A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN OLDER ADULTS IN KOREA
Phase: PHASE3
Conditions: Respiratory Syncytial Virus
Sponsor: Pfizer

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 1
A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND 
IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) 
PREFUSION F SUBUNIT VACCINE IN OLDER ADULTS IN KOREA
Study Intervention Number:
PF-06928316
Study Intervention Name:
Respiratory Syncytial Virus (RSV) Vaccine
US IND Number:
N/A
EudraCT Number:
N/A
ClinicalTrials.gov ID:  
NCT06593587
Pediatric Investigational Plan Number:
N/A
Protocol Number:
C3671053
Phase:
3
Sponsor Legal Address:
Pfizer Inc.
66 Hudson Boulevard East
New York, NY 10001
Brief Title: A Safety and Immune-Response Study of RSVpreF in Older Adults in Korea
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.
090177e1a311a43b\Approved\Approved On: 17-Mar-2025 16:38 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 2
Document History
Document 
Version Date
Amendment 1
17 March 2025
Original protocol
05 April 2024
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).  These changes to the protocol were communicated to investigators and IRBs/ECs 
prior to the initiation of study enrollment.
Protocol Amendment Summary of Changes Table
Amendment 1 (17 March 2025)
Overall Rationale for the Amendment:
To synthesize the original protocol, dated 05 April 2024, and 2 protocol administrative
change letters (PACL 1, dated 11 July 2024, and PACL 2, dated 01 August 2024) for the
licensure application to the Korean regulatory authority (MFDS).
Description of Change
Brief Rationale
Section # and Name
Substantial Modification(s)
Not applicable
Nonsubstantial Modification(s)
Added ClinicalTrials.gov 
ID
Administrative
Title Page
Section 1.1 Synopsis
Changed exclusion 
criterion 1 from 120 days 
to 180 days
Updated per PACL 2 
(01 Aug 2024) at MFDS 
request
Section 1.1 Synopsis 
Section 5.2 Exclusion Criteria
Extended the arrow and 
background color 
indicating local reactions 
and systemic events for
Visit 2
Updated per PACL 1
(11 Jul 2024) at MFDS 
request
Section 1.2 Schema
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 3
Description of Change
Brief Rationale
Section # and Name
Added the administered 
dose volume and storage 
conditions for study 
intervention
Updated per PACL 1
(11 Jul 2024) at MFDS 
request
Section 6.1 Study Intervention(s) 
Administered
Section 6.1.1 Administration
Updated text to clarify
that the site is to collect
the date of birth rather 
than year of birth
Updated per PACL 1
(11 Jul 2024) at MFDS 
request
Section 1.3 Schedule of Activities
Section 8.1 Administrative 
Procedures
Section 8.10.1 Visit 1 (Day 1 –
Vaccination)
Added weight and height 
at Visit 1, and included a 
routine physical 
examination (including
respiratory rate) at 
Visit 1, Visit 3, and 
unscheduled 
reactogenicity visit(s)
Updated per PACL 1 
(11 Jul 2024) and 
PACL 2 (01 Aug 2024) at 
MFDS request
Section 1.3 Schedule of Activities
Section 8.3 Safety Assessments
Section 8.3.1 Physical Examinations
Section 8.10.1 Visit 1 (Day 1 –
Vaccination)
Section 8.10.3 Visit 3 (1-Month 
Follow-Up)
Section 8.10.5 Unscheduled 
Reactogenicity Visit
Deleted the option for 
eConsent
Updated per PACL 1
(11 Jul 2024) at MFDS 
request
Section 10.1.3.1 Electronic Consent
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 4
TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................9
1. PROTOCOL SUMMARY...................................................................................................10
1.1. Synopsis ..................................................................................................................10
1.2. Schema ....................................................................................................................17
1.3. Schedule of Activities .............................................................................................18
2. INTRODUCTION ...............................................................................................................24
2.1. Study Rationale .......................................................................................................25
2.2. Background .............................................................................................................26
2.2.1. Clinical Overview.......................................................................................27
2.3. Benefit/Risk Assessment.........................................................................................29
2.3.1. Risk Assessment.........................................................................................30
2.3.2. Benefit Assessment.....................................................................................31
2.3.3. Overall Benefit/Risk Conclusion................................................................31
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS ...........................................................31
4. STUDY DESIGN.................................................................................................................32
4.1. Overall Design.........................................................................................................32
4.2. Scientific Rationale for Study Design.....................................................................33
4.2.1. Rationale for Comparator ...........................................................................33
4.2.2. Choice of Contraception/Barrier Requirements .........................................33
4.3. Justification for Dose ..............................................................................................33
4.4. End of Study Definition ..........................................................................................33
5. STUDY POPULATION......................................................................................................33
5.1. Inclusion Criteria.....................................................................................................34
5.2. Exclusion Criteria....................................................................................................35
5.3. Lifestyle Considerations..........................................................................................36
5.3.1. Contraception..............................................................................................36
5.4. Screen Failures ........................................................................................................37
5.5. Criteria for Temporarily Delaying 
Enrollment/Randomization/Administration of Study Intervention...........................37
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................37
6.1. Study Intervention(s) Administered........................................................................38
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 5
6.1.1. Administration............................................................................................39
6.1.2. Medical Devices .........................................................................................39
6.2. Preparation, Handling, Storage, and Accountability...............................................39
6.2.1. Preparation and Dispensing........................................................................40
6.3. Assignment to Study Intervention...........................................................................41
6.4. Blinding...................................................................................................................41
6.4.1. Blinding of Participants..............................................................................41
6.4.2. Blinding of Site Personnel..........................................................................41
6.4.3. Blinding of Sponsor Personnel...................................................................41
6.4.4. Breaking the Blind......................................................................................41
6.5. Study Intervention Compliance...............................................................................42
6.6. Dose Modification...................................................................................................42
6.7. Continued Access to Study Intervention After the End of the Study......................42
6.8. Treatment of Overdose............................................................................................42
6.9. Prior and Concomitant Therapy..............................................................................43
6.9.1. Prohibited Concomitant Vaccinations and Treatments ..............................43
6.9.2. Permitted Concomitant Vaccinations and Treatments ...............................44
6.9.3. Recording Nonstudy Vaccinations and Concomitant Medications............44
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................44
7.1. Discontinuation of Study Intervention ....................................................................44
7.2. Participant Discontinuation/Withdrawal From the Study.......................................44
7.2.1. Withdrawal of Consent...............................................................................45
7.3. Lost to Follow-Up ...................................................................................................45
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................46
8.1. Administrative Procedures ......................................................................................46
8.1.1. Telehealth Visits.........................................................................................47
8.2. Efficacy and/or Immunogenicity Assessments .......................................................47
8.2.1. Blood Collection.........................................................................................47
8.2.2. RSV Vaccine Antibody Testing .................................................................47
8.2.3. Biological Samples.....................................................................................48
8.3. Safety Assessments .................................................................................................48
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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8.3.1. Physical Examinations................................................................................49
8.3.2. Vital Signs ..................................................................................................49
8.3.3. Clinical Safety Laboratory Assessments ....................................................49
8.3.4. Electronic Diary for Reactogenicity...........................................................49
8.3.4.1. Grading Scales...........................................................................50
8.3.4.2. Local Reactions.........................................................................50
8.3.4.3. Systemic Events ........................................................................51
8.3.4.4. Temperature and Fever Assessment..........................................53
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................53
8.4.1. Time Period and Frequency for Collecting AE and SAE Information.......54
8.4.1.1. Reporting SAEs to Pfizer Safety...............................................55
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF...................55
8.4.2. Method of Detecting AEs and SAEs ..........................................................55
8.4.3. Follow-Up of AEs and SAEs......................................................................56
8.4.4. Regulatory Reporting Requirements for SAEs...........................................56
8.4.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................56
8.4.5.1. Exposure During Pregnancy......................................................57
8.4.5.2. Exposure During Breastfeeding ................................................58
8.4.5.3. Occupational Exposure .............................................................59
8.4.6. Cardiovascular and Death Events...............................................................59
8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................59
8.4.8. Adverse Events of Special Interest.............................................................59
8.4.8.1. Lack of Efficacy........................................................................59
8.4.9. Medical Device Deficiencies......................................................................60
8.4.9.1. Time Period for Detecting Medical Device Deficiencies .........60
8.4.9.2. Regulatory Reporting Requirements for Device 
Deficiencies .......................................................................................60
8.4.10. Medication Errors.....................................................................................61
8.5. Pharmacokinetics ....................................................................................................62
8.6. Genetics...................................................................................................................62
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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8.6.1. Specified Genetics ......................................................................................62
8.7. Biomarkers ..............................................................................................................62
8.8. Immunogenicity Assessments.................................................................................62
8.9. Health Economics ...................................................................................................62
8.10. Study Procedures...................................................................................................62
8.10.1. Visit 1 (Day 1 – Vaccination)...................................................................62
8.10.2. Visit 2 (1-Week Follow-Up).....................................................................65
8.10.3. Visit 3 (1-Month Follow-Up) ...................................................................65
8.10.4. Visit 4 (2-Month Follow-Up) ...................................................................66
8.10.5. Unscheduled Reactogenicity Visit............................................................66
9. STATISTICAL CONSIDERATIONS ................................................................................68
9.1. Statistical Hypotheses .............................................................................................68
9.2. Analysis Sets ...........................................................................................................69
9.3. Statistical Analyses .................................................................................................69
9.3.1. General Considerations...............................................................................69
9.3.1.1. Analyses for Binary Data ..........................................................70
9.3.1.2. Analyses for Continuous Data...................................................70
9.3.2. Primary Endpoint(s)/Estimand(s) Analysis ................................................71
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis............................................72
9.3.4. Tertiary/Exploratory Endpoint(s) Analysis ................................................72
9.4. Interim Analyses .....................................................................................................72
9.5. Sample Size Determination.....................................................................................73
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................74
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............74
10.1.1. Regulatory and Ethical Considerations ....................................................74
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................74
10.1.2. Financial Disclosure .................................................................................75
10.1.3. Informed Consent Process ........................................................................75
10.1.4. Data Protection .........................................................................................76
10.1.5. Committees Structure ...............................................................................76
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 8
10.1.5.1. Data Monitoring Committee ...................................................76
10.1.6. Dissemination of Clinical Study Data ......................................................77
10.1.7. Data Quality Assurance ............................................................................78
10.1.8. Source Documents....................................................................................79
10.1.9. Use of Medical Records............................................................................79
10.1.10. Study and Site Start and Closure ............................................................80
10.1.11. Publication Policy...................................................................................81
10.1.12. Sponsor’s Medically Qualified Individual..............................................82
10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting .....................................................................83
10.2.1. Definition of AE .......................................................................................83
10.2.2. Definition of an SAE ................................................................................84
10.2.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period............................................................................85
10.2.4. Reporting of SAEs....................................................................................89
10.2.5. Definition of NDCMC..............................................................................90
10.3. Appendix 3: Contraceptive and Barrier Guidance ................................................91
10.3.1. Male Participant Reproductive Inclusion Criteria....................................91
10.3.2. Female Participant Reproductive Inclusion Criteria.................................91
10.3.3. Woman of Childbearing Potential ............................................................91
10.3.4. Contraception Methods.............................................................................92
10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments .......93
10.5. Appendix 5: AEs, ADEs, SAEs, SADEs, USADEs, and Device 
Deficiencies: Definitions and Procedures for Recording, Evaluating, 
Follow-Up, and Reporting in Medical Device Studies .............................................95
10.5.1. Definition of AE and ADE .......................................................................95
10.5.2. Definition of SAE, SADE, and USADE ..................................................95
10.5.3. Definition of Device Deficiency...............................................................96
10.5.4. Recording/Reporting and Follow-Up of Medical Device 
Deficiencies......................................................................................................96
10.6. Appendix 6: Criteria for Allowing Inclusion of Participants With Chronic 
Stable HIV, HCV, or HBV Infection ........................................................................99
10.7. Appendix 7: Abbreviations .................................................................................100
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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11. REFERENCES ................................................................................................................104
LIST OF TABLES
Table 1.
Study Design.............................................................................................17
Table 2.
Schedule of Activities...............................................................................18
Table 3.
Objectives, Endpoints, and Estimands......................................................31
Table 4.
Study Interventions and Study Arms........................................................38
Table 5.
Grading Scale for Local Reactions...........................................................51
Table 6.
Grading Scale for Systemic Events ..........................................................52
Table 7.
Ranges for Fever.......................................................................................53
Table 8.
Primary Endpoint Analyses ......................................................................71
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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1. PROTOCOL SUMMARY 
1.1. Synopsis 
Protocol Title: A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of 
Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Older Adults in Korea
Brief Title: A Safety and Immune-Response Study of RSVpreF in Older Adults in Korea
Regulatory Agency Identification Number(s):
US IND Number:
N/A
EudraCT Number:
N/A
ClinicalTrials.gov ID:  
NCT06593587
Pediatric Investigational Plan Number:
N/A
Protocol Number:
C3671053
Phase:
3
Rationale:
Respiratory syncytial virus (RSV) is an important cause of respiratory illnesses associated 
with a high rate of morbidity and mortality in older adults, especially in those with chronic 
cardiac and pulmonary diseases. Recent epidemiology studies conducted in the Republic of 
Korea revealed that RSV infection in older adults remains a concern. In Korea, there is 
currently no licensed vaccine to prevent RSV illness, and treatment of RSV infection consists 
primarily of supportive care. 
Pfizer has developed an RSV vaccine, RSV stabilized prefusion F subunit vaccine 
(RSVpreF), to protect against the global burden of RSV-associated lower respiratory tract 
illness (LRTI-RSV) in older adults and infants. The vaccine, RSVpreF, contains 2 stabilized 
prefusion RSV F glycoproteins in equal amounts in a lyophilized dosage form for 
reconstitution. Studies of RSVpreF in both the older adult (Study C3671013) and maternal 
(Study C3671008) populations met their respective efficacy primary endpoints, and the 
vaccine has been shown to be well tolerated in both populations. Based on these studies, 
RSVpreF has received marketing authorization for use by the United States (US) Food and 
Drug Administration (FDA) and the European Commission, as well as other regulatory 
agencies. However, there are limited data on the safety and immunogenicity of RSVpreF in 
the Korean population. Demonstration of safety and immunogenicity in this study may 
support licensure of the RSV vaccine for other populations with unmet medical need, such as 
immunocompromised and high-risk adults, and infants via maternal vaccination.
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 11
After RSV natural infection, immunity is considered to be short-lived. Currently, there is no 
licensed vaccine to prevent RSV disease in older adults, and there are no specific effective 
treatments for RSV in Korea. Therefore, there is an important unmet medical need to develop 
an effective vaccine to boost the immune response sufficiently to protect older adults against 
RSV disease in Korea.
Given the significant unmet medical need in Korea and the efficacy and safety of RSVpreF 
demonstrated in global studies, this study will be conducted to evaluate the safety, 
tolerability, and immunogenicity of RSVpreF in Korean older adults to support a licensure 
application in Korea.
Objectives, Endpoints, and Estimands:
Objectives
Endpoints
Estimands
Primary: 
Primary: 
Primary: 
Safety
To describe the safety profile of 
RSVpreF when administered to 
Korean adults ≥60 years of age

