A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (RSVpreF) IN CHILDREN 2 TO <18 YEARS OF AGE
Phase: PHASE1
Conditions: RESPIRATORY SYNCYTIAL VIRUS (RSV)
Sponsor: Pfizer

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 1
A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY TO 
EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 
RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE 
(RSVpreF) IN CHILDREN 2 TO 18 YEARS OF AGE
Study Intervention Number:
PF-06928316
Study Intervention Name:
Respiratory Syncytial Virus (RSV) Vaccine
US IND Number:
017931
EU CT Number:
2022-503134-32-00
ClinicalTrials.gov ID:
NCT05900154
Pediatric Investigational Plan Number:
EMEA-002795-PIP02-21
Protocol Number:
C3671016
Phase:
1
Sponsor Legal Address:
Pfizer Inc.
66 Hudson Boulevard East
New York, NY 10001
Brief Title: A Phase 1 Study of the Safety, Tolerability, and Immunogenicity of RSVpreF 
in Children 2 to 18 Years of Age 
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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 2
Document History
Document
Version Date
Amendment 1
09 Feb 2024
Original protocol
31 Jan 2023
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs and any protocol administrative change 
letter(s). 
Protocol Amendment Summary of Changes Table
Amendment 1 (09 Feb 2024)
Overall Rationale for the Amendment: 
This amendment is made to address a CBER recommendation to amend the protocol design 
to be consistent with an early-phase clinical study.
Description of Change
Brief Rationale
Section # and Name
Substantial Modification(s)
Added the clinicaltrials.gov 
reference and sponsor legal address 
to the title page.
To reflect the trial posting to 
clinicaltrials.gov.
Title page
Removed Phase 2/3 content.
To address CBER feedback.
Throughout protocol
Nonsubstantial Modification(s)
Updated the text with respect to the 
FDA approval of RSVpreF 
(Abrysvo®) for marketing in 
individuals 60 years of age and 
older and pregnant individuals at 
32-36 weeks of gestational age in 
the US and to approvals of 
prophylactic monoclonal antibodies 
for RSV.
To provide updated information on 
approvals for the RSV vaccine and 
monoclonal antibodies.
Section 1.1
Section 2
Section 11
Updated safety profile and risk 
assessment information.
To reflect current safety data 
regarding RSVpreF.
Section 2.1
Section 2.3.1
Deleted potential risk from risk 
assessment.
The global SARS-CoV-2 pandemic
has ended per WHO and risk is no 
longer applicable.
Section 2.3.1
Updated the order of the 
prevaccination RSV serostatus 
procedure.
Updated per PACL.
Section 1.3.1.
Section 8.10.1 where applicable
Added AESI surveillance through
the end of study participation.
Updated per PACL #3.
Section 1.1
Section 1.3
Section 8.4.1
Section 8.4.8
Section 8.10 where applicable
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 3
Description of Change
Brief Rationale
Section # and Name
Updated the text to provide more
clarity regarding the analysis of 
partially missing e-diary data.
To add clarification.
Section 9.3.1
Section 9.4.1
Updated section to ensure 
compliance with current external 
regulations and internal policies.
To ensure the protocol is compliant 
with current external regulations 
and internal policies.
Section 10.1.3
Section 10.1.3.1
Section 10.1.3.2
Section 10.1.6
Section 10.1.7
Section 10.1.8
Section 10.1.9
Section 10.1.10
Made minor editorial changes.
To align with amendment and 
template updates and/or to improve 
clarity and navigation throughout 
the document for sites.
All
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 4
TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................9
1. PROTOCOL SUMMARY...................................................................................................10
1.1. Synopsis ..................................................................................................................10
1.2. Schema ....................................................................................................................18
1.3. Schedule of Activities .............................................................................................20
1.3.1. .....................................................................................................................20
2. INTRODUCTION ...............................................................................................................24
2.1. Study Rationale .......................................................................................................24
2.2. Background .............................................................................................................25
2.2.1. Clinical Overview.......................................................................................26
2.3. Benefit/Risk Assessment.........................................................................................29
2.3.1. Risk Assessment.........................................................................................30
2.3.2. Benefit Assessment.....................................................................................33
2.3.3. Overall Benefit/Risk Conclusion................................................................33
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS ...........................................................33
4. STUDY DESIGN.................................................................................................................34
4.1. Overall Design.........................................................................................................34
4.1.1. Number of Participants...............................................................................35
4.1.2. Intervention Groups and Duration..............................................................36
4.2. Scientific Rationale for Study Design.....................................................................36
4.2.1. Diversity of Study Population ....................................................................36
4.3. Justification for Dose ..............................................................................................36
4.4. End of Study Definition ..........................................................................................37
5. STUDY POPULATION......................................................................................................37
5.1. Inclusion Criteria.....................................................................................................37
5.2. Exclusion Criteria....................................................................................................38
5.3. Lifestyle Considerations..........................................................................................39
5.4. Screen Failures ........................................................................................................40
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 5
5.5. Criteria for Temporarily Delaying 
Enrollment/Randomization/Administration of Study Intervention...........................40
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................40
6.1. Study Intervention(s) Administered........................................................................41
6.1.1. Administration............................................................................................41
6.1.2. Medical Devices .........................................................................................42
6.2. Preparation, Handling, Storage, and Accountability...............................................42
6.2.1. Preparation and Dispensing........................................................................43
6.3. Assignment to Study Intervention...........................................................................44
6.4. Blinding...................................................................................................................44
6.4.1. Blinding of Participants..............................................................................44
6.4.2. Blinding of Site Personnel..........................................................................44
6.4.3. Blinding of the Sponsor..............................................................................44
6.4.4. Breaking the Blind......................................................................................44
6.5. Study Intervention Compliance...............................................................................44
6.6. Dose Modification...................................................................................................44
6.7. Continued Access to Study Intervention After the End of the Study......................44
6.8. Treatment of Overdose............................................................................................45
6.9. Prior and Concomitant Therapy..............................................................................45
6.9.1. Prohibited Concomitant Vaccinations and Treatments ..............................45
6.9.2. Permitted Concomitant Vaccinations and Treatments ...............................46
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................46
7.1. Discontinuation of Study Intervention ....................................................................46
7.2. Participant Discontinuation/Withdrawal From the Study.......................................47
7.2.1. Withdrawal of Consent...............................................................................48
7.3. Lost to Follow-Up ...................................................................................................48
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................49
8.1. Administrative Procedures ......................................................................................49
8.1.1. Telehealth Visits.........................................................................................50
8.2. Efficacy and/or Immunogenicity Assessments .......................................................50
8.2.1. Efficacy Assessments .................................................................................50
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 6
8.2.2. Immunogenicity Assessments ....................................................................50
8.2.3. Biological Samples.....................................................................................51
8.3. Safety Assessments .................................................................................................51
8.3.1. Physical Examinations................................................................................52
8.3.2. Vital Signs ..................................................................................................52
8.3.3. Clinical Safety Laboratory Assessments ....................................................52
8.3.4. Reactogenicity Electronic Diary.................................................................52
8.3.4.1. Grading Scales...........................................................................53
8.3.4.2. Local Reactions.........................................................................53
8.3.4.3. Systemic Events ........................................................................54
8.3.4.4. Fever..........................................................................................55
8.3.5. Stopping Rules............................................................................................56
8.3.6. Randomization and Vaccination After a Stopping Rule Is Met .................57
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................57
8.4.1. Time Period and Frequency for Collecting AE and SAE Information.......58
8.4.1.1. Reporting SAEs to Pfizer Safety...............................................59
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF...................59
8.4.2. Method of Detecting AEs and SAEs ..........................................................59
8.4.3. Follow-Up of AEs and SAEs......................................................................59
8.4.4. Regulatory Reporting Requirements for SAEs...........................................60
8.4.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................60
8.4.5.1. Exposure During Pregnancy......................................................61
8.4.5.2. Exposure During Breastfeeding ................................................62
8.4.5.3. Occupational Exposure .............................................................63
8.4.6. Cardiovascular and Death Events...............................................................63
8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................63
8.4.8. Adverse Events of Special Interest.............................................................63
8.4.8.1. Lack of Efficacy........................................................................64
8.4.9. Medical Device Deficiencies......................................................................64
8.4.9.1. Time Period for Detecting Medical Device Deficiencies .........64
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 7
8.4.9.2. Follow-Up of Medical Device Deficiencies..............................64
8.4.9.3. Prompt Reporting of Device Deficiencies to the Sponsor ........65
8.4.9.4. Regulatory Reporting Requirements for Device 
Deficiencies .......................................................................................65
8.4.10. Vaccination Errors....................................................................................65
8.5. Pharmacokinetics ....................................................................................................66
8.6. Genetics...................................................................................................................66
8.6.1. Specified Genetics ......................................................................................66
8.7. Biomarkers ..............................................................................................................66
8.8. Immunogenicity Assessments.................................................................................66
8.9. Health Economics ...................................................................................................67
8.10. Study Procedures...................................................................................................67
8.10.1. Visit 1 – Screening and Vaccination Visit (Clinic; Day 1) ......................67
8.10.2. Visit 2 – 1-Week Follow-Up Visit (Telehealth; 6 to 8 Days After 
Vaccination on Day 1) .....................................................................................69
8.10.3. Visit 3 – 1-Month Follow-Up Visit (Clinic; 28 to 35 Days After 
Visit 1) .............................................................................................................70
8.10.4. Visit 4 – 6-Month Follow-Up Visit (Telehealth; 175 to 189 Days 
After Visit 1)....................................................................................................70
8.11. Unscheduled Visit for Fever or a Grade 3 or Suspected Grade 4 Reaction..........71
8.12. Communication and Use of Technology...............................................................72
9. STATISTICAL CONSIDERATIONS ................................................................................73
9.1. Statistical Hypothesis ..............................................................................................73
9.2. Analysis Sets ...........................................................................................................73
9.3. Statistical Analyses .................................................................................................74
9.3.1. General Considerations...............................................................................74
9.3.1.1. Analyses for Binary Data ..........................................................74
9.3.1.2. Analyses for Continuous Data...................................................74
9.3.2. Primary Endpoint(s)/Estimand(s) Analysis ................................................75
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis............................................76
9.4. Interim Analyses .....................................................................................................76
9.4.1. Analysis Timing..........................................................................................76
9.5. Sample Size Determination.....................................................................................76
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 8
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................77
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............77
10.1.1. Regulatory and Ethical Considerations ....................................................77
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................77
10.1.2. Financial Disclosure .................................................................................78
10.1.3. Informed Consent/Assent Process ............................................................78
10.1.3.1. Electronic Consent ..................................................................79
10.1.3.2. Remote Consent ......................................................................80
10.1.4. Data Protection .........................................................................................80
10.1.5. Committees Structure ...............................................................................81
10.1.5.1. Data Monitoring Committee ...................................................81
10.1.6. Dissemination of Clinical Study Data ......................................................81
10.1.7. Data Quality Assurance ............................................................................82
10.1.8. Source Documents....................................................................................84
10.1.9. Use of Medical Records............................................................................84
10.1.10. Study and Site Start and Closure ............................................................85
10.1.11. Publication Policy...................................................................................86
10.1.12. Sponsor’s Medically Qualified Individual..............................................86
10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting .....................................................................88
10.2.1. Definition of AE .......................................................................................88
10.2.2. Definition of an SAE ................................................................................89
10.2.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period............................................................................90
10.2.4. Reporting of SAEs....................................................................................94
10.3. Appendix 3: Contraceptive and Barrier Guidance ................................................94
10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments .......95
10.5. Appendix 5: Kidney Safety Monitoring Guidelines .............................................97
10.5.1. Laboratory Assessment of Change in Kidney Function and 
Detection of Kidney Injury..............................................................................97
10.5.2. Age-Specific Kidney Function Calculation Recommendations...............97
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 9
10.5.2.1. Adolescents (12 Years to <18 Years)—Cockcroft-Gault 
Formula..............................................................................................97
10.5.2.2. Children (2 Years to <12 Years)—Modified Schwartz 
Equation.............................................................................................97
10.5.3. Adverse Event Grading for Kidney Safety Laboratory 
Abnormalities...................................................................................................97
10.6. Appendix 6: AEs, ADEs, SAEs, SADEs, USADEs, and Device 
Deficiencies: Definitions and Procedures for Recording, Evaluating, 
Follow-Up, and Reporting in Medical Device Studies .............................................98
10.6.1. Definition of AE and ADE .......................................................................98
10.6.2. Definition of SAE, SADE, and USADE ..................................................98
10.6.3. Definition of Device Deficiency...............................................................99
10.6.4. Recording/Reporting and Follow-Up of Medical Device 
Deficiencies......................................................................................................99
10.6.5. Reporting of SAEs..................................................................................101
10.6.6. Reporting of SADEs...............................................................................101
10.7. Appendix 7: Abbreviations .................................................................................102
11. REFERENCES ................................................................................................................106
LIST OF TABLES
Table 1.
Participants ...............................................................................................35
Table 2.
Local Reaction Grading Scale ..................................................................54
Table 3.
Systemic Event Grading Scale for Participants ≥2 Years of Age ............55
Table 4.
Scale for Fever..........................................................................................56
Table 5.
Primary Endpoint Analyses ......................................................................75
Table 6.
Secondary Endpoint Analyses ..................................................................76
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 10
1. PROTOCOL SUMMARY
1.1. Synopsis
Protocol Title:
A Phase 1, Open-Label, Age-Descending, Dose-Finding Study to Evaluate the Safety, 
Tolerability, and Immunogenicity of Respiratory Syncytial Virus Prefusion F Subunit 
Vaccine (RSVpreF) in Children 2 to 18 Years of Age 
Brief Title:
A Phase 1 Study of the Safety, Tolerability, and Immunogenicity of RSVpreF in Children 
2 to 18 Years of Age 
Regulatory Agency Identification Number(s):
US IND Number:
017931
EU CT Number:
2022-503134-32-00
ClinicalTrials.gov ID:
NCT05900154
Pediatric Investigational Plan Number:
EMEA-002795-PIP02-21
Protocol Number:
C3671016
Phase:
1
Rationale:
RSV is the leading cause of LRTI among infants and young children globally.
Pfizer is developing a vaccine to protect against RSV disease. The vaccine, RSVpreF, 
contains 2 stabilized prefusion RSV F glycoproteins in equal amounts in a lyophilized dosage 
form for reconstitution. On 31 May 2023 and 21 Aug 2023, the FDA approved RSVpreF 
(Abrysvo®) for marketing in individuals 60 years of age and older and in pregnant 
individuals, respectively. On 23 Aug 2023, the European Commission granted marketing 
authorization for RSVpreF to help protect infants through maternal immunization and to 
protect older adults. Additional applications are under review by other regulatory agencies 
around the world.
This proposed pediatric Phase 1 study (C3671016) will evaluate different dose levels 
of RSVpreF in children 2 to 18 years of age to identify the dose level for Phase 2/3 trials in 
this age cohort. In this study, children will be considered high risk if they are 5 to 18 years 
of age and have certain chronic medical conditions, or if they are 2 to 5 years of age and are 
healthy or have certain medical conditions. Children 2 to 5 years of age are considered at 
high risk of increased morbidity due to RSV infection based on their age alone.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 11
Objectives, Endpoints, and Estimands:
Objectives
Endpoints
Estimands
Primary:
Primary:
Primary:
To describe the safety and tolerability 
of RSVpreF at each dose level in 
children 5 to 18 years of age and 
children 2 to 5 years of age.
Prompted local reactions 
(pain at the injection site, 
redness, and swelling).
Prompted systemic events 
(fever, vomiting, diarrhea, 
headache, fatigue/tiredness, 
muscle pain, and joint 
pain).
AEs.
SAEs.
NDCMCs.
In participants receiving 1 dose of 
study intervention at each dose level, 
for each age stratum:

The percentage of participants 
reporting local reactions within 
7 days after vaccination.

The percentage of participants 
reporting systemic events within 
7 days after vaccination.

The percentage of participants 
reporting AEs from vaccination 
through 1 month after 
vaccination.

The percentage of participants 
reporting SAEs throughout the 
study.

The percentage of participants 
reporting NDCMCs throughout 
the study.
Secondary:
Secondary:
Secondary:
To describe the immune responses 
elicited by RSVpreF at each dose 
level in children 5 to 18 years of age 
and children 2 to 5 years of age.
RSV A and RSV B NTs.
In participants in compliance with 
the key protocol criteria (evaluable 
immunogenicity population):

GMTs of NT for RSV A and 
RSV B 1 month after 
vaccination.

GMTs of NT for RSV A and 
RSV B before vaccination.

GMFRs of NT for RSV A and 
RSV B from before vaccination 
to 1 month after vaccination.
To describe the cell-mediated 
immune response in children 
5 to 18 years of age and children 
2 to 5 years of age.
RSV F antigen–specific 
CD4+ T cells secreting 
IFN.
RSV F antigen–specific 
CD4+ T cells secreting 
IL-4.
In participants in compliance with 
the key protocol criteria (evaluable 
immunogenicity population):

Median frequencies of RSV
F antigen–specific CD4+ T cells
expressing IFNbefore 
vaccination and 1 month after 
vaccination.

