A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS ≥18 YEARS OF AGE IN INDIA
Phase: PHASE3
Conditions: Pneumococcal Disease
Sponsor: Pfizer

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 1
A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY 
AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE 
VACCINE IN PNEUMOCOCCAL VACCINE–NAÏVE ADULTS ≥18 YEARS OF AGE 
IN INDIA
Study Intervention Number:
PF-06482077
Study Intervention Name:
20-valent Pneumococcal Conjugate Vaccine 
(20vPnC)
US IND Number:
N/A
EudraCT Number:
N/A
ClinicalTrials.gov ID:  
TBD
Protocol Number:
B7471010
Phase:
3
Brief Title: Safety and Immunogenicity Study of 20vPnC in Adults ≥18 Years of Age in 
India
This document and accompanying materials contain confidential information belonging to Pfizer. Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this 
information in confidence and not copy or disclose it to others (except where required by applicable law) or 
use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer 
must be promptly notified.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 2
Document History
Document
Version Date
Original protocol
08 Feb 2022
Protocol amendment 1
22 December 2022
Protocol Amendment Summary of Changes Table
Amendment 1 (22 December 2022)
Overall Rationale for the Amendment: This amendment was updated to clarify the number 
of participants from the immune cohort who will have blood samples collected and also to 
add the use of the data monitoring committee.
Section # and Name
Description of Change
Brief Rationale
Section 1.1 Synopsis
Section 1.2 Schema
Section 1.3 Schedule of 
Activities
Section 4.1 Overall design
•
Added that 
immunogenicity 
assessment refers to 
“pneumococcal 
serotype-specific OPA 
titers”
•
Further clarified which 
participants will have
blood draws and how 
many in total
•
Change made at request 
of the Indian BOH
Section 8.1
•
Further clarified which 
participants will have  
blood draws and how 
many in total
•
Change made at request 
of the Indian BOH
Section 8.9.1
•
Further clarified which 
participants will have 
blood draws and how 
many in total
•
Change made at request 
of the Indian BOH
Section 9.5 Sample Size 
Determination
•
Added descriptions of
the planned sample size 
for the secondary study 
objective on 
immunogenicity
•
Table 5 added
•
Change made at request 
of the Indian BOH
Section 10.1.5.1 Data 
Monitoring Committee
•
Added that a data 
monitoring committee 
will be used for the 
safety review
•
Added in anticipation 
that this will be required 
by the Indian BOH

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 3
TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................8
1. PROTOCOL SUMMARY.....................................................................................................9
1.1. Synopsis ....................................................................................................................9
1.2. Schema ....................................................................................................................11
1.3. Schedule of Activities .............................................................................................12
2. INTRODUCTION ...............................................................................................................13
2.1. Study Rationale .......................................................................................................16
2.2. Background .............................................................................................................17
2.2.1. Clinical Overview.......................................................................................17
2.3. Benefit/Risk Assessment.........................................................................................17
2.3.1. Risk Assessment.........................................................................................18
2.3.2. Benefit Assessment.....................................................................................19
2.3.3. Overall Benefit/Risk Conclusion................................................................19
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS ...........................................................19
4. STUDY DESIGN.................................................................................................................20
4.1. Overall Design.........................................................................................................20
4.2. Scientific Rationale for Study Design.....................................................................21
4.2.1. Choice of Contraception/Barrier Requirements .........................................21
4.3. Justification for Dose ..............................................................................................21
4.4. End of Study Definition ..........................................................................................22
5. STUDY POPULATION......................................................................................................22
5.1. Inclusion Criteria.....................................................................................................22
5.2. Exclusion Criteria....................................................................................................23
5.3. Lifestyle Considerations..........................................................................................24
5.3.1. Contraception..............................................................................................24
5.4. Screen Failures ........................................................................................................25
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................25
6.1. Study Intervention(s) Administered........................................................................25
6.1.1. Administration............................................................................................25
6.1.2. Medical Devices .........................................................................................26

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
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6.2. Preparation, Handling, Storage, and Accountability...............................................26
6.2.1. Preparation and Dispensing........................................................................27
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................27
6.3.1. Allocation to Study Intervention ................................................................27
6.4. Study Intervention Compliance...............................................................................28
6.5. Dose Modification...................................................................................................28
6.6. Continued Access to Study Intervention After the End of the Study......................28
6.7. Treatment of Overdose............................................................................................28
6.8. Concomitant Therapy..............................................................................................28
6.8.1. Prohibited During the Study.......................................................................28
6.8.2. Permitted During the Study ........................................................................29
6.9. Recording Prior and Concomitant Vaccines and Concomitant Treatments............29
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................29
7.1. Discontinuation of Study Intervention ....................................................................29
7.2. Participant Discontinuation/Withdrawal From the Study.......................................29
7.2.1. Withdrawal of Consent...............................................................................30
7.3. Lost to Follow-Up ...................................................................................................30
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................31
8.1. Efficacy and/or Immunogenicity Assessments .......................................................32
8.1.1. Biological Samples.....................................................................................32
8.2. Safety Assessments .................................................................................................32
8.2.1. Participant Electronic Diary .......................................................................33
8.2.2. Grading Scale for Prompted Events ...........................................................33
8.2.2.1. Local Reactions.........................................................................34
8.2.2.2. Systemic Events – Systemic Symptoms and Fever...................35
8.2.3. Physical Examinations................................................................................37
8.2.4. Clinical Safety Laboratory Assessments ....................................................37
8.2.5. Pregnancy Testing ......................................................................................37
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................37
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......38

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
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8.3.1.1. Reporting SAEs to Pfizer Safety...............................................39
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................39
8.3.2. Method of Detecting AEs and SAEs ..........................................................39
8.3.3. Follow-Up of AEs and SAEs......................................................................39
8.3.4. Regulatory Reporting Requirements for SAEs...........................................39
8.3.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................40
8.3.5.1. Exposure During Pregnancy......................................................40
8.3.5.2. Exposure During Breastfeeding ................................................42
8.3.5.3. Occupational Exposure .............................................................42
8.3.6. Cardiovascular and Death Events...............................................................42
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................43
8.3.8. Adverse Events of Special Interest.............................................................43
8.3.8.1. Lack of Efficacy........................................................................43
8.3.9. Medical Device Deficiencies......................................................................43
8.3.9.1. Time Period for Detecting Medical Device Deficiencies .........43
8.3.9.2. Follow-Up of Medical Device Deficiencies..............................43
8.3.9.3. Prompt Reporting of Device Deficiencies to the Sponsor ........44
8.3.9.4. Regulatory Reporting Requirements for Device 
Deficiencies .......................................................................................44
8.3.10. Medication Errors.....................................................................................44
8.4. Pharmacokinetics ....................................................................................................45
8.5. Genetics...................................................................................................................46
8.5.1. Specified Genetics ......................................................................................46
8.6. Biomarkers ..............................................................................................................46
8.7. Immunogenicity Assessments.................................................................................46
8.8. Health Economics ...................................................................................................46
8.9. Study Procedures.....................................................................................................46
8.9.1. Visit 1 (Vaccination – Day 1).....................................................................46
8.9.2. Visit 2 (28 to 42 Days After Visit 1 [Study Days 29 to 43])......................48
8.10. Unscheduled Visits................................................................................................49

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 6
9. STATISTICAL CONSIDERATIONS ................................................................................50
9.1. Statistical Hypotheses .............................................................................................50
9.1.1. Estimands....................................................................................................50
9.2. Analysis Sets ...........................................................................................................51
9.3. Statistical Analyses .................................................................................................51
9.3.1. General Considerations...............................................................................51
9.3.2. Analysis for Binary Data ............................................................................52
9.3.3. Analysis for Continuous Data.....................................................................52
9.3.3.1. Geometric Mean........................................................................52
9.3.3.2. Geometric Mean Fold Rise .......................................................52
...............................52
9.3.4. Primary Endpoint(s)/Estimand(s) Analysis ................................................53
9.3.5. Secondary Endpoint(s)/Estimand(s) Analysis............................................53
9.3.6. Exploratory Endpoint(s)/Estimand(s) Analysis..........................................53
9.4. Interim Analyses .....................................................................................................53
9.5. Sample Size Determination.....................................................................................54
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................56
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............56
10.1.1. Regulatory and Ethical Considerations ....................................................56
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................57
10.1.2. Financial Disclosure .................................................................................57
10.1.3. Informed Consent Process ........................................................................57
10.1.4. Data Protection .........................................................................................58
10.1.5. Committees Structure ...............................................................................58
10.1.5.1. Data Monitoring Committee ...................................................58
10.1.6. Dissemination of Clinical Study Data ......................................................59
10.1.7. Data Quality Assurance ............................................................................60
10.1.8. Source Documents....................................................................................61
10.1.9. Study and Site Start and Closure ..............................................................62
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
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10.1.10. Publication Policy...................................................................................63
10.1.11. Sponsor’s Qualified Medical Personnel .................................................63
10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting .....................................................................65
10.2.1. Definition of AE .......................................................................................65
10.2.2. Definition of an SAE ................................................................................66
10.2.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period............................................................................68
10.2.4. Reporting of SAEs....................................................................................71
10.3. Appendix 3: Contraceptive and Barrier Guidance ................................................73
10.3.1. Male Participant Reproductive Inclusion Criteria....................................73
10.3.2. Female Participant Reproductive Inclusion Criteria.................................73
10.3.3. Woman of Childbearing Potential ............................................................74
10.3.4. Contraception Methods.............................................................................75
10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments .......77
10.5. Appendix 5: AEs, ADEs, SAEs, SADEs, USADEs, and Device 
Deficiencies: Definitions and Procedures for Recording, Evaluating, 
Follow-Up, and Reporting in Medical Device Studies .............................................79
10.5.1. Definition of AE and ADE .......................................................................79
10.5.2. Definition of SAE, SADE, and USADE ..................................................79
10.5.3. Definition of Device Deficiency...............................................................80
10.5.4. Recording/Reporting and Follow-Up of Medical Device 
Deficiencies......................................................................................................80
10.5.5. Reporting of SAEs....................................................................................82
10.5.6. Reporting of SADEs.................................................................................82
10.6. Appendix 6: Alternative Measures During Public Emergencies ..........................83
10.6.1. Telehealth Visits.......................................................................................83
10.6.2. Adverse Events and Serious Adverse Events...........................................83
10.7. Appendix 7: Abbreviations ...................................................................................84
11. REFERENCES ..................................................................................................................87

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 8
LIST OF TABLES
Table 1.
Grading Scales for Local Reactions .........................................................34
Table 2.
Grading Scales for Systemic Events.........................................................36
Table 3.
Ranges for Fever.......................................................................................37
Table 4.
Probability of Observing at Least 1 Event................................................54
.........54
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
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1. PROTOCOL SUMMARY 
1.1. Synopsis 
Pfizer has developed a 20-valent pneumococcal conjugate vaccine (20vPnC) candidate to 
further expand protection against pneumococcal disease beyond that of the 13-valent 
pneumococcal conjugate vaccine (13vPnC).  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 as 13vPnC. Safety and 
immunogenicity data from Phase 1 through Phase 3 clinical development in adults found 
that 20vPnC induces robust responses to all 20 vaccine serotypes, with comparable immune 
responses and safety profile similar to 13vPnC.  An application for licensure for an adult 
indication was approved in the US in June 2021. Furthermore, applications for 20vPnC adult 
indication are currently under review by other regulatory agencies around the world, 
including the EMA, Health Canada, and TGA in Australia. The program is described in the 
20vPnC IB.
The purpose of this study is to describe the safety and immunogenicity of 20vPnC in adults 
≥18 years of age in India.
Brief Title:
Safety and Immunogenicity Study of 20vPnC in Adults ≥18 Years of Age in India.
Rationale
Objectives, Endpoints, and Estimands
Objectives
Endpoints
Estimands
Primary:
Safety
To describe the safety profile of 
20vPnC when administered to 
adults ≥18 years of age in India.
•
Prompted local reactions 
(redness, swelling, and 
pain at the injection site)
•
Prompted systemic 
events (fever, headache, 
fatigue, muscle pain, 
and joint pain)
•
AEs
•
SAEs
In participants receiving the single 
dose of study intervention and having 
safety follow-up after vaccination, the 
percentage of participants reporting
(by age cohort):
•
Prompted local reactions within 
7 days after vaccination 
•
Prompted systemic events within 
7 days after vaccination 
•
AEs within 1 month after 
vaccination
•
SAEs within 1 month after 
vaccination

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
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Objectives
Endpoints
Estimands
Secondary:
Immunogenicity
To describe the immune response to 
20vPnC.
Pneumococcal 
serotype-specific OPA titers
In participants in compliance with the 
key protocol criteria (evaluable 
participants) receiving 20vPnC
(by age cohort):
•
GMFR in OPA titers from before 
to 1 month after vaccination
Overall Design
This is a Phase 3, single-arm, multicenter study in which participants ≥18 years of age will 
receive a single intramuscular administration of 20vPnC. This study will be conducted in 
India.
Participants will be screened and approximately equally enrolled (~200 participants/cohort) 
into 2 cohorts by age, 18 to 49 years of age and ≥50 years of age.  After clinical assessments 
and confirmation of eligibility, blood may be drawn for immunogenicity assessments of 
pneumococcal serotype-specific OPA titers (blood will be drawn for approximately 25% 
of study participants with the first approximately 50 participants in each age cohort 
[18 to 49 years of age and ≥50 years of age] for a study total of approximately 
100 participants), and a single dose of 20vPnC will be administered at the initial visit. 
Participants will be observed for 30 minutes and instructed to complete an e-diary for 7 days 
following vaccination (Day 1 is the day of vaccination) and contact the investigator site for 
significant medical illness or e-diary events. The participants will return approximately
1 month later for a follow-up blood draw for immunogenicity assessments (if applicable), 
review of continued eligibility, and collection of safety information (AEs, SAEs, e-diary 
follow-up as needed).
After approximately 50 participants in each age cohort (18 to 49 years of age and ≥50 years 
of age, 100 total) have received vaccine, the approximately 150 subsequent participants in 
these 2 age cohorts will not have blood collected (at the initial and follow-up visits).  
Intervention Group and Duration
All participants will receive 20vPnC. Each participant will participate in the study for 
approximately 1 month. Based on an estimated enrollment timing, the study duration will be 
approximately 4 months.
Number of Participants
Approximately 400 participants will be vaccinated. Participants will be assigned to a cohort
by age: 18 to 49 years of age or ≥50 years of age (approximately 200 participants per age 
cohort).

