TI V E S  
T he pri mar y o bje cti ves of t his st u d y are:  
1.  Esti mate V E of P C V 1 3 f or I P D a m o n g P L W H  ≥1 8 years of a ge , o v erall a n d, if 
feasi ble, at 3, 5, a n d 7 years of f oll o w-u p  
2.  Esti mate V E of P C V 1 3 f or p ne u m oc occal p ne u m o nia  a m o n g P L W H ≥1 8 years of 
a ge, o verall a n d, if feasi ble, at 3, 5, a n d 7 years of f oll o w -u p  
3.  E sti mate V E of P C V 1 3 f or all -ca us e p ne u m o nia a m o n g P L W H  ≥1 8 years of a ge, 
o verall a n d, if feasi ble, at 3, 5, a n d 7 years of f oll o w -u p  
T he sec o n d ar y o bjecti ves  of t his st u d y are : 
1.  Esti mate V E of P C V 1 3 f or p ne u m oc occal p ne u m o nia or  p ne u m o nia wit h u ns pecifie d 
ca uses a m o n g P L W H  ≥1 8 years of a ge, o v erall a n d , if feasi ble, at 3, 5, a n d 7 years of 
f oll o w-u p  
2.  Esti mate V E of P C V 1 3 f or p ne u m o nia wit h u ns pecifie d ca us es a m o n g P L W H  ≥1 8 
years of a ge, o verall a n d , if feasi ble, at 3, 5, a n d 7 years of f oll o w -u p  
9.  R E S E A R C H M E T H O D S  
9. 1.  St u d y D esi g n   
T h e V E st u d y will be a retr os pecti ve c o h ort st u d y usi n g healt h care a d mi nistrati ve clai ms  a n d 
la b orat or y dat a ( Fi g ure 1). 
P L W H will be i de ntifie d usi n g a d mi nistrati ve clai ms a n d i ncl u de i n di vi d uals wit h at least o ne 
i n patie nt I nter nati o nal Classificati o n of Diseas es, Ni nt h Re visi o n, Cli nical M o dificati o n (I C D-9 -
C M) or I nter nati o nal Classificati o n of Diseases, T e nt h Re visi o n, Cli nical M o dificati o n (I C D -1 0 -
C M) c o de rel ate d t o HI V ( A p pe n di x Ta ble 1) or at least 2 o ut patie nt I C D -9 -C M or I C D -1 0 -C M 
c o des rel ate d t o HI V at least 3 0 da ys , b ut n o m ore t ha n 7 3 0 da ys a part, d uri n g  Ja n uar y 1, 2 0 1 4 a n d 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 4  of 4 6  
Dece m b er 3 1, 2 0 2 1. P L W H are re q uir e d t o ha ve at least si x m o nt hs of c o nti n u o us e nr oll me nt i n o ne 
or m ore healt h pla ns a n d p har mac y b e nefits  after t heir first HI V -relat e d I C D-9 -C M or I C D -1 0 -C M 
c o de. T hes e si x m o nt hs of c o nti n u o us e nr oll me nt will be c o nsi dere d t he baseli ne peri o d, d uri n g 
w hic h baseli ne c o v ariat es i ncl u di n g de m o gra p hics, c o m or bi dities, a n d pre ve ntati ve care will be 
meas ure d. T h e baseli ne  p eri o d was als o sel ecte d t o mi ni mize t he n u m ber of o utc o me e ve nts t hat 
e xisti n g pri or t o or tri g gere d a n HI V dia g n osis . 
T he date f oll o wi n g t he last date  of t he baseli ne  p eri o d  will be defi ne d as  t he i n de x date. T he e n d of 
t he st u d y will occ ur o n t he last date t hat a d mi nistrati ve clai ms data will be a vaila ble, Se pte m ber 3 0, 
2 0 2 2.  
F or P L W H w h o recei ve P C V 1 3 after t heir i n de x date, we will i ncl u de t he ti me bet wee n t heir i n de x 
date  a n d t he 1 3 d a ys after t heir P C V 1 3 vacci nati o n date as u n vacci nate d f oll o w-u p ti me. A n y 
o utc o mes occ urri n g d uri n g t his ti me will be c o u nte d as e ve nts i n t he u n vacci nate d c o h ort. F oll o w -u p 
t hat occ urs 1 4 da ys or m ore aft er P C V 1 3 vacci nati o n will be defi ne d as vacci nate d f oll o w-u p ti me.  
U n vacci n ate d ( n o P C V 1 3) P L W H will be f oll o we d fr o m i n de x date u ntil t he earliest o cc urre nce of 
t he f oll o wi n g: 1 3 da ys after P C V 1 3 vacci nati o n, d eat h, e n d of h ealt h pla n e nr oll me nt, or e n d of 
st u d y peri o d. Vacci nate d P L W H will be f oll o we d fr o m 1 4 da ys after t heir P C V 1 3 vacci nati o n , or 
i n de x date if t he y w ere v acci nat e d d uri n g t he bas eli ne p eri o d, u ntil t he earli est occ urre nce of t he 
f oll o wi n g: deat h, e n d of healt h pla n e nr oll me nt, or e n d of st u d y peri o d .  
9. 2.  Setti n g  
Healt h care a d mi nistrati v e clai ms a n d la b orat or y d ata will be pr o vi de d b y K o m o d o Healt h. K o m o d o 
Healt h uses artifi cial i ntelli ge nce a n d data a nal ytics t o c o m bi ne a n d li n k patie nt -le vel i nf or mati o n 
fr o m m ore t ha n 1 5 0 pa y ers i n t he U nite d States, i ncl u di n g Me dicare, Me dicai d, a n d C o m mercial 
pla ns.  
K o m o d o Healt h will pr o vi de a d mi nistrati ve clai ms data a n d HI V -relate d la b orat or y data a vaila ble 
d uri n g  Ja n uar y 1, 2 0 1 4 t hr o u g h Se pte m ber 3 0, 2 0 2 2  f or i n di vi d uals w h o ha ve at least o ne I C D-9 -
C M  or I C D -1 0 -C M c o de relate d t o HI V ( A p pe n di x Ta ble 1)  or at least  o ne  A R T me dicati o n 
dis pe nse d ( A p pe n di x T a ble 2).  
9. 2. 1.  I ncl usi o n C riteri a 
T o be eli gi ble f or t he v acci ne effecti ve n ess st u d y, i n di vi d uals m ust meet t he f oll o wi n g criteria:  
1.  HI V i nfecti o n defi ne d as at least o ne i n patie nt I nter nati o nal Classificati o n of Diseases , Ni nt h 
Re visi o n, Cli nical M o dificati o n (I C D -9 -C M) or I nter nati o nal Classificati o n of Diseases, 
Te nt h Re visi o n, Cli nical M o dificati o n (I C D -1 0 -C M) c o de relate d t o HI V ( A p pe n di x Ta ble 1) 
or ≥2 o ut patie nt I C D -9 -C M or I C D -1 0 -C M c o des relate d t o HI V at least 3 0  da ys , b ut n o 
m ore t ha n 7 3 0 da ys  a p art , d uri n g Ja n uar y 1, 2 0 1 4 a n d Dece m ber 3 1, 2 0 2 1  
A N D  
2.  At least 1 8 years of a ge at t he ti me of t he first rec or di n g of HI V -relat e d I C D-9 -C M or I C D -
1 0 -C M c o de  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -
2 0 2 3    
Pa ge 1 5  of 4 6  
A N D  
3.  At least si x m o nt hs of c o nti n u o us e nr oll me nt i n me dical a n d p h ar mac y pl a ns after t he first 
HI V -relate d I C D-9 -C M or I C D -1 0 -C M c o d e bet wee n Ja n u ar y 1, 2 0 1 4 a n d Dece m b er 3 1, 
2 0 2 1. A ga p of 3 0 da ys o r less i n e nr oll me nt will be all o we d d uri n g t his si x m o nt h peri o d. 
9. 2. 2.  E xcl usi o n C riteria  
Patie nt s meeti n g  t he f oll o wi n g criterio n  will n ot be i ncl u de d i n t he st u d y:  
1.  E vi de nce of P C V 1 3 vacci nati o n bef ore t he first HI V -relat e d I C D-9 -C M or I C D -1 0 -C M c o de  
 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 1 6  of 4 6  
Fi g ure 1 . Ill ustr ati ve ti meli ne f or st u d y p artici p a nts  
 
 
 
 
J a n u ary 1, 2 0 1 4 
S e pt e m b er 3 0, 2 0 2 2  
J uly 1, 2 0 1 4 
D ec e m b er 3 1, 2 0 2 1  
A d mi nistr ativ e cl ai ms  
Eli gi bl e i n d ex d at es  
Ex a m pl e p artici p a nt  
B as eli n e  
• 6 m o nt hs e nr oll m e nt 
i n m e dic al a n d 
p h ar m acy b e n efits 
aft er first HI V -r el at e d 
I C D-9 -C M or I C D -1 0 -
C M c o d e 
U n v acci n at e d f oll o w -u p  
• U n v acci n at e d p artici p a nts - i n d ex 
d at e t o e n d of f oll o w -u p (i. e., 
h e alt h pl a n dis e nr oll m e nt, d e at h, 
or S e pt e m b er 3 0, 2 0 2 2)  
• V acci n at e d p artici p a nts -  i n d ex 
d at e t o 1 3 d a ys aft er P C V 1 3 
a d mi nistr ati o n  
V acci n at e d f oll o w -u p  
• 1 4 d a ys aft er P C V 1 3 a d mi nistr at i o n 
a n d e n d of f oll o w -u p (i. e., h e alt h pl a n 
dis e nr oll m e nt, d e at h, or S e pt e m b er 
3 0, 2 0 2 2)  
I n d e x d at e  
P C V 1 3 a d mi nistr ati o n  
First HI V c o d e  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 1 7  of 4 6  
9. 3.  V ari a bles  
T a ble 1 . V ari a bles, defi niti o ns, a n d me as ure me nt peri o ds  
V ari a ble 
t y pe 
V ari a ble  
Defi niti o n  
Me as ure me nt 
peri o d  
E x p os ure  
P C V 1 3 vacci nati o n  
C urre nt pr oce d ural 
ter mi n ol o g y ® ( C P T) c o des a n d 
Nati o nal Dr u g C o des ( N D C) 
liste d i n A p pe n di x Ta ble 3 
F oll o w -u p  
Pri mar y 
o utc o mes  
I P D 
I C D-9 -C M or I C D-1 0 -C M c o des 
liste d i n A p pe n di x Ta ble 4 
F oll o w -u p  
P ne u m oc occal 
p ne u m o nia  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A p pe n di x Ta ble 4  
F oll o w -u p  
All -ca use p n e u m o nia  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A p pe n di x Ta ble 4  
F oll o w -u p  
P ne u m oc occal 
p ne u m o nia or 
p ne u m o nia wit h 
u ns pecifie d ca uses  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A p pe n di x Ta ble 5  
F oll o w -u p  
P ne u m o nia wit h 
u ns pecifie d ca uses  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A p pe n di x Ta ble 5  
F oll o w -u p  
C o variates  
A ge  
Calc ulate d as [ year i n di vi d ual 
meets HI V criteria] –  [ birt h year] 
Cate g orize d as 1 8 -4 9, 5 0 -6 4, 6 5 -
7 4, a n d ≥7 5 years  
Baseli ne  
Se x  
Male, Fe m ale, Ot her, U n k n o w n  
Baseli ne  
S ocial V ul nera bilit y 
I n d e x ( S VI) 
S VI c haracteri zes resilie nc y of a 
c o m m u nit y w he n face d b y 
e xter nal pr ess ures a n d stresses 
[ 2 5, 2 6]. S VI ra n g es fr o m 0 t o 
1 0 0, w here a val ue of 1 0 0 
i n dicates t he m ost v ul nera ble 
p o p ulati o n. S VI wil l be 
esti mate d usi n g zi p c o de a n d 
will be cate g orize d as l o w 
(l o west q uartile), a vera ge 
( mi d dle t w o q uartiles) a n d hi g h 
( hi g hest q uartile). 
Baseli ne  
Pa y or  
Me dicai d / C HI P, Me dicare, 
C o m mercial,  D uall y eli gi ble, 
Ot her, U n k n o w n  
Baseli ne  
U S re gi o n  
N ort heast, N ort h Ce ntral, S o ut h, 
West, U n k n o w n  
Baseli ne  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 1 8  of 4 6  
V ari a ble 
t y pe 
V ari a ble  
Defi niti o n  
Me as ure me nt 
peri o d  
I n d e x year 
Cale n dar year of first HI V 
dia g n osis c o de  
Baseli ne  
Alc o h olis m  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 1 
Baseli ne a n d 
f oll o w-u p  
As ple nia  
C P T/ Healt hcare C o m m o n 
Pr oce d ure C o di n g S yste m 
(H C P C S ), I C D-1 0 -Pr oce d ure 
C o di n g S yste m (I C D -1 0 -P C S), 
I C D-9 -Pr oce d ure C o di n g S yste m 
(I C D-9 -P C S),  I C D-9 -C M, or 
I C D-1 0 -C M c o des liste d i n 
A n ne x Ta ble 1. 2  
Baseli ne a n d 
f oll o w-u p  
Ast h ma  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 3  
Baseli ne a n d 
f oll o w-u p  
C hr o nic heart dise ase  
C P T/ H C P C S, I C D -1 0 -P C S, 
I C D-9 -P C S, I C D-9 -C M, or I C D -
1 0 -C M c o des liste d i n A n ne x 
Ta ble 1. 4  
Baseli ne a n d 
f oll o w-u p  
C hr o nic ki d ne y 
disease a n d re nal 
fail ure 
C P T/ H C P C S, I C D -1 0 -P C S, 
I C D-9 -P C S, I C D-9 -C M, or I C D -
1 0 -C M c o des liste d i n A n ne x 
Ta ble 1. 5  
Baseli ne a n d 
f oll o w-u p  
C hr o nic li ver disease  
C P T/ H C P C S, I C D -1 0 -P C S, 
I C D-9 -P C S, I C D-9 -C M, or I C D -
1 0 -C M c o des liste d i n A n ne x 
Ta ble 1. 6  
Baseli ne a n d 
f oll o w-u p  
C hr o nic l u n g disease  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 7 
Baseli ne a n d 
f oll o w-u p  
Ci garette s m o ki n g  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 8 
Baseli ne a n d 
f oll o w-u p  
Dia betes mellit us  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 9 
Baseli ne a n d 
f oll o w-u p  
Ge neralize d 
mali g na nc y  
C P T/ H C P C S, I C D -1 0 -P C S, 
I C D-9 -P C S, I C D-9 -C M or I C D -
1 0 -C M c o des liste d i n A n ne x 
Ta ble 1. 1 0  
Baseli ne a n d 
f oll o w-u p  
H o d g ki n’s l y m p h o ma  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 1 1 
Baseli ne a n d 
f oll o w-u p  
I m m u n os up pressi ve 
me dicati o ns  
P L W H will c o nsi dere d o n 
i m m u n os u p pressi ve me dicati o ns 
if: 
Baseli ne a n d 
f oll o w-u p  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 1 9  of 4 6  
V ari a ble 
t y pe 
V ari a ble  
Defi niti o n  
Me as ure me nt 
peri o d  
1) ≥1 N D C, H C P C S, or I C D -1 0 -
P C S c o de i n A p pe n di x Ta ble 6  
2)  ≥ 1 N D C ( usi n g orals o nl y) i n 
A p pe n di x Ta ble 6 w here t he 
dail y d ose is ≥ 2 0 m g or 
pre d nis o ne or pre d nis o ne 
e q ui vale nt f or a d urati o n of ≥1 4 
c o nsec uti ve da ys   
Le u ke mia  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 12  
Baseli ne a n d 
f oll o w-u p  
M ulti ple m yel o ma  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 1 3  
Baseli ne a n d 
f oll o w-u p  
Ne p hr otic s y n dr o me  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 14  
Baseli ne a n d 
f oll o w-u p  
N o n -H o d g ki n's 
l y m p h o ma 
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1. 15  
Baseli ne a n d 
f oll o w-u p  
Or ga n tra ns pl a nt 
C P T/ H C P C S, I C D -1 0 -P C S, 
I C D-9 -P C S, I C D-9 -C M or I C D -
1 0 -C M c o des liste d i n A n ne x 
Ta ble 1. 1 6  
Baseli ne a n d 
f oll o w-u p  
Sic kle cell disease or 
ot her 
he m o gl o bi n o pat hies  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 1.1 7  
Baseli ne a n d 
f oll o w-u p  
He patitis B  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 2.1  
Baseli ne a n d 
f oll o w-u p  
He patitis C  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A n ne x Ta ble 2.2  
Baseli ne a n d 
f oll o w-u p  
A n n ual p h ysical e xa m  C P T/ H C P C S c o des liste d i n 
A n ne x Ta ble 3. 1  
Baseli ne a n d 
f oll o w-u p  
A n n ual i nfl ue nza 
vacci ne  
C P T/ H C P C S, I C D -1 0 -P C S, 
I C D-9 -P C S, or N D C c o d es liste d 
i n A p pe n di x Ta ble 7  
Baseli ne a n d 
f oll o w-u p  
A n y p ne u m o nia 
i nfecti o n 
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A p pe n di x Ta ble 4 
Baseli ne  
A n y h os pitalizati o n  
E vi de nce of i n p atie nt clai ms  
Baseli ne a n d 
f oll o w-u p  
O p p ort u nistic 
i nfecti o ns 
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A p pe n di x Ta ble 1 4  
Baseli ne a n d 
f oll o w-u p  
A R T  a d here n ce  
A R T use will be i de ntifie d b y 
N D C c o des liste d i n A p p e n di x 
Ta ble 2  
 