Median frequencies of RSV
F antigen–specific CD4+ T cells 
expressing IL-4 before 
vaccination and 1 month after 
vaccination.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 12
Overall Design:
This is a Phase 1, open-label, age-descending, dose-finding study of the safety, tolerability, 
and immunogenicity of RSVpreF in RSV-seropositive children 2 to 18 years of age. 
Participants will be divided into 2 age strata: 5 to 18 years and 2 to 5 years. All 
participants will receive 1 dose of RSVpreF.
A single dose of RSVpreF 120 µg will be administered to the older age stratum first. Upon 
confirmation of an acceptable safety profile by the IRC, dose administration will proceed in 
the 2- to 5-year age stratum with 60 µg. Pending IRC approval, the younger age stratum 
will receive a single 120-µg dose of the vaccine. The older age stratum may also receive a 
single dose of RSVpreF 60 µg. Stopping rules will apply.
Dependent upon safety and/or immunogenicity data generated during the course of this 
study, it is possible that dose levels may not be started, may be terminated early, and/or may 
be added at levels below the lowest stated dose.
All participants in the 2- to 5-year age stratum will require a blood sample to assess RSV
serostatus during the screening visit, and only those who are seropositive will be
administered RSVpreF on Day 1. All participants 5 years of age and older will be considered 
RSV seropositive and will not require a screening test.
Participants will have a baseline blood draw prior to vaccination on Day 1 and a postdose 
blood draw 1 month after vaccination to assess immunogenicity.
Additional blood will be required for PBMC isolation and will be collected simultaneously 
with the immunogenicity sample, both on Day 1 and again 1 month after vaccination. 
Frequencies of RSV F antigen–specific CD4+ T cells secreting specific cytokines will be 
measured both before and after vaccination.
The study duration for each participant will be approximately 6 months.
Internal Review Committee
This study will use an IRC. The IRC is independent of the study team and includes only 
internal members. The IRC charter describes in detail the roles of the IRC members.
Number of Participants:
This is an open-label dose-finding study. A single dose of RSVpreF 120 µg will be given to 
approximately 40 participants in the 5- to 18-year age stratum first, equally divided between 
healthy children and those with high-risk chronic medical conditions. Upon IRC approval, a 
dose of 60 µg will be given to 20 participants in the 2- to 5-year age stratum. If, per the 
IRC, 60 µg is determined to be safe and tolerable, another 20 participants in the 2- to 5-year
age stratum will receive the 120-µg dose. The IRC may also request that a single dose of 
RSVpreF 60 µg be given to approximately 40 participants in the 5- to 18-year age stratum. 
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 13
Dependent upon safety and/or immunogenicity data generated during the course of this 
study, it is possible that dose levels may not be started, may be terminated early, and/or may 
be added at levels below the lowest stated dose. Approximately 60 to 120 participants are 
expected to be enrolled.
Age Stratum (Years)
Number of Participants
2 to 5
~20/~20a
5 to 18
~40/~40a,b
Total
~60-120
a.
Up to 2 dose levels of RSVpreF (120 µg and 60 µg) will be tested in participants.
b.
Approximately 40 participants 5 to 18 years old will be enrolled, with ~20 healthy participants and 
~20 participants with high-risk chronic medical conditions receiving each dose level.
Study Population:
Inclusion and exclusion criteria are listed below:
Inclusion Criteria
Participants must meet the following inclusion criteria to be eligible for enrollment in the 
study:
Age and Sex:
1. Participants 2 to 18 years of age at enrollment (signing of the ICD or providing 
assent to participate) at Visit 1.
Disease Characteristics:
2. Participants 2 to 18 years of age should either be healthy or be considered by the 
investigator to be at high risk of RSV disease based on the presence of 1 of the 
following chronic medical conditions:

Cystic fibrosis

Medically treated asthma

Other chronic respiratory diseases and malformations of the lung

Down syndrome

Neuromuscular disease

Cerebral palsy
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 14

Hemodynamically significant or symptomatic congenital heart disease
Details of the chronic medical conditions listed above are further defined in the 
investigator site file.
Other Inclusion Criteria:
1. All participants 2 to 5 years of age must be seropositive for RSV as confirmed by 
serology.
2. Participants’ parent(s)/legal guardian(s) and participants, as age appropriate, who are 
willing and able to comply with all scheduled visits, investigational plan, laboratory 
tests, and other study procedures,. Participants’ parent(s)/legal guardian(s) should be 
available for telephone contact with site staff for the duration of the study.
3. The participant’s parent(s)/legal guardian is capable of giving signed informed 
consent as described in Appendix 1, which includes compliance with the 
requirements and restrictions listed in the ICD and in this protocol. Depending on the 
age of the participant and according to local requirements, participants will also be 
asked to provide assent as appropriate (verbal or written).
Exclusion Criteria
Participants with any of the following characteristics/conditions will be excluded:
Medical Conditions:
1. Immunocompromised individuals associated with known or suspected 
immunodeficiency, as determined by history and/or laboratory/physical examination.
2. Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic intervention, including but not limited to systemic lupus 
erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
3. 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.
4. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s).
5. Bleeding diathesis or condition associated with prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular injection.
6. Individuals with a history of epilepsy or other seizure disorders, or a history of 
seizures and/or other neurological complications following vaccination.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 15
Prior/Concomitant Therapy:
7. Previous vaccination with any licensed or investigational RSV vaccine or planned 
receipt during study participation. Children who may have been exposed to 
investigational RSV vaccines through maternal immunization will be permitted.
8. Receipt of investigational or approved monoclonal antibodies against RSV within 
6 months before study intervention administration, or planned receipt throughout the 
study.
9. Receipt of blood/plasma products or immunoglobulins within 28 days before study 
intervention administration, or planned receipt throughout the study.
10. Receipt of chronic systemic treatment with known immunosuppressant medications 
(including cytotoxic agents or systemic corticosteroids), or radiotherapy, within
60 days before study intervention administration, or planned receipt throughout the 
study.
Note: Systemic corticosteroids are defined as those administered for ≥14 days at a 
dose of ≥20 mg/day of prednisone or equivalent (eg, for cancer or an autoimmune 
disease). Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) 
corticosteroids are permitted.
Prior/Concurrent Clinical Study Experience:
11. Participation in other studies involving study intervention within 28 days prior to 
study entry and/or for the duration of study participation.
Diagnostic Assessments:
Not applicable.
Other Exclusion Criteria:
12. Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and sponsor 
delegate employees directly involved in the conduct of the study and their family 
members.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 16
Study Arms and Duration:
Study Arms and Study Interventions
Intervention Name
PF-06928316 (RSVpreF)
Arm Name
(group of participants receiving a specific vaccine 
or no vaccine)
Active vaccine group
Unit Dose Strength(s)
120 µg and/or 60 µg
Type
Vaccine
Route of Administration
Intramuscular
Use
Experimental
IMP or NIMP/AxMP
IMP
Dose finding will begin at 120 µg of RSVpreF in participants 5 to 18 years of age. The IRC 
will review safety data (e-diary and AEs) acquired up to 7 days after vaccination once a 
minimum of 10 and up to approximately 40 participants have been vaccinated. Upon IRC 
confirmation of an acceptable safety profile in the 5- to 18-year-olds, dose administration
may commence at 60 µg of RSVpreF in participants 2 to 5 years of age. The same process 
will be followed before vaccinating with 120 µg of RSVpreF in the 2- to 5-year-olds. Upon 
IRC review, RSVpreF 60 µg may be given to participants in the 5- to 18-year age stratum.
Study Duration:
The study duration for each participant will be approximately 6 months.
Statistical Methods:
This Phase 1 study is descriptive; thus, sample size is not based on any statistical criteria. 
Safety and immunogenicity data will be descriptively summarized for this cohort, and 
immunogenicity data in this cohort may be descriptively compared with other study results.
Ethical Considerations:
The available safety, immunogenicity, and effectiveness data from ongoing clinical trials for 
RSVpreF support a favorable benefit/risk profile. Anticipated AEs after vaccination are 
expected to be similar to those observed following vaccination with the same vaccines (mild 
to moderate reactogenicity), which are manageable using routine symptom-driven standard 
of care.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 17
Because of the history of vaccine-mediated ERD following immunization of RSV-naïve 
infants in the 1960s with an FI-RSV vaccine, this study will be limited to seropositive 
children only and will assess the cellular response (Th1/Th2 balance) to RSVpreF. Th1- and 
Th2-specific cytokines will be used as a surrogate to characterize the cellular immune 
response and predisposition to enhanced disease. Unlike the FI-RSV vaccine, RSVpreF is an 
F glycoprotein subunit stabilized in the prefusion conformation, elicits strong neutralizing 
antibodies as established in the adult studies, and has already shown efficacy in preventing 
LRTI in older adults and severe LRTI in infants born to vaccinated mothers. Available 
evidence indicates that RSVpreF is efficacious and is unlikely to confer any risk of enhanced 
disease.
The expected safety profile of this vaccine therefore supports initiation of this clinical study.

Based on the experience with RSVpreF, the potential risks are:

Local reactions and systemic events such as injection site redness, injection site 
swelling, and injection site pain; and fever, fatigue/tiredness, headache, muscle pain, 
and joint pain.

Guillain-Barré syndrome. In Study C3671013, conducted in adults 60 years of age 
and older, there were 2 cases of Guillain-Barré syndrome or its variants identified 
with a plausible temporal relationship with vaccination among >18,000 individuals 
who received RSVpreF. Both cases had confounding factors or alternative etiology.

Other events of special interest include atrial fibrillation, polyneuropathy, preterm 
birth (delivery at <37 0/7 weeks’ gestation), and hypertensive disorders of pregnancy.

Theoretical risk for RSV vaccine–elicited ERD.

The study procedure-related risks include:

Venipuncture will be performed during the study.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 18
1.2. Schema
5- to <18-Year Age Stratum
2- to <5-Year Age Stratum
Phase 1
All participants receive RSVpreF
Phase 1
All participants receive RSVpreF
120 µg (n=40)
IRCa
60 µg (n=20)
          IRCb
IRCb
60 µg (n=40)
120 µg (n=20)
          IRCc
          IRCc
RSVpreF dose level selected
RSVpreF dose level selected
a.
Progression of the study to the younger age stratum will occur upon confirmation of an acceptable safety 
assessment of data accumulated up to 7 days after vaccination at the 120-µg level, once a minimum of 10 
and up to approximately 40 participants have been vaccinated in participants from the 5- to 18-year age 
stratum.
b.
In each age stratum, based on safety assessment of data accumulated up to 7 days after vaccination, the 
IRC may request a different dose level of RSVpreF to be tested.
c.
The IRC will choose a dose level for each age stratum depending on safety, tolerability, and 
immunogenicity data accumulated from 7 days after dose administration in each age stratum.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 19
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 20
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.
1.3.1.
Visit Number
Abbreviations used in this 
table may be found in 
Appendix 7.
1
2
3
4
Notes
Visit Description
Screening and 
Vaccination
1-Week 
Follow-Up Visit
1-Month 
Follow-Up Visit
6-Month 
Follow-Up Visit
Visit Window (Days)
Day 1
6 to 8 Days After 
Vaccination Day 1
28 to 35 Days After Visit 
1
175 to 189 Days After
Visit 1
Day relative to start of 
study intervention
administration (Day 1).
Type of Visit
Clinic
Telehealth
Clinic
Telehealth
Obtain informed consent 
and assent (if applicable)
X
Informed consent should 
be obtained prior to 
undergoing any 
study-specific procedures.
See Section 10.1.3 for 
additional information.
Assign participant 
number
X
Obtain demography and 
significant medical 
history data
X
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 21
Visit Number
Abbreviations used in this 
table may be found in 
Appendix 7.
1
2
3
4
Notes
Visit Description
Screening and 
Vaccination
1-Week 
Follow-Up Visit
1-Month 
Follow-Up Visit
6-Month 
Follow-Up Visit
Visit Window (Days)
Day 1
6 to 8 Days After 
Vaccination Day 1
28 to 35 Days After Visit 
1
175 to 189 Days After
Visit 1
Day relative to start of 
study intervention
administration (Day 1).
Type of Visit
Clinic
Telehealth
Clinic
Telehealth
Perform physical 
examination (including 
height and weight)
X
Physical examinations to 
be completed before 
administration of study 
intervention.
Measure prevaccination 
temperature
X
If the temperature is 
38°C (100.4°F), 
vaccination delay criteria 
apply. See Section 5.5.
Collect nonstudy vaccine 
information
X
X
X
X
Collect prohibited 
medication use
X
X
X
X
Confirm eligibility
X
Review temporary delay 
criteria
X
Collect blood sample for 
immunogenicity
~5 mL for children 
10 years of age and 
~10 mL for children 10 to 
18 years of age
~5 mL for children 
10 years of age and 
~10 mL for children 10 to 
18 years of age
Any AEs occurring up to 
48 hours after the blood 
draw must be recorded 
(see Section 8.4.1).
Collect blood sample for
PBMC isolation
Up to 1 mL per year of 
age, but no more than 
10 mL
Up to 1 mL per year of 
age, but no more than 
10 mL
Any AEs occurring up to 
48 hours after the blood 
draw must be recorded 
(see Section 8.4.1).
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 22
Visit Number
Abbreviations used in this 
table may be found in 
Appendix 7.
1
2
3
4
Notes
Visit Description
Screening and 
Vaccination
1-Week 
Follow-Up Visit
1-Month 
Follow-Up Visit
6-Month 
Follow-Up Visit
Visit Window (Days)
Day 1
6 to 8 Days After 
Vaccination Day 1
28 to 35 Days After Visit 
1
175 to 189 Days After
Visit 1
Day relative to start of 
study intervention
administration (Day 1).
Type of Visit
Clinic
Telehealth
Clinic
Telehealth
Perform RSV serostatus test 
(for children 2 to <5 years of 
age only).
X
RSV serostatus must be 
tested and seropositivity 
confirmed prior to 
vaccination (for 
participants 2 to <5 years 
of age). 
Obtain randomization
number and study 
intervention allocation
X
Study intervention 
administration
X
See Section 6.1 for 
additional information.
Assess acute reactions for 
at least 30 minutes after 
study intervention 
administration
X
See Section 6.1.1 for 
additional information.
Provide instructions on 
the reactogenicity e-diary 
completion requirements 
to the participant’s 
parent(s)/legal guardian 
and assist with 
downloading the app or 
issue a provisioned 
device, if required
X
Parent(s)/legal guardian 
will record reactogenicity 
events each evening for 
7 days, starting on the day 
of vaccination.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 23
Visit Number
Abbreviations used in this 
table may be found in 
Appendix 7.
1
2
3
4
Notes
Visit Description
Screening and 
Vaccination
1-Week 
Follow-Up Visit
1-Month 
Follow-Up Visit
6-Month 
Follow-Up Visit
Visit Window (Days)
Day 1
6 to 8 Days After 
Vaccination Day 1
28 to 35 Days After Visit 
1
175 to 189 Days After
Visit 1
Day relative to start of 
study intervention
administration (Day 1).
Type of Visit
Clinic
Telehealth
Clinic
Telehealth
Provide thermometer and 
measuring device
X
See Section 8.3 for 
additional information.
Review reactogenicity 
e-diary data (daily review 
is optimal during the 
active diary period)
Days 1 through 7
Contact the participant if 
they report a severe 
reaction or fever in their 
e-diary; arrange an 
unscheduled visit if 
required
Days 1 through 7
Review ongoing 
reactogenicity e-diary 
symptoms reported as 
present on the last day of the 
e-diary reporting period and 
obtain stop dates
X
X
X
Ongoing reactogenicity 
e-diary events must be 
followed up to obtain stop 
dates as described in 
Section 8.3.4.
Collect AEs as appropriate
X
X
X
See Section 8.4 for 
additional information.
Collect SAEs, AESIs, and 
NDCMCs as appropriate
X
X
X
X
See Section 8.4 for 
additional information.
Collect reactogenicity 
e-diary device, if applicable
X
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 24
2. INTRODUCTION
RSVpreF is being investigated for the prevention of RSV disease in 2- to 5-year-old 
children and in 5- to 18-year-old children with high-risk chronic medical conditions.
2.1. Study Rationale
RSV is the primary viral cause of LRTI among infants and young children globally.1
A recent review of the global RSV burden estimated that, worldwide, RSV causes 3.6 million 
hospitalizations each year among children under 5 years of age, most of which occur in 
infants.2 However, emerging evidence suggests that RSV disease not only occurs at a high
rate in infancy, but also causes medically attended illness throughout the first 5 years of 
life.3,4,5,6,7,8 The burden of RSV among healthy children 5 years of age and older is less 
frequently studied; however, it is well established that certain underlying medical conditions,
including cystic fibrosis, medically treated asthma, other chronic respiratory diseases and 
malformations of the lung, Down syndrome, neuromuscular disorders, cerebral palsy, and 
hemodynamically significant or symptomatic congenital heart disease, predispose children to
increased risk of morbidity due to RSV.6,9,10,11,12 In this study, children will be considered
“high risk” of increased morbidity due to RSV if they are 5 to 18 years of age and have 1 of 
the aforementioned chronic medical conditions, or if they are 2 to 5 years of age and have 
1 of the aforementioned chronic medical conditions or are healthy. The younger age group is
considered at risk based on age alone.
Currently, there is no vaccine prophylaxis approved for use in children 2 to <18 years of age
to protect against RSV disease. A prophylactic humanized monoclonal antibody, palivizumab 
(Synagis, AstraZeneca), that binds the RSV F glycoprotein, is recommended for use only in 
high-risk infants, and can prevent infant RSV disease.13,14 A newer humanized monoclonal 
antibody targeting the prefusion conformation of RSV F glycoprotein, nirsevimab 
(Beyfortus, AstraZeneca and Sanofi), was recently approved to prevent RSV LRTD in 
neonates and infants born during or entering their first RSV season and for children up to 
24 months of age who remain vulnerable to severe RSV disease through their second RSV 
season.15
However, antibodies that are currently licensed or in development for children 2 years of 
age may be impractical for older children because of the challenges around administration of 
an appropriate volume and the limited half-life compared to the period of risk in children up 
to 5 years of age. With the lack of antiviral therapies for treatment of RSV disease, the 
limited usefulness of monoclonal antibody prophylaxis, and the absence of a licensed vaccine 
to prevent RSV disease, there exists an unmet medical need for agents that can provide 
prophylaxis against RSV disease in children 2 to 5 years of age and children 5 to 18 years 
of age who are at high risk of RSV disease.
Study C3671016 is a Phase 1 study of the safety, tolerability, and immunogenicity of 
RSVpreF in children 2 to 18 years of age, including children 5 to 18 years of age with 
high-risk medical conditions.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 25
2.2. Background
In a recent review of the global RSV burden, the annual rate of RSV-associated 
hospitalization for children 1 to 5 years of age in high-income countries was 1.6 per 1000.2
Studies conducted in Europe corroborate this global review and have shown that 
RSV-associated hospitalization still occurs after infancy, with rates between 6.4 and 15.0 per 
1000 annually among 1-year-olds and between 0.6 and 2.3 per 1000 annually among children 
2 to 4 years of age.3,4 Studies in the US and UK have shown similar ranges of RSV disease 
burden estimates for these age groups.3,4,5
In addition to the hospitalized burden of RSV among children 1 to 5 years of age, research 
suggests that RSV may also cause a significant outpatient burden in this age group. 
A population-based study conducted by the US CDC showed that when looking at all 
medically attended cases of RSV (ie, hospitalized and outpatient), 78% occurred in children 
1 to 5 years of age. This finding highlighted that a larger burden of RSV-associated disease 
exists in this age group than previously thought.7 Therefore, it is commonly considered that 
children in this age group are at higher risk for RSV disease. Furthermore, household studies 
assessing RSV transmission patterns suggest that children 1 to 5 years of age may be the 
primary reservoirs for RSV transmission within families. These data suggest that prevention 
of RSV in this age group may help indirectly protect young children who are at highest risk 
of hospitalization and severe disease.16,17,18 Despite these studies, there remains a knowledge 
gap on the full disease burden and potential vaccine benefit for this age group.7
On 31 May 2023 and 21 Aug 2023, the FDA approved RSVpreF for marketing in individuals 
60 years of age and older and in pregnant individuals, respectively.19,20 On 23 Aug 2023, the 
European Commission granted marketing authorization for RSVpreF to help protect infants 
through maternal immunization and to protect older adults.21 Additional applications are 
under review by other regulatory agencies around the world.
Because of the history of vaccine-mediated RSV disease enhancement following 
immunization of RSV-naïve infants in the 1960s with an FI-RSV,22 this study will be limited 
to seropositive children only and will assess T-cell responses to RSVpreF, specifically the 
Th1/Th2 profile. Unlike the FI-RSV vaccine, RSVpreF is an F glycoprotein subunit
stabilized in the prefusion conformation and thus elicits a high ratio of neutralizing to 
nonneutralizing antibodies more closely matching the profile in naturally exposed individuals 
where no disease enhancement has been observed. Furthermore, the vaccine has already 
shown efficacy in preventing LRTI and severe LRTI in older adults and severe LRTI in 
infants born to vaccinated mothers (refer to Section 2.2.1). Available evidence indicates that 
RSVpreF is efficacious and is unlikely to confer any risk of enhanced disease.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 26
2.2.1. Clinical Overview
Adult Program Studies
The older adult program includes 2 Phase 1/2 studies, 3 Phase 3 studies, and a Phase 2a 
human challenge study.

