A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess the Efficacy, Immunogenicity and Safety of an Ad26.RSV.preF-based Regimen in the Prevention of RT PCR-confirmed RSV-mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
Phase: PHASE2
Conditions: Respiratory Syncytial Viruses, Respiratory Tract Diseases
Sponsor: Janssen Vaccines & Prevention B.V.

CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
1
Status: Approved,Date: 16 February 2023
Janssen Vaccines & Prevention B.V.*
Clinical Protocol
A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess the Efficacy,
Immunogenicity and Safety of an Ad26.RSV.preF-based Regimen in the Prevention of
RT-PCR-confirmed RSV-mediated Lower Respiratory Tract Disease in Adults Aged
65Years and Older
Protocol VAC18193RSV2001; Phase 2b
AMENDMENT 8
CYPRESS
VAC18193 (JNJ-64400141/JNJ-64213175)
* Janssen Vaccines & Prevention B.V. is a Janssen pharmaceutical company of Johnson & Johnson and is
hereafter referred to as the sponsor of the study. The sponsor is identified on the Contact Information page
that accompanies the protocol.
US sites of this study will be conducted under US Food & Drug Administration IND regulations
(21 CFR Part 312).
Status: 
Approved
Date: 
16 February 2023
EDMS number: 
EDMS-ERI-169428083, 16.0
GCP Compliance: This study will be conducted in compliance with Good Clinical Practice, and applicable regulatory
requirements.
Confidentiality Statement
The information provided herein contains Company trade secrets, commercial or financial information that the Company
customarily holds close and treats as confidential. The information is being provided under the assurance that the recipient will
maintain the confidentiality of the information under applicable statutes, regulations, rules, protective orders or otherwise.
NCT03982199

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
2
Status: Approved,Date: 16 February 2023
TABLE OF CONTENTS
TABLE OF CONTENTS............................................................................................................................... 2
LIST OF ATTACHMENTS............................................................................................................................ 5
LIST OF IN-TEXT TABLES AND FIGURES................................................................................................ 6
PROTOCOL AMENDMENTS....................................................................................................................... 7
SYNOPSIS.................................................................................................................................................. 24
SCHEDULE OF ACTIVITIES –COHORT 1 (N=5,800).............................................................................. 48
SCHEDULE OF ACTIVITIES –COHORT 2 (N=2,000).............................................................................. 54
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORT 1A (N=120)....................................... 57
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORT 2A (N=120)....................................... 61
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORT 1B (N=135) ....................................... 66
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORT 2B (N=135) ....................................... 71
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORTS 1C AND 2C (N=240) ...................... 77
SCHEDULE OF ACTIVITIES –ASSESSMENTS FOR PARTICIPANTS WITH AN ARI EPISODE......... 83
ABBREVIATIONS...................................................................................................................................... 86
1. 
INTRODUCTION................................................................................................................................ 88
1.1. 
Background.................................................................................................................................... 88
1.2. 
Overall Rationale for the Study...................................................................................................... 93
2. 
OBJECTIVES, ENDPOINTS, AND HYPOTHESIS........................................................................... 97
2.1. 
Objectives and Endpoints .............................................................................................................. 97
2.2. 
Hypothesis ................................................................................................................................... 101
3. 
STUDY DESIGN AND RATIONALE............................................................................................... 101
3.1. 
Overview of Study Design............................................................................................................ 101
3.2. 
Study Design Rationale................................................................................................................ 110
4. 
PARTICIPANT POPULATION ........................................................................................................ 110
4.1. 
Inclusion Criteria .......................................................................................................................... 111
4.2. 
Exclusion Criteria ......................................................................................................................... 112
4.3. 
Prohibitions and Restrictions ....................................................................................................... 115
5. 
INTERVENTION ALLOCATION AND BLINDING .......................................................................... 115
6. 
DOSAGE AND ADMINISTRATION ................................................................................................ 117
7. 
STUDY VACCINE COMPLIANCE .................................................................................................. 118
8. 
PRESTUDY AND CONCOMITANT THERAPY .............................................................................. 118
9. 
STUDY EVALUATIONS.................................................................................................................. 120
9.1. 
Study Procedures......................................................................................................................... 120
9.1.1. 
Overview................................................................................................................................... 120
9.1.2. 
Visit Windows ........................................................................................................................... 126
9.1.3. 
Screening/Randomization and Vaccination (Day 1)................................................................. 127
9.1.4. 
Post-Vaccination Follow-up After Vaccination on Day 1 .......................................................... 128
9.1.5. 
Revaccination Subcohorts........................................................................................................ 130
9.1.6. 
Early Withdrawal –EarlyExit Visit............................................................................................ 132

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
3
Status: Approved,Date: 16 February 2023
9.2. 
Study Evaluations ........................................................................................................................ 133
9.2.1. 
Efficacy Evaluations.................................................................................................................. 133
9.2.1.1. 
Patient-Reported Outcomes.................................................................................................. 133
9.2.1.1.1. 
ARI Surveillance Assessment............................................................................................ 134
9.2.1.1.2. 
Respiratory Infection Intensity and Impact Questionnaire (RiiQ™v2) ............................... 134
9.2.1.1.3. 
Patient Global Impression Scores...................................................................................... 135
9.2.1.1.4. 
Thermometer Logs............................................................................................................. 135
9.2.1.2. 
Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale ....................................... 135
9.2.1.3. 
Frailty Index Score................................................................................................................. 136
9.2.1.4. 
Clinical Assessment .............................................................................................................. 136
9.2.1.5. 
Diagnosis of RSV and Other Respiratory Infections ............................................................. 136
9.2.2. 
Immunogenicity Evaluations..................................................................................................... 137
9.2.3. 
Medical Resource Utilization .................................................................................................... 139
9.2.4. 
Safety Evaluations.................................................................................................................... 139
9.2.4.1. 
Adverse Events ..................................................................................................................... 139
9.2.4.2. 
Vital Signs.............................................................................................................................. 141
9.2.4.3. 
Physical Examination ............................................................................................................ 142
9.2.4.4. 
Patient-reported Outcomes ................................................................................................... 142
10. PARTICIPANT COMPLETION/DISCONTINUATION OF STUDY INTERVENTION/
WITHDRAWAL FROM THE STUDY............................................................................................... 142
10.1. 
Completion ................................................................................................................................... 142
10.2. 
Discontinuation of Study Vaccine/Withdrawal from the Study..................................................... 142
10.3. 
Contraindications to Vaccination.................................................................................................. 143
11. STATISTICAL METHODS............................................................................................................... 144
11.1. 
Analysis Sets................................................................................................................................ 145
11.2. 
Sample Size Determination ......................................................................................................... 146
11.2.1. 
Efficacy..................................................................................................................................... 146
11.2.2. 
Immuno Subset......................................................................................................................... 147
11.2.3. 
Safety Subset ........................................................................................................................... 147
11.2.4. 
Revaccination Subcohorts........................................................................................................ 148
11.3. 
Participant Information ................................................................................................................. 150
11.4. 
Efficacy Analyses......................................................................................................................... 150
11.4.1. 
Primary Efficacy Endpoints....................................................................................................... 150
11.4.1.1. 
Analysis ................................................................................................................................. 152
11.4.2. 
Secondary Efficacy Endpoints.................................................................................................. 154
11.4.2.1. 
Analysis ................................................................................................................................. 154
11.4.3. 
Exploratory Efficacy Endpoints................................................................................................. 154
11.4.3.1. 
Analysis ................................................................................................................................. 156
11.5. 
Patient-reportedOutcomes.......................................................................................................... 157
11.5.1. 
Respiratory Infection Intensity and Impact Questionnaire (RiiQ™v2)...................................... 157
11.5.2. 
Patient Global Impression Scores ............................................................................................ 158
11.6. 
Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale.............................................. 158
11.7. 
Frailty Index Score ....................................................................................................................... 159
11.8. 
Clinical Assessment..................................................................................................................... 159
11.9. 
Immunogenicity Analyses ............................................................................................................ 159
11.9.1. 
Immuno Subset......................................................................................................................... 159
11.9.2. 
Revaccination Subcohorts........................................................................................................ 159
11.9.3. 
Correlates of Risk..................................................................................................................... 160
11.10. Medical Resource Utilization Analyses........................................................................................ 160
11.11. Safety Analyses ........................................................................................................................... 160
11.12. Planned Analyses ........................................................................................................................ 161
11.13. Independent Data Monitoring Committee .................................................................................... 165
12. ADVERSE EVENT REPORTING .................................................................................................... 165
12.1. 
Definitions .................................................................................................................................... 166
12.1.1. 
Adverse Event Definitions and Classifications ......................................................................... 166

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
4
Status: Approved,Date: 16 February 2023
12.1.2. 
Attribution Definitions................................................................................................................ 167
12.1.3. 
Severity Criteria ........................................................................................................................ 167
12.2. 
Special Reporting Situations........................................................................................................ 168
12.3. 
Procedures................................................................................................................................... 168
12.3.1. 
All Adverse Events.................................................................................................................... 168
12.3.2. 
Serious Adverse Events ........................................................................................................... 170
12.3.3. 
Pregnancy................................................................................................................................. 172
12.3.4. 
Adverse Events of Special Interest........................................................................................... 172
12.3.4.1. 
Thrombosis with Thrombocytopenia Syndrome.................................................................... 172
12.4. 
Contacting Sponsor Regarding Safety......................................................................................... 174
13. PRODUCT QUALITY COMPLAINT HANDLING............................................................................ 175
13.1. 
Procedures................................................................................................................................... 175
13.2. 
Contacting Sponsor Regarding Product Quality.......................................................................... 175
14. STUDY INTERVENTION INFORMATION ...................................................................................... 175
14.1. 
Physical Description of Study Vaccine(s).................................................................................... 175
14.2. 
Packaging and Labeling............................................................................................................... 176
14.3. 
Storage and Handling .................................................................................................................. 176
14.4. 
Vaccine Accountability................................................................................................................. 177
15. STUDY-SPECIFIC MATERIALS..................................................................................................... 177
16. ETHICAL ASPECTS....................................................................................................................... 178
16.1. 
Study-specific Design Considerations ......................................................................................... 178
16.2. 
Regulatory Ethics Compliance..................................................................................................... 180
16.2.1. 
Investigator Responsibilities ..................................................................................................... 180
16.2.2. 
Independent Ethics Committee or Institutional Review Board................................................. 180
16.2.3. 
Informed Consent ..................................................................................................................... 182
16.2.4. 
Privacy of Personal Data .......................................................................................................... 182
16.2.5. 
Long-Term Retention of Samples for Additional Future Research .......................................... 183
16.2.6. 
Country/Territory Selection....................................................................................................... 183
17. ADMINISTRATIVE REQUIREMENTS............................................................................................ 183
17.1. 
Protocol Clarification Communications ........................................................................................ 183
17.2. 
Protocol Amendments.................................................................................................................. 183
17.3. 
Regulatory Documentation .......................................................................................................... 184
17.3.1. 
Regulatory Approval/Notification .............................................................................................. 184
17.3.2. 
Required Prestudy Documentation........................................................................................... 184
17.4. 
Participant Identification, Enrollment, and Screening Logs ......................................................... 185
17.5. 
Source Documentation................................................................................................................. 185
17.6. 
Case Report Form Completion .................................................................................................... 186
17.7. 
Data Quality Assurance/Quality Control ...................................................................................... 187
17.8. 
Record Retention ......................................................................................................................... 187
17.9. 
Monitoring .................................................................................................................................... 187
17.10. Study Completion/Termination..................................................................................................... 188
17.10.1. Study Completion/End of Study................................................................................................ 188
17.10.2. Study Termination..................................................................................................................... 188
17.11. On-Site Audits.............................................................................................................................. 189
17.12. Use of Information and Publication .............................................................................................. 189
18. APPENDIX 1: GUIDANCE ON STUDY CONDUCT DURING A NATURAL DISASTER............... 191
REFERENCES.......................................................................................................................................... 193
INVESTIGATOR AGREEMENT............................................................................................................... 216

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
5
Status: Approved,Date: 16 February 2023
LIST OF ATTACHMENTS
Attachment 1: Definition of Acute Respiratory Infection ......................................................................... 195
Attachment 2: Toxicity Tables................................................................................................................. 196
Attachment 3: Clinical Assessment ........................................................................................................ 199
Attachment 4: ARI Surveillance Assessment ......................................................................................... 200
Attachment 5: Respiratory Infection Intensity and Impact Questionnaire (RiiQ™v2) –
Symptom Scale ............................................................................................................... 201
Attachment 6: Respiratory Infection Intensity and Impact Questionnaire (RiiQ™v2)............................. 202
Attachment 7: Patient Global Impression Scales ................................................................................... 204
Attachment 8: Lawton-Brody Instrumental Activities of Daily Living (Lawton-Brody IADL
Scale) .............................................................................................................................. 205
Attachment 9: Medical Resources Use Questionnaire –Baseline Version............................................ 206
Attachment 10: Medical Resources Use Questionnaire.......................................................................... 208
Attachment 11: Respiratory Infection Intensity and Impact Questionnaire (RiiQ™v2) –
Impact on Daily Activity Scale ......................................................................................... 210
Attachment 12: Medically Attended Acute Respiratory Infection (MA-ARI) Information Form................ 211
Attachment 13: Thrombotic Events to be Reported as Potential AESIs................................................... 215

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
6
Status: Approved,Date: 16 February 2023
LIST OF IN-TEXT TABLES AND FIGURES
TABLES
Table 1: 
Completed and Ongoing Studies with Ad26.RSV.preF..................................................... 91
Table 2: 
Study Design: VAC18193RSV2001 ................................................................................ 103
Table 3: 
Visit Windows for Cohort 1 Participants Not Included in a Revaccination
Subcohort ........................................................................................................................ 126
Table 4: 
Summary of Immunogenicity Assays (Humoral)............................................................. 138
Table 5: 
Summary of Immunogenicity Assays (Cellular) .............................................................. 138
Table 6: 
Distance from the Mean to the Limits of 95% CI for Pre-F ELISA, VNA, and
ELISpot............................................................................................................................ 147
Table 7: 
Probability of Observing at Least One Adverse Event or Serious Adverse
Event at a Given True Adverse Event Rate in the Safety Subset................................... 148
Table 8: 
Distance From the Mean to the Limits of 95% CI Around the Ratio Between
Day 15 Post First Vaccination and Day15 Post Second Vaccination Within a
Group for Pre-F ELISA, VNA A2, and ELISpot ............................................................... 149
Table 9: 
Distance From the Mean to the Limits of 95% CI Around the Ratio on Day 15
Post Second Vaccination Between the 2 Groups for Pre-F ELISA, VNA A2,
and ELISpot..................................................................................................................... 149
Table 10: 
Probability of Observing at Least 1 Adverse Event or Serious Adverse Event
at a Given True Adverse Event Rate in the Revaccination Subcohorts.......................... 150
Table 11: 
Symptoms of Lower Respiratory Tract Infection and Systemic Symptoms as
per RiiQ or Clinical Assessment...................................................................................... 151
Table 12: 
Ordinal Case Definition ................................................................................................... 156
Table 13: 
Laboratory Tests That May Be Performed Upon Sponsor Request on
Immunogenicity Samples Collected on Days 1 and 15 After Potential AESI
Reporting ......................................................................................................................... 173
Table 14: 
Laboratory Tests That May Be Requested by the Sponsor to be Performed
at the Central Laboratory After Potential AESI Reporting............................................... 174
FIGURES
Figure 1: 
Flow Chart for the Primary Analysis in Case the Study is Performed at the
Northern Hemisphere Only................................................................................................ 32
Figure 2: 
Flow Chart for the Primary Analysis in Case the Study is Performed at the
Northern and Southern Hemisphere ................................................................................. 33
Figure 3: 
Flow Chart for the Primary Analysis in Case the Study is Performed at the
Northern Hemisphere Only................................................................................................ 95
Figure 4: 
Flow Chart for the Primary Analysis in Case the Study is Performed at the
Northern and Southern Hemisphere ................................................................................. 96
Figure 5: 
Flow Chart for Group 1 (Active Study Vaccine on Day 1)............................................... 105
Figure 6: 
Flow Chart for Group 2 (Placebo on Day 1).................................................................... 106

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
7
Status: Approved,Date: 16 February 2023
PROTOCOL AMENDMENTS
Protocol Version 
Date
Original Protocol 
20 March 2019
Amendment 1 
11 October 2019
Amendment 2 
20 March 2020
Amendment 3 
08 May 2020
Amendment 4 
25 August 2020
Amendment 5 
04 February 2021
Amendment 6 
26 May 2021
Amendment 7 
21 September 2021
Amendment 8 
16 February 2023
Amendments below are listed beginning with the most recent amendment.
Amendment 8 (16 February 2023)
The primary reason for the amendment: The primary reason for this amendment is to remove Revaccination
Subcohort D as additional data with a Month 48 revaccination timepoint are not expected to provide novel insights
on the kinetics of the immune response after revaccination with the Ad26/protein preF RSV vaccine.
Additional changes were made, as listed below.
Applicable Section(s) 
Description of Change(s)
Rationale: Revaccination Subcohort D is removed as additional data with a Month 48 revaccination timepoint are
not expected to provide novel insights on the kinetics of the immune response after revaccination with the
Ad26/protein preF RSV vaccine.
SYNOPSIS  
Schedule ofActivities –Cohort 1
(N=5,800)
Schedule of Activities –Revaccination
Subcohorts 1D and 2D (N=240)
1.2 Overall Rationale for the Study
2 OBJECTIVES, ENDPOINTS, AND
HYPOTHESIS
3.1 Overview of Study Design
4.2 Exclusion Criteria
5 INTERVENTION ALLOCATION
AND BLINDING
8 PRESTUDY AND CONCOMITANT
THERAPY
9 STUDY EVALUATIONS
9.1.1 Overview
9.1.5 Revaccination Subcohorts
9.2.1.1.1 ARI Surveillance Assessment
9.2.2 Immunogenicity Evaluations
9.2.4.1 Adverse Events
10.1 Completion
11.1 Analysis Sets
11.9.2 Revaccination Subcohorts
11.2.4 Revaccination Subcohorts
11.12 Planned Analyses
12.3.1 All Adverse Events
12.3.2 Serious Adverse Events
16.1 Study-specific Design
Considerations
Removal of Revaccination Subcohort D.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
8
Status: Approved,Date: 16 February 2023
Rationale: To align the thrombosis with thrombocytopenia syndrome (TTS) wording across the RSV vaccine
(VAC18193) program and with the TTS Adjudication Committee (TTSAC) and RSV TTS Charter.
Schedule ofActivities – 
Cohort 1 (N=5,800) 
Schedule 
of 
Activities 
– 
Revaccination Subcohort 1A 
(N=120)
Schedule 
of 
Activities 
–
Revaccination Subcohort 2A
(N=120)
Schedule 
of 
Activities 
–
Revaccination Subcohort 1B
(N=135)
Schedule 
of 
Activities 
–
Revaccination Subcohort 2B
(N=135)
Schedule 
of 
Activities 
–
Revaccination Subcohorts 1C
and 2C (N=240)
9.2.4.1 Adverse Events
12.3.1 All Adverse Events
12.3.4.1 Thrombosis 
with
Thrombocytopenia Syndrome
Updates were made to align the TTS wording across the RSV vaccine
(VAC18193) program and with the TTSAC and RSV TTS Charter. Language
referring to laboratory diagnostic tests for the follow-up and assessment of
potential adverse events of special interest (AESIs) was added.
Rationale: To align with the most recent Janssen protocol template.
12.3.2 Serious Adverse Events 
13 PRODUCT QUALITY
COMPLAINT HANDLING
Updates were made in alignment with the latest Janssen protocol template.
Rationale: Minor textual changes, clarifications and corrections have been made.
Throughout the protocol.
Amendment 7 (21 September 2021)
The primary reason for the amendment: The primary reason for this amendment is to facilitate a specific group
of participants to co-participate in another clinical study(including interventional studies), if the other clinical study
meets prespecified criteria. It concerns potential participants for revaccination subcohorts C and D who are
currently not participating in RSV ARI follow-up.
Additional changes were made, as listed below.
Applicable Section(s) 
Description of Change(s)
Rationale: To allow flexibility on co-participating in another clinical study (including interventional studies).
4.2 Exclusion Criteria 
A note has been added to clarify in which situations co-participation in another
clinical study may be allowed.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
9
Status: Approved,Date: 16 February 2023
Rationale: To change the end date of the third RSV season.
Schedule of Activities – 
Cohort 1 (N=5,800) 
Schedule of Activities –
Assessments for Participants
with an ARI Episode
3.1 Overview of Study Design
The end of third RSV season date was changed from 30 April 2022 to 15 April
2022.
Rationale: The immunogenicity analyses for the revaccination subcohorts were revised to allow similar
immunogenicity analyses for all revaccination subcohorts.
SYNOPSIS  
11.9.2 Revaccination 
Subcohorts 
Geometric mean ratios and corresponding 95% confidence intervals between
Day 15 post first vaccination and Day 15 post second vaccination (dependent on
the revaccination subcohort) within the group receiving active study vaccine on
Day 1, will be calculated for the different assays.
Rationale: It was clarified that all cases of thrombocytopenia observed, not limited to symptomatic cases, should
be considered as potential thrombosis with thrombocytopenia syndrome (TTS) cases and therefore must be
reported as a potential adverse event of special interest (AESI).
9.2.4.1 Adverse Events 
12.3.1 All Adverse Events 
12.3.4.1 Thrombosis with
Thrombocytopenia Syndrome
The term symptomatic thrombocytopenia was adjusted to the more inclusive term
thrombocytopenia.
Rationale: It was clarified that Exclusion Criterion 22 (‘Participant has a history of TTS or heparin-induced
thrombocytopenia and thrombosis (HITT)’must be verified prior to each planned revaccination in the
revaccination subcohorts.
Schedule of Activities – 
Revaccination Subcohort 1A 
(N=120) 
Schedule of Activities –
Revaccination Subcohort 2A
(N=120)
Schedule of Activities –
Revaccination Subcohort 1B
(N=135)
Schedule of Activities –
Revaccination Subcohort 2B
(N=135)
Schedule of Activities –
Revaccination Subcohorts 1C
and 2C (N=240)
Schedule of Activities –
Revaccination Subcohorts 1D
and 2D (N=240)
In the footnotes to the Schedules of Activities for the revaccination subcohorts,
Exclusion Criterion 22 was added to the list of selected eligibility criteria that are
to be verified prior to each plannedrevaccination in the revaccination subcohorts.
Rationale: Minor textual changes, clarifications and corrections have been made.
Throughout the protocol

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
10
Status: Approved,Date: 16 February 2023
Amendment 6 (26 May 2021)
The primary reason for the amendment:This amendment has been created to provide information and guidance
for investigators on signs and symptoms and on medical management should very rare events of thrombosis with
thrombocytopenia syndrome (TTS) occur, as observed in another Ad26-based vaccine program (Ad26.COV2.S,
COVID-19 vaccine). The Ad26/protein preF RSV vaccine uses the same Ad26 vector as Ad26.COV2.S, but has
different transgene inserts. To date, no cases of TTS have been reported in Janssen’s Ad26/protein preF RSV
vaccine clinical studies nor in any other Ad26-based non-COVID-19 vaccine programs from Janssen. Nonetheless,
TTS will be followed in this protocol as adverse event of special interest (AESI).
Applicable Section(s) 
Description of Change(s)
Rationale: Following observation of very rare events of TTS after vaccination with Janssen’s Ad26-based
COVID-19 vaccine, TTS will be followed as an AESI in the Revaccination Subcohorts of this study.
SYNOPSIS  
Schedule of Activities – 
Revaccination Subcohort 2A 
(N=120)
Schedule of Activities –
Revaccination Subcohort 1B
(N=135)
Schedule of Activities –
Revaccination Subcohort 2B
(N=135)
Schedule of Activities –
Revaccination Subcohorts 1C
and 2C (N=240)
Schedule of Activities –
Revaccination Subcohorts 1D
and 2D (N=240)
ABBREVIATIONS
1.1 Background
2.1 Objectives and Endpoints
3.1 Overview of Study Design
4.2 Exclusion Criteria
8 PRESTUDY AND
CONCOMITANT THERAPY
9.1.1 Overview
9.1.5 Revaccination Subcohorts
9.2.4.1 Adverse Events
10.2 Discontinuation of Study
Vaccine/Withdrawal from the
Study
11.11 Safety Analyses
12 ADVERSE EVENT
REPORTING
12.2 Special Reporting
Situations
12.3.1 All Adverse Events
12.3.4 Adverse Events of
Special Interest
REFERENCES
Attachment 13
In the Revaccination Subcohorts, TTS is to be reported to the sponsor as an
AESI, within 24 hours of awareness. A potential AESI is defined as thrombotic
events or symptomatic thrombocytopenia.
Rationale: The objective on safety in terms of SAEs was erroneously removed in protocol amendment 5.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
11
Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
SYNOPSIS  
2.1 Objectives and Endpoints
To re-add the objective on safety in terms of SAEs during the study.
Rationale: To change the end date of the second RSV season.
Schedule of Activities –Cohort 
1 (N=5,800) 
Schedule of Activities –
Assessments for Participants
with an ARI Episode
3.1 Overview of Study Design
The end of second RSV season date was changed from 30 April 2021 to 17 May
2021.
Rationale: Clarification on SAE collection in the Revaccination subcohorts.
SYNOPSIS  
2.1 Objectives and Endpoints 
3.1 Overview of Study Design  
9.1.1 Overview  
9.1.5 Revaccination Subcohorts 
9.2.4.1 Adverse Events
12.3.1 All Adverse Events
Added clarification on the collection of SAEs classified as related to the study
vaccine, SAEs resulting in death, (S)AEs leading to discontinuation from the
study, and (S)AEs and special reporting situations related to study procedures
or to non-investigational (concomitant) Janssen products in the Revaccination
Subcohorts.
Rationale: To allow flexibility on when to stop the follow-up of ARIs for the Revaccination Subcohorts C and D.
SYNOPSIS  
Schedule of Activities – 
Revaccination Subcohorts 1C
and 2C (N=240)
Schedule of Activities –
Revaccination Subcohorts 1D
and 2D (N=240)
2.1 Objectives and Endpoints
3.1 Overview of Study Design
9.1.1 Overview
9.1.5 Revaccination Subcohorts
9.2.1.1.1 ARI Surveillance
Assessment
9.2.4.1 Adverse Events
12.3.1 All Adverse Events
12.3.2 Serious Adverse Events
For the Revaccination Subcohorts C and D, ARI follow-up will be stopped at
the end of the third RSV season at the latest.
Rationale: The option for caregivers to complete the eDiary on behalf of the participant has been removed.
SYNOPSIS  
9.1.1 Overview
Caregivers are no longer allowed to complete the eDiary.
Rationale: To correct the footnote on the timing of the post-vaccination visits in the Schedule of Activities for the
Revaccination Subcohorts.

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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
Schedule of Activities – 
Revaccination Subcohort 1A 
(N=120) 
Schedule of Activities –
Revaccination Subcohort 2A
(N=120)
Schedule of Activities –
Revaccination Subcohort 1B
(N=135)
Schedule of Activities –
Revaccination Subcohort 2B
(N=135)
Schedule of Activities –
Revaccination Subcohorts 1C
and 2C (N=240)
Schedule of Activities –
Revaccination Subcohorts 1D
and 2D (N=240)
For the Revaccination Subcohorts, the visit day is relative to the actual day of
vaccination in the first RSV season. The timing of the visit day is determined
by the visit window relative to the last vaccination.
Rationale: New section on the process for protocol clarification communications was added to align with the most
recent Jansen protocol template.
17.1 Protocol Clarification 
Communications
ABBREVIATIONS
New section on protocol clarification communications was added.
Rationale: To align the guidance on study conduct during the COVID-19 pandemic with the most recent Jansen
protocol template.
18 Appendix 1: Guidance on 
Study Conduct during a natural
disaster
GUIDANCE ON STUDY
CONDUCT DURING THE
COVID-19 PANDEMIC
The guidance on study conduct during the COVID-19 pandemic was updated.
Rationale: Minor textual changes, clarifications and corrections have been made.
Throughout the protocol
Amendment 5 (04 February 2021)
The primary reasons for the amendment: Follow-up of participants from Cohort 1 has been extended through a
third RSV season to further evaluate durability of efficacy. Furthermore, additional Revaccination Subcohorts were
added. Participants in these subcohorts will be revaccinated at different yearly intervals after the first vaccination
to determine the optimal time for revaccination, and to explore the relative contribution of each component of the
vaccine (Ad26.RSV.preF and RSV preF protein) to the immune response after revaccination.

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
Rationale: Follow-up of participants from Cohort 1 is extended through a third RSV season to further evaluate
durability of efficacy if analyses at the end of the second RSV season indicate a trend for durable efficacy or if
results on durability are inconclusive at that time. Furthermore, additional Revaccination Subcohorts are
implemented to assess the safety and immunogenicity of revaccination with active study vaccine administered at
2, 3, or 4 years after the first study vaccination to determine the optimal time for revaccination, and to explore the
relative contribution of each component (Ad26.RSV.preF and RSV preF protein) to the immune response after
revaccination.
SYNOPSIS  
Schedule of Activities – 
Cohort 1 
Schedule of Activities – 
Revaccination Subcohort 1A 
(N=120)
Schedule of Activities –
Revaccination Subcohort 2A
(N=120)
Schedule of Activities –
Revaccination Subcohort 1B
(N=135)
Schedule of Activities –
Revaccination Subcohort 2B
(N=135)
Schedule of Activities –
Revaccination Subcohorts 1C
and 2C (N=240)
Schedule of Activities –
Revaccination Subcohorts
1D and 2D (N=240)
1.2 Overall Rationale for the
Study
2.1 Objectives and Endpoints
3.1 Overview of Study
Design
3.2 Study Design Rationale
4.1 Inclusion Criteria
4.2 Exclusion Criteria
5 INTERVENTION
ALLOCATION AND
BLINDING
6 DOSAGE AND
ADMINISTRATION
7 STUDY VACCINE
COMPLIANCE
8 PRESTUDY AND
CONCOMITANT
THERAPY
9.1.1 Overview
9.1.2 Visit Windows
9.1.4 Post-Vaccination
Follow-up After Vaccination
on Day 1
9.1.5 Revaccination
Subcohorts
9.2.1.1 Patient-Reported
Outcomes
Follow-up of participants from Cohort 1 during a third RSV season is added, and
additional Revaccination Subcohorts are implemented. Participants in these
additional subcohorts will be revaccinated at 2, 3, or 4 years after the first study
vaccination. Additional study visits and additional procedures and assessments are
included for these participants.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
9.2.1.1.1 ARI Surveillance
Assessment
9.2.1.2 Lawton-Brody
Instrumental Activities of
Daily Living (IADL) Scale
9.2.2 Immunogenicity
Evaluations
9.2.4.1 Adverse Events
9.2.4.3 Physical Examination
10.1 Completion
10.3 Contraindications to
Vaccination
11.1 Analysis Sets
11.2.4 Revaccination
Subcohorts
11.4.1 Primary Efficacy
Endpoints
11.4.2 Secondary Efficacy
Endpoints
11.4.3 Exploratory Efficacy
Endpoints
11.4.3.1 Analysis
11.9.2 Revaccination
Subcohorts
11.11 Safety Analyses
11.12 Planned Analyses
12.3.1 All Adverse Events
12.3.2 Serious Adverse
Events
14.3 Storage and Handling
16.1 Study-specific Design
Considerations
Attachment 1
Rationale: Clarification that collection of ARI data will be ceased for that particular episode if a participant has
tested positive for SARS-CoV-2.
SYNOPSIS  
9.1.1 Overview  
Added clarification that collection of ARI data by the study site will be ceased for
that particular episode if a participant has tested positive for SARS-CoV-2 (by a
local test that is FDA-approved or by central laboratory PCR).
Rationale: Clarification that paper safety diaries may be used ifdesignated by the sponsor.
SYNOPSIS  
Schedule of Activities – 
Cohort 1 (N=5,800)
Schedule of Activities –
Cohort 2 (N=2,000)
Schedule of Activities –
Revaccination Subcohort 1A
(N=120)
Schedule of Activities –
Revaccination Subcohort 2A
(N=120)
Schedule of Activities –
Revaccination Subcohort 1B
(N=135)
Added clarification that paper safety diaries may be used at the sponsor’s
discretion.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
Schedule of Activities –
Revaccination Subcohort 2B
(N=135)
Schedule of Activities –
Revaccination Subcohorts 1C
and 2C (N=240)
Schedule of Activities –
Revaccination Subcohorts
1D and 2D (N=240)
3.1 Overview of Study
Design
4.1 Inclusion Criteria
9.1.1 Overview
Rationale:Clarification that ineachcaseof portal/eDevice down time, PRO data can onlybe collected upon sponsor
approval via interview using paper versions of the questionnaires.
9.2.1.1 Patient-Reported 
Outcomes 
Addedclarificationin case of portal/eDevice down time, PRO data can be collected
upon sponsor approval via interview using paper versions of the questionnaires.
Rationale: Clarification that site monitoring can include both on-site monitoring visits as well as video site
monitoring.
17.6 Data Quality 
Assurance/Quality Control 
17.8 Monitoring
Added clarification that site monitoring can be performed by using video site
monitoring.
Rationale: Minor textual changes, clarifications and corrections have been made.
Throughout the protocol
Amendment 4 (25 August 2020)
The primary reason for the amendment: A subcohort of participants will receive a second vaccination with
active study vaccine to further characterize the immune responses to vaccination.
Applicable Section(s) 
Description of Change(s)
Rationale: Addition of a Revaccination Subcohort to assess safety and immunogenicity  in a subcohort of
participants, who will be given a second vaccination with active study vaccine at 12 months after the first
immunization.
SYNOPSIS  
Schedule of Activities – 
Cohort 1 
Schedule of Activities – 
Revaccination Subcohort
Schedule of Activities –
Assessments for Participants
with an ARI Episode
1.2 Overall Rationale for the
Study
2.1 Objectives and Endpoints
3.1 Overview of Study
Design
A revaccination at 12 months after the first vaccination (ie,Day 365 visit) is added
for a separate subcohort of Cohort 1 (Revaccination Subcohort). Additional study
procedures and assessments are added for these participants and clarifications are
added regarding the open-label character of this revaccination.

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
3.2 Study Design Rationale
4.2 Exclusion Criteria
5 INTERVENTION
ALLOCATION AND
BLINDING
6 DOSAGE AND
ADMINISTRATION
7 STUDY VACCINE
COMPLIANCE
8 PRESTUDY AND
CONCOMITANT
THERAPY
9.1.1 Overview
9.1.2 Visit Windows
9.1.4 Post-Vaccination
Follow-up After Vaccination
on Day 1
9.1.5 Revaccination
Subcohort
9.1.6 Early Withdrawal –
Early Exit Visit
9.2.2 Immunogenicity
Evaluations
9.2.4 Safety Evaluations
10.3 Contraindications to
Vaccination
11.1 Analysis Sets
11.2.4 Revaccination
Subcohort
11.4.1 Primary Efficacy
Endpoints
11.9.2 Revaccination
Subcohort
11.12 Planned Analyses
12.3.1 All Adverse Events
12.3.2 Serious Adverse
Events
14.3 Storage and Handling
16.1 Study-specific Design
Considerations
Rationale: Clarification in SAE reporting
SYNOPSIS  
Schedule of Activities – 
Cohort 1
Schedule of Activities –
Revaccination Subcohort
2.1 Objectives and Endpoints
3.1 Overview of Study
Design
9.1.1 Overview
12.3.1 All Adverse Events
12.3.2 Serious Adverse
Events
The paragraphs on SAE collection are reordered for clarity. Where needed, a
sentence on SAE reporting for the Revaccination Subcohort is added.

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
Rationale: Actualization of past due dates mentioned in the protocol, including the end of the first NH RSV season,
and addition of VAC18193RSV2005 as an ongoing study.
1.1 Background 
3.1 Overview of Study 
Design  
Schedule of Activities –
Cohort 1
Ongoing study VAC18193RSV2005 was added to the Ad26.RSV.preF and RSV
preF Protein Clinical Data overview table. Due to progression of the ongoing study
past some milestone dates, the tense of these milestones is actualized.
Rationale: Addition of MA-ARI form as a new attachment, for alignment with ICF.
9.1.1 Overview  
Attachment 12
Addition of MA-ARI form as Attachment 12.
Rationale: Added video call as an option for virtual visits.
18 Appendix 1: Guidance on
Study Conduct during the
COVID-19 Pandemic
Rationale: Minor textual changes, clarifications and corrections have been made.
Throughout the protocol
Amendment 3 (8 May 2020)
The primary reason for the amendment: The Month 12 study vaccination is removed to determine if a single
dose of the vaccine can give durable efficacy against RSV-mediated LRTD during a second RSV season.
Applicable Section(s) 
Description of Change(s)
Rationale: The Month 12 vaccination is removed as it was decided to prioritize the assessment of durability of
protection after a single vaccination.
SYNOPSIS  
Schedule of Activities – 
Cohort 1 (N=5,800) 
Schedule of Activities – 
Cohort 2 (N=2,000)
1.2 Overall Rationale for
the Study
2.1 Objectives and
Endpoints
3.1 Overview of Study
Design
9.1.1 Overview
9.1.2 Visit Windows
9.1.4 Day 365 (Week 52)
9.1.5 Post-vaccination
Follow-up
9.1.7.1 Patient-Reported
Outcomes
9.1.7.1.1 ARI
Surveillance Assessment
9.1.10.3 Physical
Examination
The Month 12 study vaccination and related assessments are removed. The
post-vaccination follow-up visits in the second season are renamed relative to the first
vaccination. The assessment period is clarified as ‘during each RSV season’ or ‘both
RSV seasons’ as applicable.

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
10.3 Contraindications to
Vaccination
11.2.2 Immuno Subset
11.9.1 Immuno Subset
11.12 Planned Analyses
16.1 Study-Specific
Design Considerations
10.1 Completion  
10.2 Discontinuation of 
Study
Vaccine/Withdrawal from
the Study
Due to the removal of the Month 12 vaccination, the definition of the study
completion and discontinuation of study vaccine/withdrawal from the study changed.
SYNOPSIS  
Schedule of Activities – 
Cohort 1 (N=5,800)
Schedule of Activities –
Assessments for
Participants with an ARI
Episode
9.1.1 Overview
9.1.4 Day 365 (Week 52)
9.1.7.2 Lawton-Brody
Instrumental Activities of
Daily Living (IADL)
Scale
9.1.10.3 Physical
Examination
11.4.1 Primary Efficacy
Endpoints
Attachment 1
A new baseline has been added on Day 365 for the physical examination (except
height measurement), RiiQ, Lawton-Brody IADL, and MRU assessments.
Rationale: By removing the second vaccination, the SAE follow-up has changed in the second RSV season of the
study.
SYNOPSIS  
Schedule of Activities – 
Cohort 1 (N=5,800) 
Schedule of Activities – 
Assessments for 
Participants with an ARI
Episode
2.1 Objectives and
Endpoints
3.1 Overview of Study
Design
9.1.1 Overview
9.1.10.1 Adverse Events
12.3.1 All Adverse Events
12.3.2 Serious Adverse
Events
From the Day 365 visit until the end of the second RSV season, SAEs associated with
ARIs will be collected. During the entire study, SAEs classified as related to the study
vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation and
(S)AEs resulting from procedures and non-investigational (concomitant) Janssen
products will be collected.
Rationale: To update to background section with the latest clinical information.
1.1 Background 
The background section has been updated with the latest clinical information of the
latest Investigator’s Brochure (Edition 10, issued 4 December 2019).

VAC18193  (JNJ-64400141/JNJ-64213175)
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CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
Rationale: To clarify that the RiiQ and PGI-H questionnaires at the end of each RSV season can be completed by
the participant in the eDiary or by telephone contact.
SYNOPSIS  
Schedule of Activities – 
Cohort 1 (N=5,800) 
Schedule of Activities – 
Cohort 2 (N=2,000)
3.1 Overview of Study
Design
9.1.5 Post-vaccination
Follow-up
The RiiQ and the PGI-H at the end of the RSV season will be completed by the
participant in the eDiary or by telephone contact. If completed by telephone interview,
the study-site personnel will read aloud the questions to the participant and record the
participant’s responses on the site’s eDevice.
Rationale: To allow collection of clinical assessments on paper before entering in eDevice on the same day as the
assessments.
Schedule of Activities – 
Cohort 1 (N=5,800) 
Schedule of Activities – 
Cohort 2 (N=2,000) 
Schedule of Activities –
Assessments for
Participants with an ARI
Episode
17.4 Source
Documentation
The sponsor’s strong preference is that the results of the clinical assessment are
entered directly in the site’s eDevice, however, the results may be collected on paper
first and transferred to the site’s eDevice afterwards, on the same day as the
assessments.
Rationale:To include a Clinical EvaluationCommittee (CEC) review to determine if the ARIs are URTIs or LRTIs
and the severity of the ARIs.
SYNOPSIS  
11.4.3 Exploratory 
Efficacy Endpoints 
The CEC review will assess, independently and based on CRF/eDiary data, the
location of the ARI (upper or lower respiratory tract infection) and the ARI severity.
The CEC assessment, as well as other information based on MRU, presence of
clinically relevant disease, use of therapeutic interventions, RiiQ, clinical assessment,
Lawton-Brody IADL, and change in frailty will be used to evaluate the severity of the
RSV-positive ARIs, and will be used to explore the relation with the case definitions.
Rationale: To explore the relationship between G-ELISA and RT-PCR-confirmed RSV infection.
SYNOPSIS  
2.1 Objectives and 
Endpoints 
9.2.2 Immunogenicity
Evaluations
11.4.3 Exploratory
Efficacy Endpoints
As there is no established cut-off in G-ELISA fold-rise for serology confirmation of
RSV in older adults, the objectives related to serologic confirmation of RSV are
conditional on finding a cut-off that is sufficiently sensitive and specific.
Rationale: To collect information on influenza vaccination at the end of each RSV season.
Schedule of Activities – 
Cohort 1 (N=5,800) 
A check for seasonal influenza vaccination has been added to the assessments at the
end of each RSV season.

VAC18193  (JNJ-64400141/JNJ-64213175)
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CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
Rationale: To include bacterial panel testing for the detection of other respiratory pathogens in the midturbinate
nasal swabs.
9.1.7.5 Diagnosis of RSV 
and Other Respiratory
Infections
9.2.2 Immunogenicity
Evaluations
The midturbinate nasal swab may also be used to perform bacterial panel testing.
Rationale: To add the end of RSV season visits to the visit windows table.
9.1.2 Visit Windows 
Visits 3 and 6, ie, the end of RSV season visits, are added to the visit windows table.
Rationale: To correct that participants should store their eDevice at home at the end of the first RSV season.
9.1.5 Post-vaccination 
Follow-up 
Participants who were provided an eDevice to complete assessments at home during
the first RSV season will be instructed to store their eDevice at a safe place at home
in preparation of the second season.
Rationale: To avoid confusion between the RiiQ v2 questionnaire and the RiiQ subset, the term RiiQ subset has
been removed from this protocol.
SYNOPSIS  
Schedule of Activities – 
Assessments for 
Participants with an ARI
Episode
3.1 Overview of Study
Design
9.1.1 Overview
9.1.7 Efficacy Evaluations
17.4 Source
Documentation
Attachment 4
Attachment 5
Attachment 11
The term ‘RiiQ subset’ has been split into the RiiQ Symptom scale (Attachment 5)
and the RiiQ Impact on Daily Activities Scale (Attachment 11).
Additionally, the naming has been adjusted as needed in the protocol.
Rationale: For health and safety reasons due to the Coronavirus Disease 2019 (COVID-19), participants may not
be able to come to the study site for scheduled procedures.
Appendix 1 
Appendix 1 has been added to provide guidance to the investigator for managing
study-related procedures during the COVID-19 pandemic.
Rationale: Minor textual changes, clarifications and corrections have been made.
Throughout the protocol

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
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Status: Approved,Date: 16 February 2023
Amendment 2 (20 March 2020)
The primary reason for the amendment: The primary reason for this amendment is to shorten the ARI
surveillance to minimize participant-participant contact and participant-site contact due to safety concerns related
to increasing incidence of COVID-19 cases in US, where older adults are the highest risk group.
Applicable Section(s) 
Description of Change(s)
Rationale: To change the ARI surveillance period in the first NH RSV season to 20 March 2020 due to the
coronavirus disease 2019 (COVID-19) pandemic.
SYNOPSIS  
Schedule of Activities – 
Cohort 1 (N=5,800) 
Schedule of Activities – 
Assessments for 
Participants with an ARI 
Episode 
3.1 Overview of Study 
Design  
8 PRESTUDY AND
CONCOMITANT
THERAPY
9.1 Study Procedures
The ARI surveillance period is shortened to 20 March 2020 instead of the earlier
defined date for the end of the first NH RSV season (ie, 30 April).
For the first NH RSV season, if possible, participants who have an ongoing ARIs,
where an ARI Day 3-5 visit including the collection of a nasal swab or sputum sample
has occurred, should continue collecting daily temperature monitoring, RiiQ™ and
PGI questionnaires on their eDevices until their symptoms resolve or return to
baseline for 2 days. If possible, sites should collect ARI Day 29 visit data, but
excluding procedures that require on-site visit (ie, serology and clinical assessment),
over the telephone.
Rationale: To allow a separate unscheduled visit to follow-up on SAEs at the end of the first season visit
(Visit 3).
Schedule of Activities – 
Cohort 1 (N=5,800) 
Schedule of Activities – 
Assessments for 
Participants with an ARI
Episode
When the window for the end of season visit at the end of the first NH RSV season
(as defined in the protocol) is not coinciding with at least 6 months SAE follow-up, a
separate SAE safety follow-up call should be conducted 6 months after vaccination
and captured as an unscheduled visit.
Rationale: To add an unplanned interim analysis due to the COVID-19 pandemic.
SYNOPSIS  
11.12 Planned Analyses 
Due to the increasing incidence of COVID-19 cases, it is becoming increasingly
difficult to conduct ARI surveillance, without putting staff or study participants at
risk. As the RSV season is nearing a close, a decision has been made to stop ARI
surveillance.
Rationale: To move the secondary objective on serologic confirmation of RSV to the exploratory objectives.
SYNOPSIS  
2.1 Objectives and 
Endpoints
11.4.3 Exploratory
Efficacy Endpoints
The secondary objective on serologic confirmation of RSV is moved to the
exploratory objectives.
Rationale: Minor textual changes, clarifications and corrections have been made.
Throughout the protocol

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
22
Status: Approved,Date: 16 February 2023
Amendment 1 (11 October 2019)
The primary reason for the amendment: The primary reason for this amendment is to remove duplicates in the
ePRO assessments captured via the electronic devices (ie, the participant eDiary and the site’s eDevice) in
participants with an ARI episode.
Applicable Section(s) 
Description of Change(s)
Rationale: To align time points for assessments through the participant eDiary and the site’s eDevice in
participants with an ARI episode.
SYNOPSIS Overview of 
Study Design; Schedule of 
Activities –Assessments 
for Participants with an 
ARI Episode;
Section 3.1 Overview of
Study Design;
Section 9.1.1 Overview;
Section 9.2.1.1.3 Patient
Global Impression Scores
Completion of the PGI-H, PGI-S, PGI-C,and Return to Usual Health question on
the site’s eDevice at the ARI Days 3-5 visit has been removed from the protocol,
because these assessments will already be completed by the participant in the
eDiary during the ARI episode.
Schedule of Activities – 
Assessments for 
Participants with an ARI 
Episode;
Section 9.2.1.1.3 Patient
Global Impression Scores
The eDiary assessments on ARI Day 29 have been removed from the participant’s
device, because these assessments will already be completed by the participant on
the site’s eDevice during the ARI Day 29 visit.
Rationale: To align the analysis methods related to vaccine efficacy across the primary, secondary and
exploratory endpoints.
SYNOPSIS Statistical 
Methods; 
Section 11.1 Analysis Sets 
“Any participant with RT-PCR-confirmed RSV-mediated LRTD (according to Case
Definition #3) with onset within 14 days after vaccination will be excluded from the
PPE population” has been changed to: “Any participant with an RT-PCR-confirmed
RSV-mediated ARI with onset within 14 days after vaccination will be excluded
from the PPE population”.
SYNOPSIS Statistical 
Methods; 
Section 11.4.1.1 Analysis; 
Section 11.4.2.1 Analysis;
Section 11.4.3.1 Analysis
A Poisson model will be fitted for all of these endpoints. In addition, for some
endpoints an exact binomial confidence interval (rather than a score-based exact
confidence interval) will be calculated.
Rationale: To collect influenza vaccination information for use in the analysis of ARIs.
Schedule of Activities – 
Assessments for 
Participants with an ARI
Episode
For participants with an ARI episode, a check for seasonal influenza vaccination has
been added to the assessments of the ARI Day 3-5 and ARI Day 29 visits.
Rationale: To clarify the rescreening process for screen failed participants.
Section 9.1.3 
Screening/Randomization 
and Vaccination (Day 1) 
The possibility for rescreening has been added to the protocol. If a participant is a
screen failure but at some point in the future is expected to meet the eligibility
criteria, the participant may be rescreened on one occasion only. Participants who
are rescreened will be assigned a new participant number, undergo the informed
consent process, and then restart a new screening phase.

