A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE FORMULATED IN MULTIDOSE VIALS IN HEALTHY FEMALE ADULTS
Phase: PHASE3
Conditions: Respiratory Syncytial Virus (RSV)
Sponsor: Pfizer

PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 1
A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY, 
TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL 
VIRUS (RSV) PREFUSION F SUBUNIT VACCINE FORMULATED IN 
MULTIDOSE VIALS IN HEALTHY FEMALE ADULTS
Study Intervention Number:
PF-07850720
Study Intervention Name:
Respiratory Syncytial Virus (RSV) Vaccine
US IND Number:
017931
EudraCT Number:
Not applicable
ClinicalTrials.gov ID:
Not available
Pediatric Investigational Plan Number:
Not applicable
Protocol Number:
C4841001
Phase:
3
Sponsor Legal Address:
Pfizer Inc.
66 Hudson Boulevard East
New York, NY 10001
Brief Title: Safety, Tolerability, and Immunogenicity Study of RSVpreF Multidose Vials
in Healthy Female Adults
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.
090177e1a00703b8\Approved\Approved On: 28-Feb-2024 14:50 (GMT)

PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 2
Document History
Document
Version Date
Amendment 1
26 Feb 2024
Original protocol
06 Dec 2023
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs and any protocol administrative change 
letter(s). 
Protocol Amendment Summary of Changes Table
Amendment 1 (26 February 2024)
Overall Rationale for the Amendment:
To add a secondary immunogenicity objective in response to a regulatory request and address 
some nonsubstantial modifications to the protocol.
Description of Change
Brief Rationale
Section # and Name
Substantial Modification(s)
Added a secondary 
immunogenicity objective.
In response to CBER request.
Section 1.1 Synopsis
Section 3 Objectives, Endpoints, 
and Estimands
Section 9.1.1.2.1 Immunogenicity
Section 9.3.3 Secondary 
Endpoint(s)/Estimand(s) Analysis
Nonsubstantial Modification(s)
Corrected the fever ranges.
Typographical error.
Section 8.3.5.4 Fever (Table 4)
Changed GMTs to GMCs and 
changed “titer” to “IgG level” in 
the exploratory endpoint.
For accuracy.
Section 9.3.4 Tertiary/Exploratory 
Endpoint(s) Analysis
Amended the Tier 2 event 
description.
For clarity.
Section 9.3.2.2 Safety
Removed the exploratory 
estimand description.
To align with the Pfizer protocol 
template.
Section 9.1.1.3. Exploratory 
Estimands
Updated the section to reflect the 
replacement of the emergency 
contact card with a study 
information card.
The process for contacting an
MQI has changed from a medical 
escalation process via a Pfizer call 
center to direct clinical team 
contact using a Study Team 
Contact List.
The emergency contact card is 
being replaced by a study 
information card and will no 
longer be referenced.
Section 8.10.1 Visit 1 –
Vaccination (Clinic, Day 1)
Section 10.1.12 Sponsor’s 
Medically Qualified Individual
Section 10.7 Appendix 7: 
Abbreviations
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
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
Updated the abbreviations list to 
remove ECC (emergency contact 
card) and add GMC (geometric 
mean concentration).
To reflect the changes in the 
document.
Section 10.7 Appendix 7: 
Abbreviations
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
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 ....................................................................................................................16
1.3. Schedule of Activities .............................................................................................17
2. INTRODUCTION ...............................................................................................................20
2.1. Study Rationale .......................................................................................................20
2.2. Background .............................................................................................................20
2.2.1. Clinical Overview.......................................................................................21
2.3. Benefit/Risk Assessment.........................................................................................25
2.3.1. Risk Assessment.........................................................................................26
2.3.2. Benefit Assessment.....................................................................................28
2.3.3. Overall Benefit/Risk Conclusion................................................................28
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS ...........................................................28
4. STUDY DESIGN.................................................................................................................29
4.1. Overall Design.........................................................................................................29
4.2. Scientific Rationale for Study Design.....................................................................29
4.2.1. Diversity of Study Population ....................................................................30
4.2.2. Choice of Contraception/Barrier Requirements .........................................30
4.3. Justification for Dose ..............................................................................................30
4.4. End of Study Definition ..........................................................................................30
5. STUDY POPULATION......................................................................................................31
5.1. Inclusion Criteria.....................................................................................................31
5.2. Exclusion Criteria....................................................................................................32
5.3. Lifestyle Considerations..........................................................................................33
5.3.1. Contraception..............................................................................................33
5.4. Screen Failures ........................................................................................................34
5.5. Criteria for Temporarily Delaying 
Enrollment/Randomization/Administration of Study Intervention...........................34
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................34
6.1. Study Intervention(s) Administered........................................................................35
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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6.1.1. Administration............................................................................................36
6.1.2. Medical Devices .........................................................................................37
6.2. Preparation, Handling, Storage, and Accountability...............................................37
6.2.1. Preparation and Dispensing........................................................................38
6.3. Assignment to Study Intervention...........................................................................38
6.4. Blinding...................................................................................................................38
6.4.1. Blinding of Participants..............................................................................38
6.4.2. Blinding of Site Personnel..........................................................................39
6.4.3. Blinding of the Sponsor..............................................................................39
6.5. Study Intervention Compliance...............................................................................39
6.6. Dose Modification...................................................................................................39
6.7. Continued Access to Study Intervention After the End of the Study......................39
6.8. Treatment of Overdose............................................................................................39
6.9. Prior and Concomitant Therapy..............................................................................40
6.9.1. Recording Nonstudy Vaccinations and Concomitant Medications............40
6.9.2. Prohibited Concomitant Vaccinations and Treatments ..............................40
6.9.3. Permitted Concomitant Vaccinations and Treatments ...............................41
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................41
7.1. Discontinuation of Study Intervention ....................................................................41
7.2. Participant Discontinuation/Withdrawal From the Study.......................................41
7.2.1. Withdrawal of Consent...............................................................................42
7.3. Lost to Follow-Up ...................................................................................................42
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................43
8.1. Administrative Procedures ......................................................................................43
8.1.1. Telehealth Visits.........................................................................................43
8.2. Efficacy and/or Immunogenicity Assessments .......................................................44
8.2.1. Immunogenicity Assessments ....................................................................44
8.2.2. Biological Samples.....................................................................................44
8.3. Safety Assessments .................................................................................................44
8.3.1. Physical Examinations................................................................................45
8.3.2. Vital Signs ..................................................................................................45
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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8.3.3. Clinical Safety Laboratory Assessments ....................................................45
8.3.4. Pregnancy Testing ......................................................................................45
8.3.5. Electronic Diary..........................................................................................45
8.3.5.1. Grading Scales...........................................................................46
8.3.5.2. Local Reactions.........................................................................46
8.3.5.3. Systemic Events ........................................................................47
8.3.5.4. Fever..........................................................................................49
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................50
8.4.1. Time Period and Frequency for Collecting AE and SAE Information.......51
8.4.1.1. Reporting SAEs to Pfizer Safety...............................................52
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF...................52
8.4.2. Method of Detecting AEs and SAEs ..........................................................52
8.4.3. Follow-Up of AEs and SAEs......................................................................52
8.4.4. Regulatory Reporting Requirements for SAEs...........................................53
8.4.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................53
8.4.5.1. Exposure During Pregnancy......................................................53
8.4.5.2. Exposure During Breastfeeding ................................................55
8.4.5.3. Occupational Exposure .............................................................55
8.4.6. Cardiovascular and Death Events...............................................................55
8.4.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................55
8.4.8. Adverse Events of Special Interest.............................................................55
8.4.8.1. Lack of Efficacy........................................................................56
8.4.9. Medical Device Deficiencies......................................................................56
8.4.9.1. Time Period for Detecting Medical Device Deficiencies .........56
8.4.9.2. Regulatory Reporting Requirements for Device 
Deficiencies .......................................................................................57
8.4.10. Vaccination Errors....................................................................................57
8.5. Pharmacokinetics ....................................................................................................58
8.6. Genetics...................................................................................................................58
8.6.1. Specified Genetics ......................................................................................58
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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8.7. Biomarkers ..............................................................................................................58
8.8. Immunogenicity Assessments.................................................................................58
8.9. Health Economics ...................................................................................................58
8.10. Study Procedures...................................................................................................59
8.10.1. Visit 1 – Vaccination (Clinic, Day 1) .......................................................59
8.10.2. Visit 2 – 1-Month Follow-Up Visit (Clinic, 28 to 35 Days After 
Vaccination).....................................................................................................61
8.10.3. Visit 3 – End-of-Study Visit (Telephone, 42 to 49 Days After 
Vaccination).....................................................................................................62
8.10.4. Unscheduled Reactogenicity Visit............................................................62
9. STATISTICAL CONSIDERATIONS ................................................................................64
9.1. Statistical Hypothesis ..............................................................................................64
9.1.1. Estimands....................................................................................................64
9.1.1.1. Primary Estimand/Coprimary Estimands..................................64
9.1.1.2. Secondary Estimands ................................................................65
9.1.2. Multiplicity Adjustment..............................................................................66
9.2. Analysis Sets ...........................................................................................................66
9.3. Statistical Analyses .................................................................................................66
9.3.1. General Considerations...............................................................................67
9.3.2. Primary Endpoint(s)/Estimand(s) Analysis ................................................67
9.3.2.1. Immunogenicity ........................................................................67
9.3.2.2. Safety.........................................................................................68
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis............................................68
9.3.4. Tertiary/Exploratory Endpoint(s) Analysis ................................................69
9.3.5. Other Safety Analyses ................................................................................69
9.4. Interim Analyses .....................................................................................................69
9.5. Sample Size Determination.....................................................................................69
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................70
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............70
10.1.1. Regulatory and Ethical Considerations ....................................................70
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................70
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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10.1.2. Financial Disclosure .................................................................................71
10.1.3. Informed Consent Process ........................................................................71
10.1.3.1. Electronic Consent ..................................................................72
10.1.4. Data Protection .........................................................................................72
10.1.5. Committees Structure ...............................................................................73
10.1.5.1. Data Monitoring Committee ...................................................73
10.1.6. Dissemination of Clinical Study Data ......................................................73
10.1.7. Data Quality Assurance ............................................................................74
10.1.8. Source Documents....................................................................................75
10.1.9. Use of Medical Records............................................................................76
10.1.10. Study and Site Start and Closure ............................................................76
10.1.11. Publication Policy...................................................................................77
10.1.12. Sponsor’s Medically Qualified Individual..............................................78
10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting .....................................................................79
10.2.1. Definition of AE .......................................................................................79
10.2.2. Definition of an SAE ................................................................................80
10.2.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period............................................................................82
10.2.4. Reporting of SAEs....................................................................................85
10.3. Appendix 3: Contraceptive and Barrier Guidance ................................................87
10.3.1. Female Participant Reproductive Inclusion Criteria.................................87
10.3.2. Woman of Childbearing Potential ............................................................87
10.3.3. Contraception Methods.............................................................................88
10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments .......90
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 .............................................92
10.5.1. Definition of AE and ADE .......................................................................92
10.5.2. Definition of SAE, SADE, and USADE ..................................................92
10.5.3. Definition of Device Deficiency...............................................................93
10.5.4. Recording/Reporting and Follow-Up of Medical Device 
Deficiencies......................................................................................................93
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Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
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10.6. Appendix 6: Protocol-Specific Requirements; Criteria for Allowing 
Inclusion of Participants With Chronic Stable HIV, HCV, or HBV Infection .........96
10.7. Appendix 7: Abbreviations ...................................................................................97
11. REFERENCES ................................................................................................................100
LIST OF TABLES
Table 1.
Study Schedule of Assessment.................................................................17
Table 2.
Grading Scale for Local Reactions...........................................................47
Table 3.
Grading Scale for Systemic Events ..........................................................48
Table 4.
Ranges for Fever.......................................................................................50
Table 5.
Power to Show Noninferiority of RSVpreF in the MDV Group to 
the SDV Group .........................................................................................69
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
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, Randomized, Open-Label Trial to Evaluate the Safety, Tolerability, and 
Immunogenicity of Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine 
Formulated in Multidose Vials in Healthy Female Adults
Brief Title:
Safety, Tolerability, and Immunogenicity Study of RSVpreF Multidose Vials in Healthy 
Female Adults
Regulatory Agency Identification Number(s):
US IND Number:
017931
EudraCT Number:
Not applicable
ClinicalTrials.gov ID:
Not available
Pediatric Investigational Plan Number:
Not applicable
Protocol Number:
C4841001
Phase:
3
Rationale:
Pfizer has developed a vaccine to protect against respiratory syncytial virus (RSV) disease. 
The vaccine, respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF), 
contains 2 stabilized prefusion RSV F glycoproteins in equal amounts in a lyophilized dosage 
form for reconstitution. The efficacy and effectiveness of bivalent RSVpreF against RSV 
disease have been demonstrated in both older adult (Study C3671013) and maternal
immunization (Study C3671008) clinical trials. Currently, RSVpreF is available
preservative-free as a single-dose vial (SDV).
Vaccines are often offered in a multidose vial (MDV) presentation for use in low- and
middle-income countries (LMICs) to meet the supply needs of national immunization 
program requirements. Pfizer has partnered with the Bill & Melinda Gates Foundation to 
increase access to immunization in LMICs by developing an MDV presentation of RSVpreF 
(3 doses per vial). In SDV presentations, each dose remains sealed and protected until it is 
ready for administration, decreasing chances for wastage and contamination. Because each 
dose needs its own container, single-dose presentations typically occupy a greater volume per 
dose with regard to supply chain storage and medical waste disposal. The advantage of 
MDVs is that they generally allow the vaccine to occupy less cold-chain capacity than 
single-dose presentations, therefore reducing cold-chain and storage costs. The MDV is 
reconstituted similarly to the SDV; however, the MDV diluent contains a preservative, 
2-phenoxyethanol (2-PE), to prevent microbial growth from the first to the last dose 
administration per vial.
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
PFIZER CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
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This study will compare the safety, tolerability, and immunogenicity of RSVpreF with 2-PE
presented in MDVs to RSVpreF without 2-PE presented in SDVs.
Objectives, Endpoints, and Estimands:
Objectives
Endpoints
Estimands
Primary:
Primary:
Primary:
Immunogenicity
To demonstrate that the 
immune responses elicited by 
MDV RSVpreF are 
noninferior to the immune 
responses in adults vaccinated 
with SDV RSVpreF.