Local reactions (redness, 
swelling, and pain at the 
injection site)

Systemic events (fever, 
fatigue, headache, vomiting, 
nausea, diarrhea, muscle pain, 
and joint pain)

Adverse events (AEs) 

Serious adverse events (SAEs)

Newly diagnosed chronic 
medical conditions (NDCMCs)
In participants receiving the study 
intervention, the percentage of 
participants reporting:

Local reactions within 7 days 
after vaccination 

Systemic events within 7 days 
after vaccination

AEs within 1 month after 
vaccination

SAEs throughout the study

NDCMCs throughout the study
Immunogenicity
To describe the immune responses 
to respiratory syncytial virus 
subgroup A (RSV A) and 
respiratory syncytial virus 
subgroup B (RSV B) elicited by 
RSVpreF in Korean adults 
≥60 years of age

RSV A and RSV B serum 
neutralizing titers (NTs)
In participants in compliance with 
the key protocol criteria (evaluable 
immunogenicity population):

Geometric mean titer (GMT)
of NTs for RSV A and RSV B 
at each blood sampling visit

Geometric mean fold rise 
(GMFR) of NTs for RSV A 
and RSV B from before 
vaccination to 1 month after 
vaccination
Secondary:
Secondary:
Secondary:
Immunogenicity
To further describe the immune 
responses to RSV A and RSV B 
elicited by RSVpreF in Korean 
adults ≥60 years of age

RSV A and RSV B serum NTs Seroresponsea rate of NTs for RSV 
A and RSV B at 1 month after 
vaccination
a.
Seroresponse is defined as a postvaccination NT ≥4 times the lower limit of quantitation (LLOQ) if the 
baseline titer is below the LLOQ; or a ≥4-fold rise from baseline if the baseline titer is ≥LLOQ.
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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Overall Design:
This is a Phase 3, randomized, double-blinded, placebo-controlled, multicenter trial to 
describe the safety, tolerability, and immunogenicity of bivalent RSVpreF in adults 60 years 
of age and older in Korea.
Number of Participants:
Approximately 360 study-eligible participants will be randomized to receive RSVpreF 
120 µg or placebo in a 2:1 ratio. Randomization will be stratified by 3 age groups 
(60 through 69, 70 through 79, and ≥80 years), with approximately 100 participants to be 
enrolled in the 70- through 79-year and ≥80-year age strata combined. Study arms, blood 
draws, and safety assessment timings are presented below.
Note: “Enrolled” means a participant’s agreement to participate in a clinical study following 
completion of the informed consent process and randomization/assignment to the study 
intervention. 
Study Population:
Inclusion Criteria
Participants are eligible to be included in this study only if all of the following criteria apply:
Age and Sex:
1. Participants 60 years of age or older at Visit 1. 

Male participants able to father children must agree to use a highly effective method 
of contraception from the time of informed consent through at least 28 days after 
study intervention administration (see Section 10.3.1).

Female participants must not be of childbearing potential (see Section 10.3.3).
Disease Characteristics:
2. Healthy participants who are determined by medical history, physical examination 
(if required), and clinical judgment of the investigator to be eligible for inclusion in the 
study.
Note: Healthy participants with preexisting stable disease, defined as disease not 
requiring significant change in therapy or hospitalization for worsening disease during 
the 6 weeks before enrollment, can be included. Specific criteria for participants with 
known stable infections with human immunodeficiency virus (HIV), hepatitis C virus 
(HCV), or hepatitis B virus (HBV) can be found in this protocol.
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Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
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3. Participants who are willing and able to comply with all scheduled visits, investigational 
plan, laboratory tests, frequent symptom assessment by mobile device application 
(e-diary), and other study procedures.
4. Participants who are ambulatory and live in the community, or in assisted-living or 
long-term care residential facilities that provide minimal assistance, such that the 
participant is primarily responsible for self-care and activities of daily living (ADL).
Other Inclusion Criteria:
5. Capable of giving signed informed consent, which includes compliance with the 
requirements and restrictions listed in the informed consent document (ICD) and the 
protocol.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1.
A confirmed diagnosis of RSV infection ≤180 days before study intervention 
administration.
2. Bleeding diathesis or condition associated with prolonged bleeding that would, in the 
opinion of the investigator, contraindicate intramuscular (IM) injection.
3. Prior history of any subtype of Guillain-Barré syndrome (GBS) of any etiology.
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) or any related 
vaccine.
5. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with 
or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the 
investigator’s opinion, excludes the participant from participating in the study.
6. Immunocompromised individuals with known or suspected immunodeficiency, as 
determined by history and/or laboratory/physical examination.
7. Any 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.
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
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Prior/Concomitant Therapy:
8. Individuals who receive chronic systemic treatment with immunosuppressive therapy
(other than systemic corticosteroids meeting the criteria noted below), including 
cytotoxic agents, immunosuppressive monoclonal antibodies, or radiotherapy, eg, for 
cancer or an autoimmune disease, from 60 days before study intervention administration 
or planned receipt throughout the study.  
Note: 

Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for 
≥14 days from 28 days before study intervention.

Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids 
are permitted.
9. Receipt of blood/plasma products or immunoglobulin within 60 days before study 
intervention administration.
10. Previous vaccination with any licensed or investigational RSV vaccine, or planned 
receipt throughout the study. 
Prior/Concurrent Clinical Study Experience:
11. Previous administration with an investigational product (drug or vaccine) within 
6 months prior to study intervention administration. Participation in other studies 
involving an investigational product (drug or vaccine) at any time during participation in 
this study. 
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.
Study Arms and Duration:
Study Intervention(s)
Intervention Name
RSVpreF
Placebo
Type
Vaccine
Placebo
Use
Experimental 
Placebo 
Investigational Medicinal 
Product (IMP) or 
Noninvestigational 
Medicinal Product 
IMP 
IMP 
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Study Intervention(s)
(NIMP)/Auxiliary 
Medicinal Product 
(AxMP)
Dose Formulation
RSV vaccine 120 µg/vial powder for 
solution for injection 
Lyophile match/sterile water for 
injection
Unit Dose Strength(s)
120 µg 
Not applicable (N/A)
Dosage Level(s)
120 µg 
N/A
Route of Administration
IM
IM
Sourcing
Provided centrally by the sponsor
Provided centrally by the sponsor
Packaging and Labeling
RSVpreF is supplied as a lyophilized 
white cake, packaged in a clear glass 
2-mL vial with a rubber stopper, 
aluminum overseal, and flip-off cap. It 
is reconstituted with a prefilled 
syringe (PFS) of sterile water diluent 
for injection (supplied).
Study intervention(s) will be labeled 
as per country requirements.
Placebo is supplied as a lyophilized 
white cake containing excipients but no 
active ingredients, packaged in a clear 
glass 2-mL vial with a rubber stopper, 
aluminum overseal, and flip-off cap. It 
is reconstituted with a PFS of sterile 
water diluent for injection (supplied).
Study intervention(s) will be labeled as 
per country requirements.
Single Reference Safety 
Document (SRSD)
Investigator’s brochure (IB) 
IB
Arm Title
RSVpreF 
Participants will receive RSVpreF 
120 µg at Visit 1.
Placebo 
Participants will receive placebo at 
Visit 1.
Study Duration
Study duration for each participant is approximately 2 months from signing of 
the informed consent to the final visit.
Statistical Methods:
Since this study is descriptive in nature, the planned sample size is not based on any 
statistical hypothesis testing.
The safety primary objective for the study will be evaluated by descriptive summary statistics 
for local reactions, systemic events, AEs (including adverse events of special interest
[AESIs]), NDCMCs, and SAEs after vaccination.
GMTs of NT for RSV A and RSV B measured at each blood sampling visit, and GMFRs of 
NT for RSV A and B from before vaccination to 1 month after vaccination, will be 
descriptively summarized with associated 2-sided 95% confidence intervals (CIs). 
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Ethical Considerations:
The available safety, immunogenicity, and efficacy data from clinical trials for RSVpreF 
support a favorable benefit/risk profile and support the clinical development of the vaccine. 
Considering the measures to minimize risk to study participants, the potential risks identified 
in association with the study intervention are justified by the anticipated benefits that may be 
afforded to participants in this study.
RSVpreF is an F glycoprotein subunit stabilized in the prefusion conformation, eliciting 
strong neutralizing antibodies as established in the adult studies, and has already shown 
efficacy in preventing lower respiratory tract illness (LRTI) in older adults. 
Based on the experience with RSVpreF, the potential risks are:

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.

GBS. In Study C3671013, conducted in adults 60 years of age and older, there were 2
cases of GBS or its variants identified with a plausible temporal relationship with 
vaccination among 18,000 individuals who received RSVpreF. Both cases had 
confounding factors or an alternative etiology.

Other events of special interest include atrial fibrillation and polyneuropathy.
The study procedure–related risks include:

