A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN HEALTHY ADULTS
Phase: PHASE3
Conditions: RSV
Sponsor: Pfizer

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
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Final Protocol Amendment 1, 08 Feb 2022
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A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY 
TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 
3 LOTS OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT 
VACCINE IN HEALTHY ADULTS
Study Intervention Number:
PF-06928316 
Study Intervention Name:
Respiratory Syncytial Virus (RSV) Vaccine 
US IND Number:
EudraCT Number:
N/A
ClinicalTrials.gov ID:
TBD
Protocol Number:
C3671014
Phase:
3
Brief Title: Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to 
≤49 Years of Age
This document and accompanying materials contain confidential information belonging to Pfizer. Except as 
otherwise agreed to in writing, by accepting or reviewing these documents, you agree to hold this information 
in confidence and not copy or disclose it to others (except where required by applicable law) or use it for 
unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer must be 
promptly notified.
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PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
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Document History
Document
Version Date
Protocol amendment 1
08 Feb 2022
Original protocol
23 August 2021
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 (08 Feb 2022)
Overall Rationale for the Amendment: Increasing the overall sample size of the study.
Section # and 
Name
Description of Change
Brief Rationale
1.1 Synopsis,
1.2 Schema, 
4.1 Overall Design,
and 9 Statistical 
Considerations
Sample size was increased and the estimated enrollment 
period was removed.
Statistical methods, including sample size and power 
calculations, were updated.
In response to CBER 
feedback.
2.2.1 Clinical 
Overview
RSV program study details were updated.
To include the latest data.
4.2.2 Diversity of 
Study Population
The study number was corrected.
To correct a typographical 
error.
9.3.2 Primary 
Endpoint(s)
The definition of a Tier 2 event was updated.
To align with other studies 
within the program.

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TABLE OF CONTENTS
LIST OF TABLES.....................................................................................................................8
1. PROTOCOL SUMMARY.....................................................................................................9
1.1. Synopsis ....................................................................................................................9
1.2. Schema ....................................................................................................................13
1.3. Schedule of Activities .............................................................................................14
2. INTRODUCTION ...............................................................................................................15
2.1. Study Rationale .......................................................................................................16
2.2. Background .............................................................................................................16
2.2.1. Clinical Overview.......................................................................................17
2.3. Benefit/Risk Assessment.........................................................................................18
2.3.1. Risk Assessment.........................................................................................19
2.3.2. Benefit Assessment.....................................................................................21
2.3.3. Overall Benefit/Risk Conclusion................................................................21
3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS ...........................................................21
4. STUDY DESIGN.................................................................................................................23
4.1. Overall Design.........................................................................................................23
4.2. Scientific Rationale for Study Design.....................................................................23
4.2.1. Choice of Contraception/Barrier Requirements .........................................23
4.2.2. Diversity of Study Population ....................................................................24
4.3. Justification for Dose ..............................................................................................24
4.4. End of Study Definition ..........................................................................................25
5. STUDY POPULATION......................................................................................................25
5.1. Inclusion Criteria.....................................................................................................25
5.2. Exclusion Criteria....................................................................................................26
5.3. Lifestyle Considerations..........................................................................................27
5.3.1. Contraception..............................................................................................27
5.4. Screen Failures ........................................................................................................28
5.5. Criteria for Temporarily Delaying 
Enrollment/Randomization/Administration of Study Intervention...........................28
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................28
6.1. Study Intervention(s) Administered........................................................................29

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6.1.1. Administration............................................................................................30
6.1.2. Medical Devices .........................................................................................30
6.2. Preparation, Handling, Storage, and Accountability...............................................30
6.2.1. Preparation and Dispensing........................................................................31
6.3. Measures to Minimize Bias: Randomization and Blinding.....................................32
6.3.1. Allocation to Study Intervention ................................................................32
6.3.2. Blinding Arrangements...............................................................................32
6.3.2.1. Blinding of Study Site Personnel ..............................................32
6.3.2.2. Blinding of the Sponsor.............................................................32
6.3.3. Breaking the Blind......................................................................................32
6.4. Study Intervention Compliance...............................................................................33
6.5. Dose Modification...................................................................................................33
6.6. Continued Access to Study Intervention After the End of the Study......................33
6.7. Treatment of Overdose............................................................................................33
6.8. Concomitant Therapy..............................................................................................33
6.8.1. Prohibited Concomitant Vaccinations and Medications.............................33
6.8.2. Withholding Periods for Concomitant Vaccinations and Medications ......34
6.8.3. Permitted Nonstudy Vaccines and Medications During the Study ............34
6.8.4. Recording Nonstudy Vaccinations and Concomitant Medications............35
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................35
7.1. Discontinuation of Study Intervention ....................................................................35
7.1.1. Pregnancy ...................................................................................................35
7.2. Participant Discontinuation/Withdrawal From the Study.......................................36
7.2.1. Withdrawal of Consent...............................................................................36
7.3. Lost to Follow-Up ...................................................................................................37
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................37
8.1. Efficacy and/or Immunogenicity Assessments .......................................................38
8.1.1. Efficacy Assessments .................................................................................38
8.1.2. Immunogenicity Assessments ....................................................................38
8.1.2.1. Blood Collection .......................................................................38
8.1.2.2. RSV Vaccine Antibody Testing................................................38

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8.1.3. Biological Samples.....................................................................................39
8.2. Safety Assessments .................................................................................................39
8.2.1. Physical Examinations................................................................................39
8.2.2. Vital Signs ..................................................................................................40
8.2.3. Clinical Safety Laboratory Assessments ....................................................40
8.2.4. Electronic Diary..........................................................................................40
8.2.4.1. Local Reactions – Reactogenicity.............................................41
8.2.4.2. Systemic Events ........................................................................42
8.2.4.3. Fever Monitoring.......................................................................43
8.2.5. Pregnancy Testing ......................................................................................44
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................44
8.3.1. Time Period and Frequency for Collecting AE and SAE Information.......45
8.3.1.1. Reporting SAEs to Pfizer Safety...............................................45
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF...................45
8.3.2. Method of Detecting AEs and SAEs ..........................................................46
8.3.3. Follow-Up of AEs and SAEs......................................................................46
8.3.4. Regulatory Reporting Requirements for SAEs...........................................46
8.3.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................46
8.3.5.1. Exposure During Pregnancy......................................................47
8.3.5.2. Exposure During Breastfeeding ................................................48
8.3.5.3. Occupational Exposure .............................................................49
8.3.6. Cardiovascular and Death Events...............................................................49
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................49
8.3.8. Adverse Events of Special Interest.............................................................49
8.3.9. Medical Device Deficiencies......................................................................49
8.3.9.1. Time Period for Detecting Medical Device Deficiencies .........49
8.3.9.2. Follow-Up of Medical Device Deficiencies..............................50
8.3.9.3. Prompt Reporting of Device Deficiencies to the Sponsor ........50
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8.3.9.4. Regulatory Reporting Requirements for Device 
Deficiencies .......................................................................................50
8.3.10. Medication Errors.....................................................................................51
8.4. Pharmacokinetics ....................................................................................................52
8.5. Genetics...................................................................................................................52
8.6. Biomarkers ..............................................................................................................52
8.7. Immunogenicity Assessments.................................................................................52
8.8. Health Economics ...................................................................................................52
8.9. Study Procedures.....................................................................................................52
8.9.1. Visit 1 – Vaccination (Clinic, Day 1).........................................................52
8.9.2. Visit 2 – 1-Month Follow-Up (Clinic, 28 to 35 Days After Visit 1)..........55
8.9.3. Unscheduled Reactogenicity Visits for a Grade 3 or Suspected Grade 
4 Reaction ........................................................................................................55
9. STATISTICAL CONSIDERATIONS ................................................................................56
9.1. Statistical Hypotheses .............................................................................................56
9.1.1. Estimands....................................................................................................56
9.1.2. Statistical Hypotheses.................................................................................57
9.1.3. Multiplicity Adjustment..............................................................................57
9.2. Analysis Sets ...........................................................................................................57
9.3. Statistical Analyses .................................................................................................58
9.3.1. General Considerations...............................................................................58
9.3.1.1. Analyses for Binary Data ..........................................................58
9.3.1.2. Analyses for Continuous Data...................................................58
9.3.2. Primary Endpoint(s)....................................................................................59
9.3.3. Secondary Endpoint(s)................................................................................60
9.4. Interim Analyses .....................................................................................................61
9.5. Sample Size Determination.....................................................................................61
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................63
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............63
10.1.1. Regulatory and Ethical Considerations ....................................................63
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10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................63
10.1.2. Financial Disclosure .................................................................................64
10.1.3. Informed Consent Process ........................................................................64
10.1.4. Data Protection .........................................................................................65
10.1.5. Committees Structure ...............................................................................65
10.1.5.1. Data Monitoring Committee ...................................................65
10.1.6. Dissemination of Clinical Study Data ......................................................65
10.1.7. Data Quality Assurance ............................................................................67
10.1.8. Source Documents....................................................................................68
10.1.9. Study and Site Start and Closure ..............................................................68
10.1.10. Publication Policy...................................................................................69
10.1.11. Sponsor’s Qualified Medical Personnel .................................................70
10.2. Appendix 2: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting .....................................................................71
10.2.1. Definition of AE .......................................................................................71
10.2.2. Definition of an SAE ................................................................................72
10.2.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period............................................................................74
10.2.4. Reporting of SAEs....................................................................................77
10.3. Appendix 3: Contraceptive and Barrier Guidance ................................................78
10.3.1. Male Participant Reproductive Inclusion Criteria....................................78
10.3.2. Female Participant Reproductive Inclusion Criteria.................................78
10.3.3. Woman of Childbearing Potential ............................................................79
10.3.4. Contraception Methods.............................................................................79
10.4. Appendix 4: Liver Safety: Suggested Actions and Follow-Up Assessments .......81
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 .............................................83
10.5.1. Definition of AE and ADE .......................................................................83
10.5.2. Definition of SAE, SADE, and USADE ..................................................83
10.5.3. Definition of Device Deficiency...............................................................84

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10.5.4. Recording/Reporting and Follow-Up of Medical Device 
Deficiencies......................................................................................................84
10.5.5. Reporting of SAEs....................................................................................86
10.5.6. Reporting of SADEs.................................................................................86
10.6. Appendix 6: Alternative Measures During Public Emergencies ..........................87
10.6.1. Telehealth Visits.......................................................................................87
10.7. Appendix 7: Abbreviations ...................................................................................88
11. REFERENCES ..................................................................................................................91
LIST OF TABLES
Table 1.
Grading Scale for Local Reactions...........................................................41
Table 2.
Grading Scale for Systemic Events ..........................................................42
Table 3.
Ranges for Fever.......................................................................................44
Table 4.
Power for the Primary Immunogenicity Objective (Lot 
Consistency) .............................................................................................62

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1. PROTOCOL SUMMARY
1.1. Synopsis
Brief Title: Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to 
≤49 Years of Age
Indication
Pfizer’s RSV stabilized prefusion F subunit vaccine (RSVpreF) is a prophylactic vaccine that
is being developed for 2 indications:

Maternal: Prevention of LRTI-RSV in infants by active immunization of pregnant 
women.

Older Adult: Prevention of RSV-associated msLTRI in adults 60 years of age and older 
via active immunization.
Rationale
As of June 2021, RSVpreF has been studied in 3 completed and 3 ongoing clinical trials in 
healthy adults and pregnant women. RSVpreF was shown to be well tolerated, with an
acceptable safety profile, and was highly efficacious in the RSV human challenge model
(Section 2.2.1).
This study will examine 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
to demonstrate lot equivalence in manufacturing of RSVpreF. Additionally, the study will 
contribute data supporting the development of RSVpreF as a prophylactic vaccine against 
RSV disease in infants through maternal immunization and in older adults through active
vaccination.

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Objectives, Estimands, and Endpoints
Study Objectives, Estimands, and Endpoints 
Objectives
Estimands
Endpoints
Primary Immunogenicity 
To demonstrate that the immune 
responses induced by 
3 RSVpreF lots (Groups 1, 2,
and 3) 1 month after vaccination 
are equivalent.

The ratio of neutralizing
GMTs obtained 1 month after 
vaccination for every pair of 
RSVpreF lots 
(Group 1/Group 2, 
Group 1/Group 3, 
Group 2/Group 3) for RSV A 
and RSV B neutralization 
assays, in participants 
receiving 1 dose of study 
intervention and in compliance 
with the key protocol criteria 
(evaluable participants).

RSV A and RSV B NTs.
Primary Safety 
To evaluate the safety and 
tolerability profiles of 
3 RSVpreF lots (Groups 1, 2,
and 3).

The incidence rate of each 
safety outcome in participants 
receiving 1 dose of the study 
intervention, estimated by the 
percentage of participants 
reporting the event among 
those who receive study 
intervention, in the pooled 
RSVpreF lots and placebo.

Local reactions (redness, 
swelling, and pain at the 
injection site) self-reported 
on e-diaries for 7 days after 
vaccination.

Systemic events (fever, 
fatigue, headache, vomiting, 
nausea, diarrhea, muscle 
pain, and joint pain) 
self-reported on e-diaries for 
7 days after vaccination.

AEs from the day of consent 
through study completion.

SAEs from the day of 
consent through study 
completion.

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Overall Design
Brief Summary
This Phase 3, multicenter, parallel-group, placebo-controlled, randomized, double-blind 
study will be conducted in the US.
Healthy adults 18 to ≤49 years of age will be enrolled and randomized in a 1:1:1:1 ratio to 
receive 1 of 3 lots of RSVpreF (Group 1: Group 2: Group 3) or placebo.
There are 2 scheduled study visits 1 month apart. Participants will have blood samples for 
immunogenicity assessments collected both prior to vaccination (Visit 1) and 1 month after 
vaccination (Visit 2).
Local reactions (redness, swelling, and pain at the injection site) occurring at the RSVpreF or 
placebo injection site and systemic events (fever, fatigue, headache, vomiting, nausea, 
diarrhea, muscle pain, and joint pain) occurring within 7 days after vaccination will be 
prompted for and collected daily by the participant in an e-diary device or smartphone 
application.
AEs and SAEs will be collected from the signing of informed consent through study 
completion (Visit 2).
Number of Participants
Up to 1000 participants will be enrolled in the study. Allowing for a nonevaluable rate of 
approximately 10%, this will provide the required sample size of approximately 900
participants for the evaluable population analysis. Participants who withdraw or are 
withdrawn from the study after randomization will not be replaced, regardless of the reason 
for withdrawal.
Intervention Groups and Duration
There will be 4 study groups: Group 1, Group 2, Group 3 (representing 3 RSVpreF 
manufacturing lots), and placebo. Up to 1000 participants will be randomly assigned in a 
1:1:1:1 ratio so that each group numbers approximately 250 participants. Each randomized 
participant will receive his or her vaccine assignment, administered as a single IM injection 
into the deltoid muscle (nondominant arm preferred) at Visit 1. Participants and study 
personnel will be blinded to intervention groups and assignments.
The last study visit for each participant will be approximately 1 month after vaccination. 