VAC18193  (JNJ-64400141/JNJ-64213175)
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CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,Date: 16 February 2023
Applicable Section(s) 
Description of Change(s)
Rationale: To aid completion of screening procedures, the possibility to split screening into 2 visits has been
added.
Section 9.1.3 
Screening/Randomization 
and Vaccination (Day 1)
Screening may be split into 2 visits after consultation with the sponsor. Every effort
should be made for split visits to occur within 3 to 5 days.
Rationale: Minor textual changes, clarifications and corrections have been made.
Throughout the protocol

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,Date: 16 February 2023
SYNOPSIS
A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess the Efficacy, Immunogenicity
and Safety of an Ad26.RSV.preF-based Regimen in the Prevention of RT-PCR-confirmed RSV-mediated
Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
A human adenovirus-vectored vaccine candidate and a pre-fusion conformation-stabilized respiratory
syncytial virus (RSV) fusion (F) protein that have shown promise in preclinical animal models of RSV will
be assessed in this study:
 Ad26.RSV.preF (JNJ-64400141), a replication-incompetent adenovirus serotype 26 (Ad26) containing
a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein
(pre-F) derived from the RSV A2 strain.
 RSV preF protein (JNJ-64213175), a pre-fusion conformation-stabilized F protein derived from the RSV
A2 strain.
The active study vaccines used in the current study are Ad26.RSV.preF and RSV preF protein  each
administered alone as a single injection, and Ad26.RSV.preF/RSV preF protein mixture administered as a
single injection.
OBJECTIVES, ENDPOINTS, AND HYPOTHESIS
Objectives and Endpoints
Objectives 
Endpoints
PRIMARY
 To demonstrate the efficacy of active study vaccine in
the prevention of reverse transcriptase polymerase
chain reaction (RT-PCR)-confirmed RSV-mediated
lower respiratory tract disease (LRTD) according to
Case Definition #1a, when compared to placebo
 First occurrenceb of RT-PCR-confirmed
RSV-mediated LRTD according to Case
Definition #1
 To demonstrate the efficacy of active study vaccine in
the prevention of RT-PCR-confirmed RSV-mediated
LRTD according to Case Definition #2a, when
compared to placebo
 First occurrence of RT-PCR-confirmed RSV-
mediated LRTD according to Case Definition #2
 To demonstrate the efficacy of active study vaccine in
the prevention of RT-PCR-confirmed RSV-mediated
LRTD according to Case Definition #3a, when
compared to placebo
 First occurrence of RT-PCR-confirmed RSV-
mediated LRTD according to Case Definition #3
SECONDARY
 To assess the efficacy of active study vaccine in the
prevention of any RT-PCR-confirmed RSV disease
when compared to placebo
 First occurrence of any RT-PCR-confirmed RSV
disease
 In the Immuno Subset and in subgroups of this subset
(eg, participants at increased risk of severe RSV
disease), to evaluate the immunogenicity of active
study vaccine
 Characterization of the humoral and cellular
immune responses with emphasis on neutralizing
and binding antibodies and antigen-specific
cytokine production by T cells
a Clinical case definitions for RSV-mediated LRTD are presented in Section “Efficacy Evaluations” below.
b First occurrence of the considered endpoint is defined as the first episode of the considered endpoint in a given RSV
season (regardless ofRSV A or B strain, unless otherwise specified).

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Status: Approved,Date: 16 February 2023
Objectives 
Endpoints
 In the Safety Subset and in subgroups of this subset 
(eg, participants at increased risk of severe RSV 
disease), to evaluate the safety and reactogenicity in 
terms of solicited local and systemic adverse events 
(AEs) during 7 days after vaccination, and in terms of
unsolicited AEs during 28 days after vaccination
 Occurrence, severity, duration and relationship to
vaccination of solicited local and systemic AEs
during 7 days after vaccination and of unsolicited
AEs during 28 days after vaccination
 In the Revaccination Subcohorts, to evaluate the safety
and reactogenicity in terms of solicited local and
systemic AEs during 7 days after revaccination with
active study vaccine administered at 1, 2, or 3 years
after the first vaccination, and in terms of unsolicited
AEs during 28 days after revaccination
 Occurrence, severity, duration and relationship to
vaccination of solicited local and systemic AEs
during 7 days after revaccination at 1, 2, or 3 years
after the first vaccination and of unsolicited AEs
during 28 days after revaccination at 1, 2, or 3
years after the first vaccination
 To evaluate safety in terms of serious adverse events
(SAEs) during the RSV seasona
 To evaluate safety in terms of adverse events of special
interest (AESIs) during 6 months after revaccinationa
 Occurrence and relationship to vaccination of
SAEs during the RSV season
 Occurrence and relationship to vaccination of
AESIs during 6 months after revaccination
 To evaluate safety in terms of SAEs during the acute
respiratory infection (ARI) follow-up periodsb
 Occurrence and relationship to vaccination of
SAEs during the ARI follow-up periods
EXPLORATORY
 Explore the relationship between G-ELISA and
RT-PCR-confirmed RSV infection.
Provided a cut-off for G-ELISA fold-rise is found that
is sufficiently sensitive and specific, the following
objectives will be explored:
 Fold-rise in G-ELISA between ARI Day 3-5 and
ARI Day 29.
 First occurrence of any serology and/or
RT-PCR-confirmed RSV disease
a For participants who will not receive a revaccination, all SAEs will be reported from administration of study vaccine
on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes later). In addition,
SAEs classified as related to the study vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation,
and (S)AEs resulting from procedures and non-investigational (concomitant) Janssen products will be collected
during the entire study for all participants.
  For Revaccination Subcohort A, all SAEs will be reported from administration of study vaccine on Day 1 until the
end of the first RSV season (or 6 months after vaccination, whichever comes later), and from the time of
revaccination at Month 12 until the end of the second RSV season, or until 6 months after revaccination, whichever
comes later. For Revaccination Subcohort 2A, all SAEs and AESIs will also be collected from the time of
revaccination on Day 730 until 6 months after revaccination. For the other Revaccination Subcohorts (B and C),
SAEs and AESIs will be collected from the time of revaccination until 6 months thereafter. In addition, SAEs
classified as related to the study vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation, and
(S)AEs resulting from procedures and non-investigational (concomitant) Janssen products will be collected during
the entire study for all participants. For the participants in the Revaccination Subcohort C, these (S)AEs will be
collected retrospectively for the time period between the last end of the RSV season visit and the revaccination
upon the day of revaccination.
b For participants who will not receive a revaccination, SAEs associated with ARIs and complications related to ARIs
that classify as SAEs will be collected from the Day 365 (Month 12) visit until the end of the second RSV season,
from the end of the second RSV season until the Day 730 (Month 24) visit, and from the Day 730 (Month 24) visit
until the end of the third RSV season.
  For all Revaccination subcohorts, collection of SAEs associated with ARIs and complications related to ARIs that
classify as SAEs will stop at the end of the second RSV season for Subcohort A, on Day 730 (Month 24) for
Subcohort B, and at the latest at the end of the third RSV season for Subcohort C.

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Objectives 
Endpoints
 To assess the efficacy of active study vaccine in the
prevention of any serology and/or RT-PCR- 
confirmed RSV disease when compared to placebo 
 To assess the efficacy of active study vaccine in the 
prevention of serology-confirmed RSV-mediated
LRTD according to each case definition, when 
compared to placebo 
 To assess the efficacy of active study vaccine in the
prevention of any serology-confirmed RSV disease
when compared to placebo
 To assess the efficacy of active study vaccine in the
prevention of any serology and/or RT-PCR-
confirmed RSV-mediated LRTD according to each
case definition, when compared to placebo
 First occurrence of serology-confirmed
RSV-mediated LRTD according to each case
definition
 First occurrence of any serology-confirmed
RSV disease
 First occurrence of any serology and/or
RT-PCR-confirmed RSV-mediated LRTD
 If vaccine efficacy (VE) is demonstrated:
 To explore the efficacy of active study vaccine
during the second and third RSV season in the
prevention of RT-PCR-confirmed RSV-mediated
LRTD according to each of the 3 case definitions
in each RSV season, respectively, when compared
to placebo.
 To explore the efficacy of active study vaccine over
2 and 3 RSV seasons in the prevention of RT-PCR-
confirmed RSV-mediated LRTD according to each
of the 3 case definitions, when compared to
placebo
 The objectives assessed during the first year, might
also be explored during the second and third year
and over the 3-year period
 First occurrence of RT-PCR-confirmed RSV-
mediated LRTD during the second and third RSV
season according to each of the 3 case definitions
 First occurrence of RT-PCR-confirmed RSV-
mediated LRTD over 2 and over 3 RSV seasons
according to each of the 3 case definitions
 For objectives considering the VE during the
second and third season, the first occurrence of the
considered endpoint in the second and third season
will be assessed
 For objectives considering VE over 3 RSV seasons,
the first occurrence of the considered endpoint over
3 seasons will be assessed
 To assess the effect of active study vaccine on the
level of RSV infection when compared to placebo
 Assessment of the RSV viral load by quantitative
RT-PCR
 To explore the efficacy of active study vaccine in the
prevention of any RT-PCR-confirmed RSV disease
caused by an RSV A strain and any RT-PCR-
confirmed RSV disease caused by an RSV B strain
when compared to placebo
 First occurrence of any RT-PCR-confirmed RSV
disease caused by an RSV A strain or RSV B
strain,respectively
 To explore the effect of active study vaccine on the
potential complications of RSV disease and of any
respiratory disease
 First occurrence of potential complications of
respiratory disease (eg, pneumonia, new onset,
worsening, or an exacerbation of congestive heart
failure (CHF), asthma, and chronic obstructive
pulmonary disease (COPD) linked to any
respiratory disease and linked to any RT-PCR-
confirmed RSV disease

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Status: Approved,Date: 16 February 2023
Objectives 
Endpoints
 In the Revaccination Subcohorts, to evaluate humoral 
and cellular immunogenicity following a revaccination 
administered at 1 (humoral only), 2, or 3 years after the 
first vaccination 
 Characterization of the humoral and cellular
immune response following a revaccination at
1 (humoral only), 2, or 3 years after the first
vaccination, with emphasis on neutralizing and
binding antibodies
 To evaluate the immune response biomarkers in study 
participants as correlates of risk of RSV disease and as 
correlates of protection induced by the vaccine 
 Assessment of the correlation of humoral immune
responses with emphasis on neutralizing and
binding antibodies with the risk of RSV disease
and protection induced by the vaccine
 To explore biomarkers for the diagnosis of RSV 
infection and RSV disease severity  
 Assessment of blood samples collected during ARI
episodes for biomarkers that correlate with RSV
infection and RSV disease severity
 To explore the efficacy of active study vaccine against 
other respiratory diseases 
 Midturbinate nasal swabs may be tested for the
presence of other respiratory pathogens
 To explore the effect of active study vaccine on 
hospitalization in the overall populations and in 
subgroups 
 First occurrence of hospitalization linked to any
respiratory disease and linked to any RT-PCR
confirmed RSV disease
 To explore the impact of active study vaccine on the 
course of respiratory disease and general health status 
 Daily symptom severity reported by participants
using the Respiratory Infection Intensity and
Impact Questionnaire (RiiQ™)a, patient global
impression scales, temperature logs, Medical
Resource Utilization (MRU) and oxygen saturation
in participants with an ARI (RSV-confirmed or any
cause)
 To explore the impact of the baseline frailty and 
functioning in Instrumental Activities of Daily Living 
(IADL) on the incidence, severity, and duration of 
RT-PCR confirmed RSV-mediated LRTD  
 Assessment of RSV incidence (by RT-PCR), RSV
severity (per RiiQ questionnaire), and duration of
ARI episode(s) in relation to the baseline frailty
score and baseline Lawton-Brody IADL
 In Revaccination Subcohorts 2A and 2B, to explore 
the relative contribution of each component of the 
active vaccine on safety and reactogenicity in terms 
ofsolicited local and systemic AEs during 7 days after 
revaccination, and in terms of unsolicited AEs during
28 days after revaccination
 Occurrence, severity, duration, and relationship to
vaccination of solicited local and systemic AEs
during 7 days after revaccination and of unsolicited
AEs during 28 days after revaccination
 In Revaccination Subcohorts 2A and 2B, to explore
the relative contribution of each component of the
active vaccine on humoral and cellular
immunogenicity following revaccination
 Characterization of the humoral and cellular
immune response following revaccination, with
emphasis on neutralizing and binding antibodies
Hypothesis
The study is designedto test the primary hypothesis of VE in the Per-protocol Efficacy (PPE) population.
 The null hypothesis is that the VE for each of the 3 primary endpoints is ≤0%
 The alternative hypothesis is that the VE for at least one of the primary endpoints is >0%
a 
The Respiratory Infection Intensity and Impact Questionnaire used in this study is the RiiQ™ Version 2, 2018
(hereafter referred to as RiiQ).

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OVERVIEW OF STUDY DESIGN
This is a multi-center, randomized, double-blind, placebo-controlled Phase 2b proof-of-concept study to
establish VE of the study vaccine during the RSV season after single vaccination. A target of up to
5,800 participants (Cohort 1)a will be enrolled and randomized in parallel in a 1:1 ratio to 1 of 2 groups to
receive active study vaccine (Group 1) or placebo (Group 2).
Cohort 1 will contain the following subsets:
 Safety Subset (N=700): approximately 350 active study vaccine participants and 350 placebo
participants who have given informed consent for the additional study procedures for assessment of
safety.
 Immuno Subset (N=200 from selected study sites): approximately 100 active study vaccine participants
and 100 placebo participants who have given informed consent for the additional study procedures for
assessment of immunogenicity.
Under Amendment 4 (dated 25 August 2020), a subcohort of Cohort 1 participants will be implemented.
This Revaccination Subcohort (N=240) will consist of approximately 120 participants from Group 1 who
received active study vaccine on Day 1 and 120 participants from Group 2 who received placebo on Day
1, and who have given informed consent for the additional study procedures. Participants in this
Revaccination Subcohort will receive a revaccination with active study vaccine on Day 365 (Month 12,
1 year after the first vaccination) to assess the safety and immunogenicity of a second vaccination.
Under Amendment 5 (dated 04 February 2021), additional Revaccination Subcohorts will be implemented.
Participants in these additional Revaccination Subcohorts will receive a revaccination with active study
vaccine at 2, or 3 years after the first vaccination to assess the safety and immunogenicity of revaccination
with Ad26.RSV.preF/RSV preF protein mixture or with the individual vaccine components as indicated in
the table below.
Under Amendment 8 (dated 16 February 2023), Revaccination Subcohort D (ie, participants who would
have received a revaccination with the Ad26.RSV.preF/RSV preF protein mixture at 4 years after the first
vaccination) will be removed as additional data with a Month 48 revaccination timepoint are not expected
to provide novel insights on the kinetics of the immune response after revaccination with the
Ad26.RSV.preF/RSV preF protein mixture.
Note: Participants can be enrolledin both the Safety and the Immuno Subset. Participants in Revaccination
Subcohorts A and B cannot have participated in the Safety or the Immuno Subset.
Cohort/Group/ 
Subcohort 
Day 1 Vaccination 
Day 365 (Month 12) 
Revaccination  
Month 24 
Revaccination  
Month 36
Revaccination
(Amendment 4) 
(Amendment 5)
Cohort 1a,b
N=5,800
Group 1
N=2,900
Active vaccine mixture
     Safety Subsetc
(N 350)
     Immuno Subsetc
(N 100)
a 
In case 5,500 or more participants are enrolled from the Northern Hemisphere, no additional participants from the
Southern Hemisphere will be enrolled.

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Status: Approved,Date: 16 February 2023
Cohort/Group/
Subcohort
Day 1 Vaccination  
Day 365 (Month 12) 
Revaccination  
Month 24 
Revaccination  
Month 36
Revaccination
(Amendment 4) 
(Amendment 5)
Revaccination
Subcohort 1Ac
(N=120)
Active vaccine mixture Active vaccine mixture 
Revaccination 
Subcohort 1Bc
(N=135)
Active vaccine mixture 
Active vaccine mixture
Revaccination 
Subcohort 1Cc,d 
(N=120)
Active vaccine mixture 
Active vaccine
mixture
Group 2 
Placebo
N=2,900 
     Safety Subset c
(N 350)
     Immuno Subset c
(N 100)
Revaccination 
Subcohort 2Ac 
(N=120) 
Placebo 
Active vaccine mixture 
Ad26.RSV.preF alone
(N=40)
RSV preF protein
alone (N=40)
Active vaccine mixture
(N=40)
Revaccination 
Subcohort 2Bc 
(N=135) 
Placebo 
Active vaccine mixture Ad26.RSV.preF alone
(N=45)
RSV preF protein
alone (N=45)
Active vaccine
mixture (N=45)
Revaccination 
Subcohort 2Cc,d 
(N=120)
Placebo 
Active vaccine
mixture
Active vaccine mixture refers to Ad26.RSV.preF (1×1011 vp)/RSV preF protein (150 μg) administered as a single injection.
Ad26.RSV.preF alone refers to Ad26.RSV.preF at a dose of 1×1011 vp.
RSV preF protein alone refers to RSV preF protein at a dose of 150 μg.
a If 5,500 or more participants are enrolled from the NH, no additional participants from the SH will be enrolled. In addition,
if the number of participants enrolled in the NH is less than 5,500 but 18 or more RT PCR confirmed RSV mediated
LRTD events (using Case Definition #2) are observed in the NH before opening sites in the SH, no sites will be opened in
the SH and the study will be performed as a NH study only.
b The study progression beyond the first year is dependent on results obtained at the end of the first NH RSV season.
c Participants who provided separate informed consent.
d The study will continue with Revaccination Subcohort C depending on the 28 day post second vaccination analysis results
from Revaccination Subcohort B.
LRTD= lower respiratory tract disease, NH= Northern Hemisphere, SH= Southern Hemisphere, vp= viral particles
After administration of study vaccine, participants who experience any symptoms suggesting an ARIa
should contact the study site and start completing the eDiary ARI assessment on a daily basis (preferably
in the evening) and/or the study site should contact the participant if any ARI symptoms are recorded in the
eDiary. To help participants remember to report symptoms of a possible ARI, written instructions will be
provided, and an eDiary reminder will be sent to the participant's eDevice twice per week during all 3 RSV
seasons, as well as between the second and third RSV season. The reminder will ask participants if they
a 
An ARI is defined as the occurrence of at least one upper respiratory tract infection (URTI) or lower respiratory
tract infection (LRTI) symptom that the participant reports that is different or worse than he or she usually
experiences. See Attachment 1.

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Status: Approved,Date: 16 February 2023
have experienced any ARI symptoms, or for participants that have one or more of these symptoms at
baseline, if they have experienced any additional ARI symptoms or a worsening of their baseline symptoms.
Participants continue to receive daily reminders during an ARI episode until they report 2 consecutive days
without any symptoms of an ARI beyond those present at baseline. The daily eDiary ARI assessment will
then end and twice weekly reminders to complete the eDiary ARI surveillance assessment will resume.
All ARIs, all complications related to ARIs, and concomitant medications associated with ARIs will be
captured on the ARI form for all participants.
For participants in the Revaccination Subcohorts, follow-up of ARIs will stop at the end of the second RSV
season for Subcohort A, at the Day 730 (Month 24) visit for Subcohort B, and at the latest at the end of the
third RSV season for Subcohort C.
Procedures for Participants who Experience an ARI Episode
When any participant experiences any symptom of ARI, the following will take place:
 Participants should contact the site as soon as possible to notify the site of any symptoms suggesting
an ARI (such as rhinitis, nasal congestion, sore throat, cough, etc.), or the site will contact the
participants if ARI symptoms are recorded in the eDiary. During this telephone or telemedicine
contact, the site may confirm if the reported symptoms qualify as an ARI episode, in order to determine
whether to proceedwith the ARI procedures. The participant will then be reminded to:
 Complete the RiiQ Symptom Scale (Attachment 5) and the RiiQ Impact on Daily Activities Scale
(Attachment 11, as part of the Combined Impact Assessment), and thermometer readings every
evening (preferably), beginning on the evening of the day of symptom onset (ARI Day 1) until
the ARI episode resolves. The eDiary will also ask participants to complete the Patient Global
Impression of Health (PGI-H), the Patient Global Impression of Severity (PGI-S), the Patient
Global Impression of Change (PGI-C), and the Return to Usual Health question, as part of the
Combined Impact Assessment. (Note that the PGI-C and the Return to Usual Health question will
not be completed on ARI Day 1). A resolved ARI episode is defined as 2 consecutive days with
no symptoms listed on the RiiQ Symptom Scale, or, for participants who have RiiQ symptoms
present at baseline (assessed pre-vaccination for the first RSV season, at the Day 365 [Month 12]
visit for the second RSV season [pre-vaccination if applicable], and at the Day 730 [Month 24]
visit for the third RSV season), 2 consecutive days where all symptoms on the RiiQ Symptom
Scale have returned to the severity level reported at baseline.
If a participant is unable to complete the eDiary, a study staff member can collect information on
the participant’s symptoms and temperature, by contacting the participant by telephone or
telemedicine (or visit the participant at home), reading the questions aloud to the participant and
entering the participant’s responses on the site’s eDevice on the participant’s behalf.
 Collect a midturbinate nasal swab at home on the day of symptom onset or the day thereafter
(ARI Days 1-2). If the participant requires it, the participant's caregiver can assist the participant
to collect the midturbinate nasal swabs.
 Ensure the midturbinate nasal swabs collected at home are provided to the study staff within
4 days (preferably) after collection.
 Come to the site between 2 and 4 days after symptom onset (ARI Days 3-5), or, if a site visit is
not feasible, a member of the study staff can visit the participant at home (or at the hospital, if
needed) during this time frame.
 Between 2 and 4 days after symptom onset (ARI Days 3-5), a midturbinate nasal swab, a sputum
sample (in participants with a productive cough, when possible) and a blood sample for
seroconfirmation and exploration of biomarkers that correlate with RSV infection and RSV disease
severity  will be taken by a qualified member of the study  staff, and vital signs, including body

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temperature, blood pressure, heart rate, respiratory rate and oxygen saturation, will be measured. A
clinical assessment, including a targeted physical examination, will be completed by qualified study
staff, preferably by a physician, physician assistant, nurse practitioner or equivalent. The participant’s
functional status will also be evaluated by the Lawton-Brody  IADL questionnaire. The MRU
questionnaire will be completed based on clinical interview. The participant will complete all 4 scales
of the RiiQ v2 questionnaire on the site’s eDevice and provide the study staff member the midturbinate
nasal swab collected by the participant at home.
 At ARI Day 29 (±7 days), participants will be asked to return to the site where a blood sample will be
drawn for seroconfirmation and exploration of biomarkers that correlate with RSV infection and RSV
disease severity. A qualified member of the study staff will measure vital signs, including body
temperature, blood pressure, heart rate, respiratory rate and oxygen saturation. A clinical assessment
(including a targeted physical examination) will be performed by qualified study staff, preferably by
a physician, physician assistant, nurse practitioner or equivalent, and the Lawton-Brody  IADL
assessment and MRU questionnaire will be completed based on interview with the participant.
Participants will complete all 4 scales of the RiiQ questionnaire, and each of the PGI scales and the
Return to Usual Health question on the site’s eDevice.
For all medically attended ARIs, including those resulting in hospitalization, a standard question list will
be provided, with the aim to collect additional information on any other diagnostics (eg, chest x-rays,
spirometry, pulmonary function tests, etc.) or interventions during the clinical course of the ARI.
For participants who experience symptoms suggesting an ARI episode, RT-PCR assay of the midturbinate
nasal swabs and sputum sample (when available), taken after symptom onset will be used to determine
whether the infection was caused by RSVa. If at least one of these samples is positive for RSV, the collected
information will be applied against the clinical case definitions for RSV-mediated LRTD. For participants
hospitalized with symptoms of an ARI, confirmation of RSV infection using a Food and Drug
Administration (FDA)-approved RT-PCR test at the local (hospital) laboratory will also be obtained.
Site staff and participants will remain blinded as to the outcome of RT-PCR test results until study
unblinding, but participants and their routine health care professional (HCP) can obtain external diagnostics,
including RSV RT-PCR, as medically needed.
Collection of ARI data by the study site will be ceased for that particular episode if a participant has tested
positive for SARS-CoV-2 (by a local test that is FDA-approved or by central laboratory PCR).
At the end of the first and third RSV season, the study-site personnel will contact the participants by
telephone or telemedicine contact and read aloud the questions of the Lawton-Brody IADL questionnaire
to the participant and record the participant’s responses on the site’s eDevice. The RiiQ questionnaire and
the PGI-H will be completed by the participant in the eDiary or by telephone or telemedicine interview. At
the end of the second RSV season visit, the Lawton-Brody IADL questionnaire will be collected on-site by
interview with the participant and recorded on the site’s eDevice; the RiiQ and the PGI-H will be completed
by the participant on the site’s eDevice.
At the end of the first RSV season, each study participant will also be invited to complete an Independent
Ethics Committee (IEC)/Institutional Review Board (IRB) approved Experience Survey, to share to his/her
experience as a volunteer in this study. The responses will be collected by an external party and
anonymously provided to the sponsor.
An Independent Data Monitoring Committee (IDMC) will be commissioned for this study. In general, the
IDMC will monitor safety data on an ongoing basis to ensure the continuing safety of the participants. In
a 
For some secondary and exploratory endpoints, the determination will be made by serology.

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addition, the IDMC will formally monitor the efficacy endpoints at the time points specified under
Section “Planned Analyses” below.
During the interim analyses (IAs), as outlined in Figure 1 and Figure 2, the IDMC will evaluate in an
unblinded fashion whether superiority is established for at least one of the primary endpoints or whether
futility (conditional power <60%) is shown for all 3 multiple primary endpoints (only at the end of the RSV
seasona in the event of <18 RT-PCR-confirmed RSV-mediated LRTD events are observed).
The IDMC responsibilities, authorities, and procedures will be documented in its charter.
Figure 1: 
Flow Chart for the Primary Analysis in Case the Study is Performed at the Northern
Hemisphere Only
a Number of RT-PCR-confirmed RSV-mediated LRTD cases (based on Case Definition #2)
b The study will stop at the end of the RSV season or 6 months after vaccination on Day 1, whichever comes later.
CP =conditional power, IA =interim analysis, IDMC =Independent Data Monitoring Committee, LRTD =lower
respiratory tract disease,NH =Northern Hemisphere,PA =primary analysis, POC =proof of concept
a 
The end of the first RSV season is defined as the end of the NH RSV season in case the study is performed at the
NH only and as the end of the SH RSV season in case the study is performed at both hemispheres.

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Status: Approved,Date: 16 February 2023
Figure 2: 
Flow Chart for the Primary Analysis in Case the Study is Performed at the Northern and
Southern Hemisphere
a Number of RT-PCR-confirmed RSV-mediated LRTD cases (based on Case Definition #2).
b The study will stop at the end ofthe RSV season or 6 months after vaccination on Day 1, whichever comes later.
If the number of participants enrolled in the NH is <5,500 but ≥18 RT-PCR-confirmed RSV-mediated LRTD events
(using Case Definition #2) are observed in the NH before opening sites in the SH, no sites will be opened in the
SH and the study will be performed as a NH study only.
CP =conditional power, IA =interim analysis, IDMC =Independent Data Monitoring Committee, LRTD =lower
respiratory tract disease,NH =Northern Hemisphere, PA =primary analysis, POC =proof of concept,
SH =Southern Hemisphere
PARTICIPANT POPULATION
Participants will be adult men and women, aged ≥65 years on the day of signing the Informed Consent
Form (ICF). All participants will be in good or stable health (on the basis of physical examination, medical
history, and vital signs measurement performed on Day 1).
Participants aged ≥65 years are generally considered at high risk for severe disease. Participants in this age
range with chronic heart disease (CHF, coronary artery disease [eg, angina pectoris, ischemic
cardiomyopathy, history of myocardial infarct (MI), history of coronary artery bypass graft or coronary
artery stent]) and chronic lung disease (eg, asthma and COPD) are generally at even higher risk for severe
RSV disease; hereafter, this population will be referred to as “increased risk”. Participants at increased risk
for severe RSV disease due to these underlying medical conditions will be enrolled in the study.
Randomization will be set up to ensure enrollment of 350 participants at increased risk for severe RSV
disease in the Safety Subset and 50 participants at increased risk for severe RSV disease in the Immuno
Subset. Participants with severe chronic cardiac and lung diseases will be excluded from the study.

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
DOSAGE AND ADMINISTRATION
The active study vaccines used in this study are Ad26.RSV.preF and RSV preF protein each administered
alone as a single injection  in the deltoid muscle, and an Ad26.RSV.preF/RSV preF protein mixture
administered as a single injection in the deltoid muscle. All injections will be 1 mL in volume.
 Ad26.RSV.preF (JNJ-64400141) will be supplied at a concentration of 2×1011 vp (viral particles)/1 mL
in single-use vials. Dose levels of 1×1011 vp will be used.
 RSV preF protein (JNJ-64213175) will be supplied at a concentration of 0.3 mg/1 mL in single-use
vials. Dose levels of 150 µg will be used.
 Placebo for Ad26.RSV.preF and RSV preF protein.
On Day 1, an unblinded pharmacist, or other qualified individual, who will have no other study function
will prepare the appropriate vial and/or syringe, labeled with the participant’s identification number, and
provide the syringes for Ad26.RSV.preF/RSV preF protein and placebo in a blinded manner to the blinded
study vaccine administrator who will perform the injection.
The blinding for study vaccination received on Day 1 will be maintained for site and participants until the
database lock for the final analysis of the considered cohort, except for the participants in Revaccination
Subcohorts A and B, who will be unblinded to the Day 1 vaccination prior to re-randomization to the third
vaccination: participants who received active vaccine on Day 1 will complete the study  at that time,
participants who received placebo on Day 1 will be re-randomized to receive either Ad26.RSV.preF/RSV
preF protein mixture or the individual vaccine components in a blinded fashion.
EFFICACY EVALUATIONS
This is a proof-of-concept study to test VE. The vaccine is not expected to be 100% efficacious.
VE will be evaluated based on the first occurrence of RT-PCR-confirmed RSV-mediated LRTD (cases
defined according to the 3 primary endpoint definitions) in the active vaccine group compared to the placebo
group in the PPE population. The case definitions are defined as follows:
Case Definition #1 
Case Definition #2 
Case Definition #3
≥3 symptoms of LRTI 
(new onset or worsening) 
≥2 symptoms of LRTI
(new onset or worsening)
≥2 symptoms of LRTI,
OR
≥1 symptom of LRTI
combined with
≥1 systemic symptom
(new onset or worsening)
LRTI =lower respiratory tract infection
To meet the primary endpoint according to the respective case definitions the following criteria will be
taken into account:
 symptoms reported by participants on the RiiQ Symptom Scale and body temperature during the full
ARI episode OR
 clinical assessment terms reported by a qualified study staff member during the ARI Days 3-5 clinical
visit
in combination with
 confirmation of RSV by RT-PCR in one or more of the midturbinate nasal swabs, or in the sputum
sample (when available)

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Status: Approved,Date: 16 February 2023
Of note, on the day of the ARI Days 3-5 clinical visit, the case definitions can be met by symptoms reported
by participants on the RiiQ or by signs and symptoms reported by the qualified study staff member. Case
definitions cannot be met by a combination of symptoms reported by the participant with signs and
symptoms reported by the qualified study staff member.
Confirmation of RSV infection by RT-PCR (midturbinate swabs and sputum sample, when available) will
be performed at the central laboratory. For participants hospitalized with symptoms of an ARI, confirmation
of RSV infection using an FDA-approved RT-PCR test at the local (hospital) laboratory will also be used
for the analysis of case definitions if results from the central laboratory are not available. One positive
sample (defined as any sample with a value above the limit of detection) is sufficient.
As a sensitivity analysis, the analysis of the primary endpoint will be repeated, but participants with RSV
infection and a co-infection with at least one other respiratory virus (ie,confirmed using an FDA approved
RT-PCR test in one or more of the midturbinate nasal swabs, or in the sputum sample, when available) will
not be considered as a case for that episode, as the etiology of the symptoms will be indeterminate.
As an additional sensitivity analysis, the analysis of the primary endpoint will be repeated, taking into
account only the RT-PCR test results from the central laboratory (ie, excluding the local test results for
hospitalized participants).
Presence and severity of symptoms will be collected using participant responses to the RiiQ Symptom Scale
and temperature readings participants report in the eDiary each day throughout each ARI episode. On the
day of the ARI Days 3-5 clinical visit, signs and symptoms will also be collected by qualifiedstudy staff in
a clinical assessment.
Symptoms (new onset or worsening) occurring at the same day will be counted. When during ARI Days 3-5,
symptoms are reported more than once per day by the participant (eg, on the site’s eDevice and in the
participant eDiary), the worst severity from the RiiQ will be taken into account. On the day of the ARI
Days 3-5 clinical visit, signs and symptoms collected during the clinical assessment by a qualified study
staff member will be considered separately from the symptoms reported by the participant on the site’s
eDevice or in the participant eDiary. A new onset of a symptom is a symptom that is reported during the
ARI episode and that was not reported at baseline (defined by pre-dose assessment onthe day of vaccination
for the first RSV season, the Day 365 [Month 12] visit for the second RSV season [pre-vaccination if
applicable], and at the Day 730 [Month 24] visit for the third RSV season). Worsening of a symptom is
defined as a symptom that is reported at baseline (defined by pre-dose assessment on the day of vaccination
for the first RSV season, at the Day 365 visit for the second RSV season [pre-vaccination if applicable],
and at the Day 730 visit for the third RSV season) that worsens inseverity during the ARI episode compared
to baseline.
First occurrence of a considered endpoint is defined as the first episode of the considered endpoint in a
given RSV season (regardless A or B strain, unless otherwise specified).
RT-PCR assay of the midturbinate nasal swabs,anda sputum sample (whenavailable),taken after symptom
onset will be used to determine whether the infection was caused by RSV. For RSV positive cases, the RSV
subtype, viral load and presence of other respiratory pathogens will also be determined from the
midturbinate nasal swabs. Samples from RSV negative ARI episodes may also be assessed for the presence
of other respiratory pathogens.
IMMUNOGENICITY EVALUATIONS
Blood will be collected from all participants for humoral immunogenicity assessments before vaccination
(Day 1),and 14 days and 1 year after vaccination. These samples will be used for humoral immunogenicity
assessments for participants experiencing an ARI episode during the RSV season.

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
For participants in the Immuno Subset (approximately 100 active study vaccine participants and
100 placebo participants), blood will be collected for analysis of humoral and cellular immune responses
before vaccination on Day 1 and at 14 days, 84 days, 24 weeks, 1 year, 18 months, 24 months, and
30 months after vaccination on Day 1.
Humoral immune responses in the Revaccination Subcohorts will be assessed in approximately
240 participants in Revaccination Subcohorts A and C, and in approximately 270 participants in
Revaccination Subcohort B at the time points indicated in the Schedules of Activities for Revaccination
Subcohorts. Cellular immune responses will be assessed in all participants (at certified sites) in
Revaccination Subcohort 2A after the thirdvaccination andin Revaccination Subcohort B after the second
and third vaccination. Cellular immune responses will be assessed in  a subset of approximately
100 participants (approximately 50 per group) in Revaccination Subcohort C.
Immunogenicity assessments may include, but are not limited to,the assays summarized below.
Humoral Assays 
Purpose
Secondary endpoints
RSV neutralization A 
Analysis of neutralizing antibodies to an A strain
F protein antibodies 
(ELISA; pre F and/or post F)
Analysis of antibodies binding to RSV F protein in pre fusion and/or post fusion form
Exploratory endpoints
RSV strain cross neutralization 
Analysis of cross neutralizing antibodies to B and/or a different A strain(s)
F protein antibody specificity 
characterization 
Pre and post F specificity by binding or functional assays such as ELISA, and/or
competition ELISA. Adsorption of serum with pre F and post F protein before any
antibody assay, epitope mapping, functional VNAs
G protein antibodies (ELISA) 
Analysis of antibodies binding to RSV G protein
Adenovirus neutralization assay  
Analysis of neutralizing antibodies to adenovirus
Functional and molecular 
antibody characterization 
Analysis of antibody characteristics including, but not limited to, ADCC, ADCP,
avidity, other respiratory viral neutralizing or binding assays, Ig isotype, functional
VNAs to other respiratory viruses, and antibody assessments for antibody repertoire
Transcriptomic analysis 
RNA transcriptomic analysis maybe conducted in the revaccination subcohorts to
assess regulation of genes (clusters) and expression patterns
ADCC =antibody dependent cell mediated cytotoxicity, ADCP =antibody dependent cellular phagocytosis,
ELISA =enzyme linked immunosorbent assay, F =fusion, G =glycoprotein, Ig =immunoglobulin, RNA =ribonucleic acid;
VNA =virus neutralizing antibody
Note: Antibody analyses might be performed in nasosorption samples and serum.
The abovementioned assays might be performed on samples of the Revaccination Subcohorts to assess exploratory
endpoints.
Cellular Assays 
Purpose
Secondary endpoints
IFN γ ELISpot 
T cell IFN γ responses to RSV F protein peptides
Exploratory endpoints
ICS  
Analysis of T cell responses to RSV F protein peptide stimulated PBMC (including,
but not limited to, CD4+/CD8+, IL 2, IFN γ, TNF α, activation markers and memory)
Chemokine/cytokine analysis 
Levels of chemokines and cytokines in nasosorption samples or produced by
antigen stimulated PBMC
Sequencing of B cells 
Including but not limited to sequencing of BCR (B cell receptor) or VH/VL
(heavy/light chain characterization) for specificity
ELISpot =enzyme linked immunospot, F =fusion; ICS =intracellular cytokine staining,IFN γ =interferon gamma,
IL 2 =interleukin 2,PBMC =peripheral blood mononuclear cells,TNF α =tumor necrosis factor alpha
Nasosorption samples using synthetic absorptive matrix (SAM) will be taken from Immuno Subset
participants prior to vaccination (Day 1) and at the 14 days post-vaccination visit and will be used for
immunogenicity assessments including,but not limited to immunogenicity assessments of antigen specific
immunoglobulins (IgG and IgA), microbiome and pathogen analysis.

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
Blood samples collected between 2 and 4 days after symptom onset (ARI Days 3-5) and at 28 days after
symptom onset (ARI Day 29) from participants who experience ARI episodes will be assayed by serology
(including but not limited to RSV virus neutralizing antibodies [VNAs] or ELISA specific to RSV protein
G [glycoprotein] as available and applicable) for RSV exposure confirmation. These samples will also be
used for exploration of biomarkers that correlate with RSV infection and RSV disease severity (including
but not limited to RT-PCR for RSV, RNA transcriptomics to assess regulation of genes [clusters] and
expression patterns, cytokine/chemokine analysis as available and applicable). Additionally,these samples
might be used for other pathogen exposure seroconfirmation.
MEDICAL RESOURCE UTILIZATION
Baseline MRU will be collected from all participants prior to vaccination. MRU data will be collected from
all participants with an ARI episode, using the MRU Questionnaire completed during study visits at ARI
Days 3-5 and ARI Day 29 (±7 days) of each ARI episode.
SAFETY EVALUATIONS
Adverse Events
All participants
All participants will be closely observed for a minimum of 30 minutes after vaccination to monitor for the
development of any acute reactions, or longer if deemed necessary by the investigator.
For all participants, SAEs will be collected from administration of study vaccine on Day 1 until the end of
the first RSV season (or 6 months after vaccination, whichever comes later).a
For all participants, some subsets of SAEs will be collected for additional study periodsa:
 ARIs and complications related to ARIs that classify as SAEs will be captured and will be reported as
SAEs in the electronic case report form (eCRF) for the duration of the second RSV season, between
the second and the third RSV season, and for the duration of the third RSV season.
 From the time of vaccination (Day 1) until the end of the study period for each participant, SAEs
classified as related to the study vaccine, SAEs resulting in death, and (S)AEs leading to
discontinuation from the study will be collected.
 During the entire study, (S)AEs and special reporting situations related to study procedures or to non-
investigational (concomitant) Janssen products will be reported from the time a signed and dated ICF
is obtained onwards until the end of the study period for each participant.
The (S)AE listing in the eCRF will not be updated based on the RSV RT-PCR results and will remain listed
on the eCRF as ARIs.
Safety Subset and Revaccination Subcohorts
Additional procedures will be carried out in the Safety Subset following vaccination on Day 1 and in the
Revaccination Subcohorts following revaccination on Day 365 (Month 12)/Day 730 (Month 24)/Day 1,095
(Month 36), as described below:
 Solicited local (at the injection site) AEs, solicited systemic AEs, and body temperatures will be recorded
in the eDiary (or a paper diary, ifdesignated by the sponsor), beginning on the evening of the vaccine
a 
The windows for SAE collection in the Revaccination Subcohorts are described below under “Safety Subset and
Revaccination Subcohorts”.