Respiratory syncytial virus 
subgroup A (RSV A) and 
respiratory syncytial virus 
subgroup B (RSV B) serum 
neutralizing titers (NTs).
In participants who received the study 
intervention and in compliance with the 
key protocol criteria (evaluable 
immunogenicity population):

Geometric mean titer (GMT) ratio 
(GMR), estimated by the ratio of the 
GMTs for RSV A and RSV B NTs at 
1 month after vaccination with 
RSVpreF in MDV participants to that 
of SDV participants.
Safety
To describe the safety profile 
of RSVpreF (MDV and SDV)
as measured by the percentage 
of participants reporting local 
reactions, systemic events, 
adverse events (AEs), and 
serious adverse events (SAEs)
following study intervention 
administration.

Local reactions 
(pain at the injection site, 
redness, and swelling).

Systemic events 
(fever, fatigue, headache, 
vomiting, nausea, diarrhea, 
muscle pain, and joint pain).

AEs.

SAEs.
In participants receiving the study 
intervention:

The proportion of participants 
reporting local reactions within 
7 days following study intervention 
administration.

The proportion of participants 
reporting systemic events within 
7 days following study intervention 
administration.

The proportion of participants 
reporting AEs through 1 month 
following study intervention 
administration.

The proportion of participants 
reporting SAEs throughout the study.
Secondary:
Secondary:
Secondary:
To describe the immune 
response elicited by MDV 
RSVpreF compared to the 
immune response elicited by 
SDV RSVpreF.

RSV A and RSV B serum 
NTs.
In participants who received the study 
intervention and in compliance with the 
key protocol criteria (evaluable 
immunogenicity population):

Seroresponse rates, by vaccine group, 
defined as a ≥4-fold rise in serum NTs 
at 1 month after vaccination 
compared to the prevaccination titer; 
or ≥4 times the lower limit of 
quantitation (LLOQ) if the
prevaccination titer is below the 
LLOQ.
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
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Overall Design:
This is a Phase 3, randomized (1:1), open-label study to evaluate the safety, tolerability, and 
immunogenicity of RSVpreF with 2-PE formulated in MDVs compared to RSVpreF without 
2-PE formulated in SDVs. Approximately 452 healthy nonpregnant, nonbreastfeeding female
participants will be enrolled in the study within the United States (US). The total duration for 
each participant will be approximately 6 weeks.
Number of Participants:
Approximately 452 female participants will be enrolled in the study.
Note: "Enrolled" means a participant’s, or their legally authorized representative’s, 
agreement to participate in a clinical study following completion of the informed consent 
process and randomization to study intervention.
Study Population:
Key inclusion and exclusion criteria are listed below:
Inclusion Criteria
Participants must meet the following key inclusion criteria to be eligible for enrollment into 
the study:

Healthy nonpregnant, nonbreastfeeding females 18 through 49 years of age at Visit 1 
(Day 1).
Note: Healthy female 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 infection with human immunodeficiency virus (HIV), hepatitis C virus 
(HCV), or hepatitis B virus (HBV) can be found in the protocol.

Willing and able to comply with all scheduled visits, investigational plan, lifestyle 
considerations, and other study procedures.

Capable of giving signed informed consent as described in the protocol, which includes 
compliance with the requirements and restrictions listed in the informed consent 
document (ICD) and in this protocol.
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Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
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Exclusion Criteria 
Participants with any of the following characteristics/conditions will be excluded:

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.

History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the vaccines being administered in the 
study.

History or active autoimmune disease, including but not limited to systemic or cutaneous 
lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré 
syndrome, multiple sclerosis, Sjögren’s syndrome, idiopathic thrombocytopenia purpura, 
glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), 
psoriasis, and insulin-dependent diabetes mellitus (type 1).

Previous vaccination with any licensed or investigational RSV vaccine, or planned 
receipt of a nonstudy RSV vaccine throughout the study.

Receipt of chronic systemic treatment with immunosuppressant medications (including 
cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before 
enrollment through conclusion of the study. 
Note: If systemic corticosteroids have been administered short term (<14 days) for 
treatment of an acute illness, participants should not be enrolled into the study until 
corticosteroid therapy has been discontinued for at least 28 days before study intervention
administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) 
corticosteroids are permitted.

Receipt of blood/plasma products or immunoglobulin within 60 days before study 
intervention administration or planned receipt throughout the study.

Current alcohol abuse or illicit drug use.
Note: Marijuana use is not considered an exclusion criterion for the study when elicited 
in participant screening, though it may be considered illicit in some states.

Individuals who are pregnant or breastfeeding.

Participation in other studies involving an investigational product within 28 days prior to 
study entry and/or during study participation. Participation in purely observational studies 
is acceptable.
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PF-07850720 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C4841001
Final Protocol Amendment 1, 26 Feb 2024
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Study Arms and Duration:
Study Intervention(s)
Intervention Name
RSVpreF With 2-PE (MDV)
PF-07850720
RSVpreF Without 2-PE (SDV)
PF-06928316
Use
Experimental
Experimental
Investigational Medicinal 
Product (IMP) or 
Noninvestigational 
Medicinal Product
(NIMP)/Auxiliary
Medicinal Product (AxMP)
IMP
IMP
Dose Formulation
RSV vaccine 360 µg lyophilized
powder for solution for injection/vial
RSV vaccine 120 µg lyophilized
powder for solution for injection/vial
Unit Dose Strength(s)
120 µg
Route of Administration
Intramuscular injection (deltoid muscle of the nondominant arm [preferred])
Study Arm(s)
Arm Title
RSVpreF With 2-PE
RSVpreF Without 2-PE
Arm Description
Three doses of RSVpreF will be 
contained within each MDV. For the 
purposes of this study, only a single 
0.5-mL dose (120 µg) will be 
administered from each of the 
MDVs; the rest will be discarded. 
Participants will receive RSVpreF 
(120 µg) reconstituted with a sterile 
water diluent containing 2-PE, 
presented in a vial. The RSVpreF 
dose will be administered once at the 
vaccination visit (Day 1).
Participants will receive RSVpreF 
(120 µg) reconstituted with a PFS of 
sterile water diluent. The RSVpreF 
dose will be administered once at the 
vaccination visit (Day 1).
Study Duration:
Participants will participate in the study for approximately 6 weeks.
Statistical Methods:
The statistical analysis plan (SAP) will be developed and finalized before database lock and
will describe the participant populations to be included in the analyses and procedures for
accounting for missing, unused, and spurious data. A summary of the planned statistical
analyses for the primary endpoints can be found in the protocol. The study sample size is 
based upon the evaluation of noninferiority (NI) of RSVpreF in the MDV group to RSVpreF 
in the SDV group on the primary endpoint. Noninferiority will be evaluated using a 1.5-fold 
margin as the criterion. The NI of RSVpreF in the MDV group with respect to the SDV 
group will be evaluated at 1 month after vaccination for RSV A and RSV B NTs. Calculation 
details are presented in the protocol.
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The primary objective of NI will be met only if the statistical criteria for both RSV A and 
RSV B are met. Therefore, no multiplicity adjustment is needed.
No interim analysis is planned for this study. 
Ethical Considerations:
The available safety, immunogenicity, and effectiveness data from ongoing clinical trials for 
RSVpreF support a favorable benefit/risk profile and support the clinical development of the 
MDV presentation. The available safety data from various vaccines that currently are used 
with 2-PE as a preservative also support a favorable benefit/risk profile. 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 contains F glycoproteins stabilized in the prefusion conformation, elicits strong 
neutralizing antibodies, and has demonstrated efficacy against RSV-associated lower 
respiratory tract illness (LRTI-RSV) in older adults and severe LRTI-RSV in infants born to 
vaccinated maternal participants. The preservative in the MDV, 2-PE, is used to control 
potential microbial contamination following RSVpreF reconstitution, thereby extending the 
storage time of the vaccine. Anticipated AEs after vaccination with RSVpreF with 2-PE are
expected to be similar to those observed following vaccination with SDV RSVpreF (mild to 
moderate reactogenicity), which are manageable using routine symptom-driven standard of 
care.
Based on the experience with RSVpreF, the potential risks are:

Local reactions, such as injection site redness, injection site swelling, and injection site 
pain; systemic events, such as fatigue, headache, muscle pain, and joint pain; and fever.

Guillain-Barré syndrome. In Study C3671013, conducted in adults 60 years of age and 
older, there were 2 cases of Guillain-Barré syndrome or its variants identified with a 
plausible temporal relationship with vaccination among 18,000 individuals who 
received RSVpreF. Both cases had confounding factors or alternative etiology.

Other events of special interest include atrial fibrillation and polyneuropathy.
The study procedure-related risks include:

Venipuncture will be performed during the study.
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1.2. Schema
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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 1.
Study Schedule of Assessment
Visit Number
Abbreviations used in this table may 
be found in Appendix 7.
1
2
3
Notes
Visit Description
Vaccination
1-Month 
Follow-Up Visit
End-of-Study 
Visit
Visit Window (Days)
Day 1
28 to 35 Days 
After Vaccination
42 to 49 Days 
After Vaccination
Day relative to start of study intervention administration 
(Day 1).
Type of Visit
Clinic
Clinic 
Telephone
Obtain informed consent
X

Informed consent should be obtained prior to undergoing 
any study-specific procedures.

See Section 10.1.3 for additional information.
Assign single participant identifier
X
Obtain demography and 
significant medical history data
X
Record height, weight, and vital 
signs (blood pressure, pulse rate)
X
Perform clinical assessment 
(and physical examination if 
deemed necessary)
X

See Section 8.3.1 for additional information.

Physical examinations to be completed before 
administration of study intervention.
Perform urine pregnancy test on 
WOCBP
X
See Section 8.3.4 for additional information.
Confirm use of contraceptives 
(if appropriate)
X
See Section 5.3.1 for additional information.
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Table 1.
Study Schedule of Assessment
Visit Number
Abbreviations used in this table may 
be found in Appendix 7.
1
2
3
Notes
Visit Description
Vaccination
1-Month 
Follow-Up Visit
End-of-Study 
Visit
Visit Window (Days)
Day 1
28 to 35 Days 
After Vaccination
42 to 49 Days 
After Vaccination
Day relative to start of study intervention administration 
(Day 1).
Type of Visit
Clinic
Clinic 
Telephone
Collect nonstudy vaccine 
information 
X
X
X
See Section 6.9 for additional information.
Collect prohibited medications and 
treatments 
X
X
X
See Section 6.9 for additional information.
Confirm inclusion and exclusion 
criteria
X
Obtain prevaccination temperature
X
Review temporary delay criteria
X
Assign randomization and 
container number
X
Obtain blood sample for antibody 
assessment (~20 mL)
X
X
Assist the participant in 
downloading the e-diary 
application onto her own device or 
issue a provisioned device for 
e-diary use
X
See Section 8.3.5 for more information.
Study intervention administration
X
See Section 6.1 for additional information.
Postvaccination observation 
(at least 30 minutes) and 
assessment of immediate adverse 
reactions
X
Dispense measuring device and 
digital thermometer
X
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Table 1.
Study Schedule of Assessment
Visit Number
Abbreviations used in this table may 
be found in Appendix 7.
1
2
3
Notes
Visit Description
Vaccination
1-Month 
Follow-Up Visit
End-of-Study 
Visit
Visit Window (Days)
Day 1
28 to 35 Days 
After Vaccination
42 to 49 Days 
After Vaccination
Day relative to start of study intervention administration 
(Day 1).
Type of Visit
Clinic
Clinic 
Telephone
Provide e-diary training on daily 
reactogenicity questionnaire
X
Site review of e-diary data with 
participant follow-up until ongoing 
event resolution, if applicable
X-------------------------X

Local reactions and systemic events will be captured within 
the e-diary until the resolution date.