In Phase 1/2 study C3671001, 1233 healthy adults 18 through 49 and 50 through 
85 years of age received the 3 dose levels of RSVpreF (60 µg, 120 µg, and 240 µg), 
with or without Al(OH)3, or placebo, administered with or without concomitant 
influenza vaccine. The results have shown that the vaccine was well tolerated and 
immunogenic in both age groups. RSVpreF elicited robust neutralizing responses 
against RSV A and RSV B 1 month after vaccination for both age groups across all 
vaccine dose levels and formulations; these responses remained high through the 
12 months after vaccination. In 616 vaccinated participants in the 50- through 85-year 
age group, RSV 50% NT GMFRs were high across all arms of the study, ranging 
from 9 to 13 from before vaccination to 1 month after vaccination and from 3 to 
4 from before vaccination to 12 months after vaccination for RSV A and RSV B. 
RSVpreF was safe and well tolerated when administered alone or with SIIV, with no 
major differences observed across all dose levels and formulations. Most reported 
local reactions or systemic events were mild or moderate in severity. The proportions 
of participants reporting AEs were generally similar across RSVpreF groups, and no 
SAEs were considered related to the investigational vaccine.

Phase 1/2 study C3671002, in 250 older adults 65 through 85 years of age, studied 
the 3 dose levels of RSVpreF with Al(OH)3 or CpG/Al(OH)3 (60 µg, 120 µg, and 
240 µg), given as a single dose or on a schedule of 2 doses administered 2 months 
apart. All RSVpreF doses and formulations elicited high RSV A– and 
RSV B–neutralizing antibody GMTs 1 month after vaccination (GMFRs ranging 
from 4.8 to 11.6 and 4.5 to 14.1, respectively). CpG-containing formulations did not 
further increase neutralizing GMTs compared to RSVpreF with or without Al(OH)3. 
GMTs in all groups declined, but remained higher than baseline (before vaccination) 
and placebo (SIIV only) 12 months after vaccination (GMFRs ranging from 2.1 to 
3.5 and 2.2 to 4.3, respectively). No increase in GMTs was observed 1 month after 
Vaccination 2 (GMFR of 0.9). All doses and formulations were safe and well 
tolerated.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 27

C3671014 is a completed Phase 3, multicenter, parallel-group, placebo-controlled, 
randomized, double-blind lot-consistency study in a population of up to 1000 healthy 
adults 18 to ≤49 years of age. The study examined the immune response and the 
safety and tolerability profiles across 3 manufactured lots of RSVpreF when 
administered as a single 120-µg dose to healthy adults. The primary analyses showed 
that the ratios of neutralizing GMTs for the 3 manufactured RSVpreF lots 1 month 
after vaccination were equivalent, and that the 120-µg dose of RSVpreF was well 
tolerated and has an acceptable safety profile.

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the 
Safety, Immunogenicity and Efficacy of a Respiratory Syncytial Virus Vaccine 
(RSVpreF) in a Virus Challenge Model in Healthy Adults (NCT04785612) was 
conducted by hVIVO in 70 healthy participants 18 to 50 years of age. Participants
received a single dose of either 120 µg RSVpreF or placebo and 4 weeks later 
underwent intranasal challenge with RSV-A Memphis 37b virus. The 
immunogenicity and efficacy of RSVpreF vaccination on virus replication, clinical 
symptoms, and incidence of symptomatic RSV infection following the intranasal 
challenge were evaluated. The primary analysis of the human challenge study showed 
that a 120-µg dose of RSVpreF was well tolerated and has an acceptable safety 
profile. The study demonstrated 100% efficacy of RSVpreF against 
RT-PCR–confirmed symptomatic infection.

C3671013 is an ongoing Phase 3, multicenter, randomized, double-blind, 
placebo-controlled study to assess the safety, immunogenicity, and efficacy of 
Pfizer’s RSVpreF in prevention of RSV-associated LRTI in adults 60 years of age 
and older. Both healthy adults and adults with stable chronic cardiopulmonary 
conditions are included. Approximately 10% of participants with stable chronic 
cardiopulmonary conditions such as COPD, asthma, or CHF have been enrolled. 
The study enrolled over 37,000 participants, randomized to receive RSVpreF or 
placebo in a 1:1 ratio. This is an event-driven study with a target of 59 first episodes 
of evaluable RSV-associated LRTI cases. Interim analysis results in August 2022 
showed protection against LRTI-RSV defined by 2 or more symptoms, with VE of
66.7%. VE of 85.7% was observed in participants with a more severe disease primary 
endpoint of LRTI-RSV defined by analysis of 3 or more RSV-associated symptoms. 
The vaccine was well tolerated, with no safety concerns.23 On 31 May 2023, the FDA 
approved RSVpreF for individuals 60 years of age and older in the US.19 On 23 
August 2023, RSVpreF was also granted marketing authorization within the EU for 
active immunization of adults 60 years of age and older for the prevention of LRTD
caused by RSV.21
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 28

C3671006 is a Phase 3, multicenter, parallel-group, placebo-controlled, randomized, 
double-blind study nearing completion. 1407 healthy adults ≥65 years of age were
randomized 1:1 to either a coadministration group or a sequential-administration 
group. The intention was to demonstrate that the immune responses generated when a 
120-µg RSVpreF dose was coadministered with SIIV were noninferior to the immune 
responses when these products were administered 4 weeks apart. The safety and 
tolerability of RSVpreF were also examined. The study has yet to be analyzed.
Maternal Program Studies
The maternal program includes Phase 2b and Phase 3 studies in pregnant women and a 
Phase 2b study in nonpregnant women.

C3671003 is a completed Phase 2b multicenter, randomized, placebo-controlled study 
in up to 650 healthy pregnant women 18 through 49 years of age who received 
RSVpreF at 120 µg and 240 µg, formulated with or without Al(OH)3, or placebo. 
The final analysis provided evidence of the good tolerability and safety of RSVpreF 
in maternal vaccine recipients and the safety of maternal vaccination with RSVpreF 
for the infant.

C3671004 is a completed Phase 2b study of 713 healthy nonpregnant women 
18 through 49 years of age. A total of 709 participants received 120 µg RSVpreF or 
240 µg RSVpreF with Al(OH)3 or placebo, administered with or without concomitant 
Tdap. The study demonstrated a good safety and tolerability profile, high immune 
responses, and noninferiority of the responses to RSVpreF when coadministered with 
Tdap, with RSV A and RSV B 50% NT GMRs of 0.97 and 0.96 at 1 month after 
vaccination.

C3671008 is a completed Phase 3, multicenter, randomized, double-blinded, 
placebo-controlled study designed to evaluate the efficacy and safety of maternal 
immunization with RSVpreF against MA-LRTI in infants. Healthy participants 
≤49 years of age between 24 and 36 weeks’ gestation received either RSVpreF 
120 µg or the placebo. The study enrolled approximately 7400 pregnant individuals. 
Primary analysis results (data cutoff: September 2022) demonstrated a VE of 81.8% 
against severe MA-LRTI due to RSV in infants from birth through the first 90 days of 
life, with a high efficacy of 69.4% demonstrated through the first 6 months of 
life. RSVpreF was well tolerated with no safety concerns for both vaccinated 
individuals and their newborns.24 Based on these data, approval of RSVpreF for the 
protection of infants through maternal immunization was received in the US and EU,
with additional applications under review by regulatory agencies around the 
world.20,21
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 29
2.3. Benefit/Risk Assessment
RSV is the primary viral cause of LRTI among infants and young children globally.1
There is no approved direct vaccination to help protect against RSV disease in children. 
There is a prophylactic humanized monoclonal antibody, palivizumab (Synagis, 
AstraZeneca), that binds the RSV F glycoprotein, is recommended for use only in high-risk 
infants, and can prevent infant RSV disease.13,14 A newer humanized monoclonal antibody 
targeting the prefusion conformation of RSV F glycoprotein, nirsevimab (Beyfortus, 
AstraZeneca and Sanofi), was recently approved to prevent RSV LRTD in neonates and 
infants born during or entering their first RSV season and for children up to 24 months of age 
who remain vulnerable to severe RSV disease through their second RSV season. However, 
antibodies that are currently licensed or in development for children 2 years of age may be 
impractical for older children because of the challenges around administration of an 
appropriate volume and the limited half-life compared to the period of risk in children up to 
5 years of age. With the lack of antiviral therapies for treatment of RSV disease, the limited 
usefulness of monoclonal antibody prophylaxis, and the absence of a licensed vaccine to 
prevent RSV disease, there exists an unmet medical need for agents that can provide 
prophylaxis against RSV disease to children 2 to 5 years of age, and children 5 to 18 years 
of age who are at high risk of RSV-associated LRTI.
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of RSVpreF may be found in the IB, which is the SRSD for this study.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 30
2.3.1. Risk Assessment
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s): RSVpreF
Pfizer has identified the most common 
risks for RSVpreF as local reactions, 
such as injection site redness, injection 
site swelling, and injection site pain;
and systemic events, such as fatigue, 
headache, diarrhea, joint pain, nausea, 
vomiting, muscle pain, and fever.
Guillain-Barré syndrome has been 
identified as a potential risk for 
RSVpreF.
Other events of interest include atrial 
fibrillation, polyneuropathy, preterm 
birth, and hypertensive disorders of 
pregnancy.
The identified adverse reactions in local 
product labels may vary depending on 
the requirements of the respective 
regulatory authorities (eg, EU-SmPC 
and USPI).
These are common adverse reactions seen with 
other vaccines as well as RSVpreF.
Data available from completed and ongoing 
studies showed a low incidence of severe or 
serious events, and no clinically concerning 
safety observations. The vaccine appears to be 
safe and well tolerated across the safety 
population and within demographic subgroups 
based on age, sex, and race/ethnicity.
In Study C3671013, conducted in adults 
60 years of age and older, there was 1 case of 
Guillain-Barré syndrome and 1 case of Miller 
Fisher syndrome with a plausible temporal 
relationship with vaccination. Both cases had 
confounding factors or alternative etiologies. 
In Study C3671013, conducted in adults 
60 years of age and older, there was a 
nonsignificant numerical imbalance in the 
number of cases of atrial fibrillation reported for 
individuals who received RSVpreF compared to 
individuals who received the placebo. Most of
the participants who had atrial fibrillation and 
received RSVpreF had a pre-existing medical 
history of atrial fibrillation and/or cardiac 
disease.
In Study C3671008, conducted in pregnant 
individuals, there were no statistically 
meaningful imbalances between RSVpreF and 
placebo recipients in the overall rates of preterm 
birth (5.7% [95% CI: 4.9, 6.5] versus 4.7% 
[95% CI: 4.1, 5.5], respectively). 

The study employs the use of a reactogenicity e-diary, which 
allows the investigator to monitor local reactions and systemic 
events in real time through an electronic portal.  Severe 
reactions will require an unscheduled telephone call, and visit 
if required, to be conducted per protocol.

Collection of AEs and SAEs throughout the study. 

IRC to review all safety data.

All participants will be observed for at least 30 minutes after 
vaccination.

Specific references to risks and events of interest are made 
within the ICD, with reporting instructions if a case is 
suspected.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 31
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s): RSVpreF
However, a numerical imbalance was observed 
in upper-middle-income countries between 
RSVpreF and placebo recipients. Outcomes in 
the premature infants were similar between the 2
groups.
In Study C3671008, conducted in pregnant 
individuals there was a non-significant 
numerical imbalance in hypertensive disorders 
of pregnancy reported for participants who 
received RSVpreF compared to participants who 
received the placebo.  
The majority of preterm and hypertensive 
disorders occurred more than 30 days following 
vaccination.
Theoretical risk for RSV enhancement.
RSVpreF is being evaluated in ongoing clinical 
studies. Pfizer’s immunization approach 
circumvents the risk of vaccine-mediated disease 
enhancement that was observed in the 1960s 
following direct immunization of RSV-naive 
infants with an FI-RSV. FI-RSV elicited a 
predominantly nonneutralizing antibody 
response and a Th2-biased cell-mediated 
response, both of which are considered potential 
contributing factors to disease enhancement. 
During preclinical studies, in a standard cotton 
rat infectious RSV challenge model, the FI-RSV 
showed pathological signs of causing disease 
enhancement, and the current Pfizer vaccine 
candidate, RSVpreF, did not. Unlike the 
FI-RSV, RSVpreF is an F glycoprotein subunit 
stabilized in the prefusion conformation. 
RSVpreF elicits strong neutralizing antibodies 
(and a high neutralizing to nonneutralizing ratio) 
as established in the adult studies and has 

Assessments of AEs and SAEs will be collected and reviewed 
throughout the study.

The study will be limited to seropositive children only and will 
assess the cellular response (Th1/Th2 balance) to RSVpreF. 
Th1- and Th2-specific cytokines will be used as a surrogate to 
characterize the cellular immune response and predisposition to 
enhanced disease.

Assessment of individual cases for disease enhancement is 
challenging based on current understanding of the mechanism 
of pathogenesis, thus evaluations of any adverse or unexpected 
imbalances in severe RSV cases may provide insight into a 
potential signal for this theoretical risk.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 32
Potential Risk of Clinical 
Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s): RSVpreF
already shown efficacy in preventing LRTI in 
older adults and severe LRTI in infants born to 
vaccinated mothers (refer to Section 2.2.1). 
Available evidence indicates that RSVpreF is 
efficacious and is unlikely to confer any risk of 
enhanced disease.
Study Procedures
Venipuncture will be performed during 
the study.
There is the risk of bleeding, bruising, 
hematoma formation, and infection at the 
venipuncture site.

Only appropriately qualified personnel will obtain the blood 
draw.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 33
2.3.2. Benefit Assessment
Benefits to individual participants enrolled may be:

Receipt of a potentially efficacious RSV vaccine.