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
dosing day and on a daily basis for the following 7 days. If a solicited AE has not resolved 7 days post-
vaccination, it will continue to be followed-up until the event has returned to baseline.
 Any unsolicited, solicited local or systemic AEs will be documented in the eCRF by study-site personnel
following the 30-minutes observation period. In addition, vital signs (body temperature, blood pressure,
heart rate, respiratory rate, and oxygen saturation) will be obtained at the end of the observation period.
 All other (unsolicited) AEs and special reporting situations will be reported from the time of vaccination
through the following 28 days. Safety Subset participants will be contacted by telephone or telemedicine
contact at 28 days (+3 days) after vaccination to collect information on unsolicited AEs; for participants
in the Revaccination Subcohorts, this information will be collected at the 28-day (+3 days) post-
revaccination visit.
 All ARIs and all complications related to ARIs will be reported as AEs in the eCRF from the time of
vaccination through the following 28 days.
For Revaccination Subcohort A, all SAEs will be reported from administration of study vaccine on Day 1
until the end of the first RSV season (or 6 months after vaccination, whichever comes later), and from the
time of revaccination at Month 12 until the end of the second RSV season, or until 6 months after
revaccination, whichever comes later. For Revaccination Subcohort 2A, all SAEs and AESIs will also be
collected from the time of revaccination on Day 730 until 6 months after revaccination. For Revaccination
Subcohorts B and C, all SAEs and AESIs will be collected from the time of revaccination until 6 months
thereafter. Collection of SAEs associated with ARIs and complications related to ARIs that classify as
SAEs will stop at the end of the second RSV season for Subcohort A, on Day 730 (Month 24) for Subcohort
B, and at the latest at the end of the third RSV season for Subcohort C.
For all Revaccination Subcohorts, SAEs classified as related to the study vaccine, SAEs resulting in death,
(S)AEs leading to discontinuation from the study, and (S)AEs and special reporting situations related to
study procedures or to non-investigational (concomitant) Janssen products will be collected during the
entire study for all participants. For the participants in the Revaccination Subcohort C, these (S)AEs will
be collected retrospectively for the time period between the last end of the RSV season visit and the
revaccination upon the day of revaccination.
Other Safety Evaluations
Vital Signs
 Heart rate, respiratory rate, supine systolic blood pressure and supine diastolic blood pressure
 Body temperature
 Oxygen saturation (SpO2)
Physical Examination
A full physical examination, including body weight, will be carried out before each vaccination. Height
will be measured on Day 1 only.
STATISTICAL METHODS
Sample Size Determination
Efficacy
Under the following assumptions:
 a VE for Case Definition #2 of 70%

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
 and an incidence of Case Definition #2 of 0.75% in placebo recipients during the RSV season, assuming
vaccination occurs before the RSV season
 3 primary endpoints which are nested
 a 1-sided α of 5% (total; corrections are performed for multiple endpoints and for IAs
 10% of exclusions (due to drop-out, major protocol deviations, etc.
Simulations performed in R show that for a Northern Hemisphere (NH) only study, 2,750 participants per
vaccination group result in 80% total power to demonstrate VE >0 for Case Definition #2 at the end of the
RSV season, resulting in a total sample size of5,500 participants. The end of the first RSV season is then
defined as the end of the NH RSV season.
In case recruitment is not completed in the NH (and <18 RT-PCR-confirmed RSV-mediated LRTD events
[using Case Definition #2] are observed in the NH before opening sites in the Southern Hemisphere [SH]),
enrollment will continue in the SH. As there is the possibility to have an early IA during the NH or SH RSV
season, an additional 150 participants per vaccination group is needed to have 80% total power to
demonstrate VE >0 for Case Definition #2 at the end of the RSV season. The end of the first RSV season
is defined as the end of the SH RSV season in case the study is performed at both hemispheres. So, if
recruitment is spread over 2 hemispheres, the total sample size will be 5,800 participants.
With respect to Case Definitions #1 and #3, further simulations showed that the powerto obtain a significant
result for any case definition, after multiplicity correction that control the type I error at 5%, tended to be
similar or better than for Case Definition #2 alone, without multiplicity correction.
Immuno Subset
Immunogenicity will be assessed in the Immuno Subset, ie, approximately 200 participants, of whom
~100 are active study vaccine participants. Approximately 25% of participants in the Immuno Subset in
each region will be at increased risk of severe RSV disease.
The table below shows the actual distance from the mean to the limits of 95% CI around the actual value at
Day 15 for different assays, accounting for 10% of exclusions with the current sample size for the Immuno
Subset.
Distance from the Mean to the Limits of 95% CI for Pre-F ELISA, VNA, and ELISpot.
N 
(Active 
Group) 
Pre-F ELISA  
(SD=1.3) 
VNA  
(SD=1.5) 
ELISpot
(SD=1.2)
Distancea 
from 
Mean to 
Limits 
95%CI 
95%CI if 
Observed 
Mean is 
eg, 6,000 
Distancea 
from 
Mean to 
Limits 
95%CI 
95%CI if 
Observed 
Mean is 
eg, 6,500 
Distancea 
from 
Mean to 
Limits 
95%CI
95%CI if
Observed
Mean is
eg, 400
All 
100 
0.272 
(4,969;7,245) 
0.314 
(5,229;8,080) 
0.251 
(336;476)
Increased
Risk  
25 
0.576 
(4,025;8,944) 
0.665 
(4,099;10,306) 
0.532 
(277;578)
CI = confidence interval, ELISA = enzyme-linked immunosorbent assay, ELISpot = enzyme-linked immunospot, SD
= standard deviation, VNA = virus neutralization assay
a. 
Calculated on the log2-scale.
Safety Subset
With ~350 active study vaccine participants in the Safety Subset, the observation of 0 events in the database
would be associated with 95% confidence that the true rate is <1%. For SAEs, which are captured in all
participants, the observation of 0 events in the database would be associated with 95% confidence that the
true rate is <0.1%.

VAC18193  (JNJ-64400141/JNJ-64213175)
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CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,Date: 16 February 2023
In addition, a cap will be installed to ensure that 350 participants in the Safety Subset (~175 in each group)
are at increased risk for severe RSV disease. With 175 active study vaccine participants at increased risk of
severe RSV disease in the Safety Subset, the observation of 0 events (solicited or unsolicited) in the
database would be associated with 95% confidence that the true rate in participants at increased risk of
severe RSV disease is <1.7%.
SAEs will be captured in all participants. Outside the Safety Subset and Immuno Subset, no cap is installed
on the number of participants at increased risk of severe RSV disease. It is expected that participants at
increased risk  for severe RSV disease will represent approximately 30% of the overall population.
Assuming that 30% of the participants in the overall population are at increased risk of severe RSV disease
(~870 participants), the observation of 0 events in participants at increased risk of severe RSV disease
would be associated with 95% confidence that the true rate is <0.4%.
The following table shows the probabilities of observing at least one AE in one of the arms at given true
AE rates in the Safety Subset (overall population and participants at increased risk of severe RSV disease).
Probability of Observing at Least One Adverse Event in N Participants
True Adverse 
Overall 
Increased Risk
Event Rate 
N=350 
N=2,900 
N=175 
N=870a
0.1% 
30%  
95% 
16%  
58%
0.5% 
83%  
100%  
58% 
99%
1%  
97% 
100%  
83%  
100%
2.5% 
>99.9%  
100%  
99% 
100%
a Approximate number
Revaccination Subcohorts
Immunogenicity
Immunogenicity will also be assessed in participants of the Revaccination Subcohorts, which consist of
~120 participants (Revaccination Subcohorts A and C) or ~135 participants (Revaccination Subcohort B)
who received active study vaccine on Day 1 and ~120 participants (Revaccination Subcohorts A andC) or
~135 participants (Revaccination Subcohort B) who received placebo on  Day 1 for a total of ~750
participants. All participants in the Revaccination Subcohorts will receive a second vaccination with active
study vaccine: on Day 365 (Month 12) (Revaccination Subcohort A), on Day 730 (Month 24)
(Revaccination Subcohort B), or on Day1,095 (Month36) (Revaccination Subcohort C).
The geometric mean of the titer ratios (GMRs) between Day 15 post first vaccination and Day 15 post
second vaccination within a group, as well as the ratio of Day 15 post second vaccination between the
2 groups (active study vaccine versus placebo on Day 1), for the different assays will be calculated.
The table below shows the actual distance from the mean to the limits of 95% CI around the ratio between
Day 15 post first vaccination and Day 15 post second vaccination within a group for the different assays.
The calculations consider an exclusion rate of 10% from the sample size of revaccinated participants
(~108 participants per group for Revaccination Subcohorts A and C, and ~120 participants per group for
Revaccination Subcohort B).

VAC18193  (JNJ-64400141/JNJ-64213175)
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CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,Date: 16 February 2023
Distance From the Mean to the Limits of 95% CI Around the Ratio Between Day 15 Post First Vaccination
and Day 15 Post Second Vaccination Within a Group for Pre-F ELISA, VNA, and ELISpot
Revaccination 
Subcohort 
Assay  
N (per 
group) 
Distancea from
Mean to Limits
95%CI
95%CI if Observed
Ratio is 1
A and C 
Pre-F ELISA (SD=1.3) 
120 
0.248 
(0.84;1.19)
VNA A2 (SD=1.5) 
120 
0.286 
(0.82;1.22)
ELISpot (SD=1.2)* 
50 
0.341 
(0.79; 1.27)
B 
Pre-F ELISA (SD=1.3) 
135 
0.235 
(0.85; 1.18)
VNA A2 (SD=1.5) 
135 
0.271 
(0.83; 1.21)
ELISpot (SD=1.2) 
135 
0.217 
(0.86;1.16)
CI = confidence interval, ELISA = enzyme-linked immunosorbent assay, ELISpot = enzyme-linked immunospot
(assay), SD = standard deviation, VNA = virus neutralization assay
a Calculated on the log2-scale assuming a correlation of 0.5 between the 2 timepoints.
*: No PBMC samples are taken for Revaccination Subcohort A.
The table below shows the actual distance from the mean to the limits of 95% CI around the Day 15 post
second vaccination  ratio between the 2 groups, for the different assays. The calculations consider an
exclusion rate of 10% from the sample size of revaccinated participants (~108 participants per group for
Revaccination Subcohorts A and C, and ~120 participants per group for Revaccination Subcohort B).
Distance From the Mean to the Limits of 95% CI Around the Ratio on Day 15 Post Second Vaccination
Between the Two Groups for Pre-F ELISA, VNA and ELISpot
Revaccination 
Subcohort 
Assay
N (per 
group) 
Distancea from Mean 
to Limits 95%CI 
95%CI if Observed
Ratio is 1
A and C 
Pre-F ELISA (SD=1.3) 
120 
0.349 
(0.79;1.27)
VNA (SD=1.5) 
120 
0.402 
(0.76;1.32)
ELISpot (SD=1.2)* 
50 
0.476 
(0.72; 1.39)
B 
Pre-F ELISA (SD=1.3) 
135 
0.331 
(0.79;1.26)
VNA  A2 (SD=1.5) 
135 
0.381  
(0.77; 1.30)
ELISpot (SD=1.2) 
135 
0.305 
(0.81; 1.24)
CI = confidence interval, ELISA = enzyme-linked immunosorbent assay, ELISpot = enzyme-linked immunospot
(assay), SD = standard deviation, VNA = virus neutralization assay
a Calculated on the log2-scale.
*: No PBMC samples are taken for Revaccination Subcohort A.
Safety
With ~240 active study vaccine participants in Revaccination Subcohorts A and C, and ~270 active study
vaccine participants in Revaccination Subcohort B, the observation of 0 events in the database would be
associated with 95% confidence that the true rate is <1.5%.
The table below shows the probabilities of observing at least 1 AE in one of the arms at given true AE rates
in the Revaccination Subcohorts.

VAC18193  (JNJ-64400141/JNJ-64213175)
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CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,Date: 16 February 2023
True 
Adverse
Event
Rate 
Revaccination Subcohorts A and C 
Revaccination Subcohort B
Overall 
Per Group  
Overall 
Per Group
N=240 a 
N=120 a 
N=270 a 
N=135a 
0.1% 
21% 
11%  
24%  
13%
0.5% 
70% 
45% 
74% 
49%
1%  
91%  
70% 
93%  
74%
2.5% 
>99.9%  
95% 
100%  
97%
a Approximate number
Analysis Sets
 The Full Analysis Set (FAS) will include all randomized participants with a documented vaccine
administration, regardless of the occurrence of protocol deviations. The FAS is the primary safety
population. The analysis of solicited and unsolicited AEs after the Day 1 vaccination will be restricted
to a subset of the FAS (ie, the Safety Subset).a The analysis of solicited and unsolicited AEs after
revaccination on Day 365 (Month 12)/Day 730 (Month 24)/Day 1,095 (Month 36) will be restricted to
participants of the Revaccination Subcohorts that are part of the FAS.
 The Per-protocol Immunogenicity (PPI) population will include all randomized and vaccinated
participants for whom immunogenicity data are available. Samples taken after a participant experienced
a major protocol deviation expecting to impact the immunogenicity outcomes will be excluded from the
PPI. The analysis of immunogenicity will focus on 2 subsets of the PPI, ie, the Immuno Subset and the
Revaccination Subcohorts.
In addition, for participants who experience a natural RSV infection (based on RT-PCR, or other
sources), samples taken after the natural infection will not be taken into account in the assessment of the
immunogenicity.
The PPI population is the primary immunogenicity population. For key tables, sensitivity
immunogenicity analyses will also be performed on the FAS, including participants for whom
immunogenicity measures are available. Excluded samples might be taken into account as well in the
sensitivity analysis.
 The Per-protocol Efficacy (PPE) population will include all randomized and vaccinated participants
excluding participants with major protocol deviations expecting to impact the efficacy outcomes. Any
participant with an RT-PCR-confirmed RSV-mediated ARI with onset within 14 days after vaccination
will be excluded from the PPE population. Participants who discontinue within 14 days after vaccination
will be excluded from the PPE population as well.
The PPE population is the primary efficacy population. Sensitivity efficacy analyses will also be
performed on the FAS. For exploratory efficacy analyses focusing on data from the second RSV season
only, the participants of Revaccination Subcohort A will be additionally excluded. For analyses focusing
on data from the third RSV season, participants of Revaccination Subcohorts A and B will be excluded.
For exploratory efficacy analyses focusing on data over 2 RSV seasons, the second RSV season data
will be excluded for the participants of Revaccination Subcohort A. For analyses focusing on data over
3 RSV seasons, second and third RSV season data will be excluded for the participants of Revaccination
Subcohort A, and third RSV season data will be excluded for participants of Revaccination Subcohort
B. Participants who develop major protocol deviations expecting to impact the efficacy outcomes and
a 
The specification of this subset for analysis of solicited and unsolicited AEs does not preclude the investigator
from reporting an AE in any participant if he/she considers the event to be of clinical relevance and/or related to
the study vaccine.

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Status: Approved,Date: 16 February 2023
occurring up to the considered RSV season will be additionally excluded from the PPE when focusing
on data including the second or third RSV season.
Planned Analyses
Recruitment Completed in the Northern Hemisphere Only (Target Sample Size ≥5,500)
If participants are only enrolled in the NH and if by the end of the first NH RSV season (database cut-off
of 15 May 2020) ≥18 RT-PCR-confirmed RSV-mediated LRTD events (using Case Definition #2) are
observed, the study will be unblinded for the sponsor and the primary analysis will be performed by the
sponsor.
If, by the end of the first NH RSV season, <18 RT-PCR-confirmed RSV-mediated LRTD events (using
Case Definition #2) are observed, an IA will be performed by the IDMC. The IDMC will evaluate in an
unblinded fashion if superiority is established for at least one of the primary endpoints.
 In the event of superiority, the sponsor will be notified. The database used for the IDMC analysis will
be unblinded for the sponsor and the primary analysis will be performed by the sponsor.
 If superiority is not demonstrated, the IDMC will evaluate the conditional power to demonstrate proof
of concept (under the original assumptions of incidence and VE) if 2,000 new participants are added
to the study. If the conditional power is <60%, the database used for the IDMC analysis will be
unblinded for the sponsor and the primary analysis will be performed by the sponsor. If the conditional
power is ≥60%, 2,000 new participants (Cohort 2) will be added to the study who will be followed up
for one RSV season. The ongoing participants from Cohort 1 will be stopped at the end of RSV season
or 6 months after last vaccination whatever comes later.
Recruitment Spread Over the Northern and the Southern Hemisphere (Target Sample Size up to 5,800)
If the number of participants enrolled in the NH is <5,500 and <18 RT-PCR-confirmed RSV-mediated
LRTD events (using Case Definition #2) are observed in the NH before opening sites in the SHa, additional
participants will be enrolled in the SH up to a total sample size (NH and SH combined) of
5,800 participants. In that case, a single IA may be performed during the NH or SH RSV season. This
“early” IA will be performed by the IDMC at the earliest of those 2 predetermined time points
(15 May 2020 or 15 August 2020) where ≥14 events (RT-PCR-confirmed RSV-mediated LRTD cases per
Case Definition #2) are observed. If the early IA is performed, the IDMC will evaluate in an unblinded
fashion if superiority is established for at least one of the primary endpoints. The IDMC will notify the
sponsor of the outcome. In the event of superiority, the database used for the IDMC analysis will be
unblinded for the sponsor and the primary analysis will be performed by the sponsor. If superiority is not
shown at the IA or if the number of RT-PCR-confirmed RSV-mediated LRTD cases (using Case
Definition #2) is <14 at the second time point (15 August 2020), the primary analysis will be performed at
the end of the SH RSV season (database cut-off of 30 October 2020) in a similar way as in a NH study
only.
The IA plan is outlined in Figure 1 in case the study is performed in the NH only, and in Figure 2 in case
the study is performed in the NH and SH.
a 
If the number of participants enrolled in the NH is less than 5,500 and 18 or more RT-PCR-confirmed RSV-
mediated LRTD events (using Case Definition #2) are observed in the NH before opening sites in the SH, no sites
will be opened in the SH and the study will be performed as a NH study only.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
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Status: Approved,Date: 16 February 2023
Additional Analyses
If in a NH+SH study VE is demonstrated at the early IA, an additional analysis will be performed at the
end of the RSV season. This will count as supportive information.
If VE is demonstrated at the end of the first NH RSV season, the study will continue and the ongoing
participants from Cohort 1 will be followed up for a second RSV season. If this is the case, additional
analyses will be performed at the end of the second RSV season to evaluate if there is a trend for durable
efficacy. If analyses at the end of the second RSV season indicate a trend for durable efficacy or in case
results on durability are inconclusive, the study will continue and the ongoing participants from Cohort 1
will be followed up for a third RSV season. If this is the case, additional analyses will be performed at the
end of the third RSV season to further evaluate durability of efficacy.
Analysis 28Days Post Second Vaccination in Revaccination Subcohorts A, B, and C
This analysis will be done for each Revaccination Subcohort (A, B, and C) and will include safety and
immunogenicity data from the considered Revaccination Subcohort. The analysis will be performed on
unblinded data. Data collected up to the time of the 28-day post second vaccination visit for the last
participant in the considered Revaccination Subcohort will be included in the analysis.
The blind will be maintained at the participant/site level, with respect to the vaccination received on Day 1
until the database lock for the final analysis of the considered cohort, except for the participants in
Revaccination Subcohorts A and B, who will be unblinded to the Day 1 vaccination prior to
re-randomization to the third vaccination: participants who received active vaccine on Day 1 will complete
the study at that time, participants who received placebo on Day 1 will be re-randomized to receive either
Ad26.RSV.preF/RSV preF protein mixture or the individual vaccine components in a blinded fashion.
End of Season 2 Analysis
This analysis will include all efficacy, safety, and immunogenicity data collected up to the time of the end
of the second RSV season. If the number of RSV-positive cases observed during the second season is low,
the efficacy analysis might be restricted to a listingof major efficacy endpoints in RSV-positive participants
during the second RSV season. In case no RSV cases are reported, then the end of Season 2 analysis might
be restricted to only safety and immunogenicity.
This analysis might be split in 2 parts given the availability of the data. The first part will include all
efficacy, safety, and immunogenicity data collected until the end of the second RSV season and the second
part will include additional safety data collected between the end of the second RSV season and the end of
the SAE safety follow-up.
Analysis of Revaccination Subcohorts A and B, when Revaccination Subcohorts 2A and 2B have reached
the 28 Days Post Third Vaccination Timepoint
This analysis will be done separately for each Revaccination Subcohort (A and B) and will include safety
and immunogenicity data from the considered Revaccination Subcohort. The analysis will be performedon
unblinded data. Data collected up to the time of the 28-day post third vaccination visit for the last participant
in the considered Revaccination Subcohort will be included in the analysis.
The blind will be maintained at the participant/site level, with respect to the vaccination received on Day 1
until the database lock for the final analysis of the considered cohort, except for the participants in
Revaccination Subcohorts A and B, who will be unblinded to the Day 1 vaccination prior to
re-randomization to the third vaccination: participants who received active vaccine on Day 1 will complete
the study at that time, participants who received placebo on Day 1 will be re-randomized to receive either
Ad26.RSV.preF/RSV preF protein mixture or the individual vaccine components in a blinded fashion.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
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Status: Approved,Date: 16 February 2023
End of Efficacy Study Analysis
This analysis will include all efficacy, safety, and immunogenicity data collected until the end of the third
RSV season. Efficacy data collected up to the end of the third season visit for the last participant will be
included in the analysis.
The end of efficacy study analysis will be performed on unblinded data.
Final Analysis of Revaccination Subcohorts (A, B, and C).
This analysis will be done for each Revaccination Subcohort (A, B, and C) and will include safety and
immunogenicity data from the considered Revaccination Subcohort. The analysis will be performed on
unblinded data. Data collected up to the last visit for the last participant in the considered Revaccination
Subcohort will be included in the analysis.
Early Stop ARI Surveillance in 2020
Due to the increasing incidence of COVID-19 cases, it is becoming increasingly difficult to conduct ARI
surveillance, without putting staff or study participants at risk. As the first RSV season is nearing a close,
a decision has been made to stop ARI surveillance for the first RSV season under Amendment 2.
Unplanned Snapshot Interim Analysis
An unplanned snapshot IA may be performed to allow for early decision making on capacity planning for
the Ad26 SARS-CoV2, which is being developed for the prophylactic immunization against SARS-CoV-2
infection, and Ad26.RSV.preF vaccines. This is especially important for the production capacity in 2020
and 2021. The results of this unplanned snapshot IA will only be shared with select members of upper
management not involved in the conduct of the study. This will be described in more detail in a separate
charter.
Since this unplanned snapshot IA will only be used for internal decision making, will not further affect the
conduct of the study, and it is not expected that the number of events will drastically change for the primary
analysis, no type I error adjustment will be applied. The success of the study will solely depend on the
results of the primary analysis.
Efficacy Analyses
Primary Efficacy Endpoints
Any analysis of the primary endpoints for VE will evaluate the number of participants with (at least one
episode of) RT-PCR-confirmed RSV-mediated LRTD (cases defined according to the 3 primary endpoint
definitions) in the active vaccine group compared to the placebo group in the PPE population. Time at risk
will also be taken into account.
The α-levels for all efficacy analyses will be adjustedto account for the multiple endpoint approach and for
multiple analyses. Both methods will be combined to come to one cut-off that will be used to define
significance. The exact values depend on the number of cases already observed at the time of (interim)
analysis.
For each of the 3 primary endpoints the following will be performed: an exact Poisson regression will be
fitted with the event rate, defined as the number of cases over the follow-up time (offset) as dependent
variable and the vaccination group and age and being at increased risk for severe RSV disease (both as
stratified) as independent variables. For cases, the follow-up time is defined as the time between vaccination
and the occurrence of the first event (according to the considered endpoint), for non-cases, it is the time
between vaccination and the end of season visit. However, for participants that discontinued before the end
of the season and had an event (according to the considered endpoint), the follow-up time is defined as the
time between vaccination and the occurrence of the first event and for participants that discontinued before

VAC18193  (JNJ-64400141/JNJ-64213175)
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Status: Approved,Date: 16 February 2023
having an event, follow-up time is the time between vaccination and the date of last contact. Thus, all
participants are included in the analysis according to their follow-up time. The exact p-value corresponding
to vaccination group will be compared with the cut-off as described above.
If the p-value is below the cut-off for at least 1 of the 3 primary endpoints, proof of concept is demonstrated.
The individual 2-sided CIs (1-2 × cut-off) for the VE (1-relative risk rate), measured by each of the
3 endpoints, will be calculated from the regression model described above.
The primary analysis will be performed on the PPE population, which will take cases into account with an
onset at least 14 days after vaccination.
As a sensitivity analysis, the above model will be repeated based on the FAS (which also does not take into
account the restriction on the onset [at least 14 days] and will count cases from vaccination on Day 1
onwards). Additional sensitivity analyses will include an exact binomial test, not taking into account the
strata, based on the PPE population and the FAS. The VE (=1-relative risk) and the corresponding corrected
2-sided CI based on the exact binomial will be calculated as well.
The Clinical Evaluation Committee (CEC) review will assess, independently and based on CRF/eDiary
data, the location of the ARI (upper or lower respiratory tract infection) and the ARI severity. The CEC
assessment, as well as other information based on MRU, presence of clinically relevant disease, use of
therapeutic interventions, RiiQ, clinical assessment, Lawton-Brody IADL, and change in frailty will be
used to evaluate the severity of the RSV-positive ARIs, and will be used to explore the relation with the
case definitions.
Secondary Efficacy Endpoints
For each of the secondary endpoints an exact Poisson regression will be fitted in a similar way as for the
primary endpoint. The 95% 2-sided CI for the VE (1-relative risk rate) will be calculated from the regression
model described above.
In addition, for each of the secondary endpoints, the proportion of participants with an event will be
tabulated. The corresponding VE (1-relative risk) and the 95% 2-sided CI will be calculated without taking
the strata into account based on an exact binomial test.
Exploratory Efficacy Endpoints
For endpoints that intend to explore VE, an exact Poisson regression model will be fitted in a similar way
as for the primary endpoint. The 95% 2-sided CI for the VE (1-relative risk rate) will be calculated from
the regression model described above.
For continuous endpoints, actual values will be summarized descriptively as well as changes from baseline
(if meaningful). Categorical endpoints will be tabulated.
Immunogenicity Analyses
No formal statistical testing of the immunogenicity data is planned. All immunogenicity analyses will be
performed on the PPI population. Key tables might be repeated for the FAS (including samples that are
excluded from the PPI analysis).
Immuno Subset
No formal hypothesis on immunogenicity will be tested. Descriptive statistics (geometric mean and 95%
CI for ELISA and RSV neutralization assay; median and quartiles for IFN-γ ELISpot and ICS) will be
calculated for continuous immunologic parameters at all time points. For the humoral assays, geometric
mean fold rises from baseline and corresponding 95% CIs might additionally be calculated. Baseline is
considered as the last available assessment before the vaccination. Graphical representations of
immunologic parameters will be made as applicable.

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Status: Approved,Date: 16 February 2023
The impact of baseline factors on the humoral and cellular responses will be explored graphically or via
descriptive statistics.
Revaccination Subcohorts
No formal hypothesis on immunogenicity will be testedfor Revaccination Subcohorts. Descriptive statistics
(geometric mean and 95% CI for ELISA and RSV neutralization assay, median and quartiles for IFN-γ
ELISpot) will be calculated for continuous immunologic parameters at all time points. Geometric mean
fold rises from baseline and corresponding 95% CIs might additionally be calculated. Geometric mean
ratios and corresponding 95% CIs between Day 15 post first vaccination and Day 15 post second
vaccination within the group receiving active study vaccine on Day 1 and the day of the second vaccination
depending on the Revaccination Subcohort will be calculated for the different assays.
In addition, the GMT ratios with corresponding 95% CIs of Day 15 post second vaccination for the group
receiving active study vaccine twice versus the group receiving placebo first and active study vaccine 1, 2,
or 3years later will also be calculated for the different assays. Therefore, an analysis of variance (ANOVA)
model will be fitted with the respective titers as dependent variable and group as independent variable. The
estimate and CIs obtained as such will be back transformed (by exponentiation) to a GMT ratio and the
corresponding CI. As a sensitivity analysis, different variances between the groups will be allowed,
therefore the CIs will be calculated via Welsh’s ANOVA.
For Revaccination Subcohorts 2A and 2B that get a third vaccination with Ad26.RSV.preF/RSV preF
protein mixture or with the individual vaccine components, no formal hypothesis is tested; descriptive
statistics over time after the third vaccination will be calculated.
Graphical representations of immunologic parameters will be made as applicable.
The impact of baseline factors on the humoral responses will be explored graphically or via descriptive
statistics.
Correlates of Risk
IfVE is demonstrated, correlates of risk will be explored. More details with appropriate methods will then
be provided in a separate SAP.
Medical Resource Utilization Analyses
Medical resource utilization will be descriptively summarized.
Safety Analyses
No formal statistical testing of safety data is planned. Safety data by vaccination group and based on the
FAS will be analyzed descriptively. The analysis of solicited and unsolicited AEs will be restricted to a
subset of the FAS (ie, the Safety Subset). For SAEs, the complete FAS is considered. The impact of baseline
factors (eg, being at increased risk for severe RSV disease) might be explored as well. Additionally, the
analysis of solicited and unsolicited AEs and AESIs (if collected) will also be performed for each of the
Revaccination Subcohorts and will be restricted to participants of the Revaccination Subcohorts that are
part of the FAS.
Any ARI recorded as an (S)AE in the eCRF  will be excluded from any AE analysis if the laboratory
RT-PCR is subsequently found to be positive for RSV. ARIs arising from RSV infection will not be reported
as (S)AEs in the Clinical Study Report as they are endpoints of the study and will be tabulated separately.
Patient-reported Outcomes
Patient reported outcomes will be descriptively analyzed.

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48
Status: Approved,Date: 16 February 2023
SCHEDULE OF ACTIVITIES–COHORT 1 (N=5,800)*
Per Amendment 5, this schedule is for all participants in Cohort 1 who are not included in a Revaccination Subcohort. The procedures and
assessments for participants in a Revaccination Subcohort (A, B, or C) are shown  in separate schedules. Participants for Revaccination
Subcohort B will be identified at the end ofthe second RSV season, and participants for Revaccination Subcohorts C will be identified at the
end of the third RSV season.
Clinic Visit # 
1 
2 
2a  
2b 
2ca 
3 a  
4b,c 
5,a,b,c 
6a,b,c 
7b,c 
8a,b,c 
9b 
Visit Timing
Vac 1 
Vac 1 
+14 d  
Vac 1 
+28 d  
Vac 1 
+84 d  
Vac 1 
+24 
we 
End 1 st 
RSV 
Seasond 
Vac 1 
+ 365d
Vac 1
+18 mo
End 2nd  
RSV
Seasond 
Vac 1 
+730 d 
Vac 1 
+30 mo
End of
3 rd  RSV
Seasond
Visit Week 
0 
2 
4 
12 
24 
52 
76 
104 
130
Visit Day  
1 
15f 
29f 
85f 
169f 
365 
533f 
730 
912f
Visit Window  
+3 d  
+3 d  
±7 d  
±14 d  
+35 d  
±2 mo 
±14 d  
-7/+14 d  
±2 mokk  
±14 d  
-7/+14 d
Visit Type
Screening and
VACCINATION 1
ALL
PARTICIPANTS
SAFETY SUBSET
ONLY
IMMUNO SUBSET
ONLY
IMMUNO SUBSET
ONLY
ALL
PARTICIPANTS
ALL
PARTICIPANTS
IMMUNO SUBSET
ONLY
ALL
PARTICIPANTS
ALL
PARTICIPANTS
(except Revaccc.
Subcohorts A+B)
IMMUNO SUBSET
ONLY
ALL
PARTICIPANTS
(except Revaccc.
Subcohorts A+B)
Written informed consent g
 
 

Inclusion/exclusion criteria

Demographics

Medical history

Medical conditions of interest h
 
 j 
j
Pre-vaccination medications i

Check for seasonal influenza and SARS-CoV-2
vaccination
 
 
 
 
 
 

Physical examination k
 
 

Randomization l

Clinical assessment m(collected by study staff)
 
 

Lawton-Brody IADL q
 
p 
 
 
 
p
eDiary training and distribution r
 
s 
 

RiiQTM v2
n 
o 
n 
 
n 
o
* 
In case the study will only be conducted at the Northern Hemisphere (NH), a target number of 5,500 participants will be enrolled and randomized.

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Footnotes:
a. For Immuno Subset participants, where the timing of the 24-week,18 months, or 30 months post-vaccination visits and the end of RSV season visits overlap,
procedures can be combined.
b. Visits 4 to 9 will only take place when the study progresses beyond the first year (see Figure 1 and Figure 2).
c. An optional visit could be scheduled during the second and third RSV season for additional eDiary re-training and midturbinate nasal swab kit re-training. In
addition, an optional telephone call or contact by telemedicine may take place to discuss participation in a Revaccination Subcohort and/or extension of the study.
d. At the end of the first RSV season or 6 months after vaccination, whichever comes later, and at the end of the second and third RSV season. Of note, for the NH,
the end of the first RSV season for the onset of an ARI is defined as 20 March 2020,the end of the second RSV season for the onset of an ARI will be defined as
17 May 2021, and the end of the third RSV season for the onset of an ARI will be defined as 15 April 2022. The defined end-of-season dates for the second and
third NH RSV season may be updated in case there would be indications of a shift in season. The end of the RSV season for the SH countries is country/territory-
specific and will be specified to the sites prior to the start of dosing in the SH.
e. When the window for the end ofseason visit at the end of the first NH RSV season (as defined in footnote d) is not coinciding with at least 6 months SAE
follow-up, a separate SAE safety follow-up call should be conducted 6 months after vaccination and captured as an unscheduled visit.
f. 
The timings of the post-vaccination visits will be determined relative to the actual day of vaccination in the first RSV season.
g. Signing the ICF should be done before any study-related activity on Day 1 and resigned on Day 365 and no later than the end of the second RSV season.
Participants in the Immuno Subset and/or Safety Subset will need to consent for the additional study procedures in these subsets.
h. Medical conditions of interest will be used in the calculation of the frailty index score. For collection of medical conditions of interest, refer to Section 9.2.1.3.
i. 
Therapies administered up to 30 days before vaccination on Day 1 will be recorded.
j. 
Medical conditions of interest will be re-assessed to capture any changes that may have developed between the start of the study and the Day 365 visit, and
between the Day 365 and the Day 730 visit,and to understand if any participants have developed chronic heart and lung conditions.
k. A full physical examination, including height and body weight, will be carried out before the vaccination for the first RSV season and at the Day 365 and the
Day 730 visit for the second and third RSV season, respectively. Note: height should only be measured on Day 1.
l. 
A cap will be installed to ensure that 50 participants (from selected sites) enrolled in the Immuno Subset and 350 participants (from all sites) enrolled in the Safety
Subset are at increased risk for severe RSV disease, ie,chronic heart disease (congestive heart failure [CHF], coronary artery disease [eg, angina pectoris, ischemic
cardiomyopathy, history of myocardial infarct (MI), history of coronary artery bypass graft or coronary artery stent]) and chronic lung disease (eg, asthma and
chronic obstructive pulmonary disease [COPD]).
m. Includes measurement of vital signs (supine systolic and diastolic blood pressure, heart rate, respiratory rate,oxygen saturation [after at least 5 minutes rest] and
body temperature) by a qualified member of the study staff, and a targeted physical examination by qualified study staff, preferably by a physician, physician
assistant, nurse practitioner or equivalent. It is recommended that vital signs are measured before collection of midturbinate nasal swabs and/or nasosorption
samples and blood draws. The sponsor’s preference is to enter the results of the clinical assessment directly in the site’s eDevice, however, the results may be
collected on paper first and transferred to the site’s eDevice afterwards, on the same day as the assessments.
n. The RiiQ and the PGI-H will be completed before vaccination for the first RSV season and at the Day 365 and the Day 730 visit for the second and third RSV
season, respectively,by the participant on the site’s eDevice.
o. The RiiQ and the PGI-H at the end of each RSV season will be completed by the participant in the eDiary or by telephone or telemedicine contact. If completed by
telephone or telemedicine interview, the study-site personnel will read aloud the questions to the participant and record the participant’s responses on the site’s
eDevice.
p. The Lawton-Brody at the end of each RSV season will be completed by telephone or telemedicine contact. The study-site personnel will read aloud the questions
to the participant and record the participant’s responses on the site’s eDevice.
q. The Lawton-Brody IADL and MRU will be collected before vaccination for the first RSV season and at the Day 365 and Day 730 visits for the second and third
RSV season, respectively,by interview with the participant and recorded on the site’s eDevice.

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r. Participants may use their own eDevice using a study-specific application instead if their device (smartphone or tablet) is compatible. eDevices provided to
participants should be returned to the site at the end of the third RSV season. Participants using their own eDevice will be instructed to delete the app from their
personal device. A paper safety diary may be used, ifdesignated by the sponsor.
s. Participants will be re-trained on how to use the eDiary, if needed, and on how to collect a midturbinate nasal swab.
t. 
To include Inclusion Criteria 1, 7, 8, and 9 and Exclusion Criteria 7, 11, 14.2, 17, and 18.
u. All participants will be closely observed for a minimum of 30 minutes post-vaccination. For Safety Subset participants, any unsolicited, solicited local and
systemic AEs will be documented by study-site personnel following this observation period and vital signs (body temperature, blood pressure, heart rate,
respiratory rate, and oxygen saturation) will be obtained at the end of the observation period. Any clinically relevant abnormalities must be recorded on the adverse
event page of the eCRF. Actual values (normal and abnormal) will only be documented in the eCRF for body temperature.
v. All SAEs will be reported from administration of study vaccine on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later). From the Day 365 visit until the end of the second RSV season, from the end of the second RSV season until the Day 730 (Month 24) visit, and from the
Day 730 visit until the end of the third RSV season, SAEs associated with ARIs and complications related to ARIs that classify as SAEs will be collected. In
addition, SAEs classified as related to the study vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation and (S)AEs resulting from procedures
and non-investigational (concomitant) Janssen products will be collected during the entire study.
w. Concomitant medications will be collected for all participants when associated with an SAE. Note: refer to footnote v for the SAEs collected during the RSV
seasons.
x. On Day 365 and Day 730, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
y. During all 3 RSV seasons, and between the second and third RSV season, ARI surveillance will be via the eDiary which participants must complete at least twice
weekly. Procedures in the event of an ARI are described in the Schedule ofActivities –Assessments for Participants with an ARI Episode.
z. The cut-off date for the ARI surveillance of the first NH RSV season is 20 March 2020,17 May 2021 for the second NH RSV season, and 15 April 2022 for the
third NH RSV season. The defined end-of-season dates for the second and third NH RSV season may be updated in case there would be indications of a shift in
season.
aa. Each study participant will be invited to complete an IEC/IRB approved Experience Survey, to share to his/her experience as a volunteer in this study. The
responses will be collected by an external party and anonymously provided to the sponsor.
bb. Blood for humoral immune assessments before vaccination on Day 1 and 14,365, and 730 days after vaccination on Day 1 will be drawn from all participants.
cc. Aliquots of serum samples collected for immunogenicity tests can be reconverted for participant’s safety purposes upon sponsor request. Please refer to Table 13
for a non-exhaustive list of tests that may be requested to be performed on these samples in case of potential AESI reporting.
dd. Blood for humoral immune responses at the time points indicated will be drawn only from Immuno Subset participants.
ee. Blood for cellular immune responses at the time points indicated will be drawn only from Immuno Subset participants.
ff. Solicited local and systemic AEs will be collected via the eDiaries from vaccination until 7 days after the vaccination for Safety Subset participants. If a solicited
AE has not resolved 7 days post-vaccination, it will continue to be followed-up until the event has returned to baseline.
gg. All AEs and special reporting situations related to study procedures or to non-investigational (concomitant) Janssen products will be reported from ICF signature
onwards until the end of the study for all participants. All other AEs (unsolicited) and special reporting situations will be reported from the vaccination through the
following 28 days for Safety Subset participants only.
hh. Safety Subset participants will be contacted by telephone or telemedicine contact at 28 days (+3 days) after the vaccination to collect information on unsolicited
AEs and any special reporting situations.
ii. Concomitant medications will be collected from the time of the vaccination, through the following 28 days for Safety Subset participants only.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
53
Status: Approved,Date: 16 February 2023
jj. Vital signs (body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) will be obtained at the end of the observation period. Any
clinically relevant abnormalities must be recorded on the adverse event page of the eCRF. Actual values (normal and abnormal) will only be documented in the
eCRF for body temperature.
kk. The Day 730 visit should take place no later than by the end of November 2021.
ll. Participants may be provided a new nasal swab kit in case of expiration of their current kit.
AE =adverse event,ARI =acute respiratory infection,d=day,eCRF=electronic Case Report Form, IADL =Instrumental Activities of Daily Living,ICF =informed consent
form, IEC/IRB =Independent Ethics Committee/Institutional Review Board, mo =month, MRU =Medical Resource Utilization, NH =Northern Hemisphere, PGI-H
=Patient Global Impression of Health,RiiQ=Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) v2 (2018),RSV =respiratory syncytial virus,SAE =serious
adverse event,SAM =synthetic absorptive matrix,SARS-CoV-2 =Severe Acute Respiratory Syndrome Coronavirus-2, SH = Southern Hemisphere, vac =vaccination,we
=week

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
54
Status: Approved,Date: 16 February 2023
SCHEDULE OF ACTIVITIES –COHORT 2 (N=2,000)*
Clinic Visit # 
1 
2 
3 
Visit Timing 
Vac 
Vac
+14 d
End RSV Seasona
Visit Week 
0 
2
Visit Day  
1 
15b
Visit Window  
+3 d  
-7/+14 d
Visit Type
Screening and
VACCINATION
ALL
PARTICIPANTS
ALL
PARTICIPANTS
Written informed consent c

Inclusion/exclusion criteria

Demographics

Medical history

Medical conditions of interest d

Pre-vaccination medications e

Check for seasonal influenza and SARS-CoV-2 vaccination
 

Physical examination f

Randomization

Clinical assessment g (collected by study staff)

Lawton-Brody IADL k
 
j
eDiary training and distribution l
 
m
RiiQTM v2
h 
i
Patient Global Impression of Health (PGI-H)
h 
i
MRU questionnaire (baseline version) k

Midturbinate nasal swab kit training and distribution
 
m
Thermometer training and distribution

Vaccination

30-minute post-vaccination observation n

* 
If proof of concept is not demonstrated at the interim analysis and there is evidence for efficacy (assessed via conditional power), 2,000 new participants will be added
to the study who will be vaccinated in the next NH RSV season and followed up for one RSV season. For details refer to Section 11.12.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
56
Status: Approved,Date: 16 February 2023
Footnotes:
a. At the end of the RSV season or 6 months after vaccination, whichever comes later.
b. The timings of the post-vaccination visits will be determined relative to the actual day of vaccination.
c. Signing the ICF should be done before any study-related activity.
d. Medical conditions of interest will be used in the calculation of the frailty index score. For collection of medical conditions of interest, refer to Section 9.2.1.3.
e. Therapies administered up to 30 days before vaccination will be recorded.
f. 
A full physical examination, including height and body weight, will be carried out before vaccination.
g. Includes measurement of vital signs (supine systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation [after at least 5 minutes rest] and
body temperature) by a qualified member of the study staff, and a targeted physical examination by qualified study staff, preferably by a physician, physician
assistant, nurse practitioner or equivalent. It is recommended that vital signs are measured before collection of midturbinate nasal swabs and/or nasosorption
samples and blood draws. The sponsor’s preference is to enter the results of the clinical assessment directly in the site’s eDevice, however, the results may be
collected on paper first and transferred to the site’s eDevice afterwards, on the same day as the assessments.
h. The RiiQ and the PGI-H will be completed before vaccination by the participant on the site’s eDevice.
i. 
The RiiQ and the PGI-H at the end of the RSV season will be completed by the participant in the eDiary or by telephone or telemedicine contact. If completed by
telephone or telemedicine interview, the study-site personnel will read aloud the questions to the participant and record the participant’s responses on the site’s
eDevice.
j. 
The Lawton-Brody at the end of the RSV season will be completed by telephone or telemedicine contact. The study-site personnel will read aloud the questions to
the participant and record the participant’s responses on the site’s eDevice.
k. The Lawton-Brody IADL and MRU will be collected before vaccination by interview with the participant and recorded on the site’s eDevice.
l. 
Participants may use their own eDevice using a study-specific application instead if their device (smartphone or tablet) is compatible. eDevices provided to
participants should be returned to the site at the end of the RSV season. Participants using their own eDevice will be instructed to delete the app from their personal
device. A paper safety diary may be used, ifdesignated by the sponsor.
m. Participants will be re-trained on how to use the eDiary, if needed, and on how to collect a midturbinate nasal swab.
n. All participants will be closely observed for a minimum of 30 minutes post-vaccination.
o. All SAEs related to study procedures or to non-investigational (concomitant) Janssen products will be reported from ICF signature onwards until the end of the
study for all participants. All other SAEs will be reported from administration of study vaccine until the end of the RSV season (or 6 months after vaccination,
whichever comes later) for all participants.
p. Concomitant medications will be collected when associated with any SAE.
q. During the RSV season, ARI surveillance will be via the eDiary which participants must complete at least twice weekly. Procedures in the event of an ARI are
described in the Schedule ofActivities –Assessments for Participants with an ARI Episode.
r. Each study participant will be invited to complete an IEC/IRB approved Experience Survey, to share to his/her experience as a volunteer in this study. The
responses will be collected by an external party and anonymously provided to the sponsor.
s. Blood for humoral immune assessments pre-dose on Day 1 and 14 days after vaccination will be drawn from all participants.
AE =adverse event,ARI =acute respiratory infection,d=day,IADL =Instrumental Activities of Daily Living,ICF =informed consent form,IEC/IRB=Independent Ethics
Committee/Institutional Review Board, MRU =Medical Resource Utilization, PGI-H =Patient Global Impression of Health, RiiQ =Respiratory Infection Intensity and
Impact Questionnaire (RiiQ™) v2 (2018), RSV  =respiratory syncytial virus, SAE  =serious adverse event, SARS-CoV-2=Severe Acute Respiratory Syndrome
Coronavirus-2, vac =vaccination

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
57
Status: Approved,Date: 16 February 2023
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORT 1A (N=120)
Participants in Revaccination Subcohort 1A received active vaccine on Day 1 (Group 1) and will receive a revaccination at 1 year (Day 365)
after the first vaccination. In the table below, all visits that overlap with the Schedule ofActivities
Cohort 1 (N 5,800) are greyed out.*
Clinic Visit # 
1 
2 
2a  
3  
4 
5 
5a 
5b 
5ca 
6a 
7
Visit Timing 
Vac 1 
Vac 1 
+14 d  
Vac 1 
+28 d  
End of 
1st RSV 
Season 
Vac 2 
Vac 2 
+14 d  
Vac 2 
+28 d  
Vac 2 
+84 d  
Vac 2 
+24 we 
End of
2nd RSV
Season
Vac 2
+52 we/
Visit Month  
0 
1 
12 
13 
15 
18 
24
Visit Day  
1 
15b 
29b 
365b 
379b 
393b 
449b 
533b 
730b
Visit Window  
+3 d  
+3 d  
+35 d  
±2 mo 
+3 d 
relative 
to Vac 2 
+3 d 
relative 
to Vac 2 
±7 d 
relative 
to Vac 2 
±14 d 
relative 
to Vac 2 
7/+14 d  
±1 mo
relative to
Vac 2cc
Revaccination Subcohort 1A (N=120)
Written informed consent c 

Written informed consent for participation in
subcohort
d 
e
Inclusion/exclusion criteria 

Demographics 

Medical history 

Medical conditions of interest 
f 
g
Pre vaccination medications 
h 
 i
Check for seasonal influenza and SARS CoV 2
vaccination
 
 
 
 
 
 

Physical examination j 
 

Randomization 

Clinical assessment k(collected by study staff) 
 