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
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Data Monitoring Committee or Other Independent Oversight Committee: Yes
Statistical Methods
The study size is not based on any formal statistical hypothesis test. All statistical analyses 
will be descriptive. The primary safety objective will be evaluated by descriptive summary 
statistics for local reactions at the injection site, systemic events, AEs, and SAEs. For 
immunogenicity objectives, descriptive summary statistics will be provided for OPA 
GMFRs,
 
.
1.2. Schema
Four hundred (400) participants ≥18 years of age will be assigned into 1 of the 2 age cohorts 
(18 to 49 years of age and ≥50 years of age) at the time of enrollment. 
The first approximately 50 participants in the cohort that is 18 to 49 years of age and the first 
approximately 50 participants in the cohort that is ≥50 years of age (total of 100 participants)
will have blood drawn for OPA measurements.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
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1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures. Refer to the
STUDY ASSESSMENTS AND PROCEDURES section of the protocol for detailed 
information on each procedure and assessment required for compliance with the protocol.
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA 
table, in order to conduct evaluations or assessments required to protect the well-being of the 
participant.
Visit Number
1
2
Visit ID
Vaccination
Follow-Up 
Visit
Visit Window (Days)
Day 1
28 to 42 Days
After Visit 1
Visit Type
Clinic Visit
Clinic Visit
Obtain informed consent 
X
Assign participant number via IRT
X
Obtain demography and medical history data
X
Measure height and weight
X
Perform clinical assessmenta
X
Review prior vaccination history to confirm participants are naïve to 
pneumococcal vaccines 
X
Record concomitant nonstudy vaccinations and concomitant medications
used for treatment of SAEs
X
X
Obtain prevaccination oral temperature
X
Perform pregnancy test (if appropriate)
X
Contraception check (if appropriate)
X
Review inclusion and exclusion criteria
X
Obtain blood sample for immunogenicity assessment of OPA titers
(~30 mL)b
Xc
X
Administer study intervention 
X
Observe and record acute reactions for 30 minutes after 20vPnC 
administration 
X
Provide participant with an e-diary (device or application, if used), digital 
thermometer, and measuring device and instruct to collect prompted local 
reactions and systemic events for 7 days after vaccination 
X
Provide a participant contact card
X
Review e-diary data (daily is optimal during 7-day diary period)
X----------------------X

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
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Visit Number
1
2
Visit ID
Vaccination
Follow-Up 
Visit
Visit Window (Days)
Day 1
28 to 42 Days
After Visit 1
Visit Type
Clinic Visit
Clinic Visit
Review e-diary symptoms with participant and obtain stop dates where 
applicable
X
Collect e-diary or assist the participant to delete the application, if 
applicable
X
AEs and SAEs collection
X----------------------X
Abbreviation: IRT = interactive response technology
a.
Including, if indicated, a physical examination.
b.
Immunogenicity subset only: Blood will be drawn in the first approximately 50 participants in each age 
cohort (18 to 49 years of age and ≥50 years of age) for a study total of approximately 100 participants
(approximately 25% of all participants).
c.
Blood sample will be collected prior to vaccination.
2. INTRODUCTION
Indication of 20vPnC in India 
20vPnC is being developed in adults for active immunization for the prevention of 
pneumococcal disease (including pneumonia and invasive disease) caused by 
Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 
18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age or older.
Pneumococcal Disease
S pneumoniae are gram-positive encapsulated cocci that have been a leading cause of 
bacteremia, bacterial meningitis, pneumonia, and AOM and continue to be a major global 
public health concern.1,2,3 Serious pneumococcal disease may occur at any age; however, 
children <5 and adults ≥65 years of age are at particularly increased risk.4
Pneumococcal pneumonia is the most common clinical presentation of pneumococcal disease 
among adults. Adults with certain medical conditions are at highest risk for IPD. Conditions 
that place adults at highest risk for IPD include immunosuppressive conditions from disease 
or drugs, functional or anatomic asplenia, and renal disease. Other conditions that increase 
the risk of IPD in adults include chronic heart disease, lung disease (including asthma), liver 
disease, smoking cigarettes, alcoholism, CSF leak, and having a cochlear implant.5

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
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Several studies from India have documented the burden of pneumococcal disease, both IPD
and pneumonia, in the adult population >18 years of age.6,7 Across various studies that have 
identified the etiology of CAP in adults in India, S pneumoniae has been the most commonly
identified pathogen, accounting for about 32% to 55% of cases.8,9,10,11 Various Indian 
medical societies, such as the Indian Society of Nephrology, Indian Medical Association, 
Indian Chest Society, and Indian Association of Occupational Health, recommend 13vPnC 
for adults, including those in the 18 to 49 years of age group.12,13,14,15
The polysaccharide capsule has been identified as an important virulence factor for this 
pathogen. While more than 95 pneumococcal serotypes differentiated by their capsular 
polysaccharide composition have been identified, only a subset of serotypes is more 
commonly associated with severe disease.16,17 Anticapsular antibodies directed against the 
specific serotype bind to the capsule and promote complement-mediated opsonophagocytic 
killing and clearance of the organism.18 Pneumococcal disease can be prevented with
polysaccharide-based vaccines that induce antibody responses with functional 
(opsonophagocytic) activity and target the capsular serotypes responsible for disease.19
Vaccines to Prevent Pneumococcal Disease
Pneumococcal Polysaccharide Vaccines
Vaccines containing free polysaccharides have been licensed since the 1970s.  One such 
vaccine, PPSV23, has been licensed in the US since 1983.20,21  PPSV23 contains capsular 
polysaccharides for 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 
17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).  PPSV23 elicits a T-cell–independent immune 
response.  Unconjugated polysaccharide vaccines do not induce robust responses in certain 
populations (eg, immunocompromised persons, children <2 years of age), nor do they 
generate immunologic memory, so their protective effect wanes over 2 to 5 years.4,21,22,23  
Moreover, their ability to prevent nonbacteremic pneumonia and AOM is limited or 
lacking.19,23,24,25 They also do not have an impact on nasopharyngeal carriage and, therefore, 
do not afford herd protection.26  Another limitation is that in several studies, individuals 
vaccinated with pneumococcal polysaccharide vaccine had lower functional antibody 
responses following subsequent vaccination with either another dose of pneumococcal 
polysaccharide vaccine or a dose of pneumococcal conjugate vaccine, compared to the first 
dose of polysaccharide vaccine.27,28,29  Such “hyporesponsiveness” has been observed with 
other polysaccharide vaccines as well and raises concern regarding the quality of response 
after revaccination or natural exposure to an invading VT pneumococcus.30  Despite waning 
immunity, these concerns of hyporesponsiveness, as well as other factors, have led most 
recommending bodies to restrict PPSV23 to a single lifetime dose in adults ≥65 years of age 
and 1 to 2 doses in most other high-risk populations.30,31,32

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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Pneumococcal Polysaccharide Conjugate Vaccines
Pneumococcal conjugate vaccines contain polysaccharides that are covalently linked 
(conjugated) to an immunogenic protein.  This modification results in T-cell–dependent 
immune responses, which have been shown to be protective in young children, older adults, 
and populations with high-risk conditions.22,33  Prevenar® (7vPnC) was the first 
pneumococcal conjugate vaccine to be licensed (2000) and was indicated for prevention of 
pneumococcal disease in infants and young children on the basis of efficacy studies.  7vPnC 
contained capsular polysaccharide conjugates for 7 pneumococcal serotypes (4, 6B, 9V, 14, 
18C, 19F, and 23F), each covalently linked to CRM197, a nontoxic variant of diphtheria toxin.  
The 7vPnC components contained in a related pneumococcal conjugate vaccine were 
demonstrated to be efficacious against clinically/radiographically-defined pneumonia.34,35
Following the introduction of 7vPnC, a reduction of nasopharyngeal carriage and 
transmission has resulted in indirect herd effects, with a 92% reduction of 7vPnC VT IPD in 
older adults ≥65 years of age.36,37
Prevenar 13® (13vPnC) was developed to expand serotype coverage and was licensed in the 
US in 2010.  13vPnC includes the same S pneumoniae serotypes as 7vPnC and an additional 
6 polysaccharide conjugates for serotypes 1, 3, 5, 6A, 7F, and 19A.33,38,39 The vaccine was 
licensed for use in infants and young children based on comparisons of serotype-specific IgG 
to 7vPnC, with supportive data to demonstrate the functional activity of the immune 
responses. 13vPnC was subsequently licensed in adults based on an accelerated approval 
pathway demonstrating comparable serotype-specific OPA responses to PPSV23, followed 
by traditional approval based on demonstration of efficacy against VT CAP in
Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), a randomized
controlled study of adults ≥65 years of age.40 Prevention of nonbacteremic VT CAP in this 
older adult population was also demonstrated, and protection was observed through 4 years 
of follow-up.  This is notable given the lack of definitive data showing that PPSV23 prevents 
nonbacteremic disease in older adults, and the evidence that protection wanes significantly 
over time.21
13vPnC is now currently approved in India for the prevention of pneumonia and invasive 
disease caused by vaccine serotypes in adults 18 years of age and older.  This indication was 
based on global studies and clinical evaluation of 13vPnC in India, which found the vaccine
to be safe and immunogenic in the Indian population in adults ≥50 years of age.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
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Development of 20vPnC
The 20vPnC candidate is modeled after 7vPnC and 13vPnC.  20vPnC contains the 
polysaccharides of capsular serotypes present in 13vPnC and 7 new capsular polysaccharides 
(for serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F) individually conjugated to CRM197.  
The 7 additional serotypes were selected based on their relative prevalence as a cause of 
IPD, their generalized geographic distribution, and other factors that would support 
inclusion, such as the presence of antibiotic resistance (11A, 15B), association with 
outbreaks (8, 12F), and greater disease severity (eg, meningitis, mortality) (10A, 11A, 
and 22F).41,42,43,44,45,46,47,48,49,50,51,52,53,54 These 7 serotypes have a long-standing association 
with serious pneumococcal disease and are responsible for a substantial burden of remaining 
pneumococcal disease.  20vPnC is expected to eventually replace 13vPnC.
In Phase 1 and Phase 2 trials, 20vPnC was well tolerated, with no safety concerns, and 
induced immune responses to the pneumococcal serotypes in the vaccine. The Phase 3 
pivotal trial (B7471007) met its primary immunogenicity objectives and met the 
noninferiority criteria for all serotypes in common with licensed Prevenar 13 and 6 of the 
7 additional serotypes when compared PPSV23; 1 of the new 7 serotypes missed the 
noninferiority criteria by a small margin. Secondary immunogenicity objectives for adults 
18 to 59 years of age compared to those 60 to 64 years of age met the noninferiority criteria 
for all 20 serotypes.  The findings supported that protective antibodies against all 
20 serotypes were elicited by 20vPnC, and that protection against pneumococcal disease will 
be similar to 13vPnC.  The safety objectives were met in adults ≥18 years of age, 
demonstrating that the safety and tolerability of 20vPnC were comparable to 13vPnC.
Additionally, the Phase 3 program has demonstrated equivalence of immunogenicity among 
3 different lots of 20vPnC in a clinical lot consistency trial, and 20vPnC has acceptable 
safety and elicits immune responses to the 20 vaccine serotypes in adults previously 
vaccinated with pneumococcal vaccines.
Additional descriptions of the clinical trial results, epidemiology of the 7 serotypes, and the 
clinical (and nonclinical) program are described in the 20vPnC IB.
2.1. Study Rationale 
The purpose of the study is to describe the safety and immunogenicity of 20vPnC in adults 
≥18 years of age in India.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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2.2. Background 
20vPnC is being developed to further expand protection beyond 13vPnC against the global 
burden of vaccine-preventable pneumococcal disease in children and adults.  The clinical 
development program in adults has been generally modeled on the 13vPnC program.  The 
clinical program has supported approval in the US in June 2021, with applications under 
review by other regulatory agencies around the world, including the EMA, Health Canada, 
and TGA in Australia. Two Phase 1, 1 Phase 2, and 3 Phase 3 studies in adults were 
conducted to support the initial licensure of 20vPnC for an adult indication. These are all 
safety and immunogenicity studies. 
2.2.1. Clinical Overview
As noted above, data from Phase 1 and Phase 2 studies in adults 18 to 64 years of age, and
safety data from 3 Phase 3 adult studies have shown safety profiles consistent with other 
pneumococcal conjugate vaccines.  Immunogenicity data from the Phase 1 and Phase 2 adult 
studies showed that 20vPnC induced immune responses to all 20 vaccine serotypes and the 
pivotal Phase 3 studies demonstrated that 20vPnC induces OPA GMTs that are noninferior to 
13vPnC for the 13 matched serotypes and noninferior to PPSV23 for 6 of the 7 additional 
serotypes.  The remaining serotype demonstrated strong immune responses.  See the 
20vPnC IB for additional details.
2.3. Benefit/Risk Assessment
The safety profile of 20vPnC has been similar to 13vPnC, but AEs may be different with the 
investigational 20vPnC.  The safety profiles are expected to continue to be similar because 
20vPnC contains the same components and excipients as 13vPnC, along with the 
polysaccharide conjugates for 7 additional pneumococcal serotypes. To date, the most 
common AEs noted in adults after vaccination are primarily related to local reactions 
(injection site pain, redness, and swelling) and systemic events (fever, headache, fatigue, 
joint pain, and muscle pain).  See the 20vPnC IB for additional details.
As with any vaccine, an allergic reaction can occur.  The allergic reaction can vary from skin 
rash to swelling of the face or lips, wheezing, and/or shortness of breath.  A severe allergic 
reaction (anaphylactic shock, collapse, or shock-like state [hypotonic-hyporesponsive 
episode]) may also occur.  There may also be additional risks related to the vaccines 
administered in the study that are not known at this time.
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of 20vPnC may be found in the IB, which is the SRSD for this study.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
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2.3.1. Risk Assessment
Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s): Vaccination with 20vPnC 
The relevant key risks associated with 20vPnC 
include: local reactions (injection site pain, 
redness, and swelling); systemic events (fever,
headache, fatigue, joint pain, and muscle 
pain); and allergic reactions, including skin 
rash, face or lip swelling, wheezing, shortness 
of breath, or severe allergic reaction 
(eg, anaphylactic shock).
The risks are based on the 20vPnC IB.
Eligibility criteria have been selected to ensure that only appropriate 
participants are included in the study (see Section 5).
E-diary and AE data will be monitored by the investigator 
(or designee) and sponsor.
All study participants will be observed for 30 minutes after 
vaccination.
Study Procedures
Participants will be required to attend 
healthcare facilities during the global 
SARS-CoV-2 pandemic.
Without appropriate social distancing and 
PPE, there is a potential for increased 
exposure to SARS-CoV-2.
Pfizer will work with sites to ensure appropriate COVID-19 
prevention strategies.
There is the risk of fainting, and pain, 
swelling, bruising, and infection at the 
venipuncture site.
Venipuncture is required to collect 
immunogenicity data from participants.
Only qualified nurses, physicians, nurse practitioners, physician 
assistants, phlebotomists, or medical assistants certified or otherwise 
authorized to draw blood per the standards and procedures of the 
investigative site, as allowed by institutional, local, and country 
guidance, will be allowed to draw blood to minimize local 
complications.
Other: N/A