Venipuncture, which will be performed during the study.
Further details on RSVpreF risks and AESIs are available in this protocol. 
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1.2. Schema 
Table 1.
Study Design
~360 Healthy 
adults 
≥60 years of age
randomized 2:1
Visit 1 (Day 1)
Vaccination
Visit 2
1-Week 
Follow-Up
Telephone Call
7-13 Days After 
Vaccination
Visit 3 
1-Month
Follow-Up
Blood Draw
28-35 Days 
After Vaccination 
Visit 4 
2-Month 
Follow-Up
Telephone Call 
56-70 Days 
After Vaccination
Study Groups
Group 1 RSVpreF
n = 240
Group 2 Placebo
n = 120
Safety
Local reactions and 
systemic eventsa
Days 1 to 7 after vaccination
AEs
Informed consent 
to Month 1
AESIs
SAEs
NDCMCs
Informed consent 
to Month 2
         Immunogenicity blood draw     
     Study intervention administration
         Telephone contact for safety data
a.
Collected for 7 days, or longer for ongoing symptoms, after study intervention until symptom resolution.
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1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures. Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section of the protocol for detailed information on each procedure and assessment required for compliance with the 
protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table in order to conduct evaluations or 
assessments required to protect the well-being of the participant.
Table 2.
Schedule of Activities
Visit Number
Visit 1
Visit 2
Visit 3
Visit 4
Unscheduled 
Reactogenicity 
Visit
Notes
Visit Description
Day 1
Vaccination
1-Week 
Follow-Up
1-Month 
Follow-Up
2-Month 
Follow-Up
Safety 
Assessment
Visit Window (Days)
7 to 13 Days 
After 
Vaccination
28 to 35 Days 
After 
Vaccination
56 to 70 Days 
After 
Vaccination
N/A
Day relative to study intervention 
administration (Day 1)
Type of Visit
: Clinic visit,
: Phone visit
Obtain written informed consent
X
Written informed consent must be 
obtained prior to undergoing any 
study procedures.  
Obtain the participant’s study number 
using the IRT system
X
Participant must be present and 
consented prior to obtaining the 
study number.
Record demography
X
Birth date, sex, race, and ethnicity.
Record significant medical history
X
Record current/former tobacco usage
X
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Table 2.
Schedule of Activities
Visit Number
Visit 1
Visit 2
Visit 3
Visit 4
Unscheduled 
Reactogenicity 
Visit
Notes
Visit Description
Day 1
Vaccination
1-Week 
Follow-Up
1-Month 
Follow-Up
2-Month 
Follow-Up
Safety 
Assessment
Visit Window (Days)
7 to 13 Days 
After 
Vaccination
28 to 35 Days 
After 
Vaccination
56 to 70 Days 
After 
Vaccination
N/A
Day relative to study intervention 
administration (Day 1)
Type of Visit
: Clinic visit,
: Phone visit
Perform a clinical assessment and a 
physical examination
X
X
X
Includes measurement of 
temperature, heart rate, respiratory 
rate, and seated blood pressure. 
See Section 8.3.1 and
Section 8.10.5 for further details.
Review prior vaccination history
X
Review vaccination history in 
source documents to verify 
eligibility and prohibited prior 
vaccinations. Record 28 days of 
vaccination history in the CRF.
See Section 6.9.
Record any new nonstudy vaccinations
X
X
X
X
See Section 6.9.3.
Collect details of prohibited medications
and treatments
X
X
X
X
X
See Section 6.9.1.
Confirm eligibility
X
See Section 5.
Confirm use of appropriate contraceptives 
(if applicable)
X
X
X
See Section 10.3.1.
Obtain prevaccination temperature 
X
Oral, tympanic, or temporal artery.
Confirm no temporary vaccination delay 
criteria have been met
X
See Section 5.5.
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Table 2.
Schedule of Activities
Visit Number
Visit 1
Visit 2
Visit 3
Visit 4
Unscheduled 
Reactogenicity 
Visit
Notes
Visit Description
Day 1
Vaccination
1-Week 
Follow-Up
1-Month 
Follow-Up
2-Month 
Follow-Up
Safety 
Assessment
Visit Window (Days)
7 to 13 Days 
After 
Vaccination
28 to 35 Days 
After 
Vaccination
56 to 70 Days 
After 
Vaccination
N/A
Day relative to study intervention 
administration (Day 1)
Type of Visit
: Clinic visit,
: Phone visit
Obtain the randomization number and 
container/kit number using the IRT system
X
Do not randomize until the 
participant is physically present 
and their eligibility has been 
confirmed.
Collect a blood sample of approximately 
20 mL for antibody assessment
Xa
X
a. Visit 1 sample is collected prior 
to vaccination.
Prepare and administer the study 
intervention as an IM injection into the 
deltoid muscle of the nondominant arm 
(preferable)
X
Refer to the IPM for instructions.
Observe the participant for acute reactions 
for a minimum of 30 minutes after 
vaccination
X
Any reactions occurring in the 
30-minute period after vaccination 
must be recorded on the CRF, 
including the time of onset. Treat 
reactions as clinically indicated.
Provide a digital thermometer and a 
measuring device
X
Assist the participant with downloading 
the e-diary application, or issue 
provisioned device, if required
X
E-diary data (local reactions and 
systemic events) are collected for 
7 days, or longer for ongoing 
symptoms, after study 
intervention. 
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Table 2.
Schedule of Activities
Visit Number
Visit 1
Visit 2
Visit 3
Visit 4
Unscheduled 
Reactogenicity 
Visit
Notes
Visit Description
Day 1
Vaccination
1-Week 
Follow-Up
1-Month 
Follow-Up
2-Month 
Follow-Up
Safety 
Assessment
Visit Window (Days)
7 to 13 Days 
After 
Vaccination
28 to 35 Days 
After 
Vaccination
56 to 70 Days 
After 
Vaccination
N/A
Day relative to study intervention 
administration (Day 1)
Type of Visit
: Clinic visit,
: Phone visit
Provide e-diary training on the daily 
reactogenicity questionnaire
X
Review reactogenicity e-diary data
X
X
E-diary data are transmitted daily 
to a Web-based portal for review 
by the investigator or delegate 
(preferably on a daily basis) during 
the 7-day e-diary follow-up period. 
Assess and manage any 
noncompliance.
Ask the participant to contact site staff in 
the event of any severe local reactions or 
systemic events in the 7-day e-diary 
follow-up period
X
If the participant does not call, site 
staff must contact the participant to 
determine whether an unscheduled 
reactogenicity visit is required.
Remind the participant to bring their 
e-diary/smartphone to the next study visit
X
X
Collect stop dates for any symptoms 
marked as ongoing on the last day of the 
e-diary collection period in the CRF
X
X
X
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Table 2.
Schedule of Activities
Visit Number
Visit 1
Visit 2
Visit 3
Visit 4
Unscheduled 
Reactogenicity 
Visit
Notes
Visit Description
Day 1
Vaccination
1-Week 
Follow-Up
1-Month 
Follow-Up
2-Month 
Follow-Up
Safety 
Assessment
Visit Window (Days)
7 to 13 Days 
After 
Vaccination
28 to 35 Days 
After 
Vaccination
56 to 70 Days 
After 
Vaccination
N/A
Day relative to study intervention 
administration (Day 1)
Type of Visit
: Clinic visit,
: Phone visit
Ensure all e-diary data have been 
transferred, collect provisioned e-diary, or 
assist participant with deleting the 
application, as appropriate
X
Do not deactivate the e-diary until
all data are confirmed as having 
been transferred to the e-diary data
management system.
Obtain details and record any AEs
X
X
X
X
See Section 8.4.2.
See Section 8.4.8.
See Section 8.4.2.
Obtain details and record any AESIs
X
X
X
X
X
Obtain details and record any SAEs and 
NDCMCs
X
X
X
X
X
Measure minimum and maximum 
diameter of redness (if present) or swelling 
(if present)
X
If present, assess the severity of necrosis 
or exfoliative dermatitis at the injection 
site
X
If present, assess the severity of any 
injection site pain
X
If present, assess the severity of any 
systemic event (fatigue, headache, nausea, 
vomiting, diarrhea, muscle pain, or joint 
pain)
X
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Table 2.
Schedule of Activities
Visit Number
Visit 1
Visit 2
Visit 3
Visit 4
Unscheduled 
Reactogenicity 
Visit
Notes
Visit Description
Day 1
Vaccination
1-Week 
Follow-Up
1-Month 
Follow-Up
2-Month 
Follow-Up
Safety 
Assessment
Visit Window (Days)
7 to 13 Days 
After 
Vaccination
28 to 35 Days 
After 
Vaccination
56 to 70 Days 
After 
Vaccination
N/A
Day relative to study intervention 
administration (Day 1)
Type of Visit
: Clinic visit,
: Phone visit
If applicable, review any hospital or 
emergency room visits for management of 
postvaccination local reactions or systemic 
events
X
Complete the source documents and CRFs
X
X
X
X
X
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2. INTRODUCTION
RSV is a major cause of respiratory infection in individuals of all ages, and can result in 
severe illness in infants, older adults, and those with health conditions that put them at 
increased risk of severe RSV and complications. The burden of RSV disease is also 
significant in children, in the immunocompromised, and in those with underlying 
comorbidities at high risk of severe RSV disease.
There are 2 antigenic variants of RSV, RSV A and RSV B, that cocirculate.1 Like influenza, 
RSV infection follows a seasonal pattern, causing yearly wintertime epidemics in temperate 
climates, usually between late fall and early spring. In tropical climates, the outbreaks are 
generally associated with rainy seasons but are more unpredictable and frequently 
continuous.2  
Older adults ≥60 years of age are at increased risk of RSV infection, which can trigger 
exacerbations of underlying comorbid conditions such as COPD and CHF. In the US, RSV 
infection has been associated with up to 22% of acute COPD exacerbations in prospective 
cohort studies and 11% of wintertime hospitalizations for COPD exacerbations.3   
RSV in Korea
Data on the epidemiology of RSV in Korean adults show that RSV is a common causative 
pathogen in ARI (including ILI) or pneumonia. In a nationwide passive surveillance study of 
viruses causing ARI from 36 sentinel hospitals, the RSV positivity rate was 2.78% among 
adult patients with respiratory viruses, of which 22.76% were over 65 years of age.4 Another 
surveillance study in Korea from 2009 to 2014 with outpatient respiratory samples reported a
similar RSV detection rate of 1.6% (3/183) among adults over 65 years of age.5
Rates of RSV-related hospitalization cases in clinical surveillance averaged 280.7/week from
January 2016 to January 2020, which was comparable to the influenza-related hospitalization
weekly rate.6 RSV infection was found in 1.1% of adults hospitalized for ARI,7 and in 2.3% 
of adults with suspected viral acute respiratory infections (mean age 70 years).8 Among adult 
patients with severe pneumonia admitted to the ICU (mean/median age approximately 65 
years), RSV was detected in 5.1% to 6.1% of those tested.9,10,11 In one of these studies of
pneumonia patients requiring ICU admission, RSV was significantly more common in those 
with CAP compared to patients with HCAP (10.9% vs 2.2%, p = 0.01). Generally, RSV A is 
more prevalent than RSV B in Korean adults.9,12,13
There are limited data on the clinical outcomes of RSV disease in older adults in Korea.
However, 1 study in adults ≥65 years old hospitalized with RSV-associated pneumonia
reported a 30-day in-hospital mortality rate of 12.0% (9/75), an admission rate to the ICU of 
26.7% (20/75), and an average hospital stay of 20.4 days.12 Another study in adults 
hospitalized with RSV infection (average age 70 years) or influenza (average age 62 years) 
has shown RSV infection to be associated with a significantly higher risk of death (20-day 
all-cause mortality rate 18.4% vs 6.7%; hazard ratio 2.32; 95% CI 1.17-4.58) when compared
with influenza patients in the same hospital, and that RSV patients were more likely to be 
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residents of a long-term care facility or to have COPD, pneumonia, or respiratory bacterial 
superinfection.8 Comorbidities are common in adults hospitalized for ARI with RSV 
infection (75%-80%), and coinfection with other pathogens (eg, coronavirus, influenza, 
rhinovirus, or bacteria) is also more common in adults than children (44.4% vs 3.0% for RSV 
A coinfection), which may lead to longer hospital stays and higher risk of life-threatening 
infections or death.14,15 However, the burden of adult RSV disease could be underestimated 
since testing for RSV is less common in older adults than in children. RSV disease in adults 
is also difficult to diagnose based on clinical signs and symptoms alone, and, before the 
broader use of more sensitive detection methods, laboratory confirmation of RSV in adults 
was challenging because of low levels of virus shedding.3
RSV disease management in adults is limited to supportive measures such as hydration and 
oxygenation. Aerosolized ribavirin has limited evidence of effectiveness and is 
predominantly restricted to hospitalized, severely immunocompromised patients because of 
inconvenient administration, teratogenicity and anemia concerns, and high cost. Prevention 
of RSV disease via active immunization has the potential to make a significant impact in 
older adults, therefore making vaccine development a high priority.16,17
2.1. Study Rationale 
Pfizer has developed an RSV vaccine, RSVpreF, to protect against the global burden of 
LRTI-RSV in older adults and infants. RSVpreF contains 2 stabilized prefusion RSV F 
glycoproteins in equal amounts in a lyophilized dosage form for reconstitution. Studies of 
RSVpreF in both the older adult and maternal populations met their respective efficacy 
primary endpoints, and the vaccine has been shown to be well tolerated in both populations. 
RSVpreF development started with 2 indications using the same antigens, dose, and 
formulation:

Older adult: Prevention of LRTI-RSV in adults 60 years of age and older via active 
immunization.

Maternal: Prevention of LRTI-RSV and severe LRTI-RSV in infants from birth through 
6 months of age by active immunization of pregnant individuals.
The FDA approved RSVpreF (Abrysvo®) for marketing for individuals 60 years of age and 
older and pregnant individuals on 31 May 2023 and 21 August 2023, respectively. A 
marketing authorization for Abrysvo to help protect both infants through maternal 
immunization and older adults was granted by the European Commission on 23 August 2023, 
by the MHRA on 21 November 2023, and by Health Canada on 21 December 2023. 
RSVpreF was approved for use in Japan for pregnant individuals on 18 January 2024 and for 
individuals 60 years of age and older on 26 March 2024. Additional applications are under 
review by other regulatory agencies around the world. 
However, there are limited data on the safety and immunogenicity of RSVpreF in the Korean 
population, and further study of an older adult population is required for licensure in Korea. 
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Demonstration of safety and immunogenicity in this study may support licensure of the RSV 
vaccine in other populations with unmet medical need such as immunocompromised and 
high-risk adults, and infants via maternal vaccination.
After RSV natural infection, immunity is considered to be short-lived.1,18 Currently, there is 
no licensed vaccine to prevent RSV disease in older adults, and there are no specific effective 
treatments for RSV in Korea. Most people infected with RSV recover within 1 to 2 weeks, 
but it can cause pneumonia in older or immunocompromised individuals, which may require 
hospitalization.19 The only available prophylactic measure in Korea is a monoclonal 
antibody, which is limited to use in high-risk preterm infants and children under 2 years of 
age.20 Therefore, there is an important unmet medical need to develop an effective vaccine to 
boost the immune response sufficiently to protect older adults against RSV disease in Korea.
Given the significant unmet medical need in Korea and the efficacy and safety of RSVpreF 
demonstrated in global studies, this study will be conducted to evaluate the safety, 
tolerability, and immunogenicity of RSVpreF in Korean older adults to support a licensure 
application in Korea.  
2.2. Background 
The vaccine investigated in this study is a bivalent RSV prefusion F subunit vaccine 
(RSVpreF) developed by Pfizer. The RSV F glycoprotein facilitates fusion of the virion and 
host cell membrane through a dramatic transition from an unstable but highly immunogenic 
prefusion conformation to the more stable postfusion state.21 Preclinical studies show that 
prefusion F elicits much higher neutralizing antibody titers than postfusion F and that the 
most potent neutralizing antibodies from postinfection human sera target the prefusion 
form.22 RSVpreF is composed of engineered, stabilized, trimeric, prefusion F glycoproteins 
matching the 2 subgroups (A and B) to help ensure the broadest coverage against RSV 
illness.
Pfizer’s Phase 1 and 2 studies demonstrated proof that RSVpreF elicits robust neutralizing 
antibodies in adults that persisted for at least 12 months after vaccination (Studies C3671001 
and C3671002)23,24 and that a single 120-µg dose of RSVpreF had a 100% observed efficacy 
against qRT-PCR–confirmed symptomatic RSV infection in a human challenge model 
(Study WI257521).25
Proof that the vaccine is efficacious in preventing LRTI-RSV in older adults ≥60 years of age 
was demonstrated in a Phase 3 study (Study C3671013).26 In the primary analysis, protection 
against LRTI-RSV defined by 2 or more symptoms demonstrated a 66.7% VE. A VE of 
85.7% was observed in participants with the primary endpoint of LRTI-RSV defined by 3 or 
more RSV-associated symptoms. Additionally, the C3671008 Phase 3 maternal study 
recently demonstrated effectiveness in preventing severe LRTI-RSV in infants born to 
mothers who received RSVpreF.27
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Even though there is no correlate for protection for RSV, RSV-neutralizing antibody titers 
correlate with the duration of passive infant protection from RSV and reduction in infant 
hospitalization due to RSV disease.28,29 Additionally RSV-infected older adults have 
significantly lower serum RSV-neutralizing antibody titers and RSV-specific 
immunoglobulin G levels than uninfected age-matched controls.30,31 Additional immune 
mechanisms beyond neutralization may also aid in protection, but the existing evidence 
supports an important role for serum neutralizing antibody titers in reducing the risk of RSV 
disease in older adults.
2.2.1. Clinical Overview
The older adult program includes 2 Phase 1/2 studies, 3 Phase 3 studies, and a Phase 2a 
human challenge study.32  

Study C3671001 (NCT03529773) is a completed Phase 1/2 study in 1235 healthy adults 
in 2 age groups—18 through 49 and 50 through 85 years of age—who received 1 of 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 NT GMFRs were high across all 
study arms, ranging from 9 through 13 from before vaccination to 1 month after 
vaccination and from 3 through 4 from before vaccination to 12 months after vaccination 
for RSV A and RSV B, respectively. 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 study 
intervention.23

Study C3671002 (NCT03572062) is a completed Phase 1/2 study in 317 older adults 
65 through 85 years of age. The primary cohort evaluated 3 dose levels of RSVpreF 
(60 µg, 120 µg, and 240 µg), with Al(OH)3 or CpG/Al(OH)3, or placebo, given as a 
single dose concomitantly with SIIV; the Month 0 and Month 2 cohorts received either 
RSVpreF (240 µg) with CpG/Al(OH)3 or placebo, given without concomitant SIIV, on a 
schedule of 2 doses administered 2 months apart. For the primary cohort, 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) at 12 months 
after vaccination (GMFRs ranging from 2.1 to 3.5 and 2.2 to 4.3, respectively). For the 
Month 0 and Month 2 cohorts, no increase in GMTs was observed 1 month after 
Vaccination 2 (GMFRs of 0.9). All doses and formulations were safe and well tolerated.24
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
A Phase 2a, randomized, double-blinded, placebo-controlled study to evaluate the safety, 
immunogenicity, and efficacy of RSVpreF in a virus challenge model in healthy adults 
(NCT04785612) was conducted by hVIVO in 70 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 were evaluated. The primary 
analysis of the human challenge study showed that a 120-µg dose of RSVpreF was well 
tolerated and had an acceptable safety profile. The completed study demonstrated 100% 
efficacy of RSVpreF against RT-PCR–confirmed symptomatic respiratory infection in a 
mild-to-moderate disease model.25

Study C3671006 (NCT05301322) is a completed Phase 3, multicenter, parallel-group, 
placebo-controlled, randomized, double-blinded study. Approximately 1400 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 with a 120-µg dose of RSVpreF 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. Results demonstrated 
NI of the RSVpreF and SIIV immune responses when RSVpreF was coadministered with 
SIIV. The results of this study support the acceptability of coadministration of RSVpreF 
and SIIV in an older adult population.