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Statistical Methods
Equivalence of the 3 RSVpreF lots will be assessed by using 2-sided 95% CIs for ratios of 
lot-specific GMTs. Equivalence will be declared using a 1.5-fold criterion, ie, that the 95% 
CI for the ratio of GMTs for every pair of RSVpreF lots must be contained in the interval 
(0.667, 1.5), for both antigens simultaneously. CIs will be derived by calculating differences 
in means and CIs for natural log titers (based on the t-distribution) and then exponentiating 
the results.
Safety will be summarized using counts, percentages, and incidences of local reactions, 
systemic events, AEs, and SAEs. Incidence rates of local reactions, systemic events, AEs, 
and SAEs after vaccination in the combined RSVpreF group relative to the incidence rates in 
the placebo group will be reported.
1.2. Schema
Healthy Adults
18 to ≤49 Years of Age
Visit 1
Day 1:
Vaccination
Visit 2
1-Month
Follow-Up
Randomization 
Ratio
Randomized
(n)
1
250
RSVpreF Group 1a
1 Month
RSVpreF Group 1
1
250
RSVpreF Group 2a
RSVpreF Group 2
1
250
RSVpreF Group 3a
RSVpreF Group 3
1
250
Placebob
Placebo

Blood sampling

Vaccination

Safety assessments

Blood sampling

Safety assessments
a.
RSVpreF Groups 1 through 3 are administered a 120-µg dose of 1 of 3 RSVpreF manufacturing lots.
b.
The placebo group is administered a matching volume containing excipients reconstituted in sterile water 
for injection, containing no RSVpreF antigens.

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1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures. Refer to Study 
Assessments and Procedures in Section 8 for detailed information on each procedure and 
assessment required for compliance with the protocol.
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA
table, in order to conduct evaluations or assessments required to protect the well-being of the 
participant.
Visit Identifier
Visit 1
Visit 2
Visit Description
Vaccination
1-Month 
Follow-Up
Visit Window 
Day 1
28 to 35 Days 
After Visit 1
Type of Visit
Clinic
Clinic
Obtain informed consent
X
Obtain participant number via IRT
X
Obtain demography and medical history data
X
Perform clinical assessment (and physical examination and vital signs if 
deemed necessary)
X
Obtain prevaccination temperature (body)
X
Confirm negative urine (or serum) pregnancy test (for WOCBP)
X
Discuss contraceptive use (as appropriate)
X
Record nonstudy vaccinations
X
X
Review concomitant medication use
X
X
Review inclusion and exclusion criteria and confirm eligibility
X
Review temporary delay criteria
X
Obtain blood sample for antibody assessment 
~20 mLa
~80 mL
Obtain randomization number and product kit assignment from IRT
X
Assist with app download or issue e-diary, issue measuring device and digital 
thermometer; provide e-diary training
X
Study intervention administration
X
Postvaccination observation (30 minutes) and acute immediate reaction 
assessment
X
Provide study participant with emergency contact card
X
Review e-diary data (daily review during the 7 days following vaccination)
X
Review e-diary for ongoing reactogenicity, obtain stop dates, collect e-diary 
X
Record adverse events and serious adverse events and obtain any missing stop 
dates
X
X
Abbreviations: IRT = interactive response technology; WOCBP = women of childbearing potential.
a.
Blood sample must be collected before vaccination.

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2. INTRODUCTION
Pfizer is currently developing a vaccine, RSVpreF, for the prevention of RSV-associated 
LRTI, protecting infants by maternal immunization during pregnancy and protecting adults 
60 years of age and older via direct immunization.
RSV is the leading cause of bronchiolitis and viral pneumonia in infants and can lead to fatal 
respiratory distress, especially in those with risk factors, including premature infants with 
underlying cardiopulmonary disease, or in the absence of effective healthcare systems.1
However, most cases of RSV disease occur in healthy, full-term infants without risk factors.2
Worldwide, RSV kills approximately 118,200 children annually, with about half of those 
deaths occurring in infants under 6 months of age, and the majority of those occurring in 
resource-limited countries.3,4 In the US, RSV is the leading cause of infant hospitalization, 
with more than 60,000 hospitalizations of children 12 months of age and younger annually.5,6
There is increasing evidence that the link between severe RSV disease in infancy and 
wheezing later in childhood may be causal.7,8 Like influenza, RSV infection follows a 
seasonal pattern, causing illness primarily in the cooler months of the year in temperate 
regions and during the wet season in tropical countries with seasonal rainfall.9 Infection is 
essentially universal by the time children reach 2 years of age.10
No specific treatments for RSV exist, and available prophylactic measures (ie, RSV 
monoclonal antibody) are limited to use in only those infants at highest risk; additionally, in 
LMICs, use of available RSV prophylaxis is cost-prohibitive.11,12 While active immunization 
against RSV in infants might be an option, multiple efforts extending over half a century to 
develop a safe and effective RSV vaccine to protect infants from disease have yielded little 
success. The early peak of disease presents a further obstacle to an active vaccination 
strategy for infants. Given these challenges, maternal immunization to protect infants early in 
life offers an attractive strategy for infant disease prevention.
In addition to infants and young children, adults ≥60 years of age are at increased risk of 
RSV infection, which can trigger exacerbations of underlying comorbid conditions such as 
COPD and CHF.13 RSV infection has been associated with up to 22% of acute COPD 
exacerbations in prospective cohort studies and 11% of wintertime hospitalizations for 
COPD exacerbations.14 Current epidemiology shows that RSV is responsible for 
approximately 177,000 hospitalizations and 14,000 deaths annually in US adults 65 years of 
age and older.13 Morbidity is significant among adults hospitalized with RSV disease, with 
18% requiring intensive care, 31% needing home health services at discharge, and 26% 
dying within 1 year of hospitalization.15 In the US, RSV disease incidence rates in older 
adults are approximately half those of influenza, with variation year to year.16 Incidence rate 
and risk for severe complications from RSV infection are higher among 
immunocompromised adults and those with chronic conditions (eg, cardiopulmonary or renal 
disease, hematological malignancies, receipt of chemotherapy, or HIV infection).17,18
However, the burden of adult RSV disease could be underestimated since testing for RSV is 
less common in older adults than in children. RSV disease in adults is also difficult to 
diagnose based on clinical signs and symptoms alone, and, prior to the broader use of more 

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sensitive detection methods, laboratory confirmation of RSV in adults was challenging 
because of low levels of virus shedding.14
RSV disease management in adults is limited to supportive measures such as hydration and 
oxygenation. Aerosolized ribavirin has limited evidence of effectiveness and is 
predominantly restricted to hospitalized severely immunocompromised patients, because of 
inconvenient administration, teratogenicity and anemia concerns, and high cost, making 
vaccination a high priority.18,19
2.1. Study Rationale
The study will contribute data to support the development of RSVpreF as a prophylactic 
vaccine against severe clinical RSV disease in infants through maternal immunization and in 
older adults through preventive vaccination.
To demonstrate equivalence in manufacturing of RSVpreF, this study will examine 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.
2.2. Background
The vaccine investigated in this study is a bivalent RSV prefusion F subunit vaccine 
developed by Pfizer. The RSV F glycoprotein facilitates fusion of the virion and host cell 
membrane through a dramatic transition from an unstable but highly immunogenic prefusion 
conformation to the more stable postfusion state. Preclinical studies show that prefusion F 
elicits much higher neutralizing antibody titers than postfusion F and that the most potent 
neutralizing antibodies from postinfection human sera target the prefusion form. RSVpreF is 
composed of engineered, stabilized, trimeric, prefusion F glycoproteins matching the 
2 subgroups (A and B) to help ensure the broadest coverage against RSV illness.
RSVpreF is being developed for 2 indications: 

Maternal: Prevention of LRTI-RSV in infants by active immunization of pregnant 
women.

Older Adult: Prevention of RSV-associated msLRTI in adults 60 years of age and older 
via active immunization.

As of June 2021, RSVpreF has been studied in 3 completed and 3 ongoing clinical trials 
in healthy adults and pregnant women. RSVpreF was shown to be well tolerated, with an 
acceptable safety profile, and highly efficacious in the human challenge model 
(Section 2.2.1).

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2.2.1. Clinical Overview
Maternal Program Studies
The maternal program includes Phase 2b and 3 studies in pregnant women and a Phase 2b 
study in nonpregnant women.
•
C3671003 is a completed Phase 2b multicenter, randomized, placebo-controlled study in 
up to 650 healthy pregnant women 18 through 49 years of age who received RSVpreF at 
120 μg and 240 μg, formulated with or without Al(OH)3, or placebo. 
 
 
•
C3671004 is a completed Phase 2b study of 713 healthy nonpregnant women 18 through 
49 years of age. A total of 709 participants received 120 μg RSVpreF or 240 μg 
RSVpreF with Al(OH)3 or placebo, administered with or without concomitant Tdap. The 
study demonstrated a good safety and tolerability profile, high immune responses, and 
noninferiority of the responses to RSVpreF when coadministered with Tdap, with RSV A 
and RSV B 50% NT GMRs of 0.97 and 0.96 at 1 month after vaccination.
•
C3671008 is an ongoing Phase 3 study designed to evaluate the efficacy and safety of 
maternal immunization with RSVpreF against medically attended LRTI in infants. 
Healthy women ≤49 years of age who are between 24 and 36 weeks of gestation receive 
either RSVpreF 120 μg or placebo.
 
Adult Program Studies
The older adult program includes 2 Phase 1/2 studies, the human challenge study, and the 
planned Phase 3 study.
•
In the Phase 1/2 study (C3671001), 1233 healthy adults 18 through 49 and 50 through 
85 years of age received the 3 dose levels of RSVpreF (60 μg, 120 μg, and 240 μg), with 
or without Al(OH)3, or placebo, administered with or without concomitant influenza 
vaccine. The results have shown that the vaccine was well tolerated and immunogenic in 
both age groups. RSVpreF elicited robust neutralizing responses against RSV A and 
RSV B 1 month after vaccination for both age groups across all vaccine dose levels and 
formulations; these responses remained high through the 12 months after vaccination. In 
616 vaccinated participants in the 50- through 85-year age group, RSV 50% NT GMFRs 
were high across all arms, ranging from 9 to 13 from before vaccination to 1 month after 
vaccination and from 3 to 4 from before vaccination to 12 months for RSV A and RSV B. 
RSVpreF was safe and well tolerated when administered alone or with SIIV, with no 
major differences observed across all dose levels and formulations. Most reported local 
reactions or systemic events were mild or moderate in severity. The proportions of 
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participants reporting AEs were generally similar across RSVpreF groups, and no SAEs 
were considered related to the investigational vaccine.
•
Phase 1/2 study C3671002, in 250 older adults 65 through 85 years of age, studied the 
3 dose levels of RSVpreF with Al(OH)3, or CpG/Al(OH)3 (60 μg, 120 μg, and 240 μg), 
given as a single dose or on a schedule of 2 doses administered 2 months apart. All 
RSVpreF doses and formulations elicited high RSV A and RSV B neutralizing antibody 
GMTs 1 month after vaccination (GMFRs ranging from 4.8 to 11.6 and 4.5 to 14.1, 
respectively). CpG-containing formulations did not further increase neutralizing GMTs 
compared to RSVpreF with or without Al(OH)3. GMTs in all groups declined, but 
remained higher than baseline (before vaccination) and placebo (SIIV only) at 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.
•
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the 
Safety, Immunogenicity and Efficacy of a Respiratory Syncytial Virus Vaccine (RSVpreF) 
in a Virus Challenge Model in Healthy Adults (NCT04785612) was conducted by hVIVO 
in 70 healthy participants 18 to 50 years of age. Participants received a single dose of 
either 120 μg RSVpreF or placebo, and 4 weeks later underwent intranasal challenge with 
RSV-A Memphis 37b virus. The immunogenicity and efficacy of RSVpreF vaccination 
on virus replication, clinical symptoms, and incidence of symptomatic RSV infection 
were evaluated. The primary analysis of the human challenge study showed that a 
120-μg dose of RSVpreF is well tolerated and has an acceptable safety profile. The study 
has demonstrated 100% efficacy of RSVpreF against RT-PCR–confirmed symptomatic 
respiratory infection in a mild-to-moderate disease model.
•
C3671013 is an ongoing Phase 3, multicenter, randomized, double-blind, 
placebo-controlled study to assess the safety, immunogenicity, and efficacy of Pfizer’s 
RSVpreF in prevention of RSV-associated msLRTI in adults 60 years of age and older 
during the first RSV season and the long-term immunogenicity and efficacy of RSVpreF 
across multiple RSV seasons. Both healthy adults and adults with stable chronic diseases 
are included. Approximately 10% of participants with stable chronic cardiopulmonary 
conditions such as COPD, asthma, or CHF are being enrolled.
 
2.3. Benefit/Risk Assessment
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of RSVpreF may be found in the IB, which is the SRSD for this study.
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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
Local and systemic reactions to 
the vaccine may occur 
(injection site redness, injection 
site swelling, and injection site 
pain; fever, fatigue, headache, 
chills, muscle pain, and joint 
pain) following vaccination.
These are common adverse reactions seen with other vaccines20 as 
well as RSVpreF. The most common events reported in the FIH
C3671001 study were mild to moderate pain at the injection site, 
fatigue, headache, and muscle pain.

The study employs the use of a reactogenicity 
e-diary, which allows the investigator to monitor 
local reactions and systemic events in real time 
through an electronic portal. Severe reactions will 
require an unscheduled telephone call, and visit if 
required, to be conducted per protocol.