RiiQTM v2 l 
 
m 
 

Patient Global Impression of Health (PGI H) l 
 
m 
 

Lawton Brody IADL n 
 
o 
 

MRU questionnaire (baseline version) n 
 

eDiary training and distribution p 
 
q 
q
* Participants in Revaccination Subcohort 1A cannot have participated in the Immuno Subset of Cohort 1. Therefore, visits from the Schedule ofActivities –Cohort 1
(N=5,800) which pertain to the Immuno Subset only (Day 85 and Day 169) are not included here.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
59
Status: Approved,Date: 16 February 2023
The symbol may refer to a telephone call or a telemedicine interview/contact.
Footnotes:
a. For participants where the timing of the 24-week post-vaccination visit and the end-of-season visit overlap, procedures can be combined.
b. The visit day is relative to the actual day of vaccination in the first RSV season. The timing of the visit day is determined by the visit window relative to the last
vaccination.
c. Signing the ICF should be done before any study-related activity on Day 1.
d. Signing of the separate ICF for participation in the subcohort should be done before or at the start of the Day 365 visit.
e. Signing of a separate ICF for the Day 730 visit should be done at the end of second RSV season visit.
f. 
Medical conditions of interest will be used in the calculation of the frailty index score. For collection of medical conditions of interest, refer to Section 9.2.1.3.
g. Medical conditions of interest will be re-assessed to capture any changes that may have developed between the start of the study and revaccination and to
understand if any participants have developed chronic heart and lung conditions. For collection of medical conditions of interest, refer to Section 9.2.1.3.
h. Therapies administered up to 30 days before vaccination on Day 1 will be recorded.
i. 
Before revaccination, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
j. 
A full physical examination, including height (Day 1 only) and body weight, will be carried out before vaccination.
k. Includes measurement of vital signs (supine systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation [after at least 5 minutes rest] and
body temperature) by a qualified member of the study staff, and a targeted physical examination by qualified study staff, preferably by a physician, physician
assistant, nurse practitioner or equivalent. It is recommended that vital signs are measured before collection of midturbinate nasal swabs and blood draws. The
sponsor’s preference is to enter the results of the clinical assessment directly in the site’s eDevice, however, the results may be collected on paper first and
transferred to the site’s eDevice afterwards, on the same day as the assessments.
l. 
The RiiQ and the PGI-H will be completed before vaccination on Day 1/Day 365 by the participant on the site’s eDevice.
m. The RiiQ and the PGI-H at the end-of-season visit will be completed by the participant in the eDiary or by telephone or telemedicine contact. If completed by
telephone or telemedicine interview, the study-site personnel will read aloud the questions to the participant and record the participant’s responses on the site’s
eDevice.
n. The Lawton-Brody IADL and MRU will be collected before vaccination on Day 1/Day 365 by interview with the participant and recorded on the site’s eDevice.
o. The Lawton-Brody at the end-of-season visit will be completed by telephone or telemedicine contact. The study-site personnel will read aloud the questions to the
participant and record the participant’s responses on the site’s eDevice.
p. Participants may use their own eDevice using a study-specific application instead if their device (smartphone or tablet) is compatible. eDevices provided to
participants should be returned to the site at the end of their study participation. Participants using their own eDevice will be instructed to delete the app from their
personal device. A paper diary may be used as indicated by the sponsor.
q. Participants will be re-trained on how to use the eDiary, if needed, and on how to collect a midturbinate nasal swab.
r. To include Inclusion Criteria 5.1, 6, and 7 and Exclusion Criteria 1, 2, 4, 12, 13, 14.2,  20.1, 21.1, and 22.
s. All participants will be closely observed for a minimum of 30 minutes post-revaccination. Any unsolicited,solicited local and systemic AEs will be documented by
study-site personnel following this observation period. Vital signs (body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) will be
obtained at the end of the observation period. Any clinically relevant abnormalities must be recorded on the AE page of the eCRF. Actual values (normal and
abnormal) will only be documented in the eCRF for body temperature.
t. 
Solicited local and systemic AEs will be collected from vaccination until 7 days after vaccination. If a solicited AE has not resolved 7 days post-vaccination, it will
continue to be followed-up until the event has returned to baseline.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
60
Status: Approved,Date: 16 February 2023
u. All AEs and special reporting situations related to study procedures or to non-investigational (concomitant) Janssen products will be reported from ICF signature
onwards until the end of the participant’s study participation. All other AEs (unsolicited) and special reporting situations will be reported from revaccination
through the following 28 days.
v. All SAEs will be reported from administration of study vaccine on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later), and all SAEs will be reported from revaccination on Day 365 until the end of the second RSV season (or 6 months after vaccination, whichever comes later).
In addition, SAEs classified as related to the study vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation and (S)AEs resulting from
procedures and non-investigational (concomitant) Janssen products will be collected during the participant’s entire study participation. Note: refer to footnote z for
SAEs related to ARIs.
w. Concomitant medications will be collected for all participants when associated with an SAE. Note: refer to footnote v for the SAEs collected during the RSV
season.
x. On Day 365 and Day 730, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
y. Concomitant medications will be collected from the time of revaccination through the following 28 days. Other concomitant medications will be collected only
when associated with any SAE.
z. ARI surveillance will be via the eDiary which participants must complete at least twice weekly. Procedures in the event of an ARI are described in the Schedule of
Activities –Assessments for Participants with an ARI Episode. Collection of SAEs associated with ARIs and complications related to ARIs that classify as SAEs
will stop at the end of the second RSV season.
aa. Aliquots of serum samples collected for immunogenicity tests can be reconverted for participant’s safety purposes upon sponsor request. Please refer to Table 13
for a non-exhaustive list of tests that may be requested to be performed on these samples in case of potential AESI reporting.
bb. Each study participant will be invited to complete an IEC/IRB approved Experience Survey, to share to his/her experience as a volunteer in this study. The
responses will be collected by an external party and anonymously provided to the sponsor.
cc. The Day 730 visit should take place no later than by the end of November 2021.
dd. When the window for the end-of-season visit at the end of the NH RSV season is not coinciding with at least 6 months SAE follow-up, a separate SAE safety
follow-up call should be conducted 6 months after revaccination and captured as an unscheduled visit.
AE=adverse event, ARI=acute respiratory infection, d=day, eCRF=electronic Case Report Form, IADL=Instrumental Activities of Daily Living, ICF=informed consent
form, IEC/IRB=Independent Ethics Committee/Institutional Review Board, mo=month, MRU=Medical Resource Utilization, NH=Northern Hemisphere, PGI-H=Patient
Global Impression of Health, RiiQ=Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) v2 (2018), RSV=respiratory syncytial virus, SAE=serious adverse
event, SARS-CoV-2=Severe Acute Respiratory Syndrome Coronavirus-2, vac=vaccination, we=week

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
61
Status: Approved,Date: 16 February 2023
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORT 2A (N=120)
Participants in Revaccination Subcohort 2A received placebo on Day 1 (Group 2) and will receive a revaccination at 1 year (Day 365) and
at 2 years (Day 730) after the first vaccination. In the table below, all visits that overlap with the Schedule ofActivities
Cohort 1 (N 5,800)
are greyed out.*
Clinic Visit # 
1 
2 
2a  
3  
4 
5 
5a 
5b 
5ca 
6a
Visit Timing 
Vac 1
Vac 1 
+14 d  
Vac 1
+28 d
End of
1st RSV
Season 
Vac 2
Vac 2
+14 d
Vac 2 
+28 d  
Vac 2 
+84 d  
Vac 2
+24 we
End of
2nd RSV
Season
Visit Month 
0 
1 
12 
13 
15 
18
Visit Day  
1 
15b 
29b 
365b 
379b 
393b 
449b 
533b
Visit Window  
+3 d  
+3 d  
+35 d  
±2 mo 
+3 d 
relative 
to Vac 2 
+3 d 
relative 
to Vac 2 
±7 d 
relative 
to Vac 2 
±14 d
relative 
to Vac 2
-7/+14 d
Revaccination Subcohort 2A (N=120)
Written informed consent c 

Written informed consent for participation in subcohort d 
 
e
Inclusion/exclusion criteria 

Demographics 

Medical history 

Medical conditions of interest 
f 
g
Pre vaccination medications 
h 
 i
Check for seasonal influenza and SARS CoV 2
vaccination
 
 
 
 
 
 

Physical examination j 
 

Randomization 

Clinical assessment k(collected by study staff) 
 

RiiQTM v2 l 
 
m 
 

Patient Global Impression of Health (PGI H) l 
 
m 
 

Lawton Brody IADL n 
 
o 
 

MRU questionnaire (baseline version) n 
 

eDiary training and distribution p 
 
q 
q
Midturbinate nasal swab kit training and distribution 
 
q 
q
* Participants in Revaccination Subcohort 2A cannot have participated in the Immuno Subset of Cohort 1. Therefore, visits from the Schedule ofActivities –Cohort 1
(N=5,800) which pertain to the Immuno Subset only (Day 85 and Day 169) are not included here.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
64
Status: Approved,Date: 16 February 2023
pre-dose; any seasonal influenza vaccination must occur at least 14 days before or at least 14 days after any study vaccination; SARS-CoV-2 vaccination must
occur as follows: Live-attenuated SARS-CoV-2 vaccine: at least 28 days before or at least 28 days after study vaccination; Non-live SARS-CoV-2 vaccine: at least
14 days before or at least 14 days after study vaccination; Viral-vectored SARS-CoV-2 vaccine: at least 28 days before or at least 28 days after study vaccination
The symbol may refer to a telephone call or a telemedicine interview/contact.
Footnotes:
a. For participants where the timing of the 24-week post-vaccination visit and the end-of-season visit overlap, procedures can be combined.
b. The visit day is relative to the actual day of vaccination in the first RSV season. The timing of the visit day is determined by the visit window relative to the last
vaccination.
c. Signing the ICF should be done before any study-related activity on Day 1.
d. Signing of the separate ICF for participation in the subcohort should be done before or at the start of the Day 365 visit.
e. Signing of a separate ICF for the Day 730 visit and onwards should be done at the end of second RSV season visit.
f. 
Medical conditions of interest will be used in the calculation of the frailty index score. For collection of medical conditions of interest, refer to Section 9.2.1.3.
g. Medical conditions of interest will be re-assessed to capture any changes that may have developed between the start of the study and the Day 365 visit,and to
understand if any participants have developed chronic heart and lung conditions. For collection of medical conditions of interest, refer to Section 9.2.1.3.
h. Therapies administered up to 30 days before vaccination on Day 1 will be recorded.
i. 
Before revaccination, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
j. 
A full physical examination, including height (Day 1 only) and body weight, will be carried out before vaccination.
k. Includes measurement of vital signs (supine systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation [after at least 5 minutes rest] and
body temperature) by a qualified member of the study staff, and a targeted physical examination by qualified study staff, preferably by a physician, physician
assistant, nurse practitioner or equivalent. It is recommended that vital signs are measured before collection of midturbinate nasal swabs and blood draws. The
sponsor’s preference is to enter the results of the clinical assessment directly in the site’s eDevice, however, the results may be collected on paper first and
transferred to the site’s eDevice afterwards, on the same day as the assessments.
l. 
The RiiQ and the PGI-H will be completed before vaccination on Day 1/Day 365 by the participant on the site’s eDevice.
m. The RiiQ and the PGI-H at the end-of-season visit will be completed by the participant in the eDiary or by telephone or telemedicine contact. If completed by
telephone or telemedicine interview, the study-site personnel will read aloud the questions to the participant and record the participant’s responses on the site’s
eDevice.
n. The Lawton-Brody IADL and MRU will be collected before vaccination on Day 1/Day 365 by interview with the participant and recorded on the site’s eDevice.
o. The Lawton-Brody at the end-of-season visit will be completed by telephone or telemedicine contact. The study-site personnel will read aloud the questions to the
participant and record the participant’s responses on the site’s eDevice.
p. Participants may use their own eDevice using a study-specific application instead if their device (smartphone or tablet) is compatible. eDevices provided to
participants should be returned to the site at the end of their study participation. Participants using their own eDevice will be instructed to delete the app from their
personal device. A paper diary may be used as indicated by the sponsor.
q. Participants will be re-trained on how to use the eDiary, if needed, and on how to collect a midturbinate nasal swab, if applicable.
r. To include Inclusion Criteria 5.1, 6, and 7 and Exclusion Criteria 1, 2, 4, 12, 13, 14.2,  20.1, 21.1 and 22.
s. All participants will be closely observed for a minimum of 30 minutes post-revaccination. Any unsolicited, solicited local and systemic AEs will be documented by
study-site personnel following this observation period. Vital signs (body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) will be
obtained at the end of the observation period. Any clinically relevant abnormalities must be recorded on the AE page of the eCRF. Actual values (normal and
abnormal) will only be documented in the eCRF for body temperature.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
65
Status: Approved,Date: 16 February 2023
t. 
Participants will be re-randomized in a 1:1:1 ratio to revaccination with Ad26.RSV.preF alone, RSV preF protein alone, or Ad26.RSV.preF/RSV preF protein.
Refer to Table 2 and Figure 5/Figure 6.
u. Solicited local and systemic AEs will be collected from vaccination until 7 days after vaccination. If a solicited AE has not resolved 7 days post-vaccination, it will
continue to be followed-up until the event has returned to baseline.
v. All AEs and special reporting situations related to study procedures or to non-investigational (concomitant) Janssen products will be reported from ICF signature
onwards until the end of the participant’s study participation. All other AEs (unsolicited) and special reporting situations will be reported from revaccination
through the following 28 days.
w. All SAEs will be reported from administration of study vaccine on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later) and from revaccination on Day 365 until the end of the second RSV season (or 6 months after revaccination, whichever comes later. All SAEs and AESIs
(including potential AESIs) will be reported from revaccination on Day 730 until 6 months after revaccination. In addition, SAEs classified as related to the study
vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation and (S)AEs resulting from procedures and non-investigational (concomitant) Janssen
products will be collected during the participant’s entire study participation. Note: refer to footnote cc for SAEs related to ARIs.
x. Only applicable from the time of local approval of protocol amendment 6.
y. Concomitant medications will be collected for all participants when associated with an SAE or AESI. Note: refer to footnote w for the SAEs and AESIs collected
during the RSV season.
z. On Day 365/Day 730, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
aa. Aliquots of serum samples collected for immunogenicity tests can be reconverted for participant’s safety purposes upon sponsor request. Please refer to Table 13
for a non-exhaustive list of tests that may be requested to be performed on these samples in case of potential AESI reporting.
bb. Concomitant medications will be collected from the time of revaccination through the following 28 days. Other concomitant medications will be collected only
when associated with any SAE or AESI.
cc. ARI surveillance will be via the eDiary which participants must complete at least twice weekly. Procedures in the event of an ARI are described in the Schedule of
Activities –Assessments for Participants with an ARI Episode. Collection of SAEs associated with ARIs and complications related to ARIs that classify as SAEs
will stop at the end of the second RSV season.
dd. Each study participant will be invited to complete an IEC/IRB approved Experience Survey, to share to his/her experience as a volunteer in this study. The
responses will be collected by an external party and anonymously provided to the sponsor.
ee. The Day 730 visit should take place no later than by the end of November 2021.
ff. When the window for the end of season visit at the end of the NH RSV season is not coinciding with at least 6 months SAE or AESI follow-up, a separate SAE or
AESI safety follow-up call should be conducted 6 months after revaccination and captured as an unscheduled visit.
AE=adverse event, AESI=adverse event of special interest, ARI=acute respiratory infection, d=day, eCRF=electronic Case Report Form, IADL=Instrumental Activities
of Daily Living, ICF=informed consent form, IEC/IRB=Independent Ethics Committee/Institutional Review Board, mo=month, MRU=Medical Resource Utilization,
NH=Northern Hemisphere, PGI-H=Patient Global Impression of Health, RiiQ=Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) v2 (2018),
RSV=respiratory syncytial virus, SAE=serious adverse event, SARS-CoV-2=Severe Acute Respiratory Syndrome Coronavirus-2, vac=vaccination, we=week

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
66
Status: Approved,Date: 16 February 2023
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORT 1B (N=135)
Participants in Revaccination Subcohort 1B received active vaccine on Day 1 (Group 1) and will receive a revaccination at 2 years (Day 730)
after the first vaccination. In the table below, all visits that overlap with the Schedule ofActivities
Cohort 1 (N 5,800) are greyed out.*
Clinic Visit # 
1 
2 
2a  
3  
4 
5
Visit Timing 
Vac 1 
Vac 1 
+14 d  
Vac 1 
+28 d  
End of 
1st RSV 
Season 
Vac 1
+ 365d
End of
2nd  RSV
Season
Visit Month 
0 
1 
12
Visit Day  
1 
15a 
29a 
365a
Visit Window  
+3 d  
+3 d  
+35 d  
±2 mo 
-7/+14 d
Revaccination Subcohort 1B (N=135)
Written informed consent b 
 
 

Inclusion/exclusion criteria 

Demographics 

Medical history 

Medical conditions of interest 
d 
e
Pre vaccination medications 
f
Check for seasonal influenza and SARS CoV 2 vaccination  
 
 
 
 

Physical examination h 
 

Randomization 

Clinical assessment i(collected by study staff) 
 

RiiQTM v2 j 
 
k 
 

Patient Global Impression of Health (PGI H) j 
 
k 
 

Lawton Brody IADL l 
 
m 
 

MRU questionnaire (baseline version) l 
 

eDiary training and distribution n 
 
o
Midturbinate nasal swab kit training and distribution 
 
o 
r
Thermometer training and distribution  

Ruler training and distribution 

Verification of selected eligibility criteria 
p
Vaccination  

30 minute post vaccination observation s 

* Participants in Revaccination Subcohort 1B cannot have participated in the Immuno Subset of Cohort 1. Therefore, visits from the Schedule ofActivities –Cohort 1
(N=5,800) which pertain to the Immuno Subset only (Day 85, Day 169, and Day 533) are not included here.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
69
Status: Approved,Date: 16 February 2023
The symbol may refer to a telephone call or a telemedicine interview/contact.
Footnotes:
a. The visit day is relative to the actual day of vaccination in the first RSV season. The timing of the visit day is determined by the visit window relative to the last
vaccination.
b. Signing the ICF should be done before any study-related activity on Day 1 and resigned on Day 365 and no later than at the end of the second RSV season.
c. Signing of the separate ICF for participation in the subcohort should be done before or at the start of the Day 730 visit.
d. Medical conditions of interest will be used in the calculation of the frailty index score. For collection of medical conditions of interest, refer to Section 9.2.1.3.
e. Medical conditions of interest will be re-assessed to capture any changes that may have developed between the start of the study and the Day 365 visit, and to
understand if any participants have developed chronic heart and lung conditions. For collection of medical conditions of interest, refer to Section 9.2.1.3.
f. Therapies administered up to 30 days before vaccination on Day 1 will be recorded.
g. Before revaccination, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
h. A full physical examination, including height (Day 1 only) and body weight, will be carried out before vaccination.
i. 
Includes measurement of vital signs (supine systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation [after at least 5 minutes rest] and
body temperature) by a qualified member of the study staff, and a targeted physical examination by qualified study staff, preferably by a physician, physician
assistant, nurse practitioner or equivalent. It is recommended that vital signs are measured before collection of midturbinate nasal swabs and blood draws. The
sponsor’s preference is to enter the results of the clinical assessment directly in the site’s eDevice, however, the results may be collected on paper first and
transferred to the site’s eDevice afterwards, on the same day as the assessments.
j. 
The RiiQ and the PGI-H will be completed on Day 1 (before vaccination) and Day 365 by the participant on the site’s eDevice.
k. The RiiQ and the PGI-H at the end-of-season visit will be completed by the participant in the eDiary or by telephone or telemedicine contact. If completed by
telephone or telemedicine interview, the study-site personnel will read aloud the questions to the participant and record the participant’s responses on the site’s
eDevice.
l. 
The Lawton-Brody IADL and MRU will be collected on Day 1 (before vaccination) and Day 365 by interview with the participant and recorded on the site’s
eDevice.
m. The Lawton-Brody at the end-of-season visit will be completed by telephone or telemedicine contact. The study-site personnel will read aloud the questions to the
participant and record the participant’s responses on the site’s eDevice.
n. Participants may use their own eDevice using a study-specific application instead if their device (smartphone or tablet) is compatible. eDevices provided to
participants should be returned to the site at the end of their study participation. Participants using their own eDevice will be instructed to delete the app from their
personal device. A paper diary may be used as indicated by the sponsor.
o. Participants will be re-trained on how to use the eDiary, if needed, and on how to collect a midturbinate nasal swab, if applicable.
p. To include Inclusion Criteria 1, 7, 8, and 9 and Exclusion Criteria 7, 11, 14.2, 17, and 18.
q. To include Inclusion Criteria 5.1, 6, and 7 and Exclusion Criteria 1, 2, 4, 12, 13, 14.2,  20.1, 21.1 and 22.
r. Participants may be provided a new nasal swab kit in case of expiration of their current kit.
s. All participants will be closely observed for a minimum of 30 minutes post-revaccination. Any unsolicited,solicited local and systemic AEs will be documented by
study-site personnel following this observation period. Vital signs (body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) will be
obtained at the end of the observation period. Any clinically relevant abnormalities must be recorded on the AE page of the eCRF. Actual values (normal and
abnormal) will only be documented in the eCRF for body temperature.
t. 
Solicited local and systemic AEs will be collected from vaccination until 7 days after vaccination. If a solicited AE has not resolved 7 days post-vaccination, it will
continue to be followed-up until the event has returned to baseline.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
70
Status: Approved,Date: 16 February 2023
u. All AEs and special reporting situations related to study procedures or to non-investigational (concomitant) Janssen products will be reported from ICF signature
onwards until the end of the participant’s study participation. All other AEs (unsolicited) and special reporting situations will be reported from revaccination
through the following 28 days.
v. All SAEs will be reported from administration of study vaccine on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later), and all SAEs and AESIs (including potential AESIs) will be reported from revaccination on Day 730 until 6 months after revaccination. In addition, SAEs
classified as related to the study vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation and (S)AEs resulting from procedures and non-
investigational (concomitant) Janssen products will be collected during the participant’s entire study participation. Note: refer to footnote aa for SAEs related to
ARIs.
w. Concomitant medications will be collected for all participants when associated with an SAE or AESI. Note: refer to footnote v for the SAEs and AESIs collected
during the RSV season.
x. On Day 365/Day 730, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
y. Aliquots of serum samples collected for immunogenicity tests can be reconverted for participant’s safety purposes upon sponsor request. Please refer to Table 13
for a non-exhaustive list of tests that may be requested to be performed on these samples in case of potential AESI reporting.
z. Concomitant medications will be collected from the time of revaccination through the following 28 days. Other concomitant medications will be collected only
when associated with any SAE or AESI.
aa. ARI surveillance will be via the eDiary which participants must complete at least twice weekly. Procedures in the event of an ARI are described in the Schedule of
Activities –Assessments for Participants with an ARI Episode. Collection of SAEs associated with ARIs and complications related to ARIs that classify as SAEs
will stop on Day 730.
bb. Each study participant will be invited to complete an IEC/IRB approved Experience Survey, to share to his/her experience as a volunteer in this study. The
responses will be collected by an external party and anonymously provided to the sponsor.
cc. The Day 730 visit should take place no later than by the end of November 2021.
dd. When the window for the end of season visit at the end of the NH RSV season is not coinciding with at least 6 months SAE or AESI follow-up, a separate SAE or
AESI safety follow-up call should be conducted 6 months after revaccination and captured as an unscheduled visit.
AE=adverse event, AESI=adverse event of special interest, ARI=acute respiratory infection, d=day, eCRF=electronic Case Report Form, IADL=Instrumental Activities
of Daily Living, ICF=informed consent form, IEC/IRB=Independent Ethics Committee/Institutional Review Board, mo=month, MRU=Medical Resource Utilization,
NH=Northern Hemisphere, PGI-H=Patient Global Impression of Health, RiiQ=Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) v2 (2018),
RSV=respiratory syncytial virus, SAE=serious adverse event, SARS-CoV-2=Severe Acute Respiratory Syndrome Coronavirus-2, vac=vaccination, we=week

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
71
Status: Approved,Date: 16 February 2023
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORT 2B (N=135)
Participants in Revaccination Subcohort 2B received placebo on Day 1 (Group 2) and will receive a revaccination at 2 years (Day 730) and
at 3 years (Day 1,095) after the first vaccination. In the table below, all visits that overlap with the Schedule ofActivities
Cohort 1 (N 5,800)
are greyed out.*
Clinic Visit # 
1 
2 
2a  
3  
4 
5
Visit Timing 
Vac 1 
Vac 1 
+14 d  
Vac 1 
+28 d  
End of 
1st RSV  
Season 
Vac 1
+ 365d
End of
2nd  RSV
Season
Visit Month 
0 
1 
12
Visit Day  
1 
15a 
29a 
365a
Visit Window  
+3 d  
+3 d  
+35 d  
±2 mo 
-7/+14 d
Revaccination Subcohort 2B (N=135)
Written informed consent b 
 
 

Inclusion/exclusion criteria 

Demographics 

Medical history 

Medical conditions of interest 
d 
e
Pre vaccination medications 
f
Check for seasonal influenza and SARS CoV 2 vaccination 
 
 
 
 

Physical examination h 
 

Randomization 

Clinical assessment i(collected by study staff) 
 

RiiQTM v2 j 
 
k 
 

Patient Global Impression of Health (PGI H) j 
 
k 
 

Lawton Brody IADL l 
 
m 
 

MRU questionnaire (baseline version) l 
 

eDiary training and distribution n 
 
o
Midturbinate nasal swab kit training and distribution 
 
o 
r
Thermometer training and distribution  

Ruler training and distribution 

Verification of selected eligibility criteria 
p
* Participants in Revaccination Subcohort 2B cannot have participated in the Immuno Subset of Cohort 1. Therefore, visits from the Schedule ofActivities –Cohort 1
(N=5,800) which pertain to the Immuno Subset only (Day 85, Day 169, and Day 533) are not included here.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
75
Status: Approved,Date: 16 February 2023
pre-dose; any seasonal influenza vaccination must occur at least 14 days before or at least 14 days after any study vaccination; SARS-CoV-2 vaccination must
occur as follows: Live-attenuated SARS-CoV-2 vaccine: at least 28 days before or at least 28 days after study vaccination; Non-live SARS-CoV-2 vaccine: at least
14 days before or at least 14 days after study vaccination; Viral-vectored SARS-CoV-2 vaccine: at least 28 days before or at least 28 days after study vaccination
The symbol may refer to a telephone call or a telemedicine interview/contact.
Footnotes:
a. The visit day is relative to the actual day of vaccination in the first RSV season. The timing of the visit day is determined by the visit window relative to the last
vaccination.
b. Signing the ICF should be done before any study-related activity on Day 1 and resigned on Day 365 and no later than at the end of the second RSV season.
c. Signing of the separate ICF for participation in the subcohort should be done before or at the start of the Day 730 visit.
d. Medical conditions of interest will be used in the calculation of the frailty index score. For collection of medical conditions of interest, refer to Section 9.2.1.3.
e. Medical conditions of interest will be re-assessed to capture any changes that may have developed between the start of the study and the Day 365 visit, and to
understand if any participants have developed chronic heart and lung conditions. For collection of medical conditions of interest, refer to Section 9.2.1.3.
f. 
Therapies administered up to 30 days before vaccination on Day 1 will be recorded.
g. Before revaccination, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
h. A full physical examination, including height (Day 1 only) and body weight, will be carried out before vaccination.
i. 
Includes measurement of vital signs (supine systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation [after at least 5 minutes rest] and
body temperature) by a qualified member of the study staff, and a targeted physical examination by qualified study staff, preferably by a physician, physician
assistant, nurse practitioner or equivalent. It is recommended that vital signs are measured before collection of midturbinate nasal swabs and blood draws. The
sponsor’s preference is to enter the results of the clinical assessment directly in the site’s eDevice, however, the results may be collected on paper first and
transferred to the site’s eDevice afterwards, on the same day as the assessments.
j. 
The RiiQ and the PGI-H will be completed before vaccination on Day 1 (before vaccination) and Day 365 by the participant on the site’s eDevice.
k. The RiiQ and the PGI-H at the end-of-season visit will be completed by the participant in the eDiary or by telephone or telemedicine contact. If completed by
telephone or telemedicine interview, the study-site personnel will read aloud the questions to the participant and record the participant’s responses on the site’s
eDevice.
l. 
The Lawton-Brody IADL and MRU will be collected before vaccination on Day 1 (before vaccination) and Day 365 by interview with the participant and recorded
on the site’s eDevice.
m. The Lawton-Brody at the end-of-season visit will be completed by telephone or telemedicine contact. The study-site personnel will read aloud the questions to the
participant and record the participant’s responses on the site’s eDevice.
n. Participants may use their own eDevice using a study-specific application instead if their device (smartphone or tablet) is compatible. eDevices provided to
participants should be returned to the site at the end of their study participation. Participants using their own eDevice will be instructed to delete the app from their
personal device. A paper diary may be used as indicated by the sponsor.
o. Participants will be re-trained on how to use the eDiary, if needed, and on how to collect a midturbinate nasal swab, ifapplicable.
p. To include Inclusion Criteria 1, 7, 8, and 9 and Exclusion Criteria 7, 11, 14.2, 17, and 18.
q. To include Inclusion Criteria 5.1, 6, and 7 and Exclusion Criteria 1, 2, 4, 12, 13, 14.2,  20.1, 21.1 and 22.
r. Participants may be provided a new nasal swab kit in case of expiration of their current kit.
s. All participants will be closely observed for a minimum of 30 minutes post-revaccination. Any unsolicited, solicited local and systemic AEs will be documented by
study-site personnel following this observation period. Vital signs (body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) will be

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
76
Status: Approved,Date: 16 February 2023
obtained at the end of the observation period. Any clinically relevant abnormalities must be recorded on the AE page of the eCRF. Actual values (normal and
abnormal) will only be documented in the eCRF for body temperature.
t. 
Participants will be re-randomized in a 1:1:1 ratio to revaccination with Ad26.RSV.preF alone, RSV preF protein alone, or Ad26.RSV.preF/RSV preF protein.
Refer to Table 2 and Figure 5/Figure 6.
u. Solicited local and systemic AEs will be collected from vaccination until 7 days after vaccination. If a solicited AE has not resolved 7 days post-vaccination, it will
continue to be followed-up until the event has returned to baseline.
v. All AEs and special reporting situations related to study procedures or to non-investigational (concomitant) Janssen products will be reported from ICF signature
onwards until the end of the participant’s study participation. All other AEs (unsolicited) and special reporting situations will be reported from revaccination
through the following 28 days.
w. All SAEs will be reported from administration of study vaccine on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later), and all SAEs and AESIs (including potential AESIs) will be reported from revaccination on Day 730/Day 1,095 until 6 months after revaccination. In
addition, SAEs classified as related to the study vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation and (S)AEs resulting from procedures
and non-investigational (concomitant) Janssen products will be collected during the entire study. Note: refer to footnote bb for SAEs related to ARIs.
x. Concomitant medications will be collected for all participants when associated with an SAE or AESI. Note: refer to footnote w for the SAEs and AESI collected
during the RSV season.
y. On Day 365/Day 730/Day 1,095, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
z. Aliquots of serum samples collected for immunogenicity tests can be reconverted for participant’s safety purposes upon sponsor request. Please refer to Table 13
for a non-exhaustive list of tests that may be requested to be performed on these samples in case of potential AESI reporting.
aa. Concomitant medications will be collected from the time of revaccination through the following 28 days. Other concomitant medications will be collected only
when associated with any SAE or AESI.
bb. ARI surveillance will be via the eDiary which participants must complete at least twice weekly. Procedures in the event of an ARI are described in the Schedule of
Activities –Assessments for Participants with an ARI Episode. Collection of SAEs associated with ARIs and complications related to ARIs that classify as SAEs
will stop on Day 730.
cc. Each study participant will be invited to complete an IEC/IRB approved Experience Survey, to share to his/her experience as a volunteer in this study. The
responses will be collected by an external party and anonymously provided to the sponsor.
dd. The Day 730 visit should take place no later than by the end of November 2021.
ee. When the window for the end of season visit at the end of the NH RSV season is not coinciding with at least 6 months SAE or AESI follow-up, a separate SAE or
AESI safety follow-up call should be conducted 6 months after revaccination and captured as an unscheduled visit.
AE=adverse event, AESI=adverse event of special interest, ARI=acute respiratory infection, d=day, eCRF=electronic Case Report Form, IADL=Instrumental Activities
of Daily Living, ICF=informed consent form, IEC/IRB=Independent Ethics Committee/Institutional Review Board, mo=month, MRU=Medical Resource Utilization,
NH=Northern Hemisphere, PGI-H=Patient Global Impression of Health, RiiQ=Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) v2 (2018),
RSV=respiratory syncytial virus, SAE=serious adverse event, SARS-CoV-2=Severe Acute Respiratory Syndrome Coronavirus-2, vac=vaccination, we=week

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
77
Status: Approved,Date: 16 February 2023
SCHEDULE OF ACTIVITIES –REVACCINATION SUBCOHORTS 1C AND 2C (N=240)*
Participants in Revaccination Subcohort C received active vaccine (Group 1) or placebo (Group 2) on Day 1 and will receive a revaccination
at 3 years (Day 1,095) after the first vaccination. In the table below, all visits that overlap with the Schedule ofActivities
Cohort 1 (N 5,800)
are greyed out.
Clinic Visit # 
1 
2 
2a  
2ba 
2ca,b 
3b  
4 
5a,b 
6b
Visit Timing 
Vac 1
Vac 1 
+14 d  
Vac 1 
+28 d  
Vac 1 
+84 d  
Vac 1
+24 we 
End of 
1st RSV 
Season
Vac 1
+ 365d
Vac 1
+18 mo
End of
2nd RSV
Season
Visit Month 
0 
1 
3 
6 
12 
18
Visit Day  
1 
15c 
29c 
85c 
169c 
365c 
533c
Visit Window  
+3 d  
+3 d  
±7 d  
±14 d  
+35 d  
±2 mo 
±14 d  
-7/+14 d
Revaccination Subcohorts 1C and 2C (N=240)
Written informed consent d 
 
 

Inclusion/exclusion criteria 

Demographics 

Medical history 

Medical conditions of interest 
f 
g
Pre vaccination medications 
h
Check for seasonal influenza and SARS CoV 2 vaccination  
 
 
 
 

Physical examination j 
 

Randomization 

Clinical assessment k(collected by study staff) 
 

RiiQTM v2 l 
 
m 
 

Patient Global Impression of Health (PGI H) l 
 
m 
 

Lawton Brody IADL n 
 
o 
 

MRU questionnaire (baseline version) n 
 

eDiary training and distribution p 
 
q
Midturbinate nasal swab kit training and distribution 
 
q 
r
Thermometer training and distribution  

Ruler training and distribution 

Verification of selected eligibility criteria 
s
Contraindications to vaccination
* The study will continue with Revaccination Subcohort C depending on the 28-days post second vaccination analysis results from Revaccination Subcohort B.

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
81
Status: Approved,Date: 16 February 2023
j. 
A full physical examination, including height (Day 1 only) and body weight, will be carried out before vaccination.
k. Includes measurement of vital signs (supine systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation [after at least 5 minutes rest] and
body temperature) by a qualified member of the study staff, and a targeted physical examination by qualified study staff, preferably by a physician, physician
assistant, nurse practitioner or equivalent. It is recommended that vital signs are measured before collection of midturbinate nasal swabs and blood draws. The
sponsor’s preference is to enter the results of the clinical assessment directly in the site’s eDevice, however, the results may be collected on paper first and
transferred to the site’s eDevice afterwards, on the same day as the assessments.
l. 
The RiiQ and the PGI-H will be completed on Day 1 (before vaccination) and Day 365 by the participant on the site’s eDevice.
m. The RiiQ and the PGI-H at the end-of-season visit will be completed by the participant in the eDiary or by telephone or telemedicine contact. If completed by
telephone or telemedicine interview, the study-site personnel will read aloud the questions to the participant and record the participant’s responses on the site’s
eDevice.
n. The Lawton-Brody IADL and MRU will be collected on Day 1 (before vaccination) and Day 365 by interview with the participant and recorded on the site’s
eDevice.
o. The Lawton-Brody at the end-of-season visit will be completed by telephone or telemedicine contact. The study-site personnel will read aloud the questions to the
participant and record the participant’s responses on the site’s eDevice.
p. Participants may use their own eDevice using a study-specific application instead if their device (smartphone or tablet) is compatible. eDevices provided to
participants should be returned to the site at the end of their study participation. Participants using their own eDevice will be instructed to delete the app from their
personal device. A paper diary may be used as indicated by the sponsor.
q. Participants will be re-trained on how to use the eDiary, if needed, and on how to collect a midturbinate nasal swab, if applicable.
r. Participants may be provided a new nasal swab kit in case of expiration of their current kit.
s. To include Inclusion Criteria 1, 7, 8, and 9 and Exclusion Criteria 7, 11, 14.2, 17, and 18.
t. 
To include Inclusion Criteria 5.1, 6, and 7 and Exclusion Criteria 1, 2, 4, 12, 13, 14.2,  20.1, 21.1 and 22.
u. All participants will be closely observed for a minimum of 30 minutes post-revaccination. Any unsolicited, solicited local and systemic AEs will be documented by
study-site personnel following this observation period. Vital signs (body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) will be
obtained at the end of the observation period. Any clinically relevant abnormalities must be recorded on the AE page of the eCRF. Actual values (normal and
abnormal) will only be documented in the eCRF for body temperature.
v. Solicited local and systemic AEs will be collected from vaccination until 7 days after vaccination. If a solicited AE has not resolved 7 days post-vaccination, it will
continue to be followed-up until the event has returned to baseline.
w. All AEs and special reporting situations related to study procedures or to non-investigational (concomitant) Janssen products will be reported from ICF signature
onwards until the end of the participant’s study participation. Note that for the time period between the last end of the RSV season visit and the revaccination, the
aforementioned AEs and special reporting situations will be collected retrospectively upon the day of revaccination. All other AEs (unsolicited) and special
reporting situations will be reported from revaccination through the following 28 days.
x. All SAEs will be reported from administration of study vaccine on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later), and all SAEs and AESIs (including potential AESIs) will be reported from revaccination on Day 1,095 until 6 months after revaccination. Note: refer to
footnote dd for SAEs related to ARIs.
y. SAEs classified as related to the study vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation and (S)AEs resulting from procedures and non-
investigational (concomitant) Janssen products will be collected during the participant’s entire study participation. Note that for the time period between the last
end of the RSV season visit and the revaccination these (S)AEs will be collected retrospectively upon the day of revaccination.
z. Concomitant medications will be collected for all participants when associated with an SAE or AESI. Note: refer to footnote x for the SAEs and AESIs collected
during the RSV season.

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aa. On Day 365/Day 730/Day 1,095, changes in the use of any concomitant medication since the last visit should be recorded (refer to Section 8).
bb. Aliquots of serum samples collected for immunogenicity tests can be reconverted for participant’s safety purposes upon sponsor request. Please refer to Table 13
for a non-exhaustive list of tests that may be requested to be performed on these samples in case of potential AESI reporting.
cc. Concomitant medications will be collected from the time of revaccination through the following 28 days. Other concomitant medications will be collected only
when associated with any SAE or AESI.
dd. ARI surveillance will be via the eDiary which participants must complete at least twice weekly. Procedures in the event of an ARI are described in the Schedule of
Activities –Assessments for Participants with an ARI Episode. Collection of SAEs associated with ARIs and complications related to ARIs that classify as SAEs
will stop at the latest at the end of the third RSV season.
ee. Each study participant will be invited to complete an IEC/IRB approved Experience Survey, to share to his/her experience as a volunteer in this study. The
responses will be collected by an external party and anonymously provided to the sponsor.
ff. The Day 730 visit should take place no later than by the end of November 2021.
gg. When the window for the end of season visit at the end of the NH RSV season is not coinciding with at least 6 months SAE follow-up, a separate SAE safety
follow-up call should be conducted 6 months after revaccination and captured as an unscheduled visit.
AE=adverse event, AESI=adverse event of special interest, ARI=acute respiratory infection, d=day, eCRF=electronic Case Report Form, IADL=Instrumental Activities
of Daily Living, ICF=informed consent form, IEC/IRB=Independent Ethics Committee/Institutional Review Board, mo=month, MRU=Medical Resource Utilization,
NH=Northern Hemisphere, PGI-H=Patient Global Impression of Health, RiiQ=Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) v2 (2018),
RSV=respiratory syncytial virus, SAE=serious adverse event, SARS-CoV-2=Severe Acute Respiratory Syndrome Coronavirus-2, vac=vaccination, we=week

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Footnotes:
a. Resolution is defined as 2 consecutive days with no symptoms listed on the RiiQ Symptom Scale or, for participants who have RiiQ symptoms present at baseline
(assessed pre-vaccination for the first RSV season,at the Day 365 visit for the second RSV season [pre-vaccination if applicable],and from the Day 730 visit until
the end of the third RSV season), 2 consecutive days where all symptoms on the RiiQ Symptom Scale have returned to the severity level reported at baseline).
b. The midturbinate nasal swab collected by the participant at home should preferably be taken between 12 to 24 hours after onset of symptoms.
c. The midturbinate nasal swab collected by the study staff at the site or at home should ideally be taken at least 24 hours after the midturbinate nasal swab collected
by the participant at home.
d. For participants hospitalized with symptoms of an ARI, confirmation of RSV infection using an FDA-approved RT-PCR test from the local (hospital) laboratory
will also be used for the analysis of case definitions if results from the central laboratory are not available.
e. Five mL of cryopreserved whole blood samples may be collected from participants during Day3-5 visit following an ARI episode and may be used for
determination of exploratory biomarkers on the premise that the markers may play a role in RSV infection and RSV disease severity.
f. 2.5 mL of whole blood may be collected in a DNA Paxgene tube and 2.5 mL of whole blood may be collected in a RNA Paxgene tube during the Day 3-5 visit
following an ARI episode and may be used for determination of exploratory biomarkers on the premise that the markers may play a role in RSV infection and RSV
disease severity.
g. For the first NH RSV season due to the COVID-19 pandemic, if possible, participants with ongoing ARIs (with ARI onset up to 20 March 2020) who have already
had ARI Day 3-5 visit including a nasal midturbinate swab should continue collecting daily questionnaires until symptom resolution and, if possible, sites should
collect ARI Day 29 data, excluding procedures that require on-site visit (ie, serology and clinical assessment), over the telephone or by telemedicine contact.
h. Includes measurement of vital signs (supine systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation [after at least 5 minutes rest] and
body temperature) by a qualified member of the study staff, and a targeted physical examination by qualified study staff, preferably by a physician, physician
assistant, nurse practitioner or equivalent. It is recommended that vital signs are measured before collection of midturbinate nasal swabs and/or nasosorption
samples and blood draws. The sponsor’s preference is to enter the results of the clinical assessment directly in the site’s eDevice, however, the results may be
collected on paper first and transferred to the site’s eDevice afterwards, on the same day as the assessments.
i. Participants complete the eDiary to respond to the ARI Surveillance question, Attachment 5 (RiiQ Symptom Scale) and Attachment 11 (RiiQ Impact on Daily
Activity Scale, as part of the Combined Impact Assessment), Patient Global impression of Health (PGI-H), the Patient Global Impression of Severity (PGI-S), the
Patient Global impression of Change (PGI-C), and the Return to Usual Health question on a daily basis, as part of the Combined Impact Assessment. (Note that the
PGI-C and the Return to Usual Health question will not be completed on ARI Day 1). Participants should also record body temperature on a daily basis in the
eDiary. Details are provided in Attachment 4, ARI Surveillance Assessment.
j. ARIs and complications related to ARIs that classify as SAEs will be captured in all participants and will be reported as SAEs in the eCRF for the duration of the
first RSV season, or 6 months after vaccination, whichever is longer, and for the duration ofthe second and third RSV season. The cut-off date for a new ARI is
defined as 20 March 2020 for the first NH RSV season, 17 May 2021 for the second NH RSV season, and 15 April 2022 for the third NH RSV season. The defined
end-of-season dates for the second and third NH RSV season may be updated in case there would be indications of a shift in season. ARIs and complications
related to ARIs that do not classify as SAEs will be reported as AEs in the eCRF from the time of vaccination through the following 28 days for Safety Subset and
Revaccination Cohort participants only. In addition, all ARIs and all complications related to ARIs will be captured on the ARI form for all participants who
experience an ARI episode.
k. Concomitant medications associated with ARI episodes and with complications of ARI will be recorded for all participants during all ARI episodes for the duration
of the RSV season. Concomitant medications associated with ARIs will also be captured on the ARI form for all participants who experience an ARI episode
l. Information on seasonal influenza and SARS-CoV-2 vaccination must be recorded on the concomitant medication page of the eCRF.
m. For medically attended RT-PCR-confirmed RSV-mediated ARIs, including those resulting in hospitalization, a standard question list will be provided
(Attachment 12, Medically Attended Acute Respiratory Infection (MA-ARI) Information Form) to collect additional information on any other diagnostic tests (eg,
chest x-rays, spirometry, pulmonary function tests, etc.) or on any interventions during the clinical course of the ARI.