Baseli ne a n d 
foll o w -u p  
 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 0  of 4 6  
V ari a ble 
t y pe 
V ari a ble  
Defi niti o n  
Me as ure me nt 
peri o d  
A d here n ce will be meas ure d as 
‘Pr o p orti o n of da ys c o v ere d = 
( N u m ber of da ys c o vere d b y a n y 
A R T, e xcl u di n g rit o na vir a n d 
c o bicistat ) ÷  (t otal 
da ys) * 1 0 0 ’[ 2 7] e ver y si x m o nt hs  
 
I n di vi d uals wit h > 8 0 % of da ys 
c o vere d will be classifie d as 
‘a d here nt’ a n d i n di vi d uals wit h 
≤8 0 % of da ys c o v ere d will be 
classifie d as ‘ n o n -a d here nt’ [ 2 7] 
C D 4 cell c o u nt  
Cate g orize d as < 2 0 0, 2 0 0 -4 9 9, 
≥5 0 0  cells/ m m 3 
Baseli ne a n d 
f oll o w-u p  
P P S V 2 3 vacci nati o n  
N D C a n d C P T c o des liste d i n 
A p pe n di x Ta ble 8  
Baseli ne a n d 
f oll o w-u p  
 
A n n ual C D 4 
la b orat or y test 
C D 4 la b orat or y tests will be 
i de ntifie d b y C P T c o des liste d i n 
A p pe n di x Ta ble 9  
 
I n di vi d uals w h o  h a ve at l east 
o ne C D 4 la b orat or y test 
perf or me d d uri n g eac h y ear of 
f oll o w-u p  
Baseli ne a n d 
foll o w -u p  
A n n ual v iral l oa d 
la b orat or y test 
Viral l oa d la b orat or y tests will 
be i de ntifie d b y C P T c o des liste d 
i n A p pe n di x Ta ble 1 0  
 
I n di vi d uals w h o h a ve at l east 
o ne viral l oa d la b orat or y test 
perf or me d d uri n g eac h y ear of 
f oll o w-u p  
Baseli ne a n d 
foll o w -u p  
R es pirat or y vir us 
seas o n 
Res pirat or y vir us seas o n occ urs 
bet wee n Oct o ber 1 a n d A pril 3 0  
F oll o w -u p  
Se nsiti vit y 
a nal ysis 
o utc o me  
All -ca use p n e u m o nia 
n ot ass ociate d wit h 
HI V  
I C D-9 -C M or I C D -1 0 -C M c o des 
liste d i n A p pe n di x Ta ble 1 1  
F oll o w -u p  
 
9. 4.  D at a S o urces   
T he s o urce of data f or t h e V E st u d y will be h ealt h care a d mi nistrati ve clai ms a n d HI V-
la b orat or y dat a pr o vi de d b y K o m o d o Healt h. K o m o d o Healt h uses artificial i ntelli ge nce a n d 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 1  of 4 6  
data a nal ytics t o c o m bi ne  a n d li n k patie nt -le vel i nf or mati o n fr o m m ore t ha n 1 5 0 pa yers i n t he 
U nite d States, i ncl u di n g Me dica re, Me dicai d, a n d C o m mercial pla ns . C urre ntl y, K o m o d o 
Healt h has patie nt -l e vel data o n a p pr o xi matel y 3 2 5 milli o n i n di vi d uals  a n d t hese data i ncl u de 
i n patie nt a n d o ut patie nt clai ms, p har mac y dis pe nsi n g clai ms, pr o vi der s pecialt y clai ms, a n d 
m ortalit y i nf or m ati o n. 
K o m o d o Healt h will pr o vi de a d mi nistrati ve clai ms a vaila ble bet w ee n Ja n u ar y 1, 2 0 1 4 
t hr o u g h Se pte m ber 3 0 , 2 0 2 2 f or i n di vi d uals w h o ha ve at least o ne I C D-9 -C M or I C D -1 0 -C M 
c o de rel ate d t o HI V ( A p p e n di x Ta ble 1) or at least o ne A R T  me dicati o n dis pe nse d  
( A p pe n di x Ta ble 2). 
9. 5.  St u d y S ize 
T he pla n ne d a n al yses d o n ot i n v ol ve h y p ot hesis testi n g a n d sa m ple size cal c ulati o ns are n ot 
a p plica ble. H o w e ver, we e xa mi ne d t he precisi o n of P C V 1 3 vacci ne effecti v e ness f or I P D a n d 
all-ca use p n e u m o nia a m o n g pe o ple li vi n g wi t h HI V at 3 6 m o nt hs a n d 9 7 m o nt hs (w hic h was 
t he ma xi m u m f oll o w -u p  ti me a vaila ble fr o m feasi bilit y assess me nts) after i n de x ( Ta ble 2 a n d 
Ta ble 3) . K o m o d o H ealt h pr o vi de d t he f oll o wi n g i nf or mati o n f or t he precisi o n esti mates:  
•  1 7 5, 0 0 0  i n di vi d uals ha d ≥1 i n patie nt or ≥ 2 o ut patie nt HI V I C D-9 -C M or I C D -1 0 -
C M c o de dia g n osis c o des  bet wee n Ja n u ar y 1, 2 0 1 4 a n d Dece m ber 3 1, 2 0 2 1  
•  5 6, 0 0 0 ( 3 2 %) of t hes e i n di vi d uals recei ve d P C V 1 3 after t heir first HI V dia g n osis 
c o de  
T he  f oll o wi n g ass u m pti o ns re gar di n g i nci de n ce a n d P C V 1 3 V E f or I P D a n d all-ca use 
p ne u m o nia were use d :  
•  I P D i nci d e nce a m o n g P L W H is 1 8 3 cases p er 1 0 0, 0 0 0 p o p ulati o n [ 2 8] 
•  All -ca use p n e u m o nia i nci de nce a m o n g P L W H is 5, 4 8 7 cases per 1 0 0, 0 0 0 p o p ulati o n  
•  V E f or I P D d ue t o a n y ser ot y pe ra n g es fr o m 7. 5 % t o 2 2. 5 %  
o  P u blis he d V E esti mates f or vacci n e t y pe I P D  ra n g e fr o m 2 5 % t o 7 5 % [ 2 0]. 
Beca use o n e -t hir d of t he a d ult I P D b ur d e n is c o nsi dere d P C V 1 3 t y pe [ 2 9], we 
m ulti plie d t his ra n ge b y 3 0 % t o arri ve at 7. 5 % t o 2 2. 5 %  
•  V E f or all -ca use p n e u m o nia ra n ges fr o m 5 % t o 1 5 % [ 3 0] 
•  A n n ual ce ns ori n g of i n di vi d uals d ue t o l oss t o f oll o w -u p or deat h ma y ra n g e bet wee n 
4 % or 1 0 %  
S ur vi val a n d ce ns ori n g ti mes  were si m ulate d ass u mi n g e x p o ne ntial distri b uti o ns.   
Vacci n ati o n stat us was m o delle d as a ti me -v ar yi n g c o variate [ 3 1]. Hazar d rati os were 
ass u me d as 1  - ( V E/ 1 0 0). Si m ulati o ns were r u n 1 0 0 t o 2 0 0 ti mes per sce nari o. C o x 
re gressi o n m o dels w ere r u n o n eac h si m ulate d dat aset t o esti mate t he 9 5 % c o nfi de nce 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 2  of 4 6  
i nter vals ( CI) f or t he l o g H Rs. Mea ns were ge n erate d a n d e x p o ne ntiat e d t o o btai n t he 9 5 % 
CIs f or t he V Es usi n g ( 1  - H R) x 1 0 0 a n d use d t o descri be V E precisi o n.  
 
T a ble 2 . Precisi o n of P C V 1 3 v acci ne effecti ve n ess esti m ates f or i n v asi ve p ne u m oc occ al 
dise ase  
H y p ot hesize d 
Vacci n e 
Effecti ve n ess  
( %) 
3 6 m o nt hs of f oll o w -u p  
9 7  m o nt hs of f oll o w -u p  
L o wer 
9 5 % 
c o nfi de nc
e i nter val 
esti mate 
U p per 
9 5 % 
c o nfi de nc
e i nter val 
esti mate 
T otal 
n u m ber of 
e ve nts  
L o wer 
9 5 % 
c o nfi de nc
e i nter val 
esti mate 
U p per 
9 5 % 
c o nfi de nc
e i nter val 
esti mate 
T otal 
n u m ber of 
e ve nts  
Sce nari o # 1 –  4 % a n n ual ce ns ori n g  
7. 5  
-1 2  
2 5  
8 3 7  
-5  
1 9  
1 4 9 2  
2 2. 5  
3  
3 7  
8 1 7  
1 1  
3 3  
1 4 5 2  
Sce nari o # 2 –  1 0 % a n n ual ce ns ori n g  
7. 5  
-1 5  
2 5  
7 6 6  
-6  
2 1  
1 2 7 2  
2 2. 5  
2  
3 8  
7 5 2  
9  
3 3  
1 2 2 4  
 
T a ble 3 . Precisi o n of P C V 1 3 v acci ne effecti ve n ess esti m ates f or all -c a use p ne u m o ni a  
H y p ot hesize d 
Vacci n e 
Effecti ve n ess 
( %) 
3 6 m o nt hs of f oll o w -u p  
9 7  m o nt hs of f oll o w -u p  
L o wer 
9 5 % 
c o nfi de nc
e i nter val 
esti mate 
U p per 
9 5 % 
c o nfi de nc
e i nter val 
esti mate 
T otal 
n u m ber of 
e ve nts  
L o wer 
9 5 % 
c o nfi de nc
e i nter val 
esti mate 
U p per 
9 5 % 
c o nfi de nc
e i nter val 
esti mate 
T otal 
n u m ber of 
e ve nts  
Sce nari o # 1 –  4 % a n n ual ce ns ori n g  
5  
1  
9  
2 3, 3 7 0  
2  
7  
3 8, 8 4 8  
1 5  
1 1  
1 9  
2 3, 1 1 9  
1 3  
1 7  
3 8, 1 7 6  
Sce nari o # 2 –  1 0 % a n n ual ce ns ori n g  
5  
1  
9  
2 1, 5 5 8  
2  
8  
3 3, 2 5 7  
1 5  
1 1  
1 9  
2 1, 3 2 7  
1 2  
1 8  
3 2, 7 5 0  
 
Gi ve n t he precisi o n esti mates i n Ta bles 1  a n d 2 , t he pla n ne d st u d y s h o ul d ha ve a d e q uate 
precisi o n t o a d dress t he pri mar y o bjecti ves.  
9. 6.  D at a M a n a ge me nt  
K o m o d o will create a nal ytic files c o m prisi n g pe o ple w h o ha ve at least o ne HI V rel ate d I C D -
9 -C M or I C D -1 0 -C M c o de or clai m f or a n A R T me dicati o n t o treat HI V. T he a nal ytic file s 
will i ncl u de p ers o n-le vel data, i ncl u di n g i nf or mati o n o n baseli ne de m o gr a p hic a n d cli nical 
c haracteristics, s t u d y o utc o mes, a n d healt h pla n e nr oll me nt dates . Varia bl es will be creat e d 
base d o n i nf or mati o n fr o m healt hcare  clai ms a n d e nr oll me nt i nf or mati o n, w hic h will be 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 3  of 4 6  
li n ke d at t he pers o n le v el usi n g a u ni q ue I D , w hic h is dei de ntifie d. Data f or t his st u d y will be 
pr ocesse d a n d ma na g e d b y Pfizer, I nc. , a n d all a n al yses— as descri be d i n t he fi nal versi o n of 
t he St u d y Pr ot oc ol— will be directe d b y st u d y i n v esti gat ors.  
 