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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Final Protocol Amendment 1, 22 December 2022
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2.3.2. Benefit Assessment
20vPnC is anticipated to provide a benefit to a participant in the prevention of pneumonia 
and invasive disease caused by vaccine serotypes.
2.3.3. Overall Benefit/Risk Conclusion
Taking into account the measures to minimize risk to study participants, the potential risks 
identified in association with 20vPnC are justified by the anticipated benefits that may be 
afforded to participants.
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS
Objectives
Endpoints
Estimands
Primary:  
Safety
To describe the safety profile of 
20vPnC when administered to 
adults ≥18 years of age in India.
•
Prompted local reactions 
(redness, swelling, and pain at 
the injection site)
•
Prompted systemic events 
(fever, headache, fatigue, 
muscle pain, and joint pain)
•
AEs
•
SAEs
In participants receiving the single 
dose of study intervention and 
having safety follow-up after 
vaccination, the percentage of 
participants reporting (by age 
cohort):
•
Prompted local reactions 
within 7 days after vaccination 
•
Prompted systemic events 
within 7 days after vaccination
•
AEs within 1 month after 
vaccination
•
SAEs within 1 month after 
vaccination
Secondary:  
Immunogenicity
To describe the immune response 
to 20vPnC.
Pneumococcal serotype-specific 
OPA titers
In participants in compliance with 
the key protocol criteria 
(evaluable participants) receiving 
20vPnC (by age cohort):
•
GMFR in OPA titers from 
before vaccination to
1 month after vaccination

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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Final Protocol Amendment 1, 22 December 2022
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TMF Doc ID: 164.01
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Objectives
Endpoints
Estimands
Exploratory:
Immunogenicity
4. STUDY DESIGN
4.1. Overall Design
This Phase 3, single-arm, multicenter study will be conducted at investigator sites in India.  
The purpose of this study is to assess the safety and immunogenicity of 20vPnC in adults 
≥18 years of age.  The Schema and Schedule of Activities are found under Section 1
(Protocol Summary).
Approximately 400 eligible adults ≥18 years of age will be vaccinated with 20vPnC.
Blood samples will be taken from a subset of participants for immunogenicity assessment of
pneumococcal serotype-specific OPA titers.
At Visit 1, participants will be assessed for eligibility (including medical history).  If eligible, 
participants will be assigned into 2 cohorts by age (approximately 200 participants per 
cohort): 18 to 49 years of age and ≥50 years of age. The first 50 participants in each age 
cohort will be enrolled in the immunogenicity subset (with a study total of 100 participants). 
Participants in the immunogenicity subset will have blood drawn for immunogenicity 
assessments prior to vaccination (blood will be drawn in the first approximately 
50 participants in each age cohort [18 to 49 years of age and ≥50 years of age] for a study 
total of approximately 100 participants [approximately 25% of all participants]). The 
20vPnC will be prepared and administered by an appropriately qualified investigator site 
staff member. Participants will be observed for 30 minutes after vaccination, and any 
reactions occurring during that time will be recorded as AEs.
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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Final Protocol Amendment 1, 22 December 2022
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
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Participants will also receive an e-diary (device or mobile-device application), thermometer, 
and measuring device (caliper) at Visit 1 and will be instructed to record prompted local 
reactions (redness, swelling, and pain at the injection site) occurring at the 20vPnC injection 
site and prompted systemic events (fever, headache, fatigue, muscle pain, and joint pain) 
occurring within 7 days after vaccination (Days 1 through 7, where Day 1 is the day of 
vaccination) daily in the e-diary.  
AEs (nonserious AEs or SAEs) will be collected for each participant from the time informed 
consent is obtained through and including Visit 2.
At Visit 2 (28 to 42 days after Visit 1), participants will return to the investigator site for 
follow-up procedures.  Participants will be asked to provide information on any AEs 
(including nonserious AEs or SAEs) and on any needed e-diary follow-up.  Participants will 
also be asked for information on concomitant medications used to treat any SAEs and on any 
nonstudy vaccines they received since Visit 1.  Blood will be drawn for immunogenicity 
assessments from participants in the immunogenicity subset.
Each participant will participate in the study for approximately 1 month. Based on an 
estimated enrollment timing, the study duration will be approximately 4 months. 
In the case of extreme circumstances, such as natural disasters or a pandemic, visits for 
follow-up or procedures may need to be conducted through other means (eg, telephone, home 
visits).
4.2. Scientific Rationale for Study Design
The Phase 3 study described in this protocol will provide 20vPnC safety and immunogenicity 
data of 20vPnC in adults ≥18 years of age in India.
4.2.1. Choice of Contraception/Barrier Requirements 
Human reproductive safety data are not available for 20vPnC, but there is no suspicion of 
human teratogenicity based on the intended pharmacology of the compound. Therefore, the 
use of a highly effective method of contraception is required (see Section 10.3).
4.3. Justification for Dose
The 20vPnC candidate is modeled after 7vPnC and 13vPnC, and contains capsular 
polysaccharides from pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 
14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F individually conjugated to CRM197.  The vaccine 
formulation contains 2.2 μg of each saccharide, except for 4.4 μg of 6B, per 0.5-mL dose.  
In adults, administration of 1 dose of pneumococcal conjugate vaccine induces immune 
responses.  
For this product, the term “dose” refers to an injection of a vaccine.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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4.4. End of Study Definition
The end of the study is defined as the date of the last visit of the last participant in the study.
5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled. The 
following eligibility criteria are designed to select participants for whom participation in the 
study is considered appropriate. All relevant medical and nonmedical conditions should be 
taken into consideration when deciding whether a particular participant is suitable for this 
protocol.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. Male or female adults ≥18 years of age, at Visit 1.
•
Refer to Section 10.3 for reproductive criteria for male (Section 10.3.1) and 
female (Section 10.3.2) participants.
Type of Participant and Disease Characteristics:
2. Participants who are willing and able to comply with all scheduled visits, receipt of 
study intervention, lifestyle considerations, and other study procedures.
3. Female participant of childbearing potential or male participant who is able to father 
children and willing to use a highly effective method of contraception, as outlined in 
Section 10.3.4, for at least 28 days after the dose of study intervention; or female 
participant not of childbearing potential (defined in Section 10.3.3) or male 
participant not able to father children.
4. Participants who are determined by medical history, physical examination 
(if required), and clinical judgment of the investigator to be eligible for inclusion in 
the study.
Note: Participants with preexisting stable disease, defined as disease not requiring 
significant change in therapy or hospitalization for worsening disease during the 
12 weeks before enrollment, can be included.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
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Informed Consent:
5. Capable of giving signed informed consent as described in Section 10.1, which 
includes compliance with the requirements and restrictions listed in the ICD and in 
this protocol.
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of 20vPnC, or to any other diphtheria 
toxoid–containing vaccine.
2. History of microbiologically-proven invasive disease caused by S pneumoniae.
3. Known or suspected immune deficiency or suppression.
4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular injection.
5. Congenital, functional, or surgical asplenia.
6. Serious chronic disorder, including metastatic malignancy, severe COPD requiring 
supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the 
liver, clinically unstable cardiac disease, or any other disorder that in the 
investigator’s opinion would make the participant inappropriate for entry into the 
study.
7. Other medical or psychiatric condition including recent (within the past year) or 
active suicidal ideation/behavior or laboratory abnormality that may increase the risk 
of study participation or, in the investigator’s judgment, make the participant 
inappropriate for the study.
8. Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness 
within 48 hours before study intervention administration.
Prior/Concomitant Therapy:
9. Previous vaccination with any pneumococcal vaccine, or planned receipt of any 
pneumococcal vaccine through study participation.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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Final Protocol Amendment 1, 22 December 2022
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10. Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live 
vaccine within 28 days before study intervention administration.  The exception is 
recent vaccination of pandemic COVID-19 vaccine (>14 days prior to study 
enrollment is preferred).
11. Current treatment with immunosuppressive therapy, including cytotoxic agents or 
systemic corticosteroids, or planned receipt during the study. Participants should not 
be enrolled into the study until corticosteroid therapy has been discontinued for at 
least 28 days before study intervention administration. Inhaled/nebulized, 
intraarticular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.
12. Receipt of blood/plasma products or immunoglobulin within the 60 days before study 
intervention administration, or planned receipt during the study.
Prior/Concurrent Clinical Study Experience:
13. Participation in other studies involving investigational drugs, investigational vaccines 
(with the exception of vaccines authorized by the DCGI for pandemic use), or 
investigational devices within 28 days prior to study entry and/or during study 
participation. Participation in purely observational studies is acceptable.
Diagnostic Assessments:
Not applicable.
Other Exclusions:
14. Investigator site staff or Pfizer employees directly involved in the conduct of the 
study, site staff otherwise supervised by the investigator, and their respective family 
members.
5.3. Lifestyle Considerations
5.3.1. Contraception 
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected an appropriate method of contraception for the individual 
participant and his or her partner(s) from the permitted list of contraception methods 
(see Appendix 3: Contraceptive and Barrier Guidance, Section 10.3.4) and will confirm 
that the participant has been instructed in its consistent and correct use. At time points 
indicated in the SoA, the investigator or designee will inform the participant of the need 
to use highly effective contraception consistently and correctly and document the 
conversation and the participant’s affirmation in the participant’s chart (participants 
need to affirm their consistent and correct use of at least 1 of the selected methods of 
contraception) considering that their risk for pregnancy may have changed since the last visit.  

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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Final Protocol Amendment 1, 22 December 2022
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In addition, the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued or if pregnancy is known or suspected in the 
participant or partner.
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently assigned study intervention. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure participants to meet 
the CONSORT publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes demography, screen failure details, eligibility 
criteria, and any SAE.
Individuals who do not meet the criteria for participation in this study (screen failure) may 
not be rescreened. 
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, medical device(s), or study procedure(s) intended to be administered to a study 
participant according to the study protocol.
For the purposes of this protocol, study intervention refers to 20vPnC.
6.1. Study Intervention(s) Administered
20vPnC will be provided by the sponsor to the study sites.
20vPnC will be packed and labeled as investigational product in accordance with current 
guidelines and applicable local and legal regulatory requirements.  
20vPnC is a sterile liquid suspension formulation containing saccharides from pneumococcal 
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 
and 33F individually conjugated to CRM197.  The vaccine is formulated to contain 2.2 μg of 
each saccharide, except for 4.4 μg of 6B, per 0.5-mL dose.  The vaccine contains 5 mM 
succinate buffer, 150 mM sodium chloride, 0.02% polysorbate 80, and 125 μg aluminum as 
aluminum phosphate, per 0.5-mL dose.
20vPnC will be supplied to the site as packaged, single-use prefilled syringes.
6.1.1. Administration
20vPnC should be administered intramuscularly by injecting 0.5 mL into the deltoid muscle
of the non-dominant arm.
Any concomitant vaccines required by local recommendations and permitted by the protocol 
may be administered concomitantly with 20vPnC but must be given in a different limb.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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Standard vaccination practices must be observed, and vaccine must not be injected into blood 
vessels. Appropriate medication and other supportive measures for management of an acute 
hypersensitivity reaction should be available in accordance with local guidelines for standard 
immunization practices.
Administration of study interventions should be performed by an appropriately qualified, 
GCP-trained, and vaccine-experienced member of the study staff (eg, physician, nurse, 
physician’s assistant, nurse practitioner, pharmacist, or medical assistant) as allowed by 
local, state, and institutional guidance. 
Study intervention administration details will be recorded on the CRF.
6.1.2. Medical Devices
In this study, medical devices being deployed are the prefilled syringes containing 20vPnC.  
Instructions for medical device use are provided in the IP manual or in the package insert.
Medical device incidents, including those resulting from malfunctions of the device, must be 
detected, documented, and reported by the unblinded study personnel throughout the study.  
Please refer to Section 8.3.9 for details.
6.2. Preparation, Handling, Storage, and Accountability
1. 20vPnC will be shipped to the study site after required regulatory and legal documents 
have been received by the sponsor.  20vPnC will be shipped at +2°C to +8°C.  Upon 
receipt at the study site, the study intervention should be immediately transferred to a 
+2°C to +8°C temperature-monitored refrigerator for storage.  Study intervention must be 
stored in a horizontal orientation.
2. The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study interventions received and any discrepancies are 
reported and resolved before use of the study intervention. 
3. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention. All study interventions 
must be stored in a secure, environmentally controlled, and monitored (manual or 
automated recording) area in accordance with the labeled storage conditions with access 
limited to the investigator and authorized site staff. At a minimum, daily minimum and 
maximum temperatures for all site storage locations must be documented and available 
upon request. Data for nonworking days must indicate the minimum and maximum 
temperatures since previously documented for all site storage locations upon return to 
business.