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ARI =acute respiratory infection, COVID-19 =Coronavirus Disease 2019, DNA =deoxyribonucleic acid, FDA =Food and Drug Administration, IADL =Instrumental
Activities of Daily Living, MRU =Medical Resource Utilization, NH =Northern Hemisphere, PGI-C =Patient Global impression of Change, PGI-H =Patient Global
Impression of Health, PGI-S  =Patient Global Impression of Severity, RiiQ  =Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) v2 (2018),
RNA =ribonucleic acid, RT-PCR =reverse transcriptase polymerase chain reaction, SAE  =serious adverse event, SARS-CoV-2=Severe Acute Respiratory Syndrome
Coronavirus-2

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ABBREVIATIONS
Ad26 
adenovirus serotype 26
AE 
adverse event
AESI 
adverse event of special interest
ANOVA  
analysis of variance
ARI 
acute respiratory infection
BMI 
body mass index
CHF  
congestive heart failure
CI 
confidence interval
COPD  
chronic obstructive pulmonary disease
DNA  
deoxyribonucleic acid
eCRF  
electronic case report form
eDC  
electronic data capture
ELISA  
enzyme-linked immunosorbent assay
ELISpot 
enzyme-linked immunospot (assay)
ePRO  
electronic patient-reported outcome
ERD  
enhanced respiratory disease
F protein  
fusion protein
FAS  
Full Analysis Set
FDA  
(US) Food and Drug Administration
FI 
formalin-inactivated
FIH  
first-in-human
G 
glycoprotein
GCP  
Good Clinical Practice
GMT  
geometric mean titer
HCP  
health care professional
HITT  
heparin-induced thrombocytopenia and thrombosis
HIV  
human immunodeficiency virus
IA  
interim analysis
IADL 
Instrumental Activities of Daily Living
ICF  
informed consent form
ICH  
International Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use
ICS  
intracellular cytokine staining
IDMC  
Independent Data Monitoring Committee
IEC  
Independent Ethics Committee
IF  
information fraction
IFN-γ 
interferon gamma
IM  
intramuscularly
IPPI 
Investigational Product Preparation Instruction
IRB  
Institutional Review Board
IWRS  
interactive web response system
LRTD  
lower respiratory tract disease
LRTI 
lower respiratory tract infection
MedDRA  
Medical Dictionary for Regulatory Activities
MRU  
medical resource utilization
NH  
Northern Hemisphere
NHP  
non-human primate
NSAIDs 
non-steroidal anti-inflammatory drugs
PCC  
protocol clarification communication
PGI-C 
Patient Global Impression of Change
PGI-H 
Patient Global Impression of Health

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PGI-S 
Patient Global Impression of Severity
PPE 
Per-protocol Efficacy
PPI 
Per-protocol Immunogenicity
PQC  
Product Quality Complaint
RiiQ™ 
Respiratory Infection Intensity and Impact Questionnaire (Version 2, 2018)
RSV  
respiratory syncytial virus
RT-PCR  
reverse transcriptase polymerase chain reaction
RWE 
real world evidence
SAE 
serious adverse event
SAM  
synthetic absorptive matrix
SD  
standard deviation
SH  
Southern Hemisphere
SUSAR  
suspected unexpected serious adverse reaction
Th  
T-helper
TNF-α 
tumor necrosis factor alpha
TTS  
thrombosis with thrombocytopenia syndrome
TTSAC  
thrombosis with thrombocytopenia syndrome Adjudication Committee
URTI 
upper respiratory tract infection
US  
United States
VE 
vaccine efficacy
VITT  
vaccine-induced immune thrombotic thrombocytopenia
VNA  
virus neutralizing antibody
VNT  
virus neutralizing antibody titer
vp 
viral particles

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1. 
INTRODUCTION
A human adenovirus-vectored vaccine candidate and a pre-fusion conformation-stabilized
respiratory syncytial virus (RSV) fusion (F) protein that have shown promise in preclinical animal
models of RSV will be assessed in this study:
 Ad26.RSV.preF (JNJ-64400141), a replication-incompetent adenovirus serotype 26 (Ad26)
containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion
conformation-stabilized F protein (pre-F) derived from the RSV A2 strain.
 RSV preF protein (JNJ-64213175), a pre-fusion conformation-stabilized F protein derived
from the RSV A2 strain.
The active study vaccines used in the current study are Ad26.RSV.preF and RSV preF protein
each administered alone as a single injection, and Ad26.RSV.preF/RSV preF protein mixture
administered as a single injection.
1.1. 
Background
RSV is an important cause of serious respiratory infections in adults aged ≥60 years,
immunocompromised, and those with underlying chronic cardiopulmonary conditions.9 Although
most adults mount a long-lasting fully protective immune response, waning immune responses in
the elderly might contribute to increased susceptibility to severe disease after RSV infection
causing significant morbidity and mortality. In long-term care facilities, RSV is estimated to infect
5% to 10% of the residents per year with significant rates of pneumonia (10% to 20%) and death
(2% to 5%).10 In an epidemiology study of RSV burden, it was estimated that 11,000 elderly
persons die annually of RSV in the United States.28 These data support the importance of
developing an effective vaccine for certain adult populations, such as the elderly.
RSV is also considered to be the most important cause of serious acute respiratory infection (ARI)
in infants and children under 5 years of age: worldwide in 2005, RSV caused an estimated
33.8 million new episodes of acute lower respiratory tract infections (LRTIs) in this age range,
with 3.4 million cases requiring hospitalization due to severe illness.12,24,27
Despite the high RSV disease burden, no licensed vaccine is available for RSV. The first vaccine
candidate for use in young children, which consisted of formalin-inactivated RSV (FI-RSV), was
associated with enhanced respiratory disease (ERD) upon infection with RSV.16 Although the
mechanisms for ERD are not fully understood, it is thought that FI-RSV failed to induce adequate
neutralizing antibody titers and CD8+ priming, and induced a T-helper (Th)2 skewed response in
RSV-naïve individuals.20 As all adults have been exposed to RSV, and therefore previously primed
by a live virus infection, ERD is not expected to be a concern in adults aged ≥60 years.8
Adenoviral-vectored Vaccines
The immunogenicity profile of adenoviral vectors, with particular emphasis on Th1 responses, is
illustrated by data obtained following the immunization of adults with Ad26-vectored human
immunodeficiency virus (HIV) vaccines (Ad26.ENVA.01, Ad26.Mos.HIV and Ad26.Mos4.HIV),
an Ad26-vectored Ebola vaccine (Ad26.ZEBOV) and an Ad26-vectored malaria vaccine

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(Ad26.CS.01). These data demonstrate predominantly interferon gamma (IFN-γ) and tumor
necrosis factor alpha (TNF-α) production in CD4+ and CD8+ T cells.1,3,7,15,19,21
Clinical Safety Experience With Ad26-based Vaccines
Thrombosis in combination with thrombocytopenia (thrombosis with thrombocytopenia syndrome
[TTS]), in some cases accompanied by internal bleeding, has been observed very rarely following
vaccination with the Janssen COVID-19 (Ad26.COV2.S) vaccine. Reports include severe cases of
venous thrombosis at unusual sites such as cerebral venous sinus thrombosis (CVST), splanchnic
vein thrombosis and arterial thrombosis, in combination with thrombocytopenia. The associated
symptoms began approximately 1 to 2 weeks after vaccination, mostly in women under 60 years
of age. Thrombosis in combination with thrombocytopenia can be fatal. The exact
pathophysiology of TTS is unclear. This event has not been observed to date with any other
Janssen Ad26-based vaccines. Participants should be instructed to seek immediate medical
attention if they develop symptoms such as shortness of breath, chest pain, leg swelling, persistent
abdominal pain, severe or persistent headaches, blurred vision, skin bruising or petechiae beyond
the site of vaccination.
Ad26.RSV.preF and RSV preF Protein Preclinical Data
Ad26.RSV.preF:
Studies to evaluate the immunogenicity of intramuscularly (IM) administered Ad26.RSV.preF in
mice showed induction of T-helper type 1 (Th1)-skewed cellular immune responses, as measured
by enzyme-linked immunospot (ELISpot) assay, intracellular cytokine staining (ICS) and
multiplex cytokine enzyme-linked immunosorbent assay (ELISA). In addition, dose-dependent
induction of RSV neutralizing and RSV F binding antibodies was observed using virus
neutralization assays and ELISA, respectively. In neonatal mice, immunization with
Ad26.RSV.preF at a dose of 1×1010 viral particles (vp) induced durable (ie, up to the last
observation at 25 weeks) virus neutralizing antibodies (VNA) and RSV F-specific cellular immune
responses that were boostable by a second administration of Ad26.RSV.preF. Similar to the
observations in adult mice, immunization with Ad26.RSV.preF skewed the cytokine response
towards a Th1-type immune response.
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RSV preF Protein:
Ad26.RSV.preF and RSV preF Protein Clinical Data
Ad26.RSV.preF:
At the time of protocol amendment 4 writing, 2 Phase 1 studies (VAC18193RSV1003 and
VAC18193RSV1005) and 2 Phase 2a studies (VAC18193RSV2002 and VAC18193RSV2003)
with Ad26.RSV.preF have been completed. Three Phase 1/2a studies (VAC18193RSV1004,
VAC18194RSV2001, and VAC18194RSV2002) and 1 Phase 2a study (VAC18193RSV2005) are
ongoing (Table 1).
CCI

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Table 1: 
Completed and Ongoing Studies with Ad26.RSV.preF
Study 
Identifier 
Clinical 
Phase 
Study  
Vaccine 
N 
Planned  
Study
Population
Senior Program
VAC18193RSV1003 
completed
1 
Ad26.RSV.preF  
72 
Adult participants aged 60 years and older
VAC18193RSV1005 
completed*  
1 
Ad26.RSV.preF  
24 
Adult participants aged 18 years and older in
stable health (including 3 participants aged
>65 years)
VAC18193RSV2002 
completed
2a 
Ad26.RSV.preF  
63 
Adult participants aged 18 to 50 years
VAC18193RSV2003 
completed
2a 
Ad26.RSV.preF  
180 
Adult participants aged 60 years and older
VAC18193RSV1004 
ongoing 
1/2a 
Ad26.RSV.preF/ 
RSV preF
protein
667 
Adult participants aged 60 years and older
VAC18193RSV2005 
ongoing 
2a 
Ad26.RSV.preF/ 
RSV preF 
protein
450 
Adult participants aged 60 years and older in
stable health
Junior Program
VAC18194RSV2001 
ongoing 
1/2a 
Ad26.RSV.preF  
12 adults 
48 toddlers 
Adult participants aged 18 to 50 years and
RSV-seropositive toddlers aged 12 to
24 months
VAC18194RSV2002 
ongoing 
1/2a 
Ad26.RSV.preF  
36 toddlers Healthy RSV-seronegative toddlers aged
12 to 24 months
* Clinical study report writing in progress.
Clinical studies are ordered to align with the order in the clinical development plan.
N = actual number of participants (for completed studies) or planned number of participants (for ongoing studies).
Study VAC18193RSV1003, a single-center, randomized, placebo-controlled, double-blind,
first-in-human (FIH), Phase 1 study in male and female participants aged 60 years and older,
evaluated the safety, reactogenicity  and immunogenicity of 2 Ad26.RSV.preF vaccinations,
administered 1 year apart. Safety data demonstrated that 2 single doses of 5×1010 vp or 1×1011  vp
Ad26.RSV.preF vaccine (administered approximately 12 months apart) had acceptable safety and
tolerability in participants aged over 60 years old in stable health. Immunogenicity data confirmed
the immunogenicity of the vaccine and suggested a trend that the 1×1011 vp dose of
Ad26.RSV.preF was more immunogenic than the 5×1010 vp dose.
Note: In Study VAC18193RSV1003, Ad26.RSV.preF was provided in Formulation Buffer 1a.
Subsequent studies, including the current study, use Formulation Buffer 2b.
Study VAC18193RSV1005, a single-center, open-label, single-arm Phase 1 study in participants
aged 18 years and older in stable health (including 3 participants aged >65 years), is evaluating
the shedding and kinetics of Ad26.RSV.preF after 1 IM injection of 1×1011 vp in 24 adults aged
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≥18 years and, assessing shedding in 3 adults aged 65 years and older. Partial study results showed
that although Ad26.RSV.preF-specific DNA was observed in samples from this study, it remained
primarily at the injection site, which disappeared by Day 8, and only infrequently and at very low
levels, for other body locations/fluids.
Study VAC18193RSV2002, a single-center, randomized, placebo-controlled, double-blind
Phase 2a exploratory human RSV challenge study in healthy 18- to 50-year-old adults, evaluated
the prophylactic efficacy of a single immunization of Ad26.RSV.preF against RSV infection in a
virus challenge model. In total, 63 participants have been enrolled and have received the study
vaccine and 53 participants have been challenged with RSV. Results showed that the primary
objective of the study was met. These results showed a significant reduction in the area under the
curve (AUC) of viral load (measured by reverse transcriptase polymerase chain reaction
[RT-PCR]) over time in Ad26.RSV.preF participants compared with placebo and indicated that
the Ad26.RSV.preF vaccine shows protection against virologic RSV infection and symptomatic
RSV infection. In addition, the results showed that vaccination with Ad26.RSV.preF reduced the
percentage of infected participants following RSV challenge. And in those participants that were
infected, vaccination with Ad26.RSV.preF led to a reduction in viral load (based on the
quantitative culture assay) and symptoms compared to placebo. Vaccination with Ad26.RSV.preF
induced favorable humoral responses compared to placebo as measured prior to RSV challenge.
No safety concerns were identified.
Study VAC18193RSV2003, a single-center, randomized, placebo-controlled, double-blind
Phase 2a study in 180 male and female participants aged 60 years and older, evaluated the safety
and immunogenicity of Ad26.RSV.preF and seasonal influenza vaccine (Fluarix®), with and
without co-administration. Co-administration of Ad26.RSV.preF with Fluarix did not impact the
immune responses to both seasonal influenza vaccine and to Ad26.RSV.preF. A higher frequency
of solicited systemic adverse events (AEs) was observed in the Ad26.RSV.preF group compared
to placebo, but overall results demonstrated that the Ad26.RSV.preF vaccine at 1×1011 vp had an
acceptable tolerability profile and no safety concerns were identified.
Study VAC18194RSV2001, a randomized, double-blind, Phase 1/2a study in adults 18 to 50 years
of age and RSV-seropositive toddlers 12 to 24 months of age, is evaluating the safety,
reactogenicity and immunogenicity of Ad26.RSV.preF. Participant enrollment is completed and
the study is still blinded. Safety data from the adult cohort from the group-unblinded primary
analysis at 28 days post-dose 2 revealed no safety concerns after Ad26.RSV.preF dosing at
1×1011  vp. The Independent Data Monitoring Committee (IDMC) reviewed group-unblinded data
(safety and immunogenicity data gathered up to when 12 toddlers had reached Day 8 post-dose 1
[Ad26.RSV.preF at 5×1010 vp or placebo]) during a prescheduled interim group-unblinded
analysis and recommended to continue the study unmodified.
Study VAC18193RSV1004, a multi-center, randomized, double-blind, placebo-controlled
Phase 1/2a study in participants aged ≥60 years in stable health, is evaluating safety and
immunogenicity for regimen selection of Ad26.RSV.preF and RSV preF protein combinations
(Cohorts 1 and 2),followed by expanded safety evaluation of the selected regimen (Cohort 3). The
study is fully enrolled, all dosing is completed for Cohort 1 and 2, and all participants from

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Cohort 3 have received the first dose of study vaccine. The active study vaccine dose and regimen
to be used in the current study was determined from the primary analysis of Cohort 2.
RSV preF Protein:
Study VAC18193RSV1004  is the FIH study for RSV preF protein, and for the
Ad26.RSV.preF/RSV preF protein combination (administered as separate injections in opposite
arms) and Ad26.RSV.preF/RSV preF protein mixture (administered as a single injection).
For the most comprehensive nonclinical and clinical information regarding Ad26.RSV.preF and
nonclinical information regarding RSV preF protein, refer to the latest version of the Investigator’s
Brochure for Ad26.RSV.preF and RSV preF protein.13,14
Ad26.RSV.preF and RSV preF Protein Dose Selection
The dose levels for Ad26.RSV.preF and RSV preF protein used in the current study were
determined from the primary analysis of Cohort 2 in Study VAC18193RSV1004. From the
primary analysis, a significant increase in VNA A2 titers was observed in the groups combining
Ad26.RSV.preF and RSV preF protein comparedto Ad26.RSV.preF 1×1011 vp alone. No relevant
differences between the mixture groups and Ad26.RSV.preF alone were noted for other
immunogenicity assays available at the time of primary analysis. All regimens had acceptable
safety and reactogenicity profiles, which were similar across groups. Based on these data, the
mixture of Ad26.RSV.preF 1×1011 vp and 150 µg of the RSV preF protein was selected for the
present study.
The term "sponsor" used throughout this document refers to the entities listed in the Contact
Information page(s), which will be provided as a separate document.
1.2. 
Overall Rationale for the Study
The current study will investigate the efficacy of an Ad26.RSV.preF/RSV preF protein mixture in
participants aged ≥65 years. Three different case definitions, which all include clinical symptoms
reported by participants and positive RSV RT-PCR as a criterion, will be tested (see
Section 11.4.1) to allow selection of an appropriate case definition for the pivotal Phase 3 efficacy
study. Study vaccine or placebo will be dosed on Day 1,with surveillance for ARIa from the time
of vaccination through the ensuing RSV season.
The aim is to establish vaccine efficacy (VE) of the study vaccine during the RSV season after
single vaccination. The goal is to recruit all participants from the Northern Hemisphere (NH). If
enrollment is delayed or slower than expected so that the target sample size in the NH is not
reached, enrollment might continue in the Southern Hemisphere (SH).
a 
An ARI is defined as the occurrence of at least one upper respiratory tract infection (URTI) or lower respiratory
tract infection (LRTI) symptom that the participant reports that is different or worse than he or she usually
experiences. See Attachment 1.

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The Interim Analysis (IA) plan is outlined in detail in Section 11.12, Planned Analyses. A
summary is provided below, and in Figure 3 (in case the study is performed in the NH only), and
Figure 4 (in case the study is performed in both hemispheres). In brief:
 If participants are only enrolled from the NH, the primary analysis will be performed at the
end of the first NH RSV season, except if the incidence is exceptionally low (less than
18 observed RT-PCR-confirmed RSV-mediated lower respiratory tract disease (LRTD)
events per Case Definition #2). In that case, the IDMC will perform an IA. If successful, proof
of concept is demonstrated. If proof of concept is not demonstrated at the IA and there is
evidence for efficacy (assessed via conditional power), 2,000 new participants (Cohort 2) will
be added to the study who will be vaccinated in the next NH RSV season and followed up for
one RSV season. In that case, the ongoing participants (Cohort 1) will be stopped at the end
of the first RSV season or 6 months after vaccination on Day 1,whatever comes later.
 If enrollment is spread over the NH and SH, a single IA may be performed during the NH or
SH RSV season. The IA will be performed by the IDMC at the earliest of 2 predetermined
time points (ie, database cut-off dates of 15 May 2020 and 15 August 2020) when at least
14 RT-PCR-confirmed RSV-mediated LRTD events per Case Definition #2 are observed. If
the IA is successful, proof of concept is demonstrated. If proof of concept is not demonstrated
at the IA or if less than 14 events are observed at the second time point, the primary analysis
will be performed at the end of the SH RSV season in a similar way as in a NH study only.
If superiority is demonstrated at the end of the first NH RSV season, the study will continue and
the ongoing participants from Cohort 1 will be followed up for a second RSV season. If this is the
case, additional analyses will be performed at the end of the second RSV season to evaluate if
there is a trend for durable efficacy. If analyses at the end of the second RSV season indicate a
trend for durable efficacy or in case results on durability are inconclusive, the study will continue
and the ongoing participants from Cohort 1 will be followed up for a third RSV season. If this is
the case, additional analyses will be performed at the end of the third RSV season to further
evaluate durability of efficacy.
If VE is not demonstrated at the time of the primary analysis, the study will be stopped. The
ongoing participants from Cohort 1 will no longer be followed up.

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Figure 3: 
Flow Chart for the Primary Analysis in Case the Study is Performed at the Northern
Hemisphere Only
a Number of RT-PCR-confirmed RSV-mediated LRTD cases (based on Case Definition #2)
b The study will stop at the end of the RSV season or 6 months after vaccination on Day 1, whichever comes later.
CP =conditional power, IA =interim analysis, IDMC =Independent Data Monitoring Committee, LRTD =lower
respiratory tract disease,NH =Northern Hemisphere,PA =primary analysis, POC =proof of concept

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Figure 4: 
Flow Chart for the Primary Analysis in Case the Study is Performed at the Northern and
Southern Hemisphere
a Number of RT-PCR-confirmed RSV-mediated LRTD cases (based on Case Definition #2).
b The study will stop at the end of the RSV season or 6 months after vaccination, whichever comes later.
If the number of participants enrolled in the NH is less than 5,500 but 18 or more RT-PCR-confirmed RSV-
mediated LRTD events (using Case Definition #2) are observed in the NH before opening sites in the SH, no
sites will be opened in the SH and the study will be performed as a NH study only (see Section 11.12, Planned
Analyses).
CP =conditional power, IA =interim analysis, IDMC =Independent Data Monitoring Committee, LRTD =lower
respiratory tract disease,NH =Northern Hemisphere, PA =primary analysis, POC =proof of concept,
SH =Southern Hemisphere
In addition, this study will assess the safety and immunogenicity of revaccination with
Ad26/protein preF RSV vaccine administered at different yearly time intervals after the first
vaccination in subcohorts of participants (Revaccination Subcohorts A, B, and C) to determine the
optimal time for revaccination, and to explore the relative contribution of each component of the
vaccine (Ad26.RSV.preF and RSV preF protein) to the immune response after vaccination.

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2. 
OBJECTIVES, ENDPOINTS, AND HYPOTHESIS
2.1. 
Objectivesand Endpoints
Objectives 
Endpoints
PRIMARY
 To demonstrate the efficacy of active study
vaccine in the prevention of RT-PCR-confirmed
RSV-mediated LRTD according to Case
Definition #1a, when compared to placebo
 First occurrenceb of RT-PCR-confirmed RSV-
mediated LRTD according to Case Definition #1
 To demonstrate the efficacy of active study
vaccine in the prevention of RT-PCR-confirmed
RSV-mediated LRTD according to Case
Definition #2a, when compared to placebo
 First occurrence of RT-PCR-confirmed RSV-
mediated LRTD according to Case Definition #2
 To demonstrate the efficacy of active study
vaccine in the prevention of RT-PCR-confirmed
RSV-mediated LRTD according to Case
Definition #3a, when compared to placebo
 First occurrence of RT-PCR-confirmed RSV-
mediated LRTD according to Case Definition #3
SECONDARY
 To assess the efficacy of active study vaccine in
the prevention of any RT-PCR-confirmed RSV
disease when compared to placebo
 First occurrence of any RT-PCR-confirmed RSV
disease
 In the Immuno Subset and in subgroups of this
subset (eg, participants at increased risk of
severe RSV disease), to evaluate the
immunogenicity of active study vaccine
 Characterization of the humoral and cellular
immune responses with emphasis on neutralizing
and binding antibodies and antigen-specific
cytokine production by T cells
 In the Safety Subset and in subgroups of this
subset (eg, participants at increased risk of
severe RSV disease), to evaluate the safety and
reactogenicity in terms of solicited local and
systemic AEs during 7 days after vaccination,
and in terms of unsolicited AEs during 28 days
after vaccination
 Occurrence, severity, duration and relationship to
vaccination of solicited local and systemic AEs
during 7 days after vaccination and of unsolicited
AEs during 28 days after vaccination
 In the Revaccination Subcohorts, to evaluate the
safety and reactogenicity in terms of solicited
local and systemic AEs during 7 days after
revaccination with active study vaccine
administered at 1, 2, or 3 years after the first
vaccination, and in terms of unsolicited AEs
during 28 days after revaccination
 Occurrence, severity, duration and relationship to
vaccination of solicited local and systemic AEs
during 7 days after revaccination at 1, 2, or 3
years after the first vaccination and of unsolicited
AEs during 28 days after revaccination at 1, 2, or
3 years after the first vaccination
a
Clinical case definitions for RSV-mediated LRTD are presented in Section 11.4.1, Primary Efficacy Endpoints.
b
First occurrence of the considered endpoint is defined as the first episode of the considered endpoint in a given
RSV season (regardless ofRSV A or B strain, unless otherwise specified).

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 To evaluate safety in terms of serious adverse
events (SAEs) during the RSV seasona
 To evaluate safety in terms of adverse events of
special interest (AESIs) during 6 months after
revaccinationa
 Occurrence and relationship to vaccination
of SAEs during the RSV season
 Occurrence and relationship to vaccination
of AESIs 
during 
6 
months 
after
revaccination
 To evaluate safety in terms of serious adverse
events (SAEs) during the ARI follow-up
periodsb
 Occurrence and relationship to vaccination
of SAEs during the ARI follow-up periods
a 
For participants who will not receive a revaccination, all SAEs will be reported from administration of study
vaccine on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes later). In
addition, SAEs classified as related to the study vaccine, SAEs resulting in death, (S)AEs resulting in study
discontinuation, and (S)AEs resulting from procedures and non-investigational (concomitant) Janssen products
will be collected during the entire study for all participants.
  For Revaccination Subcohort A, all SAEs will be reported from administration of study vaccine on Day 1 until the
end of the first RSV season (or 6 months after vaccination, whichever comes later), and from the time of
revaccination at Month 12 until the end of the second RSV season, or until 6 months after revaccination, whichever
comes later. For Revaccination Subcohort 2A, all SAEs and AESIs will also be collected from the time of
revaccination on Day 730 until 6 months after revaccination. For the other Revaccination Subcohorts (B and C),
SAEs and AESIs will be collected from the time of revaccination until 6 months thereafter. In addition, SAEs
classified as related to the study vaccine, SAEs resulting in death, (S)AEs resulting in study discontinuation, and
(S)AEs resulting from procedures and non-investigational (concomitant) Janssen products will be collected during
the entire study for all participants. For the participants in the Revaccination Subcohort C, these (S)AEs will be
collected retrospectively for the time period between the last end of the RSV season visit and the revaccination
upon the day of revaccination.
b 
For participants who will not receive a revaccination, SAEs associated with ARIs and complications related to
ARIs that classify as SAEs will be collected from the Day 365 (Month 12) visit until the end of the second RSV
season, from the end of the second RSV season until the Day 730 (Month 24) visit, and from the Day 730 (Month
24) visit until the end of the third RSV season.
  For all Revaccination subcohorts, collection of SAEs associated with ARIs and complications related to ARIs that
classify as SAEs will stop at the end of the second RSV season for Subcohort A, on Day 730 (Month 24) for
Subcohort B, and at the latest at the end of the third RSV season for Subcohort C.

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EXPLORATORY
 Explore the relationship between G-ELISA
and RT-PCR-confirmed RSV infection.
Provided a cut-off for G-ELISA fold-rise is
found that is sufficiently sensitive and specific,
the following objectives will be explored:
To assess the efficacy of active study
vaccine in the prevention of any serology
and/or RT-PCR-confirmed RSV disease
when compared to placebo
To assess the efficacy of active study
vaccine in the prevention of serology-
confirmed RSV-mediated LRTD according
to each case definition, when compared to
placebo
To assess the efficacy of active study
vaccine in the prevention of any serology-
confirmed RSV disease when compared to
placebo
To assess the efficacy of active study
vaccine in the prevention of any serology
and/or RT-PCR-confirmed RSV-mediated
LRTD according to each case definition,
when compared to placebo
 Fold-rise in G-ELISA between ARI Day 3-
5 and ARI Day 29.
First occurrence of any serology and/or
RT-PCR-confirmed RSV disease
First occurrence of serology-confirmed
RSV-mediated LRTD according to each
case definition
First occurrence of any serology-
confirmed RSV disease
First occurrence of any serology and/or
RT-PCR-confirmed RSV-mediated
LRTD
 If VE is demonstrated:
 To explore the efficacy of active study vaccine
during the second and third RSV season in the
prevention of RT-PCR-confirmed RSV-
mediated LRTD according to each of the
3 case definitions in each RSV season,
respectively, when compared to placebo
 To explore the efficacy of active study vaccine
over 2 and 3 RSV seasons in the prevention of
RT-PCR-confirmed RSV-mediated LRTD
according to each ofthe 3 case definitions,
when compared to placebo
 The objectives assessed during the first year,
might also be explored during the second and
thirdyear and over the 3-year period
 First occurrence of RT-PCR-confirmed
RSV-mediated LRTD during the second
and thirdRSV season according to each of
the 3case definitions
 First occurrence of RT-PCR-confirmed
RSV-mediated LRTD over 2 andover
3 RSV seasons according to each of the
3 case definitions
 For objectives considering the VE during
the secondand thirdseason, the first
occurrence of the considered endpoint in
the secondand thirdseason will be assessed
 For objectives considering VE over 3 RSV
seasons, the first occurrence of the
considered endpoint over 3 seasons will be
assessed
 To assess the effect of active study vaccine on the
level of RSV infection when compared to placebo
 Assessment of the RSV viral load by
quantitative RT-PCR

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 To explore the efficacy of active study vaccine in
the prevention of any RT-PCR-confirmed RSV
disease caused by an RSV A strain and any
RT-PCR-confirmed RSV disease caused by an
RSV B strain when compared to placebo
 First occurrence of any RT-PCR-confirmed
RSV disease caused by an RSV A strain or
RSV B strain, respectively
 To explore the effect of active study vaccine on
the potential complications of RSV disease and of
any respiratory disease
 First occurrence of potential complications of
respiratory disease (eg, pneumonia, new onset,
worsening, or an exacerbation of congestive
heart failure (CHF), asthma, and chronic
obstructive pulmonary disease (COPD) linked
to any respiratory disease and linked to any
RT-PCR-confirmed RSV disease
 In the Revaccination Subcohorts, to evaluate
humoral and cellular immunogenicity following a
revaccination administered at 1 (humoral only),
2,or 3 years after the first vaccination
 Characterization of the humoral and cellular
immune response following a revaccination at
1 (humoral only), 2, or 3 years after the first
vaccination, with emphasis on neutralizing and
binding antibodies
 To evaluate the immune response biomarkers in
study participants as correlates of risk of RSV
disease and as correlates of protection induced by
the vaccine
 Assessment of the correlation of humoral
immune responses with emphasis on
neutralizing and binding antibodies with the
risk of RSV disease and protection induced by
the vaccine
 To explore biomarkers for the diagnosis of RSV
infection and RSV disease severity
 Assessment of blood samples collected during
ARI episodes for biomarkers that correlate
with RSV infection and RSV disease severity
 To explore the efficacy of active study vaccine
against other respiratory diseases
 Midturbinate nasal swabs may be tested for the
presence of other respiratory pathogens
 To explore the effect of active study vaccine on
hospitalization in the overall populations and in
subgroups
 First occurrence of hospitalization linked to
any respiratory disease and linked to any RT-
PCR-confirmed RSV disease
 To explore the impact of active study vaccine on
the course of respiratory disease and general
health status
 Daily symptom severity reported by
participants using the Respiratory Infection
Intensity and Impact Questionnaire (RiiQ™)a,
patient global impression scales, temperature
logs, medical resource utilization (MRU) and
oxygen saturation in participants with an ARI
(RSV-confirmed or any cause)
 To explore the impact of the baseline frailty and
functioning in Instrumental Activities of Daily
Living (IADL) on the incidence, severity, and
duration of RT-PCR confirmed RSV-mediated
LRTD
 Assessment of RSV incidence (by RT-PCR),
RSV severity (per RiiQ questionnaire), and
duration of ARI episode(s) in relation to the
baseline frailty score and baseline Lawton-
Brody IADL
a 
The Respiratory Infection Intensity and Impact Questionnaire used in this study is the RiiQ™ Version 2, 2018
(hereafter referred to as RiiQ).

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 In Revaccination Subcohorts 2A and 2B, to
explore the relative contribution of each
component of the active vaccine on safety and
reactogenicity in terms of solicited local and
systemic AEs during 7 days after revaccination,
and in terms ofunsolicited AEs during 28 days
after revaccination
 Occurrence, severity, duration,and
relationship to vaccination of solicited local
and systemic AEs during 7 days after
revaccination and of unsolicited AEs during
28 days after revaccination
 In Revaccination Subcohorts 2A and 2B, to
explore the relative contribution of each
component of the active vaccine on humoral and
cellular immunogenicity following revaccination
 Characterization of the humoral and cellular
immune response following revaccination,
with emphasis on neutralizing and binding
antibodies
2.2. 
Hypothesis
The study is designed to test the primary hypothesis of VE in the Per-protocol Efficacy (PPE)
population (see Section 11.1, for a definition of the PPE population).
 The null hypothesis is that the VE for each of the 3 primary endpoints is ≤0%
 The alternative hypothesis is that the VE for at least one of the primary endpoints is >0%
3. 
STUDY DESIGN AND RATIONALE
3.1. 
Overview of Study Design
This is a multi-center, randomized, double-blind, placebo-controlled Phase 2b proof-of-concept
study in male and female participants aged ≥65 years who are in stable health. A target of up to
5,800 participants (Cohort 1) will be enrolled and randomized in parallel in a 1:1 ratio to 1 of
2 groups to receive active study vaccine (Group 1) or placebo (Group 2) intramuscularly (Table 2).
Based on the primary analysis of safety and immunogenicity results from Cohort 2 in Study
VAC18193RSV1004 (immunogenicity including, but not limited to RSV neutralizing antibodies),
a sponsor committee has selected the study vaccine dose and regimen to be used in this study. In
making the selection, additional factors such as data from other assays, cost of goods, and ease of
administration were also taken into account.
The study comprises administration of an Ad26.RSV.preF/RSV preF protein mixture (or placebo)
to be administered as a single injection on Day 1. After vaccination, participants will be followed
for symptoms that could indicate an ARI until the end of the RSV season. The end of the first NH
RSV season for the onset of an ARI is defined as 20 March 2020 (due to the coronavirus disease
2019 [COVID-19] pandemic, Amendment 2),the endof the second NH RSV season for the onset
of an ARI will be defined as 17 May 2021, and the end of the third NH RSV season for the onset
of an ARI will be defined as 15 April 2022a. The end of the SH RSV season is country/territory-
specific and will be specified to the sites prior to the start of dosing in the SH. Study progression
a 
The defined end-of-season dates for the second and third NH RSV season may be updated in case there would be
indications of a shift in season.

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beyond the first and second RSV seasons is conditional on the results obtained at the end of each
of these RSV seasons.
Due to the COVID-19 pandemic, the study was amended (Amendment 2, 20 March 2020): for the
first NH RSV season, if possible, participants who had ongoing ARIs (with ARI onset up to 20
March 2020), where an ARI Day 3-5 visit including the collection of a nasal swab or sputum
sample had occurred, had to continue collecting daily temperature monitoring, and RiiQ and PGI
questionnaires on their eDevices until their symptoms resolved or returned to baseline for 2 days.
If possible, sites had to collect ARI Day 29 visit data as described in the Schedule ofActivities
Assessments for Participants with an ARI Episode, but excluding procedures that required on-site
visit (ie, serology and clinical assessment), over the telephone or by telemedicine contact.
Cohort 1 will contain the following subsets:
 Safety Subset (N 700): approximately 350 active study vaccine participants and 350 placebo
participants who have given informed consent for the additional study procedures for
assessment of safety.
 Immuno Subset (N 200 from selected study sites): approximately 100 active study vaccine
participants and 100 placebo participants who have given informed consent for the additional
study procedures for assessment of immunogenicity.
Under Amendment 4 (dated 25 August 2020), a subcohort of Cohort 1 participants will be
implemented. This Revaccination Subcohort (N 240) will consist of approximately
120 participants from Group 1 who received active study vaccine on Day 1 and 120 participants
from Group 2 who received placebo on Day 1, and who have given informed consent for the
additional study procedures. Participants in this Revaccination Subcohort will receive a
revaccination with active study vaccine on Day 365 (Month 12, 1 year after the first vaccination)
to assess the safety and immunogenicity of a second vaccination.
Under Amendment 5 (dated 04 February 2021), additional Revaccination Subcohorts will be
implemented. Participants in these additional Revaccination Subcohorts will receive a
revaccination with active study vaccine at 2, 3, or 4 years after the first vaccination to assess the
safety and immunogenicity of revaccination with Ad26.RSV.preF/RSV preF protein mixture or
with the individual vaccine components as indicated in Table 2.
Under Amendment 8 (dated 16 February 2023), Revaccination Subcohort D (ie, participants who
would have received a revaccination with the Ad26.RSV.preF/RSV preF protein mixture at 4 years
after the first vaccination) will be removed as additional data with a Month 48 revaccination
timepoint are not expected to provide novel insights on the kinetics of the immune response after
revaccination with the Ad26.RSV.preF/RSV preF protein mixture.
A graphical display of all Revaccination Subcohorts is presented in Figure 5 for Group 1 (active
study vaccine on Day 1) and in Figure 6 for Group 2 (placebo on Day 1).
Note: Participants can be enrolled in both the Safety and the Immuno Subset. Participants in
Revaccination Subcohorts A and B cannot have participated in the Safety or the Immuno Subset.

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Study duration will be approximately 2.6 years for participants in the first cohort. Study duration
in the Revaccination Subcohorts will be 2 years for participants in Revaccination Subcohort 1A,
3 years for participants in Revaccination Subcohorts 2A and 1B, and 4 years for participants in
Revaccination Subcohorts 2B and C.
If the study does not progress to a second RSV season, the study duration will be approximately
0.6 years. If the study does not progress to a third RSV season, the study duration will be
approximately 1.6 years.
The study will continue with Revaccination Subcohort C depending on the 28-day post second
vaccination analysis results from Revaccination Subcohort B.
Study duration will be approximately 0.6 years for the potential 2,000 extra participants in the
second cohort.
The end of the study is defined as the last participant’s last visit.
Table 2: 
Study Design: VAC18193RSV2001
Cohort/Group/ 
Subcohort 
Day 1 Vaccination 
Day 365 (Month 12) 
Revaccination  
Month 24 
Revaccination  
Month 36
Revaccination
(Amendment 4) 
(Amendment 5)
Cohort 1a,b N=5,800
Group 1 N=2,900 
Active vaccine mixture
     Safety Subsetc
(N 350)
     Immuno Subsetc
(N 100)
Revaccination Subcohort 
1Ac (N=120)
Active vaccine mixture Active vaccine mixture
Revaccination Subcohort 
1Bc(N=135) 
Active vaccine mixture 
Active vaccine
mixture
Revaccination Subcohort 
1Cc,d(N=120) 
Active vaccine mixture 
Active vaccine
mixture
Group 2 N=2,900 
Placebo
     Safety Subset c
(N 350)
     Immuno Subset c
(N 100)
Revaccination Subcohort 
2Ac (N=120) 
Placebo 
Active vaccine mixture 
Ad26.RSV.preF
alone (N=40)
RSV preF protein
alone (N=40)
Active vaccine
mixture (N=40)
Revaccination Subcohort 
2Bc (N=135) 
Placebo 
Active vaccine
mixture
Ad26.RSV.preF
alone (N=45)
RSV preF protein
alone (N=45)
Active vaccine
mixture (N=45)

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Cohort/Group/ 
Subcohort 
Day 1 Vaccination  
Day 365 (Month 12) 
Revaccination  
Month 24 
Revaccination  
Month 36
Revaccination
(Amendment 4) 
(Amendment 5)
Revaccination Subcohort 
2Cc,d(N=120) 
Placebo 
Active vaccine
mixture
Active vaccine mixture refers to Ad26.RSV.preF (1×1011 vp)/RSV preF protein (150 μg) administered as a single injection.
Ad26.RSV.preF alone refers to Ad26.RSV.preF at a dose of 1×1011 vp.
RSV preF protein alone refers to RSV preF protein at a dose of 150 μg.
a If 5,500 or more participants are enrolled from the NH, no additional participants from the SH will be enrolled (see
Section 11.2, Sample Size Determination). In addition, if the number of participants enrolled in the NH is less than
5,500 but 18 or more RT PCR confirmed RSV mediated LRTD events (using Case Definition #2) are observed in the NH
before opening sites in the SH, no sites will be opened in the SH and the study will be performed as a NH study only (see
Section 11.12, Planned Analyses).
b The study progression beyond the first year is dependent on results obtained at the end of the first NH RSV season.
c Participants who provided separate informed consent.
d The study will continue with Revaccination Subcohort C depending on the 28 day post second vaccination analysis results
from Revaccination Subcohort B.
LRTD=lower respiratory tract disease, NH=Northern Hemisphere, SH=Southern Hemisphere, vp=viral particles

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Safety
All Participants
All participants will be closely observed for a minimum of 30 minutes after vaccination to monitor
for the development of any acute reactions, or longer if deemed necessary by the investigator.
For all participants, SAEs will be collected from administration of study vaccine on Day 1 until
the end of the first RSV season (or 6 months after vaccination, whichever comes later).a
For all participants, some subsets of SAEs will be collected for additional study periodsa:
 ARIs and complications related to ARIs that classify as SAEs will be captured and will be
reported as SAEs in the electronic case report form (eCRF) for the duration of the secondRSV
season, between the second and the third RSV season, and for the duration of the third RSV
season.
 From the time of vaccination (Day 1) until the end of the study period for each participant,
SAEs classified as related to the study vaccine, SAEs resulting in death, and (S)AEs leading
to discontinuation from the study will be collected.
 During the entire study, (S)AEs and special reporting situations related to study procedures or
to non-investigational (concomitant) Janssen products will be reported from the time a signed
and dated informed consent form (ICF) is obtained onwards until the end of the study period
for each participant.
The (S)AE listing in the eCRF will not be updated based on the RSV RT-PCR results and will
remain listed on the eCRF as ARIs.
Safety Subset and Revaccination Subcohorts
For Revaccination Subcohort A, all SAEs will be reported from administration of study vaccine
on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later), and from the time of revaccination at Month 12 until the end of the second RSV season, or
until 6 months after revaccination, whichever comes later. For Revaccination Subcohort 2A, all
SAEs and AESIs will also be collected from the time of revaccination on Day 730 until 6 months
after revaccination. For Revaccination Subcohorts B andC, all SAEs and AESIs will be collected
from the time of revaccination until 6 months thereafter. Collection of SAEs associated with ARIs
and complications related to ARIs that classify as SAEs will stop at the end of the second RSV
season for Subcohort A, on Day 730 (Month 24) for Subcohort B, and at the latest at the end of
the third RSV season for Subcohort C.
For all Revaccination Subcohorts, SAEs classified as related to the study vaccine, SAEs resulting
in death, (S)AEs leading to discontinuation from the study, and (S)AEs and special reporting
situations related to study procedures or to non-investigational (concomitant) Janssen products will
a 
The windows for SAE collection in the Revaccination Subcohorts are described below under “Safety Subset and
Revaccination Subcohorts”.

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be collected during the entire study for all participants. For the participants in the Revaccination
Subcohort C, these (S)AEs will be collected retrospectively for the time period between the last
end of the RSV season visit and the revaccination upon the day of revaccination.
Additional procedures will be carried out in the Safety Subset following vaccination on Day 1,
andin  the Revaccination Subcohorts following revaccination on Day 365 (Month 12)/Day 730
(Month 24)/Day 1,095 (Month 36), as described below:
 Solicited local (at the injection site) AEs, solicited systemic AEs, and body temperatures will
be recorded in the eDiary (or a paper diary, if designated by the sponsor), beginning on the
evening of the vaccine dosing day and on a daily basis for the following 7 days. If a solicited
AE has not resolved 7 days post-vaccination, it will continue to be followed-up until the event
has returned to baseline.
 Any unsolicited, solicited local (at the injection site) and solicited systemic AEs will be
documented in the eCRF by study-site personnel following the 30-minutes observation period.
In addition, vital signs (body temperature, blood pressure, heart rate, respiratory rate, and
oxygen saturation) will be obtained at the end of the observation period. Any clinically
relevant abnormalities must be recorded on the adverse event page of the eCRF. Actual values
(normal and abnormal) will only be documented in the eCRF for body temperature.
 All other AEs (unsolicited) and special reporting situations will be reported from the time of
vaccination through the following 28 days. Safety Subset participants will be contacted by
telephone or telemedicine contact at 28 days (+3 days) after vaccination to collect information
on unsolicited AEs; for participants in the Revaccination Subcohorts, this information will be
collected at the 28-day (+3 days) post-revaccination visit.
 All ARIs and all complications related to ARIs will be reported as AEs in the eCRF from the
time of vaccination through the following 28 days.
Immunogenicity
Blood will be collected for humoral immunogenicity assessments from all participants as specified
in the Schedule of Activities. Additional procedures will be carried out in the Immuno Subset
following vaccination on Day 1 and in the Revaccination Subcohorts following revaccination.
Other Procedures
From vaccination on Day 1 until the end of the first RSV season, from the Day 365 (Month 12)
visit until the end of the second RSV season, from the end of the second RSV season until the
Day 730 (Month 24) visit, and from the Day 730 visit until the end of the third RSV season, all
participants will be followed-up twice per week to monitor for symptoms that could indicate an
ARI, as described in Section 9.1.1, Overview. For participants in the Revaccination Subcohorts,
follow-up of ARIs will stop at the end of the second RSV season for Subcohort A, at the Day 730
(Month 24) visit for Subcohort B, and at the latest at the end of the third RSV season for
Subcohort C.

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Each participant will be asked twice each week if they have experienced any ARI-like symptoms
since the previous eDiary completion, or for participants that have one or more of these symptoms
at baseline, if they have experienced any additional ARI symptoms or a worsening of their baseline
symptoms (Attachment 4).
Symptoms and impact of an ARI will be assessed on a daily basis in all participants with an ARI
episode, using the RiiQ Symptom Scale (Attachment 5) and the RiiQ Impact on Daily Activities
Scale (Attachment 11, as part of the Combined Impact Assessment), respectively, in the eDiary.
The eDiary will also ask participants to complete the Patient Global Impression of Health (PGI-H),
the Patient Global Impression of Severity (PGI-S), the Patient Global Impression of Change
(PGI-C), and the Return to Usual Health question (Attachment 7, as part of the Combined Impact
Assessment) after they complete the RiiQ Symptom Scale and RiiQ Impact on Daily Activities
Scale. (Note that the PGI-C and the Return to Usual Health question will not be completed on ARI
Day 1). The eDiary ARI assessment asks participants to record thermometer logs.
The participants will additionally complete all 4 scales of the RiiQ v2 (Attachment 6) on the site’s
eDevice during the study visits at ARI Days 3-5 and ARI Day 29 (±7 days), and each of the PGI
scales and the Return to Usual Health question on the site’s eDevice during the study visit at ARI
Day 29 (±7 days). Refer to Section 9.2.1.1, Patient-Reported Outcomes for details.
Impact of an ARI on basic functioning will also be assessed by the study staff during study visits
using the Lawton-Brody IADL assessment (Attachment 8).
Baseline MRU will be collected from all participants prior to vaccination (Attachment 9). MRU
data will be collected from all participants with an ARI episode, using the MRU Questionnaire
(Attachment 10) completed during study visits at ARI Days 3-5 and at ARI Day 29 (±7 days) of
each ARI episode. Refer to Section 9.2.3, Medical Resource Utilization for details.
At the end of the first and third RSV season, the RiiQ questionnaire and the PGI-H in the eDiary
will be completed by the participant in the eDiary or by telephone or telemedicine interview. The
Lawton-Brody will be completed by telephone or telemedicine contact. The study-site personnel
will read aloud the questions to the participant and record the participant’s responses on the site’s
eDevice. At the end of the second RSV season, the Lawton-Brody IADL questionnaire will be
collected on-site by interview with the participant and recorded on the site’s eDevice; the RiiQ and
the PGI-H will be completed by the participant on the site’s eDevice.
In addition, at the end of the first RSV season, each study participant will be invited to complete
an Independent Ethics Committee (IEC)/Institutional Review Board (IRB) approved Experience
Survey, to share his/her experience as a volunteer in this study. The responses will be collected by
an external party and anonymously provided to the sponsor. An IDMC will be commissioned for
this study. Refer to Section 11.13, Independent Data Monitoring Committee, for details.

