Final Full Clinical Study Report
Protocol B7471009

CLINICAL STUDY REPORT SYNOPSISSYNOPSIS
Study Title: Final Report: A Phase 3, Randomized, Double-Blind, Third-Party-Unblinded
Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate
Vaccine in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea,
and Taiwan
Study Number: B7471009
Regulatory Agency or Public Disclosure Identifier Number: NCT04875533
Study Phase: Phase 3
Name of Study Intervention: 20-valent Pneumococcal Conjugate Vaccine (20vPnC)Name of Sponsor/Company: Pfizer Inc.
CSR Version and Report Date: Final CSR (LPLV) Version 1.0; 13 March 2023
Number of Study Center(s) and Investigator(s):This study was conducted at 28 sites in Japan, Korea, and Taiwan.
A list of study centers and investigators involved in this study is provided inAppendix 16.1.4.1.
Publications:NoneStudy Period:
Study Initiation Date (Frist Participant First Visit [FPFV]): 14 June 2021
Study Completion Date (Last Participant Last Visit [LPLV]): 13 May 2022
This study was neither discontinued nor interrupted.
Rationale:Pfizer has developed a 20vPnC candidate to expand protection against pneumococcal diseasebeyond that covered by current pneumococcal vaccines in children and adults. 20vPnC has
the same composition as 13vPnC (Prevenar 13®) but contains an additional 7 pneumococcal
conjugates to protect against serotypes responsible for a substantial burden of remaining
pneumococcal disease. 20vPnC uses the same platform and contains the same excipients as13vPnC. 20vPnC was evaluated in a clinical development program in adults, and data fromoverseas Phase 3 studies in participants 18 years of age and older provided evidence that thePFIZER CONFIDENTIAL
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CLINICAL STUDY REPORT SYNOPSIS
safety profile was acceptable and similar to 13vPnC and induced immune responses that
supported licensure for an adult (≥18 years of age) indication in the US, EU, Great Britain,and Canada.
The purpose of this study was to assess the safety and immunogenicity of 20vPnC in adults≥60 years of age in Japan, Korea, and Taiwan and to help support use of 20vPnC in the adultpopulation in these countries/regions.
Objectives, Estimands and Endpoints:
Table S1. Objectives, Estimands and Endpoints
TypePrimary
SafetyObjective

Estimands

Endpoints

To describe the safety
profile of 20vPnC.

In participants receiving
at least 1 dose of study
intervention and havingsafety follow-up after
vaccination from eachvaccine group: The percentage ofparticipants
reporting prompted
local reactions
within 10 days after
the first vaccination(20vPnC or13vPnC).
 The percentage ofparticipants
reporting prompted
systemic events
within 7 days after
the first vaccination(20vPnC or13vPnC).
 The percentage ofparticipants
reporting AEs
within 1 month after
vaccination with
20vPnC or 13vPnC.
 The percentage ofparticipants
reporting SAEs
within 1 month after
vaccination with
20vPnC or 13vPnC.

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Page 2Prompted local
reactions (redness,swelling, and pain at
the injection site)
Prompted systemic
events (fever,headache, fatigue,
muscle pain, andjoint pain).
AEsSAEs

Final Full Clinical Study ReportProtocol B7471009

CLINICAL STUDY REPORT SYNOPSIS
Table S1. Objectives, Estimands and Endpoints
Immunogenicity

To demonstrate that theimmune responses to the13 serotypes in 13vPnC(1, 3, 4, 5, 6A, 6B, 7F,9V, 14, 18C, 19A, 19F,and 23F) induced by20vPnC are noninferior
to the immune response
induced by 13vPnC.

To demonstrate that theimmune responses to the
7 additional serotypes in20vPnC (8, 10A, 11A,12F, 15B, 22F, and 33F)
induced by 20vPnC arenoninferior to theimmune response
induced by PPSV23.

In participants incompliance with the key
protocol criteria(evaluable participants):
 For each of the 13
serotypes: GMR ofserotype-specific
OPA titers 1 monthafter 20vPnC to theserotype-specific
OPA titers 1 monthafter 13vPnC.
In evaluable participants:
 For each of the 7
additional serotypes:
GMR ofserotype-specific
OPA titers 1 monthafter 20vPnC to theserotype-specific
OPA titers 1 monthafter PPSV23.

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

Serotype-specific
OPA titers

Serotype-specific
OPA titers

Final Full Clinical Study Report
Protocol B7471009

CLINICAL STUDY REPORT SYNOPSIS
Table S1. Objectives, Estimands and Endpoints
Secondary
Immunogenicity

To describe the immune
responses to all
20 serotypes induced by20vPnC.