All study participants will be observed for at least 
30 minutes after vaccination.
Safety profile of a novel 
vaccine close to being, but not 
yet fully, characterized.
Data available from completed and ongoing studies showed a low 
incidence of severe or serious events, and no clinically concerning 
safety observations. The vaccine appears to be safe and well
tolerated across the safety population and within demographic 
subgroups based on age, sex, and race/ethnicity.

Collection and review of AEs and SAEs 
throughout the study.

All participants will be observed for at least 
30 minutes after vaccination.
Theoretical risk for RSV 
enhancement.
RSVpreF is being evaluated in ongoing clinical studies. Pfizer’s 
immunization approach circumvents the risk of vaccine-mediated 
disease enhancement that was observed in the 1960s following direct 
immunization of RSV-naive infants with an FI-RSV. FI-RSV 
elicited a predominantly nonneutralizing antibody response and a 
Th2-biased cell-mediated response, both of which are considered 
potential contributing factors to disease enhancement. During 
preclinical studies, in a standard cotton rat infectious RSV challenge 
model, FI-RSV showed pathological signs of causing disease 
enhancement, and the current Pfizer vaccine candidate, RSVpreF, 
did not. Most important, RSV vaccine-mediated disease 
enhancement has not been reported to occur in RSV-experienced 
individuals after vaccination with any RSV vaccine candidate. 
Because older adults are universally RSV-experienced, they are not 
considered at risk for a disease-enhancing immune response to the 
vaccine that could exacerbate infection in themselves.

Collection and review of AEs and SAEs 
throughout the study.

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Potential Risk of Clinical 
Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
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.
Participants will be required to 
attend healthcare facilities 
during the global SARS-CoV-2 
pandemic.
Without appropriate social distancing and PPE, there is a potential 
for increased exposure to SARS-CoV-2.

Pfizer will work with sites to ensure appropriate 
COVID-19 prevention strategies.

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2.3.2. Benefit Assessment
Benefit considerations may include:

Potential benefit of receiving study intervention that may have clinical utility in the 
future.

Contributing to the process of developing new therapies in an area of unmet need.

Medical evaluations/assessments associated with study procedures.
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 healthy participants and older participants who may be at risk of RSV.
3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS
Study Objectives, Estimands, and Endpoints
Objectives
Estimands
Endpoints
Primary Immunogenicity
To demonstrate that the immune 
responses induced by 
3 RSVpreF lots (Groups 1, 2,
and 3) 1 month after vaccination 
are equivalent.

The ratio of neutralizing
GMTs obtained 1 month after 
vaccination for every pair of 
RSVpreF lots 
(Group 1/Group 2, 
Group 1/Group 3, 
Group 2/Group 3) for RSV A 
and RSV B neutralization 
assays, in participants 
receiving 1 dose of study 
intervention and in compliance 
with the key protocol criteria 
(evaluable participants).

RSV A and RSV B NTs.

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Study Objectives, Estimands, and Endpoints
Objectives
Estimands
Endpoints
Primary Safety 
To evaluate the safety and 
tolerability profiles of 
3 RSVpreF lots (Groups 1, 2,
and 3).
•
The incidence rate of each 
safety outcome in participants 
receiving 1 dose of the study 
intervention, estimated by the 
percentage of participants 
reporting the event among 
those who receive study 
intervention, in the pooled 
RSVpreF lots and placebo.
•
Local reactions (redness, 
swelling, and pain at the 
injection site) self-reported 
on e-diaries for 7 days after 
vaccination.
•
Systemic events (fever, 
fatigue, headache, vomiting,
nausea, diarrhea, muscle 
pain, and joint pain) 
self-reported on e-diaries for 
7 days after vaccination.
•
AEs from the day of consent 
through study completion.
•
SAEs from the day of 
consent through study 
completion.
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4. STUDY DESIGN
4.1. Overall Design
This Phase 3, multicenter, parallel-group, placebo-controlled, randomized, double-blind 
study will be conducted in the US. Up to 1000 healthy women and men 18 to ≤49 years of 
age will be enrolled.
There are 2 scheduled study visits. Participants will have blood samples for immunogenicity 
assessments collected both prior to vaccination (Visit 1) and 1 month after vaccination
(Visit 2).
Local reactions (redness, swelling, and pain at the injection site) occurring at the RSVpreF or 
placebo injection site and systemic events (fever, fatigue, headache, vomiting, nausea, 
diarrhea, muscle pain, and joint pain) occurring within 7 days after vaccination will be 
prompted for and collected daily by the participant in an e-diary device or smartphone 
application.
AEs and SAEs will be collected from the signing of informed consent through Visit 2.
Number of Participants
Up to 1000 participants will be enrolled in the study. Allowing for a nonevaluable rate of 
approximately 10%, this will provide the required sample size of approximately 
900 participants for the evaluable population analysis. Participants who withdraw or are 
withdrawn from the study after randomization will not be replaced, regardless of the reason 
for withdrawal.
Intervention Groups and Duration
There will be 4 study groups: Group 1, Group 2, Group 3 (representing 3 RSVpreF 
manufacturing lots), and placebo. Up to 1000 participants will be randomly assigned in a 
1:1:1:1 ratio so that each group numbers approximately 250 participants. Each randomized 
participant will receive his or her vaccine assignment, administered as a single IM injection 
into the deltoid muscle (nondominant arm preferred) at Visit 1. Participants and study 
personnel will be blinded to intervention groups and assignments.
The last study visit for each participant will be approximately 1 month after vaccination.
4.2. Scientific Rationale for Study Design
See Section 2.1.
4.2.1. Choice of Contraception/Barrier Requirements
There is no suspicion of human teratogenicity based on the intended pharmacology of the 
compound; however, human reproductive safety data are limited for RSVpreF. Therefore, the 
use of a highly effective method of contraception is required (see Section 10.3).

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4.2.2. Diversity of Study Population
To the extent possible, recruitment attempts will be made to enroll participants so that the 
study demographic profile approximates the general population. Reasonable attempts will be 
made to enroll participants with the distribution of characteristics shown below:
Race
US Census Data21
Target for C3671014
Black or African American
13.4%
Asian
5.9%
American Indian or Alaska Native
1.3%
Native Hawaiian or other Pacific Islander
0.2%
White
76.3%
Ethnicity
US Census Data
Target for C3671014
Hispanic or Latino(a) or of Spanish origin
18.5%
4.3. Justification for Dose
The final dose and formulation of RSVpreF selected for use in this study is based on the 
safety and immunogenicity data from 3 Phase 1/2 studies and the efficacy evaluation in the 
human challenge study.

The FIH study in adults 18 through 85 years of age evaluated the safety, tolerability, and 
immunogenicity of 3 escalating dose levels of 60 μg, 120 μg, and 240 μg, with or without 
Al(OH)3, when administered alone or concomitantly with SIIV (C3671001).

A study in older adults 65 through 85 years of age evaluated the safety, tolerability, and 
immunogenicity of 60-μg, 120-μg, and 240-μg RSVpreF doses formulated with 
Al(OH)3 or CpG/Al(OH)3 adjuvant, or 240 µg RSVpreF with RSV antigens alone, when 
administered concomitantly with SIIV (C3671002).

A study in pregnant women 18 through 49 years of age evaluated the safety, tolerability,
and immunogenicity of 120-µg and 240-μg RSVpreF dose levels with and without 
Al(OH)3 (C3671003).

A study in healthy adults 18 through 50 years of age evaluated the safety, tolerability, 
immunogenicity, and efficacy of 120 µg RSVpreF in a virus challenge model 
(NCT04785612).
Based on the Phase 1/2 studies (C3671001 and C3671002), no substantial differences were 
observed between the immunogenicity or reactogenicity of 120-µg and 240-µg dose levels or 
of formulations with and without Al(OH)3 or CpG/Al(OH)3. Therefore, the 120-µg
without-Al(OH)3 formulation was chosen for the human challenge study. The acceptable 
reactogenicity and safety profile along with the high efficacy demonstrated in the 

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primarily-upper-respiratory-tract and mild-to-moderate disease human challenge model led to 
selection of 120 µg for the RSV Phase 3 studies.
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 when she/he has completed all study 
visits and procedures.
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. Use of a 
prescreener for study recruitment purposes will include collection of information that reflects 
the enrollment of a diverse participant population including, where permitted under local 
regulations, age, sex, race, and ethnicity. The following eligibility criteria are designed to 
select participants for whom participation in the study is considered appropriate. All relevant 
medical and nonmedical conditions should be taken into consideration when deciding 
whether a particular participant is suitable for this protocol.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all the following criteria apply:
Age and Sex:
1. Healthy males or nonpregnant, nonbreastfeeding females between the ages of 18 and 
≤49 years, inclusive, at Visit 1 (Day 1).
Refer to Appendix 3 for reproductive criteria for male (Section 10.3.1) and female 
(Section 10.3.2) participants.
Type of Participant and Disease Characteristics:
2. Participants who are willing and able to comply with scheduled visits, laboratory tests, 
lifestyle considerations, and other study procedures, including daily completion of the 
e-diary for 7 days after study vaccination.
3. Healthy participants as determined by medical history, physical examination (if required), 
and the clinical judgment of the investigator to be eligible for inclusion in the study. 
Participants with preexisting chronic medical conditions determined to be stable in the 
clinical judgment of the investigator may be included.

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Informed Consent:
4. Capable of giving signed informed consent as described in Appendix 1, which includes 
compliance with the requirements and restrictions listed in the ICD and in this protocol.
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. Bleeding diathesis or condition associated with prolonged bleeding time that may 
contraindicate IM injection.
2. History of severe adverse reaction associated with a vaccine and/or severe allergic 
reaction (eg, anaphylaxis) to any component of the study intervention or any related 
vaccine.
3. Unstable chronic medical condition or disease requiring significant change in therapya or 
hospitalization for worsening disease within 3 months before receipt of study 
intervention.
4. Immunocompromised individuals with known or suspected immunodeficiency, as 
determined by history and/or laboratory/physical examination.
5. Known infection with HIV, HCV, or HBV.
6. Other medical or psychiatric condition including recent (within the past year) or active 
suicidal ideation/behavior or laboratory abnormality that may increase the risk of study 
participation or, in the investigator’s judgment, make the participant inappropriate for the
study.
Prior/Concomitant Therapy:
7. Previous vaccination with any licensed or investigational RSV vaccine at any time prior 
to enrollment or planned receipt throughout the study.
8. Receipt of any blood/plasma products or immunoglobulin, from 60 days before study 
intervention administration or planned receipt throughout the study.
                                                
a A change to a new therapy category is considered significant if caused by worsening disease. A change 
in dose or therapy within a therapy category (eg, change from 1 nonsteroidal anti-inflammatory drug [NSAID] 
to another) is not considered significant.

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9. Receipt of monoclonal antibodies from 60 days before study intervention administration 
or planned receipt throughout the study.
10. Receipt of systemic treatment with known immunosuppressant medications within 
60 days before study intervention administration or the use of systemic corticosteroids 
(≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days prior to study 
enrollment. Prednisone use of <20 mg/day for <14 days is permitted. Inhaled/nebulized, 
intra-articular, intrabursal, or topical (skin, eyes, ears) corticosteroids are permitted.
11. 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 locales.
12. Current use of any prohibited concomitant medication(s) or those unwilling/unable to use 
a permitted concomitant medication(s). Refer to Section 6.8.
Prior/Concurrent Clinical Study Experience:
13. Participation in other studies involving investigational drug(s) or investigational vaccines
within 28 days prior to consent and/or during study participation.
Other Exclusions:
14. Pregnant females; breastfeeding females; and WOCBP who are unwilling or unable to 
use a highly effective method of contraception as outlined in the protocol for the duration 
of the study.
15. Men who are unwilling to comply with contraception methods as outlined in the protocol 
for the duration of the study.
16. Investigator site staff or Pfizer employees directly involved in the conduct of the study, 
site staff otherwise supervised by the investigator, and their respective family members.
5.3. Lifestyle Considerations
5.3.1. Contraception
The investigator or his or her designee, in consultation with the participant, will confirm that 
the participant has selected an appropriate method of contraception for the individual 
participant and partner(s) from the permitted list of contraception methods (see Appendix 3,
Section 10.3.4) and will confirm that the participant has been instructed in its consistent and 
correct use. At time points indicated in the SoA, the investigator or designee will inform the 
participant of the need to use highly effective contraception consistently and correctly and 
document the conversation and the participant’s affirmation in the participant’s chart 
(participants need to affirm their consistent and correct use of at least 1 of the selected 
methods of contraception) considering that their risk for pregnancy may have changed since 
the last visit. In addition, the investigator or designee will instruct the participant to call 

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immediately if the selected contraception method is discontinued or if pregnancy is known or 
suspected in the participant or partner.
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently randomly assigned to study intervention. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure participants to meet 
the CONSORT publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes demography, screen failure details, eligibility 
criteria, and any SAE.
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened under a new participant number.
5.5. Criteria for Temporarily Delaying Enrollment/Randomization/Administration of 
Study Intervention
The following conditions may allow a participant to be vaccinated once the conditions have 
resolved and the participant is otherwise eligible:

Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness 
within 48 hours before study intervention administration.

Receipt of any inactivated vaccine or any seasonal or pandemic influenza vaccine
(whether inactivated or LAIV), licensed COVID-19 vaccines, or COVID-19 vaccines 
authorized for temporary or emergency use within 14 days or any live vaccine within 
28 days before study intervention administration.

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 are permitted.
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, medical device(s), or study procedure(s) intended to be administered to a study 
participant according to the study protocol.
For the purposes of this protocol, study intervention refers to the RSVpreF and placebo 
(lyophilized cake containing excipients reconstituted in sterile water for injection, containing 
no RSVpreF antigens).