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
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4. Any excursions from the study intervention label storage conditions should be reported to 
Pfizer upon discovery along with any actions taken. The site should actively pursue 
options for returning the study intervention to the storage conditions described in the 
labeling, as soon as possible. Once an excursion is identified, the study intervention must 
be quarantined and not used until Pfizer provides permission to use the study 
intervention. Specific details regarding the definition of an excursion and information the 
site should report for each excursion will be provided to the site in the IP manual or other 
specified location.
5. Any storage conditions stated in the SRSD will be superseded by the storage conditions 
stated on the label.
6. Study interventions should be stored in their original containers.
7. The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance 
(ie, receipt, reconciliation, and final disposition records), such as the IPAL or 
sponsor-approved equivalent. All study interventions will be accounted for using a study 
intervention accountability form/record.
8. Further guidance and information for the final disposition of unused study interventions 
are provided in the IP manual. All destruction must be adequately documented. 
If destruction is authorized to take place at the investigator site, the investigator must 
ensure that the materials are destroyed in compliance with applicable environmental 
regulations, institutional policy, and any special instructions provided by Pfizer.
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IP manual.
6.2.1. Preparation and Dispensing
See the IP manual for instructions on how to prepare the study intervention for 
administration.  Study intervention should be prepared and dispensed by an appropriately 
qualified and experienced member of the study staff (eg, physician, nurse, physician’s 
assistant, nurse practitioner, pharmacy assistant/technician, or pharmacist) as allowed by 
local, state, and institutional guidance.
6.3. Measures to Minimize Bias: Randomization and Blinding
6.3.1. Allocation to Study Intervention
This is a Phase 3 single-arm study.  All participants will receive 20vPnC.
The study intervention will be dispensed at the study visit summarized in the SoA.
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.

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6.4. Study Intervention Compliance
All doses of study intervention will be administered by the appropriately designated study 
staff at the investigator site.
6.5. Dose Modification
Not applicable.
6.6. Continued Access to Study Intervention After the End of the Study
No intervention will be provided to study participants at the end of their study participation.
6.7. Treatment of Overdose
For this study, more than 1 dose of study intervention within a 24-hour time period will be 
considered an overdose.
Pfizer does not recommend specific treatment for an overdose.
In the event of an overdose, the investigator should:
1. Contact the medical monitor within 24 hours.
2. Closely monitor the participant for any AEs/SAEs.
3. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF.
4. Overdose is reportable to Pfizer Safety only when associated with an SAE.
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant.
6.8. Concomitant Therapy
6.8.1. Prohibited During the Study
•
Receipt of any investigational vaccines, drugs, or medical devices is prohibited during 
study participation.
•
Receipt of nonstudy pneumococcal vaccine is prohibited during study participation.
•
Receipt of any other licensed nonstudy vaccine is prohibited during the study, unless 
medically necessary (see Section 6.8.2).
•
Receipt of blood/plasma products, immunoglobulins, monoclonal antibodies,
radiotherapy, and/or immunosuppressive therapy (including a ≥14-day course of systemic 
corticosteroids) is prohibited during study participation.

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6.8.2. Permitted During the Study
•
If medically necessary (eg, pandemic or outbreak with pandemic potential), licensed 
influenza or other pandemic vaccines may be given at any time (however, an interval of 
>14 days after study intervention administration is preferred).
•
Prescription and nonprescription medications, vitamins, minerals, and herbal remedies 
are permitted during participation in the study.
•
Inhaled/nebulized, topical (eg, skin, eyes, or ears), or localized injections of
corticosteroids (eg, intraarticular or intrabursal administration) are permitted during study 
participation.
6.9. Recording Prior and Concomitant Vaccines and Concomitant Treatments
The name and date of administration for all nonstudy vaccinations received from the time of 
signing of the ICD to Visit 2 will be collected and recorded in the CRF.
Medications taken to treat SAEs from the time of signing of the ICD to Visit 2 will be 
recorded in the CRF.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
Since this is a single-dose study, this section is not applicable.
7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at his/her own request. Reasons for 
discontinuation from the study include the following:
•
Refused further study procedures;
•
Lost to follow-up;
•
Death;
•
Study terminated by sponsor;
•
AE;
•
Physician decision;
•
Pregnancy;
•
Protocol deviation;

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•
Screen failure;
•
Withdrawal by participant;
•
Medication error without associated AE;
•
No longer meets eligibility criteria;
•
Other.
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly.
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations should be performed, and no 
additional data should be collected. The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.
7.2.1. Withdrawal of Consent 
Participants who request to discontinue receipt of study intervention will remain in the study 
and must continue to be followed for protocol-specified follow-up procedures. The only 
exception to this is when a participant specifically withdraws consent for any further contact 
with him or her or persons previously authorized by the participant to provide this 
information. Participants should notify the investigator in writing of the decision to 
withdraw consent from future follow-up, whenever possible. The withdrawal of consent 
should be explained in detail in the medical records by the investigator, as to whether the 
withdrawal is only from further receipt of study intervention or also from study procedures 
and/or postvaccination study follow-up, and entered on the appropriate CRF page. In the 
event that vital status (whether the participant is alive or dead) is being measured, publicly 
available information should be used to determine vital status only as appropriately directed 
in accordance with local law.
7.3. Lost to Follow-Up 
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site.
The following actions must be taken if a participant fails to attend a required study visit:
•
The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible. Counsel the participant on the importance of maintaining the 
assigned visit schedule, and ascertain whether the participant wishes to and/or should 
continue in the study;

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•
Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts should be documented 
in the participant’s medical record;
•
Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 
8. STUDY ASSESSMENTS AND PROCEDURES
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures.  
The date of birth will be collected to critically evaluate the immune response and safety 
profile by age.
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed.
Safety issues should be discussed with the sponsor immediately upon occurrence or 
awareness to determine whether the participant should continue or discontinue study 
intervention.
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct.
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to perform 
the test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.

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Immunogenicity subset only: The total blood sampling volume for individual participants 
in this study is approximately 60 mL. 
8.1. Efficacy and/or Immunogenicity Assessments
Blood samples (approximately 30 mL) will be collected from all participants in the 
immunogenicity subset (see definition in Section 8.9.1), which consists of the first 
approximately 50 participants enrolled into the 2 age groups (100 participants total, 
approximately 25% of all participants), at Visit 1 (prior to administration of 20vPnC) and at
Visit 2 (approximately 1 month after Visit 1) for OPA testing.
OPA titers to the 20vPnC serotypes will be measured in sera collected at Visits 1 and 2.
Sample collection, processing, storage, and shipping information can be found in the SRM or 
equivalent manual.
8.1.1. Biological Samples 
Serum samples will be used only for scientific research. Each sample will be labeled with a 
code so that the laboratory personnel testing the samples will not know the participant’s 
identity. Samples that remain after performing assays outlined in the protocol may be stored 
by Pfizer. Unless a time limitation is required by local regulations or ethical requirements, 
the samples will be stored for up to 15 years after the end of the study and then destroyed.
If allowed by the ICD, stored samples may be used for additional testing to better understand 
the immune responses to the vaccine(s) under study in this protocol, to inform the 
development of other products, and/or for vaccine-related assay work supporting vaccine 
programs. No testing of the participant’s genetic material will be performed. 
The participant may request that his or her samples, if still identifiable, be destroyed at any 
time; however, any data already collected from those samples will still be used for this 
research. The biological samples may be shared with other researchers as long as 
confidentiality is maintained and no testing of the participant’s genetic material is performed.
8.2. Safety Assessments
A clinical assessment, including medical history and measurement of oral temperature, will
be performed on all participants prior to vaccination at Visit 1 to determine participant 
eligibility and to establish a clinical baseline.  
Significant medical history and significant findings from any physical examination 
(if performed) will be recorded as medical history in the CRF. Temperature measurement 
prior to vaccination at Visit 1 will be documented and recorded in the CRF.
The participant will be observed for 30 minutes after study vaccination and any reactions 
occurring during that time will be recorded as AEs.

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Prompted e-diary events, including local reactions (redness, swelling, and pain at the 
injection site) at the site of the 20vPnC injection and systemic events (fever, headache, 
fatigue, muscle pain, and joint pain) that occur 7 days after vaccination (where Day 1 is the 
day of vaccination), are graded as described in Section 8.2.2.1 and Section 8.2.2.2.  
Furthermore, AEs, and SAEs (as defined in Section 10.2) will be collected and reported 
according to the processes in Section 8.3.
Planned time points for all safety assessments are provided in the SoA. Unscheduled clinical 
laboratory measurements may be obtained at any time during the study to assess any 
perceived safety issues.
8.2.1. Participant Electronic Diary
Participants will be asked to monitor and record local reactions and systemic events using an 
e-diary (in a provisioned device or an application on a personal device). This allows 
recording of these assessments only within a fixed time window, thus providing the accurate 
representation of the participant’s experience. Data reported in the e-diary will be transferred 
electronically to the e-diary vendor, where they will be available for review by investigators, 
their appropriately qualified designees, and sponsor staff at all times via an internet-based 
portal.  At intervals agreed to by the vendor and Pfizer, these data will be transferred 
electronically to Pfizer for analysis and reporting.
The daily e-diary data will not be captured in the CRF. However, if a participant is 
withdrawn because of prompted events reported in the e-diary, the event(s) should be 
recorded on the AE page of the CRF, regardless of whether the investigator considers the 
event(s) to be clinically significant.
The investigator or designee must obtain stop dates for any local reactions and specific 
systemic events that were ongoing on the last day that the e-diary was completed. The stop 
dates should be entered in the CRF. 
Investigators (or an appropriately qualified designee) are required to review the e-diary data 
online at frequent intervals (daily is optimal) to evaluate participant compliance and reported 
events as part of the ongoing safety review.
8.2.2. Grading Scale for Prompted Events
The grading scales used in this study to assess prompted events as described below are based 
on concepts outlined in the FDA CBER guidelines on toxicity grading scales for healthy 
adult volunteers enrolled in preventive vaccine clinical trials.55

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8.2.2.1. Local Reactions
For the first 7 days following each study vaccination (Days 1 through 7, where Day 1 is the 
day of vaccination), the participants will be asked to assess redness, swelling, and pain at the 
20vPnC injection site and to record the symptoms in the e-diary in the evening.  Redness and 
swelling will be measured and recorded in measuring device (caliper) units (range: 1 to 21) 
and then categorized during analysis as mild, moderate, or severe based on the grading scale 
in Table 1.  Measuring device units can be converted to centimeters according to the 
following scale: 1 measuring device unit = 0.5 cm.  Pain at the vaccine injection site will be 
assessed by the participant as mild, moderate, or severe according to the grading scale in 
Table 1.  The participant will be prompted to contact the investigator if he/she experiences a 
severe (Grade 3 or above) local reaction to assess the reaction and perform an unscheduled 
assessment or visit as appropriate.
Only an investigator is able to classify a participant’s local reaction as Grade 4, after physical 
examination of the participant or documentation from another medically qualified source 
(eg, emergency room or hospital record).  If a participant experiences a Grade 4 local 
reaction, the investigator must immediately notify the sponsor.  Site staff will educate the 
participants regarding signs and symptoms that would prompt site contact.  Grade 4 reactions 
will be collected as an AE on the CRF.  The event will be graded using the AE severity 
grading scale (Section 10.2).
The procedure for notification of the sponsor is provided in the ISF or equivalent.
Table 1.
Grading Scales for Local Reactions
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3a
Grade 4b
Redness
5 to 10 measuring 
device units
=
>2.0 to 5.0 cm
11 to 20 measuring
device units
=
>5.0 to 10.0 cm
>20 measuring 
device units
=
>10.0 cm
Necrosis or 
exfoliative 
dermatitis
Swelling
5 to 10 measuring 
device units
=
>2.0 to 5.0 cm
11 to 20 measuring 
device units
=
>5.0 to 10.0 cm
>20 measuring 
device units
=
>10.0 cm
Necrosis

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Table 1.
Grading Scales for Local Reactions
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3a
Grade 4b
Pain at injection 
site
Does not interfere 
with activity
Interferes with activity
Prevents daily 
activityc
Emergency room 
visit or 
hospitalization for 
severe injection site 
pain
Abbreviation: CRF = case report form.
Note: If the size of the redness and/or swelling falls between 2 measuring device units, the higher measuring 
device unit number will be recorded in the e-diary.
a.
Participants experiencing Grade 3 local reactions are required to contact the investigator site.  In the event 
that the participant does not call, the investigator will call the participant.
b.
Grade 4 assessment should be made by the investigator; Grade 4 local reactions will not be collected in 
the e-diary but will be collected as AEs on the CRF.  The severity of the local reaction should be graded 
using the AE severity grading scale in Section 10.2.
c.
Prevents daily activity, eg, results in missed days of work or is otherwise incapacitating.
8.2.2.2. Systemic Events – Systemic Symptoms and Fever
From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, 
participants will be asked to assess headache, fatigue, muscle pain, and joint pain and to 
record the symptoms in the e-diary in the evening.  The symptoms will be assessed by the 
participant as mild, moderate, or severe according to the grading scale in Table 2 below.  
Participants will also be instructed to contact site staff or the investigator if they experience 
any possible Grade 4 prompted systemic event (ie, emergency room visit or hospitalization 
for severe headache, severe fatigue, severe muscle pain, or severe joint pain) within 7 days 
after vaccination.  Study staff may also contact the participant to obtain additional 
information on Grade 3 events entered into the e-diary.
Only an investigator is able to classify a participant’s systemic event as Grade 4, after 
physical examination of the participant or documentation from another medically qualified 
source (eg, emergency room or hospital record) or telephone contact with the participant.  
If a participant experiences a Grade 4 systemic event, the investigator must immediately 
notify the sponsor.  Grade 4 events will be collected as AEs on the CRF. The event will be 
graded using the AE severity grading scale (See Section 10.2).
The procedure for notification of the sponsor is provided in the ISF or equivalent.