Rete nti o n of st u d y -relate d data, d oc u me nts, a n d ot her materi als will be g o ver ne d b y Pfizer 
P olic y o n Rec or ds a n d I nf or mati o n Ma na ge m e nt, a n d per t his p olic y, will re mai n effecti ve 
f or a peri o d of 5 years fr o m t he date of pr oject i nitiati o n. A me n d me nts m ust be ma de o nl y 
wit h t he pri or a p pr o val of Pfizer. A gree m e nt fr o m all st u d y c olla b orat ors m ust be o btai ne d 
f or all a me n d me nts.  
9. 7.  D at a A n al ysis  
C o x pr o p orti o nal hazar ds m o dels will be use d t o esti mate t he hazar d rati o ( H R) f or eac h 
o utc o me  c o m pari n g va cci nate d P L W H wit h u n vacci nate d ( n o P C V 1 3) P L W H. T o e x pl or e 
p ote ntial c ha n ges i n V E  o ver ti me, H Rs will als o be ge nerate d d uri n g s pecific ti me peri o ds 
( 0-3, 3 -5 , 5-7  y ears  of f oll o w -u p ) usi n g piece wise C o x re gressi o n m o dels, if t here is a d e q uate 
sa m ple size. All  m o dels will be a dj uste d f or ti me-fi xe d a n d ti me-var yi n g c o variates of 
i nterest usi n g i n verse pr o ba bilit y of treat me nt wei g hti n g . T he ti me -fi xe d c o variates of 
i nterest i ncl u de se x, a g e, pa y or, S VI, pre vi o us p ne u m o nia i nfecti o n, a n d h os pitalizati o n a n d 
will be meas ure d d uri n g t he baseli ne peri o d. T he ti me -var yi n g c o v ariates i n cl u de ris k fact ors 
f or p ne u m o nia (alc o h olis m, as ple nia, ast h ma, c hr o nic heart disease, ki d ne y, li ver, a n d l u n g 
diseases, ci garette s m o ki n g, dia betes, i m m u n os u p pressi ve c o n diti o ns a n d me d icati o ns, a n d 
sic kle cell disease), a n n u al p h ysical e xa ms, a n n u al i nfl ue nza vacci ne, h os pitalizati o n, 
o p p ort u nistic i nfecti o ns , A R T a d here n ce , a n n ual C D 4 a n d viral l oa d la b orat or y tests, a n d a n 
i n dicat or f or res pirat or y vir us seas o n . 
V E  will be calc ulat e d as 1 mi n us t he esti mate d H R  f or eac h o ut c o me. 
We will c o n d uct t w o sets of a nal yses f or eac h o utc o me. I n t h e first set, we will e xa mi ne t he 
first e ve nt f or eac h o ut c o me a n d i n t he sec o n d s et, all rec urre nt o utc o me e v e nts d uri n g 
f oll o w-u p  will be i ncl u de d. I n t he first set of a n al yses, u n vacci n ate d ( n o P C V 1 3) P L W H will 
be f oll o we d fr o m i n de x date  u ntil t he earliest oc c urre nce of t he f oll o wi n g: o utc o me, P C V 1 3 
vacci nati o n, de at h, e n d of healt h pla n e nr oll me nt, or e n d of st u d y peri o d , a n d vacci nat e d 
P L W H will be f oll o we d fr o m 1 4 da ys after vacci n ati o n date , or i n de x dat e if vacci n ate d 
d uri n g t he  baseli ne peri o d , u ntil t he earliest occ urre nce of o utc o me, deat h, e n d of healt h pla n 
e nr oll me nt, or e n d of st u d y peri o d. I n t he sec o n d set of a nal yses u n v acci n ate d ( n o P C V 1 3) 
P L W H will be f oll o w e d fr o m i n de x date u ntil t he earliest oc c urre nce of P C V 1 3 vacci n ati o n, 
deat h, e n d of h ealt h pla n e nr oll me nt or e n d of st u d y peri o d a n d vacci nate d P L W H will be 
f oll o we d fr o m 1 4 da ys after vacci nati o n date , or i n de x date if vacci nat e d d uri n g t he baseli ne 
peri o d , u ntil earliest occ urre nce of deat h, e n d of h ealt h pla n e nr oll me nt,  or  e n d of st u d y 
peri o d.  
Se veral stratifie d a nal yses will be c o n d ucte d. P P S V 2 3 is rec o m me n de d f or P L W H a n d 
feasi bilit y data pr o vi de d b y K o m o d o s u g gest t hat o ne i n f o ur P W L H w h o recei ve d P C V 1 3 
d uri n g 2 0 1 4 -2 0 1 5 als o recei ve d P P S V 2 3 wit hi n t w o years. Rat h er t ha n ce n s or or e xcl u d e 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 4  of 4 6  
i n di vi d uals w h o recei ve P P S V 2 3, we will calc ulate P C V 1 3 V E a m o n g P W L H w h o 
ha ve / ha ve n ot r ecei ve d  P P S V 2 3  bef ore a n d d uri n g t he st u d y peri o d .  
Feasi bilit y assess me nts fr o m K o m o d o i n dicate t hat a p pr o xi matel y 2 5 %  of P W L H ha ve at 
least o ne C D 4 cell c o u nt or perce nta ge l a b orat or y res ult a vaila ble. T h eref ore, we will 
calc ulate P C V 1 3 V E a m o n g t he s u bset of P W L H w h o ha ve a C D 4 cell c o u nt d uri n g t he 
baseli ne peri o d or f oll o w -u p , a n d p ote ntiall y stratif y b y C D 4 cate g or y  usi n g eac h p atie nt’s 
l o west val ue d uri n g t he st u d y. 
A d diti o nal V E stratificati o ns b y A R T a d here n ce d uri n g f oll o w -u p , year of HI V dia g n osis , 
a n d a ge will be assesse d f or feasi bilit y as well, as t hese affect patie nts’ i m m u ne stat us a n d 
i m m u ne rec o nstit uti o n. D ue t o p ossi ble wa ni n g of t he V E a n d differe nt le n gt hs of f oll o w -u p 
b y i n de x year, V E stratifi cati o n b y year of HI V dia g n osis will be restricte d t o t he first 3 years 
of f oll o w -u p.  
A s e nsiti vit y a nal ys is will als o be c o n d ucte d. I n t his a nal ysis, ca uses of p ne u m o nia t hat are 
c haracteristic of HI V, f or e xa m ple p ne u m o nia d u e t o c yt o me gal o vir us, m yc o bacteria, a n d 
f u n gi, will be e xcl u de d fr o m o ur defi niti o n of all-ca use p ne u m o nia.  
Resi d ual c o nf o u n di n g of o ur V E esti mates d ue t o i na de q uate c o ntr ol f or h ealt h care see ki n g 
be ha vi or a n d i m m u ne stat us i n o ur a nal yses will be e x pl ore d. T o d o s o, we will e m pl o y a 
ne gati ve c o ntr ol e x p os ure a n d a n e gati ve c o ntr ol o utc o me. P ote ntial ne gati ve c o ntr ol 
e x p os ures i ncl u de v acci n ati o ns t hat are rec o m me n de d f or P L W H b u t w o ul d n ot be e x pect e d 
t o ha ve a n y pr ote cti ve effect a gai nst t he p ne u m o ni a o utc o mes of i nterest. If resi d ual 
c o nf o u n di n g d oes n ot e xist, t he ne gati ve c o ntr ol v acci ne w o ul d n ot ha ve a n effect o n t he 
p ne u m o nia o utc o mes. H o we ver, if t h e a nal ysis de m o nstrates  t hat t he ne gati ve c o ntr ol 
vacci ne pr otects a g ai nst t hese o utc o mes, t his s u g gests t he prese n ce of resi d ual c o nf o u n di n g .  
Si milarl y, p ote ntial ne gati ve c o ntr ol o utc o mes are o utc o mes t hat s hare t he s a me s o urces of 
biases as t he pri mar y o ut c o mes i n o ur st u d y p o p ulati o n b ut are n ot ca us all y -relate d t o P C V 1 3 
vacci nati o n. F or e x a m ple, i m m u ne stat us is a n i m p orta nt pre dict or of p ne u m o nia o utc o mes 
a m o n g P L W H, b ut we will be missi n g C D 4 la b orat or y val ues f or m ost  of o ur st u d y 
p o p ulati o n. I n or der t o detect p ote ntial  resi d ual c o nf o u n di n g b y lac k of c o ntr ol f or i m m u ne 
stat us, a p ote ntial ne gati ve c o ntr ol o utc o me  c o ul d i n cl u de a m ore c o m m o n AI D S defi ni n g  
ill ness s uc h as ca n di diasis . A gai n, if n o resi d ual c o nf o u n di n g e xists, P C V 1 3 vacci nati o n 
w o ul d ha ve n o effect o n t he occ urre n ce of t he ne g ati ve c o ntr ol o utc o mes. H o we ver, if t he 
res ults s u g gest t hat P C V 1 3 vacci nati o n pr e ve nts t he ne gati ve c o ntr ol o utc o mes, resi d ual 
c o nf o u n di n g ma y e xist.  
Detaile d met h o d ol o g y f or s u m mar y a n d statistical a nal yses of d ata c ollect e d i n t his st u d y will 
be d oc u me nte d i n a statistical anal ysis p la n ( S A P), w hic h will be date d, file d a n d mai ntai ne d 
b y t he s p o ns or. T he S A P  ma y m o dif y t he pla ns o utli ne d i n t he pr ot oc ol; a n y maj or 
m o dificati o ns of pri mar y e n d p oi nt defi niti o ns or t heir a nal yses w o ul d be reflecte d i n a 
pr ot oc ol a me n d me nt . 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 5  of 4 6  
9. 8.  Q u alit y C o ntr ol  
U p o n i nitiati o n of a nal yses, e dit, ra n ge, a n d l o gic c hec ks will be perf or m e d o n eac h d ata fiel d 
b y t he pr oject p r o gra m mer t o e ns ure t h e q ualit y a n d c o m plete ness of t he st u d y data base a n d 
all of t he varia bles t h erei n. O nl y o bser ve d dat a will be use d i n meas uri n g st u d y varia bles. It 
is a ntici pate d t hat de m o gra p hic i nf or mati o n will b e a vaila ble f or nearl y all i n di vi d uals i n t he 
st u d y p o p ulati o n. All ot her vari a bles will be defi n e d base d o n t he prese n ce of s pecific d ata 
(e. g., dia g n osis, pr oce d ure, a n d dr u g c o des) i n t he a nal ytic file; t he a bse n ce of s uc h data will 
be ass u me d t o i n dicate t h e a bse nce of t he c haracteristic /e ve nt ca pt ur e d b y t he varia ble. 
9. 9.  Li mit ati o ns  of t he R ese arc h M et h o ds  
T here are s e veral li mitati o ns i n t his st u d y. Gi ve n t hat t his is a n o bser vati o nal st u d y usi n g 
healt h care a d mi nistrati v e clai ms data, resi d ual c o nf o u n di n g d ue t o missi n g or u n meas ure d 
i nf or mati o n is p ossi ble. T o e xa mi ne t his, we will assess t he effect of P C V 1 3 o n a ne gati ve 
c o ntr ol o utc o me  a n d t he effect of a n e gati ve c o ntr ol e x p os ure  o n o ur o utc o mes of i nterest. If 
t he H Rs i n a n y of t hese m o dels are less t ha n 1. 0, it w o ul d i n dicate t hat resi d ual c o nf o u n di n g 
e xists a n d ma y res ult i n a dj ust me nt of o ur V E esti mates . 
Sec o n d, healt h care a d mi nistrati ve clai ms data will be a vaila ble fr o m Ja n uar y 1, 2 0 1 4 
t hr o u g h Se pte m ber 3 0, 2 0 2 2. T he rec o m me n dati o n t o vacci nate all P L W H was p u blis he d i n 
J u ne 2 0 1 2, a n d s o me P L W H ma y ha v e recei ve d P C V 1 3 pri or t o Ja n uar y 1, 2 0 1 4 a n d be 
mis classifie d as u n vacci nate d. I n a d diti o n, P L W H eli gi ble f or t he st u d y ma y ha ve recei ve d 
P C V 1 3 vacci nati o n d uri n g a ti me peri o d i n w hic h we d o n ot ha ve t heir clai ms data.  
Misclassificati o n of P C V 1 3 vacci ne stat us ma y l ea d t o l o wer esti mates of vacci ne 
effecti ve ness t ha n i n tr ut h, beca use o ur u n vacci nate d c o h ort will i nc orrectl y i ncl u de 
vacci nat e d P L W H.  
I n a d diti o n, we are usi n g I C D-9 -C M a n d I C D -1 0 -C M c o des t o defi ne HI V i nfecti o n. O ur 
defi niti o n of HI V i nfecti o n re q uires at least o ne HI V -relate d dia g n osis co d e i n t he i n patie nt 
setti n g or at least t w o HI V-relat e d dia g n osis c o des i n t he o ut patie nt setti n g. W hile t his 
defi niti o n of HI V has b ee n use d i n pre vi o us a d mi nistrati ve clai ms data base st u dies , it is 
p ossi ble t hat t hese  c o des ma y be use d b y healt h care pr o vi ders t o or der la b orat or y tests t o 
r ule o ut HI V i nfecti o n a n d t h us, s o me i n di vi d uals wit h o ut HI V will be i ncl u de d i n o ur st ud y 
p o p ulati o n .  
9. 1 0.  Ot her A s pects 
N ot a p plica ble  
1 0.  P R O T E C TI O N O F H U M A N P A R TI CI P A N T S  
1 0. 1.  P atie nt Inf or m ati o n  
T his st u d y i n v ol ves data t hat e xist i n dei de ntifie d /a n o n y mize d str uct ur e d f or mat a n d c o ntai n 
n o patie nt pers o nal i nf or mati o n .   
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 6  of 4 6  
1 0. 2.   P atie nt C o nse nt  
As t his st u d y i n v ol ves dei de ntifie d /a n o n y mize d str uct ure d d ata, w hic h acc or di n g t o 
a p plica ble le gal re q uire m e nt s d o n ot c o ntai n data s u bject t o pri vac y la ws, o btai ni n g i nf or me d 
c o nse nt fr o m patie nts b y Pfizer is n ot re q uire d.  
1 0. 3.  I nstit uti o n al R e vie w B o ar d (I R B)/ E t hics C o m mittee ( E C)  
T he st u d y data bases will be de -i de ntifie d pri or t o t heir release t o st u d y i n vesti gat ors, as set 
f ort h i n t he c orres p o n di n g Data Use A gree me nt. T he st u d y data bases h a ve bee n e v al uate d 
a n d certifi e d b y a n i n de p e n de nt t hir d part y t o be c o m plia nt wit h t he Healt h I ns ura nce 
P orta bilit y a n d Acc o u nta bilit y Act ( HI P A A) of 1 9 9 6 statistical de -i de ntificati o n sta n dar ds 
a n d t o satisf y t he c o n diti o ns set f ort h i n Secti o ns 1 6 4. 5 1 4 (a) -( b) 1ii of t he HI P A A Pri vac y 
R ule re gar di n g t he deter mi nati o n a n d d oc u me ntati o n of statisticall y de -i de ntifie d data. Use of 
t he st u d y data bases f or healt h ser vices researc h is t heref ore f ull y c o m plia nt wit h t he HI P A A 
Pri vac y R ule a n d fe d eral g ui da nce o n P u blic Welf are a n d t h e Pr otecti o n of H u ma n S u bjects 
( 4 5 C o de of Fe deral Re g ulati o ns [ C F R] 4 6 § 4 6. 1 0 1) a n d I R B a p pr o val is n ot re q uire d.  
1 0. 4.  Et hic al C o n d uct of t he S t u d y 
T he st u d y w ill be c o n d ucte d i n acc or da nce wit h le gal a n d re g ulat or y re q uir e me nts, as well as 
wit h scie ntific p ur p ose, v al ue a n d ri g or a n d f oll o w ge nerall y acce pte d res earc h practices 
descri be d i n G o o d P h ar m ac oe pi de mi ol o gy Pr a ctices  ( G P P) iss ue d b y t he I nter nati o nal 
S ociet y f or P har mac o e pi de mi ol o g y (I S P E), G o o d E pi de mi ol o gical Practice ( G E P) g ui deli nes 
iss ue d b y t he I nter nati o n al E pi de mi ol o gical Ass ociati o n (I E A), G o o d O utc o mes Researc h 
Practices iss ue d b y t he I nter nati o nal S ociet y f or P har mac o ec o n o mics a n d O utc o mes 
Researc h (I S P O R), I nter nati o nal Et hical G ui deli nes f or E pi de mi ol o gical R esearc h iss ue d b y 
t he C o u ncil f or I nter n ati o nal Or ga nizati o ns of Me dical Scie nces ( CI O M S), E ur o pea n 
Me dici nes A ge n c y ( E M A) E ur o pea n Net w or k of Ce ntres  f or P har m ac oe pi de mi ol o g y a n d 
P har mac o vi gila nce ( E N Ce P P) G ui de o n Met h o d ol o gical Sta n dar ds i n 
P har mac oe pi de mi ol o g y, a n d F o o d a n d Dr u g A d mi nistrati o n ( F D A) G ui d a n ce f or I n d ustr y: 
G o o d P har mac o vi gila nce a n d P har mac o e pi de mi ol o gic Assess me nt, a n d F D A Draft G ui d a nce 
f or I n d ustr y a n d F D A Staff: Best Practices f or C o n d ucti n g a n d Re p orti n g of 
P har mac oe pi de mi ol o gic Safet y St u dies Usi n g Electr o nic Healt hcare Data Sets a n d/ or 
e q ui vale nt.  
1 1.  M A N A G E M E N T A N D R E P O R TI N G O F A D V E R S E E V E N T S/ A D V E R S E 
R E A C TI O N S  
T his st u d y i n v ol ves  data t hat e xist as str uct ure d data b y t he ti me of st u d y start. I n t hese d ata 
s o urces, i n di vi d ual patie nt data are n ot retrie v e d or vali date d, a n d it is n ot p ossi ble t o li n k 
(i.e., i de ntif y a p ote ntial ass ociati o n bet wee n) a p artic ular pr o d u ct a n d me dical e ve nt f or a n y 
i n di vi d ual. T h us, t he mi ni m u m criteria f or re p orti n g a n a d verse e v e nt ( A E) (i.e., i de ntifia ble 
patie nt, i de ntifia ble re p orter, a s us pect pr o d uct, a n d e ve nt) ca n n ot be met.  
1 2.  P L A N S F O R DI S S E MI N A TI N G A N D C O M M U NI C A TI N G S T U D Y R E S U L T S  
F or mal c o m m u ni cati o n of t he res ults of t his researc h will be d o ne b y st u d y i n vesti gat ors 
t hr o u g h peer-re vie we d p u blicati o ns. F or all p u blicati o ns relati n g t o t he St u d y,  Pfizer will 
c o m pl y wit h rec o g nize d et hical  sta n dar ds c o ncer ni n g p u blicati o ns a n d a ut h ors hi p, i ncl u di n g 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 7  of 4 6  
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 h e 
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 n al C o m mittee of 
Me dical  J o ur nal E dit ors. 
I n t he e ve nt of a n y pr o hi biti o n or restricti o n i m p ose d (e. g., cli nical h ol d) b y a n a p plica ble 
c o m pete nt a ut h orit y i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n w hic h mi g ht i nfl ue nce t he e val uati o n of t he be nefits a n d ris ks of a Pfizer 
pr o d uct, Pfizer s h o ul d be i nf or me d i m me diatel y.    
1 3.  R E F E R E N C E S  
1.  
va n Aalst M, L otsc h F, S pij ker R, et al. I nci de nce of i n vasi ve p ne u m oc occal disease 
i n i m m u n oc o m pr o mise d patie nts: A s yste matic re vie w a n d meta-a nal ysis. Tra vel Me d 
I nfect Dis 2 0 1 8 ; 2 4: 8 9-1 0 0.  
2.  
Gra u I, Pallares R, T u ba u F, et al. E pi de mi ol o gic c ha n ges i n bactere mic 
p ne u m oc occal disease i n patie nts wit h h u ma n i m m u n o deficie nc y vir us i n t he era of 
hi g hl y acti ve a ntiretr o vir al t hera p y. Arc h I nter n Me d 2 0 0 5 ; 1 6 5( 1 3): 1 5 3 3-4 0.  
3.  
Fre n c h N, G or d o n S B, M wal u k o m o T, et al. A trial of a 7 -vale nt p n e u m oc occal 
c o nj u gate vacci ne i n HI V -i nfect e d a d ults. N E n gl J Me d 2 0 1 0 ; 3 6 2( 9): 8 1 2-2 2.  
4.  
L o pez A, Mariette X, Bac helez H, et al. Vacci nati o n rec o m me n dati o ns f or t he a d ult 
i m m u n os u p presse d patie nt: A s yste matic re vie w a n d c o m pre he nsi ve fiel d s y n o psis. J 
A ut oi m m u n 2 0 1 7 ; 8 0: 1 0-2 7.  
5.  
B h orat A E, Ma d hi S A, La u dat F, et al. I m m u n o ge nicit y a n d safet y of t he 1 3 -vale nt 
p ne u m oc occal c o nj u gate vacci ne i n HI V -i nf ecte d i n di vi d uals nai ve t o p ne u m oc occal 
vacci nati o n. AI D S 2 0 1 5 ; 2 9( 1 1): 1 3 4 5-5 4.  
6.  
C he n g A, C ha n g S Y, Tsai M S, et al. L o n g -ter m i m m u ne res p o nses a n d c o m parati ve 
effecti ve ness of o n e or t w o d oses of 7 -val e nt p ne u m oc occal c o nj u gate vacci ne 
( P C V 7) i n HI V-p ositi ve a d ults i n t he era of c o m bi nati o n a ntiretr o viral t hera p y. J I nt 
AI D S S oc 2 0 1 6 ; 1 9( 1): 2 0 6 3 1. 
7.  
Gles b y MJ, Wats o n W, Bri ns o n C, et al. I m m u n o ge nicit y a n d Safet y of 1 3 -Vale nt 
P ne u m oc occal C o nj u gate Vacci n e i n HI V -I nfecte d A d ults Pre vi o usl y Vacci nate d 
Wit h P ne u m oc occal P ol ysacc hari de Vacci n e.  T he J o ur nal of I nfecti o us Dis eases 
2 0 1 4 ; 2 1 2( 1): 1 8-2 7.  
8.  
S o gaar d O S, L o hse N, Har b oe Z B, et al. I m pr o vi n g t he i m m u n o ge nicit y of 
p ne u m oc occal c o nj u gate vacci ne i n HI V -i nf ecte d a d ults wit h a t oll-li ke rece pt or 9 
a g o nist a dj u va nt: a ra n d o mize d, c o ntr olle d trial. Cli n I nfect Dis 2 0 1 0 ; 5 1( 1): 4 2-5 0.  
9.  
B o nte n MJ, H uijts S M, B ol ke n baas M, et al. P ol ysacc h ari de c o nj u g ate vacci ne 
a gai nst p ne u m oc occal p n e u m o nia i n a d ults. N E n gl J Me d 2 0 1 5 ; 3 7 2( 1 2): 1 1 1 4-2 5.  
1 0.  
Mc La u g hli n J M, Jia n g Q, Ist uriz R E, et al. Effecti v e ness of 1 3 -Vale nt P ne u m oc occal 
C o nj u gate Vacci n e A gai nst H os pitalizati o n f or C o m m u nit y -Ac q uire d P ne u m o nia i n 
Ol der U S A d ults: A Test -Ne gati ve Desi g n. Cli nical I nfecti o us Diseases 2 0 1 8 ; 6 7( 1 0): 
1 4 9 8 -5 0 6.  
1 1.  
A m u S, R uffi n N, Ret hi B, C hi o di F. I m pair me nt o f B-cell f u ncti o ns d uri n g HI V -1 
i nfecti o n. AI D S 2 0 1 3 ; 2 7( 1 5): 2 3 2 3-3 4.  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 8  of 4 6  
1 2.  
Lee K -Y, Tsai M -S, K u o K -C, et al. P ne u m oc occal vacci nati o n a m o n g HI V -i nfecte d 
a d ult patie nts i n t he era of c o m bi nati o n a ntiretr o viral t hera p y. H u ma n Vacci nes & 
I m m u n ot hera pe utics 2 0 1 4 ; 1 0( 1 2): 3 7 0 0-1 0.  
1 3.  
M oir S, Fa uci A S. B cells i n HI V i nfecti o n a n d disease. Nat Re v I m m u n ol 2 0 0 9 ; 9( 4): 
2 3 5 -4 5.  
1 4.  
Tita nji K, De Milit o A, Ca gi gi A, et al. L oss of me m or y B cells i m pairs mai nte na nce 
of l o n g -ter m ser ol o gic m e m or y d uri n g HI V-1 i nfecti o n. Bl o o d 2 0 0 6 ; 1 0 8( 5): 1 5 8 0-7.  
1 5.  
Yi n Z, Rice B D, Wai g ht P, et al. I n v asi ve p ne u m o c occal disease a m o n g HI V -p ositi ve 
i n di vi d uals, 2 0 0 0-2 0 0 9. AI D S 2 0 1 2 ; 2 6( 1): 8 7-9 4.  
1 6.  
Garcia Garri d o H M, Ma k A M R, Wit F, et al. I nci d e nce a n d Ris k Fact ors f or I n v asi ve 
P ne u m oc occal Dise ase a n d C o m m u nit y -ac q uire d P ne u m o nia i n H u ma n 
I m m u n o deficie nc y Vir us-I nfecte d I n di vi d uals i n a Hi g h-i nc o me Setti n g. Cli n I nfect 
Dis 2 0 2 0 ; 7 1( 1): 4 1-5 0.  
1 7.  
S o gaar d O S, L o hse N, Gerst oft J, et al. H os pitalizati o n f or p ne u m o nia a m o n g 
i n di vi d uals wit h a n d wit h o ut HI V i nfecti o n, 1 9 9 5-2 0 0 7: a Da nis h p o p ulati o n -base d, 
nati o n wi de c o h ort st u d y. Cli n I nfect Dis 2 0 0 8 ; 4 7( 1 0): 1 3 4 5-5 3.  
1 8.  
C D C. Use of 1 3 -vale nt p ne u m oc occal c o nj u gate vacci ne a n d 2 3 -val e nt p ne u m oc occal 
p ol ysacc hari de vacci ne f or a d ults wi t h i m m u n oc o m pr o misi n g c o n diti o ns: 
rec o m me n dati o ns of t he A d vis or y C o m mittee o n I m m u nizati o n Practices ( A CI P). 
M M W R M or b M ortal W kl y Re p 2 0 1 2 ; 6 1( 4 0): 8 1 6-9.  
1 9.  
K o ba yas hi M, Farrar J L, Gier ke R, et al. Us e of 1 5 -Vale nt P ne u m oc occal C o nj u gate 
Vacci n e a n d 2 0 -V ale nt P ne u m oc occal C o nj u gate Vacci n e A m o n g U. S. A d ults: 
U p date d Rec o m me n d ati o ns of t he A d vis or y C o m mittee o n I m m u nizati o n Practices - 
U nite d States, 2 0 2 2. M M W R M or b M ortal W kl y Re p 2 0 2 2 ; 7 1( 4): 1 0 9-1 7.  
2 0.  
A n dre w Lei d ner. S u m mar y of ec o n o mic m o d els asses si n g p ne u m oc occal vacci nes i n 
U S a d ults. A CI P Prese nt ati o n Sli des: Se pte m ber 2 9, 2 0 2 1 Meeti n g. A vaila ble at: 
htt ps:// w w w.c dc. g o v/ vacci nes/a ci p/ meeti n gs/ d o w nl oa ds/sli des -2 0 2 1 -0 9 -2 9/ 0 2 -
P ne u m oc occal -Lei d ner -5 0 8. p df . Accesse d Oct o ber 2, 2 0 2 2. 
2 1.  
C h o B H, St oec ker C, Li n k -Gelles R, M o ore M R. C ost -effecti ve n ess of a d mi nisteri n g 
1 3 -vale nt p ne u m oc o ccal c o nj u gate vac ci ne i n a d diti o n t o 2 3 -vale nt p ne u m oc occal 
p ol ysacc hari de vacci ne t o a d ults wit h i m m u n oc o m pr o misi n g c o n diti o ns. Vacci n e 
2 0 1 3 ; 3 1( 5 0): 6 0 1 1-2 1.  
2 2.  
M or ga A, Ki m ura T, Fe n g Q, R ozari o N, Sc h wart z J. C o m plia nce t o A d vis or y 
C o m mittee o n I m m u nizati o n Practices rec o m me n dati o ns f or p ne u m oc occal 
vacci nati o n. V acci ne 2 0 2 2 ; 4 0( 1 5): 2 2 7 4-8 1.  
2 3.  
Vietri J, Har nett J, E mir B, C hils o n E. U pta ke of 1 3 -Vale nt P ne u m oc occal C o nj u gate 
Vacci n e a m o n g U S A d ults A ge d 1 9 t o 6 4 Years wit h I m m u n oc o m pr o misi n g 
C o n diti o ns. H u m Vacci n I m m u n ot her 2 0 2 0 ; 1 6( 1): 1 6 1-8.  
2 4.  
Sai d M A, J o h ns o n H L, N o n ya ne B A, et al. Esti mati n g t he b ur de n of p ne u m oc occal 
p ne u m o nia a m o n g a d ults: a s yste matic re vie w a n d meta -a nal ysis of dia g n ostic 