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6.1. Study Intervention(s) Administered
Intervention Name
RSVpreF
Type
Vaccine.
Dose Formulation
The active ingredients in RSVpreF are 2 stabilized RSV prefusion F antigens, in equal 
amounts from virus subgroups A and B, in a lyophilized dosage form for reconstitution. 
The RSV drug product will be 120 µg of the RSV prefusion F antigen. The drug 
product is supplied as a lyophilized white cake in a 2-mL glass vial, with a 13-mm 
lyophilization stopper, aluminum overseal, and flip-off cap.
The drug product will be reconstituted by a diluent consisting of sterile water in a PFS. 
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 PFS are designed such that the 
intended vaccine dose is delivered by injecting the entire contents of the syringe.
Dosage Level(s)
120 µg RSVpreF by single injection once only.
Route of 
Administration
IM injection into the deltoid muscle of the nondominant arm (preferred).
Use
Experimental.
Sourcing
RSVpreF will be provided by the sponsor to each study site.
Packaging and 
Labeling
The vaccine will be packaged within cartons labeled by Pfizer or its designee in 
accordance with current guidelines and applicable local and legal regulatory 
requirements.
Intervention Name
Placebo
Type
Placebo.
Dose Formulation
The placebo is supplied as a lyophilized white cake in a 2-mL glass vial, with a 13-mm 
lyophilization stopper, aluminum overseal, and flip-off cap. It contains no antigens.
The placebo will be reconstituted by a diluent consisting of sterile water in a PFS. The 
lyophilized cake contains excipients that, after reconstitution, will yield a volume 
matching the RSVpreF.
The fill volume of the placebo vial and diluent PFS is delivered by injecting the entire 
contents of the syringe.
Dosage Level(s)
N/A
Route of 
Administration
IM injection into the deltoid muscle of the nondominant arm (preferred).
Use
Placebo control.
Sourcing
Placebo will be provided by the sponsor to each study site.
Packaging and 
Labeling
The vaccine will be packaged within cartons labeled by Pfizer or its designee in 
accordance with current guidelines and applicable local and legal regulatory 
requirements.

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6.1.1. Administration
Participants will receive 1 dose of study intervention as randomized at the vaccination visit 
(Day 1) in accordance with the study’s SoA. The study intervention will be administered 
intramuscularly by injecting the entire contents of the syringe 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 blinded 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 should be available in accordance with local guidelines for standard 
immunization practices.
Administration of study interventions should be performed by an appropriately qualified, 
GCP-trained, and vaccine-experienced member of the study staff (eg, physician, nurse, 
physician’s assistant, nurse practitioner, pharmacist, or medical assistant) as allowed by 
local, state, and institutional guidance.
Study intervention administration details will be recorded on the CRF and pharmacy/study 
records.
6.1.2. Medical Devices 
In this study, medical devices being deployed are for the reconstitution diluent for the study 
intervention (RSVpreF or placebo). The study intervention supplies are provided in a kit that 
contains the study intervention (RSVpreF or placebo), a PFS containing sterile water, and a 
vial adapter.
Instructions for medical device use are provided in the IP manual.
Medical device deficiencies, including those resulting from malfunctions of the device, must 
be detected, documented, and reported by the study personnel throughout the study.
Please refer to Section 8.3.9 for details.
6.2. Preparation, Handling, Storage, and Accountability
1. The investigator or designee must confirm appropriate temperature conditions have 
been maintained during transit for all study interventions received and any 
discrepancies are reported and resolved before use of the study intervention.
2. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply or administer study intervention. All study 
interventions must be stored in a secure, environmentally controlled, and monitored 
(manual or automated recording) area in accordance with the labeled storage 
conditions with access limited to the investigator and authorized site staff. At a 
minimum, daily minimum and maximum temperatures for all site storage locations 

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must be documented and available upon request. Data for nonworking days must 
indicate the minimum and maximum temperatures since previously documented for 
all site storage locations upon return to business.
3. Any excursions from the study intervention label storage conditions should be
reported to Pfizer upon discovery along with any actions taken. The site should
actively pursue options for returning the study intervention to the storage conditions
described in the labeling, as soon as possible. Once an excursion is identified, the
study intervention must be quarantined and not used until Pfizer provides permission
to use the study intervention. Specific details regarding the definition of an excursion
and information the site should report for each excursion will be provided to the site
in the IP manual.
4. Any storage conditions stated in the SRSD will be superseded by the storage
conditions stated on the label.
5. Study interventions should be stored in their original containers.
6. See the IP manual for storage conditions of the study intervention once reconstituted.
7. The investigator, institution, or the head of the medical institution (where applicable)
is responsible for study intervention accountability, reconciliation, and record
maintenance (ie, receipt, reconciliation, and final disposition records), such as the
IPAL or sponsor-approved equivalent. All study interventions will be accounted for
using a study intervention accountability form/record.
8. Further guidance and information for the final disposition of unused study
interventions are provided in the IP manual. All destruction must be adequately
documented. If destruction is authorized to take place at the investigator site, the
investigator must ensure that the materials are destroyed in compliance with
applicable environmental regulations, institutional policy, and any special instructions
provided by Pfizer.
Upon identification of a product complaint, notify the sponsor within 1 business day of 
discovery as described in the IP manual.
6.2.1. Preparation and Dispensing
See the IP manual for instructions on how to prepare the study intervention for 
administration. Study intervention should be prepared and dispensed by an appropriately 
medically 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 
preparation and dispensing.

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6.3. Measures to Minimize Bias: Randomization and Blinding
6.3.1. Allocation to Study Intervention
Allocation (randomization) of participants to vaccine groups will proceed through the use of 
an IRT system (IWR). The site personnel (study coordinator or specified designee) will be 
required to enter or select information including but not limited to the user’s ID and 
password, the protocol number, and the participant number. The site personnel will then be 
provided with a vaccine assignment, randomization number, and DU or container number 
when study intervention is being supplied via the IRT system. The IRT system will provide a 
confirmation report containing the participant number, randomization number, and DU or 
container number assigned. The confirmation report must be stored in the site’s files.
Study intervention will be dispensed and administered at study Visit 1 summarized in the 
SoA.
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.
6.3.2. Blinding Arrangements
The study is double-blind.
6.3.2.1. Blinding of Study Site Personnel
The participant, study coordinator, and all site staff will be blinded.
Please refer to the IP manual for further details.
6.3.2.2. Blinding of the Sponsor
The majority of sponsor staff will be blinded to study intervention allocation. All laboratory 
testing personnel performing serology assays or diagnostic assays will remain blinded to 
study intervention assigned/received throughout the study.
6.3.3. Breaking the Blind
The IRT will be programmed with blind-breaking instructions. In case of an emergency, the 
investigator has the sole responsibility for determining if unblinding of a participant’s 
vaccine assignment is warranted. Participant safety must always be the first consideration in 
making such a determination. If the investigator decides that unblinding is warranted, the 
investigator should make every effort to contact the sponsor prior to unblinding a 
participant’s vaccine assignment unless this could delay further management of the 
participant. If a participant’s vaccine assignment is unblinded, the sponsor must be notified 
within 24 hours after breaking the blind. The date and reason that the blind was broken must 
be recorded in the source documentation and CRF.
The study-specific IRT reference manual and IP manual will provide the contact information 
and further details on the use of the IRT system.

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6.4. Study Intervention Compliance
When participants are vaccinated at the site, they will receive study intervention directly 
from the investigator or designee, under medical supervision. The date and time of 
vaccination will be recorded in the source documents and in the CRF. The study intervention 
identification details and study participant identification will be checked and confirmed at the 
time of and prior to administration by a second member of the study site staff who is not the 
person administering the vaccine.
The site will complete the required vaccine Preparation Record located in the IP manual. The 
use of the Preparation Record is preferred, but it does not preclude the use of an existing 
appropriate clinical site documentation system. The existing clinical site's documentation 
system should capture all pertinent/required information on the preparation and 
administration of the dose. This may be used in place of the Preparation Record after 
approval from the sponsor and/or designee.
6.5. Dose Modification
This section is not applicable.
6.6. Continued Access to Study Intervention After the End of the Study
No intervention will be provided to study participants at the end of their study participation.
6.7. Treatment of Overdose
For this study, any dose of study intervention greater than 1 dose of study intervention within 
a 24-hour time period will be considered an overdose.
There is no specific treatment for an overdose.
In the event of an overdose, the investigator should:
1. Contact the medical monitor within 24 hours.
2. Closely monitor the participant for any AEs/SAEs.
3. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF.
4. Overdose is reportable to Pfizer Safety only when associated with an SAE.
6.8. Concomitant Therapy
6.8.1. Prohibited Concomitant Vaccinations and Medications

Licensed or nonstudy investigational RSV vaccines are prohibited at any time prior to 
enrollment and thereafter during the course of the study.

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
Investigational vaccines and investigational drugs are prohibited within 28 days prior to 
enrollment and at any time during the study.
6.8.2. Withholding Periods for Concomitant Vaccinations and Medications
Unless considered medically necessary, the following restrictions apply to nonstudy licensed
vaccines and medications as well as COVID-19 vaccines authorized for temporary or 
emergency use:

COVID-19 vaccines may not be given within 14 days before or within 7 days after study 
intervention administration.

Nonstudy inactivated vaccines or seasonal or pandemic influenza vaccine (whether 
inactivated or LAIV) may not be given within 14 days before or within 7 days after study 
intervention administration.

Nonstudy live vaccines should not be given within 28 days before or within 28 days after 
study intervention administration.

Systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days should 
not be given within 28 days before study intervention administration through the
conclusion of study participation.

Chronic systemic treatment with known immunosuppressant medications should not be 
given within 60 days before study intervention administration through the conclusion of 
study participation.

Monoclonal antibodies should not be given within 60 days before study intervention 
administration through the conclusion of study participation.

Blood/plasma products or immunoglobulin should not be given within 60 days before
study intervention administration through the conclusion of study participation.

Prophylactic antipyretics and other pain medication to prevent symptoms associated with 
study intervention administration are not permitted.
6.8.3. Permitted Nonstudy Vaccines and Medications During the Study
The following restrictions apply to permitted vaccines and medications (except when they are 
considered medically necessary):

Licensed or authorized COVID-19 vaccines may be given during the study starting 
7 days after study intervention administration (Day 8).

Nonstudy inactivated vaccines and seasonal or pandemic influenza vaccine (whether 
inactivated or LAIV) may be given on Day 8, where Day 1 is the day of study 
intervention administration.

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
Nonstudy live vaccines may be given starting 28 days after study intervention
administration (Day 29).

Inhaled/nebulized, intra-articular, intrabursal, or topical (eg, skin, eyes) corticosteroids 
are permitted. Short-term use of systemic corticosteroids (equivalent of <20 mg/day of 
prednisone) for <14 days prior to the administration of study intervention is permitted.

The use of antipyretics and other pain medication to treat symptoms associated with 
study intervention administration is permitted.

Medication other than that listed in Section 6.8.1 and Section 6.8.2 required for treatment 
of preexisting stable conditions is permitted.
6.8.4. Recording Nonstudy Vaccinations and Concomitant Medications
Receipt of the following concomitant medications and vaccinations will be recorded in the 
CRF:

All nonstudy vaccinations received from 28 days prior to study enrollment through the
conclusion of study participation.

The following medications, although prohibited (Section 6.8.1), will be collected from 
Visit 1 to the end of the study if required for medical care:
o
Immunosuppressant medications.
o
Monoclonal antibodies.
o
Systemic corticosteroids, ie, oral, IM, or IV. Do not record topical, optic, otic, 
inhaled, intra-articular, or intrabursal corticosteroids.
o
Blood/plasma products or immunoglobulin.
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.
7.1.1. Pregnancy
As this is a single-dose study, in the case of a positive confirmed pregnancy after 
vaccination, the participant may remain in the study and complete study procedures. Any 
pregnancy confirmed prior to randomization will deem the participant as a screen failure.

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7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at his/her own request. Reasons for 
withdrawal from the study may include the following:

Refused further study procedures

Lost to follow-up

Death

Study terminated by sponsor

Adverse events

Physician decision

Protocol deviation

Participant request
The investigator or his or her designee should capture the reason for withdrawal in the CRF 
for all participants.
If the participant withdraws from the study and also withdraws consent (Section 7.2.1) for 
disclosure of future information, no further evaluations should be performed and no 
additional data should be collected. The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.
If a participant withdraws from the study, he/she may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly.
When a participant withdraws from the study because of an SAE, the SAE must be recorded 
on the CRF and reported on the Vaccine SAE Reporting Form.
Lack of completion of all or any of the withdrawal/early termination procedures will not be 
viewed as protocol deviations so long as the participant’s safety was preserved.
Participants who withdraw after randomization will not be replaced.
7.2.1. Withdrawal of Consent
Participants who request to discontinue receipt of study intervention will remain in the study 
and must continue to be followed for protocol-specified follow-up procedures. The only 
exception to this is when a participant specifically withdraws consent for any further contact 
with him or her or persons previously authorized by the participant to provide this 

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information. Participants should notify the investigator in writing of the decision to withdraw 
consent from future follow-up, whenever possible. The withdrawal of consent should be 
explained in detail in the medical records by the investigator, as to whether the withdrawal is 
only from further receipt of study intervention or also from study procedures and/or 
postvaccination study follow-up, and entered on the appropriate CRF page. In the event that 
vital status (whether the participant is alive or dead) is being measured, publicly available 
information should be used to determine vital status only as appropriately directed in 
accordance with local law.
7.3. Lost to Follow-Up
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site.
The following actions must be taken if a participant fails to attend a required study visit:

The site must attempt to contact the participant and reschedule the missed visit as soon as 
possible. Counsel the participant on the importance of maintaining the assigned visit 
schedule and ascertain whether the participant wishes to and/or should continue in the 
study.

Before a participant is deemed lost to follow-up, the investigator or designee must make 
every effort to regain contact with the participant (where possible, 3 telephone calls and, 
if necessary, a certified letter to the participant’s last known mailing address or local 
equivalent methods). These contact attempts should be documented in the participant’s 
medical record.

Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study.
8. STUDY ASSESSMENTS AND PROCEDURES
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures.
The date of birth will be collected to critically evaluate the immune response and safety 
profile by age.
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed.
Safety issues should be discussed with the sponsor immediately upon occurrence or 
awareness to determine whether the participant should continue or discontinue study 
intervention.
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct.

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All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
Every effort should be made to ensure that protocol-required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that may make it unfeasible to perform 
the test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol-required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that he or she has taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner.
For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to study initiation.
8.1. Efficacy and/or Immunogenicity Assessments
8.1.1. Efficacy Assessments
Efficacy assessments are not applicable to this study.
8.1.2. Immunogenicity Assessments
8.1.2.1. Blood Collection
Blood samples for immunogenicity assessments will be collected from all enrolled 
participants prior to study vaccination at Visit 1 (approximately 20 mL per sample) and at 
Visit 2 (1 month after Visit 1) (approximately 80 mL per sample).
Instructions for the collection and handling of biological samples will be provided in the 
laboratory manual. The actual date and time of each sample will be recorded.
The immunogenicity samples must be processed and shipped as indicated in the instructions 
provided to the investigator site to maintain sample integrity. Any deviations from the 
immunogenicity sample-handling procedure (eg, sample collection and processing steps, 
interim storage, or shipping conditions), including any actions taken, must be documented, 
and reported to the sponsor. On a case-by-case basis, the sponsor may make a determination 
as to whether sample integrity has been compromised.
8.1.2.2. RSV Vaccine Antibody Testing
Serum samples will be assayed for RSV A and RSV B serum NTs 
 
CCI

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RSV A and RSV B serum NTs will be determined and reported as the NT.
 