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Table 2.
Grading Scales for Systemic Events
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3a
Grade 4b
Fatigue (tiredness)
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe fatigue
Headache
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe headache
Muscle pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe muscle pain
Joint pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe joint pain
Abbreviation: CRF = case report form.
a.
Prevents daily routine activity, eg, results in missed days of work or is otherwise incapacitating; includes 
use of narcotics for analgesia.
b.
Grade 4 assessment should be made by the investigator; Grade 4 systemic events will not be collected in 
the e-diary but will be collected as AEs on the CRF.  The severity of the systemic event should be graded 
using the AE severity grading scale in Section 10.2.
8.2.2.2.1. Fever
In order to record information on fever, a digital thermometer will be given to the participant 
with instructions on how to measure oral temperature at home.  Temperature will be 
collected in the evening daily for 7 days following vaccination (Days 1 through 7, where 
Day 1 is the day of vaccination) and at any time during the 7 days that fever is suspected.  
Fever is defined as an oral temperature of ≥100.4°F (≥38.0°C).  The highest temperature for 
each day will be recorded in the e-diary.  In the event of a fever on Day 7, temperature will 
be collected daily until the fever has resolved (1 day of temperature <100.4°F [<38.0°C]) in 
order to collect a stop date in the CRF.  
Participants reporting a fever >39.0°C will be prompted to contact the study site.  Study staff 
may also contact the participant to obtain additional information if a temperature of >102.0°F 
(>38.9°C) is entered into the e-diary.
Temperature will be measured and recorded to 1 decimal place. Temperatures reported in 
degrees Fahrenheit will be programmatically converted to degrees Celsius for reporting.  
Fever will be grouped into ranges for the analysis according to Table 3.

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Table 3.
Ranges for Fever
≥38.0°C to 38.4°C
>38.4°C to 38.9°C
>38.9°C to 40.0°Ca
>40.0°C
Note: Fever is defined as a temperature of ≥38.0°C.
a.
Participants reporting a fever >39.0°C will be prompted to contact the study site.
8.2.3. Physical Examinations
A clinical assessment will be performed at Visit 1. If the clinical assessment indicates that a 
physical examination is necessary to comprehensively evaluate the participant, a physical 
examination will be performed.
Physical examination findings collected during the study will be considered source data and 
will not be required to be reported, unless otherwise noted. Any untoward physical 
examination findings that are identified during the active collection period and meet the 
definition of an AE or SAE (Section 10.2) must be reported according to the processes in
Section 8.3
8.2.4. Clinical Safety Laboratory Assessments
Clinical safety laboratory assessments will not be collected in this study. 
8.2.5. Pregnancy Testing
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least 
25 mIU/mL. Pregnancy tests will be performed in WOCBP at the times listed in the SoA, 
immediately before the administration of each vaccine dose. A negative pregnancy test result 
will be required prior to the participant’s receiving the study intervention. Pregnancy tests 
may also be repeated if requested by IRBs/ECs or if required by local regulations. In the 
case of a positive confirmed pregnancy after vaccination, the participant may remain in the 
study for safety follow-up.
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting
The definitions of an AE and an SAE can be found in Section 10.2.
The definitions of device-related safety events (ADEs and SADEs) can be found in
Section 10.5.  Device deficiencies are covered in Section 8.3.9.
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally 
authorized representative), or they may arise from clinical findings of the investigator or 
other healthcare providers (clinical signs, test results, etc.).

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The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study (see Section 7.1). 
During the active collection period as described in Section 8.3.1, each participant will be 
questioned about the occurrence of AEs in a nonleading manner.
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.
8.3.1. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before the participant’s participation in the study (ie, before undergoing 
any study-related procedure and/or receiving study intervention), through and including 
Visit 2. 
Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant permanently discontinues or temporarily discontinues study because of an AE 
or SAE, the AE or SAE must be recorded on the CRF and the SAE reported using the 
Vaccine SAE Reporting Form.
Investigators are not obligated to actively seek information on AEs or SAEs after the 
participant has concluded study participation. However, if the investigator learns of any 
SAE, including a death, at any time after a participant has completed the study, and he/she 
considers the event to be reasonably related to the study intervention, the investigator must 
promptly report the SAE to Pfizer using the Vaccine SAE Reporting Form.

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8.3.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the Vaccine SAE Reporting Form immediately 
upon awareness and under no circumstance should this exceed 24 hours, as indicated in
Section 10.2. The investigator will submit any updated SAE data to the sponsor within 
24 hours of it being available.
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF.
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant.
8.3.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Section 10.2.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.3.3. Follow-Up of AEs and SAEs
After the initial AE or SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is given in Section 10.2.
8.3.4. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
study intervention under clinical investigation are met.

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The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation.
The sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators, as necessary.
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements.
8.3.5. Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure
Environmental exposure occurs when a person not enrolled in the study as a participant 
receives unplanned direct contact with or exposure to the study intervention. Such exposure 
may or may not lead to the occurrence of an AE or SAE. Persons at risk for environmental 
exposure include healthcare providers, family members, and others who may be exposed. 
An environmental exposure may include exposure during pregnancy, exposure during 
breastfeeding, and occupational exposure.
Any such exposure to the study intervention under study is reportable to Pfizer Safety within 
24 hours of investigator awareness.
8.3.5.1. Exposure During Pregnancy
An EDP occurs if: 
•
A female participant is found to be pregnant while receiving or after discontinuing 
study intervention.
•
A male participant who is receiving or has discontinued study intervention exposes a 
female partner prior to or around the time of conception.
•
A female is found to be pregnant while being exposed or having been exposed to 
study intervention due to environmental exposure. Below are examples of 
environmental EDP: 
•
A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by eg, ingestion, inhalation, or skin 
contact.
•
A male family member or healthcare provider who has been exposed to the study 
intervention by eg, ingestion, inhalation, or skin contact then exposes his female 
partner prior to or around the time of conception.

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The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy). 
•
If EDP occurs in a participant or a participant’s partner, the investigator must report 
this information to Pfizer Safety on the Vaccine SAE Reporting Form and an EDP 
Supplemental Form, regardless of whether an SAE has occurred. Details of the 
pregnancy will be collected after the start of study intervention and until Visit 2.
•
If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the Vaccine SAE Reporting Form and EDP 
Supplemental Form. Since the exposure information does not pertain to the 
participant enrolled in the study, the information is not recorded on a CRF; however, 
a copy of the completed Vaccine SAE Reporting Form is maintained in the 
investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a live-born baby, a terminated fetus, an 
intrauterine fetal demise, or a neonatal death), the investigator should follow the procedures 
for reporting SAEs. 
Additional information about pregnancy outcomes that are reported to Pfizer Safety as SAEs 
follows: 
•
Spontaneous abortion including miscarriage and missed abortion;
•
Neonatal deaths that occur within 1 month of birth should be reported, without regard 
to causality, as SAEs. In addition, infant deaths after 1 month should be reported as 
SAEs when the investigator assesses the infant death as related or possibly related to 
exposure to the study intervention. 

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Additional information regarding the EDP may be requested by the sponsor. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays). In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner. The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.
8.3.5.2. Exposure During Breastfeeding
An exposure during breastfeeding occurs if: 
•
A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention.
•
A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure). An example of environmental 
exposure during breastfeeding is a female family member or healthcare provider who 
reports that she is breastfeeding after having been exposed to the study intervention
by eg, ingestion, inhalation, or skin contact.  
The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours 
of the investigator’s awareness, irrespective of whether an SAE has occurred. The 
information must be reported using the Vaccine SAE Reporting Form. When exposure 
during breastfeeding occurs in the setting of environmental exposure, the exposure 
information does not pertain to the participant enrolled in the study, so the information is not 
recorded on a CRF. However, a copy of the completed Vaccine SAE Reporting Form is 
maintained in the investigator site file.
An exposure during breastfeeding report is not created when a Pfizer drug specifically 
approved for use in breastfeeding women (eg, vitamins) is administered in accord with 
authorized use. However, if the infant experiences an SAE associated with such a drug, the 
SAE is reported together with the exposure during breastfeeding.
8.3.5.3. Occupational Exposure
The investigator must report any instance of occupational exposure to Pfizer Safety within 
24 hours of the investigator’s awareness using the Vaccine SAE Reporting Form, regardless 
of whether there is an associated SAE. Since the information about the occupational 
exposure does not pertain to a participant enrolled in the study, the information is not 
recorded on a CRF; however, a copy of the completed Vaccine SAE Reporting Form must be 
maintained in the investigator site file.
8.3.6. Cardiovascular and Death Events
Not applicable.

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8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable.
8.3.8. Adverse Events of Special Interest
Not applicable.
8.3.8.1. Lack of Efficacy
The investigator must report signs, symptoms, and/or clinical sequelae resulting from lack of 
efficacy. Lack of efficacy or failure of expected pharmacological action is reportable to 
Pfizer Safety only if associated with an SAE.  
8.3.9. Medical Device Deficiencies
Medical devices being provided for use in this study are the study intervention supplied in 
prefilled syringes. In order to fulfill regulatory reporting obligations worldwide, the 
investigator is responsible for the detection and documentation of events meeting the 
definitions of device deficiency that occur during the study with such devices.
The definition of a medical device deficiency can be found in Appendix 5.
Note: AEs and/or SAEs that are associated with a medical device deficiency will follow the 
same processes as other AEs or SAEs, as outlined in Section 8.3.1 through Section 8.3.4 and 
Appendix 2 of the protocol.
8.3.9.1. Time Period for Detecting Medical Device Deficiencies
Medical device deficiencies that result in an incident will be detected, documented, and 
reported during all periods of the study in which the medical device is used.
Importantly, reportable device deficiencies are not limited to problems with the device itself 
but also include incorrect or improper use of the device and even intentional misuse, etc. 
If the investigator learns of any device deficiency at any time after a participant has been 
discharged from the study, and such deficiency is considered reasonably related to a medical 
device provided for the study, the investigator will promptly notify the sponsor.
The method of documenting medical device deficiencies is provided in Section 10.5.
8.3.9.2. Follow-Up of Medical Device Deficiencies
Follow-up applies to all participants, including those who discontinue study intervention.
The investigator is responsible for ensuring that follow-up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the deficiency.

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New or updated information will be recorded on a follow-up form with all changes signed 
and dated by the investigator.
8.3.9.3. Prompt Reporting of Device Deficiencies to the Sponsor
When a device deficiency occurs: 
1. The investigator notifies the sponsor by eg, telephone, email within 1 business day of 
determining that the incident meets the protocol definition of a medical device 
deficiency.
2. The device deficiency must be recorded on the Medical Device Complaint form.
3. If an AE (either serious or non-serious) associated with the device deficiency occurs, 
then the AE must be entered into the AE section of the CRF.
4. If an SAE associated with the device deficiency is brought to the attention of the 
investigator, the investigator must immediately notify Pfizer Safety of the SAE 
(see Section 8.3.1.1). All relevant details related to the role of the device in the event 
must be included in the Vaccine SAE Reporting Form as outlined in Section 8.3.1.1
and Section 8.3.1.2
The sponsor will be the contact for the receipt of device deficiency information.
8.3.9.4. Regulatory Reporting Requirements for Device Deficiencies
The investigator will promptly report all device deficiencies occurring with any medical 
device provided for use in the study in order for the sponsor to fulfill the legal responsibility 
to notify appropriate regulatory authorities and other entities about certain safety information 
relating to medical devices being used in clinical studies.
The investigator, or responsible person according to local requirements (eg, the head of the 
medical institution), will comply with the applicable local regulatory requirements relating to 
the reporting of device deficiencies to the IRB/EC.
8.3.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Exposures to the study intervention under study may occur in clinical trial settings, such as 
medication errors.

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Safety Event
Recorded on the CRF
Reported on the Vaccine SAE 
Reporting Form to Pfizer Safety 
Within 24 Hours of Awareness
Medication errors 
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
Medication errors include:
•
Medication errors involving participant exposure to the study intervention;
•
Potential medication errors or uses outside of what is foreseen in the protocol that do 
or do not involve the study participant.
Other examples include, but are not limited to:
•
The administration of expired study intervention;
•
The administration of an incorrect study intervention;
•
The administration of an incorrect dosage;
•
The administration of study intervention that has undergone temperature excursion 
from the specified storage range, unless it is determined by the sponsor that the study 
intervention under question is acceptable for use.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
In the event of a medication dosing error, the sponsor should be notified within 24 hours.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a Vaccine SAE 
Reporting Form only when associated with an SAE.
8.4. Pharmacokinetics 
Pharmacokinetic parameters are not evaluated in this study. 

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8.5. Genetics
8.5.1. Specified Genetics
Genetics (specified analyses) are not evaluated in this study.
8.6. Biomarkers
Biomarkers are not evaluated in this study.
8.7. Immunogenicity Assessments
Immunogenicity assessments are described in Section 8.1.
8.8. Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
8.9. Study Procedures
The study procedures are summarized in the Schedule of Activities.  The day of vaccination 
is considered to be Day 1.  The timing of visit procedures (ie, prior to vaccination and after 
vaccination) must be maintained; however, there is flexibility in the order in which the 
procedures can be conducted at each visit.  The only exception is that at Visit 1, the ICD 
must be signed prior to the start of any study procedure, and the blood draw must occur 
before vaccination.
8.9.1. Visit 1 (Vaccination – Day 1)
Prior to vaccination:
•
Obtain a personally signed and dated ICD indicating that the participant has been 
informed of all pertinent aspects of the study before performing any study-specific 
procedures.
•
Assign a participant number via the IRT.
•
Obtain and record the participant’s demographic information (including date of birth, 
sex, race, and ethnicity).  The complete date of birth (ie, DD-MMM-YYYY) will be 
collected to critically evaluate the immune response and safety profile by age.
•
Obtain and record significant medical history, including the presence of chronic 
conditions (eg, diabetes, asthma, cardiac disease, COPD), and/or medical history of 
significance, such as relevant surgical procedures.

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•
Perform a clinical assessment. If the clinical assessment indicates that a physical
examination is necessary to comprehensively evaluate the participant, perform a 
physical examination and record any findings in the source documents and, if 
significant, record such findings on the medical history CRF.
•
Record nonstudy vaccinations as described in Section 6.9.
•
Review pneumococcal vaccine history; participants must be naïve to pneumococcal 
vaccines to be eligible for the study.
•
Measure height and weight.
•
If applicable, instruct the participant to use appropriate contraceptives until 28 days 
after administration of the last dose of study intervention, and document the 
conversation and the participant’s affirmation in the participant’s source document.
•
Perform urine pregnancy test (if appropriate).
•
Measure and record the participant’s oral temperature (°F/°C).
•
Ensure and document that all of the inclusion criteria and none of the exclusion 
criteria are met.
•
Obtain investigational product container number via the IRT.  This must be the last 
step before proceeding.  
•
Immunogenicity subset only (the first approximately 50 participants enrolled in 
the 18 to 49 years of age cohort and the first approximately 50 participants 
enrolled in the ≥50 years of age cohort will be included in this subset): Collect a 
blood sample of approximately 30 mL for immunogenicity assessments prior to 
vaccination.
Vaccination:
•
Administer a single 0.5-mL injection of 20vPnC into the deltoid muscle of the 
nondominant arm.
After vaccination: 
•
Site staff will observe the participant for 30 minutes after administration of 20vPnC 
for any immediate reactions.  
•
Record any AEs on the CRF and on the Vaccine SAE Reporting Form, as applicable
and as described in Section 8.3.  Record concomitant medications used to treat SAEs.