tec h ni q ues. P L o S O ne 2 0 1 3 ; 8( 4): e 6 0 2 7 3. 
2 5.  
C D C’s S ocial V ul nera bil it y I n de x ( S VI). A v aila ble at: 
htt ps:// w w w.ats dr.c dc. g o v/ placea n d h ealt h/s vi/i n de x. ht ml . Accesse d N o v e m ber 3 0, 
2 0 2 2.  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 2 9  of 4 6  
2 6.  
H yer J M, Tsili mi gras DI, Diaz A , et al. Hi g h S ocial V ul nera bilit y a n d " Te xt b o o k 
O utc o mes" after C a ncer O perati o n. J A m C oll S ur g 2 0 2 1 ; 2 3 2( 4): 3 5 1-9.  
2 7.  
de Oli veira C osta J, Z ha o Y, Pears o n S A, Sc haffer A L. Assessi n g t he i m pact of 
i m ple me nti n g m ulti ple a d here nce meas ures t o a ntiretr o viral t hera p y fr o m dis pe nsi n g 
data: a s h ort re p ort. AI D S Care 2 0 2 2 : 1-6.  
2 8.  
K o ba yas hi M, Mata n o c k A, Xi n g W, et al. I m pact of 1 3 -Vale nt P ne u m oc occal 
C o nj u gate Vacci n e o n I n vasi ve P ne u m oc occal Disease A m o n g A d ults Wit h HI V -
U nite d States, 2 0 0 8 -2 0 1 8. J Ac q uir I m m u ne Defic S y n dr 2 0 2 2 ; 9 0( 1): 6-1 4.  
2 9.  
R ya n Gier ke. C urre nt E pi de mi ol o g y of P ne u m oc occal Dise ase, U nite d Stat es -2 0 1 9 
u p dates. A CI P Prese ntati o n Sli des: J u ne 2 5, 2 0 2 1 Meeti n g. A vaila ble at: 
htt ps:// w w w.c dc. g o v/ vacci nes/aci p/ meeti n gs/ d o w nl oa ds/sli des -2 0 2 1 -0 6/ 0 2 -
P ne u m oc occal -Gier ke -5 0 8. p df . Accesse d Ja n u ar y 2 4, 2 0 2 3. 
3 0.  
Hsia o A, Ha nse n J, Ti m b ol J, et al. I n ci de nce a n d Esti mate d Vacci n e Effecti ve ness 
A gai nst H os pitalizati o ns f or All -Ca use P ne u m o nia A m o n g Ol der U S A d ults W h o 
Were Vacci nate d a n d N ot Vacci nat e d Wit h 1 3 -Vale nt P ne u m oc occal C o nj u gate 
Vacci n e. J A M A Net w O pe n 2 0 2 2 ; 5( 3): e 2 2 1 1 1 1. 
3 1.  
A usti n P C. Ge nerati n g s ur vi val ti mes t o si m ulate C o x pr o p orti o nal hazar ds m o dels 
wit h ti me -var yi n g c o vari ates. Stat Me d 2 0 1 2 ; 3 1( 2 9): 3 9 4 6-5 8.  
1 4.  LI S T O F T A B L E S  
Ta ble 1. Varia bles, defi niti o ns, a n d meas ure me nt p eri o ds  ......................................................1 7  
Ta ble 2. Precisi o n of P C V 1 3 vacci n e effecti ve n ess esti mat es f or i n vasi ve 
p ne u m oc occal disease  ...............................................................................2 2  
Ta ble 3. Precisi o n of P C V 1 3 vacci n e effecti ve n ess esti mat es f or all -ca use p ne u m o nia  .........2 2  
1 5.  LI S T O F FI G U R E S  
Fi g ure 1. Ill ustrati ve ti meli ne f or st u d y partici pa nts  ................................................................1 6  
1 6.  A P P E N DI X  
T a ble 1. Di a g n osis C o des f or I de ntif yi n g HI V i nfecti o n  
C o de  
T y pe  
Descri pti o n  
0 4 2  
I C D-9 -C M  
HI V -1 i nf ecti o n  
V 0 8  
I C D-9 -C M  
As y m pt o matic HI V disease  
B 2 0  
I C D-1 0 -C M  
HI V -1 i nf ecti o n  
Z 2 1  
I C D-1 0 -C M  
As y m pt o matic HI V disease  
T a ble 2. N ati o n al Dr u g C o des f or I de ntif yi n g HI V A ntiretr o vir als (see e xcel)  
T a ble 3. N ati o n al Dr u g C o des a n d C P T ®  C o des f or I de ntif yi n g P C V 1 3 V acci n ati o n  
C o de  
T y pe  
Descri pti o n  
5 0 0 9 0 1 9 4 4 0 9  
N D C  
1 3 -vale nt p ne u m oc occal 
c o nj u gate vac ci ne  
5 4 5 6 9 6 6 1 3 0 0  
N D C  
1 3 -vale nt p ne u m oc occal 
c o nj u gate vacci ne  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 3 0  of 4 6  
5 0 0 9 0 1 9 4 4 0 0  
N D C  
1 3 -vale nt p ne u m oc occal 
c o nj u gate vacci ne  
0 0 0 0 5 1 9 7 1 0 5  
N D C  
1 3 -vale nt p ne u m oc occal 
c o nj u gate vacci ne  
0 0 0 0 5 1 9 7 1 0 4  
N D C  
1 3 -vale nt p ne u m oc occal 
c o nj u gate vacci ne  
0 0 0 0 5 1 9 7 1 0 2  
N D C  
1 3 -vale nt p ne u m oc occal 
c o nj u gate vacci ne  
0 0 0 0 5 1 9 7 1 0 1  
N D C  
1 3 -vale nt p ne u m oc occal 
c o nj u gate vacci ne  
9 0 6 7 0  
C P T  
1 3 -vale nt p ne u m oc occal 
c o nj u gate vacci ne  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 3 1  of 4 6  
T a ble 5. Di a g n osis C o des f or I de ntif yi n g P ne u m oc occ al P ne u m o ni a a n d P ne u m o ni a wit h U ns pecifie d C a uses  
C o n diti o n  
I C D-9 -C M  
I C D-1 0 -C M  
C o des  
Descri pti o n  
C o des  
Descri pti o n  
P ne u m oc occal 
p ne u m o nia  
4 8 1  
P ne u m oc occal p ne u m o nia  
J 1 3 
P ne u m o nia d ue t o Stre pt oc occ us p ne u m o niae  
4 8 2. 9 + 
0 4 1. 2  
Bacterial p ne u m o nia, 
u ns pecifie d + p ne u m oc occ us  
J 1 5.9 + B 9 5 .3  
U ns pecifie d bacterial p ne u m o nia  + Stre pt oc occ us p ne u m o niae  
4 8 5 + 0 4 1. 2  
Br o nc h o p ne u m o nia, or ga nis m 
u ns pecifie d + p ne u m oc occ us  
J 1 8.0 + B 9 5 .3  
Br o nc h o p ne u m o nia, u ns pecifie d or ga nis m  +  Stre pt oc occ us p ne u m o niae  
4 8 6 + 0 4 1. 2  
P ne u m o nia, or ga nis m 
u ns pecifie d + p ne u m oc occ us  
J 1 8.8 + B 9 5 .3  
J 1 8.9 + B 9 5 .3  
Ot her p ne u m o nia, u ns pecifie d or ga nis m + Stre pt oc occ us p ne u m o niae  
P ne u m o nia, u ns pecifie d or ga nis m + Stre pt oc occ us p ne u m o niae  
5 1 0. x + 
0 4 1. 2  
E m p ye ma + p ne u m oc occ us  
5 1 0 + 0 4 1. 2  
E m p ye ma wit h fist ula + 
p ne u m oc occ us  
J 8 6.0 + B 9 5 .3  
P y ot h ora x wit h fist ula  + Stre pt o c occ us p ne u m o niae  
5 1 0. 9 + 
0 4 1. 2  
E m p ye ma wit h o ut me nti o n of 
fist ula + p ne u m oc occ us 
J 8 6.9 + B 9 5 .3  
P y ot h ora x wit h o ut fist ula  + Stre pt o c occ us p ne u m o niae  
P ne u m o nia 
wit h 
u ns pecifie d 
ca uses  
4 8 0 -4 8 6  
4 8 7. 0  
Viral, bacterial, u ns pecifie d p ne u m o nia  
4 8 0. 9  
Viral p ne u m o nia, u ns pecifie d  
J 1 2. 9 
Viral p ne u m o nia, u ns pecifie d  
4 8 2. 9  
Bacterial p ne u m o nia, 
u ns pecifie d  
J 1 5. 9 
U ns pecifie d bacterial p ne u m o nia  
4 8 5  
Br o nc h o p ne u m o nia, or ga nis m 
u ns pecifie d  
J 1 8. 0 
Br o nc h o p ne u m o nia, u ns pecifie d or ga nis m  
4 8 6  
P ne u m o nia, or ga nis m 
u ns pecifie d  
J 1 8. 8  
J 1 8. 9 
Ot her p ne u m o nia, u ns pecifie d or ga nis m  
P ne u m o nia, u ns pecifie d or ga nis m  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 3 2  of 4 6  
T a ble 4. Di a g n osis C o des f or I de ntif yi n g I n v asi ve P ne u m oc occ al Dise ase, All -C a use P ne u m o ni a, a n d P ne u m oc occ al 
P ne u m o ni a  
C o n diti o n  
I C D-9 -C M  
I C D-1 0 -C M  
C o des  
Descri pti o n  
C o des  
Descri pti o n  
I P D 
Bactere mia  
7 9 0. 7 + 0 4 1. 2  
7 7 1. 8 3 + 
0 4 1. 2  
Bactere mia + p ne u m oc occ us  
R 7 8 .8 1 + B 9 5 .3  
Bactere mia + Stre pt o c occ us p ne u m o niae as t h e ca use of diseases classifie d 
else w here ( Stre pt o c occ us p ne u m o niae)  
0 3 8. 2  
P ne u m oc occal se ptice mia  
A 4 0 .3  
Se psis d ue t o Stre pt oc occ us p ne u m o niae  
0 3 8. 9 + 0 4 1. 2  
U ns pecifie d se ptice mia + 
p ne u m oc occ us  
A 4 1 .9 + B 9 5 .3  
Se psis, u ns pecifie d or ga nis m + Stre pt o c occ us p ne u m o niae  
Me ni n gitis  
3 2 0. 1  
P ne u m oc occal me ni n gitis  
G 0 0 .1  
P ne u m oc occal me ni n gitis  
3 2 0. 9 + 0 4 1. 2  
Me ni n gitis d ue t o u ns pecifie d 
bacteri u m + p ne u m oc occ us  
G 0 0 .9 + B 9 5 .3  
G 0 4 .2 + B 9 5 .3  
Bacterial me ni n gitis, u ns pecifie d + Stre pt o c occ us p ne u m o niae  
Bacterial me ni n g oe nce p halitis a n d me ni n g o m yelitis, n ot else w here classifie d + 
Stre pt o c occ us p ne u m o niae  
3 2 2. 9 + 0 4 1. 2  
Me ni n gitis, u ns pecifie d + 
p ne u m oc occ us  
G 0 3 .9 + B 9 5 .3  
Me ni n gitis, u ns pecifie d + Stre pt oc occ us p ne u m o niae  
Ot her  
4 2 1. x + 0 4 1. 2  
E n d ocar ditis + p ne u m oc occ us  
4 2 1 + 0 4 1. 2  
Ac ute a n d s u bac ute b acterial 
e n d ocar ditis + p ne u m oc occ us  
I 3 3.0 + B 9 5 .3  
Ac ute a n d s u bac ute i nfecti ve e n d ocar ditis + Stre pt o c occ us p ne u m o niae  
4 2 1. 1 + 0 4 1. 2  
Ac ute a n d s u bac ute i nfecti ve 
e n d ocar ditis i n diseases 
classifie d else w here + 
p ne u m oc occ us  
I 3 9 + B 9 5.3  
E n d ocar ditis a n d heart val v e dis or ders i n diseases classifie d else w h ere + 
Stre pt o c occ us p ne u m o niae  
4 2 1. 9 + 0 4 1. 2  
Ac ute e n d ocar ditis, 
u ns pecifie d + p ne u m oc occ us  
I 3 3.9 + B 9 5 .3  
Ac ute a n d s u bac ute e n d ocar ditis, u ns pecifie d + Stre pt oc occ us p ne u m o niae  
7 1 1. 0 + 0 4 1. 2  
Se ptic art hritis + 
p ne u m oc occ us  
M 0 0 .0 0 + B 9 5 .3  
M 0 0 .2 0 + B 9 5 .3  
M 0 0 .8 0 + B 9 5 .3  
M 0 0 .9 + B 9 5 .3  
M 0 0 .1 0 + B 9 5 .3  
Sta p h yl o c occal art hritis, u ns pecifie d j oi nt + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, u ns pecifie d j oi nt + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, u ns pecifie d j oi nt + Stre pt oc occ us p ne u m o niae  
P y o ge nic art hritis, u ns pecif ie d + Stre pt o c occ us p ne u m o niae 
P ne u m oc occal art hritis, u ns pecifie d j oi nt + Stre pt o c occ us p ne u m o niae  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 3 3  of 4 6  
7 1 1. 0 1 + 
0 4 1. 2  
P y o ge nic art hritis, s h o ul d er 
re gi o n + p ne u m oc occ us 
M 0 0 .0 1 1 + B 9 5 .3  
M 0 0 .0 1 2 + B 9 5 .3  
M 0 0 .0 1 9 + B 9 5 .3  
M 0 0 .2 1 1 + B 9 5 .3  
M 0 0 .2 1 2 + B 9 5 .3  
M 0 0 .2 1 9 + B 9 5 .3  
M 0 0 .8 1 1 + B 9 5 .3  
M 0 0 .8 1 2 + B 9 5 .3  
M 0 0 .8 1 9 + B 9 5 .3  
M 0 0 .1 1 9 + B 9 5 .3  
M 0 0 .1 1 1 + B 9 5 .3  
M 0 0 .1 1 2 + B 9 5 .3  
Sta p h yl o c occal art hritis, ri g ht s h o ul d er + Stre pt o c occ us p ne u m o niae  
Sta p h yl o c occal art hritis, left s h o ul d er + Stre pt oc occ us p ne u m o niae  
Sta p h yl o c oc cal art hritis, u ns pecifie d s h o ul d er + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, ri g ht s h o ul d er + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, left s h o ul d er + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, u ns pecifie d s h o ul d er + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, ri g ht s h o ul der + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, left s h o ul d er + Stre pt oc occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, u ns pecifie d s h o ul d er + Stre pt oc occ us p ne u m o niae  
P ne u m oc occal art hritis, u ns pecifie d s h o ul d er + Stre pt oc occ us p ne u m o niae  
P ne u m oc occal art hritis, ri g ht s h o ul d er + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, left s h o ul der + Stre pt oc occ us p ne u m o niae  
7 1 1. 0 2 + 
0 4 1. 2  
P y o ge nic art hritis, u p per ar m 
+ p ne u m oc occ us  
M 0 0 .0 2 1 + B 9 5 .3  
M 0 0 .0 2 2 + B 9 5 .3  
M 0 0 .0 2 9 + B 9 5 .3  
M 0 0 .2 2 1 + B 9 5 .3  
M 0 0 .2 2 2 + B 9 5 .3  
M 0 0 .2 2 9 + B 9 5 .3  
M 0 0 .8 2 1 + B 9 5 .3  
M 0 0 .8 2 2 + B 9 5 .3  
M 0 0 .8 2 9 + B 9 5 .3  
M 0 0 .1 2 9 + B 9 5 .3  
M 0 0 .1 2 1 + B 9 5 .3  
M 0 0 .1 2 2 + B 9 5 .3  
Sta p h yl o c occal art hritis, ri g ht el b o w + Stre pt oc occ us p ne u m o niae  
Sta p h yl o c occal art hritis, left el b o w + Stre pt o c occ us p ne u m o niae  
Sta p h yl o c occal art hritis, u ns pecifie d el b o w + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, ri g ht el b o w + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, left el b o w + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, u ns pecifie d el b o w + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, ri g ht el b o w + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o o t h er bacteria, left el b o w + Stre pt oc occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, u ns pecifie d el b o w + Stre pt oc occ us p ne u m o niae  
P ne u m oc occal art hritis, u ns pecifie d el b o w + Stre pt oc occ us p ne u m o niae  
P ne u m oc occal art hritis, ri g ht el b o w + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, left el b o w + Stre pt o c occ us p ne u m o niae  
7 1 1. 0 3 + 
0 4 1. 2  
P y o ge nic art hritis, f orear m + 
p ne u m oc occ us  
M 0 0 .0 3 1 + B 9 5 .3  
M 0 0 .0 3 2 + B 9 5 .3  
M 0 0 .0 3 9 + B 9 5 .3  
M 0 0 .2 3 1 + B 9 5 .3  
M 0 0 .2 3 2 + B 9 5 .3  
M 0 0 .2 3 9 + B 9 5 .3  
M 0 0 .8 3 1 + B 9 5 .3  
M 0 0 .8 3 2 +  B 9 5 .3  
M 0 0 .8 3 9 + B 9 5 .3  
M 0 0 .1 3 9 + B 9 5 .3  
M 0 0 .1 3 1 + B 9 5 .3  
M 0 0 .1 3 2 + B 9 5 .3  
Sta p h yl o c occal art hritis, ri g ht wrist + Stre pt oc occ us p ne u m o niae  
Sta p h yl o c occal art hritis, left wrist + Stre pt oc occ us p ne u m o niae  
Sta p h yl o c occal art hritis, u ns pecifie d wrist + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, ri g ht wrist + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, left wrist + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, u ns pecifie d wrist + Stre pt oc occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, ri g ht wrist + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, left wrist + Stre pt oc occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, u ns pecifie d wrist + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, u ns pecifie d wrist + Stre pt oc occ us p ne u m o niae  
P ne u m oc occal art hritis, ri g ht wrist + Stre pt oc occ us p ne u m o niae  
P ne u m oc occal art hritis, left wrist + Stre pt o c occ us p ne u m o niae  
7 1 1. 0 4 + 
0 4 1. 2  
P y o ge nic art hritis, ha n d + 
p ne u m oc occ us  
M 0 0 .0 4 1 + B 9 5 .3  
M 0 0 .0 4 2 + B 9 5 .3  
M 0 0 .0 4 9 + B 9 5 .3  
M 0 0 .2 4 1 + B 9 5 .3  
M 0 0 .2 4 2 + B 9 5 .3  
M 0 0 .2 4 9 + B 9 5 .3  
M 0 0 .8 4 1 + B 9 5 .3  
Sta p h yl o c occal art hritis, ri g ht ha n d + Stre pt o c occ us p ne u m o niae  
Sta p h yl o c occal art hritis, left ha n d + Stre pt oc occ us  p ne u m o niae  
Sta p h yl o c occal art hritis, u ns pecifie d ha n d + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, ri g ht ha n d + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, left ha n d + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, u n s pecifie d ha n d + Stre pt oc occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, ri g ht ha n d + Stre pt oc occ us p ne u m o niae  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 3 4  of 4 6  
M 0 0 .8 4 2 + B 9 5 .3  
M 0 0 .8 4 9 + B 9 5 .3  
M 0 0 .1 4 9 + B 9 5 .3  
M 0 0 .1 4 1 + B 9 5 .3  
M 0 0 .1 4 2 + B 9 5 .3  
Art hritis d ue t o ot h er bacteria, left ha n d + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, u ns pecifie d ha n d + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, u ns pecifie d ha n d + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, ri g ht ha n d + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, left ha n d + Stre pt o c occ us p ne u m o niae   
7 1 1. 0 5 + 
0 4 1. 2  
P y o ge nic art hritis, pel vic 
re gi o n a n d t hi g h + 
p ne u m oc occ us  
M 0 0 .0 5 1 + B 9 5 .3  
M 0 0 .0 5 2 + B 9 5 .3  
M 0 0 .0 5 9 + B 9 5 .3  
M 0 0 .2 5 1 + B 9 5 .3  
M 0 0 .2 5 2 + B 9 5 .3  
M 0 0 .2 5 9 + B 9 5 .3  
M 0 0 .8 5 1 + B 9 5 .3  
M 0 0 .8 5 2 + B 9 5 .3  
M 0 0 .8 5 9 + B 9 5 .3  
M 0 0 .1 5 9 + B 9 5 .3  
M 0 0 .1 5 1 + B 9 5 .3  
M 0 0 .1 5 2 + B 9 5 .3  
Sta p h yl o c occal art hritis, ri g ht hi p + Stre pt o c occ us p ne u m o niae  
Sta p h yl o c occal art hritis, left hi p + Stre pt oc occ us p ne u m o niae  
Sta p h yl o c occal art hritis, u ns pecifie d hi p + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, ri g ht hi p + Stre pt oc occ us p n e u m o niae  
Ot her stre pt o c occal art hritis, left hi p + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, u ns pecifie d hi p + Stre pt oc occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, ri g ht hi p + Stre pt oc occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria,  left hi p + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, u ns pecifie d hi p + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, u ns pecifie d hi p + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, ri g ht hi p + Stre pt o c occ us p ne u m o niae  
P ne u m oc occa l art hritis, left hi p + Stre pt o c occ us p ne u m o niae   
7 1 1. 0 6 + 
0 4 1. 2  
P y o ge nic art hritis, l o wer le g + 
p ne u m oc occ us  
M 0 0 .0 6 1 + B 9 5 .3  
M 0 0 .0 6 2 + B 9 5 .3  
M 0 0 .0 6 9 + B 9 5 .3  
M 0 0 .2 6 1 + B 9 5 .3  
M 0 0 .2 6 2 + B 9 5 .3  
M 0 0 .2 6 9 + B 9 5 .3  
M 0 0 .8 6 1 + B 9 5 .3  
M 0 0 .8 6 2 + B 9 5 .3  
M 0 0 .8 6 9 + B 9 5 .3  
M 0 0 .1 6 9 + B 9 5 .3  
M 0 0 .1 6 1 + B 9 5 .3  
M 0 0 .1 6 2 + B 9 5 .3  
Sta p h yl o c occal art hritis, ri g ht k nee + Stre pt o c occ us p ne u m o niae  
Sta p h yl o c occal art hritis, left k nee + Stre pt oc occ us p ne u m o niae  
Sta p h yl o c occal art hritis, u ns pecifie d k nee + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, ri g ht k nee + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, left k nee + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, u ns pecifie d k nee + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, ri g ht k nee  + Stre pt oc occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, left k nee + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, u ns pecifie d k nee + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, u ns pecifie d k nee + Stre pt o c occ us p ne u m o niae  
P ne u m oc oc cal art hritis, ri g ht k nee + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal art hritis, left k nee + Stre pt o c occ us p ne u m o niae   
7 1 1. 0 7 + 
0 4 1. 2  
P y o ge nic art hritis, a n kle a n d 
f o ot + p ne u m oc occ us 
M 0 0 .0 7 1 + B 9 5 .3  
M 0 0 .0 7 2 + B 9 5 .3  
M 0 0 .0 7 9 + B 9 5 .3  
M 0 0 .2 7 1 + B 9 5 .3  
M 0 0 .2 7 2 + B 9 5 .3  
M 0 0 .2 7 9 + B 9 5 .3  
M 0 0 .8 7 1 + B 9 5 .3  
M 0 0 .8 7 2 + B 9 5 .3  
M 0 0 .8 7 9 + B 9 5 .3  
M 0 0 .1 7 9 + B 9 5 .3  
M 0 0 .1 7 1 + B 9 5 .3  
M 0 0 .1 7 2 + B 9 5 .3  
Sta p h yl o c occal art hritis, ri g ht a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
Sta p h yl o c occal art hritis, left a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
Sta p h yl o c occal art hritis, u ns pecifie d a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, ri g ht a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, left a n kle a n d f o ot + Stre pt o c occ us p ne u m o niae   
Ot her stre pt o c occal art hritis, u ns pecifie d a n kle a n d f o ot + Stre pt oc occ us 
p ne u m o niae  
Art hritis d ue t o ot h er bacteria, ri g ht a n kle a n d f o ot + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, left a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
Art hr itis d ue t o ot h er bacteria, u ns pecifie d a n kle a n d f o ot + Stre pt oc occ us 
p ne u m o niae  
P ne u m oc occal art hritis, u ns pecifie d a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 3 5  of 4 6  
P ne u m oc occal art hritis, ri g ht a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
P ne u m oc occal art hriti s, left a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
7 1 1. 0 8 + 
0 4 1. 2  
P y o ge nic art hritis, ot h er 
s pecifie d sites + 
p ne u m oc occ us  
M 0 0 .0 8 + B 9 5 .3  
M 0 0 .2 8 + B 9 5 .3  
M 0 0 .8 8 + B 9 5 .3  
M 0 0 .9 + B 9 5 .3  
M 0 0 .1 8 + B 9 5 .3  
.Sta p h yl oc occal  art hritis, verte brae + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal art hritis, verte brae + Stre pt o c occ us p ne u m o niae  
Art hritis d ue t o ot h er bacteria, verte brae + Stre pt o c occ us p ne u m o niae  
P y o ge nic art hritis, u ns pecifie d + Stre pt o c occ us p ne u m o niae  
P ne u m o c occal art hritis, verte brae + Stre pt oc occ us p ne u m o niae  
7 1 1. 0 9 + 
0 4 1. 2  
P y o ge nic art hritis, m ulti ple 
sites + p ne u m oc occ us 
M 0 0 .0 9 + B 9 5 .3  
M 0 0 .2 9 + B 9 5 .3  
M 0 0 .8 9 + B 9 5 .3  
M 0 0 .1 9 + B 9 5 .3  
Sta p h yl o c occal p ol yart hritis + Stre pt o c occ us p ne u m o niae  
Ot her stre pt o c occal p ol yart hritis + Stre pt o c occ us p ne u m o niae  
P ol y art hritis d ue t o ot h er bacteria + Stre pt o c occ us p ne u m o niae  
P ne u m oc occal p ol yart hritis + Stre pt o c occ us p ne u m o niae  
7 3 0. 0 x + 
0 4 1. 2  
7 3 0. 2 x + 
0 4 1. 2  
Oste o m yelitis + p ne u m oc occ us  
7 3 0. 0 0 + 
0 4 1. 2  
Ac ute oste o m yelitis, site 
u ns pecifie d + p ne u m oc occ us  
M 8 6. 0 0 + B 9 5 .3  
M 8 6. 1 0 + B 9 5 .3  
M 8 6. 2 0 + B 9 5 .3  
Ac ute h e mat o ge n o us oste o m yelitis, u ns pecifie d site + Stre pt o c occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, u ns pecifie d site + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m yelitis, u ns pecifie d site + Stre pt oc occ us p ne u m o niae  
7 3 0. 0 1 + 
0 4 1. 2  
Ac ute oste o m yelitis, s h o ul der 
re gi o n + p ne u m oc occ us 
M 8 6. 0 1 1 + B 9 5 .3  
M 8 6. 0 1 2 + B 9 5 .3  
M 8 6. 0 1 9 + B 9 5 .3  
M 8 6. 1 1 1 + B 9 5 .3  
M 8 6. 1 1 2 + B 9 5 .3  
M 8 6. 1 1 9 + B 9 5 .3  
M 8 6. 2 1 1 + B 9 5 .3  
M 8 6. 2 1 2 + B 9 5 .3  
M 8 6. 2 1 9 + B 9 5 .3  
Ac ute h e mat o ge n o us oste o m yelitis, ri g ht s h o ul der + Stre pt o c occ us p ne u m o niae  
Ac ute h e mat o ge n o us oste o m yelitis, left s h o ul der + Stre pt oc occ us p ne u m o niae  
Ac u te h e mat o ge n o us oste o m yelitis, u ns pecifie d s h o ul der + Stre pt o c occ us 
p ne u m o niae  
Ot her ac ute oste o m yelitis, ri g ht s h o ul d er + Stre pt o c occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, left s h o ul der + Stre pt oc occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, u ns pecifie d s h o ul der + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m yelitis, ri g ht s h o ul d er + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m yelitis, left s h o ul der + Stre pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, u ns pecifie d s h o ul d er + Stre pt oc occ us p ne u m o niae  
7 3 0. 0 2 + 
0 4 1. 2  
Ac ute oste o m yelitis, u p per 
ar m + p ne u m oc occ us  
M 8 6 .0 2 1 + B 9 5 .3  
M 8 6 .0 2 2 + B 9 5 .3  
M 8 6 .0 2 9 + B 9 5 .3  
M 8 6 .1 2 1 + B 9 5 .3  
Ac ute h e mat o ge n o us oste o m yelitis, ri g ht h u mer us + Stre pt o c occ us p ne u m o niae  
Ac ute h e mat o ge n o us oste o m yelitis, left h u mer us + Stre pt oc occ us p ne u m o niae  
Ac ute h e mat o ge n o us oste o m yelitis, u ns pecifie d h u mer us + Stre pt o c occ us 
p ne u m o niae  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 3 6  of 4 6  
M 8 6 .1 2 2 + B 9 5 .3  
M 8 6 .1 2 9 + B 9 5 .3  
M 8 6 .2 2 1 + B 9 5 .3  
M 8 6 .2 2 2 + B 9 5 .3  
M 8 6 .2 2 9 + B 9 5 .3  
Ot her ac ute oste o m yelitis, ri g ht h u mer us + Stre pt oc occ us p ne u m o nia e 
Ot her ac ute oste o m yelitis, left h u mer us + Stre pt o c occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, u ns pecifie d h u mer us + Stre pt o c occ us p ne u m o niae   
S u bac ute oste o m yelitis, ri g ht h u mer us + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m yelitis, left h u mer us + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m yelitis, u ns pecifie d h u mer us + Stre pt oc occ us p ne u m o niae  
 