 
Sample collection, processing, storage, and shipping information can be found in the 
laboratory manual. All assays will be performed by Pfizer and/or at a facility designated by 
Pfizer.
8.1.3. Biological Samples
Blood/serum samples will be used only for scientific research. Each sample will be labeled 
with a code so that the laboratory personnel testing the samples will not know the 
participant’s identity. Samples that remain after performing assays outlined in the protocol 
may be stored by Pfizer. Unless a time limitation is required by local regulations or ethical 
requirements, the samples will be stored for up to 15 years after the end of the study and then 
destroyed. If allowed by the ICD, stored samples may be used for additional testing to better 
understand the immune responses to the vaccine(s) under study in this protocol, to inform the 
development of other products, and/or for vaccine-related assay work supporting vaccine 
programs. No sequencing of the participant’s DNA will be performed.
The participant may request that his/her samples, if still identifiable, be destroyed at any 
time; however, any data already collected from those samples will still be used for this 
research. The biological samples may be shared with other researchers as long as 
confidentiality is maintained, and no sequencing of the participant’s DNA is performed.
8.2. Safety Assessments
Participants will be observed for 30 minutes after vaccination and any reactions occurring 
during that time will be recorded as AEs.
Planned time points for all safety assessments are provided in the SoA. Unscheduled clinical 
laboratory measurements may be obtained at any time during the study to assess any 
perceived safety issues.
8.2.1. Physical Examinations
If the clinical assessment indicates that a physical examination is necessary to 
comprehensively evaluate the participant, a physical examination will be performed.
CCI
CCI

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Investigators should pay special attention to clinical signs related to previous serious 
illnesses.
Physical examination findings collected during the study will be considered source data and 
will not be required to be reported, unless otherwise noted. Any untoward physical 
examination findings that are identified during the active collection period and meet the 
definition of an AE or SAE (Section 10.2) must be reported according to the processes in 
Section 8.3.1 to Section 8.3.3.
8.2.2. Vital Signs
The participant’s body temperature will be assessed prior to vaccination.
If the clinical assessment indicates that a physical examination is necessary to
comprehensively evaluate the participant, vital signs should also be evaluated. Record any 
findings in the source documents and, if clinically significant, record on the medical history 
CRF.
8.2.3. Clinical Safety Laboratory Assessments
Clinical safety laboratory assessments will not be collected in this study.
8.2.4. Electronic Diary
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 local reactions, 
systemic events, and oral temperature each evening for 7 days following vaccination (Day 1 
through Day 7, where Day 1 is the day of vaccination).
The e-diary allows recording of these assessments only within a fixed time window each day, 
thus providing the accurate representation of the participant’s experience at that time.
Data on local reactions, systemic events, and oral 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 a secure, restricted
internet-based portal. At intervals agreed to by the vendor and Pfizer, these data will be 
transferred electronically to Pfizer for analysis and reporting. These data do not need to be 
recorded by the investigator in the CRF, except for the following conditions:

If a participant withdraws because of prompted events recorded in the e-diary, the 
event(s) should be recorded on the AE page of the CRF, regardless of whether the 
investigator considers the event(s) to be clinically significant.

The investigator or designee must obtain stop dates for any reactions ongoing on the last 
day that the e-diary was completed. The stop dates should be documented in the source 
documents and the information entered in the CRF. In the event the reaction is ongoing at 
the end of the study, the reaction will be marked as ongoing.

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Investigators (or appropriately qualified designees) are required to review the e-diary data 
online at frequent intervals to evaluate participant compliance and safety. These 
prospectively collected occurrences of local reactions and systemic events are graded as 
described in Table 1, Table 2, and Table 3.
8.2.4.1. Local Reactions – Reactogenicity
Following vaccination (Day 1 through Day 7, 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 symptoms in the e-diary or appropriate device, in the evening.
Redness and swelling will be measured by the participant and recorded in measuring device 
units (range: 1 to 21 and >21; an entry in the e-diary of 21 will denote ≥21) and then 
categorized during analysis as mild, moderate, or severe based on the grading scale in
Table 1. Measuring device units can be converted to centimeters according to the following 
scale: 1 measuring device unit = 0.5 cm. Pain at the injection site will be assessed by the 
participant as absent, mild, moderate, or severe according to the grading scale in Table 1.
If a severe local reaction is reported in the reactogenicity e-diary, a telephone contact should 
occur to ascertain further details and determine whether a site visit is clinically indicated.
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 or documentation from another medically 
qualified source (eg, emergency room or hospital record) or, in the case of pain at the 
injection site only, 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 as an AE/SAE on the CRF. The event will be graded using the AE intensity grading 
scale (Section 10.2.3).
If a local reaction persists beyond the end of the e-diary period, the participant will be 
requested to report that information and/or any new AEs that develop to the investigator. The 
investigator will enter this additional information in the participant’s source notes and CRF.
Table 1.
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

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Table 1.
Grading Scale for Local Reactions
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3
Grade 4a
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 or documentation from another medically qualified source 
(eg, emergency room or hospital record) or, in the case of pain at the injection site only, contact with the 
participant. Grade 4 local reactions will be collected on the AE case report form and assessed by the 
investigator using the AE intensity grading scale detailed in Section 10.2.3.
8.2.4.2. Systemic Events
Following vaccination (Day 1 through Day 7, where Day 1 is the day of vaccination), 
participants will be asked to assess fatigue, headache, vomiting, nausea, diarrhea, muscle 
pain, and joint pain and to record the symptoms in the e-diary that evening. The symptoms 
will be assessed by the participant according to the grading scale in Table 2.
If a severe systemic event is reported in the reactogenicity e-diary, a telephone contact should 
occur to ascertain further details and determine whether a site visit is clinically
indicated.
Only an investigator or qualified designee is able to classify a participant’s systemic event as 
Grade 4, after clinical evaluation of the participant or documentation from another medically 
qualified source (eg, emergency room or hospital record) or 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 as an AE/SAE on the CRF. The event will be 
graded using the AE intensity grading scale (Section 10.2.3).
Further, if a systemic event persists beyond the end of the e-diary period, the participant will 
be requested to report that information and/or any new AEs that develop to the investigator.
The investigator will enter this additional information in the participant’s source notes and 
CRF.
Table 2.
Grading Scale for Systemic Events
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3
Grade 4a
Fatigue
(= tiredness)
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization for 
severe fatigue
Headache
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization for 
severe headache

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Table 2.
Grading Scale for Systemic Events
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3
Grade 4a
Vomiting
1 to 2 times in 
24 hours
>2 times in 24 hours
Requires intravenous 
hydration
Emergency room visit
or hospitalization for 
severe vomiting
Nausea
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization for 
severe nausea
Diarrhea
2 to 3 loose stools in 
24 hours
4 to 5 loose stools in 
24 hours
6 or more loose stools
in 24 hours
Emergency room visit
or hospitalization for 
severe diarrhea
Muscle pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization for 
severe muscle pain
Joint pain
Does not interfere 
with activity
Some interference 
with activity
Prevents daily routine 
activity
Emergency room visit 
or hospitalization for 
severe joint pain
a.
Only an investigator or qualified designee is able to classify a participant’s systemic event as Grade 4, 
after clinical evaluation of the participant or documentation from another medically qualified source 
(eg, emergency room or hospital record) or contact with the participant. Grade 4 systemic reactions will 
be collected on the AE case report form and assessed by the investigator using the AE intensity grading 
scale as detailed in Section 10.2.3.
8.2.4.3. Fever Monitoring
A digital thermometer will be given to the participant with instructions on how to measure 
oral temperature at home. Temperature will be collected in the evening for 7 days following 
vaccination (Day 1 through Day 7, where Day 1 is the day of vaccination) and at any time 
during the 7 days following vaccination that fever is suspected.
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. Temperatures recorded in degrees 
Fahrenheit will be programmatically converted to degrees Celsius and then categorized 
according to the scale shown in Table 3 during analysis.
In the event of a fever on the last day the 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 in the CRF.
If a fever of ≥39.0°C (≥102.1°F) is reported in the reactogenicity e-diary, a telephone contact 
should occur to ascertain further details and determine whether a site visit is clinically 
indicated. Only an investigator or medically qualified person is able to confirm a 
participant’s fever as >40.0°C (>104.0°F). If a participant experiences a confirmed fever 
>40.0°C (>104.0°F), the investigator must immediately notify the sponsor. Grade 4 fevers 
will be collected on the AE CRF and assessed by the investigator using the AE intensity 
grading scale as detailed in Section 10.2.3.

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Table 3.
Ranges for Fever
Mild
Grade 1
Moderate
Grade 2
Severe
Grade 3
Grade 4a
Fever
≥38.0°C to 38.4°C
(100.4-101.1°F)
>38.4°C to 38.9°C
(101.2-102.0°F)
>38.9°C to 40.0°C
(102.1-104.0°F)
>40.0°C
(>104.0°F)
a.
Only an investigator or qualified designee is able to classify a participant’s fever as Grade 4, after clinical 
evaluation of the participant, documentation from another medically qualified source (eg, emergency 
room or hospital record), or contact with the participant. Grade 4 fevers will be collected on the AE case 
report form and assessed by the investigator using the AE intensity grading scale as detailed in 
Section 10.2.3.
8.2.5. Pregnancy Testing
Pregnancy tests may be urine or serum tests but must have a sensitivity of at least 
25 mIU/mL. Pregnancy tests will be performed in WOCBP at the times listed in the SoA, 
immediately before the administration of the vaccine dose. A negative pregnancy test result 
will be required prior to the participant’s receiving the study intervention. Pregnancy tests 
may also be repeated if requested by IRBs/ECs or if required by local regulations. After 
vaccination, in the case of a positive confirmed pregnancy, the vaccinated participant may 
remain in the study for safety and immunogenicity follow-up.
8.3. Adverse Events, Serious Adverse Events, and Other Safety Reporting
The definitions of an AE and an SAE can be found in Appendix 2.
The definitions of device-related safety events (ADEs and SADEs) can be found in 
Appendix 5. 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 (Section 7).
During the active collection period as described in Section 8.3.1, each participant will be 
questioned about the occurrence of AEs in a nonleading manner.
In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up 
information in an expedited fashion.

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8.3.1. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before the participant’s participation in the study (ie, before undergoing 
any study-related procedure and/or receiving study intervention), through to a minimum of 
28 days for AEs and for SAEs, to study completion.
Follow-up by the investigator continues throughout and after the active collection period and 
until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the 
investigator.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant permanently discontinues or temporarily discontinues from the study because 
of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE reported using 
the Vaccine SAE Reporting Form.
Investigators are not obligated to actively seek information on AEs or SAEs after the 
participant has concluded study participation. However, if the investigator learns of any SAE, 
including a death, at any time after a participant has completed the study, and he/she 
considers the event to be reasonably related to the study intervention, the investigator must 
promptly report the SAE to Pfizer using the Vaccine SAE Reporting Form.
8.3.1.1. Reporting SAEs to Pfizer Safety
All SAEs occurring in a participant during the active collection period as described in 
Section 8.3.1 are reported to Pfizer Safety on the Vaccine SAE Reporting Form immediately 
upon awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 2. The investigator will submit any updated SAE data to the sponsor within 
24 hours of it being available.
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.3.1, will be recorded 
on the AE section of the CRF.
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant.
Reporting of AEs and SAEs for participants who fail screening are subject to the CRF 
requirements as described in Section 5.4.

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8.3.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 2.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.3.3. Follow-Up of AEs and SAEs
After the initial AE or SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety.
Further information on follow-up procedures is given in Appendix 2.
8.3.4. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will comply with country-specific regulatory requirements relating to safety 
reporting to the regulatory authority, IRBs/ECs, and investigators.
Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary.
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements.
8.3.5. Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure
Environmental exposure occurs when a person not enrolled in the study as a participant 
receives unplanned direct contact with or exposure to the study intervention. Such exposure 
may or may not lead to the occurrence of an AE or SAE. Persons at risk for environmental 

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exposure include healthcare providers, family members, and others who may be exposed. An 
environmental exposure may include exposure during pregnancy, exposure during 
breastfeeding, and occupational exposure.
Any such exposure to the study intervention under study is reportable to Pfizer Safety within 
24 hours of investigator awareness.
8.3.5.1. Exposure During Pregnancy
An EDP occurs if: 

A female participant is found to be pregnant while receiving or after discontinuing study 
intervention.

A male participant who is receiving or has discontinued study intervention exposes a 
female partner to or around the time of conception.

A female is found to be pregnant while being exposed or having been exposed to study 
intervention due to environmental exposure. Below are examples of environmental EDP:

A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by injection, ingestion, inhalation, or 
skin contact.

A male participant, family member, or healthcare provider who has been exposed to 
the study intervention by injection, ingestion, inhalation, or skin contact then exposes 
his female partner prior to or around the time of conception.
The investigator must report EDP to Pfizer Safety within 24 hours of the investigator’s 
awareness, irrespective of whether an SAE has occurred. The initial information submitted 
should include the anticipated date of delivery (see below for information related to 
termination of pregnancy).

If EDP occurs in a participant, the investigator must report this information to Pfizer 
Safety on the Vaccine SAE Reporting Form and an EDP Supplemental Form, regardless 
of whether an SAE has occurred. Details of the pregnancy will be collected after the start 
of study intervention and until 6 months after study intervention administration.

If EDP occurs in the setting of environmental exposure, the investigator must report 
information to Pfizer Safety using the Vaccine SAE Reporting Form and EDP 
Supplemental Form. Since the exposure information does not pertain to the participant 
enrolled in the study, the information is not recorded on a CRF; however, a copy of the 
completed Vaccine SAE Reporting Form is maintained in the investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome. The investigator will follow the pregnancy until 

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completion (or until pregnancy termination) and notify Pfizer Safety of the outcome as a 
follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural 
integrity of the neonate can be assessed at the time of birth. In the event of a termination, the 
reason(s) for termination should be specified and, if clinically possible, the structural 
integrity of the terminated fetus should be assessed by gross visual inspection (unless 
preprocedure test findings are conclusive for a congenital anomaly and the findings are 
reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly), the investigator should follow the procedures 
for reporting SAEs. Additional information about pregnancy outcomes that are reported to 
Pfizer Safety as SAEs follows: 

Spontaneous abortion including miscarriage and missed abortion.