Study C3671013 (NCT05035212) is an ongoing Phase 3, multicenter, randomized, 
double-blinded, placebo-controlled study to assess the safety, immunogenicity, and 
efficacy of Pfizer’s RSVpreF in the prevention of LRTI-RSV in adults 60 years of age 
and older. Both healthy adults and adults with stable chronic cardiopulmonary conditions 
are included. Approximately 15% of the enrolled participants have stable chronic 
cardiopulmonary conditions such as COPD, asthma, or CHF. The study enrolled over 
37,000 participants, randomized to receive either RSVpreF or placebo in a 1:1 ratio. This 
is an event-driven study with a target of 59 first episodes of evaluable LRTI-RSV cases. 
Interim analysis results (data cutoff, 14 July 2022) showed protection against LRTI-RSV 
defined by 2 or more symptoms and a demonstrated VE of 66.7%. A VE of 85.7% was 
observed in participants with the primary endpoint of LRTI-RSV defined by 3 or more 
RSV-associated symptoms.26 The vaccine was well tolerated, with no safety concerns.7
On 31 May 2023, the FDA approved RSVpreF (Abrysvo) for marketing for individuals 
60 years of age and older in the US.33 On 23 August 2023, RSVpreF (Abrysvo) 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.34
Revaccination Substudies A and B have been amended to the C3671013 protocol, each 
designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when 
administered to participants after a dosing interval of either approximately 2 years 
(Substudy A) or approximately 1 year (Substudy B). A total of at least 800 but up to 
900 participants who received RSVpreF in the efficacy study will be randomized in 
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Substudy A in a 1:1 ratio to receive RSVpreF or placebo. Up to 200 participants who 
received RSVpreF in the efficacy study will be randomized in Substudy B in a 1:1 ratio 
to receive RSVpreF or placebo. In both Substudy A and Substudy B, there are 5 
scheduled study visits: Day 1 and 1 month, 6 months, 12 months, and 18 months after 
revaccination. Serum samples collected at all 5 visits will be assayed for RSV A and RSV 
B serum NTs. Safety assessments include immediate AEs within 30 minutes after each 
vaccination, local reactions and systemic events within 7 days after each vaccination, 
AEs until 1 month after revaccination, and AESIs, NDCMCs, and SAEs from signing of 
the ICD throughout substudy participation.

Study C3671014 (NCT05096208) is a completed Phase 3, multicenter, parallel-group, 
placebo-controlled, randomized, double-blinded, 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 each of the 3 manufactured RSVpreF lots 
1 month after vaccination were equivalent, and that the 120-µg dose of RSVpreF was 
well tolerated and had an acceptable safety profile.

Study C3671023 (NCT05842967) is an ongoing Phase 3 study that will assess the safety, 
tolerability, and immunogenicity of Pfizer’s RSVpreF in adults at high risk of severe 
RSV disease in 2 distinct patient populations:  

Substudy A is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled 
study that will assess the safety, tolerability, and immunogenicity of 120 µg RSVpreF 
in adults 18 to <60 years of age considered to be at high risk of RSV disease due to 
certain chronic medical conditions.

Substudy B is a Phase 3, single-arm, open-label, multicenter study that will assess the 
safety, tolerability, and immunogenicity of 120 µg RSVpreF in immunocompromised 
adults. 
2.3. Benefit/Risk Assessment
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. Refer 
to the Study Intervention(s) table in Section 6.1 for a complete description of SRSDs.
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2.3.1. Risk Assessment
Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s): 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.
GBS has been identified as a potential risk for 
RSVpreF.
Other events of interest include atrial fibrillation 
and polyneuropathy.
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.35
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 were 2 cases of GBS or its 
variants with a plausible temporal relationship with 
vaccination among >18,000 individuals who 
received RSVpreF. Both cases had confounding 
factors or alternative etiology. 
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 
placebo. Most of the participants who had atrial 
fibrillation and received RSVpreF had a preexisting 
medical history of atrial fibrillation and/or cardiac 
disease.36

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 to determine if an unscheduled visit is
required to be conducted per protocol.

Individuals with prior history of any subtype of 
GBS of any etiology will be excluded from 
study participation. 

All study participants will be observed for at 
least 30 minutes after vaccination.

AEs and SAEs will be collected at specified 
time points throughout the study. 

Specific references to risks and events of 
interest are made within the ICD, with 
reporting instructions if a case is suspected.
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.
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2.3.2. Benefit Assessment
Benefits to individual participants enrolled may be:

Receipt of an 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 study participants.
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS
The study objectives, endpoints, and estimands are presented in Table 3.
Table 3.
Objectives, Endpoints, and Estimands
Objectives
Endpoints
Estimands
Primary:
Primary:
Primary:
Safety
To describe the safety profile of 
RSVpreF when administered to
Korean adults ≥60 years of age

Local reactions (redness, 
swelling, and pain at the 
injection site)

Systemic events (fever, 
fatigue, headache, vomiting, 
nausea, diarrhea, muscle pain, 
and joint pain)

AEs 

SAEs

NDCMCs
In participants receiving the study 
intervention, the percentage of 
participants reporting:

Local reactions within 7 days 
after vaccination 

Systemic events within 7 days 
after vaccination

AEs within 1 month after 
vaccination

SAEs throughout the study

NDCMCs throughout the study
Immunogenicity
To describe the immune responses 
to RSV A and RSV B elicited by 
RSVpreF in Korean adults 
≥60 years of age

RSV A and RSV B serum NTs
In participants in compliance with 
the key protocol criteria (evaluable 
immunogenicity population):

GMT of NTs for RSV A and 
RSV B at each blood sampling
visit

GMFR of NTs for RSV A and 
RSV B from before 
vaccination to 1 month after 
vaccination
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Table 3.
Objectives, Endpoints, and Estimands
Objectives
Endpoints
Estimands
Secondary:
Secondary:
Secondary:
Immunogenicity
To further describe the immune 
responses to RSV A and RSV B 
elicited by RSVpreF in Korean 
adults ≥60 years of age

RSV A and RSV B serum NTs
Seroresponsea rate of NTs for RSV 
A and RSV B at 1 month after 
vaccination
a.
Seroresponse is defined as a postvaccination NT ≥4 times the LLOQ if the baseline titer is below the 
LLOQ; or a ≥4-fold rise from baseline if the baseline titer is ≥ LLOQ.
4. STUDY DESIGN
4.1. Overall Design
This is a Phase 3, randomized, double-blinded, placebo-controlled, multicenter trial to 
describe the safety, tolerability, and immunogenicity of bivalent RSVpreF in adults 60 years 
of age and older in Korea.
Approximately 360 study-eligible participants will be randomized to receive either the 
120-µg dose of RSVpreF or placebo in a 2:1 ratio. Randomization will be stratified by 3 age 
groups (60 through 69, 70 through 79, and ≥80 years), with approximately 100 participants 
estimated to be enrolled in the 70- through 79-year and ≥80-year age strata combined. Due to 
recruitment conditions, the distribution of the 3 age strata may not exactly match with the age 
distribution in the global Phase 3 pivotal study. Study arms, blood draws, and safety 
assessment timings are presented below.
“Enrolled” is defined as a participant’s agreement to participate in a clinical study following 
completion of the informed consent process and randomization/assignment to the study 
intervention. 
Before any study-related procedures are performed, participants will sign an ICD. After 
screening and confirmation of eligibility, a prevaccination blood sample (~20 mL) will be 
collected for immunogenicity assessments and a single dose of study intervention (RSVpreF 
or placebo) will be administered. Participants will be observed for at least 30 minutes after 
receiving the study intervention.
Participants will report daily reactogenicity data using an electronic device. Prespecified 
local reaction and systemic event data will be collected in an e-diary during the 7-day 
collection period, or longer for ongoing symptoms, after study intervention (ie, from Day 1, 
the day of vaccination, until symptom resolution). Reported Grade 3 and potential Grade 4 
reactogenicity events will be assessed by the investigator or qualified person to determine 
unscheduled medical visit requirements.
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Participants will return approximately 1 month later for a follow-up blood draw for 
immunogenicity assessments and collection of safety information. A telephone follow-up 
visit will be conducted approximately 1 week after vaccination to review reactogenicity and
approximately 2 months after vaccination to collect safety information. The overall study 
duration for each participant will be approximately 2 months from signing of the ICD to the 
final visit.
For all participants, AEs will be collected from informed consent through 1 month following 
study intervention administration. SAEs, NDCMCs, and AESIs will be collected from 
informed consent throughout study participation. 
4.2. Scientific Rationale for Study Design
Refer to Section 2.1 for the study rationale.
4.2.1. Rationale for Comparator
As there is currently no approved vaccine for the prevention of RSV disease in Korea, a 
placebo was selected as the comparator for this protocol.
4.2.2. Choice of Contraception/Barrier Requirements 
The study intervention is approved by the US FDA and EMA for use for pregnant individuals
and older adults without any contraceptive precautions. There is no suspicion of human 
teratogenicity based on the intended pharmacology. 
4.3. Justification for Dose
The 120-µg dose, without any adjuvants, is the dose level that has been approved for use by 
the FDA and EMA and has been proven efficacious in other studies enrolling diverse 
populations, and therefore is expected to be efficacious in the Korean population in this 
study.
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 they have 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. 
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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 this study only if all of the following criteria apply:
Age and Sex:
1. Participants 60 years of age or older at Visit 1. 

Male participants able to father children must agree to use a highly effective method 
of contraception from the time of informed consent through at least 28 days after 
study intervention administration (see Section 10.3.1).

Female participants must not be of childbearing potential (see Section 10.3.3).
Disease Characteristics:
2. Healthy participants who are determined by medical history, physical examination 
(if required), and clinical judgment of the investigator to be eligible for inclusion in the 
study.
Note: Healthy participants with preexisting stable disease, defined as disease not 
requiring significant change in therapy or hospitalization for worsening disease during 
the 6 weeks before enrollment, can be included. Specific criteria for participants with 
known stable infections with HIV, HCV, or HBV can be found in Appendix 6,
Section 10.6.
3. Participants who are willing and able to comply with all scheduled visits, investigational 
plan, laboratory tests, frequent symptom assessment by mobile device application 
(e-diary), and other study procedures. 
4. Participants who are ambulatory and live in the community, or in assisted-living or 
long-term care residential facilities that provide minimal assistance, such that the 
participant is primarily responsible for self-care and ADL.
Other Inclusion Criteria:
5. Capable of giving signed informed consent as described in Section 10.1.3, which includes 
compliance with the requirements and restrictions listed in the ICD and in this protocol.
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5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. A confirmed diagnosis of RSV infection ≤180 days before study intervention 
administration.
2. Bleeding diathesis or condition associated with prolonged bleeding that would, in the 
opinion of the investigator, contraindicate IM injection.
3. Prior history of any subtype of GBS of any etiology.
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) or any related 
vaccine.
5. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with 
or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the 
investigator’s opinion, excludes the participant from participating in the study.
6. Immunocompromised individuals with known or suspected immunodeficiency, as 
determined by history and/or laboratory/physical examination.
7. Any 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.
Prior/Concomitant Therapy:
8. Individuals who receive chronic systemic treatment with immunosuppressive therapy
(other than systemic corticosteroids meeting the criteria noted below), including 
cytotoxic agents, immunosuppressive monoclonal antibodies, or radiotherapy, eg, for 
cancer or an autoimmune disease, from 60 days before study intervention administration 
or planned receipt throughout the study.  
Note: 

Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for 
≥14 days from 28 days before study intervention.

Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids 
are permitted.
9. Receipt of blood/plasma products or immunoglobulin within 60 days before study 
intervention administration.
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10. Previous vaccination with any licensed or investigational RSV vaccine, or planned 
receipt throughout the study.
Prior/Concurrent Clinical Study Experience:
11. Previous administration with an investigational product (drug or vaccine) within 
6 months prior to study intervention administration. Participation in other studies 
involving an investigational product (drug or vaccine) at any time during participation in 
this study.
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
5.3.1. Contraception
The investigator or their designee, in consultation with the participant, will confirm that the 
participant is utilizing an appropriate method of contraception for the individual participant 
from the permitted list of contraception methods (see Appendix 3, Section 10.3.1) and will 
confirm that the participant has been instructed in its consistent and correct use. The 
investigator or designee will advise the participant to seek advice about the donation and 
cryopreservation of germ cells prior to the start of study intervention, if applicable.
At time points indicated in the SoA, the investigator or designee will inform the participant 
of the need to use acceptable effective contraception consistently and correctly and document 
the conversation and the participant’s affirmation in the participant’s chart. Participants need 
to affirm their consistent and correct use of at least 1 of the selected methods of 
contraception, considering that their risk for pregnancy may have changed since the last visit. 
In addition, the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued and document the requirement to use an 
alternate protocol-specified method, including if the participant will no longer use abstinence 
as the selected contraception method, or if pregnancy is known or suspected in the participant 
or partner.
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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 with a new participant number. 
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Administration of 
Study Intervention 
The following conditions may allow a participant to be randomized and assigned a study 
intervention once the condition(s) has/have resolved and the participant is otherwise eligible. 
Participants meeting these criteria at Visit 1 will be considered screen failures if enrollment 
has closed once the condition(s) has/have resolved.
1. Current febrile illness (temperature ≥38.0°C) or other acute illness within 
48 hours before study intervention administration.
2. Receipt of any nonlive or recombinant vaccine within 14 days, or any live vaccine within 
28 days, before study intervention administration.
3. Anticipated receipt of any nonstudy vaccine within 14 days after study intervention 
administration.
4. 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. 
Note: Systemic corticosteroids administered at a dose of 20 mg/day of prednisone or 
equivalent are permitted. Inhaled/nebulized, intra-articular, intrabursal, or topical 
(skin or eyes) corticosteroids are permitted.
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study interventions are all prespecified IMPs and NIMPs, 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.