Contributing to research to help others.
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 RSVpreF are justified by the anticipated benefits that may be 
afforded to participants.
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS
Objectives
Endpoints
Estimands
Primary:
Primary:
Primary:
To describe the safety and 
tolerability of RSVpreF at each 
dose level in children 5 to 18 years 
of age and children 2 to 5 years of 
age.
Prompted local reactions (pain 
at the injection site, redness, 
and swelling).
Prompted systemic events 
(fever, vomiting, diarrhea, 
headache, fatigue/tiredness, 
muscle pain, and joint pain).
AEs.
SAEs.
NDCMCs.
In participants receiving 1 dose of 
study intervention at each dose 
level, for each age stratum:

The percentage of participants 
reporting local reactions 
within 7 days after 
vaccination.

The percentage of participants 
reporting systemic events 
within 7 days after 
vaccination.

The percentage of participants 
reporting AEs from 
vaccination through 1 month 
after vaccination.

The percentage of participants 
reporting SAEs throughout the 
study.

The percentage of participants 
reporting NDCMCs 
throughout the study.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 34
Objectives
Endpoints
Estimands
Secondary:
Secondary:
Secondary:
To describe the immune response 
elicited by RSVpreF at each dose 
level in children 5 to 18 years of 
age and children 2 to 5 years of 
age.
RSV A and RSV B NTs.
In participants in compliance with 
the key protocol criteria (evaluable 
immunogenicity population):

GMTs of NT for RSV A and 
RSV B 1 month after 
vaccination.

GMTs of NT for RSV A and 
RSV B before vaccination.

GMFRs of NT for RSV A and 
RSV B from before 
vaccination to 1 month after 
vaccination.
To describe the cell-mediated 
immune response in children 
5 to <18 years of age and children 
2 to <5 years of age.
RSV F antigen–specific 
CD4+ T cells secreting IFN.
RSV F antigen–specific 
CD4+ T cells secreting IL-4.
In participants in compliance with 
the key protocol criteria (evaluable 
immunogenicity population):

Median frequencies of RSV
F antigen–specific 
CD4+ T cells expressing IFN
before vaccination and 
1 month after vaccination.

Median frequencies of RSV
F antigen–specific 
CD4+ T cells expressing IL-4 
before vaccination and 
1 month after vaccination.
4. STUDY DESIGN
4.1. Overall Design
This is a Phase 1, open-label, age-descending, dose-finding study of the safety, tolerability, 
and immunogenicity of RSVpreF in RSV-seropositive children 2 to <18 years of age.
Participants will be divided into 2 age strata: 5 to <18 years and 2 to <5 years. All 
participants will receive 1 dose of RSVpreF.
A single dose of RSVpreF 120 µg will be administered to the older age stratum first. Upon 
confirmation of an acceptable safety assessment by the IRC, dose administration will proceed 
in the 2- to <5-year age stratum with 60 µg. Pending IRC approval, the younger age stratum 
will receive 120 µg of vaccine. The IRC may also request that a dose of RSVpreF 60 µg be 
given in the older age stratum.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 35
Dependent upon safety and/or immunogenicity data generated during the course of this 
study, it is possible that dose levels may not be started, may be terminated early, and/or may 
be added with dose levels below the lowest stated dose.
Stopping rules will apply as detailed in Section 8.3.5.
All participants within the 2- to <5-year age stratum will require a blood sample to be taken 
at the screening visit to assess serostatus, and only those who are seropositive can be enrolled 
and administered RSVpreF on Day 1. All participants 5 years of age and older will be 
considered RSV seropositive and will not require a screening test.
All participants will have blood drawn prior to vaccination on Day 1 and 1 month after 
vaccination to assess immune response elicited after vaccination with RSVpreF. An 
additional whole blood sample will be obtained prior to vaccination on Day 1 and 1 month 
after vaccination for PBMC isolation. An analysis of prespecified cytokines will be 
conducted to describe postvaccination cell-mediated immune responses 1 month after 
vaccination.
4.1.1. Number of Participants
This is an open-label dose-finding study. A single dose of RSVpreF 120 µg will be given to 
approximately 40 participants in the 5- to <18-year age stratum first, equally divided between 
healthy children and those with high-risk chronic medical conditions. Upon IRC approval, a 
dose of 60 µg will be given to 20 participants in the 2- to <5-year age stratum. If, per the 
IRC, 60 µg is safe and tolerable, another 20 participants in the 2- to <5-year age stratum will 
receive the 120-µg dose. The IRC may also request that a single dose of RSVpreF 60 µg be 
given to approximately 40 participants in the 5- to <18-year age stratum. Dependent upon 
safety and/or immunogenicity data generated during the course of this study, it is possible 
that dose levels may not be started, may be terminated early, and/or may be added with dose 
levels below the lowest stated dose. Approximately 60 to 120 participants are expected to be 
enrolled in the Phase 1 cohort. See Table 1.
Table 1.
Participants
Age Stratum (Years)
Number of Participants
2 to 5
~20/~20a
5 to 18
~40/~40a,b
Total
~60-120
a.
Up to 2 dose levels of RSVpreF (120 µg and 60 µg) will be tested in participants.
b.
Approximately 40 participants 5 to 18 years old will be enrolled in this study, with ~20 healthy 
participants and ~20 participants with high-risk chronic medical conditions receiving each dose level.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 36
4.1.2. Intervention Groups and Duration
Dose finding will begin with 120 µg of RSVpreF in participants 5 to 18 years of age. The 
IRC will review safety data (e-diary and AEs) acquired up to 7 days after dose administration
once a minimum of 10 and up to approximately 40 participants have been vaccinated. Upon 
confirmation of an acceptable safety assessment by the IRC, dose administration may 
commence with 60 µg in participants 2 to 5 years of age. The same process with an IRC 
review of safety data (e-diary and AEs) acquired up to 7 days after dose administration at the 
low-dose level from participants 2 to 5 years of age will be followed before administering 
the 120-µg dose to this younger stratum.
In the 2- to 5-year age stratum, if 60 µg is considered unacceptable based on the safety 
assessment, administration of the 120-µg dose level will not commence. In this case, an 
optional lower dose level may commence. Upon IRC review, RSVpreF 60 µg may also be 
given to participants in the 5- to 18-year age stratum.
Duration: The study duration for each participant will be approximately 6 months.
4.2. Scientific Rationale for Study Design
See Section 2.1.
4.2.1. Diversity of Study Population
Reasonable attempts will be made to enroll participants with the distribution of 
characteristics to ensure that the study population is representative of the population that will 
use RSVpreF in clinical practice.
4.3. Justification for Dose
The dose and formulation plan for this study is to start with 120 µg RSVpreF without any 
adjuvants in participants 5 to 18 years of age, before initiating the 60-µg dose level.
The FIH study in adults 18 through 85 years of age evaluated the safety, tolerability, and 
immunogenicity of 3 escalating RSVpreF dose levels of 60 µg, 120 µg, and 240 µg, with or 
without Al(OH)3, when administered alone or concomitantly with SIIV (Study C3671001).
A study in older adults 65 through 85 years of age evaluated the safety, tolerability, and 
immunogenicity of 60-µg, 120-µg, and 240-µg RSVpreF doses formulated with 
Al(OH)3 or a CpG/Al(OH)3 adjuvant, or 240 µg RSVpreF with RSV antigens alone, when 
administered concomitantly with SIIV (Study C3671002).
A Phase 3 study in adults 65 years of age and older evaluated the safety, tolerability, and 
immunogenicity of 120 µg RSVpreF when administered concomitantly with 
SIIV (Study C3671006).
A study in healthy adults 18 through 50 years of age evaluated the safety, immunogenicity, 
and efficacy of 120 µg RSVpreF in a virus challenge model (NCT04785612).
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 37
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.
A participant is considered to have completed the study if he/she has completed all periods of 
the study, including the last visit.
5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled, including 
participants across diverse and representative racial and ethnic backgrounds. If a 
prescreening tool is utilized for study recruitment purposes, it will include collection of 
information that reflects the enrollment of a diverse participant population including, where 
permitted under local regulations, age, sex, race, and ethnicity. 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. Participants 2 to 18 years of age at enrollment (signing of the ICD or providing 
assent to participate) at Visit 1.
Disease Characteristics:
2. Participants 2 to 18 years of age should either be healthy or be considered by the 
investigator to be at high risk of RSV disease based on the presence of 1 of the 
following chronic medical conditions9,10,25:

Cystic fibrosis

Medically treated asthma

Other chronic respiratory diseases and malformations of the lung

Down syndrome

Neuromuscular disease

Cerebral palsy
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 38

Hemodynamically significant or symptomatic congenital heart disease
Details of the chronic medical conditions listed above are further defined in the 
investigator site file.
Other Inclusion Criteria:
3. All participants 2 to 5 years of age must be seropositive for RSV as confirmed by 
serology.
4. Participants’ parent(s)/legal guardian(s) and participants, as age appropriate, who are 
willing and able to comply with all scheduled visits, investigational plan, laboratory 
tests, and other study procedures. Participants’ parent(s)/legal guardian(s) should be 
available for telephone contact with site staff for the duration of the study.
5. The participant’s parent(s)/legal guardian is 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. Depending on the 
age of the participant and according to local requirements, participants will also be 
asked to provide assent as appropriate (verbal or written).
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. Immunocompromised individuals associated with known or suspected 
immunodeficiency, as determined by history and/or laboratory/physical examination.
2. Individuals with a history of autoimmune disease or an active autoimmune disease 
requiring therapeutic intervention, including but not limited to systemic lupus 
erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
3. 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.
4. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention(s).
5. Bleeding diathesis or condition associated with prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular injection.
6. Individuals with a history of epilepsy or other seizure disorders, or a history of 
seizures and/or other neurological complications following vaccination.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 39
Prior/Concomitant Therapy:
7. Previous vaccination with any licensed or investigational RSV vaccine or planned 
receipt during study participation. Children who may have been exposed to 
investigational RSV vaccines through maternal immunization will be permitted.
8. Receipt of investigational or approved monoclonal antibodies against RSV within 
6 months before study intervention administration, or planned receipt throughout the 
study.
9. Receipt of blood/plasma products or immunoglobulins within 28 days before study 
intervention administration, or planned receipt throughout the study.
10. Receipt of chronic systemic treatment with known immunosuppressant medications 
(including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 
60 days before study intervention administration, or planned receipt throughout the 
study.
Note: Systemic corticosteroids are defined as those administered for ≥14 days at a 
dose of ≥20 mg/day of prednisone or equivalent (eg, for cancer or an autoimmune
disease). Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) 
corticosteroids are permitted.
Prior/Concurrent Clinical Study Experience:
11. Participation in other studies involving study intervention within 28 days prior to 
study entry and/or for the duration of study participation.
Diagnostic Assessments:
Not applicable.
Other Exclusion Criteria:
12. Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and sponsor 
delegate employees directly involved in the conduct of the study and their family 
members.
5.3. Lifestyle Considerations
There are no lifestyle restrictions required for the participants in this study.
All pregnancies discovered in female participants during the study participation, which 
begins after obtaining informed consent as described in Section 8.4.1, will be recorded in the 
CRF in addition to completing the EDP (Section 8.4.5.1) and EDB (Section 8.4.5.2) reporting 
processes.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 40
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently enrolled in the study. 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, and any SAEs.
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened under a different participant number.
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Administration of 
Study Intervention
The following conditions may allow a participant to be vaccinated once the conditions have 
resolved and the participant is otherwise eligible:

Current febrile illness (temperature ≥38.0°C [≥100.4°F]) or other acute illness within 
48 hours before study intervention administration.

Receipt of any live vaccine within 28 days before study intervention administration. 
Receipt of any nonlive vaccine (including COVID-19 vaccines authorized for 
temporary or emergency use) within 14 days before study intervention administration.

Anticipated receipt of any nonstudy vaccine within 14 days after study intervention 
administration at Visit 1 (before Day 15).

Receipt of short-term (14 days) systemic corticosteroids (equivalent of ≥20 mg/day
of prednisone). Study intervention administration should be delayed until systemic 
corticosteroid use has been discontinued for at least 28 days. Inhaled/nebulized, 
intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are 
permitted.
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study interventions are all prespecified investigational and medical devices and other 
interventions (eg, surgical and behavioral) intended to be administered to the study 
participants during the study conduct.
For the purposes of this protocol, study intervention refers to RSVpreF.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 41
6.1. Study Intervention(s) Administered
Study Intervention(s)
Intervention Name
PF-06928316 (RSVpreF)
Arm Name
(group of participants receiving 
a specific vaccine or no vaccine)
Active vaccine group
Unit Dose Strength(s)
120 µg and/or 60 µg
Type
Vaccine
Dose Formulation
The active ingredients in RSVpreF are 2 stabilized RSV prefusion 
F antigens, in equal amounts from virus subgroups A and B, in a 
lyophilized dosage form for reconstitution. The RSVpreF formulation 
will contain 120 µg of the RSV prefusion F antigen. RSVpreF is 
supplied as a lyophilized white cake in a 2-mL glass vial, with a 13-mm 
lyophilization stopper, aluminum overseal, and flip-off cap.
RSVpreF will be reconstituted by a diluent consisting of sterile water in 
a PFS. The lyophilized RSVpreF formulation contains excipients that, 
after reconstitution, will yield a solution as detailed in the IB. The fill 
volume of the RSVpreF vial and diluent PFS are designed such that the 
120-µg vaccine dose is delivered by injecting the entire contents of the 
syringe.
The 60-µg vaccine dose is delivered by injecting 0.25 mL of a 
graduated syringe content.
Route of Administration
Intramuscular
Use
Experimental
IMP or NIMP/AxMP
IMP
Sourcing
Provided centrally by the sponsor
Packaging and Labeling
The vaccine will be packaged within cartons labeled by Pfizer or its 
designee in accordance with current guidelines and applicable local and 
legal regulatory requirements.
Study Arms(s)
Arm Title
Active vaccine
Arm Type
Experimental
6.1.1. Administration
Participants will receive 1 dose of study intervention at the vaccination visit (Day 1) in 
accordance with the study’s SoA. The study intervention will be administered 
intramuscularly by injecting the entire contents of the syringe (for 120 µg RSVpreF) or 
0.25 mL of a graduated syringe content (for 60 µg RSVpreF) into the deltoid muscle, 
preferably of the nondominant arm, unless medically contraindicated, in which case the 
injection may be administered in the dominant arm. Study intervention administration will be 
performed by appropriately designated study staff at the investigator site.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 42
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 for the reconstitution diluent for the study 
intervention (RSVpreF or placebo). The study intervention supplies are provided in a kit that 
contains the study intervention (RSVpreF or placebo lyophilized powder in a vial), a PFS 
containing sterile water, and a vial adapter.
Instructions for medical device use are provided in the IPM.
All medical device deficiencies (including malfunction, use error, and inadequate labeling) 
shall be documented and reported by the investigator throughout the clinical investigation 
(see Section 10.6) and appropriately managed by the sponsor.
6.2. Preparation, Handling, Storage, and Accountability
1. The investigator or designee must confirm that appropriate conditions
(eg, temperature) have been maintained during transit for all study interventions 
received and any discrepancies are reported and resolved before use of the study 
intervention.
2. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply, prepare, and/or administer study intervention.
3. 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 upon 
return to business.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 43
4. Any excursions from the study intervention label storage conditions should be 
reported to Pfizer upon discovery along with actions taken. The site should actively 
pursue options for returning the study intervention to labeled storage conditions, 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 excursion definition and information to 
report for each excursion will be provided to the site in the IPM.
5. Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the label. See the IPM for storage conditions of the study 
intervention once reconstituted.
6. Study interventions should be stored in their original containers.
7. The investigator, institution, head of the medical institution (where applicable), 
or authorized site staff 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 IPM. 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 IPM.
6.2.1. Preparation and Dispensing
See the IPM 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. A second staff member will verify the dispensing.
Study intervention will be prepared by qualified site personnel according to the IPM or 
package insert, and the study intervention will be administered in an open-label manner.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 44
6.3. Assignment to Study Intervention
The study intervention to be dispensed to the participant will be assigned using an IRT 
system. The site will utilize the IRT system to assign the DU or container number(s) prior to 
the start of study intervention administration for each participant. The site will record the 
study intervention assignment on the applicable CRF, if required.
Study intervention will be dispensed at the study visit(s) summarized in the SoA.
6.4. Blinding
6.4.1. Blinding of Participants
This is an open-label study. Participants and their caregivers will be unblinded to their 
assigned study intervention.
6.4.2. Blinding of Site Personnel
The study is open-label, and all site personnel, including the investigator, investigator staff, 
and study staff receiving, storing, dispensing, preparing, and administering the study 
interventions, will be unblinded.
Please refer to the IPM for further details.
6.4.3. Blinding of the Sponsor
To facilitate rapid review of data in real time, sponsor staff will be unblinded to study 
intervention allocation for the participants throughout the study.
6.4.4. Breaking the Blind
Not applicable. 
6.5. Study Intervention Compliance
When participants are dosed at the site, they will receive study intervention directly from 
the investigator or designee, under medical supervision. The date and time, as well as the 
anatomical location of each dose administered in the clinic, will be recorded in the source 
documents, and recorded in the CRF. The dose of study intervention and study participant 
identification will be confirmed at the time of dose administration by a member of the study 
site staff other than the person administering the study intervention.
6.6. Dose Modification
Not applicable.
6.7. Continued Access to Study Intervention After the End of the Study
No study intervention will be provided to participants at the end of their study participation. 
It is expected that participants will be treated as required with standard-of-care treatments, as 
advised by their usual care physician.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 45
6.8. Treatment of Overdose
For this study, any dose of study intervention greater than 1 dose of study intervention within 
a 24-hour time period will be considered an overdose.
In the event of an overdose, the investigator should:
1. Contact the study medical monitor within 24 hours.
2. Closely monitor the participant for any AEs/SAEs as medically appropriate and at 
least until the next scheduled follow-up.
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 study medical monitor as needed based on the clinical evaluation of the 
participant.
6.9. Prior and Concomitant Therapy
The following concomitant medications, vaccinations, and treatments will be recorded in the 
CRF:

Any vaccinations received from 28 days prior to study enrollment until the last study 
visit.