Neonatal deaths that occur within 1 month of birth should be reported, without regard to 
causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs 
when the investigator assesses the infant death as related or possibly related to exposure 
to the study intervention.
Additional information regarding the EDP may be requested by the sponsor. Further 
follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on 
preterm infants to identify developmental delays). In the case of paternal exposure, the 
investigator will provide the participant with the Pregnant Partner Release of Information 
Form to deliver to his partner. The investigator must document in the source documents that 
the participant was given the Pregnant Partner Release of Information Form to provide to his 
partner.
8.3.5.2. Exposure During Breastfeeding
Exposure during breastfeeding occurs when:

A vaccinated female participant breastfeeds or donates breast milk to an infant or child at 
any time during her participation in the study.

A female is found to be breastfeeding while being exposed or having been exposed to 
study intervention (ie, environmental exposure). An example of environmental exposure 
during breastfeeding is a female family member or healthcare provider who reports that 
she is breastfeeding after having been exposed to the study intervention by injection, 
ingestion, inhalation, or skin contact.
The investigator must report exposure during breastfeeding to Pfizer Safety within 24 hours 
of the investigator’s awareness, irrespective of whether an SAE has occurred. The 
information must be reported using the Vaccine SAE Reporting Form. When exposure 
during breastfeeding occurs in the setting of environmental exposure, the exposure 

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information does not pertain to the participant enrolled in the study, so the information is not 
recorded on a CRF. However, a copy of the completed Vaccine SAE Reporting Form is 
maintained in the investigator site file.
An exposure during breastfeeding report is not created when a Pfizer drug specifically 
approved for use in breastfeeding women (eg, vitamins) is administered in accord with 
authorized use. However, if the infant experiences an SAE associated with such a drug, the 
SAE is reported together with the exposure during breastfeeding.
8.3.5.3. Occupational Exposure
The investigator must report any instance of occupational exposure to Pfizer Safety within 
24 hours of the investigator’s awareness using the Vaccine SAE Reporting Form, regardless 
of whether there is an associated SAE. Since the information about the occupational exposure 
does not pertain to a participant enrolled in the study, the information is not recorded on a 
CRF; however, a copy of the completed Vaccine SAE Reporting Form must be maintained in 
the investigator site file.
8.3.6. Cardiovascular and Death Events
Not applicable.
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable.
8.3.8. Adverse Events of Special Interest
Not applicable.
8.3.9. Medical Device Deficiencies
Medical devices being provided for use in this study are for the purpose of administering the 
study intervention. 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 8.3.1 through 8.3.4 and 
Appendix 2 of the protocol.
8.3.9.1. Time Period for Detecting Medical Device Deficiencies
Medical device deficiencies that result in an incident will be detected, documented, and 
reported during all periods of the study in which the medical device is used.

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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.
The method of documenting medical device deficiencies is provided in Appendix 5.
8.3.9.2. Follow-Up of Medical Device Deficiencies
Follow-up applies to all participants, including those who discontinue study intervention.
The investigator is responsible for ensuring that follow-up includes any supplemental 
investigations as indicated to elucidate the nature and/or causality of the deficiency.
New or updated information will be recorded on a follow-up form with all changes signed 
and dated by the investigator.
8.3.9.3. Prompt Reporting of Device Deficiencies to the Sponsor
When a device deficiency occurs: 
1. The investigator notifies the sponsor by telephone or email within 1 business day of 
determining that the incident meets the protocol definition of a medical device 
deficiency.
2. The device deficiency must be recorded on the Medical Device Complaint form.
3. If an AE (either serious or nonserious) associated with the device deficiency occurs, 
then the AE must be entered into the AE section of the CRF.
4. If an SAE associated with the device deficiency is brought to the attention of the 
investigator, the investigator must immediately notify Pfizer Safety of the SAE (see 
Section 8.3.1.1). All relevant details related to the role of the device in the event must 
be included in the Vaccine SAE Reporting form as outlined in Sections 8.3.1.1 and 
8.3.1.2.
The sponsor will be the contact for the receipt of device deficiency information.
8.3.9.4. Regulatory Reporting Requirements for Device Deficiencies
The investigator will promptly report all device deficiencies occurring with any medical 
device provided for use in the study in order for the sponsor to fulfill the legal responsibility 
to notify appropriate regulatory authorities and other entities about certain safety information 
relating to medical devices being used in clinical studies.

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The investigator, or responsible person according to local requirements (eg, the head of the 
medical institution), will comply with the applicable local regulatory requirements relating to 
the reporting of device deficiencies to the IRB/EC.
8.3.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Exposures to the study intervention under study may occur in clinical trial settings, such as 
medication errors.
Safety Event
Recorded on the CRF
Reported on the Vaccine SAE 
Reporting Form to Pfizer Safety 
Within 24 Hours of Awareness
Medication errors 
All (regardless of whether 
associated with an AE)
Only if associated with an SAE
Medication errors include:

Medication errors involving participant exposure to the study intervention.

Potential medication errors or uses outside of what is foreseen in the protocol that do or 
do not involve the study participant.

The administration of expired study intervention.

The administration of an incorrect study intervention.

The administration of an incorrect dosage.

The administration by an incorrect route.

The administration of study intervention that has undergone temperature excursion from 
the specified storage range, unless it is determined by the sponsor that the study 
intervention under question is acceptable for use.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
In the event of a medication dosing error, the sponsor should be notified within 24 hours.

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Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF.
Medication errors should be reported to Pfizer Safety within 24 hours on a Vaccine SAE 
Reporting Form only when associated with an SAE.
8.4. Pharmacokinetics
Pharmacokinetic parameters are not evaluated in this study.
8.5. Genetics
Genetics (specified analyses) are not evaluated in this study.
8.6. Biomarkers
Biomarkers are not evaluated in this study.
8.7. Immunogenicity Assessments
Immunogenicity assessments are described in Section 8.1.2.
8.8. Health Economics
Health economics/medical resource utilization and health economics parameters are not 
evaluated in this study.
8.9. Study Procedures
8.9.1. 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 his or her designee will also sign and date the ICD. A copy of the signed 
and dated ICD must be given to the participant. The source data must reflect that the 
informed consent was obtained before participation in the study.
It is anticipated that the procedures below will be conducted in a stepwise manner; ensure 
that procedures listed prior to administration of the vaccine are conducted prior to 
vaccination.

Obtain written informed consent from the participant before performing any 
study-specific procedures.

Assign a single participant identifier using the IRT system.

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
Obtain and record the participant demography (including complete date of birth 
[dd-Mmm-YYYY], sex, race, racial designation, and ethnicity). The full date of birth will 
be collected to critically evaluate the immune response and safety profile by age.

Obtain and record any medical history of clinical significance.

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 evaluate vital signs and record any findings in the source documents 
and, if clinically significant, record on the medical history CRF.

Measure and record prevaccination temperature.

Prior to vaccination, perform a urine pregnancy test on WOCBP as described in
Section 8.2.5. Record the result in the source documents. A negative pregnancy test result 
will be required prior to the participant’s receiving the study intervention.

Discuss contraceptive use as described in Section 10.3.4.

Obtain details of any nonstudy vaccinations as described in Section 6.8.

Review concomitant medication use as described in Section 6.8.

Ensure and document that all the inclusion criteria and none of the exclusion criteria are 
met.

Ensure that the participant meets none of the temporary delay criteria as described in 
Section 5.5. If delay criteria are met, reschedule the Visit 1 blood draw and 
randomization/vaccination for a later date.

Prior to vaccination, collect a blood sample of approximately 20 mL for antibody 
assessment.

Obtain the participant’s randomization number and study intervention kit number using 
the IRT system. Refer to the IRT manual for further instructions on this process.

Issue a measuring device to measure local reactions at the injection site and a 
thermometer for recording daily temperatures.

Explain the e-diary technologies available for this study (Section 8.2.3), and assist the 
participant in downloading the e-diary application onto the participant’s own device or, if 
required, issue a sponsor-provisioned e-diary.

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
Work with the participant to set up the device/e-diary and provide training on daily 
e-diary completion. Ask the participant to complete the reactogenicity e-diary each 
evening between 6 pm and midnight, starting on Day 1 and completing on Day 7, where
Day 1 is the day of vaccination.

Qualified site staff member(s) will administer a single dose of study intervention into the 
deltoid muscle of the nondominant arm (preferred arm).

Observe the participant for any acute reactions for at least 30 minutes after study 
intervention administration. Record any acute reactions including the time of onset, in the 
participant’s source documents, on the AE page of the CRF, and on the Vaccine SAE 
Reporting Form if applicable.

Provide the participant with an ECC and instruct the participant on its use.

Ask the participant to contact the site staff or investigator immediately if he/she 
experiences any of the following reactions from Day 1 to Day 7 after vaccination (where 
Day 1 is the day of vaccination) to determine if an unscheduled reactogenicity visit is 
required (Section 8.9.3):
Fever ≥39.0°C (≥102.1°F).
Redness or swelling at the injection site measuring >20 measuring device units 
(greater than 10 cm).
Severe pain at the injection site.
Any severe systemic event.
OR

Any emergency room attendance or hospitalization.

Advise the participant that study staff may contact him or her to obtain additional 
information on events entered in the e-diary.

Advise the participant to inform the study staff of any AEs and SAEs that occur for the 
duration of the study as described in Section 8.3.

Request that the participant bring the completed e-diary to the next visit.

Complete the source documents.

The investigator or an authorized designee completes the CRFs and the blinded 
dispenser/administrator completes the study intervention accountability records.

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
The investigator or appropriately qualified designee reviews the daily e-diary data online 
following vaccination to evaluate participant compliance and as part of the ongoing 
safety review.
8.9.2. Visit 2 – 1-Month Follow-Up (Clinic, 28 to 35 Days After Visit 1)

Record details of any nonstudy vaccinations and concomitant medications as described in 
Section 6.8.

Collect a blood sample of approximately 80 mL for antibody assessment.

Review the participant’s e-diary data. Collect stop dates of any e-diary events ongoing on 
the last day that the e-diary was completed and record stop dates in the CRF. Collect any 
sponsor-provisioned e-diary.

Record AEs and SAEs as described in Section 8.3. Obtain and record any missing AE 
stop dates.

Complete the source documents.

The investigator or an authorized designee completes the CRF.
8.9.3. Unscheduled Reactogenicity Visits for a Grade 3 or Suspected Grade 4 Reaction
If a severe local reaction (Section 8.2.4.1), severe systemic event (Section 8.2.4.2), or fever
≥39.0°C (≥102.1°F) (Section 8.2.4.3) is reported in the e-diary, a telephone contact should 
occur to ascertain further details and determine whether a site visit is clinically indicated. If a 
suspected Grade 4 local reaction, systemic event, or fever is reported in the reactogenicity 
e-diary, a telephone contact or site visit should occur to confirm whether the event meets the 
criteria for Grade 4.
A site visit or referral to a healthcare facility should be scheduled as soon as possible to 
assess the extent of the reaction, unless:

The participant is unable to attend the unscheduled visit, or

The reaction is no longer present at the time of the contact, or

The participant recorded an incorrect value in the e-diary (confirmation of an e-diary data 
entry error), or

The investigator or appropriate designee determines that an unscheduled visit 
(Section 8.9.3) is not required.
This contact will be recorded in the participant’s source notes and in the CRF.
Any ongoing reactions must be assessed at the next scheduled visit.

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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 body temperature and record any fever (Table 3).
•
If present, measure the minimum and maximum diameters of redness at the injection site.
•
If present, measure the minimum and maximum diameters of swelling at the injection 
site.
•
Assess any injection site pain in accordance with the reactogenicity grading scale 
provided in Table 1.
•
Assess any systemic events (fatigue, headache, vomiting, nausea, diarrhea, muscle pain, 
or joint pain) that are present in accordance with the reactogenicity grading scale 
provided in Table 2.
•
Assess for other findings associated with the reaction and record on the AE page of the 
CRF, if appropriate.
•
Record AEs and SAEs as described in Section 8.3.1.2.
•
Complete the participant’s source documents.
•
The investigator or an authorized designee will complete the 
unscheduled-visit-assessment CRF.
9. STATISTICAL CONSIDERATIONS
Methodology for summary and statistical analyses of the data collected in this study is 
described here and further detailed in the SAP, which will be maintained by the sponsor. The 
SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment.
9.1. Statistical Hypotheses
9.1.1. Estimands
The estimands corresponding to each primary 
 objective are described in 
Section 3.
The estimands to evaluate the immunogenicity objectives are based on the evaluable 
immunogenicity population (Section 9.2). These estimands estimate the vaccine effect in the 
hypothetical settings where participants follow the study schedules and protocol requirements 
as directed. Missing serology results will not be imputed, as MCAR is assumed.
CCI

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In the primary safety objective evaluations, completely missing reactogenicity e-diary data 
will not be imputed. Missing AE dates will be imputed according to Pfizer safety rules. No 
other missing information will be imputed in the safety analysis.
9.1.2. Statistical Hypotheses
This study has 1 primary immunogenicity objective, which is to demonstrate that the immune 
responses for RSV A and RSV B induced by 3 lots of RSVpreF are equivalent. The objective 
will be evaluated at 1 month after vaccination for RSV A and RSV B using the evaluable 
immunogenicity population.
The null hypothesis (H0) for lot consistency for RSV A and RSV B is as follows:
H0: |ln(μ1) - ln(μ2)| ≥ln(1.5) or |ln(μ1) - ln(μ3)| ≥ln(1.5) or |ln(μ2) - ln(μ3)| ≥ln(1.5)
where ln(1.5) corresponds to a 1.5-fold equivalence margin, and ln(μ1), ln(μ2), and ln(μ3)
are the natural log of the geometric mean of RSV antigen-specific NTs from participants 
receiving RSVpreF in Group 1, Group 2, and Group 3, respectively, measured 1 month after 
vaccination.
Lot consistency will be declared if the 2-sided 95% CI for the ratio of GMTs for every pair of 
RSVpreF lots is contained in the interval (0.667, 1.5), for both antigens simultaneously.
9.1.3. Multiplicity Adjustment
No multiplicity adjustment will be applied for this study. The primary objective of 
equivalence will be achieved only if the 1.5-fold equivalence criterion is met for every pair of 
between-lot comparisons from 3 lots and for both RSV A and RSV B antigens 
simultaneously. Each of the 6 statistical tests (3 pairwise comparisons between lots × 2 RSV 
antigens) will use a 2-sided alpha level of 0.05.
9.2. Analysis Sets
Population
Description
Enrolled 
All participants who sign the ICD.
Randomly assigned to study 
intervention
All participants who are assigned a randomization number in the IRT system.
Evaluable immunogenicity
All participants who are eligible, receive the study intervention to which they 
were randomized, have valid and determinate immunogenicity result from the 
blood sample collected within an appropriate window at 1 month after 
vaccination, and have no major protocol violations.
mITT
All randomized participants who receive study intervention and have at least 1 
valid and determinate assay result after vaccination.
Safety
All randomized participants who receive study intervention.