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•
Issue the participant a measuring device to measure 20vPnC injection site reactions 
and a digital thermometer and provide instructions on their use.
•
Issue the participant an e-diary (device or application) and provide instructions on its 
use and completion.  Ask the participant to complete the e-diary from Day 1 to Day 7, 
with Day 1 being the day of vaccination.
•
Ask the participant to contact the investigator site staff or investigator as soon as 
possible during the 7-day postvaccination period if the participant experienced any 
severe local reactions (eg, redness and/or swelling at the 20vPnC injection site 
measuring >20 measuring device units [>10 cm], or severe injection site pain 
[prevents daily activity]) to determine if the event requires further assessment by the 
investigator (refer to Section 8.10).
•
Ask the participant to contact the investigator site staff or the investigator as soon as
possible if they experience any possible Grade 4 prompted local reaction or systemic 
event within 7 days, after vaccination (refer to Section 8.10).
•
Ask the participant to contact the site staff or investigator immediately if any 
significant illness or medical event (eg, emergency room visit or hospitalization) 
occurs.
•
Provide the participant with the participant contact card containing the study and 
investigator information.
•
Inform the participant that they may be contacted by site staff to obtain additional 
information on reports of fever >102.0°F (>38.9°C) or Grade 3 events entered into 
the e-diary.
•
Remind the participant to use appropriate contraceptives until 28 days after 
vaccination, if applicable.
•
The investigator or an authorized designee completes the CRF and the source 
documents and updates the study intervention accountability records.
•
The investigator or appropriately qualified designee reviews the e-diary data online at 
frequent intervals (daily is optimal) for the 7 days (Day 1 is the day of vaccination) 
following vaccination to evaluate participant compliance and as part of the ongoing 
safety review.
8.9.2. Visit 2 (28 to 42 Days After Visit 1 [Study Days 29 to 43])
•
Record nonstudy vaccinations as described in Section 6.9.

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•
Collect the e-diary (if applicable) or assist the participant to remove the study 
application from his or her own personal device (if applicable).
•
Review the participant’s e-diary data.  Collect stop dates of any e-diary events 
(local reactions or systemic events) ongoing on the last day that the e-diary was 
completed and record stop dates in the CRF.
•
Determine if any SAEs or AEs have occurred since the previous visit, follow up on 
any previously reported events to determine the outcome (ie, record stop dates or 
confirm if they are still continuing), record as described in Section 8.3, and record 
concomitant medications used to treat SAEs.
•
Immunogenicity subset only: Collect a blood sample of approximately 30 mL for 
immunogenicity assessments.
•
The investigator or an authorized designee completes the CRF and the source 
documents.
8.10. Unscheduled Visits
If the participant reports redness or swelling at the 20vPnC injection site measuring 
>20 measuring device units (>10.0 cm), or severe injection site pain during the 7 days
following vaccination, a telephone contact must occur as soon as possible between the 
investigator or medically qualified designee and the participant to assess if an unscheduled 
investigator site visit is required.  A site visit should be scheduled as soon as possible to 
assess the extent of the injection site reaction unless any of the following is true:
•
The participant is unable to attend the unscheduled visit.
•
The reaction is no longer present at the time of the telephone contact.
•
The participant recorded an incorrect value in the e-diary (confirmation of an e-diary 
data entry error).
•
The PI or authorized designee determined it was not needed.
This telephone contact will be recorded in the participant’s source documentation and the 
CRF.
If the participant is unable to attend the unscheduled visit, or the PI or authorized designee 
determined it was not needed, any ongoing reactions must be assessed at the next study visit.
During the unscheduled visit, the reactions should be assessed by the investigator or a 
medically qualified member of the study staff, such as a study physician or a study nurse, as 
applicable to the investigator’s local practice, who will:

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•
Measure oral temperature (°F/°C).
•
Measure minimum and maximum diameters of redness (if present).
•
Measure minimum and maximum diameters of swelling (if present).
•
Assess injection site pain (if present) in accordance with the grades provided in 
Section 8.2.2.1.
•
Assess for other findings associated with the reaction and record on the AE page of 
the CRF, if appropriate.
The investigator or an authorized designee will complete the unscheduled visit assessment 
page of the CRF.
Participants will also be instructed to contact site staff or the investigator if they experience 
any possible Grade 4 prompted systemic event (ie, emergency room visit or hospitalization 
for headache, fatigue, muscle pain, or joint pain) or local reaction in the 20vPnC injection 
site (ie, necrosis, exfoliative dermatitis, or emergency room visit/hospitalization for injection 
site pain) within 7 days after vaccination.
Participants will be instructed to contact site staff or the investigator to report any significant 
illness, medical event, or hospitalization that occurs during the study period.  
The investigator site staff should determine if an unscheduled visit to further evaluate the 
event is warranted in all such cases.
Additionally, site staff may contact the participant to obtain additional information on fever 
>102.0°F (> 38.9°C) or Grade 3 events entered into the e-diary.
9. STATISTICAL CONSIDERATIONS
Methodology for summary and statistical analyses of the data collected in this study is 
described here and further detailed in a SAP, which will be maintained by the sponsor. 
The SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment.
9.1. Statistical Hypotheses
There is no statistical hypothesis planned for this study.
9.1.1. Estimands
The estimand corresponding to the primary safety objective is described in the table in 
Section 3. 

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In the evaluation of the primary safety objective, missing e-diary data will not be imputed. 
A partial AE start date (missing day, missing both month and day) will be imputed by 
assigning the earliest possible start date using all available information, such as the stop date 
of the AE and the vaccination date(s) from the same participant, following the Pfizer 
standard of handling incomplete AE start date. An AE with a completely missing start date 
is not allowed in the data collection. No other missing information will be imputed in the 
safety analysis.
The estimand to evaluate the immunogenicity objective will be based on the specified
evaluable immunogenicity population.  This estimand estimates the vaccine effect in the 
hypothetical setting where participants follow the study schedules and protocol requirements 
as directed. Missing serology results will not be imputed. Immunogenicity results that are 
below the LLOQ will be set to 0.5 × LLOQ in the analysis.
9.2. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Participant Analysis Set
Description
Enrolled in the study
All participants who signed an ICD.
Assigned to study 
intervention 
All participants who are assigned an enrollment number in the 
IWR system.
Safety 
All participants who receive any study intervention and have 
safety data assessed after vaccination.
Evaluable immunogenicity
All randomized participants in the immunogenicity subset who 
receive 1 dose of the study intervention with at least 
1 valid immunogenicity result from the blood sample 
collection within an appropriate window 1 month after
vaccination and have no other major protocol deviations as 
determined by the clinician. 
9.3. Statistical Analyses
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data.
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints.
9.3.1. General Considerations
CIs for all endpoints will be presented as 2-sided at the 95% level unless specified otherwise.
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All safety analyses will be performed using the safety analysis set for the entire study cohort.
For all the immunogenicity endpoints, the analysis will be primarily based on the evaluable 
immunogenicity population.  
 
 
All safety and immunogenicity results will also be summarized separately for each age 
cohort and all participants.
9.3.2. Analysis for Binary Data 
Descriptive statistics for categorical variables (eg, proportions) are the percentage (%), the 
numerator (n), and the denominator (N) used in the percentage calculation, and the 2-sided 
95% CIs where applicable. The exact 95% CI for binary endpoints will be computed using 
the F distribution (Clopper-Pearson). 
9.3.3. Analysis for Continuous Data
Unless otherwise stated, descriptive statistics for continuous variables are n, mean, median, 
standard deviation, minimum, and maximum. 
9.3.3.1. Geometric Mean
The geometric mean for each vaccine group will be calculated as the mean of the 
logarithmically transformed assay results and then exponentiating the mean.  The 2-sided 
95% CI will be obtained by exponentiating the limits of the CI for the mean of the 
logarithmically transformed assay results based on Student’s t-distribution.
9.3.3.2. Geometric Mean Fold Rise
The GMFR for each vaccine group is defined as the geometric mean of the fold rise in the 
assay results from the specified time points. Only data from participants with nonmissing 
assay results at both time points will be included in the GMFR calculation.
GMFR will be calculated as the mean difference of the logarithmically transformed assay 
results (time point after vaccination - before vaccination) and exponentiating the mean 
difference. The 2-sided 95% CI will be obtained by exponentiating the limits of the CI for 
the mean difference of the logarithmically transformed assay results based on Student’s 
t-distribution.
 
 
CCI
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9.3.4. Primary Endpoint(s)/Estimand(s) Analysis
Objectives
Endpoint and Estimand
Statistics 
Safety
•
Proportions of participants (by age cohort) with 
local reactions (redness, swelling, and pain at 
the injection site) within 7 days after 
vaccination.
•
Proportions of participants (by age cohort) with 
systemic events (fever, headache, fatigue, 
muscle pain, and joint pain) within 7 days after 
vaccination.
Descriptive summary statistics for 
participants with each local 
reaction/systemic event by 
intensity level.
•
Proportions of participants (by age cohort) with 
AEs within 1 month after vaccination.
Descriptive summary statistics.
•
Proportions of participants (by age cohort) with 
SAEs within 1 month after vaccination.
Descriptive summary statistics.
9.3.5. Secondary Endpoint(s)/Estimand(s) Analysis
Objectives
Endpoint and Estimand
Statistics 
Immunogenicity
GMFR in pneumococcal serotype-specific OPA 
titers from before to 1 month after vaccination
(by age cohort).
GMFR and 2-sided 95% CI.
9.3.6. Exploratory Endpoint(s)/Estimand(s) Analysis
9.4. Interim Analyses
No formal interim analysis is planned for this study.  
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9.5. Sample Size Determination
The study size is not based on any formal statistical hypothesis test. Approximately
400 eligible adults ≥18 years of age will be vaccinated with 20vPnC. With 400 vaccinated 
participants, the probabilities of observing at least 1 AE, local reaction, or systemic event 
when the true rate is 0.5%, 1%, and 5% are presented in Table 4 below. 
Table 4.
Probability of Observing at Least 1 Event
True Event Rate
Probability of Observing at Least 1 Event
N=200
N=400
0.5%
63.3%
86.5%
1%
86.6%
98.2%
5%
>99.9%
>99.9%
Additionally, a subset of approximately 100 participants will participate in the 
immunogenicity assessment of pneumococcal serotype-specific OPA titers (blood will 
be drawn for approximately 25% of study participants with the first approximately 
50 participants in each age cohort (18 to 49 years of age and ≥50 years of age).
 
The study has a greater than 99% probability to 
show higher 
 compared to 
before vaccination (defined by LB of the 2-sided 95% CI for GMFR >1) for all 20 serotypes. 
CCI
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With 50 participants in each age cohort, the probability of showing a greater than 2-fold 
increase in 
, compared to before 
vaccination for all serotypes, will be >99%.
CCI
CCI

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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:
•
Consensus ethical principles derived from international guidelines, including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines;
•
Applicable ICH GCP guidelines;
•
Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor, submitted to an IRB/EC 
by the investigator, and reviewed and approved by the IRB/EC before the study is initiated.
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard to 
study participants.
The investigator will be responsible for the following:
•
Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC;
•
Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures;
•
Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH GCP guidelines, the IRB/EC, European regulation 
536/2014 for clinical studies (if applicable), European Medical Device Regulation 
2017/745 for clinical device research (if applicable), and all other applicable local 
regulations.

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10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately. 
In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of the ICH GCP guidelines that the investigator 
becomes aware of.
10.1.2. Financial Disclosure
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or his/her representative will explain the nature of the study, including the 
risks and benefits, to the participant and answer all questions regarding the study. The 
participant should be given sufficient time and opportunity to ask questions and to decide 
whether or not to participate in the trial.
Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH guidelines, privacy and data protection requirements, where 
applicable, and the IRB/EC or study center.
The investigator must ensure that each study participant is fully informed about the nature 
and objectives of the study, the sharing of data related to the study, and possible risks 
associated with participation, including the risks associated with the processing of the 
participant’s personal data. 
The participant must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities.

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The investigator further must ensure that each study participant is fully informed about his or 
her right to access and correct his or her personal data and to withdraw consent for the 
processing of his or her personal data.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date on which the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICD.
Participants must be reconsented to the most current version of the ICD(s) during their 
participation in the study.
A copy of the ICD(s) must be provided to the participant.
10.1.4. Data Protection
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data.
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password-protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible 
for determining whether a personal data breach has in fact occurred and, if so, providing 
breach notifications as required by law.
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to his or her actual identity and medical record ID. In case of 
data transfer, the sponsor will protect the confidentiality of participants’ personal data 
consistent with the clinical study agreement and applicable privacy laws.
10.1.5. Committees Structure
10.1.5.1. Data Monitoring Committee 
This study will use an EDMC. The EDMC is independent of the study team and includes 
only external members. The EDMC charter describes the role of the EDMC in more detail.

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The EDMC will be responsible for ongoing monitoring of the safety of participants in the 
study according to the charter. The recommendations made by the EDMC will be forwarded 
to the appropriate authorized Pfizer personnel for review and final decision. Pfizer will 
communicate such decisions, which may include summaries of aggregate analyses of safety 
data, to regulatory authorities and investigators as appropriate.
10.1.6. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT, and/or 
www.pfizer.com, and other public registries in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs.
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted. These results are 
submitted for posting in accordance with the format and timelines set forth by US law.
EudraCT
Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies in 
accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used 
to identify individual participants have been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are
posted to www.clinicaltrials.gov.
Documents within marketing authorization packages/submissions
Pfizer complies with the European Union Policy 0070, the proactive publication of clinical 
data to the EMA website. Clinical data, under Phase 1 of this policy, includes clinical 
overviews, clinical summaries, CSRs, and appendices containing the protocol and protocol 
amendments, sample CRFs, and statistical methods. Clinical data, under Phase 2 of this 
policy, includes the publishing of individual participant data. Policy 0070 applies to new 
marketing authorization applications submitted via the centralized procedure since 

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01 January 2015 and applications for line extensions and for new indications submitted via 
the centralized procedure since 01 July 2015.
Data sharing
Pfizer provides researchers secure access to patient-level data or full CSRs for the purposes 
of “bona-fide scientific research” that contributes to the scientific understanding of the 
disease, target, or compound class. Pfizer will make data from these trials available 
24 months after study completion. Patient-level data will be anonymized in accordance with 
applicable privacy laws and regulations. CSRs will have personally identifiable information 
redacted.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.7. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document.
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password-protected or secured in a locked room to 
prevent access by unauthorized third parties.
QTLs are predefined parameters that are monitored during the study. Important deviations 
from the QTLs and any remedial actions taken will be summarized in the clinical study 
report.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents. This 
verification may also occur after study completion. It is important that the investigator(s) 
and their relevant personnel are available during the monitoring visits and possible audits or 
inspections and that sufficient time is devoted to the process.