Site staff to evaluate participant compliance and as part of 
the ongoing safety review following vaccination. 

After e-diary collection, the site will follow up with the 
participant for any ongoing events. 
Record AEs, as appropriate
X
X
See Section 8.4 for additional information.
Record AESIs, as appropriate
X
X
X
See Section 8.4 for additional information.
Record SAEs, as appropriate
X
X
X
See Section 8.4 for additional information.
Collect e-diary device/assist 
participant with deletion of e-diary 
application from personal device, 
as appropriate
X
Ensure all e-diary data have been transferred prior to e-diary 
deactivation or removal of the app.
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2. INTRODUCTION
Pfizer developed a vaccine to protect against RSV disease. The vaccine, RSVpreF, contains 
2 stabilized prefusion RSV F glycoproteins in equal amounts in a lyophilized dosage form for 
reconstitution. The efficacy and effectiveness of RSVpreF against RSV disease have been 
demonstrated in older adult1 (Study C3671013) and maternal immunization2,3 (Studies
C3671003, C3671008) clinical trials. Currently, RSVpreF is available preservative free as an
SDV presentation.
Vaccines are often offered in an MDV presentation for use in LMICs to meet the supply 
needs of national immunization program requirements. Pfizer has partnered with the 
Bill & Melinda Gates Foundation to increase access to immunization in LMICs by 
developing an MDV presentation of RSVpreF (3 doses per vial). In SDV presentations, 
each dose remains sealed and protected until it is ready for administration, decreasing 
chances for wastage and contamination. Because each dose needs its own container, 
single-dose presentations typically occupy a greater volume per dose with regard to supply 
chain storage and medical waste disposal.4,5 This issue is a significant problem when storage 
and transport space are limited. The advantage of multidose vials is that they generally allow 
the vaccine to occupy less cold-chain capacity than single-dose presentations, therefore 
reducing cold-chain and storage costs.6 Unlike SDVs that are discarded immediately after 
single use, MDVs are used more than once after the vial is opened. As the vaccine vial is 
repeatedly used, a preservative not present in single-dose syringes is required. 
2-Phenoxyethanol is the preservative that will be added to the RSVpreF vaccine in MDVs in 
order to prevent microbial growth. This preservative is a phenolic derivative used as a
preservative in a number of commercially available vaccines.7
2.1. Study Rationale
Studies have shown nonpregnant and pregnant individuals vaccinated with RSVpreF to have 
an elevated immune response to RSVpreF.2,8 To streamline and expedite the availability of 
the MDV presentation in LMICs, this study will be conducted with nonpregnant individuals.
Study C4841001 will compare the safety, tolerability, and immunogenicity of RSVpreF with
2-PE presented in MDVs to RSVpreF without 2-PE presented in SDVs.
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 transition from an unstable but highly immunogenic prefusion 
conformation to the more stable postfusion state.9 Preclinical studies show that prefusion F 
elicits much higher NTs than postfusion F and that the most potent neutralizing antibodies 
from postinfection human sera target the prefusion form.10 RSVpreF is composed of 
engineered, stabilized, trimeric, prefusion F glycoproteins matching the 2 subgroups 
(RSV A and B) to help ensure the broadest coverage against RSV illness.
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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 by active 
immunization of pregnant individuals.
As of November 2023, RSVpreF in the single-dose form has been studied in 7 completed 
trials in healthy adults and pregnant individuals, and 2 ongoing Phase 3 clinical trials in older 
adults. RSVpreF was shown to be well tolerated, with an acceptable safety profile, and 
highly efficacious in older adults and infants of individuals vaccinated during pregnancy.
This will be the first study of the MDV.
The efficacy and effectiveness of RSVpreF against RSV disease has been demonstrated in 
older adult1 (Study C3671013) and maternal immunization2,3 (Studies C3671003, C3671008) 
clinical trials. RSVpreF (Abrysvo™) was approved for marketing in the US for the older 
adult population on 31 May 202311 and for pregnant individuals on 21 August 2023.12
On 23 August 2023, RSVpreF (Abrysvo) was granted marketing authorization within the EU 
for the older adult population and for pregnant individuals.13
2.2.1. Clinical Overview
Adult Program Studies
The older adult program includes 2 Phase 1/2 studies, 3 Phase 3 studies, and a Phase 2a 
human challenge study.

In the completed Phase 1/2 Study C3671001, 1233 healthy adults 18 through 49 and 
50 through 85 years of age received the 3 dose levels of RSVpreF (60 µg, 120 µg, and 
240 µg), with or without Al(OH)3, or placebo, administered with or without concomitant 
influenza vaccine. The results have shown that the vaccine was well tolerated and 
immunogenic in both age groups. RSVpreF elicited robust neutralizing responses against 
RSV A and RSV B 1 month after vaccination for both age groups across all vaccine dose 
levels and formulations; these responses remained high through the 12 months after 
vaccination. RSVpreF was safe and well tolerated when administered alone or with SIIV, 
with no major differences observed across all dose levels and formulations. Most 
reported local reactions or systemic events were mild or moderate in severity. The 
proportions of participants reporting AEs were generally similar across RSVpreF groups, 
and no SAEs were considered related to the investigational vaccine.14
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
In the completed Phase 1/2 Study C3671002, 250 older adults 65 through 85 years of age
received the 3 dose levels of RSVpreF (60 µg, 120 µg, and 240 µg) with Al(OH)3 or 
CpG/Al(OH)3, given as a single dose or on a schedule of 2 doses administered 2 months 
apart. All RSVpreF doses and formulations elicited high RSV A– and RSV B–
neutralizing antibody GMTs 1 month after vaccination (GMFRs ranging from 4.8 to 11.6 
and 4.5 to 14.1, respectively). CpG-containing formulations did not further increase 
neutralizing antibody GMTs compared to RSVpreF with or without Al(OH)3. GMTs in 
all groups declined but remained higher than baseline (before vaccination) and placebo 
(SIIV only) 12 months after vaccination (GMFRs ranging from 2.1 to 3.5 and 2.2 to 4.3, 
respectively). No increase in GMTs was observed 1 month after Vaccination 2 (GMFR of 
0.9). All doses and formulations were safe and well tolerated.15

Study C3671014 is a completed Phase 3, multicenter, parallel-group, placebo-controlled, 
randomized, double-blind, lot-consistency study in a population of up to 1000 healthy 
adults 18 through 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 antibody GMTs for the 3 manufactured RSVpreF lots 1 month after 
vaccination were equivalent, and that the 120-µg dose of RSVpreF was well tolerated and 
has an acceptable safety profile.

A Phase 2a, randomized, double-blind, placebo-controlled study to evaluate the safety, 
immunogenicity, and efficacy of an RSV vaccine (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 RSVpreF 120 µg or 
placebo, and 4 weeks later underwent intranasal challenge with RSV-A Memphis 37b 
virus. The immunogenicity and efficacy of RSVpreF vaccination on virus replication, 
clinical symptoms, and incidence of symptomatic RSV infection following the intranasal 
challenge were evaluated. The primary analysis of the human challenge study showed 
that a 120-µg dose of RSVpreF was well tolerated and has an acceptable safety profile. 
The completed study demonstrated 100% efficacy of RSVpreF against RT-PCR–
confirmed symptomatic infection.16

Study C3671013 is an ongoing Phase 3, multicenter, randomized, double-blind, 
placebo-controlled study to assess the safety, immunogenicity, and efficacy of 
Pfizer’s RSVpreF in prevention of LRTI-RSV in adults 60 years of age and older. 
Both healthy adults and adults with stable chronic cardiopulmonary conditions are 
included. Approximately 10% of participants with stable chronic cardiopulmonary 
conditions such as COPD, asthma, or CHF have been enrolled. The study enrolled over 
37,000 participants, randomized to receive RSVpreF or placebo in a 1:1 ratio. This is an 
event-driven study with a target of 59 first episodes of evaluable LRTI-RSV cases. 
Interim analysis results in August 2022 showed protection against LRTI-RSV defined by 
2 or more symptoms, with VE of 66.7%. VE of 85.7% was observed in participants with 
a more severe disease primary endpoint of LRTI-RSV, defined by analysis of 3 or more 
RSV-associated symptoms. The vaccine was well tolerated, with no safety concerns.1
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On 31 May 2023, the FDA approved RSVpreF (Abrysvo) for individuals 60 years of age 
and older in the US.11 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.13

Study C3671006 is a completed Phase 3, multicenter, parallel-group, placebo-controlled, 
randomized, double-blind study. One thousand four hundred three healthy adults 
≥65 years of age were randomized in a 1:1 ratio to either a coadministration group or a 
sequential-administration group. The intention of this study was to demonstrate that the 
immune responses generated when a 120-μg dose of RSVpreF was coadministered with 
SIIV were noninferior to the immune responses generated 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 C3671016 is an ongoing Phase 1/2/3 study of RSVpreF in participants 
2 to 18 years of age at high risk of RSV disease that was initiated in June 2023. The 
study will consist of 2 phases: Phase 1 and Phase 2/3. Phase 1 is an open-label, 
age-descending, dose-finding study to assess the safety, tolerability, and immunogenicity 
of RSVpreF in children. Phase 1 will evaluate 2 doses—120 µg and 60 µg—in children 
5 to <18 years and 2 to <5 years of age who are either healthy or have high risk chronic 
medical conditions. Participants have been enrolled in Phase 1 and will be followed for 
6 months after vaccination. Safety and immunogenicity will be assessed prior to selecting 
a dose and commencing Phase 2/3. Phase 2/3 is a placebo-controlled, randomized, 
double-blind study to evaluate the safety, tolerability, and immunogenicity of RSVpreF 
based on dose selection activities from the Phase 1 study.

Study C3671023 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. Study C3671023 – Substudy A is a Phase 3, multicenter, 
randomized, double-blind, placebo-controlled study that will assess the safety, 
tolerability, and immunogenicity of Pfizer’s RSVpreF in adults 18 to <60 years of age 
considered to be at high risk of RSV disease due to certain chronic medical conditions, 
and Study C3671023 – Substudy B is a Phase 3, single-arm, open-label, multicenter study 
that will assess the safety, tolerability, and immunogenicity of Pfizer’s RSVpreF in
immunocompromised adults. The 120-µg dose will be evaluated in both substudies.
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Maternal Participant Program Studies
RSVpreF is also being studied in the maternal program, which includes 2 Phase 2b studies 
and a Phase 3 study in nonpregnant and pregnant participants.

Study C3671003 is a completed Phase 2b multicenter, randomized, placebo-controlled 
study. Up to 650 healthy pregnant individuals 18 through 49 years of age received 
RSVpreF (120 µg or 240 µg), formulated with or without Al(OH)3, or placebo. The 
completed final analysis provided evidence of the good tolerability and safety of 
RSVpreF in maternal vaccine recipients and the safety of maternal vaccination with 
RSVpreF for infants led to a dose selection of RSVpreF 120 µg without Al(OH)3.