7 3 0. 0 3 + 
0 4 1. 2  
Ac ute oste o m yelitis, f orear m  
M 8 6 .0 3 1 + B 9 5 .3  
M 8 6 .0 3 2 + B 9 5 .3  
M 8 6 .0 3 9 + B 9 5 .3  
M 8 6 .1 3 1 + B 9 5 .3  
M 8 6 .1 3 2 + B 9 5 .3  
M 8 6 .1 3 9 + B 9 5 .3  
M 8 6 .2 3 1 + B 9 5 .3  
M 8 6 .2 3 2 + B 9 5 .3  
M 8 6 .2 3 9 + B 9 5 .3  
Ac ute h e mat o ge n o us oste o m yelitis, ri g ht ra di us a n d ul na + Stre pt o c occ us 
p ne u m o niae  
Ac ute h e mat o ge n o us oste o m yelitis, left ra di us a n d ul na + Stre pt oc occ us 
p ne u m o niae  
Ac ute h e mat o ge n o us oste o m yelitis, u ns pecifie d ra di us a n d ul na +  Stre pt o c occ us 
p ne u m o niae  
Ot her ac ute oste o m yelitis, ri g ht ra di us a n d ul n a + Stre pt oc occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, left ra di us a n d ul na + Stre pt o c occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, u ns pecifie d ra di us a n d ul na + Stre pt o c occ us 
p ne u m o ni ae 
S u bac ute oste o m yelitis, ri g ht ra di us a n d ul na + Stre pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, left ra di us a n d ul n a + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m yelitis, u ns pecifie d ra di us a n d ul na + Stre pt oc occ us p ne u m o niae  
7 3 0. 0 4 + 
0 4 1. 2  
Ac ute oste o m yelitis, ha n d + 
p ne u m oc occ us  
M 8 6 .0 4 1 + B 9 5 .3  
M 8 6 .0 4 2 + B 9 5 .3  
M 8 6 .0 4 9 + B 9 5 .3  
M 8 6 .1 4 1 + B 9 5 .3  
M 8 6 .1 4 2 + B 9 5 .3  
M 8 6 .1 4 9 + B 9 5 .3  
M 8 6 .2 4 1 + B 9 5 .3  
M 8 6 .2 4 2 + B 9 5 .3  
M 8 6 .2 4 9 + B 9 5 .3  
Ac ute h e mat o ge n o us oste o m yelitis, ri g ht ha n d + Stre pt oc occ us p ne u m o niae  
Ac ute  he mat o ge n o us oste o m yelitis, left ha n d + Stre pt o c occ us p ne u m o niae  
Ac ute h e mat o ge n o us oste o m yelitis, u ns pecifie d ha n d + Stre pt oc occ us 
p ne u m o niae  
Ot her ac ute oste o m yelitis, ri g ht ha n d + Stre pt o c occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, left ha n d + Stre pt oc occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, u ns pecifie d ha n d + Stre pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, ri g ht ha n d + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m yelitis, left ha n d + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m yelitis, u ns pecifie d ha n d + St re pt o c occ us p ne u m o niae  
7 3 0. 0 5 + 
0 4 1. 2  
Ac ute oste o m yelitis, pel vic 
re gi o n a n d t hi g h + 
p ne u m oc occ us  
M 8 6 .0 5 1 + B 9 5 .3  
M 8 6 .0 5 2 + B 9 5 .3  
M 8 6 .0 5 9 + B 9 5 .3  
M 8 6 .1 5 1 + B 9 5 .3  
M 8 6 .1 5 2 + B 9 5 .3  
M 8 6 .1 5 9 + B 9 5 .3  
M 8 6 .2 5 1 + B 9 5 .3  
M 8 6 .2 5 2 + B 9 5 .3  
M 8 6 .2 5 9 + B 9 5 .3  
Ac ute he mat o ge n o us oste o m yelitis, ri g ht fe m ur + Stre pt o c occ us p ne u m o nia  
Ac ute h e mat o ge n o us oste o m yelitis, left fe m ur + Stre pt o c occ us p ne u m o nia  
Ac ute h e mat o ge n o us oste o m yelitis, u ns pecifie d fe m ur + Stre pt o c occ us 
p ne u m o nia  
Ot her ac ute oste o m yelitis, ri g ht fe m ur + Stre pt oc occ us p ne u m o nia  
Ot her ac ute oste o m yelitis, left fe m ur + Stre pt oc occ us p ne u m o nia  
Ot her ac ute oste o m yelitis, u ns pecifie d fe m ur + Stre pt o c occ us p ne u m o nia  
S u bac ute oste o m yelitis, ri g ht fe m ur + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m yelitis, left fe m ur  + Stre pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, u ns pecifie d fe m ur + Stre pt oc occ us p ne u m o niae  
7 3 0. 0 6 + 
0 4 1. 2  
Ac ute oste o m yelitis, l o wer le g 
+ p ne u m oc occ us  
M 8 6 .0 6 1 + B 9 5 .3  
M 8 6 .0 6 2 + B 9 5 .3  
M 8 6 .0 6 9 + B 9 5 .3  
M 8 6 .1 6 1 + B 9 5 .3  
Ac ute he mat o ge n o us oste o m yelitis, ri g ht ti bia a n d fi b ula + Stre pt oc occ us p ne u m o niae  
Ac ute he mat o ge n o us oste o m yelitis, left ti bia a n d fi b ula + Stre pt oc occ us p ne u m o niae  
Ac ute he mat o ge n o us oste o m yelitis, u ns pecifie d ti bia a n d fi b ula + Stre pt oc occ us 
p ne u m o niae  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 3 7  of 4 6  
M 8 6 .1 6 2 + B 9 5 .3  
M 8 6 .1 6 9 + B 9 5 .3  
M 8 6 .2 6 1 + B 9 5 .3  
M 8 6 .2 6 2 + B 9 5 .3  
M 8 6 .2 6 9 + B 9 5 .3  
Ot her ac ute oste o m yelitis, ri g ht ti bia a n d fi b ula + Stre pt oc occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, left ti bia a n d fi b ula + Stre pt oc occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, u ns pecifie d ti bia a n d  fi b ula + Stre pt oc occ us p ne u m o niae 
S u bac ute oste o m yelitis, ri g ht ti bia a n d fi b ula + Stre pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, left ti bia a n d fi b ula + Stre pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, u ns pecifie d ti bia a n d fi b ula + Stre pt oc occ us p ne u m o niae  
7 3 0. 0 7  + 
0 4 1. 2  
Ac ute oste o m yelitis, a n kle a n d 
f o ot + p ne u m oc occ us 
M 8 6 .0 7 1 + B 9 5 .3  
M 8 6 .0 7 2 + B 9 5 .3  
M 8 6 .0 7 9 + B 9 5 .3  
M 8 6 .1 7 1 + B 9 5 .3  
M 8 6 .1 7 2 + B 9 5 .3  
M 8 6 .1 7 9 + B 9 5 .3  
M 8 6 .2 7 1 + B 9 5 .3  
M 8 6 .2 7 2 + B 9 5 .3  
M 8 6 .2 7 9 + B 9 5 .3  
Ac ute he mat o ge n o us oste o m yelitis, ri g ht a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
Ac ute he mat o ge n o us oste o m yelitis, left a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
Ac ute he mat o ge n o us oste o m yelitis, u ns pecifie d a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
Ot her ac ute oste o m yeliti s, ri g ht a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae 
Ot her ac ute oste o m yelitis, left a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, u ns pecifie d a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, ri g ht a n kle a n d f o ot + Str e pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, left a n kle a n d f o ot + Stre pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, u ns pecifie d a n kle a n d f o ot  + Stre pt oc occ us p ne u m o niae  
7 3 0. 0 8 + 
0 4 1. 2  
Ac ute oste o m yelitis, ot her 
s pecifie d sites + 
p ne u m oc occ us  
M 8 6 .0 8 + B 9 5 .3  
M 8 6 .1 8 + B 9 5 .3  
M 8 6 .2 8 + B 9 5 .3  
Ac ute h e mat o ge n o us oste o m yelitis, ot h er sites + Stre pt oc occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, ot h er site + Stre pt oc occ us p ne u m o niae  
S u bac ute oste o m yelitis, ot her site + Stre pt oc occ us p ne u m o niae  
7 3 0. 0 9 + 
0 4 1. 2  
A c ute oste o m yelitis, m ulti ple sites 
+ p ne u m oc occ us  
M 8 6 .0 9 + B 9 5 .3  
M 8 6 .1 9 + B 9 5 .3  
M 8 6 .2 9 + B 9 5 .3  
Ac ute h e mat o ge n o us oste o m yelitis, m ulti ple sites + Stre pt oc occ us p ne u m o niae  
Ot her ac ute oste o m yelitis, m ulti ple sites + Stre pt o c occ us p ne u m o niae  
S u bac ute oste o m y elitis, m ulti ple sites + Stre pt o c occ us p ne u m o niae  
7 3 0. 2 + 0 4 1. 2  
7 3 0. 2 1 + 
0 4 1. 2  
7 3 0. 2 2 + 
0 4 1. 2  
7 3 0. 2 3 + 
0 4 1. 2  
7 3 0. 2 4 + 
0 4 1. 2  
7 3 0. 2 5 + 
0 4 1. 2  
7 3 0. 2 6 + 
0 4 1. 2  
7 3 0. 2 7 + 
0 4 1. 2  
7 3 0. 2 9 + 
0 4 1. 2  
U ns pecifie d oste o m yelitis, site 
u ns pecifie d + p ne u m oc occ us  
U ns pecifie d oste o m yelitis, 
s h o ul der re gi o n + p ne u m oc occ us 
U ns pecifie d oste o m yelitis, u p per 
ar m + p ne u m oc occ us  
U ns pecifie d oste o m yelitis, 
f orear m + p ne u m oc occ us 
U ns pecifie d oste o m yelitis, ha n d + 
p ne u m oc occ us  
U ns pecifie d oste o m yelitis, pel vic 
regi o n a n d t hi g h + p ne u m oc occ us  
U ns pecifie d oste o m yelitis, l o wer 
le g + p ne u m oc occ us 
U ns pecifie d oste o m yelitis, a n kle 
a n d f o ot + p ne u m oc occ us  
U ns pecifie d oste o m yelitis, 
m ulti ple sites + p ne u m oc occ us  
M 8 6 .9 + B 9 5 .3  
Oste o m yelitis, u ns pecifie d + Stre pt o c occ us p ne u m o niae  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 3 8  of 4 6  
7 3 0. 2 8 + 
0 4 1. 2  
U ns pecifie d oste o m yelitis, 
ot h er s pecifie d sites + 
p ne u m oc occ us  
M 4 6 .2 0 + B 9 5 .3  
M 4 6 .2 1 + B 9 5 .3  
M 4 6 .2 2 + B 9 5 .3  
M 4 6 .2 3 + B 9 5 .3  
M 4 6 .2 4 + B 9 5 .3  
M 4 6 .2 5 + B 9 5 .3  
M 4 6 .2 6 + B 9 5 .3  
M 4 6 .2 7 + B 9 5 .3  
M 4 6 .2 8 + B 9 5 .3  
Oste o m yelitis of verte bra, site u ns pecifie d + Stre pt oc occ us p ne u m o niae  
Oste o m yelitis of verte bra, occi pit o -atla nt o -a xial re gi o n + Stre pt oc occ us p ne u m o niae  
Oste o m yelitis of verte bra, cer vical re gi o n + Stre pt oc occ us p ne u m o niae  
Oste o m yelitis of verte bra, cer v ic ot h oracic re gi o n + Stre pt oc occ us p ne u m o niae 
Oste o m yelitis of verte bra, t h oracic re gi o n + Stre pt oc occ us p ne u m o niae  
Oste o m yelitis of verte bra, t h orac ol u m bar re gi o n + Stre pt oc occ us p ne u m o niae  
Oste o m yelitis of verte bra, l u m bar re gi o n + Stre pt oc occ us p ne u m o ni ae 
Oste o m yelitis of verte bra, l u m b osacral re gi o n + Stre pt oc occ us p ne u m o niae  
Oste o m yelitis of verte bra, sacral a n d sacr oc occ y geal re gi o n + Stre pt oc occ us p ne u m o niae  
P ne u m o ni a  
  