Placebo (lyophile match).
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6.1. Study Intervention(s) Administered
Table 4.
Study Interventions and Study Arms
Study Intervention(s)
Intervention Name
RSVpreF
Placebo
Type
Vaccine
Placebo
Use
Experimental 
Placebo 
IMP or NIMP/AxMP
IMP 
IMP 
Dose Formulation
RSV vaccine 120 µg/vial powder for 
solution for injection 
Lyophile match/sterile water for 
injection
Unit Dose Strength(s)
120 µg 
N/A
Administered Volume
0.5 mL (entire contents of PFS)
0.5 mL (entire contents of PFS)
Dosage Level(s)
120 µg 
N/A
Route of Administration
IM
IM
Sourcing
Provided centrally by the sponsor
Provided centrally by the sponsor
Storage Conditions
The lyophilized vaccine drug product 
and the diluent are stored at 2°C to 
8°C. Vaccine drug product vials 
should be reconstituted only when 
ready for preparing the doses in a 
syringe. The prepared vaccine dose 
should be stored as directed by the 
administration manual. The 
reconstituted vaccine should be 
handled at ambient temperature and 
should not be frozen or refrigerated.
The lyophilized cake and the diluent 
are stored at 2°C to 8°C. Placebo 
vials should be reconstituted only 
when ready for preparing the doses 
in a syringe. The prepared placebo 
dose should be stored as directed by 
the administration manual. The 
reconstituted placebo should be 
handled at ambient temperature and 
should not be frozen or refrigerated.
Packaging and Labeling
RSVpreF is supplied as a lyophilized 
white cake, packaged in a clear glass 
2-mL vial with a rubber stopper, 
aluminum overseal, and flip-off cap. 
It is reconstituted with a PFS of 
sterile water diluent for injection 
(supplied).
Study intervention(s) will be labeled 
as per country requirements.
Placebo is supplied as a lyophilized 
white cake containing excipients but 
no active ingredients, packaged in a 
clear glass 2-mL vial with a rubber 
stopper, aluminum overseal, and 
flip-off cap. It is reconstituted with a 
PFS of sterile water diluent for 
injection (supplied).
Study intervention(s) will be labeled 
as per country requirements.
SRSD
IB 
IB
Study Arm(s)
Arm Title
RSVpreF
Placebo
Participants will receive 1 dose 
(0.5 mL) of RSVpreF 120 µg at 
Visit 1.
Participants will receive 1 dose
(0.5 mL) of placebo at Visit 1.
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6.1.1. Administration
Participants will receive 1 dose (0.5 mL) of study intervention (RSVpreF 120 µg or placebo) 
at Visit 1 (Day 1) in accordance with the study’s SoA. The entire contents of the PFS
(0.5 mL) are to be administered. 
The study intervention should be administered intramuscularly into the deltoid muscle, 
preferably of the nondominant arm, unless medical contraindicated, in which case the 
injection may be administered in the dominant arm.
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 must be available in accordance with local guidelines for standard 
immunization practices.
Administration of study interventions will be performed by an appropriately qualified, 
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.
Following administration of study intervention(s) at the site, participants will be observed for 
30 minutes by an appropriately qualified and trained member of the study staff. Appropriate 
medication and other supportive measures for management of a medical emergency will be 
available in accordance with local guidelines and institutional guidelines.
6.1.2. Medical Devices 
1. The medical devices provided for use in this study are a vial adapter and PFS. 
Note: The vial adapters are being deployed 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.
2. Instructions for medical device use are provided in the IPM.
3. All medical device deficiencies (including malfunction, use error, and inadequate 
labeling) shall be documented and reported by the study personnel throughout the clinical 
investigation (see Section 8.4.9) 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. 
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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.
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.
9. 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 interventions should be prepared and dispensed by an appropriately qualified and 
experienced member of the study staff (eg, physician, nurse, physician’s assistant, nurse 
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practitioner, pharmacy assistant/technician, or pharmacist) as allowed by local, state, and 
institutional guidance. A second staff member will verify the dispensing.
Note: Vials are single-use.
6.3. Assignment to Study Intervention
Allocation of participants to vaccine groups will proceed through the use of an IRT system. 
The site personnel (study coordinator or specified designee) will be required to enter or select 
information, including but not limited to the user’s ID and password, the protocol number, 
and the participant number. The site personnel will then be provided with a randomization 
number corresponding to the assigned vaccine group, and DU or container number(s) when 
the study intervention is being supplied via the IRT system. The IRT system will provide a 
confirmation report containing the participant number, randomization number, and DU or 
container number assigned. The confirmation report must be stored in the site’s files. 
Study interventions will be dispensed at the study visits summarized in the SoA. 
The study-specific IRT reference manual and IPM will provide the contact information and 
further details on the use of the IRT system.
6.4. Blinding
This is a double-blinded study, as the physical appearance of RSVpreF and placebo will not 
differ.
6.4.1. Blinding of Participants
Participants will be blinded to their assigned study intervention.
6.4.2. Blinding of Site Personnel
Investigators and other site staff will be blinded to participants’ assigned study intervention.
Please refer to the IPM for further details.
6.4.3. Blinding of Sponsor Personnel
The majority of sponsor staff will be blinded to study intervention allocation. All laboratory 
testing personnel performing serological assays or diagnostic assays will remain blinded to 
study interventions assigned/received throughout the study.
Sponsor staff assigned to support blind-breaking cases will be unblinded.
6.4.4. Breaking the Blind 
The IRT will be programmed with blind-breaking instructions. In case of an emergency, the 
investigator has the sole responsibility for determining if unblinding of a participant’s study 
intervention assignment is warranted. Participant safety must always be the first 
consideration in making such a determination. If the investigator decides that unblinding is 
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warranted, the investigator should make every effort to contact the study medical monitor 
prior to unblinding a participant’s study intervention assignment unless this could delay 
further management of the participant. If a participant’s study intervention assignment is 
unblinded, the sponsor must be notified within 24 hours after breaking the blind. The date 
and reason that the blind was broken must be recorded in the source documentation and CRF.
The study-specific IRT reference manual and IPM will provide the contact information and 
further details on the use of the IRT system. The contact information for the study medical 
monitor is documented in the Study Team Contact List located in the supporting study 
documentation.
6.5. Study Intervention Compliance
Participants will receive the study intervention directly from the investigator or designee, 
under medical supervision. The date and time of the administration will be recorded in the 
source documents and recorded in the CRF. The study intervention identification details and 
study participant ID will be confirmed at the time of dosing by a member of the study site 
staff other than the person administering the study intervention.
The site will complete the required vaccine Preparation Record located in the IPM. The use 
of the Preparation Record is preferred, but it does not preclude the use of an existing 
appropriate clinical site documentation system. The existing clinical site's documentation 
system should capture all pertinent/required information on the preparation and 
administration of the dose. This may be used in place of the Preparation Record after 
approval from the sponsor and/or designee.
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.
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.
There is no specific treatment for 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 follow up
until resolution, stabilization, the event is otherwise explained, or the participant is lost to 
follow-up (as defined in Section 7.3).
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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.
6.9. Prior and Concomitant Therapy
6.9.1. Prohibited Concomitant Vaccinations and Treatments
Receipt of the following vaccines and medications during the time periods listed below may 
exclude a participant from the per-protocol analysis from that point onward; however, it is 
anticipated that the participant would not be withdrawn from the study (unless documented 
as per Section 7.2). Medications and vaccinations should not be withheld if required for a 
participant’s medical care.

Investigational vaccines other than RSV vaccines and investigational drugs are prohibited 
within 6 months prior to study intervention administration and thereafter during the 
course of the study.

Previous vaccination with any licensed or nonstudy investigational RSV vaccines or 
receipt of these vaccines during the course of the study are prohibited.

Nonstudy nonlive or recombinant vaccines other than RSV vaccines should not be given 
within 14 days before or after study intervention administration, unless medically 
necessary.

Nonstudy live vaccines should not be given within 28 days before or after study 
intervention administration, unless medically necessary.

Receipt of blood/plasma products or immunoglobulin should not be given within 60 days 
prior to study intervention administration through the Visit 3 blood draw.
Note: Monoclonal antibodies with targeted mechanisms of action used in the 
management of chronic illnesses (eg, migraine headaches, osteoporosis) are permitted, 
provided they do not meet exclusion criterion 8.

Receipt of chronic systemic treatment with known immunosuppressant medications,
other than systemic corticosteroids meeting the criteria noted below, within 60 days prior 
to study intervention administration through the Visit 3 blood draw. 

Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for 
≥14 days is prohibited from 28 days prior to study intervention administration through 
the Visit 3 blood draw.
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
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

Nonstudy nonlive or recombinant licensed vaccines other than RSV vaccines may be 
given starting 14 days after study intervention administration (Day 15).

Nonstudy live licensed vaccines may be given starting 28 days after study intervention 
administration (Day 29). 

Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) 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.
6.9.3. Recording Nonstudy Vaccinations and Concomitant Medications
The following prior and concomitant medications, vaccinations, and treatments will be 
recorded in the CRF:

Any nonstudy vaccinations received from 28 days prior to study intervention 
administration until the last study visit.

Prohibited medications and treatments listed in Section 6.9.1 (with the exception of 
antipyretics and other pain medications to prevent symptoms), if taken, will be recorded 
and include start and stop dates, name of the medication, dose, unit, route, and frequency. 
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
Since this is a single-dose study, this section is not applicable.
7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at their own request. Reasons for 
discontinuation from the study include the following:

Refused further study procedures;

Lost to follow-up;

Death;
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
Study terminated by sponsor;

Reactogenicity event;

AE;

Investigator/physician request;

Protocol deviation;

Participant request;

Other.
If a participant withdraws from the study, they may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly.
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations 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.
7.2.1. Withdrawal of Consent 
Participants who request to discontinue active study participation (eg, biological sample 
collection) will remain in the study and must continue to be followed for protocol-specified 
safety follow-up procedures. The only exception to this is when a participant specifically 
withdraws consent for any further contact with them or persons previously authorized by the 
participant to provide this information. Participants should notify the investigator in writing 
of the decision to withdraw consent from future follow-up, whenever possible. The 
withdrawal of consent should be explained in detail in the medical records by the investigator 
as to whether the withdrawal is only from specified study procedures and/or postvaccination 
safety 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 is unable to be contacted by the study site.
The following actions must be taken if a participant fails to attend a required study visit:

The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible. Counsel the participant on the importance of maintaining the assigned visit 
schedule, and ascertain whether the participant wishes to and/or should continue in the 
study;
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
Before a participant is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, 
if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
medical record;

Should the participant continue to be unreachable, the participant will be considered to 
have withdrawn from the study. 
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 age of each participant will be collected to critically evaluate the immune response and 
safety profile.
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.
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.
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8.1.1. Telehealth 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. Assessments that may be performed 
during a telehealth visit are described in the SoA.
Study participants must be reminded to promptly notify site staff about any change in their 
health status.
8.2. Efficacy and/or Immunogenicity Assessments
8.2.1. Blood Collection
Blood samples (approximately 20 mL per sample) will be collected from participants for 
immunogenicity testing as specified in the SoA. Blood samples will be collected from all 
participants at Visit 1 (prior to study vaccination) and Visit 3 (1 month after study 
vaccination) for antibody assessment. The total blood sampling volume for individual 
participants is approximately 40 mL.
Blood samples will be processed at the study site, where the serum will be extracted, frozen,
and stored. The serum samples will then be shipped to the central laboratory for analysis. 
Instructions for the collection and handling of blood and serum samples will be provided in 
the laboratory manual. The date and time of each sample will be recorded. The 
immunogenicity serum samples must be processed and shipped as indicated in the 
instructions provided to the investigator site to maintain sample integrity. Any deviations 
from the immunogenicity sample handling procedure (eg, sample collection and processing 
steps, interim storage, or shipping conditions), including any actions taken, must be 
documented and reported to the sponsor. On a case-by-case basis, the sponsor may make a 
determination as to whether sample integrity has been compromised.
8.2.2. RSV Vaccine Antibody Testing
RSV A– and RSV B–neutralizing antibody titers will be measured at each blood sampling 
time point. 
Sample collection may be halted or discontinued upon notification by Pfizer. This includes 
discontinuing sampling in dosed participants who are no longer eligible for the study as well 
as discontinuation for groups of participants or all participants.
All serum sample assays will be performed by Pfizer and/or at a facility designated by Pfizer.
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8.2.3. Biological Samples 
Serum 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.
The participant may request that their 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 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 a physical examination and medical history, will be 
performed on all participants at their first visit to establish a baseline. Significant medical 
history and any clinically significant observations from any physical examination will be 
documented in the CRF.
AEs, SAEs, NDCMCs, and AESIs will be collected, recorded, and reported as defined in 
Section 8.4.
Participants will be observed for at least 30 minutes after vaccination and any acute reactions 
occurring during the first 30 minutes after administration of the study intervention will be 
recorded on the CRF.
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. These prospectively self-collected occurrences of local reactions and systemic 
events are graded as described in Table 5, Table 6, and Table 7.
Unscheduled safety measurements may be obtained at any time during the study to assess 
any perceived safety issues.
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8.3.1. Physical Examinations
A clinical assessment and physical examination will be performed at Visit 1, Visit 3, and 
unscheduled reactogenicity visits.
A physical examination should include vital signs (oral or tympanic or temporal artery
temperature, heart rate, respiratory rate, and seated BP) and evaluation of any clinically 
significant abnormalities within the following body systems: general appearance; skin; head,
eyes, ears, nose, and throat; heart; lungs; abdomen; musculoskeletal; extremities; and lymph 
nodes.
Investigators should pay special attention to clinical signs related to previous serious 
illnesses.
Physical examination findings collected during the study will be considered source record 
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 
Sections 8.4.1 to 8.4.3.
8.3.2. Vital Signs
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 Sections 8.4.1 to 8.4.3.
8.3.3. Clinical Safety Laboratory Assessments
Clinical safety laboratory assessments will not be collected in this study.
8.3.4. Electronic Diary for Reactogenicity
Participants will be required to complete a reactogenicity e-diary through an application 
installed on a provisioned device or on the personal device of the participant. They will be 
asked to monitor and record prespecified local reactions, systemic events, and temperature 
daily for 7 days or longer following vaccination, where Day 1 is the day of vaccination. 
Participants will receive reminders to complete the reactogenicity e-diary on a daily basis, 
starting on the day of study intervention administration (Day 1) through Day 7, or longer if 
there are ongoing symptoms. 
The e-diary allows recording of these assessments each day, thus providing an accurate 
representation of the participant’s experience.
Data on local reactions, systemic events, and temperature recorded in the e-diary will be 
transferred electronically to the e-diary vendor, where they will be available for review by 
investigators, their qualified designees, and sponsor staff at all times via an internet-based 
portal. At intervals agreed to by the vendor and Pfizer, these data will be transferred 
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electronically to Pfizer for analysis and reporting. These data do not need to be recorded by 
the investigator in the CRF, except for the following conditions:

Grade 4 local reactions will be collected in the CRF.