Study C3671004 is a completed Phase 2b study of 713 healthy nonpregnant individuals
18 through 49 years of age. A total of 709 participants received RSVpreF 120 µg or 
RSVpreF 240 µg with Al(OH)3 or placebo, administered with or without concomitant 
Tdap. The study demonstrated a good safety and tolerability profile, high immune 
responses, and NI of the responses to RSV A, RSV B, tetanus, and diphtheria when 
coadministered with Tdap, with RSV A and RSV B 50% NT GMRs of 0.97 and 0.96, 
respectively, at 1 month after vaccination.8

Study C3671008 is a completed Phase 3, multicenter, randomized, double-blind, 
placebo-controlled study designed to evaluate the efficacy and safety of maternal 
immunization with RSVpreF against MA-LRTI in infants. Healthy participants ≤49 years 
of age at 24 through 36 weeks’ gestation received either RSVpreF 120 µg or placebo. 
The study enrolled approximately 7400 pregnant individuals.3,17 Interim analysis results 
in October 2022 demonstrated VE of 81.8% against severe MA-LRTI due to RSV in 
infants from birth through the first 90 days of life, with high efficacy of 69.4% 
demonstrated through the first 6 months of life. RSVpreF was well tolerated with no 
safety concerns for both vaccinated individuals and their newborns.3 On 21 August 2023, 
the FDA approved RSVpreF (Abrysvo) for active immunization of pregnant individuals 
at 32 through 36 weeks’ gestation for the prevention of LRTD and severe LRTD caused 
by RSV in infants from birth through 6 months of age in the US.12 On 23 August 2023, 
RSVpreF (Abrysvo) was granted marketing authorization within the EU for passive 
protection against LRTD caused by RSV in infants from birth through 6 months of age 
following maternal immunization during pregnancy.13
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2.3. Benefit/Risk Assessment
The available safety, immunogenicity, and effectiveness data from ongoing clinical trials for 
RSVpreF support a favorable benefit/risk profile.
When using multidose containers, preservatives are necessary to prevent contamination of 
future doses extracted from the same vial after the first dose. The risk of infection due to 
administration of a contaminated dose far outweighs the risk of any AE from the preservative 
used. In this case, 2-PE, the preservative used to control microbial contamination in the
MDV, is a widely used preservative in cosmetics and vaccines, and one that already meets 
strict EP and WHO criteria for antimicrobial suppression and open-vial policy.18
Many licensed vaccines containing 2-PE (eg, poliovirus vaccine inactivated [Ipol]);
pneumococcal vaccines [Prevnar 13®]; diphtheria, tetanus, and pertussis–containing 
vaccines [DTwP and DT acellular]; hexavalent vaccines) have been shown to be
immunogenic and safe.19,20 Many other vaccines in development are using 2-PE due to its
safety profile.21
MDV RSVpreF will support the clinical development of the vaccine and improve RSVpreF 
availability and accessibility in resource-limited countries. Anticipated AEs after vaccination 
are expected to be similar to those observed following vaccination with SDV RSVpreF
(mild to moderate reactogenicity), which are manageable using routine symptom-driven 
standard of care. The expected safety profile of this vaccine therefore supports initiation of 
this clinical study.
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 (SDV) & RSVpreF with 2-PE (MDV)
Pfizer has identified the most common risks 
for RSVpreF as local reactions, such as 
injection site redness, injection site 
swelling, and injection site pain, and 
systemic events, such as fatigue, headache, 
diarrhea, joint pain, nausea, vomiting, 
muscle pain, and fever.
Guillain-Barré syndrome has been identified 
as a potential risk for RSVpreF.
Other events of interest include 
atrial fibrillation 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.22
Data available from completed and ongoing studies showed a 
low incidence of severe or serious events, and no clinically 
concerning safety observations.23,24 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 Guillain-Barré syndrome 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 
the placebo. Most of the participants who had atrial 
fibrillation and received RSVpreF had a preexisting medical 
history of atrial fibrillation.
In Study C3671008, conducted in pregnant individuals, there 
were no statistically meaningful imbalances between 
RSVpreF and placebo recipients in the overall rates of 
preterm birth (5.7% [95% CI: 4.9, 6.5] versus 
4.7% [95% CI: 4.1, 5.5], respectively). However, a numerical 
imbalance was observed in upper-middle-income countries 
between RSVpreF and placebo recipients. Outcomes in the 
premature infants were similar between the 2 groups.

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.

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.
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Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s) 
RSVpreF (SDV) & RSVpreF with 2-PE (MDV)
In Study C3671008, conducted in pregnant individuals, there 
was a nonsignificant numerical imbalance in hypertensive 
disorders of pregnancy reported for participants who received 
RSVpreF compared to participants who received the placebo. 
The majority of preterm and hypertensive disorders occurred 
more than 30 days following vaccination. 
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 a potentially efficacious RSV vaccine.

Contributing to the process of developing new therapies in an area of unmet need.
2.3.3. Overall Benefit/Risk Conclusion
Taking into account the measures to minimize risk to study participants, the potential risks 
identified in association with RSVpreF are justified by the anticipated benefits that may be 
afforded to participants.
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS
Objectives
Endpoints
Estimands
Primary:
Primary:
Primary:
Immunogenicity
To demonstrate that the immune
responses elicited by MDV
RSVpreF are noninferior to the 
immune responses in adults 
vaccinated with SDV RSVpreF.
RSV A and RSV B serum 
NTs.
In participants who received the 
study intervention and in compliance 
with the key protocol criteria 
(evaluable immunogenicity 
population):
GMT ratio (GMR), estimated by 
the ratio of the GMTs for RSV A 
and RSV B serum NTs at 
1 month after vaccination with 
RSVpreF in MDV participants to 
that of SDV participants.
Safety
To describe the safety profile of 
RSVpreF (MDV and SDV) as 
measured by the percentage of 
participants reporting local 
reactions, systemic events, AEs, 
and SAEs following study 
intervention administration.
Local reactions 
(pain at the injection site, 
redness, and swelling).
Systemic events 
(fever, fatigue, headache, 
vomiting, nausea, diarrhea, 
muscle pain, and joint pain).
AEs.
SAEs.
In participants receiving the study
intervention:
The proportion of participants
reporting local reactions within 
7 days following study 
intervention administration.
The proportion of participants
reporting systemic events within 
7 days following study 
intervention administration.
The proportion of participants
reporting AEs through 1 month 
following study intervention 
administration.
The proportion of participants
reporting SAEs throughout the 
study.
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Objectives
Endpoints
Estimands
Secondary:
Secondary:
Secondary:
To describe the immune response 
elicited by MDV RSVpreF 
compared to the immune response 
elicited by SDV RSVpreF.

RSV A and RSV B serum 
NTs.
In participants who received the 
study intervention and in compliance 
with the key protocol criteria 
(evaluable immunogenicity 
population):
Seroresponse rates, by vaccine 
group, defined as a ≥4-fold rise 
in serum NTs at 1 month after 
vaccination compared to the 
prevaccination titer; or ≥4 times 
the LLOQ if the prevaccination 
titer is below the LLOQ. 
Exploratory:
Exploratory:
Exploratory:
To further describe the immune 
responses induced by MDV
RSVpreF following vaccination.
RSV A and RSV B prefusion 
F–binding IgG.
Not applicable.
4. STUDY DESIGN
4.1. Overall Design
This is a Phase 3, randomized, open-label study to evaluate the safety, tolerability, and 
immunogenicity of RSVpreF with 2-PE formulated in MDVs compared to RSVpreF without 
2-PE formulated in SDVs. Approximately 452 healthy nonpregnant, nonbreastfeeding female
participants 18 through 49 years of age will be enrolled and randomized in a 1:1 ratio in the 
study within the US. The total duration for each participant will be approximately 6 weeks.
Note: "Enrolled" means a participant's, or their legally authorized representative’s, 
agreement to participate in a clinical study following completion of the informed consent 
process and randomization to study intervention.
4.2. Scientific Rationale for Study Design
Vaccines are often presented in an MDV for use in developing countries. The advantage of 
MDVs is that they allow the vaccine to occupy less cold-chain capacity than SDS or SDV 
presentations. Pfizer has partnered with the Bill & Melinda Gates Foundation to increase 
access to immunization in LMICs by developing an MDV presentation of RSVpreF. As the 
vaccine vial is repeatedly used, a preservative (2-PE) that is not present in SDVs will be 
added to prevent microbial growth.
This study will compare the safety, tolerability, and immunogenicity of RSVpreF with 2-PE
in MDVs to RSVpreF without 2-PE in SDVs.
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4.2.1. Diversity of Study Population
This study can fulfill its objectives only if appropriate participants are enrolled, including 
participants across diverse and representative racial and ethnic backgrounds. The diversity 
strategy for this study will include the following: 

Selecting sites that have access to diverse participants within their locales.

Educating sites about the importance of increasing diversity in clinical trials and Pfizer’s 
commitments to diversity and inclusion. 

Using real-world data to target outreach and potential referring physicians. 

Continual monitoring of diverse enrollment to identify additional opportunities to include 
diverse populations.
4.2.2. Choice of Contraception/Barrier Requirements 
RSVpreF is approved for use in the US and Europe, as detailed in Section 4.3, without any 
contraceptive precautions. There is no suspicion of human teratogenicity based on the 
intended pharmacology. See Appendix 3 for contraceptive requirements. 
4.3. Justification for Dose
The 120-µg dose, without any adjuvants, has been shown to have low reactogenicity and an 
acceptable safety profile, and will be the dose given in this study. RSVpreF has been licensed 
for use in the US in older adults on 31 May 202311 and for pregnant individuals on 
21 August 2023.12 On 23 August 2023, RSVpreF (Abrysvo) was granted marketing 
authorization within the EU for the older adult population and for pregnant individuals.13
MDVs reduce the cold-chain capacity and the delivery and storage costs associated with 
SDV vaccines in LMICs. The preservative 2-PE will be used to prevent microbial growth in 
MDVs following reconstitution.
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.
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5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled, including 
participants across diverse and representative racial and ethnic backgrounds. If a 
prescreening tool is utilized for study recruitment purposes, it will include collection of 
information that reflects the enrollment of a diverse participant population including, where 
permitted under local regulations, age, sex, race, and ethnicity. The following eligibility 
criteria are designed to select participants for whom participation in the study is considered 
appropriate. All relevant medical and nonmedical conditions should be taken into 
consideration when deciding whether a particular participant is suitable for this protocol.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1. Inclusion Criteria
Participants are eligible to be included in this study only if all of the following criteria apply:
Age and Sex:
1. Healthy nonpregnant, nonbreastfeeding females 18 through 49 years of age at Visit 1 
(Day 1).
Note: Healthy female 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 infection with HIV, HCV, or HBV can be found in Section 10.6.