In evaluable participants
for each of the20 serotypes:
 Serotype-specific
OPA GMTs
1 month after
vaccination* in eachvaccine group.
 GMFRs inserotype-specific
OPA titers frombefore to 1 monthafter vaccination* ineach vaccine group.
 Percentage ofparticipants with
≥4-fold rise inserotype-specific
OPA titers frombefore to 1 monthafter vaccination* ineach vaccine group.
 Percentage ofparticipants withserotype-specific
OPA titers greaterthan or equal to the
LLOQ 1 month after
vaccination* in eachvaccine group.

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

Serotype-specific
OPA titers

Final Full Clinical Study Report
Protocol B7471009

CLINICAL STUDY REPORT SYNOPSIS
Table S1. Objectives, Estimands and Endpoints
In participants receiving
 Prompted local
at least 1 dose of study
reactions (redness,intervention and having
swelling, and pain atsafety follow-up after
the injection site)
vaccination from each Prompted systemic
vaccine group:events (fever, The percentage ofheadache, fatigue,participantsmuscle pain, andreporting prompted
joint pain)
local reactions
within 10 days after
the second
vaccination(PPSV23 or saline).
 The percentage ofparticipants
reporting prompted
systemic events
within 7 days after
the second
vaccination(PPSV23 or saline).
* Note: “1 month after vaccination” refers to 1 month after vaccination with 20vPnC (20vPnC/salinegroup), or 1 month after vaccination with 13vPnC for the 13 matched serotypes or PPSV23 for the7 additional serotypes (13vPnC/PPSV23 group).
Abbreviations: 13vPnC = 13-valent pneumococcal conjugate vaccine, 20vPnC = 20-valent pneumococcal
conjugate vaccine, AE = adverse event, GMR = geometric mean ratio, LLOQ = lower limit of quantitation,
OPA = opsonophagocytic activity, PPSV23 = 23-valent pneumococcal polysaccharide vaccine,
SAE = serious adverse event,
SafetyTo describe thereactogenicity profile of
PPSV23 following
13vPnC in Japaneseparticipants (only forparticipants enrolled atJapan sites).

Methodology:
This was a Phase 3, multicenter, randomized, double-blind, third-party-unblinded study.
Approximately 1400 participants 60 years of age and older at enrollment were randomized
into 2 groups in a 1:1 ratio by center-based randomization stratified by age (60 to 64 year ofage and ≥65 years of age): 20vPnC/saline group and 13vPnC/PPSV23 group. Eachparticipant was randomized to receive either 20vPnC or 13vPnC (control vaccine) at
Vaccination 1. Participants who received 20vPnC at Vaccination 1 in the 20vPnC/salinegroup received saline at Vaccination 2 (1 month after Vaccination 1). Participants who
received 13vPnC at Vaccination 1 in the 13vPnC/PPSV23 group received PPSV23 atVaccination 2 (1 month after Vaccination 1).
Immunogenicity Evaluations
Blood samples were collected from all participants at Visit 1 (prior to administration of20vPnC or 13vPnC), at Visit 2 (prior to administration of saline or PPSV23), and at Visit 3.

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Protocol B7471009

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OPA titers for serotypes present in 20vPnC (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14,15B, 18C, 19A, 19F, 22F, 23F, and 33F) were determined on all sera collected prior to study
vaccination and 1 month (28 to 42 days) after Vaccination 1. OPA titers for the 7 additional
serotypes only were determined on sera collected 1 month (28 to 42 days) after
Vaccination 2.
Safety Evaluations
Participants recorded local reactions for 10 days, and systemic events and antipyretic/pain
medication usage for 7 days, each evening following Vaccination 1 (Day 1 was the day ofvaccination) using an e-diary (in a provisioned device or an application on a personaldevice). For Japan sites only, the participants were asked to complete an e-diary after
Vaccination 2.
AEs and SAEs were reported by the participant (or, when appropriate, by a caregiver,surrogate, or the participant’s legally authorized representative). The AEs and SAEs werecollected from the time the participant provided informed consent, through and including
Visit 3.
Number of Participants (planned and analyzed):
This study planned to enroll approximately 1400 participants. A total of 1425 participants
were randomized in the study with 1421 participants included in the safety population,
1377 participants included in the 13-matched immunogenicity population and1382 participants in the evaluable 7-additional immunogenicity population.
Diagnosis and Main Criteria for Inclusion and Exclusion:
Key inclusion/exclusion criteria were as follows:
Inclusion Criteria:
Male or female participants ≥60 years of age at the time of consent.

Adults determined by clinical assessment, including medical history and clinicaljudgment, to be eligible for the study, including adults with preexisting stable disease,defined as disease not requiring significant change in therapy in the previous 6 weeks or
hospitalization for worsening disease within 12 weeks before receipt of study
intervention.
For adults 60 through 64 years of age enrolled at Japan sites only:Participants were required to have a preexisting chronic stable disease with anelevated risk for pneumococcal disease (eg, chronic cardiac disease, chronic
pulmonary disease, chronic hepatic disease, diabetes mellitus, and/or chronic renaldisorders).
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Final Full Clinical Study Report
Protocol B7471009

CLINICAL STUDY REPORT SYNOPSIS
Exclusion Criteria:
History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of 20vPnC, 13vPnC, or any other diphtheria
toxiod-containing vaccine or PPSV23.