Any local reactions or systemic events occurring within the first 30 minutes after study 
vaccination must be recorded on the CRF. The time of onset (relative to vaccination) 
must be recorded.

If a participant withdraws because of prespecified event(s) recorded in the e-diary, the 
event(s) should be recorded on the CRF, regardless of whether the investigator considers 
the event(s) to be clinically significant.

The investigator or designee must obtain stop dates for any symptoms ongoing on the last 
day, from Day 7 onwards until resolution. The stop dates should be documented in the 
source documents and the information entered in the CRF.
Investigators (or appropriately qualified designees) are required to review the e-diary data 
online at frequent intervals to evaluate participant compliance and as part of the ongoing 
safety review.
All provisioned e-diary devices must be collected per the study 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 volunteers enrolled in preventive vaccine clinical trials.35
8.3.4.2. Local Reactions
Following vaccination (where Day 1 is the day of vaccination), participants will be asked to 
assess redness, swelling, and pain at the injection site, and to record the symptoms in the 
e-diary or appropriate device daily.
Redness and swelling will be measured by the participant and recorded in measuring device 
units (range: 1 to 21; an entry in the e-diary of 21 will be denoted as ≥21), and then 
categorized during analysis as absent, mild, moderate, or severe based on the grading scale in 
Table 5. Measuring device units can be converted to centimeters according to the following 
scale: 1 measuring device unit = 0.5 cm. Pain at the injection site will be assessed by the 
participant as absent, mild, moderate, or severe according to the grading scale in Table 5.
If a severe (Grade 3) local reaction 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.
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Only an investigator or a qualified designee is able to classify a participant’s local reaction as 
Grade 4, after clinical evaluation of the participant, documentation from another medically 
qualified source (eg, emergency room or hospital record), or telephone contact with the 
participant. If a participant experiences a Grade 4 local reaction, the investigator must 
immediately notify the sponsor. A Grade 4 local reaction will be collected on the CRF.
If a local reaction persists beyond the end of the 7-day e-diary collection period, the 
participant will be requested to report that information and/or any new events that develop to 
the investigator or the study staff. The investigator will enter this additional information in 
the participant’s source notes and CRF.
Table 5.
Grading Scale for Local Reactions
Mild 
(Grade 1)
Moderate
(Grade 2)
Severe
(Grade 3)
Grade 4a
Redness
2.0 cm to 5.0 cm 
(5 to 10 measuring 
device units)
5.0 cm to 10.0 cm 
(11 to 20 measuring 
device units)
10 cm 
(20 measuring device 
units)
Necrosis or exfoliative 
dermatitis
Swelling
2.0 cm to 5.0 cm 
(5 to 10 measuring 
device units)
5.0 cm to 10.0 cm 
(11 to 20 measuring 
device units)
10 cm 
(20 measuring device 
units)
Necrosis
Pain (at the 
injection site)
Does not interfere 
with activity
Interferes with activity Prevents daily activity Emergency room visit 
or hospitalization for 
severe pain at the 
injection site
a.
Only an investigator or qualified designee is able to classify a participant’s local reaction as Grade 4, after 
clinical evaluation of the participant, documentation from another medically qualified source 
(eg, emergency room or hospital record), or telephone contact with the participant. Grade 4 local reactions 
will be collected on the CRF and assessed by the investigator or qualified designee.
8.3.4.3. Systemic Events
Following vaccination (where Day 1 is the day of vaccination), participants will be asked to 
assess fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain, and to 
record the symptoms in the e-diary or appropriate device daily. The systemic symptoms will 
be assessed by the participant as absent, mild, moderate, or severe according to the grading 
scale in Table 6.
If a severe (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.
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Only an investigator or qualified designee is able to classify a participant’s systemic event as 
Grade 4, after clinical evaluation of the participant, documentation from another medically 
qualified source (eg, emergency room or hospital record), or telephone contact with the 
participant. If a participant experiences a Grade 4 systemic event, the investigator must 
immediately notify the sponsor. A Grade 4 systemic event will be collected on the CRF.  
Further, if a systemic event persists beyond the end of the 7-day e-diary collection period, the 
participant will be requested to report that information and/or any new events that develop to 
the investigator or the study staff. The investigator will enter this additional information in 
the participant’s source notes and CRF.
Table 6.
Grading Scale for Systemic Events
Mild 
(Grade 1)
Moderate
(Grade 2)
Severe
(Grade 3)
Grade 4a
Fatigue
(= tiredness in 
e-diaries)
Does not interfere with 
activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe fatigue
Headache
Does not interfere with 
activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe headache
Vomiting
1 to 2 times in 24 hours
2 times 
in 24 hours
Requires IV 
hydration
Emergency room 
visit 
or hospitalization 
for severe vomiting
Nausea
Does not interfere with 
activity
Some interference 
with activity
Prevents daily 
routine activity
Emergency room 
visit or 
hospitalization for 
severe nausea
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
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, documentation from another medically qualified source 
(eg, emergency room or hospital record), or telephone contact with the participant. Grade 4 systemic 
events will be collected on the CRF and assessed by the investigator or qualified designee.
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8.3.4.4. Temperature and Fever Assessment 
A digital thermometer will be given to the participant with instructions on how to measure 
oral temperature at home. Temperature will be collected daily for 7 days or longer following 
vaccination (where Day 1 is the day of vaccination). 
Fever is defined as an oral temperature of ≥38.0°C. The highest temperature for each day will 
be recorded in the e-diary, where possible. Temperature will be measured and recorded 
to 1 decimal place. 
In the event of a fever on the last day the diary was completed, temperature will be measured 
daily until the fever has resolved (1 day of temperature 38.0°C) in order to collect a stop 
date in the CRF.
If a fever of 38.9°C is reported in the e-diary, a telephone contact should occur to ascertain 
further details and determine whether a site visit is clinically indicated.
Only an investigator or qualified designee is able to classify a participant’s fever as Grade 4, 
after clinical evaluation of the participant, documentation from another medically qualified 
source (eg, emergency room or hospital record), or telephone contact with the participant. 
Grade 4 fevers will be collected on the CRF.
Table 7.
Ranges for Fever
Mild 
(Grade 1)
Moderate
(Grade 2)
Severe
(Grade 3)
Grade 4a
Fever
≥38.0°C to 38.4°C
38.4°C to 38.9°C
38.9°C to 40.0°C
40.0°C
a.
Only an investigator or qualified designee is able to classify a participant’s fever as Grade 4, after clinical 
evaluation of the participant, documentation from another medically qualified source (eg, emergency 
room or hospital record), or telephone contact with the participant. Grade 4 fevers will be collected on the 
CRF.
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 10.5. Device deficiencies are covered in Section 8.4.9.
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally 
authorized representative), or they may arise from clinical findings of the investigator or 
other healthcare providers (clinical signs, test results, etc).
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The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study (see Section 7.1). 
During the active collection period as described in Section 8.4.1 each participant will be 
questioned about the occurrence of AEs in a nonleading manner.
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.
8.4.1. 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 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 4. At Visit 4 (2-month follow-up), the participant will be contacted by telephone to 
inquire about SAEs, including hospitalizations, NDCMCs, and AESIs since Visit 3.

Nonserious AEs will be collected from informed consent through 1 month following 
study intervention administration (Visit 3).

SAEs, including hospitalizations, NDCMCs, and AESIs will be collected from informed 
consent through the last study visit (Visit 4).
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 the study because of an 
AE or SAE, the AE or SAE must be recorded on the CRF and the SAE reported via PSSA or 
using the Vaccine SAE Report Form.
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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 concluded study participation, 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 Report Form or, if applicable, via 
PSSA.
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 Report Form or, if applicable,
via PSSA, 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.
If a participant begins a new therapy, the recording period for nonserious AEs ends at the 
time the new treatment is started; however, SAEs must continue to be recorded on the CRF 
during the above-indicated active collection period. A switch to a commercially available 
version of the study intervention is considered as a new therapy for the purposes of SAE 
reporting.
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 is the preferred method to inquire about 
AE occurrences.
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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).
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.
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8.4.5.1. Exposure During Pregnancy
An EDP occurs if:

A male participant who is receiving or has discontinued the study intervention 
inseminates a female partner. 

A female participant is found to be pregnant while receiving or after discontinuing the 
study intervention.

A female nonparticipant is found to be pregnant while being exposed or having been 
exposed to the 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 needlestick injury, inhalation, or 
skin contact.

A male family member or healthcare provider who has been exposed to the study 
intervention by needlestick injury, inhalation, or skin contact then inseminates his 
female partner prior to or around the time of conception.
The investigator must report the 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 an EDP occurs in a participant/participant’s partner, the investigator must report this 
information to Pfizer Safety via PSSA or using the Vaccine SAE Report 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 end of study.

If an EDP occurs in the setting of environmental exposure, the investigator must report 
this information to Pfizer Safety using the Vaccine SAE Report Form and an 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 report 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 report. In the case of a live birth, the structural integrity of the neonate 
can be assessed at the time of birth. In the event of a termination, the reason(s) for 
termination should be specified and, if clinically possible, the structural integrity of the 
terminated fetus should be assessed by gross visual inspection (unless preprocedure test 
findings are conclusive for a congenital anomaly and the findings are reported).
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Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a live-born baby, or a terminated fetus), 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 nonparticipant is found to be breastfeeding while being exposed or having been 
exposed to the 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 needlestick 
injury, inhalation, or skin contact.  
The investigator must report the 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 Report Form or, if applicable, via PSSA. 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 report is maintained in the investigator site file.
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.
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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 Report 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 report is 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
The following events are considered as AESIs:

Diagnosis of GBS;

Diagnosis of acute polyneuropathy without an underlying etiology;

Diagnosis of atrial fibrillation.
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. 
All AESIs must be reported as an AE or SAE following the procedures described in 
Sections 8.4.1 through 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 
Report Form.
8.4.8.1. Lack of Efficacy
This section is not applicable for these cohorts, as efficacy is yet to be demonstrated in the 
study population.
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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 Section 10.5.3. 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 Sections 8.4.1 through 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.
Refer to Section 10.5.4 for instructions for documenting and reporting medical device 
deficiencies. 
8.4.9.2. 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.
Note: There are additional reporting obligations for medical device deficiencies that are 
potentially related to SAEs (ie, an 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.
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
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.
8.4.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Medication errors are recorded and reported as follows:
Recorded on the 
Medication Error Page of 
the CRF
Recorded on the 
Adverse Event Page 
of the CRF
Reported on the Vaccine 
SAE Report Form/PSSA
to Pfizer Safety Within 
24 Hours of Awareness
All (regardless of whether 
associated with an AE)
Any AE or SAE associated 
with the medication error
Only if associated with an 
SAE
Medication errors include:

Medication errors involving participant exposure to the study intervention;

Potential medication errors or uses outside of what is foreseen in the protocol that do or 
do not involve the study participant;

The administration of an expired study intervention;

The administration of an incorrect study intervention;

The administration of an incorrect dosage;

The administration by an incorrect route;

The administration of a 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.
Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, such medication errors occurring to a study participant are recorded on the 
medication error page of the CRF, which is a specific version of the AE page and, if 
applicable, any associated serious and nonserious AE(s) are recorded on the AE page of the 
CRF.
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In the event of a medication dosing error, the sponsor should be notified within 24 hours.
Medication errors should be reported to Pfizer Safety within 24 hours on a Vaccine SAE 
Report Form or via PSSA 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.
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 (Day 1 – Vaccination)
Before enrollment and before any study-related procedures are performed, voluntary, written,
study-specific informed consent will be obtained from the participant. Each signature on the 
ICD must be personally dated by the signatory.
The investigator or their designee will also sign and date the ICD. A copy of the signed and 
dated ICD must be given to the participant. The source data must reflect that the informed 
consent 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 study intervention are conducted prior to 
study vaccination.

Obtain written informed consent from the participant before performing any 
study-specific procedures.

Assign a single participant identifier using the IRT system.

Obtain and record the participant demography (including complete date of birth 
[DD/MMM/YYYY], sex, race, racial designation, and ethnicity). The age of each 
participant will be collected to critically evaluate the immune response and safety profile. 
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
Obtain and record significant medical history, including but not limited to, heart disease, 
lung disease, asthma, diabetes mellitus, liver disease, and renal disease.

Obtain and record current/former tobacco usage.

Perform a clinical assessment and physical examination and record any findings in the 
source documents and, if clinically significant, record on the medical history CRF.

Measure weight and height.

Obtain details of any nonstudy vaccinations as described in Section 6.9.3.

Obtain details of prohibited medications and treatments as described in Section 6.9.1.

Ensure and document that all the inclusion criteria and none of the exclusion criteria are 
met.

Discuss contraceptive use, if applicable, as described in Section 10.3.1.

Measure and record prevaccination temperature.

Ensure that the participant meets none of the temporary delay criteria as described in 
Section 5.5.

Obtain the participant’s randomization number and study intervention kit number using
the IRT system. Refer to the IRT manual for further instructions on this process.

Prior to vaccination, collect a blood sample of approximately 20 mL for immunogenicity
assessment.

The qualified site staff member(s) will prepare and administer a single-vial 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 instructions on this procedure.

Site staff must observe the participant for any acute reactions for at least 30 minutes after 
study intervention administration. Record any acute reactions in the participant’s source 
documents, on the CRF, and on the Vaccine SAE Report Form or PSSA as applicable.
All acute reactions must have the time of onset (relative to time of vaccination) recorded 
in the CRF.

Issue the participant a measuring device and a digital thermometer and provide 
instructions on their use. 
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
Explain the e-diary technologies available for this study and assist the participant in 
downloading the study application onto their own device or issue a provisioned device if 
required. 

Provide instructions on reactogenicity e-diary completion and ask the participant to 
complete the reactogenicity e-diary from Day 1 through Day 7, or longer, until any 
symptoms that are ongoing are resolved, with Day 1 being the day of vaccination.

Ask the participant 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 (Section 8.10.5).

Fever ≥39.0°C.

Redness or swelling at the injection site measuring 20 measuring device units.

Severe pain at the injection site. 

Any severe systemic event.

Remind the participant that study staff may contact them to obtain additional information 
on symptoms entered into the e-diary until they resolve.