Refer to Appendix 3 for reproductive criteria for female participants.
Disease Characteristics:
Not applicable.
Other Inclusion Criteria:
2. Willing and able to comply with all scheduled visits, investigational plan, lifestyle 
considerations, and other study procedures.
3. Available for the duration of the study and can be contacted by telephone during study 
participation.
4. Capable of giving signed informed consent as described in Appendix 1 (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. 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.
2. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the vaccines being administered in the 
study.
3. Immunocompromised participants with known or suspected immunodeficiency, as 
determined by history, laboratory tests, and/or physical examination.
4. History or active autoimmune disease, including but not limited to systemic or cutaneous 
lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré 
syndrome, multiple sclerosis, Sjögren’s syndrome, idiopathic thrombocytopenia purpura, 
glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), 
psoriasis, and insulin-dependent diabetes mellitus (type 1).
5. Bleeding diathesis or any condition that would, in the opinion of the investigator, 
contraindicate intramuscular injection.
Prior/Concomitant Therapy:
6. Previous vaccination with any licensed or investigational RSV vaccine, or planned 
receipt of a nonstudy RSV vaccine throughout the study.
7. Receipt of chronic systemic treatment with immunosuppressant medications 
(including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days 
before enrollment through conclusion of the study.
Note: If systemic corticosteroids have been administered short term (14 days) for 
treatment of an acute illness, participants should not be enrolled into the study until 
corticosteroid therapy has been discontinued for at least 28 days before study intervention
administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) 
corticosteroids are permitted.
8. Receipt of blood/plasma products or immunoglobulin within 60 days before study 
intervention administration or planned receipt throughout the study.
9. Current alcohol abuse or illicit drug use.
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Note: Marijuana use is not considered an exclusion criterion for the study when elicited 
in participant screening, though it may be considered illicit in some states.
10. Individuals who are pregnant or breastfeeding.
Prior/Concurrent Clinical Study Experience:
11. Participation in other studies involving an investigational product within 28 days prior to 
study entry and/or during study participation. Participation in purely observational studies 
is acceptable.
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 
and their partner(s) from the permitted list of contraception methods (see Section 10.3.3) 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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All pregnancies discovered in participants during the study participation, which begins after 
obtaining informed consent as described in Section 8.4.1, will be recorded in accordance with
the EDP (Section 8.4.5.1) and EDB (Section 8.4.5.2) reporting processes.
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 AEs.
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened under a different participant number once eligibility criteria are met. Participants 
who are rescreened are required to sign a new ICD.
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Administration of 
Study Intervention
The following conditions may allow a participant to be randomized once the conditions have 
resolved and the participant is otherwise eligible:
1. Current febrile illness (body temperature >38.0°C [>100.4°F]) or other acute illness 
within 48 hours before study intervention administration.
2. Receipt of any inactivated vaccine within 14 days and any live vaccine within 28 days 
before, or anticipated receipt of any vaccine within the 14 days after, study intervention
administration.
3. Receipt of short-term (<14 days) systemic corticosteroids. Study intervention 
administration should be delayed until systemic corticosteroid use has been discontinued 
for at least 28 days. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) 
corticosteroids do not require temporary delay of study intervention administration.
The prevaccination blood draw and vaccination should take place on the same day. 
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study interventions are all prespecified investigational products and medical devices, and 
other interventions (eg, surgical and behavioral) intended to be administered to the study 
participants during the study conduct. 
For the purposes of this protocol, study intervention refers to RSVpreF with the preservative 
2-PE presented in MDVs and RSVpreF without 2-PE in SDVs.
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6.1. Study Intervention(s) Administered
Study Intervention(s)
Intervention Name
RSVpreF with 2-PE (MDV)
PF-07850720
RSVpreF without 2-PE (SDV)
PF-06928316
Type
Vaccine
Vaccine
Use
Experimental
Experimental
IMP or NIMP/AxMP
IMP
IMP
Dose Formulation
RSV vaccine 360 µg lyophilized powder 
for solution for injection/vial
RSV vaccine 120 µg lyophilized powder 
for solution for injection/vial
Unit Dose Strength(s)
120 µg
Dosage Level(s)
RSVpreF 120 µg
Route of 
Administration
Intramuscular injection (deltoid muscle 
of the nondominant arm [preferred])
Intramuscular injection (deltoid muscle 
of the nondominant arm [preferred])
Sourcing
Provided centrally by Pfizer
Provided centrally by Pfizer
Packaging and Labeling Study intervention will be provided in a 
glass vial as an open-label supply. 
The RSV drug product MDV will 
contain 3 doses of 120 µg per dose of 
the RSVpreF antigens. RSVpreF is 
supplied as a lyophilized white cake, 
packaged in a glass vial with a 13‑mm 
lyophilization stopper, aluminum 
overseal, and flip-off cap. It is 
reconstituted with a sterile water diluent 
consisting of 2-PE (preservative) in a 
glass vial. The lyophilized drug product 
contains excipients that, after 
reconstitution, will yield a solution as 
detailed in the IB.
The fill volume of the drug product vial 
and diluent vials are designed to ensure 
that each vial can supply 3 doses of 
vaccine and 120 µg for each dose. Each 
kit will be labeled as required per 
country requirement.
The vaccine will be packaged within 
cartons labeled by Pfizer or its designee 
in accordance with current guidelines 
and applicable local and legal regulatory 
requirements.
Study intervention will be provided in a 
glass vial as an open-label supply. 
The RSV drug product SDV will contain 
a single dose of 120 µg of the RSVpreF
antigens. 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 and a 
vial adaptor (supplied). Each kit will be 
labeled as required per country 
requirement.
The vaccine will be packaged within 
cartons labeled by Pfizer or its designee 
in accordance with current guidelines 
and applicable local and legal regulatory 
requirements.
SRSD
IB
IB/SmPC
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Study Intervention(s)
Study Arm(s)
Arm Title
RSVpreF With 2-PE
RSVpreF Without 2-PE
Arm Description
Three doses of RSVpreF will be 
contained within each MDV. For the 
purposes of this study, only a single 
0.5-mL dose (120 µg) will be 
administered from each of the MDVs;
the rest will be discarded. Participants 
will receive RSVpreF (120 µg) 
reconstituted with a sterile water diluent 
containing 2-PE, presented in a vial, in 
accordance with the IPM.
The RSVpreF dose will be administered 
once at the vaccination visit (Day 1).
Participants will receive RSVpreF 
(120 µg) reconstituted with a PFS of 
sterile water diluent in accordance with 
the IPM.
The RSVpreF dose will be administered 
once at the vaccination visit (Day 1).
6.1.1. Administration
Participants will receive 1 dose of study intervention at the vaccination visit (Day 1) in 
accordance with the study’s SoA. The study intervention will be administered 
intramuscularly by injecting a 0.5-mL dose from the MDV, or the entire contents of the SDV,
into the deltoid muscle, preferably of the nondominant arm, unless medically contraindicated, 
in which case the injection may be administered in the dominant arm. Study intervention 
administration will be performed by appropriately designated study staff at the investigator 
site.
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.
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6.1.2. Medical Devices 
1. The manufactured medical devices provided for use in this study are a vial adaptor and 
PFS.
Note: The vial adapter is being deployed for the reconstitution diluent for the study 
intervention, RSVpreF without 2-PE (SDV) only. The study intervention supplies are 
provided in a kit that contains the study intervention (RSVpreF 120 µg 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. Medical device deficiencies, including those resulting from malfunctions of the device, 
must be detected, documented, and reported by the study personnel throughout the study.
4. All medical device deficiencies (including malfunction, use error, and inadequate 
labeling) shall be documented and reported by the investigator throughout the clinical 
investigation (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. 
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, package insert, or equivalent for storage conditions of 
the study intervention once reconstituted.
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6. Study interventions should be stored in their original containers.
7. The investigator, institution, head of the medical institution (where applicable), or 
authorized site staff is responsible for study intervention accountability, reconciliation, 
and record maintenance (ie, receipt, reconciliation, and final disposition records), such as 
the IPAL or sponsor-approved equivalent. All study interventions will be accounted for 
using a study intervention accountability form/record.
8. Further guidance and information for the final disposition of unused study interventions 
are provided in the IPM. All destruction must be adequately documented. If destruction is 
authorized to take place at the investigator site, the investigator must ensure that the 
materials are destroyed in compliance with applicable environmental regulations, 
institutional policy, and any special instructions provided by Pfizer.
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IPM.
6.2.1. Preparation and Dispensing
See the IPM for instructions on how to prepare the study intervention for administration. 
Study intervention should be prepared and dispensed by an appropriately qualified and 
experienced member of the study staff (eg, physician, nurse, physician’s assistant, nurse 
practitioner, pharmacy assistant/technician, or pharmacist) as allowed by local, state, and 
institutional guidance. A second staff member will verify the dispensing.
6.3. Assignment to Study Intervention
Allocation of participants to vaccine groups (randomization) will proceed through the use of 
an IRT system. The site will utilize the IRT system to assign the DU or container number(s) 
prior to the start of study intervention administration for each participant. The site will record 
the study intervention assignment on the applicable CRF, if required.
Study intervention will be dispensed and administered at Visit 1 as 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 an open-label study.
6.4.1. Blinding of Participants
Participants will be unblinded to their assigned study intervention. 
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6.4.2. Blinding of Site Personnel
This is an open-label study, and all site personnel including the investigator and investigator 
staff, and staff receiving, storing, dispensing, preparing, and administering the study 
interventions will be unblinded.
6.4.3. Blinding of the Sponsor
Sponsor staff will be unblinded to participants’ assigned study intervention.
As this is an open-label study, the sponsor may conduct unblinded reviews of the data during 
the course of the study for the purpose of safety assessment and supporting clinical 
development.
6.5. Study Intervention Compliance
When participants are dosed at the site, they will receive study intervention directly from the 
investigator or designee, under medical supervision. The date and time of each dose 
administered in the clinic will be recorded in the source documents and recorded in the CRF. 
The dose of study intervention and study participant 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.
6.6. Dose Modification
Dose modification is not applicable to this protocol.
6.7. Continued Access to Study Intervention After the End of the Study
No study intervention will be provided to participants at the end of their study participation.
It is expected that participants will be treated as required with standard-of-care treatments, as 
advised by their usual care physician.
6.8. Treatment of Overdose
For this study, any dose of RSVpreF greater than 1 dose of RSVpreF 120 µg within a 
24-hour time period will be considered an overdose. 1 dose of study intervention is either a 
0.5-mL dose from the MDV, or the entire contents of the SDV.
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 and laboratory abnormalities 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).
3. Document the quantity of the excess dose as well as the duration of the overdose in the 
CRF.
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4. Overdose is reportable to Pfizer Safety only when associated with an SAE.
6.9. Prior and Concomitant Therapy
6.9.1. Recording Nonstudy Vaccinations and Concomitant Medications 
The following concomitant medications, vaccinations, and treatments will be recorded in the 
CRF:

Any vaccinations received from 28 days prior to study enrollment until the last study 
visit.
Participants should not enroll if they are taking or plan to take any prohibited medications 
and treatments listed in Section 6.9.2. However, if a participant is enrolled and required to 
receive prohibited medications or treatments after enrollment due to unforeseen medical 
reasons, record the start and stop dates, name of the prohibited product, dose, unit, route, and 
frequency. An AE or SAE should also be documented that reflects the medical reason why 
the prohibited medication or treatment was taken. 
6.9.2. 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 should not be withheld if required for a participant’s medical 
care.

Receipt of any nonstudy RSV vaccine at any time prior to or during study participation.

Investigational vaccines, drugs, or medical devices are prohibited during the course of the 
study. 

Receipt of blood/plasma products or immunoglobulin, from 60 days before study 
intervention administration and thereafter during the course of the study.

Receipt of any inactivated vaccine within 14 days, or any live vaccine within 28 days,
before study intervention administration.

Nonstudy vaccines may not be given concomitantly with the study intervention or within 
14 days after study intervention administration (Day 1 through Day 14), except if 
medically necessary (eg, during an outbreak or pandemic situation).

Receipt of chronic systemic treatment with known immunosuppressant medications,
other than systemic corticosteroids meeting the criteria noted below, within 60 days of 
administration of study intervention through conclusion of the study.
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
Receipt of short-term systemic corticosteroids (≥20 mg/day of prednisone or equivalent) 
for ≥14 days is prohibited from 28 days prior to enrollment through Day 28 after 
administration of study intervention (Day 1).
Note: Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) 
corticosteroids are permitted.

Prophylactic antipyretics and other pain medication to prevent symptoms associated with 
study intervention administration are not permitted prior to study intervention
administration. 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.
6.9.3. Permitted Concomitant Vaccinations and Treatments

Licensed vaccines may be given during the study starting 14 days after study intervention 
administration (Day 15).

Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) 
corticosteroids are permitted.

The use of antipyretics and other pain medication to treat symptoms associated with 
study intervention administration is permitted after study intervention administration and 
during the participant’s participation in the study.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
Since this is a single-dose study, this section is not applicable.
7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at their own request. Reasons for 
discontinuation from the study include the following:

Refused further study procedures;

Lost to follow-up;

Death;

Study terminated by sponsor;

Withdrawal due to reactogenicity;

AEs;
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
Participant request;

Investigator request;

Protocol deviation.
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 or surveillance for disease endpoints) will remain in the study 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;

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;
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
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.
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.
The total blood sampling volume for individual participants in this study is approximately 
40 mL. The actual collection times of blood samples may change. 
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.
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8.2. Efficacy and/or Immunogenicity Assessments
8.2.1. Immunogenicity Assessments
Blood samples (approximately 20 mL per sample) will be collected from all participants for 
serum immunogenicity testing at Visit 1 (prior to study vaccination) and Visit 2 (1 month
after vaccination) for antibody assessment as detailed in Section 1.3. The total volume of 
blood collected for antibody assessment over the course of the study will be approximately 
40 mL.
Sera collected will be assayed for RSV A– and RSV B–neutralizing antibody titers. RSV A–
and RSV B–neutralizing antibody titers will be determined for each serum sample and 
reported as the NT. 
8.2.2. Biological Samples
Blood samples will be used only for scientific research. Each sample will be labeled with a 
code so that the laboratory analyst testing the samples will not know the participant’s 
identity, study visit, or study cohort associated with the sample. Samples that remain after 
performing assays outlined in the protocol may be stored by Pfizer. Unless a time limitation 
is required by local regulations or ethical requirements, the samples will be stored for up to 
15 years after the end of the study and then destroyed. If allowed by the ICD, stored samples 
may be used for additional testing to better understand the immune responses to the 
vaccine(s) under study in this protocol, to inform the development of other vaccines or 
vaccine-related products, and/or for vaccine-related assay work supporting vaccine programs.
No testing of the participant’s DNA will be performed.
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 significant medical history, will be performed on all
participants at their first visit to establish a baseline. Significant medical history and 
observations from any physical examination and vital sign assessments, if performed, will be 
documented in the CRF.
AEs and SAEs are to be collected, recorded, and reported as defined in Section 8.4.
Acute reactions within the first 30 minutes after administration of the study intervention will 
be assessed and documented in the CRF.
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Safety parameters also include reactogenicity e-diary reports of local reactions and systemic 
events (including fever) that occur in the first 7 days or longer after administration of the 
study intervention. These prospectively self-collected occurrences of local reactions and 
systemic events are graded as described in Section 8.3.5.2 and Section 8.3.5.3.
8.3.1. Physical Examinations
If the clinical assessment indicates that a physical examination is necessary to 
comprehensively evaluate the participant, a physical examination will be performed.
Physical examination findings collected during the study will be considered source 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
The participant’s prevaccination temperature will be measured as per usual clinical practice.
Additionally, height, weight, seated blood pressure, and pulse rate will be measured prior to 
the participant’s vaccination.
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. Pregnancy Testing 
Pregnancy tests may be urine or serum tests, but must have a sensitivity of at least 
25 mIU/mL. Pregnancy tests will be performed in WOCBP at Visit 1, immediately before the 
administration of study intervention. A negative pregnancy test result will be required prior 
to receiving the study intervention. Pregnancy tests may also be repeated if requested by 
IRBs/ECs or if required by local regulations. In the case of a positive confirmed pregnancy, 
the participant will be withdrawn from administration of study intervention and from the 
study.
8.3.5. Electronic Diary
All participants will be required to use an e-diary, installed on a provisioned device or as an 
application on a personal device, and will be asked to monitor and record prespecified local 
reactions and systemic events, and temperature daily for 7 days or longer following 
vaccination (Day 1 is the day of vaccination).
The e-diary allows recording of assessments each day, thus providing the accurate 
representation of the participant’s experience at that time.
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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 electronically 
into Pfizer’s database for analysis and reporting. These data do not need to be reported by the 
investigator in the CRF except the following conditions:

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 local reactions or 
systemic events ongoing at Day 7 through 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. These prospectively collected occurrences of local reactions and systemic 
events are graded as described in Section 8.3.5.2 and Section 8.3.5.3. Please note that all 
provisioned e-diary devices must be collected per the SoA.
8.3.5.1. 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.22
8.3.5.2. Local Reactions
Following vaccination (where Day 1 is the day of vaccination), the participants will be asked
to assess redness, swelling, and pain at the injection site, and to record the events in the 
e-diary or appropriate device daily, based on local practice.
Participants will be provided with a measuring device. Redness and swelling will be 
measured and recorded in measuring device units in the e-diary (range: 1 to 21).
Note: An entry in the e-diary of 21 will be used to denote measurements ≥21. Measurements 
will be categorized during analysis as mild, moderate, or severe, based on the grading scale 
in Table 2. Measuring device units can be converted to centimeters according to the 
following formula: 1 measuring device unit = 0.5 cm. Pain at the injection site will be 
assessed by the participant as absent, mild, moderate, or severe according to the grading scale 
in Table 2.
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A participant with severe redness, swelling, or pain at the injection site will be prompted to 
contact the investigator to perform an unscheduled visit to assess the reaction or may be 
referred to the appropriate healthcare facility at the discretion of the study staff if there are 
any concerns, as appropriate. In the event that the participant does not call, the investigator or 
qualified designee will contact the participant.
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 reaction will be collected on the CRF. 
The site staff will educate the participant regarding signs and symptoms that would prompt 
site contact.
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 investigational site staff will continue to contact the 
participant to assess and record the information daily until resolution unless recorded in the 
e-diary. The investigator will enter this additional information and the end date in the 
participant’s source notes and CRF.
Table 2.
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.
8.3.5.3. 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 events in the e-diary or appropriate device daily, based on local practice. 
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The events will be assessed by the participant according to the grading scale in Table 3. 
A participant with severe fatigue, headache, vomiting, nausea, diarrhea, muscle pain, or joint 
pain will be prompted to contact the investigator to perform an unscheduled visit to assess 
the systemic event or may be referred to the appropriate healthcare facility at the discretion 
of the study staff if there are any concerns, as appropriate.
Participants will also be instructed to contact site staff if they visit the emergency room, have 
a medically attended visit, or are hospitalized for severe fatigue, headache, vomiting, nausea, 
diarrhea, muscle pain, or joint pain within 7 days after vaccination.
Based on local practice, participants may be referred to the appropriate healthcare facility at 
the discretion of the study staff if there are any concerns, as applicable. In the event that the 
participant does not call, the investigator or qualified designee will contact the participant. 
The study staff may also contact the participant to obtain additional information on events 
entered into the e-diary.
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. Grade 4 reactions will be collected on the CRF.
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 investigational site staff will continue to contact the 
participant to assess and record the information daily until resolution unless recorded in the 
e-diary. The investigator will enter this additional information and the end date in the 
participant’s source notes and CRF.
Table 3.
Grading Scale for Systemic Events
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3
Grade 4a
Fatigue
(= tiredness in 
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 
intravenous 
hydration
Emergency room 
visit
or hospitalization 
for severe vomiting
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Table 3.
Grading Scale for Systemic Events
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3
Grade 4a
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.
8.3.5.4. Fever
A digital thermometer will be given to the participant with instructions on how to measure 
oral temperature at home. Temperature will be collected for 7 days or longer for ongoing 
events following vaccination (where Day 1 is the day of vaccination). 
Fever is defined as an oral temperature of ≥38.0°C (≥100.4°F). The highest temperature for 
each day will be recorded in the e-diary, where possible.
In the event of a fever on the last day the e-diary was completed, temperature will be 
measured daily until fever has resolved (1 day of temperature 38.0°C [100.4°F]) in order 
to collect a stop date. The investigator will enter this additional information in the 
participant’s source notes and CRF.
A participant with a fever 38.9°C (102.0°F) will be prompted to contact the investigator. 
Based on local practice in certain countries/locales, participants may be referred to the 
appropriate healthcare facility at the discretion of the study staff if there are any concerns, as 
applicable. In the event that the participant does not call, the investigator or a qualified 
designee will contact the participant. The investigator or qualified designee will assess the 
fever and perform an unscheduled visit as appropriate.
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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 and assessed by the investigator.
Temperature will be measured and recorded to 1 decimal place and then categorized during 
analysis as mild, moderate, or severe, based on the intensity grading scale provided in 
Table 4.
Table 4.
Ranges for Fever
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3
Grade 4a
Fever
≥38.0°C-38.4°C 
(100.4°F-101.1°F)
>38.4°C-38.9°C 
(101.2°F-102.0°F)
>38.9°C-40.0°C 
(102.1°F-104.0°F)
>40.0°C (>104.0°F)
a.
Only an investigator or qualified designee is able to classify 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 and assessed by the investigator or qualified designee.
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 
Sections 10.5.1 and 10.5.2. Device deficiencies are covered in Section 10.5.3.
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally 
authorized representative), or they may arise from clinical findings of the investigator or 
other healthcare providers (clinical signs, test results, etc).
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study (see Section 7.1). 
During the active collection period as described in Section 8.4.1, each participant 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.
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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 2 (1 month after study vaccination).
In this study, the investigator and site staff will ensure the active elicitation and collection of 
safety events as detailed below:

The active collection period for nonserious AEs begins once informed consent has been 
provided and continues through and including Visit 2.

The active collection period for AESIs and SAEs begins once informed consent has been 
provided until the participant completes the study.

AEs occurring up to 48 hours after blood draws that are related to study procedures must 
be reported in the CRF.
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 study because of an AE 
or SAE, the AE or SAE must be recorded on the CRF and the SAE reported using the PSSA.
Investigators are not obligated to actively seek information on AEs or SAEs after the 
participant has concluded study participation. However, if the investigator learns of any SAE, 
including a death, at any time after a participant has completed the study, and they consider 
the event to be reasonably related to the study intervention, the investigator must promptly 
report the SAE to Pfizer via PSSA.
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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 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.
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 Section 10.2.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.4.3. 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 Section 10.2.
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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.
8.4.5.1. Exposure During Pregnancy
An EDP occurs if:

A female participant is found to be pregnant while receiving or after discontinuing study 
intervention.

A female nonparticipant is found to be pregnant while being exposed or having been 
exposed to study intervention because of environmental exposure. Below are examples of 
environmental EDP:

A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by inhalation or skin contact.

A male family member or healthcare provider who has been exposed to the study 
intervention by inhalation or skin contact then inseminates his female partner prior to 
or around the time of conception.
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The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy). 

If EDP occurs in a participant the investigator must report this information to Pfizer 
Safety using the PSSA 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 the study.

If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the PSSA 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 pre-procedure test 
findings are conclusive for a congenital anomaly and the findings are reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a live-born baby 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.
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8.4.5.2. Exposure During Breastfeeding
An EDB occurs if:

A female participant is found to be breastfeeding while receiving or after discontinuing 
study intervention.

A female nonparticipant is found to be breastfeeding while being exposed or having been 
exposed to study intervention (ie, environmental exposure). An example of 
environmental EDB is a female family member or healthcare provider who reports that 
she is breastfeeding after having been exposed to the study intervention by inhalation or 
skin contact.
The investigator must report EDB to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The information must be reported 
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.
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 via PSSA, 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 active collection period for AESIs begins once informed consent has been provided until 
the participant completes the study.
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The following events are considered AESIs:

Diagnosis of Guillain-Barré syndrome

Diagnosis of acute polyneuropathy without an underlying etiology

Diagnosis of atrial fibrillation

Preterm delivery (delivery at 37 0/7 weeks’ gestation)

Diagnosis of hypertensive disorder of pregnancy
Details of the AESIs listed above are further defined in the investigator site file.
AESIs are examined as part of routine safety data review procedures throughout the clinical 
trial and as part of signal detection processes. Should an aggregate analysis indicate that 
these prespecified events occur more frequently than expected, eg, based on epidemiological 
data, literature, or other data, then this will be submitted and reported in accordance with 
Pfizer’s safety reporting requirements. Aggregate analyses of safety data will be performed 
on a regular basis per internal SOPs. 
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.
8.4.8.1. Lack of Efficacy
This section is not applicable, as efficacy is not an outcome in this study. 
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.
Note: AEs and/or SAEs that are associated with a medical device deficiency will follow the 
same processes as other AEs or SAEs, as outlined in Section 8.4.1 through Section 8.4.4 and
Section 10.2 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.
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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.

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. Vaccination Errors
Vaccination errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Vaccination errors are recorded and reported as follows:
Recorded on the 
Medication Error Page 
of the CRF
Recorded on the 
Adverse Event Page 
of the CRF
Reported on the 
PSSA to Pfizer Safety 
Within 24 Hours of Awareness
All (regardless of whether 
associated with an AE)
Any AE or SAE associated with 
the vaccination error
Only if associated with an SAE
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Vaccination errors include:

Vaccination errors involving participant exposure to the study intervention;

Potential vaccination errors or uses outside of what is foreseen in the protocol that do or 
do not involve the study participant.

The administration of expired study intervention;

The administration of an incorrect study intervention;

The administration of an incorrect dosage;

The administration of study intervention that has undergone temperature excursion from 
the specified storage range, unless it is determined by the sponsor that the study 
intervention under question is acceptable for use.
Whether or not the vaccination error is accompanied by an AE, as determined by the 
investigator, such vaccination 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.
In the event of a vaccination dosing error, the sponsor should be notified within 24 hours.
Vaccination errors should be reported to Pfizer Safety within 24 hours 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.
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8.10. Study Procedures
8.10.1. Visit 1 – Vaccination (Clinic, Day 1)
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 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 vaccine are conducted prior to 
vaccination and after signing informed consent.

Assign a participant number using the IRT system.

Obtain the participant’s demography (including age, sex, race, and ethnicity). The age
will be collected to critically evaluate the immune response and safety profile by age.

Obtain and record any medical history of clinical significance.

Measure the participant’s weight and height, seated blood pressure, and pulse rate.

Perform a clinical assessment. If the clinical assessment indicates that a physical 
examination is necessary to comprehensively evaluate the participant, perform a physical 
examination and record any positive findings in the source documents and, if significant, 
record such findings on the medical history CRF.

Prior to vaccination, perform a urine pregnancy test on WOCBP as described in 
Section 8.3.4. Record the result in the source documents. A negative pregnancy test result 
will be required prior to the participant’s receiving the study intervention.

Verify understanding of and compliance with protocol requirements for contraception as 
described in Section 5.3.1.

Record nonstudy vaccinations given up to 28 days prior to study intervention 
administration, in source documents and in the CRF, if applicable. (Refer to
Section 6.9 for acceptable concomitant vaccines and prohibited vaccines.)

Obtain details of prohibited medications and treatments. See Section 6.9.

Ensure and document that all the inclusion criteria and none of the exclusion criteria are 
met.
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
Measure and record the participant’s prevaccination body temperature using a method 
according to routine local practice (°C).

Ensure that the participant meets none of the temporary delay criteria as described in
Section 5.5.