Prohibited medications and treatments listed in Section 6.9.1 if taken, will be 
recorded, including start and stop dates, name of the medication, dose, unit, route, and 
frequency.
6.9.1. Prohibited Concomitant Vaccinations and Treatments

Receipt of any nonstudy RSV vaccine at any time prior to or during study 
participation.

Receipt of investigational or approved monoclonal antibodies against RSV within 
6 months prior to or during study participation.

Investigational vaccines, drugs, or medical devices are prohibited during the course of 
the study. Note: COVID-19 vaccines authorized for temporary, or emergency use will 
not be prohibited during the course of this study if administered more than 14 days 
prior to study intervention administration or at least 14 days (from Day 15 onwards) 
after study intervention administration.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 46

Receipt of blood/plasma products or immunoglobulin, from 28 days before study 
intervention administration and thereafter during the course of the study.

Nonstudy vaccines may not be given concomitantly with the study intervention or 
within 14 days after study intervention administration (Day 1 through Day 14), except 
if medically necessary (eg, during an outbreak or pandemic situation).

Receipt of chronic systemic treatment with known immunosuppressant medications 
other than systemic corticosteroids meeting the criteria noted below, within 60 days
of administration of study intervention, through conclusion of the study.

Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for 
≥14 days is prohibited from 28 days prior to enrollment through Day 28 after 
administration of study intervention (Day 1).

Prophylactic antipyretics and other pain medication to prevent symptoms associated 
with study intervention administration are not permitted. However, if a participant is 
taking a medication for another condition, even if it may have antipyretic or 
pain-relieving properties, it should not be withheld prior to study vaccination.
6.9.2. Permitted Concomitant Vaccinations and Treatments

Licensed vaccines may be given during the study starting 14 days after study 
intervention administration (Day 15).

Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) 
corticosteroids are permitted.

The use of antipyretics and other pain medication to treat symptoms associated with 
study intervention administration is permitted during the participant’s participation in 
the study.
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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 47
7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at their own request. Reasons for 
discontinuation from the study include the following:

Refused further study procedures;

Lost to follow-up;

Death;

Study terminated by sponsor;

AEs;

Participant request;

Investigator request;

Protocol deviation.
If a participant withdraws from the study, the participant’s parent(s)/legal guardian 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.
A participant may discontinue from the study procedure but continue to participate in 
protocol-specified AE-monitoring activities as outlined in Section 1.3, as long as the 
participant or participant’s parent(s)/legal guardian does not withdraw consent.
If the participant’s parent(s)/legal guardian or a child who has provided assent during 
any phase of the study withdraws from the study and also withdraws consent/assent 
(Section 7.2.1) for disclosure of further information, no further evaluations will be performed 
and no additional data will be collected. The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.
Lack of completion of all or any of the withdrawal/early-termination procedures will not be 
viewed as protocol deviations so long as the participant’s safety was preserved.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 48
7.2.1. Withdrawal of Consent
Participants who request (or whose parent[s]/legal guardian requests) 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 or 
participant’s parent(s)/legal guardian specifically withdraws consent for any further contact 
with them or persons previously authorized by the participant or participant’s parent(s)/legal 
guardian to provide this information. Participants or participants’ parent(s)/legal guardians
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 the participant repeatedly fails to return 
for scheduled visits and the participant or participant’s parent(s)/legal guardian is unable to 
be contacted by the study site.
The following actions must be taken if a participant and participant’s parent(s)/legal guardian 
fail to attend a required study visit:

The site must attempt to contact the participant’s parent(s)/legal guardian and 
reschedule the missed visit as soon as possible. Counsel the participant’s 
parent(s)/legal guardian on the importance of maintaining the assigned visit schedule, 
and ascertain whether the participant’s parent(s)/legal guardian wishes for the 
participant to and/or whether the participant should continue in the study;

Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant’s parent(s)/legal guardian 
(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’s parent(s)/legal guardian continue to be unreachable, the 
participant will be considered to have withdrawn from the study.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 49
8. STUDY ASSESSMENTS AND PROCEDURES
8.1. Administrative 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.
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.
Procedures conducted as part of the participant’s routine clinical management (eg, blood 
count) and obtained before signing of the ICD may be utilized for screening or baseline 
purposes provided the procedures met the protocol-specified criteria and were performed 
within the time frame defined in the SoA.
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 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 they have 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.
The total blood sampling volume for individual participants in this study is expected to be no 
more than 40 mL.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 50
8.1.1. 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 participations at scheduled visits per the SoA or unscheduled 
visits.
Telehealth visits may be used to assess participant safety and collect data points. Telehealth 
includes the exchange of healthcare information and services via telecommunication 
technologies (eg, audio, video, videoconferencing 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 (see the SoA):

Review and record any AEs and SAEs since the last contact. Refer to Section 8.4.

Review and record any new concomitant medications or changes in concomitant 
medications since the last contact.

Procedures as indicated for  unscheduled visits for fever or a Grade 3 or suspected 
Grade 4 reactions 
(Section 8.11).
Study participants or participants’ parent(s)/legal guardians must be reminded to
promptly notify site staff about any change in the participant’s health status.
8.2. Efficacy and/or Immunogenicity Assessments
8.2.1. Efficacy Assessments 
There are no efficacy assessments in this study.
8.2.2. Immunogenicity Assessments
RSV serostatus will be determined for participants 2 to 5 years of age prior to vaccination at 
Visit 1.
Blood samples (approximately 5 mL per sample for children 10 years of age and 10 mL 
for children 10 to 18 years of age) will be collected from participants for immunogenicity 
testing at both Visit 1 and Visit 3 (refer to Section 1.3, SoA). RSV A– and 
RSV B–neutralizing antibody titers will be measured for each blood sample at each time 
point and reported as the NTs.
Additionally, all participants will provide blood samples for PBMCs (approximately 1 mL 
per year of age but no more than 10 mL), to be collected at both Visit 1 and Visit 3. PBMC 
samples will be used to characterize the cell-mediated immune response through measuring 
RSV F antigen–specific CD4+ T cells secreting IFNand F antigen–specific CD4+ T cells 
secreting IL-4. Instructions for the collection and handling of biological samples will be 
provided in the laboratory manual.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 51
8.2.3. Biological Samples
Blood samples will be used only for scientific research. Each sample will be labeled with 
a code so that the laboratory analyst testing the samples will not know the participant’s 
identity, study visit, or study cohort associated with the sample. 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 vaccines or 
vaccine-related products, and/or for vaccine-related assay work supporting vaccine programs. 
No testing of the participant’s DNA will be performed using blood samples including those 
for PBMC isolation.
The participant or the participant’s parent(s)/legal guardian may request that the participant’s
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/DNA is performed.
8.3. Safety Assessments
Planned time points for all safety assessments are provided in the SoA. Unscheduled safety 
measurements may be obtained at any time during the study to assess any perceived safety 
issues.
A clinical assessment, including medical history, will be performed on all participants at their 
first visit to establish a baseline. Significant medical history and observations from any 
physical examination will be documented in the CRF.
AEs and SAEs will be collected, recorded, and reported as defined in Section 8.4.
The participant will have his or her body temperature measured prior to each vaccination and 
will be observed for at least 30 minutes after vaccination. Any acute reactions within the first 
30 minutes after administration of the study intervention will be assessed and documented in 
the AE CRF.
The safety parameters also include reactogenicity e-diary reports of local reactions and 
systemic events (including fever) that occur in the 7 days after administration of the study 
intervention. The e-diary device will prompt the participant or the participant’s 
parent(s)/legal guardian to report these self-collected occurrences of local reactions and 
systemic events. These participant-reported local reactions and systemic events (including 
fever) are graded as described in Section 8.3.4.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 52
8.3.1. Physical Examinations
A physical examination will be performed at Visit 1. A brief physical examination will 
include, at a minimum, measurement of height and weight, assessments of general 
appearance, lungs, cardiovascular system, and lymph node survey as applicable.
Investigators should pay special attention to clinical signs related to previous serious 
illnesses.
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 (Appendix 2) must be reported according to the processes in 
Section 8.4.1 to Section 8.4.3.
8.3.2. Vital Signs
The participant’s prevaccination temperature will be measured as per usual clinical practice.
Any untoward vital sign findings that are identified during the active collection period and 
meet the definition of an AE or SAE (Appendix 2) must be reported according to the 
processes in Section 8.4.1 to Section 8.4.3.
8.3.3. Clinical Safety Laboratory Assessments
Clinical safety laboratory assessments will not be collected in this study.
8.3.4. Reactogenicity Electronic Diary
The participant or participant’s parent(s)/legal guardian will be required to complete a 
reactogenicity e-diary after each vaccination. These participants or participants’ 
parent(s)/legal guardians will be asked to monitor and record local reactions, systemic events,
and temperature for 7 days from the day of administration of the study intervention. The 
reactogenicity e-diary allows recording of these assessments only within a fixed time 
window, thus providing an accurate representation of the participant’s experience at that 
time. Data on local reactions and systemic events reported in the reactogenicity e-diary will 
be transferred electronically to a third-party vendor, where they will be continually available 
for review by investigators, Pfizer clinicians, and other selected study team members via an 
internet-based portal.
At intervals agreed to by the vendor and Pfizer, these data will be transferred electronically 
into Pfizer's database for analysis and reporting. These data do not need to be reported by the 
investigator in the CRF as AEs.
Investigators (or designee) will be required to review the reactogenicity e-diary data online at 
frequent intervals as part of the ongoing safety review.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 53
The investigator or designee must obtain stop dates from the participant or participant’s 
parent(s)/legal guardian for any reactions ongoing on the last day that the reactogenicity
e-diary was completed. The stop dates should be documented in the source documents and 
the information entered in the CRF.
Please note that all provisioned e-diary devices must be collected at the end of Visit 3
(1-month follow-up visit) per the SoA.
8.3.4.1. Grading Scales
The grading scales used in this study to assess local reactions and systemic events as 
described below are derived from the FDA CBER guidelines on toxicity grading scales for 
healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials,26 with 
adaptations for applicability to healthy younger children.
8.3.4.2. Local Reactions
During the reactogenicity e-diary reporting period, participants or participants’ parents/legal 
guardians will be asked to assess redness, swelling, and pain at the injection site and to 
record the symptoms in the reactogenicity e-diary daily for 7 days (Days 1 through 7) after 
each vaccination. If a local reaction persists beyond the end of the reactogenicity e-diary 
period following vaccination, the participant or participant’s parent(s)/legal guardian will be 
requested to report that information. The investigator will enter this additional information in 
the CRF.
Participants will be provided with a measuring device. Redness and swelling will be 
measured and recorded in caliper units (measuring device units; range: 1 to 14 caliper units 
for participants ≥2 to 12 years of age and 1 to 21 caliper units for participants ≥12 to 
18 years of age) for the first 7 days following vaccination (Days 1 through 7), and then 
categorized as absent, mild, moderate, or severe using the scale shown in Table 2. Measuring 
device units can be converted to centimeters according to the following formula: 1 measuring 
device unit = 0.5 cm. Pain at the injection site will be assessed by the participants or 
participants’ parent(s)/legal guardians as absent, mild, moderate, or severe according to the 
grading scale in Table 2.
If a Grade 3 local reaction is reported in the reactogenicity e-diary (redness or swelling 
14 caliper units for participants 12 years of age or 20 caliper units for participants 
≥12 years of age; Grade 3 pain at the injection site), a telephone contact should occur to 
ascertain further details and determine whether a site visit is clinically indicated. Only an 
investigator or medically qualified person is able to classify a participant’s local reaction as 
Grade 4. If a participant experiences a confirmed Grade 4 local reaction, the investigator 
must immediately notify the sponsor and, if it is determined to be related to the 
administration of the study intervention, further vaccinations (if applicable) will be 
discontinued in that participant.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 54
Table 2.
Local Reaction Grading Scale
Participant
Age
Mild
(Grade 1)
Moderate
(Grade 2)
Severea
(Grade 3)
Potentially 
Life-Threateningb
(Grade 4)
Pain at 
the 
injection 
site
≥2 Years
Does not 
interfere with 
activity
Interferes with 
activity
Prevents daily 
activity
Emergency room visit or 
hospitalization for severe 
pain at the injection site
Redness
≥2 Years to
12 years
1 to 4 caliper 
units (or 
measuring 
device units)
= 0.5 to 2.0 cm
5 to 14 caliper 
units (or 
measuring 
device units)
= >2.0 to 7.0 cm
>14 caliper units 
(or measuring 
device units)
= >7 cm
Necrosis or exfoliative 
dermatitis
≥12 Years
5 to 10 caliper 
units (or 
measuring 
device units)
= >2.0 to 5.0 cm
11 to 20 caliper 
units (or 
measuring 
device units)
= >5.0 to 10.0 
cm
>20 caliper units 
(or measuring 
device units)
= >10 cm
Necrosis or exfoliative 
dermatitis
Swelling
≥2 Years to
12 years
1 to 4 caliper 
units (or 
measuring 
device units)
= 0.5 to 2.0 cm
5 to 14 caliper 
units (or 
measuring 
device units)
= >2.0 to 7.0 cm
>14 caliper units 
(or measuring 
device units)
= >7 cm
Necrosis
≥12 Years
5 to 10 caliper 
units (measuring 
device units)
= >2.0 cm to 
5.0 cm
11 to 20 caliper 
units (measuring 
device units)
= >5.0 cm to 
10.0 cm
>20 caliper units 
(or measuring 
device units)
= >10 cm
Necrosis
a.
Parent(s)/legal guardians of participants 12 years of age experiencing local reactions 14 caliper units 
(7 cm), participants or parent(s)/legal guardians of participants ≥12 years of age experiencing local 
reactions 20 caliper units (10 cm), and parent(s)/legal guardians of participants experiencing Grade 3 
pain at the injection site are to be contacted by the study site. An unscheduled visit may be required.
b.
Only an investigator or qualified designee is able to classify a participant’s local reaction as Grade 4, 
after clinical evaluation of the participant or documentation from another medically qualified source 
(eg, emergency room or hospital record). Grade 4 local reactions will be collected on the AE CRF and 
assessed by the investigator using the AE intensity grading scale as detailed in Section 10.2.3.
8.3.4.3. Systemic Events
During the reactogenicity e-diary reporting period, participants or participants’ 
parent(s)/legal guardians will be asked to assess vomiting, diarrhea, headache, 
fatigue/tiredness, muscle pain, and joint pain and to record the symptoms in the 
reactogenicity e-diary. The symptoms will be assessed by the participant or participant’s 
parent(s)/legal guardian as absent, mild, moderate, or severe according to the grading scale 
in Table 3.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 55
If a Grade 3 systemic event is reported in the reactogenicity e-diary, a telephone contact 
should occur to ascertain further details and determine whether a site visit is clinically 
indicated. Only an investigator or medically qualified person is able to classify a participant’s 
systemic event as Grade 4. If a participant experiences a confirmed Grade 4 systemic event, 
the investigator must immediately notify the sponsor and, if it is determined to be related to 
the administration of the study intervention, further vaccinations (if applicable) will be 
discontinued in that participant.
Table 3.
Systemic Event Grading Scale for Participants ≥2 Years of Age
Mild
(Grade 1)
Moderate
(Grade 2)
Severe
(Grade 3)
Potentially 
Life-Threatening 
(Grade 4)a
Vomiting
1-2 times in 
24 hours
>2 times in 24 hours Requires IV 
hydration
Emergency room 
visit or 
hospitalization for 
severe vomiting
Diarrhea
2 to 3 loose stools in 
24 hours
4 to 5 loose stools in 
24 hours
6 or more loose 
stools in 24 hours
Emergency room 
visit or 
hospitalization for 
severe diarrhea
Headache
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or
hospitalization for 
severe headache
Fatigue/tiredness
Does not interfere 
with activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe 
fatigue/tiredness
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
a.
Only an investigator or qualified designee is able to classify a participant’s systemic event as Grade 4, 
after clinical evaluation of the participant or documentation from another medically qualified source 
(eg, emergency room or hospital record). Grade 4 local reactions will be collected on the AE CRF and 
assessed by the investigator using the AE intensity grading scale as detailed in Section 10.2.3.
8.3.4.4. Fever
In order to record information on fever, a thermometer will be given to participants with 
instructions on how to measure oral temperature at home. Temperature will be collected in 
the reactogenicity e-diary in the evening daily during the reactogenicity e-diary reporting 
period. It will also be collected at any time during the reactogenicity e-diary data collection 
periods when fever is suspected. Fever is defined as an oral temperature ≥38.0°C (100.4°F). 
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 56
The highest temperature for each day will be recorded in the reactogenicity e-diary. 
Temperature will be measured and recorded to 1 decimal place. Temperatures recorded 
in degrees Fahrenheit will be programmatically converted to degrees Celsius and then 
categorized according to the scale shown in Table 4 during analysis.
If a fever of ≥39.0°C (≥102.1°F) is reported in the reactogenicity e-diary, a telephone contact 
should occur to ascertain further details and determine whether a site visit is clinically 
indicated. Only an investigator or medically qualified person is able to confirm a 
participant’s fever as 40.0°C (104.0°F). If a participant experiences a confirmed fever 
40.0°C (104.0°F), the investigator must immediately notify the sponsor and, if it is 
determined to be related to the administration of the study intervention, further vaccinations 
(if applicable) will be discontinued in that participant.
Table 4.
Scale for Fever
≥38.0-38.4°C (100.4-101.1°F)
38.4-38.9°C (101.2-102.0°F)
38.9-40.0°C (102.1-104.0°F)
40.0°C (104.0°F)
8.3.5. Stopping Rules
The following stopping rules apply by age group and are in place for all participants, based 
on review of AE data and e-diary reactogenicity data, through 30 days after the 
administration of study intervention in each age group. These data will be monitored on an 
ongoing basis by the investigator (or medically qualified designee) and sponsor in order to 
promptly identify and flag any event that potentially contributes to a stopping rule.
The sponsor study team will be unblinded during the study, so they will be able to assess 
whether or not a stopping rule has been met on the basis of a participant’s individual study 
intervention allocation.
In the event that sponsor personnel confirm that a stopping rule is met, the following actions 
will commence:

The IRC will review all appropriate data.