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Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques 
(central, virtual, or on-site monitoring), are provided in the data management plan and 
monitoring plan maintained and utilized by the sponsor or designee.
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data.
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained.
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems.
The investigator(s) will notify the sponsor or its agents immediately of any regulatory retain 
notification in relation to the study. Furthermore, the investigator will cooperate with the 
sponsor or its agents to prepare the investigator site for the inspection and will allow the 
sponsor or its agent, whenever feasible, to be present during the inspection. The investigator 
site and investigator will promptly resolve any discrepancies that are identified between the 
study data and the participant's medical records. The investigator will promptly provide 
copies of the inspection findings to the sponsor or its agent. Before response submission to 
the regulatory authorities, the investigator will provide the sponsor or its agents with an 
opportunity to review and comment on responses to any such findings.
10.1.8. Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator site.
Data reported on the CRF or entered in the eCRF that are from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available.
Definition of what constitutes source data and its origin can be found in the Study 
Monitoring Plan, which is maintained by the sponsor.

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Description of the use of the computerized system is documented in the Data Management 
Plan, which is maintained by the sponsor.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP guidelines, and all applicable regulatory requirements.
10.1.9. Study and Site Start and Closure
The study start date is the date on which the clinical study will be open for recruitment of 
participants.
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date.
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon 
study completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time upon notification to the sponsor 
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:
•
Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor's procedures, or the ICH GCP 
guidelines;
•
Inadequate recruitment of participants by the investigator;
•
Discontinuation of further study intervention development.
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.

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Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights.
10.1.10. Publication Policy
The results of this study may be published or presented at scientific meetings by the 
investigator after publication of the overall study results or 1 year after the end of the study 
(or study termination), whichever comes first. 
The investigator agrees to refer to the primary publication in any subsequent publications,
such as secondary manuscripts, and submits all manuscripts or abstracts to the sponsor 
30 days before submission. This allows the sponsor to protect proprietary information 
and to provide comments, and the investigator will, on request, remove any previously 
undisclosed confidential information before disclosure, except for any study- or Pfizer 
intervention–related information necessary for the appropriate scientific presentation or 
understanding of the study results.
For all publications relating to the study, the investigator will comply with recognized ethical 
standards concerning publications and authorship, including those established by the 
International Committee of Medical Journal Editors.
The sponsor will comply with the requirements for publication of the overall study results 
covering all investigator sites. In accordance with standard editorial and ethical practice, the 
sponsor will support publication of multicenter studies only in their entirety and not as 
individual site data. In this case, a coordinating investigator will be designated by mutual 
agreement.
Authorship of publications for the overall study results will be determined by mutual 
agreement and in line with International Committee of Medical Journal Editors authorship 
requirements. 
If publication is addressed in the clinical study agreement, the publication policy set out in 
this section will not apply.
10.1.11. Sponsor’s Qualified Medical Personnel
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the supporting study 
documentation/study portal or other electronic system. 
To facilitate access to appropriately qualified medical personnel for study-related medical 
questions or problems, participants are provided with an Emergency Contact Card (ECC) at 
the time of informed consent. The ECC contains, at a minimum, (a) protocol and study 
intervention identifiers, (b) participant’s study identification number, (c) site emergency 
phone number active 24 hours/day, 7 days per week, and (d) Pfizer Call Center number.

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The ECC is intended to augment, not replace, the established communication pathways 
between the investigator, site staff, and study team. The ECC is to be used by healthcare 
professionals not involved in the research study only, as a means of reaching the investigator 
or site staff related to the care of a participant. The Pfizer Call Center number should only be 
used when the investigator and site staff cannot be reached. The Pfizer Call Center number 
is not intended for use by the participant directly; if a participant calls that number directly, 
he or she will be directed back to the investigator site.

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10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting
10.2.1. Definition of AE
AE Definition
•
An AE is any untoward medical occurrence in a patient or clinical study participant, 
temporally associated with the use of study intervention, whether or not considered 
related to the study intervention.
•
Note: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study intervention.
Events Meeting the AE Definition
•
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator. Any abnormal laboratory test 
results that meet any of the conditions below must be recorded as an AE:
•
Is associated with accompanying symptoms.
•
Requires additional diagnostic testing or medical/surgical intervention.
•
Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional concomitant 
drug treatment, or other therapy.
•
Exacerbation of a chronic or intermittent preexisting condition, including either an 
increase in frequency and/or intensity of the condition.
•
New condition detected or diagnosed after study intervention administration, even 
though it may have been present before the start of the study.
•
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.
•
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported 
as an AE or SAE unless it is an intentional overdose taken with possible 
suicidal/self-harming intent. Such overdoses should be reported regardless of sequelae.

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Events NOT Meeting the AE Definition
•
Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.
•
The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the participant’s 
condition.
•
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads 
to the procedure is the AE.
•
Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
•
Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present or 
detected at the start of the study that do not worsen.
10.2.2. Definition of an SAE
An SAE is defined as any untoward medical occurrence that, at any dose, meets one 
or more of the criteria listed below:
a. Results in death
b. Is life-threatening
The term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event 
that hypothetically might have caused death if it were more severe.
c.
Requires inpatient hospitalization or prolongation of existing hospitalization
In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious.

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Hospitalization for elective treatment of a preexisting condition that did not worsen 
from baseline is not considered an AE.
d. Results in persistent or significant disability/incapacity
•
The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.
•
This definition is not intended to include experiences of relatively minor medical 
significance, such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle), that may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Is a suspected transmission via a Pfizer product of an infectious agent, pathogenic 
or non-pathogenic, is considered serious 
The event may be suspected from clinical symptoms or laboratory findings indicating 
an infection in a participant exposed to a Pfizer product. The terms “suspected 
transmission” and “transmission” are considered synonymous. These cases are 
considered unexpected and handled as serious expedited cases by pharmacovigilance 
personnel. Such cases are also considered for reporting as product defects, if 
appropriate.
g. Other situations:
•
Medical or scientific judgment should be exercised by the investigator in deciding 
whether SAE reporting is appropriate in other situations, such as significant
medical events that may jeopardize the participant or may require medical or 
surgical intervention to prevent one of the other outcomes listed in the above 
definition. These events should usually be considered serious.
•
Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse.

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10.2.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During the Active 
Collection Period 
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording AEs on the CRF and for 
reporting SAEs on the Vaccine SAE Reporting Form to Pfizer Safety throughout the active 
collection period. These requirements are delineated for 3 types of events: (1) SAEs; 
(2) nonserious AEs; and (3) exposure to the study intervention under study during 
pregnancy or breastfeeding, and occupational exposure. 
It should be noted that the Vaccine SAE Reporting Form for reporting of SAE information 
is not the same as the AE page of the CRF. When the same data are collected, the forms 
must be completed in a consistent manner. AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the Vaccine SAE 
Reporting Form for reporting of SAE information.
Safety Event
Recorded on the CRF
Reported on the Vaccine 
SAE Reporting Form to
Pfizer Safety Within 24 
Hours of Awareness
SAE
All
All
Nonserious AE
All
None
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding.
All AEs or SAEs associated 
with exposure during 
pregnancy or breastfeeding.
Note: Instances of EDP or 
EDB not associated with an 
AE or SAE are not captured 
in the CRF.
All instances of EDP are 
reported (whether or not 
there is an associated 
SAE).*
All instances of EDB are 
reported (whether or not 
there is an associated 
SAE).**
Environmental or 
occupational exposure to 
the product under study to 
a non-participant (not 
involving EDP or EDB).
None.  Exposure to a study 
non-participant is not 
collected on the CRF.
The exposure (whether or 
not there is an associated 
AE or SAE) must be 
reported.***
*
EDP (with or without an associated AE or SAE): any pregnancy information is reported to Pfizer 
Safety using the Vaccine SAE Reporting Form and EDP Supplemental Form; if the EDP is 
associated with an SAE, then the SAE is reported to Pfizer Safety using the Vaccine SAE Reporting 
Form. 
** EDB is reported to Pfizer Safety using the Vaccine SAE Reporting Form, which would also include 
details of any SAE that might be associated with the EDB. 
*** Environmental or occupational exposure: AEs or SAEs associated with occupational exposure are 
reported to Pfizer Safety using the Vaccine SAE Reporting Form. 

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•
When an AE or SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostic reports) 
related to the event.
•
The investigator will then record all relevant AE or SAE information in the CRF.
•
It is not acceptable for the investigator to send photocopies of the participant’s medical 
records to Pfizer Safety in lieu of completion of the Vaccine SAE Reporting Form/AE
or SAE CRF page.
•
There may be instances when copies of medical records for certain cases are requested 
by Pfizer Safety. In this case, all participant identifiers, with the exception of the 
participant number, will be redacted on the copies of the medical records before 
submission to Pfizer Safety.
•
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis 
(not the individual signs/symptoms) will be documented as the AE or SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the following categories: 
•
Mild: Asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated.
•
Moderate: Minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental ADL. Instrumental ADL refers to preparing meals, 
shopping for groceries or clothes, using the telephone, managing money, etc.  
•
Severe: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling, limiting self 
care ADL. Self care ADL refers to bathing, dressing and undressing, feeding self, 
using the toilet, taking medications, and not bedridden.  
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe.
GRADE 
If required on the AE page of the CRF, the investigator will use the 
adjectives MILD, MODERATE, SEVERE to describe the 
maximum intensity of the AE. For purposes of consistency, these 
intensity grades are defined as follows:
1
MILD
Does not interfere with participant's 
usual function.
2
MODERATE
Interferes to some extent with 
participant's usual function.

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3
SEVERE
Interferes significantly with 
participant's usual function.
Assessment of Causality
•
The investigator is obligated to assess the relationship between study intervention and 
each occurrence of each AE or SAE. The investigator will use clinical judgment to 
determine the relationship.
•
A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot be 
ruled out.
•
Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention 
administration, will be considered and investigated.
•
The investigator will also consult the IB and/or product information, for marketed 
products, in his/her assessment.
•
For each AE or SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE or SAE and has provided an assessment of causality.
•
There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is very 
important that the investigator always make an assessment of causality for every 
event before the initial transmission of the SAE data to the sponsor.
•
The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality assessment.
•
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.
•
If the investigator does not know whether or not the study intervention caused the
event, then the event will be handled as “related to study intervention” for reporting 
purposes, as defined by the sponsor. In addition, if the investigator determines that an 
SAE is associated with study procedures, the investigator must record this causal 
relationship in the source documents and CRF, and report such an assessment in the 
dedicated section of the Vaccine SAE Reporting Form and in accordance with the SAE 
reporting requirements.

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Follow-Up of AEs and SAEs
•
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations, as medically indicated or as requested by the 
sponsor, to elucidate the nature and/or causality of the AE or SAE as fully as possible.
This may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other healthcare providers.
•
If a participant dies during participation in the study or during a recognized follow-up 
period, the investigator will provide Pfizer Safety with a copy of any postmortem 
findings, including histopathology.
•
New or updated information will be recorded in the originally submitted documents.
•
The investigator will submit any updated SAE data to the sponsor within 24 hours of 
receipt of the information.
10.2.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool
•
The primary mechanism for reporting an SAE to Pfizer Safety will be the electronic 
data collection tool.
•
If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) to report the event within 24 hours.
•
The site will enter the SAE data into the electronic system as soon as the data become 
available.
•
After the study is completed at a given site, the electronic data collection tool will be 
taken off-line to prevent the entry of new data or changes to existing data.
•
If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic data collection tool has been 
taken off-line, then the site can report this information on a paper SAE form 
(see next section) or to Pfizer Safety by telephone.

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SAE Reporting to Pfizer Safety via Vaccine SAE Reporting Form
•
Facsimile transmission of the Vaccine SAE Reporting Form is the preferred method to 
transmit this information to Pfizer Safety.
•
In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the Vaccine SAE Reporting Form sent by overnight mail or 
courier service.
•
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Vaccine SAE Reporting Form pages within the designated 
reporting time frames.

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10.3. Appendix 3: Contraceptive and Barrier Guidance 
10.3.1. Male Participant Reproductive Inclusion Criteria
Male participants are eligible to participate if they agree to the following requirements during 
the intervention period and for at least 28 days after the last dose of study intervention, which 
corresponds to the time needed to eliminate reproductive safety risk of the study 
intervention(s): 
•
Refrain from donating sperm.
PLUS either:
•
Be abstinent from heterosexual intercourse with a female of childbearing potential as 
their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and 
agree to remain abstinent.
OR
•
Must agree to use contraception/barrier as detailed below:
•
Agree to use a male condom and should also be advised of the benefit for a 
female partner to use a highly effective method of contraception as a condom may 
break or leak when having sexual intercourse with a woman of childbearing 
potential who is not currently pregnant.
•
In addition to male condom use, a highly effective method of contraception may be 
considered in WOCBP partners of male participants (refer to the list of highly 
effective methods below in Section 10.3.4).
10.3.2. Female Participant Reproductive Inclusion Criteria
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at 
least 1 of the following conditions applies:
•
Is not a WOCBP (see definitions below in Section 10.3.3).
OR
•
Is a WOCBP and using an acceptable contraceptive method as described below 
during the intervention period (for a minimum of 28 days after the last dose of 
study intervention). The investigator should evaluate the effectiveness of the 
contraceptive method in relationship to the first dose of study intervention.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 

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10.3.3. Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP:
1. Premenopausal female with 1 of the following:
•
Documented hysterectomy;
•
Documented bilateral salpingectomy;
•
Documented bilateral oophorectomy.
For individuals with permanent infertility due to an alternate medical cause other than the 
above, (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview. The method of documentation should be recorded in the participant’s medical 
record for the study.
2. Postmenopausal female:
•
A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. In addition:
•
A high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years of age and not using hormonal 
contraception or HRT. 
•
A female on HRT and whose menopausal status is in doubt will be required to use 
one of the nonestrogen hormonal highly effective contraception methods if they 
wish to continue their HRT during the study. Otherwise, they must discontinue 
HRT to allow confirmation of postmenopausal status before study enrollment.