Prior to vaccination, obtain the participant’s randomization number and study 
intervention allocation using the IRT system. Refer to the IRT manual for further
instructions on this process. A site staff member will prepare the study intervention 
according to the IPM.

Collect approximately 20 mL of blood prior to study intervention administration.

Site staff member(s) will administer the 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 (see Section 6.1.1). 

Site staff will observe the participant for 30 minutes after administration of the study 
intervention for any acute reactions. Record any acute reactions (including time of onset) 
in the participant’s source documents and on the CRF, and via PSSA, as applicable.

Provide the participant with a measuring device to measure injection site reactions and a 
digital thermometer and provide instructions on their use.

Explain the e-diary technologies available for this study and assist the participant in 
downloading the study application onto the participant’s own device or issue a 
provisioned device, if required. Provide instructions on e-diary completion and ask the 
participant to complete the e-diary from Day 1 to 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 she 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
(see Section 8.3.5):

Redness and/or swelling at the injection site measuring 20 measuring device units 
(10 cm);

Severe injection site pain (causes limitation of limb movement);

Fever 38.9°C (102.0°F);

Any severe systemic event.
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
Remind participants that the study staff may contact them to obtain additional 
information on symptoms entered into the e-diary until they resolve.

Ask the participant to contact the site staff or investigator immediately if any significant 
illness or medical event (eg, emergency room visit, a medically attended visit, or 
hospitalization) occurs to the participant.

Provide the participant with the Pfizer study information card.

Remind the participant to inform the study staff of any AEs, AESIs, and SAEs that occur 
for the duration of the study.

Remind the participant to bring the completed e-diary to the next visit (if applicable).

Schedule an appointment for the participant to return for the next study visit.

The investigator or an authorized designee completes the CRF and the source documents 
and updates the study intervention accountability records.

The investigator or an appropriately qualified designee reviews the e-diary data online 
following study intervention administration to evaluate participant compliance and as part 
of the ongoing safety review.
8.10.2. Visit 2 – 1-Month Follow-Up Visit (Clinic, 28 to 35 Days After Vaccination)

Ensure and document that the participant continues to be eligible for the study and meets 
none of the participant withdrawal criteria in Section 7.2.

Record nonstudy vaccinations since the last visit in the source documents and in the CRF, 
if applicable, as described in Section 6.9.3.

Review the participant’s e-diary data and record assessment in the CRF. Assess 
compliance and collect stop dates for any symptoms ongoing on the last day of e-diary 
collection period after study intervention administration. Document in the CRF.

Collect the sponsor-provisioned e-diary/assist the participant with removing the e-diary 
study application from her personal device. 

Ensure that all data have been transferred before deactivating the e-diary or deleting the 
application.

Remind participants that the study staff may contact them to obtain additional 
information on events entered into the e-diary until they resolve.
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
Determine if any AEs (including nonserious AEs, AESIs, and SAEs) have occurred since 
the previous visit, follow up on any previously reported events to determine the outcome 
(ie, record stop dates or report as ongoing), and record such AEs as described in
Section 8.4.1.

Record details of any nonstudy vaccinations and prohibited concomitant medications and 
treatments as described in Section 6.9.1 and Section 6.9.2.

Collect approximately 20 mL of blood for antibody assessment.

The investigator or an authorized designee completes the CRF and the source documents.
8.10.3. Visit 3 – End-of-Study Visit (Telephone, 42 to 49 Days After Vaccination)

Determine if any AESIs or SAEs have occurred since the previous visit, follow up on any 
previously reported events to determine the outcome (ie, record stop dates or report as 
ongoing), and record such events in the CRF.

Record details of any nonstudy vaccinations and prohibited concomitant medications and 
treatments as described in Section 6.9.1 and Section 6.9.2.
8.10.4. Unscheduled Reactogenicity Visit 
If a severe local reaction (Section 8.3.5.2), systemic event (Section 8.3.5.3), or fever 
(Section 8.3.5.4) is reported in the reactogenicity e-diary, contact must occur between the 
participant and the investigator, or a medically qualified member of the study site staff to 
ascertain further details and determine whether a site visit is clinically indicated. 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 severe reactogenicity assessment via 
medical records and/or telehealth assessment.
Note: All contact must be recorded in the participant’s source notes and in the CRF.
Any ongoing reactions must be assessed until resolved prior to or at the next scheduled visit.
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The 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, who will:

Measure temperature.

Measure the participant’s heart rate.

Measure the participant’s blood pressure (seated).

Measure the minimum and maximum diameters of redness (if present) on the arm in 
which the study intervention was administered.

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.

Assess if any exfoliative dermatitis is present.

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 8.3.5.2.

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 8.3.5.3.

Ask the participant if she attended an emergency room visit, had a medically attended 
visit, or was hospitalized.

For severe pain at the injection site resulting in an emergency room visit or 
hospitalization, severe systemic events associated with an emergency room visit or 
hospitalization, any necrosis on the arm in which the study intervention was
administered, or exfoliative dermatitis, the investigator or qualified designee must assess 
these events.

Record AEs, AESIs, and SAEs as described in Section 8.4.

Complete the participant’s source documents.

The investigator or an authorized designee will complete the CRFs.

The study staff may contact the participant to obtain additional information on events 
entered into the e-diary, as appropriate.
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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 and 
finalized before database lock. The SAP may modify what is outlined in the protocol where 
appropriate; however, any major modifications of the primary endpoint definitions or their 
analyses will also be reflected in a protocol amendment.
9.1. Statistical Hypothesis
Hypothesis testing will be used to assess the primary objectives of NI of the immune 
responses for RSV A and RSV B of the MDV RSVpreF group to the SDV RSVpreF group.
For the primary objective, the null hypotheses (H0) for both RSV A and RSV B are: 
RSV A:
H0A: ln(µMDV) – ln(µSDV) ≤-ln(1.5),
RSV B: 
H0B: ln(µMDV) – ln(µSDV) ≤-ln(1.5),
where ln(μMDV) is the mean of natural logarithm–transformed antibody concentration at 
1 month after vaccination from participants in the MDV RSVpreF group, and ln(μSDV) is the 
mean of natural logarithm–transformed antibody concentration at 1 month after vaccination 
from participants in the SDV RSVpreF group. The antibody titer data will be logarithmically 
transformed for analysis of GMT ratios along with 95% CIs, and results will be presented on 
the original scale.
The NI of RSVpreF of the MDV group with respect to the SDV group will be evaluated at 
1 month after vaccination for RSV A and RSV B NTs. The primary objective of NI will be 
met if 

The lower bounds of the 2-sided 95% CI for the GMT ratio (MDV group divided by 
SDV group) are greater than the predefined limit of 0.67 (NI margin of 1.5-fold) for both 
RSV A and RSV B NTs. 
9.1.1. Estimands
9.1.1.1. Primary Estimand/Coprimary Estimands
9.1.1.1.1. Immunogenicity
The estimand is defined by the following attributes:
Population: Participants receiving 1 dose of study intervention and in compliance with the 
key protocol criteria (evaluable participants).
Endpoints: 

Functional antibody levels estimated by the GMT for RSV A and RSV B serum NTs
before vaccination and at 1 month after vaccination.
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
GMR, estimated by the ratio of the GMTs for RSV A and RSV B serum NTs of the 
MDV group to the SDV group before vaccination and at 1 month after vaccination.
Treatment condition: The randomized MDV group or SDV group.
Intercurrent events: The following intercurrent events could impact the interpretation or the 
measurement of the immune response: 1) The participants with major protocol violation who 
received a prohibited vaccine or 2) treatment that may alter the immune response and 
subsequently impact the vaccine protection. The immunogenicity data after intercurrent 
events will be excluded (hypothetical strategy). Major protocol violations will be determined 
by clinical review. Missing serology results will not be imputed, as MCAR is assumed. 
Population-level summary: GMR of the GMTs for RSV A and RSV B serum NTs of the 
MDV group to the SDV group.
9.1.1.1.2. Safety 
The estimand is defined by the following attributes:
Population: Participants receiving 1 dose of study intervention.
Endpoints:

Local reactions within 7 days after vaccination.

Systemic events within 7 days after vaccination.

The percentage of participants having AEs through 1 month after vaccination.

The percentage of participants reporting SAEs throughout the study.
Treatment condition: The administered MDV group or SDV group.
Intercurrent events: There are no intercurrent events to be considered. All data collected after 
discontinuation or major protocol deviation would be included. Missing e-diary data will not 
be imputed; missing AE dates and missing AE intensity data will be handled according to 
Pfizer safety rules.
Population-level summary: The percentage of participants reporting local reactions, systemic 
events, AEs, and SAEs in each group.
9.1.1.2. Secondary Estimands
9.1.1.2.1. Immunogenicity
The estimand is defined by the following attributes:
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Population: Participants receiving 1 dose of study intervention and in compliance with the 
key protocol criteria (evaluable immunogenicity participants).
Endpoint: Seroresponse rates, defined as a ≥4-fold rise in serum NTs at 1 month after 
vaccination compared to the prevaccination titer; or ≥4 times the LLOQ if the prevaccination 
titer is below the LLOQ. 
Treatment condition: The randomized MDV group or SDV group.
Intercurrent events: The intercurrent events listed in Section 9.1.1.1.1 apply. 
The immunogenicity data after intercurrent events will be excluded (hypothetical strategy). 
Major protocol violations will be determined by clinical review. Missing serology results will 
not be imputed, as MCAR is assumed. 
Population-level summary: Seroresponse rates by vaccine group.
9.1.2. Multiplicity Adjustment
No multiplicity adjustment is needed for this study, as both RSV A and RSV B need to meet 
the NI criteria. 
9.2. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Participant Analysis Set
Description
Enrolled 
All participants who sign the ICD.
Randomized
All participants who are assigned a randomization number in the IRT system.
Safety
All participants who receive the study intervention.
Defined Analysis Set
Description
Evaluable immunogenicity
All participants who are eligible, receive the study intervention to which they 
were randomized, have blood drawn for assay testing within the specified 
time frame, have valid and determinate assay results for the proposed 
analysis, and have no major protocol violations.
mITT immunogenicity
All randomized participants who receive the study intervention and have at 
least 1 valid and determinate assay result for the proposed analysis.
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, secondary, and 
exploratory endpoints.
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9.3.1. General Considerations
In general, the study data will be summarized by study intervention group. CIs for all 
endpoints in the statistical analysis will be presented as 2-sided at the 95% level.
For all the immunogenicity endpoints, the analysis will be primarily based on the evaluable 
immunogenicity population. An additional analysis will be performed based on the 
mITT population if there is a large enough difference in the number of participants included 
between the mITT and the evaluable immunogenicity populations. Participants will be 
summarized according to the study intervention group to which they were randomized. 
Missing laboratory results will not be imputed.
The safety analyses are based on the safety population. Participants will be summarized 
according to the study interventions they received.
9.3.2. Primary Endpoint(s)/Estimand(s) Analysis
9.3.2.1. Immunogenicity
Endpoint
Statistical Analysis Methods
Primary – immunogenicity

GMT for RSV A and RSV B serum NTs and the associated 
2-sided 95% CIs will be provided, by study intervention,
before vaccination and at 1 month after vaccination.

GMR, estimated by the ratio of the GMTs for RSV A and 
RSV B serum NTs of the MDV group to the SDV group 
and the associated 2-sided 95% CIs will be provided, by 
study intervention, before vaccination and at 1 month after 
vaccination.

For GMT analysis, a titer reported as < LLOQ will be 
converted to a value of ½ LLOQ.

The analysis is based on the evaluable population. 
An additional analysis will be performed based on the 
mITT population if there is a large enough difference in the 
number of participants included between the mITT and the 
evaluable immunogenicity populations. Participants will be 
summarized according to the study intervention group to 
which they were randomized.

Missing serology data will not be imputed.
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9.3.2.2. Safety
Endpoint
Statistical Analysis Methods
Primary – safety

Point estimates and the associated exact 2-sided 95% CIs will be 
calculated using the Clopper-Pearson method for the proportion of 
participants reporting each event (local reactions, systemic events, 
AEs, and SAEs) for each study intervention.

AEs and SAEs will be categorized according to MedDRA terms. 

A 3-tier approach will be used to summarize AEs. For both Tier 1 
and Tier 2 events, the 95% CIs for the difference in the percentage 
of participants reporting the events between RSVpreF in the 
MDV group and RSVpreF in the SDV group will be calculated 
using the test statistic proposed by Miettinen and Nurminen,25 in 
addition, for Tier 1 events, the asymptotic p-values will also be 
presented for the difference in the percentage of participants 
reporting the events, based on the same test statistic and under the 
assumption that the test statistic is asymptotically normally 
distributed. A MedDRA preferred term is defined as a Tier 2 event 
if there are at least 1% of participants with the AE term in at least 
1 vaccine group. Descriptive summary statistics (counts and 
percentages) will be provided for Tier 3 events for each vaccine 
group.