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3.2. 
Study Design Rationale
Vector Selection
The rationale behind the selection of the Ad26 vector is described in Section 1.1.
Dose Selection
The rationale behind the selection of the Ad26 dose is described in Section 1.1.
Rationale for Vaccine Regimen Selection
The active vaccine for this study was determined from the primary analysis of Cohort 2 in Study
VAC18193RSV1004.
Blinding, Control, Study Phase/Periods, Intervention Groups
A placebo control will be used to establish the frequency and magnitude of changes in clinical
endpoints that may occur in the absence of active intervention. Randomization will be used to
minimize bias in the assignment of participants to vaccine groups (ie, active vaccine [Group 1] or
placebo [Group 2] for all participants in Cohort 1, and assignment to Ad26.RSV.preF/RSV preF
protein mixture or the individual vaccine components for Revaccination Subcohorts 2A and 2B),
to increase the likelihood that known and unknown participant attributes (eg,demographic and
baseline characteristics) are evenly balanced across groups, and to enhance the validity of
statistical comparisons across groups. Blinded intervention will be used to reduce potential bias
during data collection and evaluation of clinical endpoints.
For the Revaccination Subcohorts, all participants will receive active study vaccine at the time of
revaccination. The blinding for the study vaccine received on Day 1 will be maintained for the site
and participants until the database lock for the final analysis of the considered cohort, except for
Revaccination Subcohorts A and B, who will be unblinded to the Day 1 vaccination prior to
re-randomization to the third vaccination: participants who received active vaccine on Day 1 will
complete the study at that time, participants who received placebo on Day 1 will be re-randomized
to receive either Ad26.RSV.preF/RSV preF protein mixture or the individual vaccine components
in a blinded fashion.
Medical Resource Utilization Data Collection
Prophylaxis of RSV infection may reduce the need for and duration of supportive care (eg,
hospitalization, oxygen supplementation, etc.). The study will evaluate the impact of active study
vaccine versus placebo on the development and clinical course of RSV disease.
4. 
PARTICIPANT POPULATION
Screening for eligible participants will be performed pre-vaccination on Day 1. Only participants
aged 65 years or older will be enrolled in the study.
Participants aged ≥65 years are generally considered at high risk for severe disease. Participants
in this age range with chronic heart disease (CHF, coronary artery disease [eg, angina pectoris,
ischemic cardiomyopathy, history of myocardial infarct (MI), history of coronary artery bypass

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graft or coronary artery stent]) and chronic lung disease (eg, asthma and COPD) are generally at
even higher risk for severe RSV disease23; hereafter, this population will be referred to as
“increased risk”. Participants at increased risk for severe RSV disease due to these underlying
medical conditions will be enrolled in the study. Randomization will be set up to ensure enrollment
of 350 participants at increased risk for severe RSV disease in the Safety Subset and
50 participants at increased risk for severe RSV disease in the Immuno Subset. Participants with
severe chronic cardiac and lung diseases will be excluded from the studyper Exclusion Criterion 2.
The inclusion and exclusion criteria for enrolling participants in this study are described in the
following 2 subsections. If there is a question about the inclusion or exclusion criteria below, the
investigator must consult with the appropriate sponsor representative and resolve any issues before
enrolling a participant in the study. Waivers are not allowed.
For a discussion of the statistical considerations of participant selection, refer to Section 11.2,
Sample Size Determination.
4.1. 
Inclusion Criteria
Each potential participant must satisfy all of the following criteria to be enrolled in the study:
1. 
Each participant must sign an ICF indicating that he or she understands the purpose of,
and procedures required for, the study, is willing to participate in the study and attend
all scheduled visits, and is willing and able to comply with all study procedures and
adhere to the prohibitions and restrictions specified in this document.
2. 
Participant must be a man or woman, ≥65 years old on the day of signing the ICF and
expected to be available for the duration of the study.
3. 
Participant must have a body mass index (BMI) <40 kg/m2.
4. 
Before randomization, a woman must be:
 postmenopausal (postmenopausal state is defined as no menses for 12 months
without an alternative medical cause); and
 not intending to conceive by any methods.
Note: Hysterectomized women are also eligible for the study.
5. 
Criterion modified per Amendment 4:
  5.1 
In the investigator’s clinical judgment, participant must be either in good or stable
health. Participants may have mild to moderate (according to the Toxicity Table in
Attachment 2) underlying illnesses such as chronic cardiac diseases and chronic lung
disease (asthma and COPD), CHF, hypertension, type 2 diabetes mellitus,
hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable
and medically controlled in the judgment of the investigator. Participants will be

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included on the basis of physical examination, medical history, and vital signsa
performed between ICF signature and vaccination on Day 1.
Note: For participants in the Revaccination Subcohorts: In the investigator’s clinical
judgment, participant must be either in good or stable health. Participants may have mild
to moderate (according to the Toxicity Table in Attachment 2) underlying illnesses as
long as their symptoms and signs are stable and medically controlled in the judgment of
the investigator at the time of revaccination.
6. 
From the time of vaccination through 3 months after vaccination, participant agrees not
to donate blood.
7. 
Participant must be able to read, understand, and complete questionnaires in the eDiary
(or a paper safety diary, ifdesignated by the sponsor).
8. 
Participant must be able to work with smartphones/tablets/computers.
9. 
Participant must be willing to provide verifiable identification, have means to be
contacted and to contact the investigator during the study.
4.2. 
Exclusion Criteria
Any potential participant who meets any of the following criteria will be excluded from
participating in the study:
1. 
Participant has an acute illness (including acute respiratory illnesses) or body
temperature ≥38.0 ºC within 24 hours prior to administration of study vaccine. In such
a situation, enrollment at a later date is permitted.
2. 
Participant has a severe or potentially life-threatening chronic disorder according to the
Toxicity Table in Attachment 2, such as severe chronic cardiac diseases and severe
chronic lung disease (asthma and COPD), advanced CHF, end-stage renal disease with
or without dialysis, clinically unstable cardiac disease, Alzheimer’s disease,or has any
condition for which, in the opinion of the investigator, participation would not be in the
best interest of the participant (eg, compromise well-being) or that could prevent, limit,
or confound the protocol-specified assessments.
3. 
Participant has a history of malignancy within 5 years before screening (exceptions are
squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or
malignancy, which is considered cured with minimal risk of recurrence).
4. 
Participant has had major surgery (per the investigator’s judgment), within 4 weeks
before dosing, or will not have fully recovered from surgery, or has surgery planned
during the time the participant is expected to participate in the study or within 6 months
after (the last dose of) study vaccine.
Note: Participants with planned surgical procedures to be conducted under local or
locoregional anesthesia and/or not judged as major by the investigator may participate
upon sponsor approval.
a 
Participants can be enrolled with Grade 1 or Grade 2 values for vital signs measurements (refer to Attachment 2).

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5. 
Per medical history, participant has chronic active hepatitis B or hepatitis C infection.
6. 
Per medical history, participant has HIV type 1 or type 2 infection.
7. 
Participant has major psychiatric illness and/or drug or alcohol abuse which in the
investigator’s opinion would compromise the participant’s safety and/or compliance
with the study procedures.
8. 
Participant has a known allergy, or history of anaphylaxis or other serious adverse
reactions to vaccines or vaccine components (including any of the constituents of the
study vaccine).
9. 
Participant has a history of chronic urticaria (recurrent hives) or a history of chronic or
recurrent 
eczema 
and/or 
atopic 
dermatitis 
that 
requires 
oral/parenteral
immunomodulators/immunosuppressors.
10. 
Participant has a history of acute polyneuropathy (eg, Guillain-Barré syndrome).
11. 
Participant has abnormal function of the immune system resulting from:
 Clinical conditions (eg, autoimmune disease or immunodeficiency)
 Chronic (longer than 10 days) or recurrent use of systemic corticosteroids within
6 months before administration of study vaccine (Note: Ocular, topical, intra-
articular, or inhaled steroids are allowed)
 Administration of antineoplastic and immunomodulating agents or radiotherapy
during the study and within 6 months before administration of study vaccine.
12. 
Participant has received treatment with immunoglobulins in the last 2 months,
immunoglobulins specific to RSV, human metapneumovirus or parainfluenza viruses
in the last 12 months, or blood products in the 4 months before the planned
administration of study vaccine or has any plans to receive such treatment during the
study.
13. 
Participant is in receipt of, or planning to receive, licensed live attenuated vaccine
within 28 days of study vaccination (ie, before and after); other licensed vaccines (ie,
not live: eg, influenza, tetanus, hepatitis A or B, rabies) should be given at least 14 days
before or at least 14 days after study vaccination.
14. 
Criterion modified per Amendment 7:
14.1 
Criterion modified per Amendment 8:
  14.2 
Participant has received an investigational drug or used an invasive investigational
medical device within 30 days or received an investigational vaccine within 6 months
before the planned administration of study vaccine or is currently enrolled or plans to
participate in another investigational study during the course of this study.
Note: Participation in an observational clinical study (ie, with no intervention) is
allowed upon approval of the sponsor.
Note: Potential participants for revaccination subcohort C who are currently not
participating in RSV ARI follow-up may be allowed to concurrently enroll in another
clinical study upon approval of the sponsor. In general, concurrent participation in an

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observational study is encouraged over an interventional study. The concurrent
interventional studies must fulfill these criteria:
 The concurrent interventional study must be finished before the planned
administration of study vaccine in the revaccination subcohort.
 The concurrent interventional study must not administer another investigational
RSV vaccine, other preventive RSV measures, or RSV treatments.
 The last administration of investigational vaccines in the concurrent interventional
study must be at least 6 months before the planned administration of study vaccine
in the revaccination subcohort.
 The last administration of investigational drugs or use of invasive medical devices
in the concurrent interventional study must be at least 30 days before the planned
administration of study vaccine in the revaccination subcohort.
 Any investigational products administered in the concurrent interventional study
must not have a long-term impact in a participant’s immune response (the last dose
of radiotherapy, antineoplastic and immunomodulating agents, or systemic
corticosteroids must be administered at least 6 months before the planned
administration of study vaccine in the revaccination subcohort).
 The last dose of immunoglobulin-based therapies administered in the concurrent
interventional study should follow Exclusion Criterion 12, relative to the planned
administration of study vaccine in the revaccination subcohort.
15. 
Participant has a contraindication to intramuscular injections and blood draws,
eg,bleeding disorders.
16. 
Participant has received active RSV vaccine in a previous RSV vaccine study at any
time prior to randomization.
17. 
Participant who, in the opinion of the investigator, is unlikely to adhere to the
requirements of the study, or is unlikely to complete the full course of vaccination and
observation.
18. 
Participant cannot communicate reliably with the investigator.
19. 
Participant is an employee of the investigator or study site, with direct involvement in
the proposed study or other studies under the direction of that investigator or study site,
as well as family members of the employees or the investigator, or an employee of the
sponsor.
20. 
Criterion modified per Amendment 4:
  20.1 
For participants in the Safety Subset and Revaccination Subcohorts only: participants
who have significant scarring, tattoos, abrasions, cuts, or infections over the deltoid
region of both arms that, in the investigator’s opinion, could interfere with evaluation
of injection site local reactions.

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21. 
Criterion modified per Amendment 5:
21.1 
Participant is in receipt of, or planning to receive, a SARS-CoV-2 vaccine (licensed or
used under Emergency Use Authorization):
 Live-attenuated SARS-CoV-2 vaccine: within 28 days before or within 28 days
after study vaccination.
 Non-live SARS-CoV-2 vaccine: within 14 days before or within 14 days after
study vaccination.
 A viral-vectored SARS-CoV-2 vaccine: within 28 days before or within 28 days
after study vaccination.
22. 
22. 
Criterion added per Amendment 6:
Participant has a history of TTS or heparin-induced thrombocytopenia and thrombosis
(HITT).
NOTE: Investigators must ensure that all study enrollment criteria have been met before
randomization and administration of the study vaccine on Day 1. Section 17.5, Source
Documentation, describes the required documentation to support meeting the enrollment criteria.
4.3. 
Prohibitions and Restrictions
Potential participants must be willing and able to adhere to the following prohibitions and
restrictions during the course of the study to be eligible for participation:
1. 
Refer to Section 8 Prestudy and Concomitant Therapy, for details regarding prohibited
and restricted therapies and vaccines during the study.
2. 
Agree to follow all requirements that must be met during the study as noted in the
inclusion and exclusion criteria (Section 4.1 and Section 4.2, respectively).
5. 
INTERVENTION ALLOCATION AND BLINDING
Study Vaccine Allocation
Central randomization will be implemented in this study. Participants will be randomly assigned
to 1 of 2 groups (active vaccine [Group 1] or placebo [Group 2]) on Day 1 based on a computer-
generated randomization schedule prepared before the study by or under the supervision of the
sponsor. Participants who have given additional informed consent will be enrolled in the Safety
Subset and/or in the Immuno Subset on Day 1. On Day 365 (Month12)/Day 730 (Month 24)/
Day 1,095 (Month 36), participants who have given their additional informed consent for
revaccination will be enrolled in the Revaccination Subcohorts.
The interactive web response system (IWRS) will assign a unique code, which will dictate the
group assignment for the participant. The requestor must use his or her own user identification and
personal identification number when contacting the IWRS, and will then give the relevant
participant details to uniquely identify the participant.

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In elderly participants, the incidence of RSV-mediated LRTD is expected to increase with age.
The incidence might also be higher in participants with chronic heart or lung disease (ie,
participants at increased risk for severe RSV). Therefore, the randomization will be stratified by
age categories (65-74 years, 75-84 years, ≥85 years) and by being at increased risk for severe RSV
disease (yes/no), and done in blocks to ensure balance across arms.
The randomization will also be stratified to ensure balance across arms of participants in the Safety
Subset and in the Immuno Subset (or a combination of both). The Safety Subset will consist of
approximately 700 participants, and 350 of them should be at increased high risk for severe RSV
disease. The Immuno Subset will consist of 200 participants, and 50 of them should be at increased
high risk for severe RSV disease. The non-increased risk Safety Subset must be fully enrolled
before further enrollment of non-increased risk participants in Cohort 1. The increased risk Safety
Subset must be fully enrolled before further enrollment of increased risk participants in Cohort 1.
Immuno Subset participants will be enrolled only at a selection of sites.
There are no restrictions on the size of the other strata.
Revaccination Subcohorts A, and C will each consist of approximately 120 participants from
Group 1 who received active study vaccine on Day 1 and approximately 120 participants from
Group 2 who received placebo on Day 1, and who have given informed consent for the additional
study procedures. Revaccination Subcohort B will consist of at least 135 participants from Group
1 who received active study vaccine on Day 1 and at least 135 participants from Group 2 who
received placebo on Day 1, and who have given informed consent for the additional study
procedures. Participants in the Revaccination Subcohorts will receive a revaccination with active
study vaccine at 1, 2, or 3 years after the first vaccination, as shown in Table 2. The enrollment of
Revaccination Subcohorts A and C will stop when both groups have reached at least
120 participants. The enrollment of Revaccination Subcohorts B will stop when both groups have
reached at least 135 participants.
Participants in Revaccination Subcohorts 2A and 2B will be re-randomized to Ad26.RSV.preF/
RSV preF protein mixture or the individual vaccine components in a 1:1:1 ratio in a blinded
manner.
Blinding
The investigator will not be provided with randomization codes. The codes will be maintained
within the IWRS, which has the functionality to allow the investigator to break the blind for an
individual participant.
In general, randomization codes will be disclosed fully only if the study is completed and the
clinical database is closed. The study participants, study-site personnel (except for those with
primary responsibility for study vaccine preparation and dispensing), and investigator will be
blinded to study vaccine allocation throughout the study. The sponsor will be blinded to study
vaccine allocation until the database lock for the primary analysis. Site staff and participants will
remain blinded until the end of the study.

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In the Revaccination Subcohorts, all participants will receive active study vaccine at the time of
revaccination (Ad26.RSV.preF/RSV preF protein mixture or the individual vaccine components
as shown in Table 2). The blinding for the study vaccine received on Day 1 will be maintained for
site and participants until the database lock for the final analysis of the considered cohort, except
for Revaccination Subcohorts A and B, who will be unblinded to the Day 1 vaccination prior to
re-randomization to the third vaccination: participants who received active vaccine on Day 1 will
complete the study at that time, participants who received placebo on Day 1 will be re-randomized
to receive either Ad26.RSV.preF/RSV preF protein mixture or the individual vaccine components
in a blinded fashion.
From the primary analysis onwards, group level results may be shared externally as needed,
however, efforts will be made to preserve the blinding to the individual participant allocation.
The investigator may in an emergency determine the identity of the intervention by contacting the
IWRS. While the responsibility to break the intervention code in emergency situations resides
solely with the investigator, it is recommended that the investigator contact the sponsor or its
designee if possible to discuss the particular situation, before breaking the blind. Telephone contact
with the sponsor or its designee will be available 24 hours per day, 7 days per week. In the event
the blind is broken, the sponsor must be informed as soon as possible. The date, time, and reason
for the unblinding must be documented by the IWRS, in the appropriate Section of the eCRF, and
in the source document. Documentation received from the IWRS indicating the code break must
be retained with the participant’s source documents in a secure manner. The investigator is advised
not to reveal the study vaccine assignment to the study-site personnel or sponsor personnel/sponsor
representative.
If the randomization code is broken by the investigator or the study-site personnel, the participant
must discontinue further study vaccine administration (if applicable) and must be followed as
appropriate until the end of the RSV season (refer to Section 10.2 for details). If the randomization
code is broken by the sponsor for safety reporting purposes, the participant should not discontinue
further study vaccine administration (if applicable) and may remain in the study (if the
randomization code is still blinded to the study-site personnel and the participant).
6. 
DOSAGE AND ADMINISTRATION
The active study vaccines used in this study are Ad26.RSV.preF and RSV preF protein each
administered alone as a single injection in the deltoid muscle, and an Ad26.RSV.preF/RSV preF
protein mixture administered as a single injection in the deltoid muscle, according to the schedule
shown in Table 2:
 Ad26.RSV.preF (JNJ-64400141) will be supplied at a concentration of 2×1011  vp/1 mL in
single-use vials. Dose levels of 1×1011  vp will be used.
 RSV preF protein (JNJ-64213175) will be supplied at a concentration of 0.3 mg/1 mL in
single-use vials. Dose levels of 150 μg will be used.
 Placebo for Ad26.RSV.preF and for RSV preF protein.

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All injections will be 1 mL in volume.
On Day 1,an unblinded site pharmacist, or other qualified individual, who will have no other study
function will prepare the syringe, labeled with the participant’s identification number, and provide
the syringes for Ad26.RSV.preF/RSV preF protein and placebo in a blinded manner to the blinded
study vaccine administrator who will perform the injection. The unblinded pharmacist, or other
qualified individual, may also perform vaccine administration, but will have no other study
function following dosing.
Revaccination Subcohorts 2A and 2B will receive a revaccination with Ad26.RSV.preF/RSV preF
protein mixture or with the individual vaccine components. The other Revaccination Subcohorts
will receive a revaccination with Ad26.RSV.preF/RSV preF protein mixture.
Full details of study vaccine preparation will be provided in the Site Investigational Product
Procedures Manual and in the Investigational Product Preparation Instruction (IPPI).
7. 
STUDY VACCINE COMPLIANCE
Study vaccine on  Day 1 (active or placebo) will be administered IM  by a blinded vaccine
administrator 
 a trained and qualified study nurse, medical doctor, or otherwise qualified
healthcare professional. The unblinded pharmacist, or other qualified individual, may also perform
vaccine administration, but will have no other study function following dosing.
The blinding for study vaccination received on Day 1 will be maintained for site and participants
until the database lock for the final analysis of the considered cohort, except for Revaccination
Subcohorts A and B, who will be unblinded to the Day 1 vaccination prior to re-randomization to
the third vaccination: participants who received active vaccine on Day 1 will complete the study
at that time, participants who received placebo on Day 1 will be re-randomized to receive either
Ad26.RSV.preF/RSV preF protein mixture or the individual vaccine components in a blinded
fashion.
The date and time of study vaccine administration will be recorded in the eCRF.
8. 
PRESTUDY AND CONCOMITANT THERAPY
For All Participants
Prestudy therapies administered up to 30 days before first administration of study vaccine must be
recorded in the eCRF.
Live attenuated vaccines should be given at least 28 days before (or at least 28 days after) any
administration of study vaccine. Other licensed vaccines (eg, influenza, tetanus, hepatitis A,
hepatitis B, rabies) should be given at least 14 days before (or at least 14 days after) administration
of study vaccine in order to avoid potential confusion of adverse reactions and potential immune
interference. If a vaccine is indicated in a post-exposure setting (eg, rabies or tetanus), it must take
priority over the study vaccine.

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SARS-CoV-2 vaccines should be given as follows: Live-attenuated SARS-CoV-2 vaccine at least
28 days before or at least 28 days after any administration of study vaccine; Non-live SARS-CoV-
2 vaccine at least 14 days before or at least 14 days after any administration of study vaccine; viral-
vectored SARS-CoV-2 vaccine at least 28 days before or at least 28 days after any administration
of study vaccine.
Seasonal influenza vaccination is recommended, but must occur at least 14 days before or at least
14 days after study vaccination.
Chronic use (longer than 10 days) or recurrent use of systemic corticosteroids must be documented
during the study. Antineoplastic and immunomodulating agents or radiotherapy are prohibited
during the study. If chronic use of systemic corticosteroids, antineoplastic or immunomodulating
agents becomes medically indicated during the study for any participant, the sponsor should be
contacted.
On Day 365 (Month 12), changes in the use of any concomitant medication since the last visit
should be recorded.
Concomitant therapies associated with an SAE meeting the criteria outlined in Section 12.3.2,
Serious Adverse Events will be collected and recorded in the eCRF from ICF signature through
the end of the study.
Concomitant medications associated with ARI episodes and with complications of ARI will be
recorded for all reported ARIs as defined in the protocol.
The sponsor must be notified in advance (or as soon as possible thereafter) of any instances in
which prohibited therapies are administered.
For Participants in the Safety Subset and the Revaccination Subcohorts
Concomitant therapies associated with unsolicited AEs will be collected and recorded in the eCRF
from the time of each vaccine administration through 28 days after vaccination. Concomitant
therapies associated with solicited AEs will be collected by the participants in the eCRF from the
time of vaccine administration through 7 days after vaccination.
For the Revaccination Subcohorts, concomitant therapies associated with an AESI meeting the
criteria outlined Section 12.3.4, Adverse Events of Special Interest will be collected and recorded
in the eCRF from ICF signature through the end of the study.
Information on concomitant use of herbal supplements or vitamins will not be collected.
Analgesic/antipyretic medications and non-steroidal anti-inflammatory drugs (NSAIDs) may be
used post-vaccination only in cases of medical need (eg, fever or pain) and their use must be
documented in the eCRF through 28 days after vaccination.
On Day 730 (Month 24)/Day 1,095 (Month 36) (as applicable), changes in the use of any
concomitant medication since the last visit should be recorded.

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9. 
STUDY EVALUATIONS
9.1. 
Study Procedures
9.1.1. 
Overview
The Schedule of Activities summarizes the frequency and timing of all measurements applicable
to this study. Unscheduled visits may be performed based on the investigator’s clinical judgment
and may include further evaluations, as needed.
If multiple assessments are scheduled for the same time point, it is recommended that procedures
be performed in the following sequence: electronic patient-reported outcome (ePRO), clinical
assessments, midturbinate nasal swab and/or nasosorption sample, blood draws. Actual dates and
times of assessments will be recorded in the source documentation and/or eCRF and/or eDevice.
eDevices will be provided for participants who require them. Instructions for completing eDiaries
(on provided eDevice or the participant's own eDevice), thermometers, and a midturbinate nasal
swab sample kit will be given to all participantsa on Day 1. Participants will receive eDiary training
on the day of study vaccination (Day 1), and they will be re-trained at Visit 2 (ie, 14 days post-
vaccination site visit), if needed and at Visit 4 (see Schedule ofActivities
Cohort 1 (N 5,800)).
Participants will use an eDiary (or paper safety diary, ifdesignated by the sponsor).b Participants
who were provided an eDevice to complete assessments at home will be instructed to return the
eDevice to the site at the end of their study participation. Participants using their own eDevice will
be instructed to delete the app from their personal device.
Participants in the Revaccination Subcohorts will also receive eDiary training on the day of
revaccination, and they will be retrained at the post-revaccination site visit(s), if needed (see
Schedules of Activities for Revaccination Subcohorts).
Participants will also be trained when and how to collect a midturbinate nasal swab, and how to
use a thermometer if they experience any symptoms that could indicate an ARI. Participants in the
Safety Subset and in the Revaccination Subcohorts will additionally be provided with a ruler to
measure local injection site reactions.
ARI Surveillance
From vaccination on Day 1 until the end of the first RSV season, from the Day 365 (Month 12)
visit until the end of the second RSV season, from the end of the second RSV season until the
Day 730 (Month 24) visit, and from the Day 730 visit until the end of the third RSV season,
Cohort 1 participants will be followed-up to identify potential cases of RSV infection (see
Attachment 1). For the participants in the Revaccination Subcohorts, follow-up of ARIs will stop
a 
Participants may also access the eDiary via their own eDevice if their device (smartphone or tablet) is compatible.
b 
Note that in view of safety data collection,all references to “eDiary” from this point in the protocol onwards
may therefore mean eDiary or paper diary.

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at the end of the second RSV season for Subcohort A, at the Day 730 (Month 24) visit for
Subcohort B, and at the latest at the end of the third RSV season for Subcohort C.
After administration of study vaccine, participants who experience any symptoms suggesting an
ARI should contact the study site and start completing the eDiary ARI assessment on a daily basis
(preferably in the evening) and/or the study site should contact the participant if any ARI
symptoms are recorded in the eDiary. To help participants remember to report symptoms of a
possible ARI, written instructions will be provided, and an eDiary reminder will be sent to the
participant’s eDevice twice per week during periods of ARI data collection. The reminder will ask
participants if they have experienced any ARI symptoms, or for participants that have one or more
of these symptoms at baseline (assessed pre-vaccination for the first RSV season, at the Day 365
[Month 12] visit for the second RSV season [pre-vaccination if applicable], and at the Day 730
[Month 24] visit for the third RSV season), if they have experienced any additional ARI symptoms
or a worsening of their baseline symptoms. Participants continue to receive daily reminders during
an ARI episode until they report 2 consecutive days without any symptoms of an ARI beyond
those present at baseline. The daily eDiary ARI assessment will then end and twice weekly
reminders to complete the eDiary ARI surveillance assessment will resume.
All ARIs, all complications related to ARIs, and concomitant medications associated with ARIs
will be captured on the ARI form for all participants.
Procedures for Participants who Experience an ARI Episode
When any participant experiences any symptom of ARI, the following will take place:
 Participants should contact the site as soon as possible to notify the site of any symptoms
suggesting an ARI (such as rhinitis, nasal congestion, sore throat, cough, etc.), or the site
should contact the participants if ARI symptoms are recorded in the eDiary. During this
telephone or telemedicine contact, the site may confirm if the reported symptoms qualify as
an ARI episode, in order to determine whether to proceed with the ARI procedures. The
participant will then be reminded to:
 Complete the eDiary including the RiiQ (Attachment 5) and Impact on Daily Activities
Scale (Attachment 11, as part of the Combined Impact Assessment), and thermometer
readings every evening (preferably), beginning on the evening of the day of symptom onset
(ARI Day 1) until the ARI episode resolves. The eDiary will also ask participants to
complete the PGI-H, the PGI-S, the PGI-C, and the Return to Usual Health question
(Attachment 7, as part of the Combined Impact Assessment). (Note that the PGI-C and the
Return to Usual Health question will not be completed on ARI Day 1). A resolved ARI
episode is defined as 2 consecutive days with no symptoms listed on the RiiQ Symptom
Scale or, for participants who have RiiQ symptoms present at baseline (assessed
pre-vaccination for the first RSV season, at the Day 365 [Month 12] visit for the second
RSV season [pre-vaccination if applicable], and at the Day 730 [Month 24] visit for the
third RSV season), 2 consecutive days where all symptoms on the RiiQ Symptom Scale
have returned to the severity level reported at baseline.
If a participant is unable to complete the eDiary, study staff can collect information on the
participant’s symptoms and temperature, by contacting the participant by telephone or
telemedicine contact (or visit the participant at home), reading the questions aloud to the

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participant and entering the participant’s responses on the site’s eDevice on the
participant’s behalf.
 Collect a midturbinate nasal swab at home on the day of symptom onset or the day
thereafter (ARI Days 1-2). If the participant requires it, the participant's caregiver can assist
the participant to collect the midturbinate nasal swabs.
 Ensure the midturbinate nasal swabs collected at home are provided to the study staff
within 4 days (preferably) after collection.
 Come to the site between 2 and 4 days after symptom onset (ARI Days 3-5), or, if a site
visit is not feasible, a member of the study staff can visit the participant at home (or at the
hospital, if needed) during this time frame.
 Between 2 and 4 days after symptom onset (ARI Days 3-5), a midturbinate nasal swab, a
sputum sample (in participants with a productive cough, when possible) and a blood sample
for seroconfirmation and exploration of biomarkers that correlate with RSV infection and
RSV disease severity will be taken by a qualified member of the study staff, and vital signs,
including body temperature,blood pressure, heart rate,respiratory rate and oxygen saturation,
will be measured. A clinical assessment, including a targeted physical examination, will be
completed by qualified study staff, preferably by a physician, physician assistant, nurse
practitioner, or equivalent. The participant’s functional status will also be evaluated by the
Lawton-Brody IADL questionnaire. The MRU questionnaire will be completed based on
clinical interview. The participant will complete all 4 scales of the RiiQ v2 questionnaire on
the site’s eDevice and provide the study staff member the midturbinate nasal swab collected
by the participant at home.
 At ARI Day 29 (±7 days), participants will be asked to return to the site where a blood sample
will be drawn for seroconfirmation and exploration of biomarkers that correlate with RSV
infection and RSV disease severity. A qualified member of the study staff will measure vital
signs, including body temperature, blood pressure, heart rate, respiratory rate and oxygen
saturation. A clinical assessment (including a targeted physical examination) will be
performed by qualified study staff, preferably by a physician, physician assistant, nurse
practitioner or equivalent, and the Lawton-Brody IADL assessment and MRU questionnaire
will be completed based on interview with the participant. Participants will complete all
4 scales of the RiiQ questionnaire, and each of the PGI scales and the Return to Usual Health
question on the site’s eDevice.
For all medically attended ARIs, including those resulting in hospitalization, a standard question
list will be provided, with the aim to collect additional information (Attachment 12) on any other
diagnostics (eg, chest x-rays, spirometry, pulmonary function tests, etc.) or interventions during
the clinical course of the ARI. Every effort should be made to collect data on the clinical course
of ARIs, including information on hospitalization, oxygenation status, supplemental oxygen
requirements and specific drug treatments, as well as other concurrent respiratory illness present
at the time of symptom onset and up to symptom resolution. If an expected eDiary recording has
been missed by a participant, a member of the staff should contact the participant the next morning
to confirm that eDiaries are being completed as required. Telephone calls to or telemedicine
contacts with the participants to facilitate compliance with the study procedures between study
visits are encouraged.

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For participants who experience symptoms suggesting an ARI episode, RT-PCR assay of the
midturbinate nasal swabs and sputum sample (when available) taken after symptom onset will be
used to determine whether the infection was caused by RSVa. If at least one of these samples is
positive for RSV, the collected information will be applied against the clinical case definitions for
RSV-mediated LRTD. For participants hospitalized with symptoms of an ARI, confirmation of
RSV infection using a Food and Drug Administration (FDA)-approved RT-PCR test at the local
(hospital) laboratory will also be obtained.
Site staff and participants will remain blinded as to the outcome of the RT-PCR test results until
study unblinding, but participants and their routine health care professional (HCP) can obtain
external diagnostics, including RSV RT-PCR, as medically needed.
Collection of ARI data by the study site will be ceased for that particular episode if a participant
has tested positive for SARS-CoV-2 (by a local test that is FDA-approved or by central laboratory
PCR).
Immunogenicity
Blood will be collected from all participants for humoral immunogenicity assessments before
vaccination on Day 1, and 14 days and 1 year after vaccination on Day 1. These samples will be
used for humoral immunogenicity assessments for participants experiencing an ARI episode
during the RSV season.
For participants in the Immuno Subset, blood will be collected for analysis of humoral and cellular
immune responses before vaccination on Day 1, and at 14 days, 84 days, 24 weeks, 1 year,
18 months, 24 months, and 30 months after vaccination on Day 1.
For participants in the Revaccination Subcohorts, blood will be collected for analysis of humoral
and cellular immune responses before and at different time points after revaccination as indicated
in the Schedules of Activities for the Revaccination Subcohorts.
Nasosorption samples using synthetic absorptive matrix (SAM) will be taken from Immuno Subset
participants prior to vaccination on Day 1 and at the 14-day post-vaccination visit.
Blood samples collected between 2 and4 days after symptom onset (ARI Days 3-5) and at 28 days
after symptom onset (ARI Day 29) from participants who experience ARI episodes will be assayed
by serology for RSV exposure confirmation. These samples will also be used for exploration of
biomarkers that correlate with RSV infection and RSV disease severity (including but not limited
to RT-PCR for RSV, RNA transcriptomics to assess regulation of genes [clusters] and expression
patterns, cytokine/chemokine analysis as available and applicable). Additionally, these samples
might be used for other pathogen exposure seroconfirmation.
a 
For some secondary and exploratory endpoints, the determination will be made by serology.

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Over the entire study, the total blood volume to be collected from each participant in the Immuno
Subset will be approximately 220 mL when the study does not progress beyond the first year,
330 mL when the study is continued beyond the first year, and 440 mL when the study is continued
beyond the second year. For all other participants in Cohort 1 who are not included in a
Revaccination Subcohort, the total blood volume to be collected will be 30 mL when the study
does not progress beyond the first year, 45 mL when the study is continued beyond the first year,
and 60 mL when the study is continued beyond the second year.
For participants in the Revaccination Subcohorts, the total blood volume to be collected from each
participant will be: Revaccination Subcohort 1A and 2A: 120 mL and 490 mL, respectively;
Revaccination Subcohort 1B and 2B: 430 mL and 755 mL, respectively; and Revaccination
Subcohort 1C and 2C: 160 mL (360 mL in a subset of approximately 100 participants).
For participants in Cohort 2, the total blood volume to be collected will be 30 mL.
The maximum volume of blood to be drawn at any given visit would be 55 mL for participants in
the Immuno Subset, 15 mL for all other participants in Cohort 1 who are not included in a
Revaccination Subcohort, and 62.5 mL for participants in the Revaccination Subcohorts.
During each ARI episode, 40 mL additional blood will be sampled.
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with the
samples.
Safety
All participants
All participants will be closely observed for a minimum of 30 minutes after vaccination to monitor
for the development of any acute reactions, or longer if deemed necessary by the investigator.
A full physical examination, including body weight, will be carried out before each vaccination.
Height will be measured on Day 1 only.
For all participants, SAEs will be collected from administration of study vaccine on Day 1 until
the end of the first RSV season (or 6 months after vaccination, whichever comes later).a
For all participants, some subsets of SAEs will be collected for additional study periodsa:
 ARIs and complications related to ARIs that classify as SAEs will be captured and will be
reported as SAEs in the eCRF for the duration of the second RSV season, between the second
and the third RSV season, and for the duration of the third RSV season.
a 
The windows for SAE collection in the Revaccination Subcohorts are described below under “Safety Subset and
Revaccination Subcohorts”.

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 From the time of vaccination (Day 1) until the end of the study period for each participant,
SAEs classified as related to the study vaccine, SAEs resulting in death, and (S)AEs leading
to discontinuation from the study will be collected.
 During the entire study, (S)AEs and special reporting situations related to study procedures or
to non-investigational (concomitant) Janssen products will be reported from the time a signed
and dated informed consent form (ICF) is obtained onwards until the end of the study period
for each participant.
The (S)AE listing in the eCRF will not be updated based on the RSV RT-PCR results and will
remain listed on the eCRF as ARIs.
Safety Subset and Revaccination Subcohorts
The following additional procedures will be carried out in participants in  the Safety Subset
following vaccination on Day 1, and in the Revaccination Subcohorts following revaccination on
Day 365 (Month 12)/Day 730 (Month 24)/Day 1,095 (Month 36), as described below:
 Any unsolicited, solicited local or solicited systemic AEs will be documented in the eCRF by
study-site personnel following the 30-minutes observation period. In addition, vital signs
(body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) will be
obtained at the end of the observation period. Any clinically relevant abnormalities must be
recorded on the AE page of the eCRF. Actual values (normal and abnormal) will only be
documented in the eCRF for body temperature
 Participants will be instructed how to properly record solicited AEs in their eDiary. Each
participant will record solicited local (at the injection site) AEs, solicited systemic AEs, and
body temperatures in the eDiary, beginning on the evening of the vaccine dosing day and on
a daily basis for the following 7 days. Body temperatures (oral route preferred) should be
taken at approximately the same time each day. Study-site personnel will review the
participant’s eDiary and complete the eCRF where appropriate. If a solicited AE has not
resolved 7 days post-vaccination, it will continue to be followed-up until the event has
returned to baseline.
 All other (unsolicited) AEs and special reporting situations will be collected from the time of
vaccine administration through the following 28 days. AEs, including any that are ongoing at
28 days after vaccine administration will be followed until clinical resolution or stabilization.
Concomitant therapies associated with unsolicited AEs will be collected and recorded in the
eCRF from the time of vaccine administration through 28 days after vaccination. Safety
Subset participants will be contacted by telephone or telemedicine contact at 28 days after
vaccination to collect information on unsolicited AEs and associated concomitant
medications. For participants in the Revaccination Subcohorts, this information will be
collected at the 28-day post-revaccination visit.
 All ARIs and all complications related to ARIs will be reported in the eCRF as AEs from the
time of vaccination through the following 28 days.
For Revaccination Subcohort A, all SAEs will be reported from administration of study vaccine
on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later), and from the time of revaccination at Month 12 until the end of the second RSV season, or
until 6 months after revaccination, whichever comes later. For Revaccination Subcohort 2A, all

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SAEs and AESIs will also be collected from the time of revaccination on Day 730 until 6 months
after revaccination. For Revaccination Subcohorts B andC, all SAEs and AESIs will be collected
from the time of revaccination until 6 months thereafter. Collection of SAEs associated with ARIs
and complications related to ARIs that classify as SAEs will stop at the end of the second RSV
season for Subcohort A, on Day 730 (Month 24) for Subcohort B, and at the latest at the end of
the third RSV season for Subcohort C.
For all Revaccination Subcohorts, SAEs classified as related to the study vaccine, SAEs resulting
in death, (S)AEs leading to discontinuation from the study, and (S)AEs and special reporting
situations related to study procedures or to non-investigational (concomitant) Janssen products will
be collected during the entire study for all participants. For the participants in the Revaccination
Subcohort C, these (S)AEs will be collected retrospectively for the time period between the last
end of the RSV season visit and the revaccination upon the day of revaccination.
Medical Resource Utilization
Medical resource utilization data will be collected. Refer to Section 9.2.3, Medical Resource
Utilization for details.
9.1.2. 
Visit Windows
For the following visits, windows will be allowed as indicated in Table 3.
Note that Table 3 applies to the Cohort 1 participants who are not included in a Revaccination
Subcohort. The windows for participants in a Revaccination Subcohort are provided in the
Schedules of Activities for the Revaccination Subcohorts.
Table 3: 
Visit Windows for Cohort 1 Participants Not Included in a Revaccination Subcohort
Clinic Visit #  
Visit Day/
Visit Week 
Visit Window  
Primary Purpose
2 
15/ 
2
+ 3 days 
14 days after vaccination, Safety and Immuno visit
2a 
29/ 
4 
+ 3 days 
28 days after vaccination, Safety visit, by telephone or
telemedicine contact
2b 
85/ 
12
± 7 days 
84 days after vaccination, Immuno visit
2c 
169/ 
24
± 14 days 
24 weeks after vaccination, Immuno visit
3 
+ 35 days 
End of the first RSV season visit, by telephone or
telemedicine contact (For Immuno Subset participants,
where the timing of Visit 2c and Visit 3 overlap, procedures
can be combined)
4 
365/ 
52
± 2 months 
12 months after vaccination, Safety and Immuno visit
5 
533/ 
76
± 14 days 
18 months after vaccination, Immuno visit

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Clinic Visit #
Visit Day/
Visit Week 
Visit Window  
Primary Purpose
6 
-7/+14 days
End of the second RSV season visit, by telephone or
telemedicine contact (For Immuno Subset participants,
where the timing of Visit 5 and Visit 6 overlap, procedures
can be combined)
7
730/
104
± 2 months 
24 months after vaccination, Safety and Immuno visit
8 
912/ 
130
± 14 days 
30 months after vaccination, Immuno visit
9 
-7/+14 days
End of the third RSV season visit, by telephone or
telemedicine contact (For Immuno Subset participants,
where the timing of Visit 8 and Visit 9 overlap, procedures
can be combined)
Visits 4 to 6 will only take place when the study progresses beyond the first year. Visits 7 to 9 will only take place
when the study progresses beyond the second year.
Visit 2a is for Safety Subset participants only. Visits 2b, 2c,5, and 8 are for Immuno Subset participants only.
9.1.3. 
Screening/Randomization and Vaccination (Day 1)
Only participants in good or stable health without acute illness or fever and complying with the
inclusion and exclusion criteria specified in Section 4 will be included into the study. Screening
may be split into 2 visits after consultation with the sponsor. Every effort should be made for split
visits to occur within 3 to 5 days.
The investigator will provide detailed information on the study to the participants and will obtain
written informed consent prior to each participant’s participation in the study. All procedures
described in the Schedule of Activities will only take place after written informed consent has been
obtained.
The following evaluations will be performed to determine eligibility requirements as specified in
the inclusion and exclusion criteria:
 Physical examination including height and weight.
 Demographic information.
 Medical history, including social history (eg, smoking history).
 Medical conditions of interest, including medical conditions that place participants at
increased risk for severe RSV disease and information needed to calculate the frailty index
score.
 Review of pre-study medications administered up to 30 days before vaccination; any seasonal
influenza vaccination must occur at least 14 days before or at least 14 days after study
vaccination.
 Review of inclusion/exclusion criteria.

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 Clinical assessment (Attachment 3), including vital signs measurement (respiratory rate, heart
rate, supine systolic and diastolic blood pressure, oxygen saturation and body temperature).
 After medical history, vital signs, and physical examination findings have been reviewed for
completeness and adherence to inclusion and exclusion criteria, the participant can be deemed
eligible for the study and randomized as described in Section 5.
 The RiiQ questionnaire (Attachment 6), the PGI-H (Attachment 7), and the Lawton-Brody
IADL questionnaire (Attachment 8) will be completed and baseline MRU data (Attachment 9)
will be collected prior to vaccination.
 Pre-dose bloodsamples for baseline immunogenicity will be collected.
 A nasosorption sample will be collected for participants in the Immuno Subset.
 Administration of study vaccine according to Table 2.
If a participant is a screen failure but at some point in the future is expected to meet the eligibility
criteria, the participant may be rescreened on one occasion only. Participants who are rescreened
will be assigned a new participant number, undergo the informed consent process, and then restart
a new screening phase.
Participants will be closely observed for a minimum of 30 minutes post vaccination to monitor for
the development of any acute reactions, or longer if deemed necessary by the investigator. For
Safety Subset participants, any unsolicited, solicited local or solicited systemic AEs will be
documented in the eCRF by study-site personnel following this observation period and vital signs
(body temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) will be
obtained at the end of the observation period. Any clinically relevant abnormalities must be
recorded on the adverse event page of the eCRF. Actual values (normal and abnormal) will only
be documented in the eCRF for body temperature.
Participants will receive eDiary training. Participants will be provided with a thermometer and a
midturbinate nasal swab kit,andwill be trainedwhen and how to collect a swab at home, and how
to use a thermometer if they experience any symptoms that could indicate an ARI. Participants in
the Safety Subset will additionally be provided with a ruler.
9.1.4. 
Post-Vaccination Follow-up After Vaccination on Day 1
Visit 2 (14 Days After Vaccination)
 Check for seasonal influenza vaccination; any seasonal influenza vaccination must occur at
least 14 days before or at least 14 days after study vaccination.
 Blood samples for immunogenicity will be collected.
 The study staff will review the solicited local and systemic AEs collected via the eDiaries
from participants in the Safety Subset.
 For participants in the Immuno Subset, a nasosorption sample will be collected at Visit 2.

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Participants will also receive repeat eDiary training, if needed. Participants will also be re-trained
when and how to collect a midturbinate nasal swab.
Visits 2a at 28 days post-vaccination will be a telephone call to collect information on unsolicited
AEs (for Safety Subset participants only).
The additional visits (Visit 2b at 84 days after vaccination and Visit 2c at 24 weeks after
vaccination) are for Immuno Subset participants only to collect blood samples for immunogenicity
assessments to further characterize the vaccine-elicited humoral and cellular immune responses.
End of First RSV Season
At the end of the first RSV season, the study-site personnel will contact the participants by
telephone, and read aloud the questions of the Lawton-Brody IADL (Attachment 8) questionnaire
to the participant and record the participant’s responses on the site’s eDevice. The participant will
complete the RiiQ questionnaire (Attachment 6) and the PGI-H (Attachment 7) in the eDiary or
by telephone interview with the study site. Participants who were provided an eDevice to complete
assessments at home during the first RSV season will be instructed to store their eDevice at a safe
place at home in preparation of the second season. At the end of the first RSV season, each study
participant will also be invited to complete an IEC/IRB approved Experience Survey, to share to
his/her experience as a volunteer in this study. The responses will be collected by an external party
and anonymously provided to the sponsor.
Day 365(Month 12)
The study progression beyond the first year is conditional on results obtained at the end of the first
NH RSV season (see Section 11.12). In the event that the study continues beyond the first NH
RSV season, all ongoing participants will be followed up during a second RSV season. The study
progression beyond the second year is conditional on results obtained at the end of the second NH
RSV season (see Section 11.12). In the event that the study continues beyond the second NH RSV
season, all ongoing participants will be followed up during a thirdRSV season. For the participants
who do not receive a revaccination on Day 365, the following evaluations will be performed:
 Verification of selected eligibility criteria (see Schedule ofActivities
Cohort 1 (N 5,800),
footnote t).
 A full physical examination, except height measurement,will be performed.
 Medical conditions of interest, including medical conditions that place participants at
increased risk for severe RSV disease and information needed to calculate the frailty index
score will be re-assessed.
 Changes in the use of any concomitant medication since the last visit should be recorded and
any seasonal influenza vaccination and SARS-CoV-2 vaccination.
 Clinical assessment (Attachment 3), including vital signs measurement (respiratory rate, heart
rate, supine systolic and diastolic blood pressure, oxygen saturation and body temperature).