Remind participants to inform the study staff of any illnesses or medical events
(eg, healthcare visits or hospitalization) that occur for the duration of the trial as 
described in Section 8.3.4 and Section 10.5.

Remind the participant to bring the e-diary to the next visit.

Record AE, NDCMCs, SAEs, and AESIs as described in Section 8.4 and Section 10.2.

Schedule an appointment for the participant to return for the 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 e-diary data online 
following vaccination to evaluate participant compliance and as part of the ongoing 
safety review.
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8.10.2. Visit 2 (1-Week Follow-Up)

Contact the participant by telephone.  

Review the participant’s e-diary data and record the assessment in the CRF. Assess 
compliance, record any medically attended events (including hospitalizations), and 
collect stop dates of any symptoms ongoing on the last day of the e-diary collection 
period in the CRF. For symptoms still ongoing, continue to follow up until resolution and 
document and record stop dates in the CRF.

Remind the participant to bring the e-diary to the next visit.

Obtain details of any nonstudy vaccinations and prohibited medications and treatments as 
described in Section 6.9.1.

Record AE, NDCMCs, SAEs, and AESIs as described in Section 8.4 and Section 10.2.

Remind participants to inform the study staff of any illnesses or medical events 
(eg, healthcare visits or hospitalization) that occur for the duration of the trial as 
described in Section 8.3.4 and Section 10.5.

If appropriate, discuss contraceptive use as described in Section 10.3.1.

Complete the source documents.

The investigator or an authorized designee completes the CRFs.
8.10.3. Visit 3 (1-Month Follow-Up)

Perform a clinical assessment and physical examination and record any findings in the 
source documents and, if the findings are clinically significant and meet the definition of 
an AE or SAE, record them on the CRF and according to the processes in Section 8.4.1 to
Section 8.4.3.

Obtain details of any nonstudy vaccinations and prohibited medications and treatments as 
described in Section 6.9.1.

Collect a blood sample of approximately 20 mL for antibody assessment.

Review ongoing reactogenicity e-diary symptoms reported as present on the last day of 
the e-diary collection period and obtain stop dates. Record stop dates in the CRF if 
required. Any ongoing reactions must be assessed at the next contact.

Ensure that all data have been transferred from the e-diary prior to deactivating the 
application. 
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
Collect the participant’s e-diary provisioned device or assist the participant with 
removing the study application from their personal device.

Record AEs, AESIs, NDCMCs, and SAEs as described in Section 8.4 and Section 10.2. 

If appropriate, discuss contraceptive use as described in Section 10.3.1.

Complete the source documents.

The investigator or an authorized designee completes the CRFs.
8.10.4. Visit 4 (2-Month Follow-Up)

Contact the participant by telephone.  

Obtain details of any nonstudy vaccinations and prohibited medications and treatments as 
described in Section 6.9.1.

Review ongoing reactogenicity e-diary symptoms reported as present on the last day of 
the e-diary collection period and obtain stop dates. Record stop dates in the CRF if 
required.

Record SAEs, NDCMCs, and AESIs as described in Section 8.4 and Section 10.2.

Complete the source documents.

The investigator or an authorized designee completes the CRFs.
8.10.5. Unscheduled Reactogenicity Visit
Phone Contact
If the participant reports 1 or more of the following, a phone contact must occur as soon as 
possible between the participant and the investigator, or a medically qualified member of the 
study site staff, to assess if an unscheduled reactogenicity visit is required, including:

Fever ≥39.0°C,

Redness at the injection site on the arm in which the study intervention was administered
measuring 20 measuring device units (10.0 cm),

Swelling at the injection site on the arm in which the study intervention was administered
measuring 20 measuring device units (10.0 cm),

Severe injection site pain in the arm in which the study intervention was administered, 

Any severe systemic event.
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If a suspected Grade 4 local reaction (Section 8.3.4.2), systemic event (Section 8.3.4.3), or 
fever (Section 8.3.4.4) 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 or 
referral to a healthcare facility should be scheduled as soon as possible to assess the extent of 
the reaction, unless:

The participant is unable to attend the unscheduled visit, or

The reaction is no longer present at the time of the contact, or

The participant recorded an incorrect value in the e-diary (confirmation of an e-diary data 
entry error), or

The investigator or appropriate designee determines that the visit is not required, or

The investigator or appropriate designee confirmed a severe reactogenicity assessment 
via medical records and/or telehealth assessment.
This contact will be recorded in the participant’s source notes and in the CRF.
Any ongoing reactions must be assessed at the next scheduled visit.
Site Visit Procedures
If an unscheduled reactogenicity site visit is required, reactogenicity events should be 
assessed by the investigator or a medically qualified member of the site staff such as a study 
physician or a study nurse, as applicable to the investigator’s local practice or healthcare 
facility. Perform a clinical assessment and physical examination:

Measure temperature (oral, tympanic, or temporal artery),

Measure BP (seated),

Measure heart rate,

Measure respiratory rate,

Using a ruler or tape measure, measure the minimum and maximum diameters of redness 
(if present) on the arm in which the study intervention was administered,

Using a ruler or tape measure, measure the minimum and maximum diameters of 
swelling (if present) on the arm in which the study intervention was administered,

Assess if necrosis is present at the injection site on the arm in which the study 
intervention was administered,
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
Assess if any exfoliative dermatitis is present at the injection site on the arm in which the 
study intervention was administered,

Assess any injection site pain that is present in the arm in which the study intervention 
was administered in accordance with the reactogenicity grading scale provided in
Section 8.3.4.2,

Assess any systemic events (fatigue, headache, nausea, vomiting, diarrhea, muscle pain, 
or joint pain) that are present in accordance with the reactogenicity grading scale 
provided in Section 8.3.4.3.
Additionally,

Record any nonstudy vaccinations and prohibited medications and treatments as 
described in Section 6.9.1,

Ask the participant if he/she attended an emergency room visit or was hospitalized for 
management of postvaccination local reactions or systemic events,

Record AEs, AESIs, NDCMCs, and SAEs as described in Section 8.4 and Section 10.2,

Complete the participant’s source documents,

Complete the CRFs.
The study staff may contact the participant to obtain additional information on events entered 
into the e-diary until they resolve.
9. STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined 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 Hypotheses
This is a descriptive study without any hypothesis testing.
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9.2. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Participant Analysis Set
Description
Screened population
All participants who have a signed ICD in the study.
Randomized population
All screened participants who are assigned a randomization 
number in the IRT system in this study.
Safety population
All screened participants who receive the study intervention 
in the study.
Defined Analysis Set
Description
Evaluable immunogenicity 
population 
All participants who meet the following criteria:

Are eligible for the study;

Receive the study intervention to which they were 
randomized;

Have the 1-month postvaccination blood collection visit 
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 were randomized and had at least 1 valid 
and determinate assay result after receiving the study 
intervention.
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
Unless stated otherwise, “vaccine group” in this section refers to the study intervention 
group. CIs for all endpoints in the statistical analysis will be presented as 2-sided at the 
95% level unless specified otherwise.
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The safety analyses are based on the safety population. Participants will be summarized by 
vaccine group according to the study interventions they received. Missing AE dates will be 
handled according to the Pfizer safety rules.
For all the immunogenicity endpoints, the analysis will be based on the evaluable 
immunogenicity population. An additional analysis may be performed based on the mITT 
immunogenicity population if there is a large enough difference in sample size between the 
mITT immunogenicity population and the evaluable immunogenicity population. Participants 
will be summarized according to the vaccine group to which they were randomized. Missing 
immunogenicity results will not be imputed. Immunogenicity results that are below the 
LLOQ will be set to 0.5 × LLOQ in the analysis; this may be adjusted once additional data 
on the assay characteristics become available.
9.3.1.1. Analyses for Binary Data
Descriptive statistics for binary variables (eg, proportions) are the percentage (%), the 
numerator (n) and the denominator (N) used in the percentage calculation, and the 95% CIs 
where applicable.
The exact 95% CI for binary endpoints for each group will be computed using the 
F distribution (Clopper-Pearson).37
The 95% CI for the difference in the proportions will be computed using the Miettinen and 
Nurminen method.38 The 95% CI will be presented in terms of percentage.
9.3.1.2. Analyses for Continuous Data
Unless otherwise stated, descriptive statistics for continuous variables are n, mean, median, 
SD, minimum, and maximum.
CIs for the mean of the continuous variables will be constructed by the standard method 
based on the Student t distribution.
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 log e scale based on the t distribution, and then exponentiating the 
results.
9.3.1.2.2. Geometric Mean Fold Rises
Fold rises are defined as ratios of the results after vaccination to the results before 
vaccination. The calculations of fold rises are limited to participants with nonmissing values 
at both time points.
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GMFRs will be calculated as the mean of the difference of logarithmically transformed assay 
results (later time point minus earlier time point) and exponentiating the mean. 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 8.
Primary Endpoint Analyses
Endpoint
Statistical Analysis Methods
Safety

Descriptive statistics will be provided for each reactogenicity 
endpoint for each vaccine group. Local reactions (redness, swelling,
and pain at the injection site) and systemic events (fever, nausea, 
fatigue, 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% CIs 
(Section 9.3.1.1).

AEs (including AESIs), NDCMCs, and SAEs will be categorized 
according to MedDRA terms. All AEs within 1 month after study 
intervention administration, and all AESIs, NDCMCs, and SAEs 
throughout the study will be descriptively summarized with counts, 
percentages, and associated Clopper-Pearson 95% CIs for each 
vaccine group (Section 9.3.1.1).

A 3-tier approach will be used to summarize AEs. (1) Tier 1 events 
are prespecified events of clinical importance and are identified in a 
list in the product’s safety review plan and described in detail in the 
SAP. (2) Tier 2 events are considered “relatively common” events; a 
MedDRA preferred term is defined as a Tier 2 event if at least 4
participants in at least 1 vaccine group report the event. (3) Tier 3 
events are those that are neither Tier 1 nor Tier 2 events. 
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Table 8.
Primary Endpoint Analyses
Endpoint
Statistical Analysis Methods

For Tier 1 and Tier 2 events, the 95% CIs for the difference in the 
percentage of participants reporting the events between the RSVpreF 
group and the placebo group will be calculated using the test statistic 
proposed by Miettinen and Nurminen. In addition, for Tier 1 events, 
the p-values will be presented for the difference between groups in 
the percentage of participants reporting the events. For Tier 3 events, 
counts and percentages for each vaccine group will be provided.  
Immunogenicity

GMTs and their associated 95% CIs will be descriptively 
summarized, by vaccine group, for both RSV A and RSV B at each 
blood sampling visit (Section 9.3.1.2.1).

GMFRs of NTs from before vaccination to 1 month after vaccination 
will be descriptively summarized with 95% CIs, by vaccine group, 
for both RSV A and RSV B (Section 9.3.1.2.2).

Empirical RCDCs will be provided for RSV A and RSV B NTs at 
1 month after vaccination (Section 9.3.1.2.3).
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis
Endpoint
Statistical Analysis Methods
Immunogenicity

RSV A NT and RSV B NT seroresponse rate at 1 month after 
vaccination will be provided with the associated 
Clopper-Pearson 2-sided 95% CIs (Section 9.3.1.1). 

Immunogenicity data may be further summarized by age stratum.
9.3.4. Tertiary/Exploratory Endpoint(s) Analysis
Not applicable.
9.4. Interim Analyses
No interim analysis is planned. One final analysis will be performed when all
immunogenicity and safety data are cleaned.
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9.5. Sample Size Determination
As this study is not a hypothesis-testing study, the sample size was not based on study power 
for success. 
It is expected that 240 participants will receive RSVpreF, with a total of 360 participants 
randomized in a 2:1 ratio. Assuming an ~10% nonevaluable rate, ~210 participants in the 
RSVpreF group will be assessed for immunogenicity. 
Based on historical data, the GMFR at 1 month after vaccination with RSVpreF was 
~10 (or 2.3 in the log e scale) among participants ≥60 years of age. With 210 participants 
expected to be evaluable after receiving RSVpreF, there is a 2.4% and 5% possibility of 
observing an LB of the 95% CI for the GMFR <7.5 for RSV A and RSV B, respectively.
Antigen/
Strain
Common SD of 
Fold Rise 
(Log e Scale)a
Probability of Observing an LB of 95% CI for the 
GMFR <7.5 (or 2.0 in the Log e Scale) 
RSV A
1.1
2.4%
RSV B
1.2
5.0%
a.
Based on Study C3671013. 
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:

Consensus ethical principles derived from international guidelines, including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines;

Applicable ICH GCP guidelines;

Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor, submitted to an IRB/EC 
by the investigator, and reviewed and approved by the IRB/EC before the study is initiated.
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard to 
study participants.
The investigator will be responsible for the following:

Providing written summaries of the status of the study to the IRB/EC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/EC;

Notifying the IRB/EC of SAEs or other significant safety findings as required by IRB/EC 
procedures;

Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 CFR, ICH GCP guidelines, the IRB/EC, European regulation 536/2014 for clinical 
studies, European Medical Device Regulation 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. 
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In addition, the investigator will inform Pfizer immediately of any urgent safety measures 
taken by the investigator to protect the study participants against any immediate hazard, and 
of any serious breaches of this protocol or of the ICH GCP guidelines that the investigator 
becomes aware of.
10.1.2. Financial Disclosure
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or the investigator’s representative will explain the nature of the study, 
including the risks and benefits, to the participant and answer all questions regarding the 
study. The participant should be given sufficient time and opportunity to ask questions and to 
decide whether or not to participate in the trial.
Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH guidelines, privacy and data protection requirements, where 
applicable, and the IRB/EC or study center.
The investigator must ensure that each participant is fully informed about the nature and 
objectives of the study, the sharing of data related to the study, and possible risks associated 
with participation, including the risks associated with the processing of the participant’s 
personal data. 
The participant must be informed that their personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.
The participant must be informed that their 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 is fully informed about their
right to access and correct their personal data and to withdraw consent for the processing of 
their personal data.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date on which the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICD.
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Participants must be reconsented to the most current version of the IRB/EC-approved ICD(s) 
during their participation in the study as required per local regulations.
A copy of the ICD(s) must be provided to the participant.
Participants who are rescreened are required to sign a new ICD.
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.
10.1.5. Committees Structure
10.1.5.1. Data Monitoring Committee 
This study will not use an EDMC.
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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
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.
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Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.7. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document.
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password protected or secured in a locked room to 
prevent access by unauthorized third parties.
QTLs are predefined parameters that are monitored during the study. Important deviations 
from the QTLs and any remedial actions taken will be summarized in the 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.
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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.
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 re-identified from their medical records, the 
following actions must be taken when medical records are sent to the sponsor or sponsor 
designee:
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
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, birth date, 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). 