The safety analyses are based on the safety population. 
Participants will be summarized by the vaccine group they 
actually received. Missing e-diary data will not be imputed; 
missing AE dates and missing AE intensity will be addressed 
using the Pfizer safety rules.
9.3.3. Secondary Endpoint(s)/Estimand(s) Analysis
Endpoint
Statistical Analysis Methods
Secondary – immunogenicity

Seroresponse rates, by vaccine group, defined as a ≥4-fold rise in 
serum NTs at 1 month after vaccination compared to the 
prevaccination titer; or ≥4 times the LLOQ if the prevaccination 
titer is below the LLOQ. 

Exact 2-sided 95% CIs for the percentages (seroresponders) will 
be provided using the Clopper-Pearson method.

The analysis is based on the evaluable immunogenicity 
population. An additional analysis will be performed based on the 
mITT population if there is a large enough difference in the 
number of participants included between the mITT and the 
evaluable immunogenicity populations. Participants will be 
summarized according to the study intervention group to which 
they were randomized.

Missing serology data will not be imputed.
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9.3.4. Tertiary/Exploratory Endpoint(s) Analysis
Endpoint
Statistical Analysis Methods
Exploratory – immunogenicity

GMC for RSV A and RSV B prefusion F–binding IgG and the 
associated 2-sided 95% CIs will be provided, by study 
intervention, before vaccination and at 1 month after vaccination.

For GMC analysis, an IgG level reported as LLOQ will be 
converted to a value of ½ LLOQ.

The analysis is based on the evaluable population. An additional 
analysis will be performed based on the mITT population if there 
is a large enough difference in the number of participants 
included between the mITT and the evaluable immunogenicity 
populations. Participants will be summarized according to the 
study intervention group to which they were randomized.

Missing serology data will not be imputed.
9.3.5. Other Safety Analyses
All safety analyses will be performed on the safety population.
9.4. Interim Analyses
No interim analysis will be conducted for this study.
9.5. Sample Size Determination
The study sample size is based on the evaluation of NI of RSVpreF in the MDV group to 
RSVpreF in the SDV group on the primary endpoint. NI will be evaluated using a 
1.5-fold margin as the criterion. With the assumption of SD (ln scale) from the historical 
study, Table 5 presents the power to demonstrate NI for both RSV A and RSV B. The overall 
power to demonstrate NI for both RSV A and RSV B is 90.0%.
Assuming a nonevaluable rate of 10%, the study will randomize approximately 
452 participants to achieve 203 evaluable participants in each group.
Table 5.
Power to Show Noninferiority of RSVpreF in the MDV Group to the SDV 
Group
Endpoint
ln(SD)
Assumed GMT Ratio
NI Margin
N Evaluable/Group
Power
MDV
SDV
RSV A
1.09
1
1.5-fold
203
203
96.2%
RSV B
1.17
1
1.5-fold
203
203
93.6%
Power to show NI for both RSV A and RSV B
90.0%
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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 MDR 2017/745 for clinical device research, and all other applicable 
local regulations.
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, Pfizer should be informed immediately. 
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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.
10.1.3.1. Electronic Consent 
Participants may be able to experience the informed consent process by electronic means 
(eConsent). The eConsent process includes an electronic presentation of the informed 
consent document (eICD), clinical trial educational components (as applicable), and 
electronic signatures (if allowed by local regulations). The use of eConsent does not replace 
or alter the ICD content or informed consent process as described above. The eConsent 
process complies with applicable regulations and sponsor policies to ensure reliability and 
data privacy.
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.
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10.1.5. Committees Structure
10.1.5.1. Data Monitoring Committee 
This study will not use an EDMC. 
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.
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Data sharing
Pfizer provides researchers secure access to participant-level data or full CSRs for the 
purposes of “bona-fide scientific research” that contributes to the scientific understanding of 
the disease, target, or compound class. Pfizer will make data from these trials available 
18 months after study completion. Participant-level data will be anonymized in accordance 
with applicable privacy laws and regulations. CSRs will have personally identifiable 
information anonymized.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.7. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document.
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.
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Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained.
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems.
The investigator(s) will notify the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study. Furthermore, the investigator will cooperate 
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the sponsor or its agent, whenever feasible, to be present during the inspection. The 
investigator site and investigator will promptly resolve any discrepancies that are identified 
between the study data and the participant’s medical records. The investigator will promptly 
provide copies of the inspection findings to the sponsor or its agent. Before response 
submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings.
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.
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10.1.9. Use of Medical Records
There may be instances when copies of medical records for certain cases are requested by 
Pfizer Safety, 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:

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 
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants.
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Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:

Failure of the investigator to comply with the protocol, the requirements of the IRB/EC 
or local health authorities, the sponsor’s procedures, or the ICH GCP guidelines;

Inadequate recruitment of participants by the investigator;

Discontinuation of further study intervention development.
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights.
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.
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For all publications relating to the study, the investigator and Pfizer will comply with 
recognized ethical standards concerning publications and authorship, including those 
established by the International Committee of Medical Journal Editors. The investigator will 
disclose any relationship with Pfizer and any relevant potential conflicts of interest, including 
any financial or personal relationship with Pfizer, in any publications. All authors will have 
access to the relevant statistical tables, figures, and reports (in their original format) required 
to develop the publication.
10.1.12. Sponsor’s Medically Qualified Individual 
The 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 investigator site file or equivalent. 
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 identification number, and (c) principal investigator 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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An SAE is defined as any untoward medical occurrence that, at any dose, meets one 
or more of the criteria listed below:
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.
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10.2.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During the Active 
Collection Period 
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording AEs on the CRF and for 
reporting SAEs 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. 
It should be noted that the 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 PSSA for reporting of SAE 
information.
Safety Event
Recorded on the CRF
Reported on the 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 PSSA and EDP 
Supplemental Form; if the EDP is associated with an SAE, then the SAE is reported to Pfizer Safety 
using the PSSA or Vaccine SAE Report Form.
**
EDB is reported to Pfizer Safety using the 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 PSSA. 

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 PSSA/AE or SAE CRF page.
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AE and SAE Recording/Reporting

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: 
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 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 the back-up method to 
transmit this information to Pfizer Safety in case PSSA is unavailable for more than 
24 hours. 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.
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10.3. Appendix 3: Contraceptive and Barrier Guidance 
10.3.1. Female Participant Reproductive Inclusion Criteria
The criteria below are part of inclusion criterion 1 (Age and Sex; Section 5.1) and specify the 
reproductive requirements for including female participants. Refer to Section 10.3.3. for a 
complete list of contraceptive methods permitted in the study. 
A female participant is eligible to participate if she is not pregnant or breastfeeding and at 
least 1 of the following conditions applies:

Is not a WOCBP (see definitions below in Section 10.3.2).
OR

Is a WOCBP and agrees to use an acceptable contraceptive method during the 
intervention period (for a minimum of 28 days after the last dose of study intervention). 
The investigator should evaluate the effectiveness of the contraceptive method in 
relationship to the first dose of study intervention.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy.
10.3.2. 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. Premenarchal.
2. Premenopausal female with 1 of the following:

Documented hysterectomy;

Documented bilateral salpingectomy;

Documented bilateral oophorectomy.
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.
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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.
3. 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.
10.3.3. Contraception Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
The following contraceptive methods are appropriate for this study:
Highly Effective Methods That Have Low User Dependency 
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device.
3. Intrauterine hormone-releasing system.
4. Bilateral tubal occlusion.
5. Vasectomized partner:

Vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the WOCBP and the absence of sperm has been 
confirmed. If not, an additional highly effective method of contraception should be 
used. The spermatogenesis cycle is approximately 90 days.
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Highly Effective Methods That Are User Dependent 
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:

Oral;

Intravaginal;

Transdermal.
7. Progestogen-only hormone contraception associated with inhibition of ovulation:

Oral;

Injectable.
8. Sexual abstinence

Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention. The reliability of sexual abstinence needs to be evaluated 
in relation to the duration of the study and the preferred and usual lifestyle of the 
participant.
Other Effective Methods
9. Progestogen-only oral hormonal contraception where inhibition of ovulation is not the 
primary mode of action.
10. Male or female condom, with or without spermicide.
11. Cervical cap, diaphragm, or sponge with spermicide.
12. A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods).
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10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome. These participants fail to adapt and therefore are 
“susceptible” to progressive and serious liver injury, commonly referred to as DILI. 
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are “adaptors” or are “susceptible.”
LFTs are not required as a routine safety monitoring procedure in this study. However, should 
an investigator deem it necessary to assess LFTs because a participant presents with clinical 
signs/symptoms, such LFT results should be managed and followed as described below.
In the majority of DILI cases, elevations in AST and/or ALT precede 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).

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).
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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 an 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 any contact method 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.
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Device Deficiency Recording

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 
in regard to the SAE must be included in the PSSA as outlined in Section 8.4.1.1 and 
Section 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 and/or product information, for marketed 
products in their assessment.
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Assessment of Causality Occurring in Conjunction With a Medical Device Deficiency

For each device deficiency, the investigator must document in the medical notes that 
they have reviewed the device deficiency and have provided an assessment of 
causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to the sponsor. However, it is very 
important that the investigator always make an assessment of causality for every event 
before the initial transmission of the SAE data to the sponsor.

The investigator may change their opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.
Follow-Up of Medical Device Deficiency

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 using the PSSA within 
24 hours of receipt of the information, according to the requirements provided in 
Appendix 2.
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10.6. Appendix 6: Protocol-Specific Requirements; 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
1. 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
2. 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:
3. HBeAg negative, anti-HBe positive;
4. Serum HBV DNA 2000 IU/mL;
5. Persistently normal ALT and/or AST levels;
6. 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 used in the protocol.
Abbreviation
Term
2-PE
2-phenoxyethanol
ADE
adverse device effect
AE
adverse event
AESI
adverse event of special interest
Al(OH)3
aluminum hydroxide
ALT
alanine aminotransferase
AST
aspartate aminotransferase
AxMP
auxiliary medicinal product
-hCG
beta-human chorionic gonadotropin
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
DTwP
diphtheria, tetanus, and whole-cell pertussis vaccine
DU
dispensable unit
EC
ethics committee
ECG
electrocardiogram or electrocardiography
eCRF
electronic case report form
EDB
exposure during breastfeeding
e-diary
electronic diary
EDMC
external data monitoring committee
EDP
exposure during pregnancy
eICD
electronic informed consent document
EP
European Pharmacopoeia
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
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMC
geometric mean concentration
GMFR
geometric mean fold rise
GMR
geometric mean ratio
GMT
geometric mean titer
HBe
hepatitis B e
HBeAg
hepatitis B e antigen
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
HCV
hepatitis C virus
HIV
human immunodeficiency virus
HRT
hormone replacement therapy
IB
investigator’s brochure
ICD
informed consent document
ICH
International Council for Harmonisation of Technical Requirements for Pharmaceuticals 
for Human Use
ID
identification
IgG
immunoglobulin G
IMP
investigational medicinal product
IND
investigational new drug application
INR
international normalized ratio
IP
Internet Protocol
IPAL
Investigational Product Accountability Log
IPM
investigational product manual
IRB
institutional review board
IRT
interactive response technology
ISO
International Organization for Standardization
LFT
liver function test
LLOQ
lower limit of quantitation
LMIC
low- and middle-income country
LRTD
lower respiratory tract disease
LRTI
lower respiratory tract illness
LRTI-RSV
RSV-associated lower respiratory tract illness
MA-LRTI
medically attended lower respiratory tract illness
MCAR
missing completely at random
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Abbreviation
Term
MDR
Medical Device Regulation
MDV
multidose vial
MedDRA
Medical Dictionary for Regulatory Activities
mITT
modified intent-to-treat
MQI
medically qualified individual
NI
noninferiority
NIMP
new investigational product
NT
neutralizing titer
PFS
prefilled syringe
PSSA
Pfizer's Serious Adverse Event Submission Assistant
PT
prothrombin time
QTL
quality tolerance limit
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
SDS
single-dose syringe
SDV
single-dose vial
SIIV
seasonal inactivated influenza vaccine
SmPC
summary of product characteristics
SoA
schedule of activities
SOP
standard operating procedure
SRSD
single reference safety document
SUSAR
suspected unexpected serious adverse reaction
T bili
total bilirubin
Tdap
tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed
UADE
unanticipated adverse device effect
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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1985;4(2):213-26.
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