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10.3.4. Contraception Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device.
3. Intrauterine hormone-releasing system.
4. Bilateral tubal occlusion (eg, bilateral tubal ligation).
5. Vasectomized partner:
•
A vasectomized partner is a highly effective contraceptive method provided that 
the partner is the sole sexual partner of the woman of childbearing potential and 
the absence of sperm has been confirmed. If not, an additional highly effective 
method of contraception should be used. The spermatogenesis cycle is 
approximately 90 days.
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:
•
Oral;
•
Intravaginal;
•
Transdermal.
7. Progestogen-only hormone contraception associated with inhibition of ovulation:
•
Oral;
•
Injectable.
8. Sexual abstinence:
•
Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention. The reliability of sexual abstinence needs to be 
evaluated in relation to the duration of the study and the preferred and usual 
lifestyle of the participant.

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9. Progestogen-only oral hormonal contraception where inhibition of ovulation is not the 
primary mode of action.
10. Male or female condom with or without spermicide.
11. Cervical cap, diaphragm, or sponge with spermicide.
12. A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods).

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10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments 
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome. These participants fail to adapt and therefore are 
"susceptible" to progressive and serious liver injury, commonly referred to as DILI. 
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are “adaptors” or are “susceptible.”
LFTs are not required as a routine safety monitoring procedure in this study. However, 
should an investigator deem it necessary to assess LFTs because a participant presents with 
clinical signs/symptoms, such LFT results should be managed and followed as described 
below.
In the majority of DILI cases, elevations in AST and/or ALT precede TBili elevations 
(>2 × ULN) by several days or weeks. The increase in TBili typically occurs while 
AST/ALT is/are still elevated above 3 × ULN (ie, AST/ALT and TBili values will be 
elevated within the same laboratory sample). In rare instances, by the time TBili elevations 
are detected, AST/ALT values might have decreased. This occurrence is still regarded as a 
potential DILI. Therefore, abnormal elevations in either AST OR ALT in addition to TBili 
that meet the criteria outlined below are considered potential DILI (assessed per Hy’s law 
criteria) cases and should always be considered important medical events, even before all 
other possible causes of liver injury have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions. Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values:
•
Participants with AST/ALT and TBili baseline values within the normal range who 
subsequently present with AST OR ALT values >3 × ULN AND a TBili value 
>2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available.
•
For participants with baseline AST OR ALT OR TBili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:
•
Preexisting AST or ALT baseline values above the normal range: AST or ALT 
values >2 times the baseline values AND >3 × ULN; or >8 × ULN (whichever is 
smaller).

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•
Preexisting values of TBili above the normal range: TBili level increased from 
baseline value by an amount of at least 1 × ULN or if the value reaches >3 × ULN 
(whichever is smaller).
Rises in AST/ALT and TBili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor.
The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results. This evaluation should 
include laboratory tests, detailed history, and physical assessment. 
In addition to repeating measurements of AST and ALT and TBili for suspected Hy’s law
cases, additional laboratory tests should include albumin, CK, direct and indirect bilirubin, 
GGT, PT/INR, total bile acids, and alkaline phosphatase. Consideration should also be given 
to drawing a separate tube of clotted blood and an anticoagulated tube of blood for further 
testing, as needed, for further contemporaneous analyses at the time of the recognized initial 
abnormalities to determine etiology. A detailed history, including relevant information, such 
as review of ethanol, acetaminophen/paracetamol (either by itself or as a coformulated 
product in prescription or over-the-counter medications), recreational drug, or supplement 
(herbal) use and consumption, family history, sexual history, travel history, history of contact 
with a jaundiced person, surgery, blood transfusion, history of liver or allergic disease, and 
potential occupational exposure to chemicals, should be collected. Further testing for acute 
hepatitis A, B, C, D, and E infection, liver imaging (eg, biliary tract), and collection of serum 
samples for acetaminophen/paracetamol drug and/or protein adduct levels may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
TBili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found. Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities. 
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.

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10.5. Appendix 5: AEs, ADEs, SAEs, SADEs, USADEs, and Device Deficiencies:
Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting in 
Medical Device Studies
Definitions of a Medical Device Deficiency
The definitions and procedures detailed in this appendix are in accordance with ISO 14155
and the European MDR 2017/745 for clinical device research (if applicable). 
Both the investigator and the sponsor will comply with all local reporting requirements for 
medical devices.
The detection and documentation procedures described in this protocol apply to all sponsor 
medical devices provided for use in the study (see Section 6.1.2 for the list of sponsor 
medical devices).
10.5.1. Definition of AE and ADE
AE and ADE Definition 
•
An AE is defined in Appendix 2 (Section 10.2.1).
•
An ADE is defined as an AE related to the use of an investigational medical device.
This definition includes any AEs resulting from insufficient or inadequate instructions 
for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device as well as any event resulting from use error or from 
intentional misuse of the investigational medical device.
10.5.2. Definition of SAE, SADE, and USADE
SAE Definition
•
An SAE is defined in Appendix 2 (Section 10.2.2).
SADE Definition
•
An SADE is defined as an adverse device effect that has resulted in any of the 
consequences characteristic of an SAE.
•
Any device deficiency that might have led to an SAE if appropriate action had not been 
taken, intervention had not occurred, or circumstances had been less fortunate.

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USADE Definition
•
A USADE is a serious adverse device effect that by its nature, incidence, severity, or 
outcome has not been identified in the current version of the risk analysis management 
file.
10.5.3. Definition of Device Deficiency
Device Deficiency Definition
•
A device deficiency is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance. Device deficiencies include 
malfunctions, use errors, and inadequate information supplied by the manufacturer.
10.5.4. Recording/Reporting and Follow-Up of Medical Device Deficiencies
Device Deficiency Recording
•
When a device deficiency occurs, it is the responsibility of the investigator to review 
all documentation (eg, hospital progress notes, laboratory reports, and diagnostic 
reports) related to the event.
•
The investigator will then record all relevant device deficiency information in the 
participant’s medical records, in accordance with the investigator’s normal clinical 
practice and will also capture the required information on the Medical Device 
Complaint form.
•
It is not acceptable for the investigator to send photocopies of the participant’s medical 
records to Pfizer Safety in lieu of following the reporting process described in the
Medical Device Complaint form.
•
There may be instances when copies of medical records for certain cases are requested 
by Pfizer Safety. In this case, all participant identifiers, with the exception of the 
participant number, will be redacted on the copies of the medical records before 
submission to Pfizer Safety.
•
If the investigator determines that the medical device deficiency may have injured the 
participant (ie, the medical device deficiency is associated with an AE or SAE), then 
the investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis will be 
documented in the participant’s medical record and recorded as the AE or SAE rather 
than the individual signs/symptoms. Requirements for recording and reporting an AE
or SAE are provided in Appendix 2 (Section 10.2.3).

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•
For device deficiencies, it is very important that the investigator describes any 
corrective or remedial actions taken to prevent recurrence of the incident.
•
A remedial action is any action other than routine maintenance or servicing of a 
medical device where such action is necessary to prevent recurrence of a device 
deficiency. This includes any amendment to the device design to prevent 
recurrence.
Assessment of Causality Occurring in Conjunction With a Medical Device Deficiency
•
If an AE or SAE has occurred in conjunction with a medical device deficiency, the 
investigator must assess the relationship between each occurrence of the AE or SAE 
and the medical device deficiency. The investigator will use clinical judgment to 
determine the relationship.
•
A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot be 
ruled out.
•
Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated.
•
The investigator will also consult the IB in his/her assessment.
•
For each device deficiency, the investigator must document in the medical notes that 
he/she has reviewed the device deficiency and has provided an assessment of causality.
•
There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is very 
important that the investigator always make an assessment of causality for every event 
before the initial transmission of the SAE data to the sponsor.
•
The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality assessment.
•
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.

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Follow-Up of Medical Device Deficiency
•
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations, as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the device deficiency as fully as 
possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.
•
New or updated information regarding the nature of the device deficiency will be 
recorded in the originally completed Medical Device Complaint form.
•
New or updated information regarding any SAE that was potentially associated with 
the medical device deficiency will be submitted to Pfizer Safety on the Vaccine SAE 
Reporting Form within 24 hours of receipt of the information, according to the 
requirements provided in Appendix 2.
10.5.5. Reporting of SAEs
Reporting of an SAE to Pfizer Safety must be performed according to the processes 
described in Appendix 2 (Section 10.2.4).
10.5.6. Reporting of SADEs
SADE Reporting to Pfizer Safety
Note: There are additional reporting obligations for medical device deficiencies that are 
potentially related to SAEs (ie, a SADE) that must fulfill the legal responsibility to notify 
appropriate regulatory authorities and other entities about certain safety information 
relating to medical devices being used in clinical studies.
•
Any device deficiency that is associated with an SAE must be reported to the 
sponsor within 24 hours after the investigator determines that the event meets the 
definition of a device deficiency.
•
The sponsor shall review all device deficiencies and determine and document in 
writing whether they could have led to an SAE. These shall be reported to the 
regulatory authorities and IRBs/ECs as required by national regulations.

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10.6. Appendix 6: Alternative Measures During Public Emergencies
The alternative study measures described in this section are to be followed during public 
emergencies, including the COVID-19 pandemic. This appendix applies for the duration of 
the COVID-19 pandemic in India and will become effective for other public emergencies 
only upon written notification from Pfizer. 
Use of these alternative study measures is expected to cease upon the return of business as 
usual (including the lifting of any quarantines and travel bans/advisories). 
10.6.1. Telehealth Visits
In the event that in-clinic study visits cannot be conducted, every effort should be 
made to follow up on the safety of study participants at scheduled visits per the 
Schedule of Activities or unscheduled visits. Telehealth visits may be used to continue to 
assess participant safety and collect data points. Telehealth includes the exchange of 
healthcare information and services via telecommunication technologies (eg, audio, video, 
video-conferencing software) remotely, allowing the participant and the investigator to 
communicate on aspects of clinical care, including medical advice, reminders, education, and 
safety monitoring. The following assessments must be performed during a telehealth visit.
•
Review and record any AEs and SAEs since the last contact. Refer to Section 8.3.
•
Review and record any new concomitant medications to treat SAEs or changes in 
concomitant medications since the last contact.
•
Confirm that the participant is adhering to the contraception method(s) required in the 
protocol. Refer to Section 10.3 regarding contraption methods and Section 8.2.5
regarding pregnancy tests.
Study participants must be reminded to promptly notify site staff about any change in their 
health status.
10.6.2. Adverse Events and Serious Adverse Events
If a participant has COVID-19 during the study, this should be reported as an AE or SAE and 
appropriate medical intervention should be provided. 

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10.7. Appendix 7: Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
7vPnC
7-valent pneumococcal conjugate vaccine
13vPnC
13-valent pneumococcal conjugate vaccine
20vPnC
20-valent pneumococcal conjugate vaccine
ADE
adverse device effect
ADL
activities of daily living
AE
adverse event
ALT
alanine aminotransferase
AOM
acute otitis media
AST
aspartate aminotransferase
BOH
Board of Health
CAP
community-acquired pneumonia
CAPiTA
Community-Acquired Pneumonia Immunization Trial in Adults
CBER
Center for Biologics Evaluation and Research
CFR
Code of Federal Regulations
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CONSORT
Consolidated Standards of Reporting Trials
COPD
chronic obstructive pulmonary disease
COVID-19
coronavirus disease 2019
CRF
case report form
CRM197
cross-reactive material 197
CRO
contract research organization
CSF
cerebrospinal fluid
CSR
clinical study report
DCGI
Drugs Controller General of India
DILI
drug-induced liver injury
DMC
data monitoring committee
EC
ethics committee
ECC
emergency contact card
ECG
electrocardiogram
e-diary
electronic diary
EDB
exposure during breastfeeding
EDMC
electronic data monitoring committee
EDP
exposure during pregnancy
EMA
European Medicines Agency

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Abbreviation
Term
EU
European Union
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMFR
geometric mean fold rise
GMT
geometric mean titer
HRT
hormone replacement therapy
IB
investigator’s brochure
ICD
informed consent document
ICH
International Council for Harmonisation
ID
identification
IgG
immunoglobulin G
IND
investigational new drug application
INR
international normalized ratio
IP manual
investigational product manual
IPAL
Investigational Product Accountability Log
IPD
invasive pneumococcal disease
IRB
institutional review board
IRT
interactive response technology
ISO
International Organization for Standardization
ISF
investigator site file
IWR
interactive Web-based response
LB
lower bound
LFT
liver function test
LLOQ
lower limit of quantitation
MDR
Medical Device Regulation
N/A
not applicable
OPA
opsonophagocytic activity
PI
principal investigator
PPSV23
23-valent pneumococcal polysaccharide vaccine
PT
prothrombin time
QTL
quality tolerance limit
SADE
serious adverse device effect
SAE
serious adverse event
SAP
statistical analysis plan
SoA
schedule of activities
CCI

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
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Abbreviation
Term
SOP
standard operating procedure
SRM
study reference manual
SRSD
single reference safety document
SUSAR
suspected unexpected serious adverse reaction
TBili
total bilirubin
TGA
Therapeutic Goods Administration
UB
upper bound
ULN
upper limit of normal
US
United States
USADE
unanticipated serious adverse device effect
VT
vaccine-type
WOCBP
woman/women of childbearing potential

PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 87
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PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 88
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PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 89
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PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 90
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PF-06482077 (20-valent Pneumococcal Conjugate Vaccine [20vPnC])
Protocol B7471010
Final Protocol Amendment 1, 22 December 2022
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 March 2021)
TMF Doc ID: 164.01
Page 91
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