  
All -Ca use  
4 8 0 -4 8 6  
4 8 7. 0  
Viral, bacterial, u ns pecifie d p ne u m o nia  
4 8 0  
P ne u m o nia d ue t o a de n o vir us  
J 1 2.0  
A de n o viral p ne u m o nia  
4 8 0. 1  
P ne u m o nia d ue t o res pirat or y 
s y nc ytial vir us 
J 1 2.1  
Res pirat or y s y nc ytial vir us p ne u m o nia  
4 8 0. 2  
P ne u m o nia d ue t o 
parai nfl u e nza vir us  
J 1 2.2  
Parai nfl u e nza vir us p ne u m o nia  
4 8 0. 3  
P ne u m o nia d ue t o S A R S -
ass ociate d c or o na vir us  
J 1 2.8 1  
J 1 2. 8 2 
P ne u m o nia d ue t o S A R S -ass ociate d c or o na vir us  
P ne u m o nia d ue t o c or o na vir us disease 2 0 1 9  
4 8 0. 8  
P ne u m o nia d ue t o ot her vir us 
n ot else w here classifie d  
J 1 2.3  
J 1 2.8 9  
H u ma n meta p ne u m o vir us p ne u m o nia  
Ot her viral p ne u m o nia  
4 8 0. 9  
Viral p ne u m o nia, u ns pecifie d  
J 1 2.9  
Viral p ne u m o nia, u ns pecifie d  
4 8 1  
P ne u m oc occal p ne u m o nia 
[ Stre pt o c occ us p ne u m o niae 
p ne u m o nia]  
J 1 8.1  
J 1 3 
L o bar p ne u m o nia, u ns pecifie d or ga nis m  
P ne u m o nia d ue t o Stre pt oc occ us p ne u m o niae  
4 8 2  
P ne u m o nia d ue t o Kle bsiella 
p ne u m o niae  
J 1 5.0  
P ne u m o nia d ue t o Kle bsiella p ne u m o niae  
4 8 2. 1  
P ne u m o nia d ue t o 
Pse u d o m o nas  
J 1 5.1  
P ne u m o nia d ue t o Pse u d o m o nas  
4 8 2. 2  
P ne u m o nia d ue t o He m o p hil us 
i nfl u e nzae [ H. i nfl ue nzae] 
J 1 4 
P ne u m o nia d ue t o He m o p hil us i nfl u e nzae  
4 8 2. 3  
P ne u m o nia d ue t o 
Stre pt o c occ us, u ns pecifie d  
J 1 5.4  
P ne u m o nia d ue t o ot her stre pt oc occi  
4 8 2. 3 1  
P ne u m o nia d ue t o 
Stre pt o c occ us, gr o u p A  
J 1 5.4  
P ne u m o nia d ue t o ot her stre pt oc occi  
4 8 2. 3 2  
P ne u m o nia d ue t o 
Stre pt o c occ us, gr o u p B  
J 1 5.3  
P ne u m o nia d ue t o stre pt o c occ us, gr o u p B  
4 8 2. 3 9  
P ne u m o nia d ue t o ot her 
Stre pt o c occ us  
J 1 5.4  
P ne u m o nia d ue t o ot her stre pt oc occi  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 3 9  of 4 6  
4 8 2. 4  
P ne u m o nia d ue t o 
Sta p h yl o c occ us, u ns pecifie d  
J 1 5.2 0  
P ne u m o nia d ue t o sta p h yl o c occ us, u ns pecifie d  
4 8 2. 4 1  
Met hicilli n s usce pti ble 
p ne u m o nia d ue t o 
Sta p h yl o c occ us a ure us  
J 1 5.2 1 1  
P ne u m o nia d ue t o Met hicilli n s usce pti ble Sta p h yl o c occ us a ure us  
4 8 2. 4 2  
Met hicilli n resista nt 
p ne u m o nia d ue t o 
Sta p h yl o c occ us a ure us  
J 1 5.2 1 2  
P ne u m o nia d ue t o Met hicilli n resista nt Sta p h yl oc occ us a ure us  
4 8 2. 4 9  
Ot her Sta p h yl oc occ us 
p ne u m o nia  
J 1 5.2 9  
P ne u m o nia d ue t o ot her sta p h yl oc occ us  
4 8 2. 8 1  
P ne u m o nia d ue t o a naer o bes  
J 1 5.8  
P ne u m o nia d ue t o ot her s pecifie d bacteria  
4 8 2. 8 2  
P ne u m o nia d ue t o esc heric hia 
c oli [ E. c oli] 
J 1 5.5  
P ne u m o nia d ue t o Esc heric hia c oli  
4 8 2. 8 3  
P ne u m o nia d ue t o ot her gra m -
ne gati ve bacteria  
J 1 5.6  
P ne u m o nia d ue t o ot her aer o bic Gra m -ne gati ve bacteria  
4 8 2. 8 4  
P ne u m o nia d ue t o 
Le gi o n naires' disease  
A 4 8 .1  
Le gi o n naires' disease  
4 8 2. 8 9  
P ne u m o nia d ue t o ot her 
s pecifie d bacteria 
J 1 5.8  
P ne u m o nia d ue t o ot her s pecifie d bacteria  
4 8 2. 9  
Bacterial p ne u m o nia, 
u ns pecifie d  
J 1 5.9  
U ns pecifie d bacterial p ne u m o nia  
4 8 3  
P ne u m o nia d ue t o 
m yc o plas ma p ne u m o niae  
J 1 5.7  
P ne u m o nia d ue t o M yc o plas ma p ne u m o niae  
4 8 3. 1  
P ne u m o nia d ue t o c hla m y dia  
J 1 6.0  
C hla m y dial p ne u m o nia  
4 8 3. 8  
P ne u m o nia d ue t o ot her 
s pecifie d or ga nis m 
J 1 6.8  
P ne u m o nia d ue t o ot her s pecifie d i nfecti o us or ga nis ms 
4 8 4. 1  
P ne u m o nia i n c yt o me galic 
i n cl usi o n disease 
B 2 5 .0  
C yt o me gal o viral p ne u m o nitis  
4 8 4. 3  
P ne u m o nia i n w h o o pi n g 
c o u g h 
A 3 7 .9 1  
A 3 7 .0 1  
A 3 7 .1 1  
A 3 7 .8 1  
W h o o pi n g c o u g h, u ns pecifie d s pecies wit h p ne u m o nia  
W h o o pi n g c o u g h d ue t o B or detella pert ussis wit h p ne u m o nia  
W h o o pi n g c o u g h d ue t o B or detella para pert ussis wit h p ne u m o nia  
W h o o pi n g c o u g h d ue t o ot her B or detella s pecies wit h p ne u m o nia  
4 8 4. 5  
P ne u m o nia i n  a nt hra x 
A 2 2 .1  
P ul m o nar y a nt hra x  
4 8 4. 6  
P ne u m o nia i n as per gill osis  
B 4 4 .0  
I n vasi ve p ul m o nar y as per gill osis 
4 8 4. 7  
P ne u m o nia i n ot her s yste mic 
m yc oses  
J 1 7 
P ne u m o nia i n diseases classifie d else w here  
4 8 4. 8  
P ne u m o nia i n ot her i nfecti o us 
diseases classifie d else w here  
J 1 7  
B 7 7 .8 1  
P ne u m o nia i n diseases classifie d else w here  
Ascariasis p ne u m o nia  
4 8 5  
Br o nc h o p ne u m o nia, or ga nis m 
u ns pecifie d  
J 1 8.0  
Br o nc h o p ne u m o nia, u ns pecifie d or ga nis m  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 4 0  of 4 6  
4 8 6  
P ne u m o nia, or ga nis m 
u ns pecifie d  
J 1 8.8  
J 1 8.9  
Ot her p ne u m o nia, u ns pecifie d or ga nis m  
P ne u m o nia, u ns pecifie d or ga nis m  
4 8 7  
I nfl u e nza wit h p ne u m o nia 
J 1 0.0 0  
J 1 0.0 8  
J 1 1.0 0  
J 1 1.0 8  
J 1 2.9  
I nfl ue nza d ue t o ot her i de ntifie d i nfl ue nza vir us wit h u ns pecifie d t y pe of p ne u m o nia  
I nfl ue nza d ue t o ot her i de ntifie d i nfl ue nza vir us wit h ot her s pecifie d p ne u m o nia  
I nfl ue nza d ue t o u ni de ntifie d i nfl ue nza vir us wit h u ns pecifie d t y pe of p ne u m o nia  
I nfl uenza d ue t o u ni de ntifie d i nfl ue nza vir us wit h s pecifie d p ne u m o nia  
Viral p ne u m o nia, u ns pecifie d  
5 1 0. x  
E m p ye ma  
5 1 0  
E m p ye ma wit h fist ula  
J 8 6.0  
P y ot h ora x wit h fist ula  
5 1 0. 9  
E m p ye ma wit h o ut me nti o n of 
fist ula 
J 8 6.9  
P y ot h ora x wit h o ut fist ula  
 