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9.3. Statistical Analyses
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data. 
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints.
9.3.1. General Considerations
Unless stated otherwise, “vaccine group” in this section refers to participants receiving any 1 
of the 3 RSVpreF lots or placebo. CIs for all endpoints in the statistical analysis will be 
presented as 2-sided at the 95% level unless specified otherwise.
For all the immunogenicity endpoints, the analysis will be based on the evaluable 
immunogenicity population. An additional analysis will be performed based on the mITT 
population if there is a large enough difference in sample size between the mITT population 
and the evaluable immunogenicity population. Participants will be summarized according to 
the vaccine group to which they were randomized.
The safety analyses will be based on the safety population. Participants will be summarized
by vaccine group according to the study interventions they actually received.
9.3.1.1. Analyses for Binary Data
Descriptive statistics for categorical variables (eg, proportions) are the percentage (%), the 
numerator (n) and the denominator (N) used in the percentage calculation, and the 95% CIs 
where applicable.
The exact 95% CI for binary endpoints for each group will be computed using the 
F distribution (Clopper-Pearson).
9.3.1.2. Analyses for Continuous Data
Unless otherwise stated, descriptive statistics for continuous variables are n, mean, median, 
SD, minimum, and maximum.
9.3.1.2.1. Geometric Mean Ratios
The GMRs will be calculated as the mean of the difference of logarithmically transformed 
assay results between 2 vaccine groups and exponentiating the mean. Two-sided CIs will be 
obtained by calculating CIs using Student’s t-distribution for the mean difference of the 
logarithmically transformed assay results and exponentiating the confidence limits.
9.3.1.2.2. Geometric Means
The geometric means will be calculated as the mean of the assay results after making the 
logarithm transformation and then exponentiating the mean to express results on the original 
scale. Two-sided 95% CIs will be obtained by taking log transforms of assay results, 

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calculating the 95% CI with reference to Student’s t-distribution, and then exponentiating the 
confidence limits.
9.3.2. Primary Endpoint(s)
Endpoint
Statistical Analysis Methods
Immunogenicity
GMRs of RSV NTs for each between-lot comparison (Group 1/Group 2, 
Group 1/Group 3, and Group 2/Group 3) for RSV A and RSV B at 
1 month after vaccination will be provided along with associated 2-sided 
95% CIs (Section 9.3.1.2.1).
Using a 1.5-fold equivalence margin, lot consistency will be declared if 
the 2-sided 95% CI for each GMR is contained in the interval 
(0.667, 1.5).
CCI

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Endpoint
Statistical Analysis Methods
Safety
Descriptive statistics will be provided for each reactogenicity endpoint 
in the pooled RSVpreF lots (Groups 1, 2, and 3) and placebo. Local 
reactions (redness, swelling, and pain at the injection site) and systemic 
events (fever, fatigue, headache, vomiting, nausea, diarrhea, muscle 
pain, and joint pain) from Day 1 through Day 7 after vaccination will be 
presented by severity and cumulatively across severity levels. 
Descriptive summary statistics will include counts and percentages of 
participants with the indicated endpoint and the associated 
Clopper-Pearson 95% CIs (Section 9.3.1.1).
AEs and SAEs will be categorized according to MedDRA terms. 
Counts, percentages, and the associated Clopper-Pearson 95% CIs of 
AEs and SAEs after vaccination will be provided for the pooled 
RSVpreF lots and placebo.
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 percentage of 
participants reporting the events between the pooled RSVpreF lots and 
placebo will be calculated using the test statistic proposed by Miettinen 
and Nurminen;22 in addition, for Tier 1 events, the asymptotic p-values 
will also be presented for the difference in percentage of participants 
reporting the events, based on the same test statistic and under the 
assumption that the test statistic is asymptotically normally distributed. 
There is no preidentified Tier 1 event for this study. A MedDRA 
preferred term is defined as a Tier 2 event if its incidence is at least 1% 
in the pooled RSVpreF group or in the placebo group. 
9.3.3. Secondary Endpoint(s)
Not applicable.

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9.4. Interim Analyses
No formal interim analysis will be conducted for this study. Only 1 analysis will be 
performed at the completion of the study.
9.5. Sample Size Determination
Table 4 presents the power to demonstrate that the immune responses induced by 3 lots of 
RSVpreF are equivalent in regard to the 2 RSV antigens.
Pairwise lot-consistency comparisons will be based on the GMRs and the corresponding 95% 
CIs. For both antigens, it is assumed that true differences between lots are not larger than 0
(on the natural log scale). The SDs of the log titers for RSV A and RSV B are based on Study 
C3671001 data.
With 225 evaluable participants per vaccine group and the above assumptions, the power is 
93.3% for declaring the overall equivalence of the 3 RSVpreF lots for both RSV A and 
RSV B.
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Allowing for a nonevaluable rate of approximately 10%, up to 1000 participants will be 
enrolled in the study to provide the required sample size of approximately 900 participants 
for the evaluable population analysis. Participants who withdraw or are withdrawn from the 
study after randomization will not be replaced, regardless of the reason for withdrawal.
Table 4.
Power for the Primary Immunogenicity Objective (Lot Consistency)
Endpoint
Within-Lot 
SD (Log 
Scale)a
Maximum Lot 
Difference
(Log Scale)
Consistency 
Margin
Number of Evaluable 
Participants per 
Vaccine Group
Power to 
Declare 
Consistencyb
RSV A
0.96
0
1.5-fold
225
98.5%
RSV B
1.07
0
1.5-fold
225
94.7%
Overall power to declare consistency for RSV A and RSV B simultaneously
93.3%
a.
The reference study is C3671001.
b.
The power to declare equivalence between all 3 pairwise comparisons assuming a mean difference of 0 
between any 2 RSVpreF lots, at a 0.05 alpha level (2-sided).

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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:

Consensus ethical principles derived from international guidelines, including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines;

Applicable ICH GCP guidelines;

Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents 
(eg, advertisements) must be reviewed and approved by the sponsor, submitted to an IRB/EC 
by the investigator, and reviewed and approved by the IRB/EC before the study is initiated.
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard to 
study participants.
The investigator will be responsible for the following:

Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC;

Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures;

Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH GCP guidelines, the IRB/EC, European regulation 
536/2014 for clinical studies (if applicable), European Medical Device Regulation 
2017/745 for clinical device research (if applicable), and all other applicable local 
regulations.
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 study and for 
1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or his/her representative will explain the nature of the study, including the 
risks and benefits, to the participant and answer all questions regarding the study. The 
participant should be given sufficient time and opportunity to ask questions and to decide 
whether or not to participate in the trial.
Participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, 
local regulations, ICH guidelines, privacy and data protection requirements, where 
applicable, and the IRB/EC or study center.
The investigator must ensure that each study participant is fully informed about the nature 
and objectives of the study, the sharing of data related to the study, and possible risks 
associated with participation, including the risks associated with the processing of the 
participant’s personal data.
The participant must be informed that his/her personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant.
The participant must be informed that his/her medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/EC members, and by inspectors from regulatory authorities.
The investigator further must ensure that each study participant is fully informed about his or 
her right to access and correct his or her personal data and to withdraw consent for the 
processing of his or her personal data.
The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date on which the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICD.

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Participants must be reconsented to the most current version of the ICD(s) during their 
participation in the study.
A copy of the ICD(s) must be provided to the participant.
Participants who are rescreened may be required to sign a new ICD as per IRB, local 
regulations, etc.
10.1.4. Data Protection
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data.
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password-protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible for 
determining whether a personal data breach has in fact occurred and, if so, providing breach 
notifications as required by law.
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to his or her actual identity and medical record ID. In case of 
data transfer, the sponsor will protect the confidentiality of participants’ personal data 
consistent with the clinical study agreement and applicable privacy laws.
10.1.5. Committees Structure
10.1.5.1. Data Monitoring Committee 
This study will not use a DMC.
10.1.6. Dissemination of Clinical Study Data
Pfizer fulfills its commitment to publicly disclose clinical study results through posting the 
results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT, and/or 
www.pfizer.com, and other public registries in accordance with applicable local 
laws/regulations. In addition, Pfizer reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs.
In all cases, study results are reported by Pfizer in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.

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www.clinicaltrials.gov
Pfizer posts clinical trial results on www.clinicaltrials.gov for Pfizer-sponsored interventional 
studies (conducted in patients) that evaluate the safety and/or efficacy of a product, 
regardless of the geographical location in which the study is conducted. These results are 
submitted for posting in accordance with the format and timelines set forth by US law.
EudraCT
Pfizer posts clinical trial results on EudraCT for Pfizer-sponsored interventional studies in 
accordance with the format and timelines set forth by EU requirements.
www.pfizer.com
Pfizer posts public disclosure synopses (CSR synopses in which any data that could be used 
to identify individual participants have been removed) on www.pfizer.com for 
Pfizer-sponsored interventional studies at the same time the corresponding study results are 
posted to www.clinicaltrials.gov.
Documents within marketing authorization packages/submissions
Pfizer complies with the European Union Policy 0070, the proactive publication of clinical 
data to the EMA website. Clinical data, under Phase 1 of this policy, includes clinical 
overviews, clinical summaries, CSRs, and appendices containing the protocol and protocol 
amendments, sample CRFs, and statistical methods. Clinical data, under Phase 2 of this 
policy, includes the publishing of individual participant data. Policy 0070 applies to new 
marketing authorization applications submitted via the centralized procedure since 
01 January 2015 and applications for line extensions and for new indications submitted via 
the centralized procedure since 01 July 2015.
Data sharing
Pfizer provides researchers secure access to patient-level data or full CSRs for the purposes 
of “bona-fide scientific research” that contributes to the scientific understanding of the 
disease, target, or compound class. Pfizer will make data from these trials available 
24 months after study completion. Patient-level data will be anonymized in accordance with 
applicable privacy laws and regulations. CSRs will have personally identifiable information 
redacted.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.

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10.1.7. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document.
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password protected or secured in a locked room to 
prevent access by unauthorized third parties.
QTLs are predefined parameters that are monitored during the study. Important deviations 
from the QTLs and any remedial actions taken will be summarized in the clinical study 
report.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source data documents. This 
verification may also occur after study completion. It is important that the investigator(s) and 
their relevant personnel are available during the monitoring visits and possible audits or 
inspections and that sufficient time is devoted to the process.
Monitoring details describing strategy, including definition of study-critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques 
(central, virtual, or on-site monitoring), are provided in the data management plan and 
monitoring plan maintained and utilized by the sponsor or designee.
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data.
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained.
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems.

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The investigator(s) will notify the sponsor or its agents immediately of any regulatory retain 
notification in relation to the study. Furthermore, the investigator will cooperate with the 
sponsor or its agents to prepare the investigator site for the inspection and will allow the 
sponsor or its agent, whenever feasible, to be present during the inspection. The investigator 
site and investigator will promptly resolve any discrepancies that are identified between the 
study data and the participant's medical records. The investigator will promptly provide 
copies of the inspection findings to the sponsor or its agent. Before response submission to 
the regulatory authorities, the investigator will provide the sponsor or its agents with an 
opportunity to review and comment on responses to any such findings.
10.1.8. Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator site.
Data reported on the CRF or entered in the eCRF that are from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available.
Definition of what constitutes source data and its origin can be found in the monitoring plan, 
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 data) that supports the 
information entered in the CRF.
Study monitors will perform ongoing source data verification to confirm that data entered 
into the CRF by authorized site personnel are accurate, complete, and verifiable from source 
documents; that the safety and rights of participants are being protected; and that the study is 
being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP guidelines, and all applicable regulatory requirements.
10.1.9. Study and Site Start and Closure
The study start date is the date on which the clinical study will be open for recruitment of 
participants.
The first act of recruitment is the date of the first participant’s first visit and will be the study 
start date.
The sponsor designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed.

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The investigator may initiate study-site closure at any time upon notification to the sponsor 
or designee/CRO if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:

Failure of the investigator to comply with the protocol, the requirements of the IRB/EC 
or local health authorities, the sponsor's procedures, or the ICH GCP guidelines.

Inadequate recruitment of participants by the investigator.

Discontinuation of further study intervention development.
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights.
10.1.10. Publication Policy
The results of this study may be published or presented at scientific meetings by the 
investigator after publication of the overall study results or 1 year after the end of the study 
(or study termination), whichever comes first.
The investigator agrees to refer to the primary publication in any subsequent publications, 
such as secondary manuscripts, and submits all manuscripts or abstracts to the sponsor 
30 days before submission. This allows the sponsor to protect proprietary information and to 
provide comments, and the investigator will, on request, remove any previously undisclosed 
confidential information before disclosure, except for any study or Pfizer intervention-related 
information necessary for the appropriate scientific presentation or understanding of the 
study results.
For all publications relating to the study, the investigator will comply with recognized ethical 
standards concerning publications and authorship, including those established by the 
International Committee of Medical Journal Editors.
The sponsor will comply with the requirements for publication of the overall study results 
covering all investigator sites. In accordance with standard editorial and ethical practice, the 
sponsor will support publication of multicenter studies only in their entirety and not as 
individual site data. In this case, a coordinating investigator will be designated by mutual 
agreement.