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 The RiiQ questionnaire (Attachment 6), the PGI-H (Attachment 7), and the Lawton-Brody
IADL questionnaire (Attachment 8) will be completed and baseline MRU data (Attachment 9)
will be collected.
 Blood samples for immunogenicity will be collected.
Participants will receive repeat eDiary training. Participants will also be provided with a
midturbinate nasal swab kit (and a thermometer, if needed), will be re-trained when and how to
collect a swab at home, and how to use a thermometer if they experience any symptoms that could
indicate an ARI.
Note: Per Amendment 4 and Amendment 5, Schedule ofActivities
Cohort 1 (N 5,800) is for all
participants who do not receive a revaccination. Procedures and assessments for the Revaccination
Subcohorts are described in separate Schedules of Activities for the Revaccination Subcohorts.
End of Second RSV Season
At the end of the second RSV season, the RiiQ questionnaire (Attachment 6), the PGI-H
(Attachment 7), and the Lawton-Brody IADL questionnaire (Attachment 8) will be completed on
site.
End of Third RSV Season
At the end of the third RSV season, study-site personnel will contact the participants by telephone
or telemedicine contact, and read aloud the questions of the Lawton-Brody IADL (Attachment 8)
questionnaire to the participant and record the participant’s responses on the site’s eDevice. The
participant will complete the RiiQ questionnaire (Attachment 6) and the PGI-H (Attachment 7) in
the eDiary or by telephone or telemedicine interview with the study site. Participants who were
provided an  eDevice to complete assessments at home during the first RSV season will be
instructed to return the eDevice to the site. Participants using their own eDevice will be instructed
to delete the app from their personal device.
All SAEs will be reported continuously from vaccination on Day 1 until the end of the first RSV
season, from the Day 365 (Month 12) visit until the end of the second RSV season, and from the
Day 730 (Month 24) visit until the end of the third RSV season. SAEs associated with ARIs and
complications related to ARIs that classify as SAEs will also be collected from the end of the
second RSV season until the Day 730 visit.
9.1.5. 
Revaccination Subcohorts
Participants who provide separate informed consent for participation in a Revaccination Subcohort
will follow  the procedures and assessments as indicated in the Schedules of Activities for
Revaccination Subcohorts.

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The following evaluations will be performed:
Revaccination (Visits at Day 365[Month 12]/Day 730 [Month 24]/Day 1,095[Month 36], as
applicable per Revaccination Subcohort)
 Verification of selected eligibility criteria.
 Medical conditions of interest, including medical conditions that place participants at
increased risk for severe RSV disease and information needed to calculate the frailty index
score will be re-assessed.
 Review of concomitant medications used since the last visit; any seasonal influenza
vaccination must occur at least 14 days before or at least 14 days after study vaccination;
live-attenuated SARS-CoV-2 vaccination must occur at least 28 days before or at least 28 days
after study vaccination; non-live SARS-CoV-2 vaccination must occur at least 14 days before
or at least 14 days after study vaccination; and viral-vectored SARS-CoV-2 vaccination must
occur at least 28 days before or at least 28 days after study vaccination.
 A full physical examination, except height measurement,will be performed.
 Clinical assessment (Attachment 3), including vital signs measurement (respiratory rate, heart
rate, supine systolic and diastolic blood pressure, oxygen saturation and body temperature).
 Check for any contraindications to revaccination, including symptoms of an acute illness or
body temperature ≥38.0°C.
 The RiiQ questionnaire (Attachment 6), the PGI-H (Attachment 7), and the Lawton-Brody
IADL questionnaire (Attachment 8) will be completed and baseline MRU data (Attachment 9)
will be collected prior to revaccination (Day 365 only for Revaccination Subcohorts A and B;
Day 365 and Day 730 only for Revaccination Subcohort C).
 Blood samples for immunogenicity will be collected prior to revaccination.
 Administration of active study vaccine according to Table 2.
Revaccination Subcohort participants will be closely observed for a minimum of 30 minutes post
revaccination to monitor for the development of any acute reactions, or longer if deemed necessary
by the investigator. Any unsolicited, solicited local or solicited systemic AEs will be documented
in the eCRF by study-site personnel following this observation period and vital signs (body
temperature, blood pressure, heart rate, respiratory rate, and oxygen saturation) will be obtained at
the end of the observation period. Any clinically relevant abnormalities must be recorded on the
AE page of the eCRF. Actual values (normal and abnormal) will only be documented in the eCRF
for body temperature.
Revaccination Subcohort participants will receive repeat eDiary training, including how to record
solicited local and systemic AEs and unsolicited AEs in the eDiary. Revaccination Subcohort
participants will also be provided with a ruler, a thermometer, and a midturbinate nasal swab kit
(as applicable per Revaccination Subcohort), and will be trained when and how to collect a swab
at home, and how to use a thermometer if they experience any symptoms that could indicate an
ARI.

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Post-revaccination Visits
Post-revaccination visits are scheduled at the following time points:
 7 days after revaccination at Month 24: for Revaccination Subcohort 2A
 7 days after revaccination at Months 24 and 36: for Revaccination Subcohort B
 14, 28 and 84 days after (each) revaccination: for Revaccination Subcohorts A, B, and C
 24 weeks after (each) revaccination: for Revaccination Subcohorts A, B, and C
 1 year after (each) revaccination: for Revaccination Subcohorts A, B, and C
At each post-revaccination visit, blood samples will be drawn for immunogenicity and information
on unsolicited AEs will be collecteduntil 28 days post dose. The solicited local and systemic AEs
collected in the diaries will be reviewed by the study staff at the post-revaccination visits at 7 or
14 days after revaccination.
For Revaccination Subcohort A, all SAEs will be reported from administration of study vaccine
on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later), and from the time of revaccination at Month 12 until the end of the second RSV season, or
until 6 months after revaccination, whichever comes later. For Revaccination Subcohort 2A, all
SAEs and AESIs will also be collected from the time of revaccination on Day 730 until 6 months
after revaccination. For Revaccination Subcohorts B andC, all SAEs and AESIs will be collected
from the time of revaccination until 6 months thereafter. Collection of SAEs associated with ARIs
and complications related to ARIs that classify as SAEs will stop at the end of the second RSV
season for Subcohort A, on Day 730 (Month 24) for Subcohort B, and at the latest at the end of
the third RSV season for Subcohort C.
For all Revaccination Subcohorts, SAEs classified as related to the study vaccine, SAEs resulting
in death, (S)AEs leading to discontinuation from the study, and (S)AEs and special reporting
situations related to study procedures or to non-investigational (concomitant) Janssen products will
be collected during the entire study for all participants. For the participants in the Revaccination
Subcohort C, these (S)AEs will be collected retrospectively for the time period between the last
end of the RSV season visit and the revaccination upon the day of revaccination.
9.1.6. 
Early Withdrawal –Early Exit Visit
For those participants who are unable to continue participation in the study until the final visit, but
who do not withdraw consent, an early exit visit will be conducted. In the event of early withdrawal
from the study, all procedures as required at the end of the RSV season (see Section 9.1.4 and
Section 9.1.5) will be performed.
The early exit visit will be conducted by telephone or telemedicine contact.

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9.2. 
Study Evaluations
9.2.1. 
EfficacyEvaluations
This is a proof-of-concept study to test VE. The vaccine is not expected to be 100% efficacious.
VE will be evaluated based on the first occurrence of RT-PCR-confirmed RSV-mediated LRTD
(cases defined according to the 3 primary endpoint definitions) in the active vaccine group
compared to the placebo group in the PPE population. Time at risk will also be taken into account.
To meet the primary endpoint according to the respective case definitions the following criteria
will be taken into account:
 symptoms reported by participants on the RiiQ Symptom Scale and body temperature during
the full ARI episode OR
 clinical assessment terms reported by a qualified study staff member during the ARI Days 3-5
clinical visit
in combination with
 confirmation of RSV by RT-PCR in one or more of the midturbinate nasal swabs, or in the
sputum sample (when available)
Of note, on the day of the ARI Days 3-5 clinical visit, the case definitions can be met by symptoms
reported by participants on the RiiQ or by signs and symptoms reported by the qualified study staff
member. Case definitions cannot be met by a combination of symptoms reported by the participant
with signs and symptoms reported by the qualified study staff member.
Confirmation of RSV infection by RT-PCR (midturbinate swabs and sputum sample, when
available) will be performed at the central laboratory. For participants hospitalized with symptoms
of an ARI, confirmation of RSV infection using an FDA-approved RT-PCR test at the local
(hospital) laboratory will also be used for the analysis of case definitions if results from the central
laboratory are not available. One positive sample (defined as any sample with a value above the
limit of detection) is sufficient.
9.2.1.1. 
Patient-Reported Outcomes
Participants in this study will complete self-assessments of their health, symptoms, and functional
status in questionnaires on an eDevice (smartphone or tablet). During study visits, participants
complete questionnaires on the site’s eDevice. For ARI surveillance, participants complete
questionnaires at home in an eDiary on their own eDevice or one provided for this study. In each
case ofportal/eDevice down time, data can only be collected upon sponsor approval via interview
using paper versions of the questionnaires.
Timing for these ePRO assessments are described in the Schedule of Activities. Use of ePRO has
been linked to many improvements in  the quality, completeness, and adherence to assessment
times required for PRO assessments in clinical studies.25

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Requirements for investigators and study monitors will be detailed in separate documents.
9.2.1.1.1. 
ARI Surveillance Assessment
During the vaccination visits and Day 365 (Month 12)/Day 730 (Month 24) visits, as applicable,
sites will instruct participants to report any new or worsening of usual cold-like symptoms in the
eDiary on their eDevice at home. A reminder to complete the ARI Surveillance Assessment
(Attachment 4) will be sent to the participants’ eDevice twice a week during the periods of ARI
data collection, to maintain awareness among participants that they should report any symptoms
that could indicate an ARI episode in the eDiary within 24 hours of onset.
For participants in the Revaccination Subcohorts, follow-up of ARIs will stop at the end of the
second RSV season for Subcohort A, at the Day 730 (Month 24) visit for Subcohort B, and at the
latest at the end of the third RSV season for Subcohort C.
If the participant indicates no new symptoms or no worsening of symptoms present at baseline in
response to the ARI surveillance question, the eDiary reminds the participant to contact the site in
case of any possible (S)AE and the ARI Surveillance assessment ends.
If the participant indicates a new symptom or worsening of existing symptoms possibly indicating
an ARI episode, the eDiary will present the following for the participant to complete before ending
the eDiary assessment and reminding the participant to contact the site in case of any possible
(S)AE: RiiQ (Attachment 5), RiiQ Impact on Daily Activities Scale (Attachment 11, as part of the
Combined Impact Assessment), PGI-H, PGI-S, PGI-C, Return to Usual Health  question
(Attachment 7, as part of the Combined Impact Assessment), and temperature log. Note that the
PGI-C and the Return to Usual Health question will not be completed on ARI Day 1.
9.2.1.1.2. 
Respiratory Infection Intensity and Impact Questionnaire (RiiQ™v2)
The RiiQ will be used to identify possible ARI episodes, to define cases of RSV-mediated LRTD
(for participants with RT-PCR confirmed RSV infection), to evaluate severity of RSV disease
episodes, and to assess the impact of an ARI episode on the participant’s daily life (Attachment 6).
The RiiQ was adapted for RSV based on the Flu-iiQ™ originally developed and validated for
monitoring influenza symptoms and their impact in vaccine studies.22,29 The RiiQ  includes
3 additional lower respiratory tract symptoms common in patients with RSV-related illness and
one additional daily activity item to address limitations in opportunity for activity for patients
hospitalized for treatment of RSV disease.
The RiiQ asks participants to rate level of severity or impairment on a 4-point scale with higher
scores indicating greater severity or negative impact of an ARI episode. Questions ask participants
to report symptoms at their worst during the past 24 hours to monitor the severity of RVS-related
illness, but also identify pre-existing symptoms and functional limitations at baseline associated
with comorbidities common in adults at risk for more severe illness due to RSV infection.

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The RiiQ consists of 4 scales that are scored separately:
 RiiQ Symptom Scale captures presence and severity of 13 symptoms commonly reported by
adults with RSV infection. The symptoms reported on the RiiQ symptom scale will be used
to define cases of RSV-mediated LRTD for participants whose ARI episode has been
confirmed as due to RSV infection via RT-PCR.
 RiiQ Impact Scales (Questions 2 to 4). The RiiQ also assesses health-related quality of life
(HRQL) associated with RSV-related disease in 3 impact scales:
 RiiQ  Impact on Daily Activity scale (Question 2) asks participants to rate degree of
impairment they have in 7 common daily activities such as trouble concentrating or ability
to do usual activities.
 RiiQ Impact on Emotions scale (Question 3) asks participants to rate the degree to which
they felt 4 negative emotions - Irritable, Helpless, Worried, and Frustrated.
 RiiQ Impact on Relationships scale (Question 4) asks participants to rate the degree to
which they were concerned about 5 problems that a respiratory infection may cause in
relationships with others, such as being a burden, causing worry or annoyance, and
dependence on others.
9.2.1.1.3. 
Patient Global Impression Scores
Patient Global Impression Scores (Attachment 7) developed for this study will be collected. These
questions will be used to evaluate overall health and to help identify how much change in RiiQ
scale scores can be considered clinically important.
 PGI-H asks participants to report their overall impression of their health status today.
 PGI-S asks participants experiencing symptoms associated with ARI episodes to rate the
severity of their respiratory illness.
 PGI-C asks participants to rate the amount of change in their health each day during an ARI
episode.*
 Return to Usual Health asks participants whether they have returned to their usual health after
developing symptoms suggesting an ARI.*
* The PGI-C and the Return to Usual Health question will not be completed on ARI Day 1.
9.2.1.1.4. 
Thermometer Logs
Participants who experience symptoms suggestive of an ARI also will record readings from
thermometers provided for this study as part of the ARI Surveillance eDiary assessment
(Attachment 4) each evening (preferably) throughout each ARI episode.
9.2.1.2. 
Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale
The Lawton-Brody IADL Scale (Attachment 8) will be used in this study to evaluate the
participant’s functional status.18 The questionnaire will be completed (based on interview with the
participant) at baseline (assessed pre-vaccination for the first RSV season, at the Day 365
[Month 12] visit for the second RSV season [pre-vaccination if applicable], and at the Day 730

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[Month 24] visit for the third RSV season), during ARI episodes on ARI Days 3-5 and ARI Day 29,
and at the end of the RSV seasons.
The questionnaire covers 8 domains (ability to use telephone, shopping, food preparation,
housekeeping, laundry, mode of transportation, responsibility for own medications, and ability to
handle finances). Within each domain, participants are scored according to their highest level of
functioning in that domain (either 0 or 1).
9.2.1.3. 
Frailty Index Score
The frailty index score will be calculated from medical conditions of interest, the RiiQ, and the
Lawton-Brody IADL.
The medical conditions of interest used for the calculation of the frailty index score will include,
but not be limited to,endocrine (diabetes mellitus), cardiac (angina, arrhythmia, valvular, previous
myocardial infarction  [MI], congestive heart failure), vascular (peripheral vascular,
hyperlipidemia, hypertension, cerebrovascular (stroke, transient ischemic attack  [TIA]),
pulmonary (eg,asthma, COPD), renal (chronic renal failure, nephrotic syndrome), neuro-muscular
(seizure disorder, spinal cord injury, Parkinson’s), liver (hepatic cirrhosis), gastrointestinal
(inflammatory bowel disease [Crohn’s, ulcerative colitis], peptic ulcer, gastroesophageal reflux
disease [GERD]), cancer (non-metastatic solid tumor), mental health (depression, anxiety, bipolar
mood disorder).
9.2.1.4. 
Clinical Assessment
At baseline, and between 2 and 4 days after symptom onset (ARI Days 3-5) and at ARI Day 29, a
study staff member will perform a clinical assessment (Attachment 3):
 Vital signs: body temperature, systolic and diastolic blood pressure, heart rate, respiratory
rate,and oxygen saturation measurement.
 Symptom collection and targeted physical examination: cough, sputum production, shortness
of breath, and malaise (tiredness)
 Upper respiratory: nasal discharge, pharyngitis, and sinus tenderness
 Lower respiratory: dyspnea, rales, rhonchi or other, wheezing, and respiratory effort
9.2.1.5. 
Diagnosis of RSV and Other Respiratory Infections
The midturbinate nasal swabs and a sputum sample (when available), taken after symptom onset
will be analyzed at the central laboratory using a rapid RT-PCR based diagnostic assay  to
determine whether the infection was caused by RSV. For RSV positive cases, the RSV subtype,
viral load and presence of other respiratory pathogens will also be determined from the
midturbinate nasal swabs using a broad respiratory pathogen panels. Samples from RSV negative
ARI episodes may also be assessed for the presence of other respiratory pathogens. Midturbinate
nasal swabs from other ARI episodes may also be assessed for the presence of other respiratory
pathogens.

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Site staffand participants will remain blinded as to the outcome of RT-PCR test results until study
unblinding.
For participants hospitalized with symptoms of an ARI, confirmation of RSV infection using an
FDA-approved RT-PCR test at the local (hospital) laboratory will also be obtained.
9.2.2. 
Immunogenicity Evaluations
Venous blood samples of approximately 15 mL and 40 mL will be collected for the determination
of humoral and cellular immune responses, respectively. Timings of blood draws are specified in
the Schedule of Activities. Sample collection and processing will be performed according to
current versions of approved standard operating procedures.
Immunogenicity assessments may include, but are not limited to, the humoral and cellular
immunogenicity assays (as available and applicable) summarized in Table 4 and Table 5 below.
Humoral immune responses will be assessed in participants experiencing an ARI episode,
participants in the Immuno Subset (ie, 200 randomized participants, 100 per group), and
participants in the Revaccination Subcohorts (ie, approximately 240 participants, 120 per group
[Revaccination Subcohorts A and C]; or approximately 270 participants, 135 per group
[Revaccination Subcohort B]).
Cellular immune responses will be assessed in the Immuno Subset and in all participants (at
certified sites) in Revaccination Subcohort 2A after the third vaccination and in Revaccination
Subcohort B after the second and third vaccination. Cellular immune responses will be assessed in
a subset of approximately  100 participants (approximately 50 per group) in Revaccination
Subcohort C.

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Table 4: 
Summary of Immunogenicity Assays (Humoral)
Assay 
Purpose
Secondary endpoints
RSV neutralization A  
Analysis of neutralizing antibodies to an A strain
F protein antibodies 
(ELISA; pre-F and/or post-F) 
Analysis of antibodies binding to RSV F protein in pre-fusion and/or
post-fusion form
Exploratory endpoints
RSV strain cross-neutralization 
Analysis of cross-neutralizing antibodies to B and/or a different A strain(s)
F protein antibody specificity 
characterization 
Pre- and post-F specificity by binding or functional assays such as ELISA,
and/or competition ELISA. Adsorption of serum with pre-F and post-F protein
before any antibody assay, epitope mapping, functional VNAs
G protein antibodies (ELISA) 
Analysis of antibodies binding to RSV G protein
Adenovirus neutralization assay  Analysis of neutralizing antibodies to adenovirus
Functional and molecular 
antibody characterization  
Analysis of antibody characteristics including, but not limited to, ADCC,
ADCP, avidity, other respiratory viral neutralizing or binding assays, Ig isotype,
functional VNAs to other respiratory viruses, and antibody assessments for
antibody repertoire
Transcriptomic analysis 
RNA transcriptomic analysis maybe conducted in the revaccination subcohorts
to assess regulation of genes (clusters) and expression patterns
ADCC =antibody dependent cell mediated cytotoxicity, ADCP =antibody dependent cellular phagocytosis,
ELISA =enzyme linked immunosorbent assay, F =fusion, G =glycoprotein, Ig =immunoglobulin, RNA =ribonucleic
acid; VNA =virus neutralizing antibody
Note: Antibody analyses might be performed in nasosorption samples and serum.
The abovementioned assays may be performed on samples of the Revaccination Subcohorts to assess exploratory
endpoints.
Table 5: 
Summary of Immunogenicity Assays (Cellular)
Assay 
Purpose
Secondary endpoints
IFN-γ ELISpot 
T-cell IFN-γ responses to RSV F protein peptides
Exploratory endpoints
ICS  
Analysis of T-cell responses to RSV F protein peptide-stimulated PBMC
(including, but not limited to, CD4+/CD8+, IL-2, IFN-γ, TNF-α, activation
markers and memory)
Chemokine/cytokine analysis 
Levels of chemokines and cytokines in nasosorption samples or produced by
antigen-stimulated PBMC
Sequencing of B-cells 
Including but not limited to sequencing of BCR (B-cell receptor) or VH/VL
(heavy/light chain characterization) for specificity
ELISpot =enzyme linked immunospot, F =fusion; ICS =intracellular cytokine staining, IFN γ =interferon gamma,
IL 2 =interleukin 2, PBMC =peripheral blood mononuclear cells, TNF α =tumor necrosis factor alpha
Nasosorption samples using SAM taken from Immuno Subset participants prior to vaccination on
Day 1 and at the 14 days post-vaccination visit will be used for immunogenicity assessments
including, but not limited to immunogenicity assessments of antigen specific immunoglobulins
(IgG and IgA), microbiome and pathogen analysis.
Blood samples collected between 2 and4 days after symptom onset (ARI Days 3-5) and at 28 days
after symptom onset (ARI Day 29) from participants who experience ARI episodes will be assayed
by serology (including but not limited to RSV VNAs or ELISA specific to RSV protein G
[glycoprotein] as available and applicable) for RSV exposure confirmation. In addition, blood
samples collected at ARI Day 3-5 including DNA and RNA preserved blood samples will be used
for exploration of biomarkers that correlate with RSV infection and RSV disease severity

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(including but not limited to immunoprofiling, RT-PCR for RSV, RNA transcriptomics and host
genotyping array to assess regulation of genes [clusters] and expression patterns, associated
cytokine/chemokine analysis as available and applicable). Additionally, these samples might be
used for other pathogen exposure seroconfirmation.
Instructions for the collection, handling, storage, and shipment of blood and nasosorption samples
for immunogenicity assessments can be found in the Laboratory Manual that will be provided.
Collection, handling, storage, and shipment of the samples must be under the specified, and where
applicable, controlled temperature conditions as indicated in the Laboratory Manual.
9.2.3. 
Medical Resource Utilization
Medical resource utilization associated with medical encounters, related to RSV and/or respiratory
illness will be collected in the site’s eDevice by the investigator and study-site personnel between
2 and 4 days (ARI Days 3-5) and at 28 days after onset of each ARI episode (ARI Day 29 ±7 days)
for all participants with an ARI episode. Protocol-mandated procedures, tests, and encounters are
excluded. For comparison, baseline data MRU will be collected prior to vaccination for each
participant in the study. The data collected may be used to conduct exploratory economic analyses
and will include:
 Number and type of medical consultations (including primary care and specialist visits)
 Number and duration of hospital and/or institutional care admissions (total days length of stay,
including duration by wards; eg,intensive care unit)
 Number and type of professional home care visits
9.2.4. 
Safety Evaluations
Details regarding the IDMC are provided in Section 11.13, Independent Data Monitoring
Committee.
The study will include the following evaluations of safety and reactogenicity according to the time
points provided in the Schedule of Activities:
 Adverse Events
 Vital Signs
 Physical Examination
 Patient-reported Outcomes
9.2.4.1. 
Adverse Events
AEs will be reported as specified in Section 12, Adverse Event Reporting. Any clinically
significant abnormalities persisting at the end of the study/early withdrawal will be followed by
the investigator until resolution or until a clinically stable condition is reached.

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All Participants
For all participants, SAEs will be collected from administration of study vaccine on Day 1 until
the end of the first RSV season (or 6 months after vaccination, whichever comes later).a
For all participants, some subsets of SAEs will be collected for additional study periodsa:
 ARIs and complications related to ARIs that classify as SAEs will be captured and will be
reported as SAEs in the eCRF for the duration of the second RSV season, between the second
and the third RSV season, and for the duration of the third RSV season.
 From the time of vaccination until the end of the study period for each participant, SAEs
classified as related to the study vaccine, SAEs resulting in death, and (S)AEs leading to
discontinuation from the study will be collected.
 During the entire study, (S)AEs and special reporting situations related to study procedures or
to non-investigational (concomitant) Janssen products will be reported from the time a signed
and dated informed consent form (ICF) is obtained onwards until the end of the study period
for each participant.
The (S)AE listing in the eCRF will not be updated based on the RSV RT-PCR results and will
remain listed on the eCRF as ARIs.
Safety Subset and Revaccination Subcohorts
These participants will be asked to note in the eDiary occurrences of injection site pain/tenderness,
erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (Day 1
for the Safety Subset; Day 365 (Month 12)/Day 730 (Month 24)/Day 1,095 (Month 36) for the
Revaccination Subcohorts). The extent (largest diameter) of any erythema and swelling should be
measured (using the ruler supplied) and recorded daily. The case definitions for solicited injection
site events can be found in Gidudu et al.11 and in Kohl et al.17
Solicited systemic AEs: fatigue, headache, nausea, myalgia, and fever (defined as an endogenous
elevation of body temperature ≥38.0°C, as recorded in at least one measurement). Body
temperature (oral route preferred) should be measured at approximately the same time each day,
preferably in the evening, using the thermometer supplied. If more than one measurement is made
on any given day, the highest temperature of that day will be used in the eDiary.
Unsolicited AEs will be collected from the time of vaccine administration through the following
28 days.b All AEs, including any that are ongoing at 28 days after vaccine administration will be
followed until clinical resolution or stabilization. Concomitant therapies associated with
a 
The windows for SAE collection in the Revaccination Subcohorts are described below under “Safety Subset and
Revaccination Subcohorts”.
b 
AEs that start more than 28 days after a vaccination, but that are still present at the time of the next vaccination
will also be recorded.

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unsolicited AEs will be collected and recorded in the eCRF from time of vaccine administration
through 28 days after vaccination.
Relatedness and severity of these events will be graded by the investigator according to the criteria
presented in Section 12.1.2 and Section 12.1.3, respectively.
All ARIs and all complications related to ARIs will be reported as AEs in the eCRF from the time
of vaccination through the following 28 days for Safety Subset and Revaccination Subcohort
participants only.
For Revaccination Subcohort A, all SAEs will be reported from administration of study vaccine
on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later), and from the time of revaccination at Month 12 until the end of the second RSV season, or
until 6 months after revaccination, whichever comes later. For Revaccination Subcohort 2A, all
SAEs and AESIs will also be collected from the time of revaccination on Day 730 until 6 months
after revaccination. For Revaccination Subcohorts B andC, all SAEs and AESIs will be collected
from the time of revaccination until 6 months thereafter. Collection of SAEs associated with ARIs
and complications related to ARIs that classify as SAEs will stop at the end of the second RSV
season for Subcohort A, on Day 730 (Month 24) for Subcohort B, and at the latest at the end of
the third RSV season for Subcohort C.
For all Revaccination Subcohorts, SAEs classified as related to the study vaccine, SAEs resulting
in death, (S)AEs leading to discontinuation from the study, and (S)AEs and special reporting
situations related to study procedures or to non-investigational (concomitant) Janssen products will
be collected during the entire study for all participants. For the participants in the Revaccination
Subcohort C, these (S)AEs will be collected retrospectively for the time period between the last
end of the RSV season visit and the revaccination upon the day of revaccination.
From the time of local approval of protocol amendment 6 onwards, TTS is considered to be an
AESI. Thrombotic events and/or thrombocytopenia (defined as platelet count below
150,000 cells/mm³) are considered to be potential AESIs. All AESIs, including potential AESIs,
will be reported to the sponsor from the moment of revaccination until 6 months after
revaccination.
9.2.4.2. 
Vital Signs
Blood pressure and pulse/heart rate measurements will be assessed with a completely automated
device. Manual techniques will be used only if an automated device is not available.
Vital signs measurements should be preceded by at least 5 minutes of rest in a quiet setting without
distractions (eg, television, cell phones).
The following measurements will be performed:
 Heart rate (beats per minutes), respiratory rate (breaths per minute), supine systolic blood
pressure (mmHg) and supine diastolic blood pressure (mmHg)

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 Body temperature (oral route preferred, or in accordance with the local standard of care)
 Oxygen saturation (SpO2)
9.2.4.3. 
Physical Examination
A full physical examination, including body weight, will be carried out before each vaccination.
Height will be measured on Day 1 only.
9.2.4.4. 
Patient-reported Outcomes
Details for PRO assessments in this study are described in Section 9.2.1.1.
10. 
PARTICIPANT COMPLETION/DISCONTINUATION OF STUDY
INTERVENTION/ WITHDRAWAL FROM THE STUDY
10.1. 
Completion
A participant will be considered to have completed study vaccination if he or she has received the
vaccination on Day 1, or if he or she has received the vaccination on Day 1 and Day 365
(Month 12)/Day 730 (Month 24)/Day 1,095 (Month 36), as applicable, in case of Revaccination
Subcohort participants.
A participant will be considered to have completed the study if he or she has completed all
assessments at the final visit.
The end of the study is defined as the last participant’s last visit.
10.2. 
Discontinuation of Study Vaccine/Withdrawal from the Study
Discontinuation of Study Vaccine
A participant’s study vaccination must be discontinued if:
 The participant withdraws consent to receive study vaccination.
 The investigator believes that for safety reasons or reactogenicity reasons (eg, AE) it is in the
best interest of the participant to discontinue study vaccination.
Study vaccine assigned to the participant who discontinued study vaccination may not be assigned
to another participant.
Withdrawal from the Study
Each participant has the right to withdraw from the study at any time for any reason without
affecting the right to treatment by the investigator. The investigator should make an attempt to
contact participants who did not return for scheduled visits or follow-up. Although the participant
is not obliged to give a reason for withdrawing prematurely, the investigator should make a
reasonable effort to ascertain the reason(s) while fully respecting the participant’s rights.
A participant will be withdrawn from the study for any of the following reasons:

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 Lost to follow-up
 Withdrawal of consent
 Death
 Repeated failure to comply with protocol requirements
 Decision by the sponsor or the investigator to stop or cancel the study
 Decision by local regulatory authorities and IRB/IEC to stop or cancel the study
 If the randomization code is broken by the investigator or the study-site personnel.
If the randomization code is broken by the sponsor for safety reporting purposes, the
participant should not discontinue further study vaccine administration (if applicable) and may
remain in the study (if the randomization code is still blinded to the study-site personnel and
the participant).
Any unnecessary study discontinuation should be avoided. Should a participant be withdrawn, all
efforts should be made to complete and report the observations as thoroughly as possible.
Whenever a participant is withdrawn from the study, independent of the reason, all procedures
required at the final visit will be performed (see Section 9.1.6) and the major reason for which the
participant was withdrawn must be stated. If the reason for withdrawal from the study is
withdrawal of consent then no additional assessments are allowed.
If a participant is lost to follow-up, every reasonable effort must be made by the study-site
personnel to contact the participant and determine the reason for discontinuation/withdrawal. The
measures taken to follow-up must be documented.
When a participant withdraws before completing the study, the reason for withdrawal is to be
documented in the eCRF and in the source document. Study vaccine assigned to the withdrawn
participant may not be assigned to another participant. Additional participants will not be entered.
Participants who wish to withdraw consent from participation in the study will be offered a single
exit visit for safety follow-up (prior to formal withdrawal of consent). They have the right to refuse.
Withdrawal from the Use of Samples in Future Research
The participant may withdraw consent for use of samples for research (refer to Section 16.2.5,
Long-Term Retention of Samples for Additional Future Research). In such a case, samples will be
destroyed after they are no longer needed for the clinical study. Details of the sample retention for
research are presented in the ICF.
10.3. 
Contraindications to Vaccination
The following events constitute a contraindication to vaccination at that point in time:
 Severe acute illness at the time of vaccination.
 Fever (body temperature ≥38.0°C) at the time of vaccination.

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If any of these events occur at the scheduled time for administration of study vaccine on Day 1,
enrollment at a later date is permitted at the discretion of the investigator and after discussion with
the sponsor. In case of occurrence at the time of revaccination, revaccination at a later date is
permitted under the same conditions.
11. 
STATISTICAL METHODS
Statistical analysis will be done by the sponsor or under the authority of the sponsor. A general
description of the statistical methods to be used to analyze the efficacy and safety data is outlined
below. Specific details will be provided in the Statistical Analysis Plan.
In the following sections, the following terminology is used to describe the different analyses of
the primary efficacy endpoints of the study:
An interim analysis (IA) is any analysis performed by the IDMC before the primary analysis. The
outcome of an IA can be any of the following:
 “superiority”: proof of concept is reached, there is statistically significant proof that the active
study vaccine prevents more RT-PCR-confirmed RSV-mediated LRTD compared to placebo
(for at least one case definition),
 “futility”: it is unlikely that continuing the study will result in statistically significant proof
that the active study vaccine prevents more RT-PCR-confirmed RSV-mediated LRTD
compared to placebo (for all case definitions),
 “continue”: neither superiority nor futility is shown and the study should continue as planned.
The sponsor will remain blinded to the actual results of any IA and will only receive the outcome
as described above from the IDMC. Interim analysis can occur at the end of the RSV season (if
the required number of RT-PCR-confirmed RSV-mediated LRTD  events is not reacheda). In
addition, if participants are also enrolled in the SH, an IA (“early IA”) can also occur during the
NH or SH RSV season.
The primary analysis is the analysis performed by the sponsor that addresses the primary efficacy
objectives of the study. The primary analysis can be triggered in 1 of 3 ways:
 by an IA performed by the IDMC with “superiority” or “futility” as outcome;
 by a predefined number of RT-PCR-confirmed RSV-mediated LRTD events at the end of the
first RSV season. The end of the first RSV season is defined as the end of the NH RSV season
in case the study is performed in the NH only, and as the end of the SH RSV season in case
the study is performed in both hemispheres;
 when the end of the second RSV season is reached (if applicable).
a 
The cut-off of 14 RT-PCR-confirmed RSV-mediated LRTD events at the early IA analysis and the cut-off of
18 RT-PCR-confirmed RSV-mediated LRTD events at the end of the RSV season are based on modelling and
simulations described in a separate modeling and simulations report.

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In case the primary analysis is triggered by an IA performed by the IDMC, the primary analysis
will be performed on the same database as the IDMC to guarantee consistent results.
More information on the planned analyses can be found in Section 11.12.
11.1. 
Analysis Sets
Vaccination assignment will follow the as-treated principle.
 The Full Analysis Set (FAS) will include all randomized participants with a documented
vaccine administration, regardless of the occurrence of protocol deviations. The FAS is the
primary safety population. The analysis of solicited and unsolicited AEs after the Day 1
vaccination will be restricted to a subset of the FAS (ie, the Safety Subset).a The analysis of
solicited and unsolicited AEs after revaccination on Day 365 (Month 12)/Day 730
(Month 24)/Day 1,095 (Month 36) will be restricted to participants of the Revaccination
Subcohorts that are part of the FAS.
 The Per-protocol Immunogenicity (PPI) population will include all randomized and
vaccinated participants, for whom immunogenicity data are available. Samples taken after a
participant experienced a major protocol deviation expecting to impact the immunogenicity
outcomes will be excluded from the PPI. The list of major protocol deviations to be excluded
from the immunogenicity analysis will be specified in the Statistical Analysis Plan (SAP) or
major protocol deviation criteria document which will be finalized before database lock and
unblinding. The analysis of immunogenicity will focus on 2 subsets of the PPI, ie, the Immuno
Subset and the Revaccination Subcohorts.
In addition, for participants who experience a natural RSV infection (based on RT-PCR, or
other sources), samples taken after the natural infection will not be taken into account in the
assessment of the immunogenicity.
The PPI population is the primary immunogenicity population. For key tables, sensitivity
immunogenicity analyses will also be performed on the FAS, including participants for whom
immunogenicity measures are available. Excluded samples might be taken into account as
well in the sensitivity analysis.
 The Per-protocol Efficacy (PPE) population will include all randomized and vaccinated
participants excluding participants with major protocol deviations expecting to impact the
efficacy outcomes. The list of major protocol deviations to be excluded from the efficacy
analysis will be specified in the SAP or major protocol deviation criteria document which will
be finalized before database lock and unblinding. Any participant with an RT-PCR-confirmed
RSV-mediated ARI with onset within 14 days after vaccination will be excluded from the PPE
population. Participants who discontinue within 14 days after vaccination will be excluded
from the PPE population as well.
The PPE population is the primary efficacy population. Sensitivity efficacy analyses will also
be performed on the FAS. For exploratory efficacy analyses focusing on data from the second
a 
The specification of this subset for analysis of solicited and unsolicited AEs does not preclude the investigator
from reporting an AE in any participant if he/she considers the event to be of clinical relevance and/or related to
the study vaccine.

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RSV season only, the participants of Revaccination Subcohort A will be additionally
excluded. For analyses focusing on  data from  the third RSV season, participants of
Revaccination Subcohorts A and B will be excluded. For exploratory efficacy analyses
focusing on data over 2 RSV seasons, the second RSV season data will be excluded for the
participants of RevaccinationSubcohort A. For analyses focusing on data over 3 RSV seasons,
second and third RSV season data will be excluded for the participants of Revaccination
Subcohort A, and third RSV season data will be excluded for participants of Revaccination
Subcohort B. Participants who develop major protocol deviations expecting to impact the
efficacy outcomes and occurring up to the considered RSV season will be additionally
excluded from the PPE when focusing on data including the second or third RSV season.
11.2. 
Sample Size Determination
11.2.1. 
Efficacy
Under the following assumptions:
 a VE for Case Definition #2 of 70%
 and an incidence of Case Definition #2 of 0.75% in placebo recipients during the RSV season,
assuming vaccination occurs before the RSV season
 3 primary endpoints which are nested (see Section 11.4.1)
 a 1-sided α  of 5% (total: as described in Section 11.4.1.1, corrections are performed for
multiple endpoints and for IAs outlined in Section 11.12)
 10% of exclusions (due to drop-out, major protocol deviations, etc.)
Simulations performed in R show that for a NH only study, 2,750 participants per vaccination
group result in 80% total power to demonstrate VE >0 for Case Definition #2 at the end of the
RSV season, resulting in a total sample size of 5,500 participants. The end of the first RSV season
is then defined as the end of the NH RSV season.
In case recruitment is not completed in the NH  (and less than 18 RT-PCR-confirmed RSV-
mediated LRTD events (using Case Definition #2) are observed in the NH before opening sites in
the SH), enrollment will continue in the SH. As there is the possibility to have an early IA during
the NH or SH RSV season (see Section 11.12), an additional 150 participants per vaccination
group is needed to have 80% total power to demonstrate VE >0 for Case Definition #2 at the end
of the RSV season. The end of the first RSV season is defined as the end of the SH RSV season in
case the study is performed at both hemispheres. So, if recruitment is spread over 2 hemispheres,
the total sample size will be 5,800 participants.
With respect to Case Definitions #1 and #3, further simulations showed that the power to obtain a
significant result for any case definition, after multiplicity correction that control the type I error
at 5%, tended to be similar or better than for Case Definition  #2 alone, without multiplicity
correction. This result was valid over a broad range of incidence and vaccine efficacies, unless the
VE for the most common case definition (Case Definition #3), was >20% lower than the VE for
Case Definition #2. Case Definition #2, which incidence lies between that of Case Definition #1

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and #3, was chosen as basis for the power calculations and decision rule, as more prior information
was available for this case definition in the literature. Under the assumptions described above, it
is expected to observe 26 cases.
Under conditions described in Section 11.12 (less than 18 RT-PCR-confirmed RSV-mediated
LRTD events by the end of the first RSV season for Case Definition #2, with a negative IA
performed by the IDMC but a conditional power of 60% or more), 2,000 new participants may be
vaccinated at the beginning of the second RSV season who will be followed up for one RSV
season. This will increase the total power of the study to approximately 82%.
The operating characteristics of the methods used with the sample size are described in a separate
modeling and simulations report.
11.2.2. 
Immuno Subset
Immunogenicity will be assessed in the Immuno Subset, ie, approximately 200 participants, of
whom ~100 are active study vaccine participants. Approximately 25% of participants in the
Immuno Subset in each region will be at increased risk of severe RSV disease.
Table 6 shows the actual distance from the mean to the limits of 95% CI around the actual value
at Day 15 for different assays, accounting for 10% of exclusions with the current sample size for
the Immuno Subset.
Table 6: 
Distance from the Mean to the Limits of 95% CI for Pre-F ELISA, VNA, and ELISpot
N 
(Active 
Group) 
Pre-F ELISA  
(SD=1.3) 
VNA  
(SD=1.5) 
ELISpot
(SD=1.2)
Distancea 
from 
Mean to 
Limits 
95%CI 
95%CI if 
Observed 
Mean is 
eg, 6,000 
Distancea 
from 
Mean to 
Limits 
95%CI 
95%CI if 
Observed 
Mean is 
eg, 6,500 
Distancea 
from 
Mean to 
Limits 
95%CI
95%CI if
Observed
Mean is
eg, 400
All 
100 
0.272 
(4,969;7,245) 
0.314 
(5,229;8,080) 
0.251 
(336;476)
Increased
Risk  
25 
0.576 
(4,025;8,944) 
0.665 
(4,099;10,306) 
0.532 
(277;578)
CI = confidence interval, ELISA = enzyme-linked immunosorbent assay, ELISpot = enzyme-linked immunospot,
SD = standard deviation, VNA = virus neutralization assay
a Calculated on the log2-scale.
11.2.3. 
Safety Subset
While mild to moderate vaccine reactions (local injection site, systemic responses) are expected,
AEs that preclude further vaccine administration (if applicable) are not anticipated.
With ~350 active study vaccine participants in the Safety Subset, the observation of 0 events in
the database would be associated with 95% confidence that the true rate is less than 1%. For SAEs,
which will be captured in all participants, the observation of 0 events in the database would be
associated with 95% confidence that the true rate is less than 0.1%.
In addition, a cap will be installed to ensure that 350 participants in the Safety Subset (~175 in
each group) are at increased risk  for severe RSV disease. With 175 active study vaccine

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participants at increased risk  of severe RSV disease in the Safety Subset, the observation of
0 events (solicited or unsolicited) in the database would be associated with 95% confidence that
the true rate in participants at increased risk of severe RSV disease is less than 1.7%.
SAEs will be captured in all participants. Outside the Safety Subset and Immuno Subset, no cap is
installed on the number of participants at increased risk of severe RSV disease. It is expected that
participants at increased risk for severe RSV disease will represent approximately 30% of the
overall population. Assuming that 30% of the participants in the overall population are at increased
risk  of severe RSV disease (~870 participants), the observation of 0 events in participants at
increased risk of severe RSV disease would be associated with 95% confidence that the true rate
is less than 0.4%.
Table 7 shows the probabilities of observing at least one AE in one of the arms at given true AE
rates in the Safety Subset (overall population and participants at increased risk of severe RSV
disease).
Table 7: 
Probability of Observing at Least One Adverse Event or Serious Adverse Event at a Given True
Adverse Event Rate in the Safety Subset
Probability of Observing at Least One Adverse Event in N Participants
True Adverse 
Overall 
Increased Risk
Event Rate 
N=350 
N=2,900 
N=175 
N=870a
0.1% 
30%  
95% 
16%  
58%
0.5% 
83%  
100%  
58% 
99%
1%  
97% 
100%  
83%  
100%
2.5% 
>99.9%  
100%  
99% 
100%
a Approximate number
11.2.4. 
Revaccination Subcohorts
Immunogenicity
Immunogenicity will also be assessed in participants of the Revaccination Subcohorts, which
consist of ~120 participants (Revaccination Subcohorts A and C) or ~135 participants
(Revaccination Subcohort B) who received active study vaccine on Day 1 and ~120 participants
(Revaccination Subcohorts A  and C) or ~135 participants (Revaccination  Subcohort B) who
received placebo on Day 1 for a total of ~750 participants. All participants in the Revaccination
Subcohorts will receive a second vaccination with active study vaccine: on Day 365 (Month 12)
(Revaccination Subcohort A), on Day 730 (Month 24) (Revaccination Subcohort B), or on Day
1,095 (Month 36) (Revaccination Subcohort C).
The geometric mean of the titer ratios (GMRs) between Day 15 post first vaccination and Day 15
post second vaccination within a group, as well as the ratio of Day 15 post second vaccination
between the 2 groups (active study vaccine versus placebo on Day 1), for the different assays will
be calculated.
Table 8 shows the actual distance from the mean to the limits of 95% CI around the ratio between
Day 15 post first vaccination and Day 15 post second vaccination within a group for the different
assays. The calculations consider an exclusion rate of ~10% from the sample size of revaccinated

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participants (~108 participants per group for Revaccination Subcohorts A and C, and
~120 participants per group for Revaccination Subcohort B).
Table 8: 
Distance From the Mean to the Limits of 95% CI Around the Ratio Between Day 15 Post First
Vaccination and Day 15Post Second Vaccination Within a Group for Pre-F ELISA, VNA A2,
and ELISpot
Revaccination
Subcohort 
Assay
N (per
group)
Distancea from
Mean to Limits
95%CI
95% CI if Observed
Ratio is 1
A and C  
Pre-F ELISA (SD=1.3) 
120 
0.248 
(0.84;1.19)
VNA A2 (SD=1.5) 
120 
0.286 
(0.82;1.22)
ELISpot (SD=1.2)* 
50 
0.341 
(0.79; 1.27)
B 
Pre-F ELISA (SD=1.3) 
135 
0.235 
(0.85; 1.18)
VNA A2 (SD=1.5) 
135 
0.271 
(0.83; 1.21)
ELISpot (SD=1.2) 
135 
0.217 
(0.86;1.16)
CI = confidence interval, ELISA = enzyme-linked immunosorbent assay, ELISpot = enzyme-linked immunospot
(assay), SD = standard deviation, VNA = virus neutralization assay
a Calculated on the log2-scale assuming a correlation of 0.5 between the 2 timepoints.
*: No PBMC samples are taken for Revaccination Subcohort A.
Table 9 shows the actual distance from the mean to the limits of 95% CI around the Day 15 post
second vaccination ratio between the 2 groups, for the different assays. The calculations consider
an exclusion rate of 10% from the sample size of revaccinated participants (~108 participants per
group for Revaccination Subcohorts A and C, and ~120 participants per group for Revaccination
Subcohort B).
Table 9: 
Distance From the Mean to the Limits of 95% CI Around the Ratio on Day 15 Post Second
Vaccination Between the 2 Groups for Pre-F ELISA, VNA A2, and ELISpot
Revaccination 
Subcohort 
Assay
N (per 
group) 
Distancea from Mean 
to Limits 95% CI 
95% CI if Observed
Ratio is 1
A and C 
Pre-F ELISA (SD=1.3) 
120 
0.349 
(0.79;1.27)
VNA (SD=1.5) 
120 
0.402 
(0.76;1.32)
ELISpot (SD=1.2)* 
50 
0.476 
(0.72; 1.39)
B 
Pre-F ELISA (SD=1.3) 
135 
0.331 
(0.79;1.26)
VNA A2 (SD=1.5) 
135 
0.381 
(0.77; 1.30)
ELISpot (SD=1.2) 
135 
0.305 
(0.81; 1.24)
CI = confidence interval, ELISA = enzyme-linked immunosorbent assay, ELISpot = enzyme-linked immunospot
(assay),SD = standard deviation, VNA = virus neutralization assay
a Calculated on the log2-scale.
*: No PBMC samples are taken for Revaccination Subcohort A.
Safety
With ~240 active study vaccine participants in Revaccination Subcohorts A andC, and ~270 active
study vaccine participants in Revaccination Subcohort B, the observation of 0 events in the
database would be associated with 95% confidence that the true rate is <1.5%.
Table 10 shows the probabilities of observing at least 1 AE in one of the arms at given true AE
rates in the Revaccination Subcohorts.