J 8 5.1  
A bscess of l u n g wit h p ne u m o nia  
1 3 6. 3  
P ne u m oc yst osis  
B 5 9  
P ne u m oc yst osis  
P ne u m oc occa
l 
4 8 1  
P ne u m oc occal p ne u m o nia  
J 1 3 
P ne u m o nia d ue t o Stre pt oc occ us p ne u m o niae  
4 8 2. 9 + 0 4 1. 2  
Bacterial p ne u m o nia, 
u ns pecifie d + p ne u m oc occ us  
J 1 5.9 + B 9 5 .3  
U ns pecifie d bacterial p ne u m o nia  + Stre pt oc occ us p ne u m o niae  
4 8 5 + 0 4 1. 2  
Br o nc h o p ne u m o nia, or ga nis m 
u ns pecifie d + p ne u m oc occ us  
J 1 8.0 + B 9 5 .3  
Br o nc h o p ne u m o nia, u ns pecifie d or ga nis m  + Stre pt oc occ us p ne u m o niae  
4 8 6 + 0 4 1. 2  
P ne u m o nia, or ga nis m 
u ns pecifie d + p ne u m oc occ us  
J 1 8.8 + B 9 5 .3  
J 1 8.9 + B 9 5 .3  
Ot her p ne u m o nia, u ns pecifie d or ga nis m + Stre pt oc occ us p ne u m o niae  
P ne u m o nia, u ns pecifie d or ga nis m + Stre pt oc occ us p ne u m o niae  
5 1 0. x + 0 4 1. 2  
E m p ye ma + p ne u m oc occ us  
5 1 0 + 0 4 1. 2  
E m p ye ma wit h fist ula + 
p ne u m oc occ us  
J 8 6.0 + B 9 5 .3  
P y ot h ora x wit h fist ula  + Stre pt o c occ us p ne u m o niae  
5 1 0. 9 + 0 4 1. 2  
E m p ye ma wit h o ut me nti o n of 
fist ula + p ne u m oc occ us 
J 8 6.9 + B 9 5 .3  
P y ot h ora x wit h o ut fist ula  + Stre pt o c occ us p ne u m o niae  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 4 1  of 4 6  
T a ble 6. N ati o n al Dr u g C o des a n d Pr oce d ure C o des f or I de ntif yi n g I m m u n os u p pressi ve 
Me dic ati o ns (see e xcel)  
T a ble 7. N ati o n al Dr u g C o des a n d Pr oce d ure C o des f or I de ntif yi n g I nfl ue nz a 
V acci n ati o ns (see e x cel)  
T a ble 8. N ati o n al Dr u g C o des a n d C P T ®  C o des f or I de ntif yi n g P P S V 2 3 V acci n ati o n  
C o de  
T y pe  
Descri pti o n  
9 0 7 3 2  
C P T  
P ne u m o va x 2 3  
0 0 0 0 6 4 7 3 9 0 0  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 7 3 9 0 1  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 7 3 9 5 0  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 7 4 1 0 0  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 8 3 7 0 1  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 8 3 7 0 2  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 8 3 7 0 3  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 8 9 4 0 0  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 8 9 4 0 0  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 9 4 3 0 0  
N D C  
P ne u m o va x 2 3  
0 0 0 0 6 4 9 4 3 0 1  
N D C  
P ne u m o va x 2 3  
0 0 2 4 7 0 4 0 2 0 1  
N D C  
P ne u m o va x 2 3  
5 0 0 9 0 1 4 5 2 0 0  
N D C  
P ne u m o va x 2 3  
5 0 0 9 0 1 4 5 2 0 9  
N D C  
P ne u m o va x 2 3  
5 4 5 6 9 1 4 1 2 0 0  
N D C  
P ne u m o va x 2 3  
5 4 5 6 9 6 5 3 8 0 0  
N D C  
P ne u m o va x 2 3  
5 4 8 6 8 3 3 3 9 0 1  
N D C  
P ne u m o va x 2 3  
5 4 8 6 8 3 3 3 9 0 9  
N D C  
P ne u m o va x 2 3  
5 4 8 6 8 4 3 2 0 0 0  
N D C  
P ne u m o va x 2 3  
5 4 8 6 8 4 3 2 0 0 9  
N D C  
P ne u m o va x 2 3  
5 5 0 4 5 3 5 4 2 0 2  
N D C  
P ne u m o va x 2 3  
0 0 0 0 5 2 3 0 9 3 1  
N D C  
P n u -I m u ne 2 3 
0 0 0 0 5 2 3 0 9 3 3  
N D C  
P n u -I m u ne 2 3 
5 4 8 6 8 0 7 0 7 0 0  
N D C  
P n u -I m u ne 2 3 
 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 
0 1 -A u g -2 0 2 3    
Pa ge 4 2  of 4 6  
T a ble 9. C P T ® c o des t o i de ntif y C D 4 l a b or at or y tests  
C o de  
T y pe  
Descri pti o n  
8 6 3 6 1  
C P T  
A bs ol ute C D 4 c o u nt  
8 6 3 6 0  
C P T  
A bs ol ute C D 4  a n d C D 8 
c o u nts wit h rati o  
 