The stopping rule will PAUSE randomization and study intervention administration 
for all dose levels in the impacted age group.

For all participants vaccinated, all other routine study conduct activities, including 
ongoing data entry, reporting of AEs, participant reactogenicity e-diary completion, 
blood sample collection, and participant follow-up, will continue during the pause.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 57
A stopping rule is met if any of the following rules occur after administration of RSVpreF. 
Reactogenicity e-diary data confirmed by the investigator as being entered by the participant 
in error will not contribute toward a stopping rule.
The RSVpreF dose levels within an age group will contribute to stopping rules collectively; 
vaccine candidate dose levels will contribute to stopping rules together.
Stopping Rule Criteria:
1. If any participant vaccinated with RSVpreF at any dose level develops an SAE that is 
assessed by the investigator as possibly related, or for which there is no alternative, 
plausible, attributable cause.
2. If any participant vaccinated with RSVpreF at any dose level develops a Grade 4 
local reaction or systemic event after vaccination (Section 8.3.4) that is assessed as 
possibly related by the investigator, or for which there is no alternative, plausible, 
attributable cause.
3. If any participant vaccinated with RSVpreF at any dose level develops a fever 
40.0°C (104.0°F) for at least 1 daily measurement after vaccination (see
Section 8.3.4.4) that is assessed as possibly related by the investigator, or for which 
there is no alternative, plausible, attributable cause.
4. If any 2 participants vaccinated with RSVpreF at any dose level within the same age 
group report the same or similar severe (Grade 3) AE after vaccination that is
assessed as possibly related by the investigator, or for which there is no alternative, 
plausible, attributable cause. Note that the local reactions, systemic events, and fever 
specified in Section 8.3.4 reported within 7 days of (Day 1 through Day 7) 
administration of the study intervention, irrespective of whether they are recorded in 
the e-diary or as AEs, are excluded from this stopping rule.
5. If there is an ICU admission or participant death that is assessed by the investigator to 
be attributed to RSV infection, all available clinical and preclinical data should be 
reviewed to evaluate for RSV vaccine–elicited ERD.
8.3.6. Randomization and Vaccination After a Stopping Rule Is Met 
Once the IRC has reviewed the safety data and provided guidance, a notification will be sent 
from the sponsor to the sites with guidance on how to proceed.
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting
The definitions of an AE and an SAE can be found in Appendix 2.
The definitions of device-related safety events (ADEs and SADEs) can be found in 
Section 10.6. Device deficiencies are covered in Section 8.4.9.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 58
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).
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 8.4.1, each participant’s 
parent(s)/legal guardian/legally authorized representative 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.
8.4.1. 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’s parent(s)/legal guardian
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 3. In addition, AEs occurring up to 48 hours after 
blood draws  that are related to study procedures must be reported in the CRF.
SAEs, AESIs, and NDCMCs will be collected from the time the participant’s parent(s)/legal 
guardian provides informed consent through the duration of the study.
Follow-up by the investigator continues throughout the active collection period and until the 
AE or SAE or its sequelae resolve or stabilize at a level acceptable to the investigator.
When a clinically important AE remains ongoing at the end of the active collection period, 
follow-up by the investigator continues until the AE or SAE or its sequelae resolve or 
stabilize at a level acceptable to the investigator and Pfizer concurs with that assessment.
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 from the 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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 59
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 they consider 
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.
8.4.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period as described in
Section 8.4.1 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 
Appendix 2. The investigator will submit any updated SAE data to the sponsor within 
24 hours of its being available.
8.4.1.2. 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 8.4.1, 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.
As part of ongoing safety reviews conducted by the sponsor, any nonserious AE that is 
determined by the sponsor to be serious will be reported by the sponsor as an SAE. To assist 
in the determination of case seriousness, further information may be requested from the 
investigator to provide clarity and understanding of the event in the context of the clinical 
study.
8.4.2. 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 Appendix 2.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant or participant’s parent(s)/legal guardian is 
the preferred method to inquire about AE occurrences.
8.4.3. 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).
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 60
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 provided in Appendix 2.
8.4.4. 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.
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.
8.4.5. 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 EDP, EDB, and occupational exposure.
Any such exposures to the study intervention under study are reportable to Pfizer Safety 
within 24 hours of investigator awareness.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 61
8.4.5.1. 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 
inseminates a female partner.

A female nonparticipant is found to be pregnant while being exposed or having been 
exposed to study intervention because of 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 inadvertent product 
administration via needlestick or skin contact.

A male family member or healthcare provider who has been exposed to the study 
intervention by inadvertent product administration via needlestick or skin contact
then inseminates his female partner prior to or around the time of conception.
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/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 the 
participant’s last visit of the study.

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 
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 62
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), 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 should be reported 
as an SAE;

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.
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.
8.4.5.2. Exposure During Breastfeeding
An EDB occurs if:

A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention.

A female nonparticipant is found to be breastfeeding while being exposed or having 
been exposed to study intervention (ie, environmental exposure). An example of 
environmental EDB is a female family member or healthcare provider who reports 
that she is breastfeeding after having been exposed to the study intervention by
injection or skin contact.
The investigator must report EDB 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 EDB 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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 63
An EDB report is not created when a Pfizer drug specifically approved for use in 
breastfeeding women (eg, vitamins) is administered in accordance with authorized use. 
However, if the infant experiences an SAE associated with such a drug, the SAE is reported 
together with the EDB.
8.4.5.3. 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.
8.4.6. Cardiovascular and Death Events
Not applicable.
8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable.
8.4.8. Adverse Events of Special Interest

Diagnosis of Guillain-Barré syndrome

Diagnosis of acute polyneuropathy without an underlying etiology

Diagnosis of atrial fibrillation

Preterm delivery (delivery at <37 0/7 weeks’ gestation)

Diagnosis of a hypertensive disorder of pregnancy
Details of the AESIs listed above are further defined in the investigator site file.
AESIs are examined as part of routine safety data review procedures throughout the clinical 
trial and as part of signal detection processes. Should an aggregate analysis indicate that 
these prespecified events occur more frequently than expected, eg, based on epidemiological 
data, literature, or other data, then this will be submitted and reported in accordance with 
Pfizer’s safety reporting requirements. Aggregate analyses of safety data will be performed 
on a regular basis per internal SOPs. 
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 64
All AESIs must be reported as an AE or SAE following the procedures described in 
Sections 8.4.1 through Section 8.4.4. An AESI is to be recorded as an AE or SAE on the 
CRF. In addition, an AESI that is also an SAE must be reported via PSSA or using the 
Vaccine SAE Reporting Form. The active collection period for AESIs is from the signing of 
the ICD until the end of the study for all participants.
8.4.8.1. Lack of Efficacy
This section is not applicable for this study, as efficacy is yet to be demonstrated in the study 
population.
8.4.9. Medical Device Deficiencies
Medical devices being provided for use in this study are those listed in Section 6.1.2. 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 6.
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 8.4.1 through Section 8.4.4 and 
Appendix 2 of the protocol.
8.4.9.1. 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 10.6.
8.4.9.2. 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.
New or updated information will be recorded on a follow-up form with all changes signed 
and dated by the investigator.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 65
8.4.9.3. Prompt Reporting of Device Deficiencies to the Sponsor
When a device deficiency occurs:
1. The investigator notifies the sponsor by a contact method as detailed in the IPM
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 nonserious) 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 8.4.1.1). 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 8.4.1.1
and Section 8.4.1.2.
The sponsor will be the contact for the receipt of device deficiency information.
8.4.9.4. 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.
8.4.10. Vaccination Errors
Vaccination 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.
Vaccination errors are recorded and reported as follows:
Recorded on the 
Vaccination Error Page 
of the CRF
Recorded on the 
Adverse Event Page 
of the CRF
Reported on the Vaccine 
SAE Reporting Form to 
Pfizer Safety Within 
24 Hours of Awareness
All (regardless of whether 
associated with an AE)
Any AE or SAE associated 
with the vaccination error
Only if associated with an 
SAE
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 66
Vaccination errors include:
1. Vaccination errors involving participant exposure to the study intervention;
2. Potential vaccination errors or uses outside of what is foreseen in the protocol that do or 
do not involve the study participant;
3. The administration of expired study intervention;
4. The administration of an incorrect study intervention;
5. The administration of an incorrect dosage;
6. The administration by an incorrect route;
7. 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 vaccination errors occurring to a study participant are to be captured on the vaccination
error page of the CRF, which is a specific version of the AE page.
Whether or not the vaccination error is accompanied by an AE, as determined by the 
investigator, the vaccination error is recorded on the vaccination error page of the CRF and, 
if applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of 
the CRF.
In the event of a vaccination dosing error, the sponsor should be notified within 24 hours.
Vaccination errors should be reported to Pfizer Safety within 24 hours on a Vaccine SAE 
Reporting Form only when associated with an SAE.
8.5. Pharmacokinetics
Pharmacokinetic parameters are not evaluated in this study.
8.6. Genetics
8.6.1. Specified Genetics
Specified genetic analyses are not evaluated in this study.
8.7. Biomarkers
Biomarkers are not evaluated in this study.
8.8. Immunogenicity Assessments
Immunogenicity assessments are described in Section 8.2.2.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 67
8.9. Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
8.10. Study Procedures
8.10.1. Visit 1 – Screening and Vaccination Visit (Clinic; Day 1)
Voluntary, written, study-specific informed consent (from the participant’s parent[s]/legal 
guardian), and assent (from the participant, where appropriate), will be obtained before 
enrollment and before any study-related procedures are performed. Each signature on the 
ICD must be personally dated by the signatory. The investigator or his or her designee 
will also sign the ICD. A copy of the signed and dated ICD must be given to the 
participant/participant’s parent(s)/legal guardian. The source data must reflect that the 
informed consent (and assent if appropriate) was obtained before participation in the study.
It is anticipated that the procedures below will be conducted in a stepwise manner; ensure 
that procedures listed prior to administration of the investigational vaccine are conducted 
prior to study vaccination. If screening and vaccination are not on the same day, all 
procedures listed as “on the day of and prior to vaccination” must be conducted prior to 
vaccination and on the day of the vaccination.

Assign a single participant number using the IRT system.

Obtain the participant’s demography (including date of birth, sex, race, and ethnicity). 
The full date of birth will be collected to critically evaluate the immune response and 
safety profile by age.

Obtain the participant’s medical history of clinical significance.

On the day of and prior to vaccination, perform a physical examination, including, at a 
minimum, measurement of height and weight, assessments of general appearance, lungs, 
cardiovascular system, and lymph node survey.

For participants 2 to 5 years of age: This procedure must be repeated on the day of 
and prior to vaccination if serostatus results will not be available on the same day as 
vaccination.

On the day of and prior to vaccination, measure the participant’s temperature as per usual 
clinical practice.

For participants 2 to 5 years of age: This procedure must be repeated on the day of 
and prior to vaccination if serostatus results will not be available on the same day as 
vaccination.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 68

All eligible participants will proceed to complete the vaccination visit.

Record nonstudy vaccinations as described in Section 6.9.

Obtain details of prohibited medication used as described in Section 6.9.1.

On the day of and prior to vaccination, ensure and document that all of the inclusion 
criteria and none of the exclusion criteria are met.

On the day of and prior to vaccination, ensure that the participant meets none of the 
temporary delay criteria as described in Section 5.5.

On the day of and prior to vaccination, collect a blood sample (approximately 5 mL for 
children 10 years of age and approximately 10 mL for children 10 to 18 years of age) 
for immunogenicity.

On the day of and prior to vaccination, collect a blood sample for PBMC isolation.

On the day of and prior to vaccination, children 2 to 5 years of age will have RSV 
serostatus tested.
Note: Participants 2 to 5 years of age who are seropositive can be enrolled and 
administered RSVpreF on Day 1. All participants 5 years of age and older will be 
considered RSV seropositive and will not require a screening test.

On the day of and prior to vaccination, obtain the participant’s randomization number and 
study intervention allocation using the IRT system. Refer to the IRT manual for further 
instructions on this process.

Qualified site staff member(s) will administer a single dose of study intervention into the 
deltoid muscle of the (preferably) nondominant arm, unless medically contraindicated, in 
which case the injection may be administered in the dominant arm. Please refer to the 
IPM for further instruction on this procedure.

Site staff must observe the participant for at least 30 minutes after study intervention 
administration for any acute reactions. Record any acute reactions (including time of 
onset) in the participant’s source documents and on the AE page of the CRF, and on an 
SAE form as applicable.

Explain the e-diary technologies available for this study (see Section 8.3.4) and assist the 
participant’s parent(s)/legal guardian in downloading the study application onto his or her 
own device or issue a provisioned device if required.

Issue a measuring device to measure local reactions at the injection site and a 
thermometer for recording daily temperatures and provide instructions on their use.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 69

Provide instructions on reactogenicity e-diary completion and ask the participant’s 
parent(s)/legal guardian to complete the reactogenicity e-diary from Day 1 through 
Day 7, with Day 1 being the day of vaccination.

Ask the participant’s parent(s)/legal guardian, as appropriate, to contact the site staff or 
investigator immediately if the participant experiences any of the following from Day 1 
through Day 7 after vaccination (where Day 1 is the day of vaccination) to determine if 
an unscheduled reactogenicity visit is required:

Fever ≥39.0°C (102.1°F).

Redness or swelling at the injection site 14 caliper units (or 7 cm) for children 
12 years old and/or 20 caliper units (or 10 cm) for children ≥12 years old.

Grade 3 pain at the injection site.

Any severe systemic event.

If the participant doesn’t call, the site should contact the participant to determine if an 
unscheduled reactogenicity visit is required.

Record AEs, SAEs, AESIs, and NDCMCs as described in Section 8.4.

Ask the participant’s parent(s)/legal guardian to contact the site staff or investigator 
immediately if a medically attended event (eg, doctor’s visit, emergency room visit) 
or hospitalization occurs.

Schedule an appointment for the participant’s next study visit.

Complete the source documents.

The investigator or an authorized designee completes the CRFs and the 
dispenser/administrator completes the study intervention accountability records.

The investigator or appropriately qualified designee reviews the reactogenicity e-diary 
data online following vaccination to evaluate participant compliance and as part of the 
ongoing safety review. Daily review is optimal during the active diary period.
8.10.2. Visit 2 – 1-Week Follow-Up Visit (Telehealth; 6 to 8 Days After Vaccination on
Day 1)

Contact the participant’s parent(s)/legal guardian by telephone.

Obtain details of any nonstudy vaccinations and prohibited concomitant medications and 
treatments as described in Section 6.9.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 70

Review the participant’s reactogenicity e-diary data. Collect stop dates of any 
reactogenicity e-diary events ongoing on the last day that the reactogenicity e-diary was 
completed and record stop dates in the CRF if required.

Record AEs, SAEs, AESIs, and NDCMCs as described in Section 8.4.

Schedule an appointment for the participant’s next study visit.

Remind the participant’s parent(s)/legal guardian to bring the e-diary to the next visit.

Complete the source documents.

The investigator or an authorized designee completes the CRFs.
8.10.3. Visit 3 – 1-Month Follow-Up Visit (Clinic; 28 to 35 Days After Visit 1)

Obtain details of any nonstudy vaccinations and prohibited concomitant medications and 
treatments as described in Section 6.9.

Collect a blood sample (approximately 5 mL for children 10 years of age and 
approximately 10 mL for children 10 to 18 years of age) for immunogenicity.

Collect a blood sample for PBMC isolation.

Review ongoing reactogenicity e-diary symptoms reported as present on the last day of 
the e-diary and obtain stop dates. Record stop dates in the CRF if required.

Record AEs, SAEs, AESIs, and NDCMCs as described in Section 8.4.

Ask the participant’s parent(s)/legal guardian to contact the site staff or investigator if a 
medically attended event (eg, doctor’s visit, emergency room visit) or hospitalization 
occurs.

Collect the participant’s e-diary or assist the participant with removing the study 
application from his or her own personal device (if this has not been done already).