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Authorship of publications for the overall study results will be determined by mutual 
agreement and in line with International Committee of Medical Journal Editors authorship 
requirements.
If publication is addressed in the clinical study agreement, the publication policy set out in 
this section will not apply.
10.1.11. Sponsor’s Qualified Medical Personnel
The contact information for the sponsor's appropriately qualified medical personnel for the 
study is documented in the study contact list located in the supporting study 
documentation/study portal or other electronic system.
To facilitate access to appropriately qualified medical personnel for study-related medical 
questions or problems, participants are provided with an Emergency Contact Card (ECC) at 
the time of informed consent. The ECC contains, at a minimum, (a) protocol and study 
intervention identifiers, (b) participant’s study identification number, (c) site emergency 
phone number active 24 hours/day, 7 days per week, and (d) Pfizer Call Center number.
The ECC is intended to augment, not replace, the established communication pathways 
between the investigator, site staff, and study team. The ECC is to be used by healthcare 
professionals not involved in the research study only, as a means of reaching the investigator 
or site staff related to the care of a participant. The Pfizer Call Center number should only be 
used when the investigator and site staff cannot be reached. The Pfizer Call Center number is 
not intended for use by the participant directly; if a participant calls that number directly, he 
or she will be directed back to the investigator site.

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

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

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

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

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When an AE or SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostic reports) 
related to the event.
The investigator will then record all relevant AE or SAE information in the CRF.
It is not acceptable for the investigator to send photocopies of the participant’s medical 
records to Pfizer Safety in lieu of completion of the Vaccine SAE Reporting Form/AE
or SAE CRF page.
There may be instances when copies of medical records for certain cases are requested 
by Pfizer Safety. In this case, all participant identifiers, with the exception of the 
participant number, will be redacted on the copies of the medical records before 
submission to Pfizer Safety.
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE or SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported during 
the study and assign it to 1 of the following categories:
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.

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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 his/her assessment.
For each AE or SAE, the investigator must document in the medical notes that he/she 
has reviewed the AE or SAE and has provided an assessment of causality.
There may be situations in which an SAE has occurred, and the investigator has minimal 
information to include in the initial report to the sponsor. However, it is very important 
that the investigator always make an assessment of causality for every event before 
the initial transmission of the SAE data to the sponsor.
The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality assessment.
The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.
If the investigator does not know whether or not the study intervention caused the event, 
then the event will be handled as “related to study intervention” for reporting purposes, 
as defined by the sponsor. In addition, if the investigator determines that an SAE is 
associated with study procedures, the investigator must record this causal relationship in 
the source documents and CRF, and report such an assessment in the dedicated section 
of the Vaccine SAE Reporting Form and in accordance with the SAE reporting 
requirements.
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.

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10.2.4. Reporting of SAEs
SAE Reporting to Pfizer Safety via an Electronic Data Collection Tool

The primary mechanism for reporting an SAE to Pfizer Safety will be the electronic data 
collection tool.

If the electronic system is unavailable, then the site will use the paper SAE data 
collection tool (see next section) to report the event within 24 hours.

The site will enter the SAE data into the electronic system as soon as the data become 
available.

After the study is completed at a given site, the electronic data collection tool will be 
taken off-line to prevent the entry of new data or changes to existing data.

If a site receives a report of a new SAE from a study participant or receives updated data 
on a previously reported SAE after the electronic data collection tool has been taken 
off-line, then the site can report this information on a paper SAE form (see next section) 
or to Pfizer Safety by telephone.
SAE Reporting to Pfizer Safety via Vaccine SAE Reporting Form

Facsimile transmission of the Vaccine SAE Reporting Form is the preferred method to 
transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, notification by telephone is 
acceptable with a copy of the Vaccine SAE Reporting Form sent by overnight mail or 
courier service.

Initial notification via telephone does not replace the need for the investigator to 
complete and sign the Vaccine SAE Reporting Form pages within the designated 
reporting time frames.

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

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

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1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device.
3. Intrauterine hormone-releasing system.
4. Bilateral tubal occlusion (eg, bilateral tubal ligation).
5. Vasectomized partner:

A vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the woman of childbearing potential and the 
absence of sperm has been confirmed. If not, an additional highly effective method of 
contraception should be used. The spermatogenesis cycle is approximately 90 days.
6. Combined (estrogen- and progestogen-containing) hormonal contraception associated 
with inhibition of ovulation:

Oral;

Intravaginal;

Transdermal.
7. Progestogen-only hormone contraception associated with inhibition of ovulation:

Oral;

Injectable.
8. Sexual abstinence:

Sexual abstinence is considered a highly effective method only if defined as 
refraining from heterosexual intercourse during the entire period of risk associated 
with the study intervention. The reliability of sexual abstinence needs to be evaluated 
in relation to the duration of the study and the preferred and usual lifestyle of the 
participant.
9. Progestogen-only oral hormonal contraception where inhibition of ovulation is not the 
primary mode of action.
10. Male or female condom with or without spermicide.
11. Cervical cap, diaphragm, or sponge with spermicide.
12. A combination of male condom with either cervical cap, diaphragm, or sponge with 
spermicide (double-barrier methods).

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

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

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

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

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

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Follow-Up of Medical Device Deficiency

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations, as medically indicated or as requested by the 
sponsor to elucidate the nature and/or causality of the device deficiency as fully as 
possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.

New or updated information regarding the nature of the device deficiency will be 
recorded in the originally completed Medical Device Complaint form.

New or updated information regarding any SAE that was potentially associated with 
the medical device deficiency will be submitted to Pfizer Safety on the Vaccine SAE
Reporting Form within 24 hours of receipt of the information, according to the 
requirements provided in Appendix 2, Section 10.2.
10.5.5. Reporting of SAEs
Reporting of an SAE to Pfizer Safety must be performed according to the processes 
described in Appendix 2 (Section 10.2.4).
10.5.6. Reporting of SADEs
SADE Reporting to Pfizer Safety
Note: There are additional reporting obligations for medical device deficiencies that are 
potentially related to SAEs (ie, a SADE) that must fulfill the legal responsibility to notify 
appropriate regulatory authorities and other entities about certain safety information relating 
to medical devices being used in clinical studies.

Any device deficiency that is associated with an SAE must be reported to the 
sponsor within 24 hours after the investigator determines that the event meets the 
definition of a device deficiency.

The sponsor shall review all device deficiencies and determine and document in 
writing whether they could have led to an SAE. These shall be reported to the 
regulatory authorities and IRBs/ECs as required by national regulations.

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10.6. Appendix 6: Alternative Measures During Public Emergencies
The alternative study measures described in this section are to be followed during public 
emergencies, including the COVID-19 pandemic. This appendix applies for the duration of 
the COVID-19 pandemic globally and will become effective for other public emergencies 
only upon written notification from Pfizer.
Use of these alternative study measures is expected to cease upon the return of business as 
usual (including the lifting of any quarantines and travel bans/advisories).
10.6.1. Telehealth Visits
In the event that in-clinic study visits cannot be conducted, every effort should be made to 
follow up on the safety of study participants at scheduled visits per the Schedule of 
Activities or unscheduled visits. Telehealth visits may be used to continue to assess 
participant safety and collect data points. Telehealth includes the exchange of healthcare 
information and services via telecommunication technologies (eg, audio, video, 
video-conferencing software) remotely, allowing the participant and the investigator to 
communicate on aspects of clinical care, including medical advice, reminders, education, and 
safety monitoring. The following assessments must be performed during a telehealth visit:

Review and record any AEs and SAEs since the last contact. Refer to Section 8.3.

Obtain details of any nonstudy vaccinations, concomitant medications, and treatments 
as described in Section 6.8.

Confirm that the participant is adhering to the contraception method(s) required in the 
protocol.
Study participants must be reminded to promptly notify site staff about any change in their 
health status.

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10.7. Appendix 7: Abbreviations
The following is a list of abbreviations that may be used in the protocol.
Abbreviation
Term
ADE
adverse device effect
AE
adverse event
Al(OH)3
aluminum hydroxide
ALT
alanine aminotransferase
AST
aspartate aminotransferase
CBER
Center for Biologics Evaluation and Research
CFR
Code of Federal Regulations
CHF
congestive heart failure
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CONSORT
Consolidated Standards of Reporting Trials
COPD
chronic obstructive pulmonary disease
COVID-19
coronavirus disease 2019
CRF
case report form
CRO
contract research organization
CSR
clinical study report
DILI
drug-induced liver injury
dLIA
direct-binding Luminex immunoassay
DMC
data monitoring committee
DNA
deoxyribonucleic acid
DU
dispensable unit
EC
ethics committee
ECC
emergency contact card
ECG
electrocardiogram
eCRF
electronic case report form
EDB
exposure during breastfeeding
e-diary
electronic diary
EDP
exposure during pregnancy
EMA
European Medicines Agency
EU
European Union
EudraCT
European Clinical Trials Database
FIH
first-in-human
FI-RSV
formalin-inactivated respiratory syncytial virus vaccine
FSH
follicle-stimulating hormone
GCP
Good Clinical Practice
GGT
gamma-glutamyl transferase
GMFR
geometric mean fold rise
GMT
geometric mean titer

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671014
Final Protocol Amendment 1, 08 Feb 2022
PFIZER CONFIDENTIAL
Page 89
Abbreviation
Term
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
ID
identification
IM
intramuscular
IND
investigational new drug application
INR
international normalized ratio
IP manual
investigational product manual
IPAL
Investigational Product Accountability Log
IRB
institutional review board
IRT
interactive response technology
ISO
International Organization for Standardization
IV
intravenous
IWR
interactive Web-based response
LAIV
live attenuated influenza vaccine
LFT
liver function test
LMIC
low- and middle-income country 
LRTI
lower respiratory tract illness
LRTI-RSV
RSV-associated lower respiratory tract illness
MCAR
missing completely at random
MDR
medical device regulation
MedDRA
Medical Dictionary for Regulatory Activities
mITT
modified intent-to-treat
msLRTI
moderate to severe lower respiratory tract illness
N/A
not applicable
NT
neutralizing titer
PCR
polymerase chain reaction
PFS
prefilled syringe
PPE
personal protective equipment
PT
prothrombin time
QTL
quality tolerance limit
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
CCI
CCI

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671014
Final Protocol Amendment 1, 08 Feb 2022
PFIZER CONFIDENTIAL
Page 90
Abbreviation
Term
SADE
serious adverse device effect
SAE
serious adverse event
SAP
statistical analysis plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2 
SD
standard deviation
SIIV
seasonal inactivated influenza vaccine
SoA
schedule of activities
SOP
standard operating procedure 
SRSD
single reference safety document
SUSAR
suspected unexpected serious adverse reaction
TBD
to be determined
TBili
total bilirubin
Tdap
tetanus toxoid, reduced diphtheria toxoid and acellular pertussis 
vaccine, adsorbed
Th2
T-helper type 2
ULN
upper limit of normal
US
United States
USADE
unanticipated serious adverse device effect
WOCBP
woman/women of childbearing potential

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671014
Final Protocol Amendment 1, 08 Feb 2022
PFIZER CONFIDENTIAL
Page 91
11. REFERENCES
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Fischer M, eds. Principles and practice of pediatric infectious diseases. 5th ed. 
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2
Hall CB, Weinberg GA, Blumkin AK, et al. Respiratory syncytial virus–associated 
hospitalizations among children less than 24 months of age. Pediatrics. 
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3
Shi T, McAllister DA, O’Brien KL, et al. Global, regional, and national disease burden 
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4
Scheltema NM, Gentile A, Lucion F, et al. Global respiratory syncytial virus-associated 
mortality in young children (RSV GOLD): a retrospective case series. Lancet Glob
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5
Parikh RC, McLaurin KK, Margulis AV, et al. Chronologic age at hospitalization for 
respiratory syncytial virus among preterm and term infants in the United States. Infect
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6
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Guidelines Committee. Policy statement—updated guidance for palivizumab 
prophylaxis among infants and young children at increased risk of hospitalization for 
respiratory syncytial virus infection. Pediatrics. 2014;134(2):415-20.
7
Blanken MO, Rovers MM, Molenaar JM, et al. Respiratory syncytial virus and recurrent 
wheeze in healthy preterm infants. N Engl J Med. 2013;368(19):1791-9.
8
Stein RT, Sherrill D, Morgan WJ, et al. Respiratory syncytial virus in early life and risk 
of wheeze and allergy by age 13 years. Lancet. 1999;354(9178):541-5.
9
Weber MW, Mulholland EK, Greenwood BM. Respiratory syncytial virus infection in 
tropical and developing countries. Trop Med Int Health. 1998;3(4):268-80.
10
Glezen WP, Taber LH, Frank AL, et al. Risk of primary infection and reinfection with 
respiratory syncytial virus. Am J Dis Child. 1986;140(6):543-6.
11
American Academy of Pediatrics. Respiratory syncytial virus. In: Kimberlin DW, Brady 
MT, Jackson MA, et al, eds. Red book: 2018-2021 report of the Committee on 
Infectious Diseases. 31st ed. Itasca, IL: American Academy of Pediatrics; 2018:682-92.

PF-06928316 (Respiratory Syncytial Virus [RSV] Vaccine)
Protocol C3671014
Final Protocol Amendment 1, 08 Feb 2022
PFIZER CONFIDENTIAL
Page 92
12
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Falsey AR, Hennessey PA, Formica MA, et al. Respiratory syncytial virus infection in 
elderly and high-risk adults. N Engl J Med. 2005;352(17):1749-59.
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Murata Y, Falsey AR. Respiratory syncytial virus infection in adults. Antivir Ther.
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Ackerson B, Tseng HF, Sy LS, et al. Severe morbidity and mortality associated with 
respiratory syncytial virus versus influenza infection in hospitalized older adults. Clin 
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Sundaram ME, Meece JK, Sifakis F, et al. Medically attended respiratory syncytial virus 
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Belongia EA, King JP, Kieke BA, et al. Clinical features, severity, and incidence of 
RSV illness during 12 consecutive seasons in a community cohort of adults ≥60 
years old. Open Forum Infect Dis. 2018;5(12):ofy316.
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Wyffels V, Kariburyo F, Gavart S, et al. A real-world analysis of patient characteristics 
and predictors of hospitalization among US Medicare beneficiaries with respiratory 
syncytial virus infection. Adv Ther. 2020;37(3):1203-17.
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Domachowske JB, Anderson EJ, Goldstein M. The future of respiratory syncytial virus 
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Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985;4(2):213-
26.

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