T a ble 1 0. C P T ®  c o des t o i de ntif y vir al l o a d l a b or at or y tests  
C o de  
T y pe  
Descri pti o n  
8 7 5 3 4  
C P T  
I nfecti o us a g e nt detecti o n b y 
n ucleic aci d ( D N A or 
R N A); HI V -1, dir ect pr o be 
tec h ni q ue 
8 7 5 3 5  
C P T  
I nfecti o us a g e nt detecti o n b y 
n ucle ic aci d ( D N A or 
R N A); HI V -1, a m plifie d 
pr o be tec h ni q ue  
8 7 5 3 6  
C P T  
I nfecti o us a g e nt detecti o n b y 
n ucleic aci d ( D N A or 
R N A); HI V -1, 
q ua ntificati o n  
 
 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 4 3  of 4 6  
T a ble 1 1. Di a g n osis C o des f or I de ntif yi n g All -C a use P ne u m o ni a n ot d ue t o HI V  
C o n diti o n  
I C D-9 -C M  
I C D-1 0 -C M  
C o des  
Descri pti o n  
C o des  
Descri pti o n  
All -Ca use  
4 8 0 -4 8 6  
4 8 7. 0  
Viral, bacterial, u ns pecifie d p ne u m o nia  
4 8 0  
P ne u m o nia d ue t o a de n o vir us  
J 1 2.0  
A de n o viral p ne u m o nia  
4 8 0. 1  
P ne u m o nia d ue t o res pirat or y 
s y nc ytial vir us 
J 1 2.1  
Res pirat or y s y nc ytial vir us p ne u m o nia  
4 8 0. 2  
P ne u m o nia d ue t o 
parai nfl u e nza vir us  
J 1 2.2  
Parai nfl u e nza vir us p ne u m o nia  
4 8 0. 3  
P ne u m o nia d ue t o S A R S -
ass ociate d c or o na vir us  
J 1 2.8 1  
J 1 2. 8 2 
P ne u m o nia d ue t o S A R S -ass ociate d c or o na vir us  
P ne u m o nia d ue t o c or o na vir us disease 2 0 1 9  
4 8 0. 8  
P ne u m o nia d ue t o ot her vir us 
n ot else w here classifie d  
J 1 2.3  
J 1 2.8 9  
H u ma n meta p ne u m o vir us p ne u m o nia  
Ot her viral p ne u m o nia  
4 8 0. 9  
Viral p ne u m o nia, u ns pecifie d  
J 1 2.9  
Viral p ne u m o nia, u ns pecifie d  
4 8 1  
P ne u m oc occal p ne u m o nia 
[ Stre pt o c occ us p ne u m o niae 
p ne u m o nia]  
J 1 8.1  
J 1 3 
L o bar p ne u m o nia, u ns pecifie d or ga nis m  
P ne u m o nia d ue t o Stre pt oc occ us p ne u m o niae  
4 8 2  
P ne u m o nia d ue t o Kle bsiella 
p ne u m o niae  
J 1 5.0  
P ne u m o nia d ue t o Kle bsiella p ne u m o niae  
4 8 2. 1  
P ne u m o nia d ue t o 
Pse u d o m o nas  
J 1 5.1  
P ne u m o nia d ue t o Pse u d o m o nas  
4 8 2. 2  
P ne u m o nia d ue t o He m o p hil us 
i nfl u e nzae [ H. i nfl ue nzae] 
J 1 4 
P ne u m o nia d ue t o He m o p hil us i nfl u e nzae  
4 8 2. 3  
P ne u m o nia d ue t o 
Stre pt o c occ us, u ns pecifie d  
J 1 5.4  
P ne u m o nia d ue t o ot her stre pt oc occi  
4 8 2. 3 1  
P ne u m o nia d ue t o 
Stre pt o c occ us, gr o u p A  
J 1 5.4  
P ne u m o nia d ue t o ot her stre pt oc occi  
4 8 2. 3 2  
P ne u m o nia d ue t o 
Stre pt o c occ us, gr o u p B  
J 1 5.3  
P ne u m o nia d ue t o stre pt o c occ us, gr o u p B 
4 8 2. 3 9  
P ne u m o nia d ue t o ot her 
Stre pt o c occ us  
J 1 5.4  
P ne u m o nia d ue t o ot her stre pt oc occi  
4 8 2. 4  
P ne u m o nia d ue t o 
Sta p h yl o c occ us, u ns pecifie d  
J 1 5.2 0  
P ne u m o nia d ue t o sta p h yl o c occ us, u ns pecifie d  
4 8 2. 4 1  
Met hicilli n s usce pti ble 
p ne u m o nia d ue t o 
Sta p h yl o c occ us a ure us  
J 1 5.2 1 1  
P ne u m o nia d ue t o Met hicilli n s usce pti ble Sta p h yl o c occ us a ure us  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 4 4  of 4 6  
4 8 2. 4 2  
Met hicilli n resista nt 
p ne u m o nia d ue t o 
Sta p h yl o c occ us a ure us  
J 1 5.2 1 2  
P ne u m o nia d ue t o Met hicilli n resista nt Sta p h yl oc occ us a ure us  
4 8 2. 4 9  
Ot her Sta p h yl oc occ us 
p ne u m o nia  
J 1 5.2 9  
P ne u m o nia d ue t o ot her sta p h yl oc occ us  
4 8 2. 8 1  
P ne u m o nia d ue t o a naer o bes  
J 1 5.8  
P ne u m o nia d ue t o ot her s pecifie d bacteria  
4 8 2. 8 2  
P ne u m o nia d ue t o esc heric hia  
c oli [ E. c oli] 
J 1 5.5  
P ne u m o nia d ue t o Esc heric hia c oli  
4 8 2. 8 3  
P ne u m o nia d ue t o ot her gra m -
ne gati ve bacteria  
J 1 5.6  
P ne u m o nia d ue t o ot her aer o bic Gra m -ne gati ve bacteria  
4 8 2. 8 4  
P ne u m o nia d ue t o 
Le gi o n naires' disease  
A 4 8 .1  
Le gi o n naires' disease  
4 8 2. 8 9  
P ne u m o nia d ue t o ot her 
s pecifie d bacteria 
J 1 5.8  
P ne u m o nia d ue t o ot her s pecifie d bacteria  
4 8 2. 9  
Bacterial p ne u m o nia, 
u ns pecifie d  
J 1 5.9  
U ns pecifie d bacterial p ne u m o nia  
4 8 3. 1  
P ne u m o nia d ue t o c hla m y dia  
J 1 6.0  
C hla m y dial p ne u m o nia  
4 8 3. 8  
P ne u m o nia d ue t o ot her 
s pecifie d or ga nis m 
J 1 6.8  
P ne u m o nia d ue t o ot her s pecifie d i nfecti o us or ga nis ms  
4 8 4. 3  
P ne u m o nia i n w h o o pi n g 
c o u g h 
A 3 7 .9 1  
A 3 7 .0 1  
A 3 7 .1 1  
A 3 7 .8 1  
W h o o pi n g c o u g h, u ns pecifie d s pecies wit h p ne u m o nia  
W h o o pi n g c o u g h d ue t o B or detella pert ussis wit h p ne u m o nia  
W h o o pi n g c o u g h d ue t o B or detella para pert ussis wit h p ne u m o nia  
W h o o pi n g c o u g h d ue t o ot her B or detella s pecies wit h p ne u m o nia  
4 8 4. 5  
P ne u m o nia i n a nt hra x  
A 2 2 .1  
P ul m o nar y a nt hra x  
J 1 7 
P ne u m o nia i n diseases classifie d else w here  
4 8 4. 8  
P ne u m o nia i n ot her i nfecti o us 
diseases classifie d else w here  
J 1 7  
B 7 7 .8 1  
P ne u m o nia i n diseases classifie d else w here  
Ascariasis p ne u m o nia  
4 8 5  
Br o nc h o p ne u m o nia, or ga nis m 
u ns pecifie d  
J 1 8.0  
Br o nc h o p ne u m o nia, u ns pecifie d or ga nis m  
4 8 6  
P ne u m o nia, or ga nis m 
u ns pecifie d  
J 1 8.8  
J 1 8.9  
Ot her p ne u m o nia, u ns pecifie d or ga nis m  
P ne u m o nia, u ns pecifie d or ga nis m  
4 8 7  
I nfl u e nza wit h p ne u m o nia 
J 1 0.0 0  
J 1 0.0 8  
J 1 1.0 0  
J 1 1.0 8  
J 1 2.9  
I nfl ue nza d ue t o ot her i de ntifie d i nfl ue nza vir us wit h u ns pecifie d t y pe of p ne u m o nia  
I nfl ue nza d ue t o ot her i de ntifie d i nfl ue nza vir us wit h ot her s pecifie d p ne u m o nia  
I nfl ue nza d ue t o u ni de ntifie d i nfl ue nza vir us wit h u ns pecifie d t y pe of p ne u m o nia  
I nfl uenza d ue t o u ni de ntifie d i nfl ue nza vir us wit h s pecifie d p ne u m o nia  
Viral p ne u m o nia, u ns pecifie d  
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 2 1 N o ve m ber  2 0 2 3   
 
P FI Z E R C O N FI D E N TI A L   
C T 2 4 -WI -G L 0 2 -R F 0 2 5 . 0 N o n-I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy 0 1 -A u g -2 0 2 3    
Pa ge 4 5  of 4 6  
5 1 0. x  
E m p ye ma  
5 1 0  
E m p ye ma wit h fist ula  
J 8 6.0  
P y ot h ora x wit h fist ula  
5 1 0. 9  
E m p ye ma wit h o ut me nti o n of 
fist ula 
J 8 6.9  
P y ot h ora x wit h o ut fist ula  
J 8 5.1  
A bscess of l u n g wit h p ne u m o nia  
 
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)

1 3 -vale nt P ne u m oc occal C o nj u gate Vacci ne  
B 1 8 5 1 2 1 7  N O N -I N T E R V E N TI O N A L S T U D Y P R O T O C O L 
Versi o n 3 . 0, 0 6 Dece m ber  2 0 2 3  
 
P FI Z E R G E N E R A L B U SI N E S S  
C T 2 4 -WI -G L 0 2 -R F 0 2 4 . 0 N o n -I nterve nti o n al St u dy Pr ot oc ol Te m pl ate F or Sec o n d ary D at a C ollecti o n St u dy  0 1 -J u n -2 0 2 2   
Pa ge 4 6  of 4 6  
T a ble 1 2 . N ati o n al Dr u g C o des a n d C P T®  C o des f or I de ntif yi n g Rec o m bi n a nt Z oster  
V acci n ati o n  
C o de  
T y pe  
Descri pti o n  
5 8 1 6 0 0 8 2 8 0 1  
N D C  
S hi n gri x  
5 8 1 6 0 0 8 2 8 0 3  
N D C  
S hi n gri x  
5 0 0 9 0 5 1 4 7 0 0  
N D C  
S hi n gri x  
5 8 1 6 0 0 8 1 9 1 2  
N D C  
S hi n gri x  
5 8 1 6 0 0 8 2 3 1 1  
N D C  
S hi n gri x  
5 0 0 9 0 3 3 7 2 0 0  
N D C  
S hi n gri x  
9 0 7 5 0  
C P T  
Z oster Vacci ne 
Rec o m bi na nt, A dj u va nte d, 
S us pe nsi o n f or 
I ntr a m usc ular I njecti o n 
 
T a ble 1 3. N ati o n al Dr u g C o des f or I de ntif yi n g C a n di di asis A ntif u n g als (see e x cel)  
 
T a ble 1 4. Di a g n osis C o des f or I de ntif yi n g O p p ort u nistic I nfecti o ns  (see e xcel) 
A N N E X 1. LI S T O F S T A N D A L O N E D O C U M E N T S  
If t here is n o d o c u me nt t o be liste d, delete t he ta bl e a n d write “ N o ne”.  
N u m ber  
D oc u m e nt refere nce 
n u m ber  
D ate  
Title  
1  
1  
Ja n uar y 2 4, 
2 0 2 3  
A n ne x C o de Ta bles  
 
A N N E X 2. E N C E P P C H E C K LI S T F O R S T U D Y P R O T O C O L S  
N ot re q uire d  
A N N E X 3. A D DI TI O N A L I N F O R M A TI O N  
N ot a p plica ble   
0 9 0 1 7 7 e 1 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( 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 9f 6 c df 4 7\ A p pr o v e d\ A p pr o v e d O n: 1 1- D e c- 2 0 2 3 1 8: 2 6 ( G M T)
P P D