Schedule an appointment for the participant for the next study visit.

Complete the source documents.

The investigator or an authorized designee completes the CRFs.
8.10.4. Visit 4 – 6-Month Follow-Up Visit (Telehealth; 175 to 189 Days After Visit 1)

Contact the participant’s parent(s)/legal guardian by telephone.

Obtain details of any nonstudy vaccinations as detailed in Section 6.9.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 71

Record details of any of the prohibited medications specified in Section 6.9.1. Review 
ongoing reactogenicity e-diary symptoms reported as present on the last day of the 
e-diary and obtain stop dates. Record stop dates in the CRF if required.

Record SAEs, AESIs, and NDCMCs as described in Section 8.4.

Complete the source documents.

The investigator or an authorized designee completes the CRFs.
8.11. Unscheduled Visit for Fever or a Grade 3 or Suspected Grade 4 Reaction
If a participant or participant’s parent(s)/legal guardian reports redness or swelling 
14 caliper units (or 7 cm) for participants 12 years of age and 20 caliper units 
(or 10 cm) for participants ≥12 years of age or a Grade 3 local reaction (Table 2), any 
Grade 3 systemic event (Table 3), or fever 39.0°C (102.1°F) (Table 4) in the reactogenicity 
e-diary, a telephone contact should occur to ascertain further details and determine whether a 
site visit is clinically indicated. If suspected Grade 4 local reaction (Table 2), systemic event 
(Table 3), or fever 40.0°C (104.0°F) (Table 4) is reported in the reactogenicity e-diary, a 
telephone contact or site visit should occur to confirm whether the event meets the criteria for 
Grade 4. A site visit must be scheduled as soon as possible to assess the participant unless 
any of the following is true:

The participant is unable to attend the unscheduled visit.

The local reaction/systemic event is no longer present at the time of the telephone 
contact.

The participant or participant’s parent(s)/legal guardian recorded an incorrect value in the 
reactogenicity e-diary (confirmation of a reactogenicity e-diary data entry error).

The PI or authorized designee determined it was not needed.

This telephone contact (or site visit) 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 local reactions/systemic events must be assessed 
at the next study visit.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 72
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:

Measure body 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 Table 2.

Assess systemic events (if present) in accordance with the grades provided in Table 3.

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.
8.12. Communication and Use of Technology
In a study of this nature that requires illness events to be reported outside of scheduled study 
visits, it is vital that communication between the study site and the participant or participant’s 
parent(s)/legal guardian is maintained so that safety events or endpoint events are not missed. 
This study will employ various methods, tailored to the individual participant, to ensure that 
communication is maintained, and study information can be transmitted securely. Using 
appropriate technology, such as a study application, a communication pathway between the 
participant or participant’s parent(s)/legal guardian and the study site staff will be 
established. The participant or participant’s parent(s)/legal guardian may be able to utilize his 
or her own device to access this technology, or use a device provided by the sponsor. 
Traditional methods of telephone communication will also be available. The technology 
solution may facilitate the following:

An alert in the event that the participant is hospitalized.

Visit reminders.

Messages of thanks and encouragement from the study team.

A platform for recording local reactions and systemic events (e-diary). See Section 8.3.4.
If a participant or participant’s parent(s)/legal guardian is not actively completing the 
reactogenicity e-diary, the investigator or designee is required to contact the participant or 
participant’s parent(s)/legal guardian to ascertain the reason and also to obtain details of any 
missed events.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 73
9. STATISTICAL CONSIDERATIONS
Methodology for summary and statistical analyses of the data collected in this study is 
described here and further detailed in the 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 Hypothesis
There is no statistical hypothesis testing in this study.
9.2. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Participant Analysis Set
Description
Enrolled
All participants who have a signed ICD.
Randomized population
All enrolled participants who are assigned a randomization 
number in the IRT system.
Safety population
All enrolled participants who receive the study intervention.
Defined Analysis Set
Description
Evaluable immunogenicity 
population
This population will be defined as all participants who meet 
the following criteria:

Are eligible for the study;

Receive the intervention;

Have the 1-month postvaccination blood collection within 
an appropriate window;

Have at least 1 valid and determinate assay result 1 month 
after vaccination;

Have no major protocol violations from vaccination 
through the 1-month postvaccination blood draw.
mITT immunogenicity 
population
All participants who are randomized and have at least 1 valid 
and determinate assay result at any time point after receiving 
study intervention.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 74
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 in the statistical analysis will be presented as 2-sided at the 95% level 
unless specified otherwise.
The safety analyses are based on the safety population. Participants will be summarized by 
vaccine group according to the study interventions they actually received. Missing AE dates 
will be imputed according to Pfizer safety rules. Completely missing e-diary data (ie, all 
7 days of e-diary collection were missing) will not be imputed. For partially complete e-diary 
data (ie, 1-6 days of reactogenicity data are available), it is expected that these missing 
e-diary days would be queried by the investigator, and any missed reported reactogenicity 
would be entered in the AE CRF; therefore, the primary analysis will use the reactogenicity 
recorded in the AE CRF to impute the partially missed e-diary data to estimate the
reactogenicity rates during the 7-day period.
For all the immunogenicity endpoints, the analysis will be based on the evaluable 
immunogenicity population. An additional analysis will be performed based on the mITT 
population if there is a large enough difference in sample size between the mITT population 
and the evaluable immunogenicity population. 
9.3.1.1. Analyses for Binary Data
Descriptive statistics for categorical variables (eg, proportions) are the percentage (%) and
the numerator (n) and the denominator (N) used in the percentage calculation. 
The exact 95% CI for binary endpoints for each group will be computed using the 
F distribution (Clopper-Pearson).27
9.3.1.2. Analyses for Continuous Data
Unless otherwise stated, descriptive statistics for continuous variables are n, mean, median, 
SD, minimum, and maximum.
9.3.1.2.1. Geometric Means
Continuous immunogenicity endpoints will be logarithmically transformed for analysis. 
Geometric means and associated 2-sided 95% CIs will be derived by calculating group 
means and CIs on the natural log scale based on the t distribution, and then exponentiating 
the results.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 75
9.3.1.2.2. Geometric Mean Fold Rises
GMFRs will be calculated as the group mean of the difference of logarithmically transformed 
assay results (later time point minus earlier time point) and exponentiating the mean. GMFRs 
are limited to participants with nonmissing values at both time points. The associated 2-sided 
95% CIs will be obtained by constructing CIs using the Student t distribution for the mean 
difference on the logarithm scale and exponentiating the confidence limits.
9.3.1.2.3. Reverse Cumulative Distribution Curves
Empirical RCDCs will plot proportions of participants with values equal to or exceeding a 
specified assay value versus the indicated assay value, for all observed assay values. Data 
points will be joined by a step function with the line first going down and then to the right to 
the next assay value.
9.3.2. Primary Endpoint(s)/Estimand(s) Analysis
Table 5.
Primary Endpoint Analyses
Endpoint
Statistical Analysis Methods
Safety

Descriptive statistics will be provided for each reactogenicity endpoint 
for each RSVpreF dose level within each age stratum. Local reactions 
(redness, swelling, and pain at the injection site) and systemic events 
(fever, fatigue/tiredness, headache, vomiting, diarrhea, muscle pain, and 
joint pain) from Day 1 through Day 7 after vaccination will be presented 
by maximum severity and any severity. Descriptive summary statistics 
will include counts and percentages of participants with the indicated 
endpoint and the associated Clopper-Pearson 95% CI (Section 9.3.1.1).

AEs and SAEs will be categorized according to MedDRA terms. All of 
the AEs within 1 month and SAEs/NDCMCs throughout the study will 
be descriptively summarized with counts, percentages, and associated 
Clopper-Pearson 95% CIs for each RSVpreF dose level within each age 
stratum (Section 9.3.1.1).

Descriptive summaries may also be provided for the combined age 
group (2 to 18 years) within the same RSVpreF dose level.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 76
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis
Table 6.
Secondary Endpoint Analyses
Endpoint
Statistical Analysis Methods
Immunogenicity 
GMTs before vaccination and 1 month after vaccination will be 
descriptively summarized with 2-sided 95% CIs for each RSVpreF 
dose level within each age stratum for both RSV A and RSV B 
subgroup NTs (Section 9.3.1.2.1).

GMFRs from before vaccination to 1 month after vaccination will be 
descriptively summarized with 2-sided 95% CIs for each RSVpreF 
dose level within each age stratum for both RSV A and RSV B 
subgroup NTs (Section 9.3.1.2.2).

GMTs, GMFRs, and associated 95% CIs may also be descriptively 
summarized for the combined age group (2 to 18 years) for each 
RSVpreF dose level for both RSV A and RSV B subgroup NTs.

The frequency of CD4+ T cells expressing IFNand the frequency of
CD4+ T cells expressing IL-4 before vaccination and 1 month after 
vaccination will be descriptively summarized.
9.4. Interim Analyses
No interim analysis is planned.
9.4.1. Analysis Timing
As Phase 1 is open-label, the sponsor may conduct reviews of the data during the study for 
the purpose of decision making.
One final analysis will be performed when all data are cleaned.
9.5. Sample Size Determination
Phase 1 enrollment is not based on a statistical criterion.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 77
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, European MDR 2017/745 for clinical device research, 
and all other applicable local regulations.
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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 78
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/Assent Process
The investigator or their representative will explain the nature of the study to the 
participant and their parent(s)/legal guardian and answer all questions regarding the 
study. The participant and their parent(s)/legal guardian should be given sufficient time 
and opportunity to ask questions and to decide whether or not to participate in the trial.
When consent is obtained from a participant’s parent(s)/legal guardian, the participant’s 
assent (affirmative agreement) must be subsequently obtained when the participant has the 
capacity to provide assent, as determined by the IRB/EC. If the investigator determines that a 
participant’s decisional capacity is so limited, they cannot reasonably be consulted, then, as 
permitted by the IRB/EC and consistent with local regulatory and legal requirements, the 
participant’s assent may be waived with source documentation of the reason assent was not 
obtained. If the study participant does not provide their own assent, the source documents 
must record why the participant did not provide assent (for example, the child is not of 
assenting age per local regulations or policies), how the investigator determined that the 
person signing the consent was the participant’s parent(s)/legal guardian, the consent signer’s 
relationship to the study participant, and that the participant’s assent was obtained or 
waived. If assent is obtained verbally, it must be documented in the source documents.
If study participants are minors who reach the age of majority or if a child reaches the age of 
assent (per local IRB/EC requirements) during the study, as recognized under local law, the 
child or adolescent must then provide the appropriate assent or consent to document their
willingness to continue in the study. For an adolescent who reaches the age of consent, 
parental consent would no longer be valid. If the enrollment of emancipated minors is 
permitted by the IRB/EC and local law, the participant must provide documentation of legal 
status to give consent without the permission of a legally authorized representative.
Participants and their parent(s)/legal guardians must be informed that their participation is 
voluntary. The participant’s parent(s)/legal guardian will be required to sign a statement of 
informed consent that meets the requirements of 21 CFR 50, local regulations, ICH 
guidelines, HIPAA requirements, where applicable, and the IRB/EC or study center.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 79
The investigator must ensure that each study participant’s parent(s)/legal guardian and the 
study participant, as applicable, are 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’s parent(s)/legal guardian must be informed that the participant’s 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’s parent(s)/legal 
guardian.
The participant’s parent(s)/legal guardian must be informed that the participant’s 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.
The investigator further must ensure that each study participant’s parent(s)/legal guardian is 
fully informed about their right to access and correct their child’s personal data and to 
withdraw consent for the processing of their child’s personal data, keeping in mind the 
privacy rights that may restrict access of older adolescents’ medical records by their 
parent(s)/legal guardians in certain regions.
The source documentation must include a statement that written informed consent, and as 
applicable, assent, was obtained before the participant was enrolled in the study and the date 
the written consent/assent was obtained. The authorized person obtaining the informed 
consent must also sign the ICD.
Parent(s)/legal guardian and the participant must be reconsented to the most current version 
of the ICD(s)/assent during their participation in the study as required per local regulations.
A copy of the ICD(s) and assent, if written, must be provided to the parent(s)/legal 
guardian and the participant.
If participants are rescreened, the participants’ parent(s)/legal guardians or the participants,
where appropriate, are required to sign a new ICD/assent (as applicable).
10.1.3.1. Electronic Consent 
Participants may be able to experience the informed consent process by electronic means 
(eConsent). The eConsent process includes an electronic presentation of the informed 
consent document (eICD), clinical trial educational components (as applicable), and 
electronic signatures (if allowed by local regulations). The use of eConsent does not replace 
or alter the ICD content or informed consent process as described above. The eConsent 
process complies with applicable regulations and sponsor policies to ensure reliability and 
data privacy.  
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 80
10.1.3.2. Remote Consent 
Participants may be able to experience the informed consent process at their location rather 
than in person at the site. There are 2 types of remote consent, both of which involve the 
participant not being physically present with the study investigator or delegated site staff: 
(1) obtaining consent with the active participation of a PI or delegated site staff during the 
consenting process; and (2) obtaining consent without the active participation of a PI or 
delegated site staff, such as a via a healthcare website or portal.
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 their 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.
Information technology systems used to collect, process, and store study-related data are 
secured by technical and organizational security measures designed to protect such data 
against accidental or unlawful loss, alteration, or unauthorized disclosure or access.
The sponsor maintains SOPs on how to respond in the event of unauthorized access, use, or 
disclosure of sponsor information or systems.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 81
10.1.5. Committees Structure
10.1.5.1. Data Monitoring Committee
This study will use an IRC. The IRC is independent of the study team and includes only 
internal (IRC) members. The IRC charter describes the role of the IRC in more detail.
The responsibility of the IRC will include at a minimum:

Review of safety data in the case of a stopping rule being met.

Review of safety data accumulated for up to 7 days following vaccination of the 
5- to 18-year age group to make a recommendation for commencing dose 
administration in the 2- to 5-year age group.

Review of safety data accumulated for up to 7 days following vaccination of the 
2- to 5-year age group to make a recommendation for dose escalation.

Review of safety and immunogenicity data accumulated from 7 days following 
vaccination of both the 2- to 5-year and 5- to 18-year age groups to make a 
recommendation for dose selection for Phase 2/3.

Review of safety and immunogenicity data accumulated for 1 month following 
vaccination.
The IRC will be responsible for ongoing monitoring of the safety of participants in the study 
according to the charter. The recommendations made by the IRC 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/CTIS, and/or 
www.pfizer.com, and other public registries and websites 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
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 82
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/CTIS
Pfizer posts clinical trial results on EudraCT/CTIS for Pfizer-sponsored interventional studies 
in accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Pfizer posts CSR synopses and plain-language study results summaries on www.pfizer.com 
for Pfizer-sponsored interventional studies at the same time the corresponding study results 
are posted to www.clinicaltrials.gov. CSR synopses will have personally identifiable 
information anonymized.
Documents within marketing applications
Pfizer complies with applicable local laws/regulations to publish clinical documents included 
in marketing applications. Clinical documents include summary documents and CSRs 
including the protocol and protocol amendments, sample CRFs, and SAPs. Clinical 
documents will have personally identifiable information anonymized.
Data sharing
Pfizer provides researchers secure access to participant-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 
18 months after study completion. Participant-level data will be anonymized in accordance 
with applicable privacy laws and regulations. CSRs will have personally identifiable 
information anonymized.
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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 83
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 CSR.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source records and 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.
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 
inspection 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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 84
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 a source document, and its origin can be found in the Source 
Document Locator, which is maintained by the sponsor.
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 record) that supports the 
information entered in the CRF.
The sponsor or designee will perform monitoring 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. Use of Medical Records
In certain situations, sponsor review of redacted copies of participant medical records for 
SAE reporting may be performed, where ethically and scientifically justified and permitted 
by local regulations, to ensure participant safety. 
Due to the potential for a participant to be reidentified from their medical records, the 
following actions must be taken when medical records are sent to the sponsor or sponsor 
designee:

The investigator or site staff must redact personal information from the medical 
record. The personal information includes, but is not limited to, the following: 
participant names or initials, participant dates (eg, birthdate, date of hospital 
admission/discharge, date of death), participant identification numbers (eg, Social 
Security number, health insurance number, medical record number, 
hospital/institution identifier), participant location information (eg, street address, 
city, country, postal code, IP address), participant contact information
(eg, telephone/fax number, email address).