Serious chronic disorder, including metastatic malignancy, severe COPD requiring
supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of theliver, clinically unstable cardiac disease, or any other disorder that, in the investigator’sopinion, excludes the participant from participating in the study.

Previous vaccination with any licensed or investigational pneumococcal vaccine, orplanned receipt through study participation.

Study Interventions, Dose, Mode of Administration, and Batch Number(s):Participants received either 20vPnC or 13vPnC (control vaccine) at Vaccination 1.
Participants who received 20vPnC at Vaccination 1 received saline at Vaccination 2.
Participants who received 13vPnC at Vaccination 1 received PPSV23 at Vaccination 2.
At Vaccination 1 (Visit 1), a 0.5-mL dose of 20vPnC or 13vPnC was administeredintramuscularly in the deltoid muscle of the nondominant arm by a blinded site staff member.
At Vaccination 2 (Visit 2), a 0.5-mL dose of saline or PPSV23 was prepared andadministered by third-party unblinded site staff member(s) and was administeredintramuscularly in the deltoid muscle of the nondominant arm to blinded participants.
The manufacturing lot numbers for the study interventions dispensed in this study areprovided in Table S2.
Table S2. Study Intervention Administered
Investigational Product
20vPnC
13vPnCPPSV23

Manufacturer
Pfizer
PfizerMerck & Co.,
IncVendor Lot
Number
DW1636
DN3806
T032855

Pfizer Lot
Numbera20-002030
20-001731
20-AE-00068

T038629
T032852
CW763321-AE-00071
21-AE-00164
19-004626

Placebo (0.9% Sodium Chloride for
PfizerInjection)
a. Lot number assigned to the investigational product by Pfizer Global Clinical Supply.
Protocol B7471009 Investigational Product Lot Numbers Table – Version 1.0, 10Nov2022.

Duration of Study Intervention:
Each participant was in the study for approximately 2 months.
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Final Full Clinical Study Report
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CLINICAL STUDY REPORT SYNOPSIS
Summary of Results:
Demographic and Other Baseline Characteristics:
A total of 1425 participants were randomized in the study to receive either 20vPnC/saline or
13vPnC/PPSV23, 1421 (99.7%) received Vaccination 1, 1394 (97.8%) received
Vaccination 2, and 1391 (97.6%) completed all visits in the study. Disposition was similar inthe 2 vaccine groups and the most common reason for withdrawal was “withdrawal byparticipant”.
The demographic characteristics and smoking history of the safety population were generally
similar in the 20vPnC/saline and 13vPnC/PPSV23 groups. There were 832, 349, and
240 participants in Japan, Korea, and Taiwan, respectively. There were more male thanfemale participants. The majority of the participants (59%) never smoked.
Immunogenicity Results:
The immune responses to all 13-matched vaccine serotypes induced by 20vPnC werenoninferior to those induced by 13vPnC.

The immune responses to 6 of the 7 additional vaccine serotypes induced by 20vPnC
were noninferior to those induced by PPSV23.

Serotype 8 narrowly missed the statistical NI criterion 1 month after 20vPnC. However,the serotype 8 immune response is expected to be similarly protective as the 19 vaccine
serotypes in 20vPnC that met NI, based on OPA GMT, GMFR, proportion of participants
with a ≥4-fold rise in OPA titers, and proportion of participants with OPA titers ≥ LLOQ.

Robust immune responses to all 20 vaccine serotypes 1 month after 20vPnC wereobserved in adults ≥60 years of age, based on OPA GMTs, GMFRs, proportions ofparticipants with a ≥4-fold-rise in OPA titers, and proportions of participants with OPAtiters ≥ LLOQ.

Immune responses to all 20 vaccine serotypes were increased after 20vPnC for each of
the 3 countries.

Safety Results:
The proportions of participants who reported prompted local reactions and systemic
events were similar in the 2 groups. Most local reactions and systemic events were mildor moderate in severity.

Rates of AEs within 1 month after 20vPnC or 13vPnC were similar in the 2 groups. Nosafety concerns were identified.

The proportions of participants reporting any SAEs were low and similar in the 2 groups.
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CLINICAL STUDY REPORT SYNOPSISNo SAEs were consideredrelated to 20vPnC in this study.
Conclusions:
20vPnC was observed to have a tolerability and safety profile similar to 13vPnC. Based on
the robust immune responses and comparability to licensed pneumococcal vaccines (13vPnC
and PPSV23) for applicable serotypes, these data support that 20vPnC will be protective
against pneumococcal disease due to the 20 serotypes in adults 60 years of age and older inJapan, Korea, and Taiwan.

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