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 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.
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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.
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.
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10.1.12. Sponsor’s Medically Qualified Individual 
The sponsor will designate a medically qualified individual (MQI, also known as the medical 
monitor) to advise the investigator on study-related medical questions. The contact 
information for the study medical monitor is documented in the Study Team Contact List 
located in the supporting study documentation. 
Participants are provided with a Pfizer study information card at the time of informed 
consent, which includes contact information for their investigator in case of study-related 
medical questions. The study information card contains, at a minimum, (a) study number, 
(b) participant’s study ID number, and (c) PI contact information.
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10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting
10.2.1. Definition of AE
AE Definition

An AE is any untoward medical occurrence in a patient or clinical study participant, 
temporally associated with the use of study intervention, whether or not considered 
related to the study intervention.

Note: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally 
associated with the use of study intervention.
Events Meeting the AE Definition

Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator. Any abnormal 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.
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Events NOT Meeting the AE Definition

Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.

The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the participant’s 
condition.

Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads 
to the procedure is the AE.

Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).

Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present or 
detected at the start of the study that do not worsen.
10.2.2. Definition of an SAE
An SAE is defined as any untoward medical occurrence that, at any dose, meets one 
or more of the criteria listed below:
a.
Results in death
b. Is life-threatening
The term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might have caused death if it were more severe.
c.
Requires inpatient hospitalization or prolongation of existing hospitalization
In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious.
Hospitalization for elective treatment of a preexisting condition that did not worsen 
from baseline is not considered an AE.
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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 using the Vaccine SAE Report Form or, if applicable, via PSSA 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.
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It should be noted that the Vaccine SAE Report Form/PSSA 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 Report Form/PSSA for reporting of SAE information.
Safety Event
Recorded on the CRF
Reported on the Vaccine 
SAE Report Form/PSSA
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 SAE) is reported to Pfizer Safety using the Vaccine SAE Report 
Form or, if applicable, via PSSA.
**
EDB is reported to Pfizer Safety using the Vaccine SAE Report Form or, if applicable, via PSSA,
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 Report 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 Report Form/AE or 
SAE CRF page.
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
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. Refer to Section 10.1.9 for actions that must be taken 
when medical records are sent to the sponsor or sponsor designee.

The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis 
(not the individual signs/symptoms) will be documented as the AE or SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported during 
the study and assign it to 1 of the following categories: 

Mild: A type of AE that is usually transient and may require only minimal treatment or 
therapeutic intervention. The event does not generally interfere with usual ADL.

Moderate: A type of AE that is usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual ADL, causing discomfort, but poses no 
significant or permanent risk of harm to the research participant.  

Severe: A type of AE that interrupts usual ADL, or significantly affects clinical status, 
or may require intensive therapeutic intervention.  
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.
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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.

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 Report Form/PSSA and in accordance with the 
SAE reporting requirements.
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Follow-Up of AEs and SAEs

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations, as medically indicated or as requested by the 
sponsor, to elucidate the nature and/or causality of the AE or SAE as fully as possible.
This may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other healthcare providers.

If a participant dies during participation in the study or during a recognized follow-up 
period, the investigator will provide Pfizer Safety with a copy of any postmortem 
findings, including histopathology.

New or updated information will be recorded in the originally submitted documents.

The investigator will submit any updated SAE data to the sponsor within 24 hours of 
receipt of the information.
10.2.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic DCT

The primary mechanism for reporting an SAE to Pfizer Safety will be the electronic 
DCT (eg, eSAE or PSSA).

If the electronic system is unavailable, then the site will use the paper SAE report form 
(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.
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SAE Reporting to Pfizer Safety via the Vaccine SAE Report Form

Facsimile transmission of the Vaccine SAE Report Form is one of the preferred 
methods 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 Report 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 Report Form pages within the designated reporting 
time frames.
10.2.5. Definition of NDCMC
An NDCMC is defined as a disease or medical condition, not previously identified, that is 
expected to be persistent or otherwise long-lasting in its effects (eg, asthma).
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10.3. Appendix 3: Contraceptive and Barrier Guidance
10.3.1. Male Participant Reproductive Inclusion Criteria
Male participants are eligible to participate if they agree to the following requirements during 
the intervention period and for at least 28 days after the last dose of study intervention, which 
corresponds to the time needed to eliminate reproductive safety risk of the study 
intervention(s): 

Refrain from donating sperm.
PLUS either:

Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent 
on a long-term and persistent basis) and agree to remain abstinent. 
OR

Must agree to use contraception/barrier as detailed below:

Agree to use a male condom when having sexual intercourse with a WOCBP who is 
not currently pregnant.
10.3.2. Female Participant Reproductive Inclusion Criteria
A female participant is eligible to participate if she is not a WOCBP (see definitions below in 
Section 10.3.3).
10.3.3. Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).
If fertility is unclear (eg, amenorrhea or oligomenorrhea) and a menstrual cycle cannot be 
confirmed before the first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP:
1. Premenopausal female with 1 of the following: 

Documented hysterectomy;

Documented bilateral salpingectomy;

Documented bilateral oophorectomy.
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For individuals with permanent infertility due to a medical cause other than the above
(eg, mullerian agenesis, androgen insensitivity), investigator discretion should be applied to 
determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history
interview. The method of documentation should be recorded in the participant’s medical 
record for the study.
2. Postmenopausal female:

A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. In addition:

A high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years of age and not using hormonal 
contraception or HRT. 

A female on HRT and whose menopausal status is in doubt will be required to use 
one of the highly effective nonestrogen hormonal contraception methods if she 
wishes to continue her HRT during the study. Otherwise, she must discontinue 
HRT to allow confirmation of postmenopausal status before study enrollment.
10.3.4. Contraception Methods
Not applicable for female participants. 
Refer to Section 10.3.1 for male participants.
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10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments 
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome. These participants fail to adapt and therefore are 
“susceptible” to progressive and serious liver injury, commonly referred to as DILI. 
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are “adaptors” or are “susceptible.”
LFTs are not required as a routine safety monitoring procedure in this study. However, 
should an investigator deem it necessary to assess LFTs because a participant presents with 
clinical signs/symptoms, such LFT results should be managed and followed as described 
below.
In the majority of DILI cases, elevations in AST and/or ALT precede 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).
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
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, eosinophils (%), 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, total bile acids, 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.
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10.5. Appendix 5: AEs, ADEs, SAEs, SADEs, USADEs, and Device Deficiencies:
Definitions and Procedures for Recording, Evaluating, Follow-Up, and Reporting in 
Medical Device Studies
Definitions of a Medical Device Deficiency
The definitions and procedures detailed in this appendix are in accordance with ISO 14155
and the European MDR 2017/745 for clinical device research (if applicable). 
Both the investigator and the sponsor will comply with all local reporting requirements for 
medical devices.
The detection and documentation procedures described in this protocol apply to all sponsor 
medical devices provided for use in the study (see Section 6.1.2) for the list of sponsor 
medical devices).
10.5.1. Definition of AE and ADE
AE and ADE Definition

An AE is defined in Appendix 2, Section 10.2.1.

An ADE is defined as an AE related to the use of an investigational medical device. 
This definition includes any AEs resulting from insufficient or inadequate instructions 
for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device as well as any event resulting from use error or from 
intentional misuse of the investigational medical device.
10.5.2. Definition of SAE, SADE, and USADE
SAE Definition

An SAE is defined in Appendix 2, Section 10.2.2.
SADE Definition

An SADE is defined as an 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.
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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.
10.5.3. Definition of Device Deficiency
Device Deficiency Definition

A device deficiency is an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance. Device deficiencies include 
malfunctions, use errors, and inadequate information supplied by the manufacturer.
10.5.4. Recording/Reporting and Follow-Up of Medical Device Deficiencies
Device Deficiency Recording

When a device deficiency occurs, it is the responsibility of the investigator to review 
all documentation (eg, hospital progress notes, laboratory reports, and diagnostic 
reports) related to the event.

The investigator will then record all relevant device deficiency information in the 
participant’s medical records, in accordance with the investigator’s normal clinical 
practice.

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.

The investigator will notify the sponsor study team by telephone or email within 
1 business day of determining that the incident meets the protocol definition of a 
medical device deficiency.

The sponsor study team will capture the required information on the Medical Device 
Complaint form along with any associated AE (either serious or nonserious) when 
applicable and send to the appropriate product quality complaint group.

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. All relevant details related to the role of the device 
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in regard to the SAE must be included in the Vaccine SAE Report Form as outlined in 
Sections 8.4.1.1 and 8.4.1.2.

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. Refer to Section 10.1.9 for actions that must be taken 
when medical records are sent to the sponsor or sponsor designee.

For device deficiencies, it is very important that the investigator describes any 
corrective or remedial actions taken to prevent recurrence of the incident.

A remedial action is any action other than routine maintenance or servicing of a 
medical device where such action is necessary to prevent recurrence of a device 
deficiency. This includes any amendment to the device design to prevent 
recurrence.
Assessment of Causality Occurring in Conjunction With a Medical Device Deficiency

If an AE or SAE has occurred in conjunction with a medical device deficiency, the 
investigator must assess the relationship between each occurrence of the AE or SAE 
and the medical device deficiency. The investigator will use clinical judgment to 
determine the relationship.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot be 
ruled out.

Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention 
administration will be considered and investigated.

The investigator will also consult the IB in 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.
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
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

Follow-up applies to all participants, including those who discontinue study 
intervention.

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 by the sponsor 
study team.

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 
Report Form within 24 hours of receipt of the information, according to the 
requirements provided in Appendix 2.
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10.6. Appendix 6: Criteria for Allowing Inclusion of Participants With Chronic Stable 
HIV, HCV, or HBV Infection 
Potential participants with chronic stable HIV, HCV, or HBV infection may be considered 
for inclusion if they fulfill the following respective criteria.
Known HIV infection

Confirmed stable HIV disease defined as documented viral load <50 copies/mL and CD4 
count >200 cells/mm3 within 6 months before enrollment, and on stable antiretroviral 
therapy for at least 6 months.
Known HCV infection

History of chronic HCV infection with evidence of sustained virological response 
(defined as undetectable HCV RNA) for ≥12 weeks following HCV treatment or without 
evidence of HCV RNA viremia (undetectable HCV viral load).
Known HBV infection
Confirmed inactive chronic HBV infection, defined as HBsAg present for ≥6 months and the 
following:

HBeAg negative, anti-HBe positive

Serum HBV DNA <2000 IU/mL

Persistently normal ALT and/or AST levels

In those who have had a liver biopsy performed, findings that confirm the absence of 
significant necroinflammation
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10.7. Appendix 7: Abbreviations
The following is a list of abbreviations that may be used in the protocol. 
Abbreviation
Term
ADE
adverse device effect
ADL
activity/activities of daily living
AE
adverse event
AESI
adverse event of special interest
Al(OH)3
aluminum hydroxide
ALT
alanine aminotransferase
ARI
acute respiratory illness
AST
aspartate aminotransferase
AxMP
auxiliary medicinal product
BP
blood pressure
CAP
community-acquired pneumonia
CBER
Center for Biologics Evaluation and Research (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
CpG
cytosine phosphate guanine
CRF
case report form
CRO
contract research organization
CSR
clinical study report
CTIS
Clinical Trial Information System
DCT
data collection tool
DILI
drug-induced liver injury
DNA
deoxyribonucleic acid
DU
dispensable unit
EC
ethics committee
ECG
electrocardiogram or electrocardiography
eCRF
electronic case report form
EDB
exposure during breastfeeding
EDMC
external data monitoring committee
EDP
exposure during pregnancy
eICD
electronic informed consent document
EMA
European Medicines Agency
eSAE
electronic serious adverse event
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Abbreviation
Term
EU
European Union
EudraCT
European Union Drug Regulating Authorities Clinical Trials 
(European Clinical Trials Database)
FDA
Food and Drug Administration (United States)
FSH
follicle-stimulating hormone
GBS
Guillain-Barré syndrome
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMFR
geometric mean fold rise
GMT
geometric mean titer
HBe
hepatitis B e
HBeAg
hepatitis B e antigen
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
HCAP
healthcare-associated pneumonia
HCV
hepatitis C virus
HIV
human immunodeficiency virus
HRSV 
human respiratory syncytial virus
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
ILI
influenza-like illness
IM
intramuscular
IMP
investigational medicinal product
IND
investigational new drug
INR
international normalized ratio
IP
Internet Protocol
IPAL
investigational product accountability log
IPM
investigational product manual
IRB
institutional review board
IRT
interactive response technology
ISO
International Organization for Standardization
IV
intravenous(ly)
LB
lower bound
LFT
liver function test
LLOQ
lower limit of quantitation
log e
natural logarithm
LRTD
lower respiratory tract disease
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Abbreviation
Term
LRTI
lower respiratory tract illness
LRTI-RSV
RSV-associated lower respiratory tract illness
MDR
medical device regulation
MedDRA
Medical Dictionary for Regulatory Activities
MFDS
Ministry of Food and Drug Safety (Republic of Korea)
MHRA
Medicines and Healthcare products Regulatory Agency (United 
Kingdom)
mITT
modified intent-to-treat
MQI
medically qualified individual
N/A
not applicable
NDCMC
newly diagnosed chronic medical condition
NI
noninferiority
NIMP
noninvestigational medicinal product
NT
neutralizing titer
PACL
protocol administrative change letter
PFS
prefilled syringe
PI
principal investigator
PSSA
Pfizer's Serious AE Submission Assistant
PT
prothrombin time
qRT-PCR
quantitative reverse transcription–polymerase chain reaction
QTL
quality tolerance limit
RCDC
reverse cumulative distribution curve
RNA
ribonucleic acid
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
RT-PCR
reverse transcription–polymerase chain reaction
SADE
serious adverse device effect
SAE
serious adverse event
SAP
statistical analysis plan
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
TBA
to be announced
T bili
total bilirubin
UADE
unanticipated adverse device effect
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Abbreviation
Term
ULN
upper limit of normal
US
United States
USADE
unanticipated serious adverse device effect
USPI
United States prescribing information
VE
vaccine efficacy
WHO
World Health Organization
WOCBP
woman/women of childbearing potential
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Final Protocol Amendment 1, 17 March 2025
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090177e1a311a43b\Approved\Approved On: 17-Mar-2025 16:38 (GMT)

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671053
Final Protocol Amendment 1, 17 March 2025
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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