Each medical record must be transmitted to the sponsor or sponsor designee using 
systems with technical and organizational security measures to ensure the protection 
of personal data (eg, Florence is the preferred system if available). 
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 85

There may be unplanned situations where the sponsor may request medical records (eg, 
sharing medical records so that the sponsor can provide study-related advice to the 
investigator). The medical records should be submitted according to the procedure 
described above.
10.1.10. Study and Site Start and Closure
The study start date is the date of the first participant’s first visit.
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, including (but not limited to) 
regulatory authority decision, change in opinion of the IRB/EC, or change in benefit-risk 
assessment. 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.
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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 86
10.1.11. Publication Policy
For multicenter trials, the primary publication will be a joint publication developed by the 
investigator and Pfizer reporting the primary endpoint(s) of the study covering all study sites. 
The investigator agrees to refer to the primary publication in any subsequent publications. 
Pfizer will not provide any financial compensation for the investigator’s participation in the 
preparation of the primary congress abstract, poster, presentation, or primary manuscript for 
the study.
Investigators are free to publish individual center results that they deem to be clinically 
meaningful after publication of the overall results of the study or 12 months after primary 
completion date or study completion at all sites, whichever occurs first, subject to the other 
requirements described in this section.
The investigator will provide Pfizer an opportunity to review any proposed publication or 
any other type of disclosure of the study results (collectively, “publication”) before it is 
submitted or otherwise disclosed and will submit all publications to Pfizer 30 days before 
submission. If any patent action is required to protect intellectual property rights, the 
investigator agrees to delay the disclosure for a period not to exceed an additional 60 days 
upon request from Pfizer. This allows Pfizer 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-intervention or Pfizer-related 
information necessary for the appropriate scientific presentation or understanding of the 
study results. For joint publications, should there be disagreement regarding interpretation 
and/or presentation of specific analysis results, resolution of, and responsibility for, such 
disagreements will be the collective responsibility of all authors of the publication.
For all publications relating to the study, the investigator and Pfizer will comply with 
recognized ethical standards concerning publications and authorship, including those 
established by the International Committee of Medical Journal Editors. The investigator will 
disclose any relationship with Pfizer and any relevant potential conflicts of interest, including 
any financial or personal relationship with Pfizer, in any publications. All authors will have 
access to the relevant statistical tables, figures, and reports (in their original format) required 
to develop the publication.
10.1.12. Sponsor’s Medically Qualified Individual
The contact information for the sponsor’s MQI for the study is documented in the study 
contact list located in the supporting study documentation/study portal or other electronic 
system.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 87
To facilitate access to their investigator and the sponsor’s MQI for study-related medical 
questions or problems from nonstudy healthcare professionals, participants are provided with 
an 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.
The ECC is intended to augment, not replace, the established communication pathways 
between the participant and their investigator and site staff, and between the investigator and 
sponsor study team. The ECC is only to be used by healthcare professionals not involved in 
the research study, as a means of reaching the investigator or site staff related to the care of a 
participant. The Pfizer Call Center number is to be used when the investigator and site staff 
are unavailable. The Pfizer Call Center number is not for use by the participant directly; if a 
participant calls that number directly, they will be directed back to the investigator site.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 88
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 an 
increase in either 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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 89
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.
Hospitalization for elective treatment of a preexisting condition that did not worsen 
from baseline is not considered an AE.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 90
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 nonpathogenic
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.
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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 91
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 EDP or EDB
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 nonparticipant (not 
involving EDP or EDB)
None. Exposure to a study 
nonparticipant 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.

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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 92

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:
GRADE
If required on the AE page of the CRF, the investigator will use the 
adjectives MILD, MODERATE, SEVERE, or LIFE-THREATENING 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.
3
SEVERE
Interferes significantly with participant’s usual 
function.
4
LIFE-THREATENING
Life-threatening consequences; urgent 
intervention indicated.
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.
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 their assessment.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 93

For each AE or SAE, the investigator must document in the medical notes that they 
have reviewed the AE or SAE and have 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 their 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.
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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 94
10.2.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic DCT

The primary mechanism for reporting an SAE to Pfizer Safety will be the electronic 
DCT.

If the electronic system is unavailable, then the site will use the paper SAE DCT
(see next section) to report the event within 24 hours.

The site will enter the SAE data into the electronic DCT (eg, eSAE or PSSA) or paper 
form (as applicable) as soon as the data become available.

After the study is completed at a given site, the electronic DCT 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 DCT 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.
SAE Reporting to Pfizer Safety via the 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, an alternative method should be 
used, eg, secured (Transport Layer Security) or password-protected email. If none of 
these methods can be used, 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.
10.3. Appendix 3: Contraceptive and Barrier Guidance
Not applicable.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 95
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 T bili elevations 
(2 × ULN) by several days or weeks. The increase in T bili typically occurs while AST/ALT 
is/are still elevated above 3 × ULN (ie, AST/ALT and T bili values will be elevated within 
the same laboratory sample). In rare instances, by the time T bili 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 T bili 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 T bili baseline values within the normal range who 
subsequently present with AST OR ALT values ≥3 × ULN AND a T bili 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 T bili 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).
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 96

Preexisting values of T bili above the normal range: T bili level increased from 
baseline value by an amount of ≥1 × ULN or if the value reaches ≥3 × ULN 
(whichever is smaller).
Rises in AST/ALT and T bili 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 T bili 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 
T bili 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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 97
10.5. Appendix 5: Kidney Safety Monitoring Guidelines
10.5.1. Laboratory Assessment of Change in Kidney Function and Detection of Kidney 
Injury
Standard kidney safety monitoring requires assessment of baseline and postbaseline serum 
creatinine (Scr measurement to eGFR [Scr-based eGFR] or [eCrCl]). Baseline and 
postbaseline Scys makes it feasible to distinguish AKI from other causes of Scr increase. If 
Scr increase is confirmed after baseline, then reflex measurement of Scys is indicated to 
estimate the combined Scr-Scys eGFR calculation (for adults only).
Regardless of whether kidney function monitoring tests are required as a routine safety 
monitoring procedure in the study, if the investigator or sponsor deems it necessary to further 
assess kidney safety and quantify kidney function, then these test results should be managed 
and followed per standard of care.
10.5.2. Age-Specific Kidney Function Calculation Recommendations
10.5.2.1. Adolescents (12 Years to <18 Years)—Cockcroft-Gault Formula
CrCl (mL/min)
Males: Cr/Cl = [(140 - age) × body weight (in kg)] / [Scr (in mg/dL) × 72]
Females: Cr/Cl = 0.85 × [(140 - age) × body weight (in kg)] / [Scr (in mg/dL) × 72]
10.5.2.2. Children (2 Years to <12 Years)—Modified Schwartz Equation
CrCl normalized to BSA (mL/min/1.73 m2) = (K × Ht) / Scr
Ht in centimeters; Scr in mg/dL.
K (proportionality constant): Female child <12 years: K = 0.55.
Male child <12 years: K = 0.70.
10.5.3. Adverse Event Grading for Kidney Safety Laboratory Abnormalities
AE grading for decline in kidney function (ie, eGFR or eCrCl) will be according to KDIGO
criteria.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 98
10.6. Appendix 6: 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).
10.6.1. 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.
10.6.2. Definition of SAE, SADE, and USADE
SAE Definition

An SAE is defined in Appendix 2 (Section 10.2.2).
SADE Definition

A SADE is defined as an ADE 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.
USADE Definition

A USADE (also identified as UADE in US Regulations 21 CFR 813.3) is a SADE that
by its nature, incidence, severity, or outcome has not been identified in the current 
version of the risk analysis management file.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 99
10.6.3. 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.
10.6.4. 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).

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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 100
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 and/or product information, for marketed 
products, in their assessment.

For each device deficiency, the investigator must document in the medical notes that 
they have reviewed the device deficiency and have 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 their 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.
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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 101
10.6.5. 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).
10.6.6. 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.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 102
10.7. Appendix 7: Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
ADE
adverse device effect
AE
adverse event
AESI
adverse event of special interest
AKI
acute kidney injury
Al(OH)3
aluminum hydroxide
ALT
alanine aminotransferase
AST
aspartate aminotransferase
AxMP
auxiliary medicinal product
BSA
body surface area
CBER
Center for Biologics Evaluation and Research (United States)
CDC
Centers for Disease Control and Prevention (United States)
CFR
Code of Federal Regulations (United States)
CHF
congestive heart failure
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
CRO
contract research organization
CSR
clinical study report
CT
clinical trial
CTIS
Clinical Trial Information System
DCT
data collection tool
DILI
drug-induced liver injury
DNA
deoxyribonucleic acid
DU
dispensable unit
EC
ethics committee
ECC
emergency contact card
ECG
electrocardiogram
eCrCl
estimated creatinine clearance
eCRF
electronic case report form
EDB
exposure during breastfeeding
e-diary
electronic diary
EDP
exposure during pregnancy
eGFR
estimated glomerular filtration rate
eICD
electronic informed consent document
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 103
Abbreviation
Term
EMEA
European Medicines Agency
ERD
enhanced respiratory disease
eSAE
electronic serious adverse event
EU
European Union
EudraCT
European Clinical Trials Database
FDA
Food and Drug Administration (United States)
FIH
first-in-human
FI-RSV
formalin-inactivated respiratory syncytial virus vaccine
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMFR
geometric mean fold rise
GMR
geometric mean ratio
GMT
geometric mean titer
HIPAA
Health Insurance Portability and Accountability Act
Ht
height
IB
investigator’s brochure
ICD
informed consent document
ICH
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use
ICU
intensive care unit
ID
identification
IFN
interferon 
IL-4
interleukin-4
IMP
investigational medicinal product
IND
investigational new drug application
INR
international normalized ratio
IP
Internet Protocol
IPAL
investigational product accountability log
IPM
investigational product manual
IRB
institutional review board
IRC
internal review committee
IRT
interactive response technology
ISO
International Organization for Standardization
IV
intravenous
K
proportionality constant for Bedside and Modified Schwartz 
Equations (kidney function)
KDIGO
Kidney Disease: Improving Global Outcomes
LFT
liver function test
LRTD
lower respiratory track disease
LRTI
lower respiratory tract illness
LRTI-RSV
RSV-associated lower respiratory tract illness
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 104
Abbreviation
Term
MA-LRTI
medically attended lower respiratory tract illness
MDR
Medical Device Regulation
MedDRA
Medical Dictionary for Regulatory Activities
mITT
modified intent-to-treat
MQI
medically qualified individual
NDCMC
newly diagnosed chronic medical condition
NIMP
noninvestigational medicinal product
NT
neutralizing titer
PACL
protocol administrative change letter
PBMC
human peripheral blood mononuclear cell
PFS
prefilled syringe
PI
principal investigator
PSSA
Pfizer's Serious Adverse Event Submission Assistant
PT
prothrombin time
QTL
quality tolerance limit
RCDC
reverse cumulative distribution curve
RSV
respiratory syncytial virus
RSV A
respiratory syncytial virus subgroup A
RSV B
respiratory syncytial virus subgroup B
RSVpreF
respiratory syncytial virus stabilized prefusion F subunit vaccine
RTI
respiratory tract illness
RTI-RSV
RSV-associated respiratory tract illness
RT-PCR
reverse transcription–polymerase chain reaction
SAE
serious adverse event
SADE
serious adverse device effect
SAP
statistical analysis plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
Scr
serum creatinine
Scys
serum cystatin C
SD
standard deviation
SIIV
seasonal inactivated influenza vaccine
SmPC
summary of product characteristics
SoA
schedule of activities
SOP
standard operating procedure 
SRSD
single reference safety document
SUSAR
suspected unexpected serious adverse reaction
T bili
total bilirubin
Tdap
tetanus toxoid, reduced diphtheria toxoid and acellular pertussis 
vaccine, adsorbed
Th1
T-helper type 1
Th2
T-helper type 2
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 105
Abbreviation
Term
UK
United Kingdom
ULN
upper limit of normal
US
United States
UADE
unanticipated adverse device effect
USADE
unanticipated serious adverse device effect
USPI
United States prescribing information
VE
vaccine efficacy
WHO
World Health Organization
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 106
11. REFERENCES
1
Nair H, Nokes DJ, Gessner BD, et al. Global burden of acute lower respiratory 
infections due to respiratory syncytial virus in young children: a systematic review and 
meta-analysis. Lancet. 2010;375(9725):1545-55.
2
Li Y, Wang X, Blau DM, et al. Global, regional, and national disease burden estimates 
of acute lower respiratory infections due to respiratory syncytial virus in children 
younger than 5 years in 2019: a systematic analysis. Lancet. 2022;399(10340):2047-64.
3
Ajayi-Obe EK, Coen PG, Handa R, et al. Influenza A and respiratory syncytial virus 
hospital burden in young children in East London. Epidemiol Infect. 2008;136(8):1046-
58.
4
Hall CB, Weinberg GA, Blumkin AK, et al. Respiratory syncytial virus–associated 
hospitalizations among children less than 24 months of age. Pediatrics. 
2013;132(2):e341-e48.
5
Barr R, Green CA, Sande CJ, et al. Respiratory syncytial virus: diagnosis, prevention 
and management. Ther Adv Infect Dis. 2019;6:2049936119865798.
6
Centers for Disease Control and Prevention. People at high risk for RSV, RSV in infants 
and young children. National Center for Immunization and Respiratory Diseases 
(NCIRD), Division of Viral Diseases. Atlanta, GA. 26 Jun 2018. Available from: 
https://www.cdc.gov/rsv/high-risk/infants-young-children.html.  Accessed: 05 Aug 
2021.
7
Hall CB, Weinberg GA, Iwane MK, et al. The burden of respiratory syncytial virus 
infection in young children. N Engl J Med. 2009;360(6):588-98.
8
Committee on Infectious Diseases, Bronchiolitis Guidelines Committee. Updated 
guidance for palivizumab prophylaxis among infants and young children at increased 
risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 
2014;134(2):415-20.
9
Goldstein E, Finelli L, O'Halloran A, et al. Hospitalizations associated with respiratory 
syncytial virus and influenza in children, including children diagnosed with asthma. 
Epidemiology. 2019;30(6):918-26.
10
Kristensen K, Hjuler T, Ravn H, et al. Chronic diseases, chromosomal abnormalities, 
and congenital malformations as risk factors for respiratory syncytial virus 
hospitalization: a population-based cohort study. Clin Infect Dis. 2012;54(6):810-7.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 107
11
Thwaites R, Buchan S, Fullarton J, et al. Clinical burden of severe respiratory syncytial 
virus infection during the first 2 years of life in children born between 2000 and 2011 in 
Scotland. Eur J Pediatr. 2020;179(5):791-9.
12
Manzoni P, Figueras-Aloy J, Simões EA, et al. Defining the incidence and associated 
morbidity and mortality of severe respiratory syncytial virus infection among children 
with chronic diseases. Infect Dis Ther. 2017;6(3):383-411.
13
IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus 
monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection 
in high-risk infants. The IMpact-RSV Study Group. Pediatrics. 1998;102(3 Pt 1):531-7.
14
Prescott WA Jr, Doloresco F, Brown J, et al. Cost effectiveness of respiratory syncytial 
virus prophylaxis: a critical and systematic review. Pharmacoeconomics. 
2010;28(4):279-93.
15
FDA. Beyfortus BLA BL 7611328 approval letter. 26 Sep 2022. Available from: 
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761328Orig1s000ltr.pdf
Accessed: 5 Feb 2024.
16
Munywoki PK, Koech DC, Agoti CN, et al. The source of respiratory syncytial virus 
infection in infants: a household cohort study in rural Kenya. J Infect Dis. 
2014;209(11):1685-92.
17
Heikkinen T, Valkonen H, Waris M, et al, eds. Transmission of respiratory syncytial 
virus infection within families. Open Forum Infect Dis; 2015;2(1):ofu118.
18
Hall CB, Geiman JM, Biggar R, et al. Respiratory syncytial virus infections within 
families. N Engl J Med. 1976;294(8):414-9.
19
FDA. Abrysvo BLA BL 125769/0 approval letter. 31 May 2023. Available from: 
https://www.fda.gov/media/168890/download. Published: 31 May 2023. Accessed:
07 Aug 2023.
20
FDA. Abrysvo BLA BL 125769/26 assignment/prior approval supplement letter. 
21 August 2023. Available from: https://www.fda.gov/media/171523/download. 
Published: 21 Aug 2023. Accessed: 30 Aug 2023.
21
EU. Commission implementing decision. 23 August 2023. Available from: 
https://ec.europa.eu/health/documents/community-
register/2023/20230823160227/dec_160227_en.pdf. Accessed: 12 Sep 2023.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671016
Final Protocol Amendment 1, 09 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 108
22
Kim HW, Canchola JG, Brandt CD, et al. Respiratory syncytial virus disease in infants 
despite prior administration of antigenic inactivated vaccine. Am J Epidemiol. 
1969;89(4):422-34.
23
Walsh EE, Pérez Marc G, Zareba AM, et al. Efficacy and safety of a bivalent RSV 
prefusion F vaccine in older adults. N Engl J Med. 2023;388(16):1465-77.
24
Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to 
prevent RSV illness in infants. N Engl J Med. 2023;388(16):1451-64.
25
Haerskjold A, Kristensen K, Kamper-Jørgensen M, et al. Risk Factors for hospitalization 
for respiratory syncytial virus infection: a population-based cohort study of Danish 
children. Pediatr Infect Dis J. 2016;35(1):61-5.
26
US Food and Drug Administration. Guidance for industry: toxicity grading scale for 
healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. 
Rockville, MD: Center for Biologics Evaluation and Research; Sep 2007.
27
Agresti A. Introduction: distributions and inference for categorical data. Chapter 1. In: 
Agresti A, ed. Categorical data analysis. 2nd ed. Hoboken, NJ: John Wiley & Sons; 
2002:1-35.
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)

Document Approval Record
Document Name:
	
	   	   


Document Title:
  ! 	 "!#$%&!% '!$(! !#()#' (" !$)#()#'  *
+(, *" !-%+*! *!  !*, *"%!.&)%)*, #( )//+#"'
!#))*, " .! ).*".,  ,#,*)% -).+ .!+ )"#   +
&+#)* -)#! 0. -1 )# )%(.!#  *" 2	3 ,!. " '
!
Signed By:
Date(GMT)
Signing Capacity

$$
 	7	7

8 9
		$$
 	77	
8 9
090177e19fe66c14\Approved\Approved On: 11-Feb-2024 16:32 (GMT)
PPD
PPD