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Table 10: 
Probability of Observing at Least 1 Adverse Event or Serious Adverse Event at a Given True
Adverse Event Rate in the Revaccination Subcohorts
True 
Adverse
Event
Rate 
Revaccination Subcohorts A and C  
Revaccination Subcohort B
Overall 
Per Group  
Overall 
Per Group
N=240a 
N=120a 
N=270 a 
N=135a
0.1% 
21% 
11%  
24%  
13%
0.5% 
70% 
45% 
74% 
49%
1%  
91%  
70% 
93%  
74%
2.5% 
>99.9%  
95% 
100%  
97%
a Approximate number
11.3. 
Participant Information
For all participants in the FAS, demographic characteristics (eg, age, height, weight, BMI, race,
and gender), and other baseline characteristics (eg, physical examinationfindings, medical history,
and concomitant diseases) will be tabulated and summarized with descriptive statistics. Important
tables might be repeated for other analysis sets.
11.4. Efficacy Analyses
11.4.1. 
Primary Efficacy Endpoints
Three primary efficacy endpoints are defined as follows:
 First occurrence of RT-PCR-confirmed RSV-mediated LRTD  according to Case
Definition #1
 First occurrence of RT-PCR-confirmed RSV-mediated LRTD  according to Case
Definition #2
 First occurrence of RT-PCR-confirmed RSV-mediated LRTD according to Case Definition#3
The case definitions are defined as follows:
Case Definition #1 
Case Definition #2 
Case Definition #3
≥3 symptoms of LRTI 
(new onset or worsening) 
≥2 symptoms of LRTI
(new onset or worsening)
≥2 symptoms of LRTI,
OR
≥1 symptom of LRTI
combined with
≥1 systemic symptom
(new onset or worsening)
LRTI = lower respiratory tract infection
To meet the primary endpoint according to the respective case definitions the following criteria
will be taken into account:
 symptoms reported by participants on the RiiQ Symptom Scale and body temperature during
the full ARI episode OR
 clinical assessment terms reported by a qualified study staff member during the ARI Days 3-5
clinical visit

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in combination with
 confirmation of RSV by RT-PCR in one or more of the midturbinate nasal swabs, or in the
sputum sample (when available)
Of note, on the day of the ARI Days 3-5 clinical visit, the case definitions can be met by symptoms
reported by participants on the RiiQ or by signs and symptoms reported by the qualified study staff
member. Case definitions cannot be met by a combination of symptoms reported by the participant
with signs and symptoms reported by the qualified study staff member.
Confirmation of RSV infection by RT-PCR (midturbinate swabs and sputum sample, when
available) will be performed at the central laboratory. For participants hospitalized with symptoms
of an ARI, confirmation of RSV infection using an FDA-approved RT-PCR test at the local
(hospital) laboratory will also be used for the analysis of case definitions if results from the central
laboratory are not available. One positive sample (defined as any sample with a value above the
limit of detection) is sufficient.
As a sensitivity analysis, the analysis of the primary endpoint will be repeated, but participants
with RSV infection and a co-infection with at least one other respiratory virus (ie,confirmed using
an FDA approved RT-PCR test in one or more of the midturbinate nasal swabs, or in the sputum
sample, when available) will not be considered as a case for that episode, as the etiology of the
symptoms will be indeterminate.
As an additional sensitivity analysis, the analysis of the primary endpoint will be repeated, taking
into account only the RT-PCR test results from the central laboratory (ie, excluding the local test
results for hospitalized participants).
Presence and severity of symptoms will be collected using participant responses to the RiiQ
Symptom Scale and temperature readings participants report in the eDiary each day throughout
each ARI episode. On the day of the ARI Days 3-5 clinical visit, signs and symptoms will also be
collected by qualified study staff in a clinical assessment.
Table 11: 
Symptoms of Lower Respiratory Tract Infection and Systemic Symptoms as per RiiQor
Clinical Assessment
Symptoms from Case 
Definition 
RiiQTerm  
Clinical Assessment Term
(ARI Days 3-5 Clinical Visit)
Symptoms of LRTI 
Cough  
Cough  
Cough
Shortness of breath  
Short of breath  
Dyspnea or decreased oxygen
saturation*
Sputum production 
Coughing up phlegm (sputum) 
Sputum production
Wheezing 
Wheezing 
Wheezing; rhonchi, rales or
other sign of consolidation
Tachypnea** 
Tachypnea
Systemic Symptoms 
Fatigue 
Fatigue (tiredness) 
Malaise (tiredness)
Fever***,**** 
Fever
Feverishness**** 
Feeling feverish
* Decreased oxygen saturation is defined as oxygen saturation of <90% for participants with a baseline oxygen
saturation of ≥90% at randomization; for participants with baseline oxygen saturation <90%, decreased oxygen
saturation is defined as a ≥3% decrease in their oxygen saturation from baseline.

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** Tachypnea is defined as respiratory rate >20 breaths per minute.
*** Fever (ie, temperature >37.8oC) will be reported via daily temperature measurement and during ARI Days 3-5
clinical visit.
**** Feeling feverish and fever are considered as 1 symptom.
LRTI =lower respiratory tract infection, RiiQ = Respiratory Infection Intensity and Impact Questionnaire
Symptoms (new onset or worsening) occurring at the same day will be counted. When during ARI
Days 3-5, symptoms are reported more than once per day by the participant (eg, on the site’s
eDevice and in the participant eDiary), the worst severity from the RiiQ will be taken into account.
On the day of the ARI Days 3-5 clinical visit, signs and symptoms collected during the clinical
assessment by a qualified study staff member will be considered separately from the symptoms
reported by the participant on the site’s eDevice or in the participant eDiary. A new onset of a
symptom is a symptom that is reported during the ARI episode and that was not reported at baseline
(defined by pre-dose assessment on the day of vaccination for the first RSV season, the Day 365
[Month 12] visit for the second RSV season [pre-vaccination if applicable], and at the Day 730
[Month 24] visit for the third RSV season). Worsening of a symptom is defined as a symptom that
is reported at baseline (defined by pre-dose assessment on the day of vaccination for the first RSV
season, at the Day 365 visit for the second RSV season [pre-vaccination if applicable], and at the
Day 730 visit for the third RSV season) that worsens in severity during the ARI episode compared
to baseline.
First occurrence of a considered endpoint is defined as the first episode of the considered endpoint
in a given RSV season (regardless A or B strain, unless otherwise specified).
11.4.1.1. 
Analysis
Any analysis of the primary endpoints for VE will evaluate the number of participants with (at
least one episode of) RT-PCR-confirmed RSV-mediated LRTD (cases defined according to the
3 primary endpoint definitions) in the active vaccine group compared to the placebo group in the
PPE population. Time at risk will also be taken into account. The null hypothesis of VE ≤0% for
all 3 primary endpoints will be tested versus the alternative hypothesis VE >0% for at least one
primary endpoint.
The α-levels for all efficacy analyses will be adjusted:
 To account for the multiple endpoint approach. The multiplicity correction method for the
3 primary endpoints is based on the approach by Spiessens and Debois.26 The exact value will
be calculated based on the number of events observed for each definition at the time of
analysis, targeting the same α-level for each of the 3 primary endpoints.
 To account for multiple analyses (see Section 11.12 for details on the planned analyses):
 use estimated proportion of events already observed (PIA) and Pocock rule to set α' for
the IA
o 
PIA  obtained from epidemiological/disease transmission model and real world
evidence (RWE)
o 
This α' will be equally divided across the 3 primary endpoints based on the observed
incidence

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 at the end of the study, based on Case Definition #2, calculate the actual information
fraction (IF) at the IA based on the total number of events
o 
From this information and α', calculate the α'' level for the final analysis.
o 
This α'' will again be equally divided across the 3 primary endpoints based on the
incidence of the 3 case definitions.
Both methods will be combined to come to one cut-off that will be used to define significance.
The exact values cannot yet be provided as they depend on the number of cases already observed
at the time of (interim) analysis.
For example: assume in a NH and SH study an IA was performed with 18 RT-PCR-confirmed
RSV-mediated LRTD events observed of the expected 26: the IFs for the interim and primary
analyses are 0.7 and 1, respectively. With a total α of 0.05, the α at each analysis (IA and primary
analysis) will be 0.0335 using Pocock’s rule. If then at the IA the total number of events are as
follows: 14 events with Case Definition #1, 18 events with Case Definition #2, and 25 events with
Case Definition #3, the IFs at the IA are: 0.56, 0.72, and 1. Again, using Pocock's rule, the α for
each individual case definition will be 0.0175. So, proof of concept will be declared at the IA if,
for any endpoint, the comparison of the number of events on vaccine compared to placebo if the
p-value is <0.0175.
For each of the 3 primary endpoints the following will be performed: an exact Poisson regression
will be fitted with the event rate, defined as the number of cases over the follow-up time (offset)
as dependent variable and the vaccination group and age and being at increased risk for severe
RSV disease (both as stratified) as independent variables. For cases, the follow-up time is defined
as the time between vaccination and the occurrence of the first event (according to the considered
endpoint), for non-cases, it is the time between vaccination and the end of season visit. However,
for participants that discontinued before the end of the season and had an event (according to the
considered endpoint), the follow-up time is defined as the time between vaccination and the
occurrence of the first event and for participants that discontinued before having an event, follow-
up time is the time between vaccination and the date of last contact. Thus, all participants are
included in the analysis according to their follow-up time. The exact p-value corresponding to
vaccination group will be compared with the cut-off as described above.
If the p-value is below the cut-off for at least 1 of the 3 primary endpoints, proof of concept is
demonstrated. The individual 2-sided CIs (1-2 × cut-off) for the VE (1-relative riskrate), measured
by each of the 3 endpoints, will be calculated from the regression model described above.
The primary analysis will be performed on the PPE population, which will take cases into account
with an onset at least 14 days after vaccination.
As a sensitivity analysis, the above model will be repeated based on the FAS (which also does not
take into account the restriction on the onset [at least 14 days] and will count cases from
vaccination on Day 1 onwards). Additional sensitivity analyses will include an exact binomial test,
not taking into account the strata, based on the PPE population and the FAS. The VE ( 1-relative

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risk) and the corresponding corrected 2-sided CI based on the exact binomial will be calculated as
well.
11.4.2. 
Secondary Efficacy Endpoints
Secondary objectives are defined as follows:
 First occurrence of any RT-PCR-confirmed RSV disease
This is defined as new onset or worsening of any of the clinical symptoms (LRTI or upper
respiratory tract infection [URTI]) indicated in  Attachment 1 in combination with RSV
confirmation by RT-PCR in at least one of the samples taken at the visits after symptom onset
(one positive sample is sufficient)
 First occurrence of a considered endpoint is defined as the first episode of the considered
endpoint in a given RSV season (regardless A or B strain, unless otherwise specified).
11.4.2.1. 
Analysis
For each of the above secondary endpoints an exact Poisson regression will be fitted in a similar
way as for the primary endpoint. The 95% 2-sided CI for the VE (1-relative risk rate) will be
calculated from the regression model described above.
In addition, for each of the above secondary endpoints, the proportion of participants with an event
will be tabulated. The corresponding VE ( 1- relative risk) and the 95% 2-sided CI will be
calculated without taking the strata into account based on an exact binomial test.
11.4.3. 
Exploratory Efficacy Endpoints
 Explore the relationship between G-ELISA and RT-PCR confirmed RSV infection.
Provided a cut-off for G-ELISA fold-rise between ARI Day 3-5 and ARI Day 29 is found that
is sufficiently sensitive and specific for serology confirmation of RSV infection, the following
objectives will be explored:
 First occurrence of any serology and/or RT-PCR-confirmed RSV disease
This is defined as new onset or worsening of any of the clinical symptoms (LRTI or
URTI) indicated in Attachment 1 in combination with RSV confirmation by RT-PCR in
at least one of the samples taken at the visits after symptom onset (one positive sample is
sufficient) or serology confirmation of RSV
 First occurrence of serology-confirmed RSV-mediated LRTD  according to each case
definition
This is determined in a similar way as the primary endpoints but instead of RT-PCR
confirmation of RSV, serology confirmation of RSV is needed. Serology confirmation is
determined based on the serology sample obtained approximately 28 days after ARI
onset.
 First occurrence of any serology-confirmed RSV disease
This is defined as new onset or worsening of any of the clinical symptoms (LRTI or
URTI) indicated in Attachment 1 in combination with serology confirmation of RSV

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 If the primary objective is demonstrated after one RSV season:
 First occurrence of RT-PCR-confirmed RSV-mediated LRTD during the second RSV
season and during the third RSV season according to each of the 3 case definitions
This is defined similarly as the primary endpoint, but only counted in the respective
season. The baseline assessment for the second RSV season is the Day 365 (Month 12)
visit and for the third RSV season it is the Day 730 (Month 24) visit. New onset or
worsening is defined similarly as for the primary endpoint, by comparing symptoms
occurring during the ARI episode to symptoms reported at the new baseline (instead of
by comparing to Day 1). First occurrence of a considered endpoint during the second or
third RSV season is defined as the first episode of the considered endpoint in a given RSV
season (regardless A or B strain, unless otherwise specified).
 First occurrence of RT-PCR-confirmed RSV-mediated LRTD over 2 RSV seasons and
over 3 RSV seasons according to each of the 3 case definitions
This is defined similarly as the primary endpoint but taking into account events over the
2 or 3 seasons. The baseline assessment for the second RSV season is the Day 365
(Month 12) visit and for the third RSV season it is the Day 730 (Month 24) visit. New
onset or worsening is defined similarly as for the primary endpoint, by comparing
symptoms occurring during the ARI episode to symptoms reported at the new baseline
(instead of comparing to Day 1). When evaluating the vaccine efficacy over 2 and
3 seasons, first occurrence of a considered endpoint over 2 or 3 seasons is defined as the
first episode of the considered over the considered period (2 RSV seasons or 3 RSV
seasons respectively, regardless A or B strain, unless otherwise specified).
Other secondary or exploratory objectives that were assessed during the first RSV season
(as defined in section 11.4.2 and below), might also be explored during the second and
the third RSV season and over 2 and 3 RSV seasons. These endpoints are defined
similarly as the corresponding endpoints during the first RSV season, but baseline, new
onset or worsening, and first occurrence are defined in a similar way as for RT-PCR-
confirmed RSV-mediated LRTD, during the second and the third RSV season and over
2 or 3 RSV seasons (see above).
 First occurrence of any RT-PCR-confirmed RSV disease caused by an RSV A or RSV B
strain, respectively
 First occurrence of potential complications of respiratory disease (eg, pneumonia, new onset,
worsening, or an exacerbation of CHF, asthma, and COPD) linked to any respiratory disease
and linked to any RT-PCR confirmed RSV disease
 Efficacy of active study vaccine against other respiratory diseases
Midturbinate nasal swabs may be tested for the presence of other respiratory pathogens
 First occurrence of hospitalizationlinked to any respiratory disease and linked to anyRT-PCR
confirmed RSV disease
 Determination of oxygen saturation during clinical assessment during ARI episodes
 First occurrence of RT-PCR-confirmed RSV-mediated LRTD according an ordinal case
definition

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The ordinal case definitions are provided in Table 12.
Table 12: 
Ordinal Case Definition
Ordinal Case definition
Ordinal variable
Participants
fulfilling
≥3 symptoms of LRTI (new onset or worsening), in combination with
confirmation of RSV by RT-PCR in one or more of the midturbinate
nasal swabs, or in the sputum sample (when available)
4
Case Definition
1, 2 and 3
2 symptoms of LRTI (new onset or worsening), in combination with
confirmation of RSV by RT-PCR in one or more of the midturbinate
nasal swabs, or in the sputum sample (when available)
3
Case Definition 2
and 3 (not Case
definition 1)
1 symptom of LRTI (new onset or worsening), in combination with
confirmation of RSV by RT-PCR in one or more of the midturbinate
nasal swabs, or in the sputum sample (when available)
2
Only Case
Definition 3 (not
Case definitions
1 and 2)
Other
1
No case
definition
The CEC review will assess,independently and based on CRF/eDiary data,the location of the ARI
(upper or lower respiratory tract infection) and the ARI severity. The CEC assessment, as well as
other information based on MRU, presence of clinically relevant disease, use of therapeutic
interventions, RiiQ, clinical assessment, Lawton-Brody IADL, and change in frailty will be used
to evaluate the severity of the RSV-positive ARIs, and will be used to explore the relation with the
case definitions.
11.4.3.1. 
Analysis
For endpoints that intend to explore VE, an exact Poisson regression model will be fitted in a
similar way as for the primary endpoint. The 95% 2-sided CI for the VE (1-relative risk rate) will
be calculated from the regression model described above.
For exploratory endpoints regarding only season 2 data, the follow-up time for cases in season 2
is defined as the time between the Day 365 (Month 12) visit and the occurrence of the first event
(according to the considered endpoint) in the considered season, for non-cases in season 2, it is the
time between the Day 365 visit and the end of the second season visit. However, for participants
that discontinued before the end of the second season and had an event in Season 2 (according to
the considered endpoint), the follow-up time is defined as the time between the Day 365 visit and
the occurrence of the first event and for participants that discontinued before having an event in
season 2, follow-up time is the time between the Day 365 visit and the date of last contact.
Participants that discontinued prior to the Day 365 visit as well as participants that are part of
Revaccination Subcohort A will be excluded from the analysis.
For exploratory endpoints regarding only Season 3 data, the follow-up time for cases in Season 3
is defined as the time between the Day 730 (Month 24) visit and the occurrence of the first event
(according to the considered endpoint) in the considered season, for non-cases in Season 3, it is
the time between the Day 730 visit and the end of the third season visit. However, for participants
that discontinued before the end of the third season and had an event in Season 3 (according to the

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considered endpoint), the follow-up time is defined as the time between the Day 730 visit and the
occurrence of the first event and for participants that discontinued before having an event in Season
3, follow-up time is the time between the Day 730 visit and the date of last contact. Participants
that discontinued prior to the Day 730 visit as well as participants that are part of Revaccination
Subcohorts A and B will be excluded from the analysis.
For exploratory endpoints over 2 seasons (Season 1 and Season 2), the follow-up time is defined
as the time between the Day 1 vaccination and the occurrence of the first event (according to the
considered endpoint) in the first 2 seasons, for non-cases, it is the time between the Day 1
vaccination and the end of the second season visit. However, for participants that discontinued
before the end of the second season and had an event (according to the considered endpoint), the
follow-up time is defined as the time between the Day 1 vaccination and the occurrence of the first
event and for participants that discontinued before having an event, follow-up time is the time
between the Day 1 vaccination and the date of last contact. For Revaccination Subcohort A
participants, only the first season is taken into account: for cases during the first season, the follow-
up time is the time between the Day 1 vaccination and the occurrence of the first event (according
to the considered endpoint), for non-cases it is the time between the Day 1 vaccination and end of
first season visit.
For exploratory endpoints over 3 seasons (Season 1, 2 and 3), the follow-up time is defined similar
as for endpoints over 2 seasons, but data up to the end of the third season are taken into account
(instead only data up to the end of the second RSV season). For Revaccination Subcohort A
participants, only the first season is taken into account and follow-up time is defined similar as
explained above. For Revaccination Subcohort B participants only the first 2 seasons are taken
into account: for cases during the first 2 seasons, the follow-up time is the time between the Day 1
vaccination and the occurrence of the first event (according to the considered endpoint), for non-
cases it is the time between the Day 1 vaccination and the end of second season visit.
For continuous endpoints, actual values and changes from baseline (if meaningful) will be
summarized descriptively. Categorical endpoints will be tabulated.
11.5. Patient-reportedOutcomes
Daily symptom severity reported by participants using the RiiQ Symptom Scale, temperature log,
and Patient Global Impression Scales from symptom onset to symptom resolution will be
descriptively analyzed by group (active vaccine or placebo). Changes from baseline functioning
associated with ARI collected using the RiiQ Impact Scales will also be analyzed.
Details on validation of the PRO questionnaires will be provided in a separate analysis plan.
11.5.1. 
Respiratory Infection Intensity and Impact Questionnaire (RiiQ™v2)
The RiiQ consists of 4 scales that are scored separately:
 RiiQ Symptom Scale (Question 1). Each symptom is rated on the following scale: 0 None,
1 Mild, 2 Moderate, and 3 Severe. The RiiQ Symptom scale can be scored as a mean of all

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scores (Total Symptom Score) or 2 subscales scores, Respiratory Symptoms and Systemic
Symptoms:
 The RiiQ Respiratory Symptoms Subscale score is the mean of 6 symptoms, ie, 2 URTI
symptoms (Nasal congestion and Sore throat) and 4 LRTI symptoms (Cough, Wheezing,
Shortness of breath, and Coughing up phlegm/sputum)
 The RiiQ Systemic Symptom subscale score is the mean of 7 systemic symptoms
(Headache, Feeling feverish, Neck pain, Body aches and pain, Fatigue/tiredness,
Interrupted sleep, and Loss of appetite).
 RiiQ Impact Scales (Questions 2 to 4):
 RiiQ Impact on Daily Activity scale (Question 2) consists of 7 activities. Ability to
perform each activity item is rated on the following scale: 0 No difficulty, 1 Some
difficulty, 2 Moderate Difficulty, and 3 Great difficulty. Scale scores are calculated as
the mean of all 7 items (range 0-3).
 RiiQ Impact on Emotions scale (Question 3) consists of rating 4 negative emotions, rated
on the following scale: 0 Not at all, 1 Somewhat, 2 Moderately, and 3 Extremely.
Scale scores are calculated as the mean of all 4 items (range 0-3).
 RiiQ Impact on Relationships scale (Question 4) consists of 5 problems that a respiratory
infection may cause in relationships with others, rated on the following scale: 0 Not at
all concerned, 1 Somewhat concerned, 2 Moderately concerned, and 3 Extremely
concerned) with scale scores calculated as the mean of all 5 items (range 0-3).
11.5.2. 
Patient Global Impression Scores
 Patient Global Impression of Health (PGI-H). Participants report their overall impression of
their health status today on the following scale: 0 Very poor, 1 Poor, 2 Fair, 3 Good,
4 Very good.
 Patient Global Impression of Severity (PGI-S). Participants rate the severity of their
respiratory illness on the following scale: 0 I feel fine (no respiratory illness), 1 I feel a little
ill, 2 I feel very ill, 3 I feel extremely ill.
 Patient Global Impression of Change (PGI-C). Participants rate the amount of change in their
health each day during an ARI episode on the following scale: -3 Very much better, -2 Much
better, -1 A little better, 0 About the same/no change, 1 A little worse, 2 Much worse,
3 Very much worse
 Return to Usual Health. Participants are being asked whether they have returned to their usual
health after developing symptoms suggesting an ARI.
11.6. Lawton-Brody Instrumental Activities of Daily Living (IADL) Scale
The Lawton-Brody IADL questionnaire (Attachment 8) covers 8 domains. Women are scored on
all 8 domains; historically, for men, the domains of food preparation, housekeeping, and
laundering are excluded from the analysis. Participants are scored according to their highest level
of functioning in that category (either 0 or 1). A summary score ranges from 0 (low function,
dependent) to 8 (high function, independent) for women, and from 0 through 5 for men.

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Change from baseline independence status associated with ARI collected using the Lawton-Brody
IADL questionnaire will be descriptively analyzed.
11.7. 
Frailty Index Score
The frailty index score will be calculated from the medical conditions of interest, RiiQ, and the
Lawton-Brody IADL. More details will be provided in the SAP.
The change from baseline in frailty indexscore will be determined. The following correlations will
be explored (descriptively or graphically):
 the correlation between the baseline frailty index score and RSV infection incidence, severity
(as determined from the RiiQ questionnaire) and duration.
 the correlation between the baseline frailty index score and the primary endpoints.
 the correlation between the change in frailty index score and presence of an RSV ARI.
11.8. Clinical Assessment
Symptoms from the clinical assessment will be scored on a 4-point scale (from 0 through 3), with
higher scores indicating greater severity. The scores will be analyzed descriptively.
11.9. 
Immunogenicity Analyses
No formal statistical testing of the immunogenicity data is planned. All immunogenicity analyses
will be performed on the PPI population. Key tables might be repeated for the FAS (including
samples that are excluded from the PPI analysis).
11.9.1. 
Immuno Subset
No formal hypothesis on immunogenicity will be tested. Descriptive statistics (geometric mean
and 95% CI for ELISA and RSV neutralization assay; median and quartiles for IFN-γ ELISpot and
ICS) will be calculated for continuous immunologic parameters at all time points. For the humoral
assays, geometric mean fold rises from baseline and corresponding 95% CIs might additionally be
calculated. Baseline is considered as the last available assessment before the vaccination.
Graphical representations of immunologic parameters will be made as applicable.
The impact of baseline factors on the humoral and cellular responses will be explored graphically
or via descriptive statistics.
11.9.2. 
Revaccination Subcohorts
No formal hypothesis on immunogenicity will be testedfor Revaccination Subcohorts. Descriptive
statistics (geometric mean and 95% CI for ELISA and RSV neutralization assay, median and
quartiles for IFN-γ ELISpot) will be calculated for continuous immunologic parameters at all time
points. Geometric mean fold rises from baseline and corresponding 95% CIs might additionally
be calculated. Geometric mean ratios and corresponding 95% CIs between Day 15 post first
vaccination and Day 15 post second vaccination within the group receiving active study vaccine

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on Day 1 and the day of the second vaccination depending on the Revaccination Subcohort will
be calculated for the different assays.
In addition, the GMT ratios with corresponding 95% CIs of Day 15 post second vaccination for
the group receiving active study vaccine twice versus the group receiving placebo first and active
study vaccine 1, 2, or 3 years later will also be calculated for the different assays. Therefore, an
analysis of variance (ANOVA) model will be fitted with the respective titers as dependent variable
and group as independent variable. The estimate and CIs obtained as such will be back transformed
(by exponentiation) to a GMT ratio and the corresponding CI. As a sensitivity analysis, different
variances between the groups will be allowed, therefore the CIs will be calculated via Welsh’s
ANOVA.
For Revaccination Subcohorts 2A and 2B that get a third vaccination with Ad26.RSV.preF/RSV
preF protein mixture or with the individual vaccine components, no formal hypothesis is tested;
descriptive statistics over time after the third vaccination will be calculated.
Graphical representations of immunologic parameters will be made as applicable.
The impact of baseline factors on the humoral responses will be explored graphically or via
descriptive statistics.
11.9.3. 
Correlates of Risk
If VE is demonstrated, correlates of risk will be explored. More details with appropriate methods
will then be provided in a separate SAP.
11.10. Medical Resource Utilization Analyses
Medical resource utilization data will be descriptively summarized by intervention group.
11.11. Safety Analyses
No formal statistical testing of safety data is planned. Safety data by vaccination group and based
on the FAS will be analyzed descriptively. The analysis of solicited and unsolicited AEs will be
restricted to a subset of the FAS (ie, the Safety Subset). For SAEs, the complete FAS is considered.
The impact of baseline factors (eg, being at increased risk  for severe RSV disease) might be
explored as well. Additionally, the analysis of solicited and unsolicited AEs and AESIs (if
collected) will also be performed for each of the Revaccination Subcohorts and will be restricted
to participants of the Revaccination Subcohorts that are part of the FAS.
Adverse Events (Solicited and Unsolicited)
The verbatim terms used in the eCRF  by investigators to report AEs will be coded using the
Medical Dictionary for Regulatory Activities (MedDRA). All reported AEs with onset during the
active vaccination phase (ie, AEs occurring after vaccination up to 28 days post-vaccination), and
all SAEs and AESIs will be included in the analysis. For each AE, the number and percentage of
participants who experience at least 1 occurrence of the given event will be summarized by group.

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Solicited local (at the injection site) and systemic AEs will be summarized descriptively. The
overall frequencies per group  as well as frequencies according to severity and duration will be
calculated for solicited AEs.
Summaries, listings, datasets, or participant narratives may be provided, as appropriate, for those
participants who die, who discontinue the study (or study vaccination,if applicable) due to an AE,
or who experience a severe AE,an SAE, or an AESI.
Any ARI recorded as an (S)AE in the eCRF will be excluded from any AE analysis if the laboratory
RT-PCR is subsequently found to be positive for RSV. ARIs arising from RSV infection will not
be reported as (S)AEs in the Clinical Study Report as they are endpoints of the study and will be
tabulated separately.
Vital Signs
A tabulation of the distribution of temperatures in the 7 days after vaccination, per half degree
intervals, will be provided. For systolic and diastolic blood pressures, pulse rate and respiratory
rate, the percentage of participants with values beyond clinically relevant limits will be
summarized.
Physical Examination
Abnormalities resulting from a physical examination will be documented as medical history or as
AE. Therefore, no physical examination specific tables or listings will be generated for Day 1.
Abnormalities resulting from a physical examination on other timepoints will be listed.
11.12. Planned Analyses
Recruitment Completed in the Northern Hemisphere Only (Target Sample Size ≥5,500)
If participants are only enrolled in the NH and if by the end of the first NH RSV season (database
cut-off of 15 May 2020) 18 or more RT-PCR-confirmed RSV-mediated LRTD events (using Case
Definition #2) are observed, the study will be unblinded for the sponsor and the primary analysis
will be performed by the sponsor.
If, by the end of the first NH RSV season, less than 18 RT-PCR-confirmed RSV-mediated LRTD
events (using Case Definition #2) are observed, an IA will be performed by the IDMC. The IDMC
will evaluate in an unblinded fashion if superiority is established for at least one of the primary
endpoints.
 In the event of superiority, the sponsor will be notified. The database used for the IDMC
analysis will be unblinded for the sponsor and the primary analysis will be performed by the
sponsor.
 If superiority is not demonstrated, the IDMC will evaluate the conditional power to
demonstrate proof of concept (under the original assumptions of incidence and VE) if
2,000 new participants are added to the study. If the conditional power is less than 60%, the
database used for the IDMC analysis will be unblinded for the sponsor and the primary

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analysis will be performed by the sponsor. If the conditional power is 60% or more, 2,000 new
participants (Cohort 2) will be added to the study who will be followed up for one RSV season.
The ongoing participants from Cohort 1 will be stopped at the end of RSV season or 6 months
after vaccination whatever comes later.
Recruitment Spread Over the Northern and the Southern Hemisphere (Target Sample
Size up to 5,800)
If the number of participants enrolled in the NH is less than 5,500 and less than 18 RT-PCR-
confirmed RSV-mediated LRTD events (using Case Definition #2) are observed in the NH before
opening sites in the SHa, additional participants will be enrolled in the SH up to a total sample size
(NH and SH combined) of 5,800 participants. In that case, a single IA may be performed during
the NH or SH RSV season. This “early” IA  will be performed by the IDMC at one of
2 predetermined time points:
 The first time point will be at the end of the NH RSV season. The database cut-off for this
analysis will be 15 May 2020.
 The secondtime point will be determined by operational and regulatory considerations to start
Phase 3 the next year. The database cut-off for this analysis will be 15 August 2020.
The IA will be performed by the IDMC at the earliest of those 2 predetermined time points where
at least 14 events (RT-PCR-confirmed RSV-mediated LRTD cases per Case Definition #2) are
observed. If the early IA is performed, the IDMC will evaluate in an unblinded fashion if
superiority is established for at least one of the primary endpoints. The IDMC will notify the
sponsor of the outcome. In the event of superiority, the database used for the IDMC analysis will
be unblinded for the sponsor and the primary analysis will be performed by the sponsor. If
superiority is not shown at the IA or if the number of RT-PCR-confirmed RSV-mediated LRTD
cases (using Case Definition #2) is less than 14 at the second time point, the primary analysis will
be performed at the end of the SH RSV season (database cut-off of30 October 2020) in a similar
way as in a NH study only.
The IA plan is outlined in Figure 3 in case the study is performed in the NH only, and in Figure 4
in case the study is performed in the NH and SH.
Additional Analyses
If in a NH+SH study VE is demonstrated at the early IA, an additional analysis will be performed
at the end of the RSV season. This will count as supportive information.
If VE is demonstrated at the end of the first NH RSV season, the study will continue and the
ongoing participants from Cohort 1 will be followed up for a second RSV season. If this is the
case, additional analyses will be performed at the end of the second RSV season to evaluate if
a 
If the number of participants enrolled in the NH is less than 5,500 and 18 or more RT-PCR-confirmed RSV-
mediated LRTD events (using Case Definition #2) are observed in the NH before opening sites in the SH, no sites
will be opened in the SH and the study will be performed as a NH study only.

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there is a trend for durable efficacy. If analyses at the end of the second RSV season indicate a
trend for durable efficacy or in case results on durability are inconclusive, the study will continue
and the ongoing participants from Cohort 1 will be followed up for a third RSV season as indicated
in the Schedule of Activities. If this is the case, additional analyses will be performed at the end
of the third RSV season to further evaluate durability of efficacy.
Analysis 28 Days Post Second Vaccination in Revaccination Subcohorts A, B, and C
This analysis will be done for each Revaccination Subcohort (A, B, and C) and will include safety
and immunogenicity data from the considered Revaccination Subcohort. The analysis will be
performed on unblinded data. Data collected up to the time of the 28-day post second vaccination
visit for the last participant in the considered Revaccination Subcohort will be included in the
analysis.
The blind will be maintained at the participant/site level, with respect to the vaccination received
on Day 1 until the database lock for the final analysis of the considered cohort, except for the
participants in Revaccination Subcohorts A and B, who will be unblinded to the Day 1 vaccination
prior to re-randomization to the third vaccination: participants who received active vaccine on
Day 1 will complete the study at that time, participants who received placebo on Day 1 will be
re-randomized to receive either Ad26.RSV.preF/RSV preF protein mixture or the individual
vaccine components in a blinded fashion.
End of Season 2 Analysis
This analysis will include all efficacy, safety, and immunogenicity data collected up to the time of
the end of the second RSV season. If the number of RSV-positive cases observed during the second
season is low, the efficacy analysis might be restricted to a listing of major efficacy endpoints in
RSV-positive participants during the second RSV season. In case no RSV cases are reported, then
the end of Season 2 analysis might be restricted to only safety and immunogenicity.
This analysis might be split in 2 parts given the availability of the data. The first part will include
all efficacy, safety, and immunogenicity data collected until the end of the second RSV season and
the second part will include additional safety data collected between the end of the second RSV
season and the end of the SAE safety follow-up.
Analysis of Revaccination Subcohorts A and B, when Revaccination Subcohorts 2A and 2B
have reached the 28 Days Post Third Vaccination Timepoint
This analysis will be done separately for each Revaccination Subcohort (A and B) and will include
safety and immunogenicity data from the considered Revaccination Subcohort. The analysis will
be performed on unblinded data. Data collected up to the time of the 28-day post third vaccination
visit for the last participant in the considered Revaccination Subcohort will be included in the
analysis.
The blind will be maintained at the participant/site level, with respect to the vaccination received
on Day 1 until the database lock for the final analysis of the considered cohort, except for the
participants in Revaccination Subcohorts A and B, who will be unblinded to the Day 1 vaccination

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prior to re-randomization to the third vaccination: participants who received active vaccine on
Day 1 will complete the study at that time, participants who received placebo on Day 1 will be
re-randomized to receive either Ad26.RSV.preF/RSV preF protein mixture or the individual
vaccine components in a blinded fashion.
End of Efficacy Study Analysis
This analysis will include all efficacy, safety, and immunogenicity data collected until the end of
the third RSV season. Efficacy data collected up to the end of the third season visit for the last
participant will be included in the analysis.
The end of efficacy study analysis will be performed on unblinded data.
Final Analysis of Revaccination Subcohorts (A, B, and C).
This analysis will be done for each Revaccination Subcohort (A, B, and C) and will include safety
and immunogenicity data from the considered Revaccination Subcohort. The analysis will be
performed on unblinded data. Data collected up to the last visit for the last participant in the
considered Revaccination Subcohort will be included in the analysis.
Early Stop ARI Surveillance in 2020
Due to the increasing incidence of COVID-19 cases, it is becoming increasingly difficult to
conduct ARI surveillance, without putting staff or study participants at risk. As the first RSV
season is nearing a close, a decision has been made to stop ARI surveillance for the first RSV
season under Amendment 2.
Unplanned Snapshot Interim Analysis
An unplanned snapshot IA may be performed to allow for early decision making on capacity
planning for the Ad26 SARS-CoV2, which is being developed for the prophylactic immunization
against SARS-CoV-2 infection, and Ad26.RSV.preF vaccines. This is especially important for the
production capacity in 2020 and 2021. The results of this unplanned snapshot IA will only be
shared with select members of upper management not involved in the conduct of the study. This
will be described in more detail in a separate charter.
Since this unplanned snapshot IA will only be used for internal decision making, will not further
affect the conduct of the study, and it is not expected that the number of events will drastically
change for the primary analysis, no type I error adjustment will be applied. The success of the
study will solely depend on the results of the primary analysis.
Validation of the PRO Questionnaires
Validation of PRO questionnaires will be performed in a blinded manner to ensure unbiased
validation. More details will be provided in a separate analysis plan.

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11.13. Independent Data Monitoring Committee
The study will be formally monitored by an IDMC. In general, the IDMC will monitor safety data
on an ongoing basis to ensure the continuing safety of the participants. In addition, the IDMC will
formally monitor the efficacy endpoints at the time points specified in Section 11.4. The IDMC
will evaluate in an unblinded fashion whether superiority is established for at least one of the
primary endpoints (at the early IA or at the end of the RSV seasonin the event that less than 18 RT-
PCR-confirmed RSV-mediated LRTD events are observed) or whether futility (conditional power
<60%) is shown for all 3 primary endpoints (at the end of the first RSV season in the event that
less than 18 RT-PCR-confirmed RSV-mediated LRTD events are observed).
The details on the superiority and futility assessment of the IDMC are described in Section 11.12.
The IDMC will consist of at least one medical expert in the relevant therapeutic area and at least
one statistician. The IDMC responsibilities, authorities, and procedures will be documented in its
charter.
12. 
ADVERSE EVENT REPORTING
Timely, accurate, and complete reporting and analysis of safety information from clinical studies
are crucial for the protection of participants, investigators, and the sponsor, and are mandated by
regulatory agencies worldwide. The sponsor has established Standard Operating Procedures in
conformity with regulatory requirements worldwide to ensure appropriate reporting of safety
information; all clinical studies conducted by the sponsor or its affiliates will be conducted in
accordance with those procedures.
Method of Detecting Adverse Events, AESIs, and Serious Adverse Events
Care will be taken not to introduce bias when detecting AEs, AESIs, or SAEs. Open-ended and
nonleading verbal questioning of the participant is the preferred method to inquire about
AE occurrence.
Solicited Adverse Events
Solicited AEs are predefined local (at the vaccine injection sites) and systemic events for which
the participant is specifically questioned and which are noted by participants in the Safety Subset
in their eDiary (see Section 9.2.4, Safety Evaluations).
Unsolicited Adverse Events
Unsolicited AEs are all AEs for which the participant is specifically not questioned in the
participant eDiary.
AESIs
For details, refer to Section 12.3.4.

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12.1. 
Definitions
12.1.1. 
Adverse Event Definitions and Classifications
Adverse Event
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal
(investigational or non-investigational) product. An AE does not necessarily have a causal
relationship with the intervention. An AE can therefore be any unfavorable and unintended sign
(including an abnormal finding), symptom, or disease temporally associated with the use of a
medicinal (investigational or non-investigational) product, whether or not related to that medicinal
(investigational or non-investigational) product. (Definition per International Council for
Harmonisation [ICH])
This includes any occurrence that is new in onset or aggravated in severity or frequency from the
baseline condition, or abnormal results of diagnostic procedures, including laboratory test
abnormalities.
Refer to Section 12.3.1, All Adverse Events, for AEs collected in this study.
Serious Adverse Event
An SAE based on ICH and EU Guidelines on Pharmacovigilance for Medicinal Products for
Human Use is any untoward medical occurrence that at any dose:
 Results in death
 Is life-threatening
(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.)
 Requires inpatient hospitalization or prolongation of existing hospitalization
 Results in persistent or significant disability/incapacity
 Is a congenital anomaly/birth defect
 Is a suspected transmission of any infectious agent via a medicinal product
 Is Medically Important*
*Medical and scientific judgment should be exercised in deciding whether expedited reporting is
also appropriate in other situations, such as important medical events that may not be immediately
life threatening or result in death or hospitalization but may jeopardize the participant or may
require intervention to prevent one of the other outcomes listed in the definition above. These
should usually be considered serious.
If a serious and unexpected AE occurs for which there is evidence suggesting a causal relationship
between the study intervention and the event (eg, death from anaphylaxis), the event must be
reported as a serious and unexpected suspected adverse reaction (SUSAR) by the sponsor to health
authorities and by the investigator to the IRB/IEC according to regulatory and local requirements.

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Unlisted (Unexpected) Adverse Event/Reference Safety Information
An AE is considered unlisted if the nature or severity is not consistent with the applicable product
reference safety information. For Ad26.RSV.preF and RSV preF protein, the expectedness of an
AE will be determined by whether or not it is listed in the Investigator's Brochure.13,14
Adverse Event Associated With the Use of the Intervention
An AE is considered associated with the use of the intervention if the attribution is related by the
definitions listed in Section 12.1.2, Attribution Definitions.
12.1.2. 
Attribution Definitions
Every effort should be made by the investigator to explain any AE and assess its potential causal
relationship, ie, to administration of study vaccine or to alternative causes (eg, natural history of
the underlying diseases, concomitant therapy). This applies to all AEs, whether serious or non-
serious.
Causality of AEs should be assessed by the investigator based on the following:
Related: there is suspicion that there is a relationship between study vaccine and the AE (without
determining the extent of probability); there is a reasonable possibility that study vaccine
contributed to the AE.
Unrelated: there is no suspicion that there is a relationship between study vaccine and the AE;
there are other more likely causes and administration of study vaccine is not suspected to have
contributed to the AE.
By definition, all solicited AEs at the injection site (local) will be considered related to study
vaccine administration.
12.1.3. 
Severity Criteria
All AEs will be coded for severity using the revised FDA toxicity grading table in Attachment 2.
For AEs not identified in the grading table, the following guidelines will be applied:
Mild (Grade 1): No interference with activity.
Moderate (Grade 2): Some interference with activity not requiring medical intervention.
Severe (Grade 3): Prevents daily activity and requires medical intervention.
Potentially life-threatening (Grade 4): Symptoms causing inability to perform basic self-care
functions OR medical or operative intervention indicated to prevent permanent impairment,
persistent disability.
The investigator should use clinical judgment in assessing the severity of events not directly
experienced by the participant (eg,laboratory abnormalities).

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The severity of solicited AEs will be graded in the eDiary by the participant based on the severity
assessment provided in the eDiary and then verified by the investigator using the FDA toxicity
grading table in Attachment 2.
12.2. 
Special Reporting Situations
Safety events of interest on a sponsor study intervention that may require expedited reporting or
safety evaluation include, but are not limited to:
 Suspected abuse/misuse of a sponsor study intervention
 Accidental or occupational exposure to a sponsor study intervention
 Medication error involving a sponsor product (with or without participant/patient exposure to
the sponsor study intervention, eg, name confusion)
Special reporting situations should be recorded in the eCRF. Any special reporting situation that
meets the criteria of an SAE should be recorded on the Serious Adverse Event page of the eCRF.
12.3. 
Procedures
12.3.1. 
All Adverse Events
All AEs and special reporting situations related to study procedures or to non-investigational
(concomitant) Janssen products will be reported from the time a signed and dated ICF is obtained
onwards. All other AEs (unsolicited) will be reported from the time of vaccination through the
following 28 days for Safety Subset participants, and from the time of revaccination through the
following 28 days for the Revaccination Subcohort participants. AEs, including any that are
ongoing at 28 days after vaccine administration, will be followed until clinical resolution or
stabilization. Safety Subset participants will be contacted by telephone or telemedicine contact at
28 days (+3 days) after the first vaccination to collect information on unsolicited AEs and
associated concomitant medications. For participants in the Revaccination Subcohorts, this
information will be collected at the 28-day (+3 days) post-revaccination visit.
Solicited local (at the injection site) AEs and solicited systemic AEs will be recorded by each
Safety Subset and Revaccination Subcohort participant in the eDiary beginning on the evening of
the vaccine dosing day (Day 1 and Day 365 [Month 12]/Day 730 [Month 24]/Day 1,095
[Month 36], respectively) and on a daily basis for the following 7 days. Study-site personnel will
review participant eDiary information and confirm the entries. If a solicited AE has not resolved
7 days post-vaccination, it will continue to be followed-up until the event has returned to baseline.
For all participants, SAEs will be collected from administration of study vaccine on Day 1 until
the end of the first RSV season (or 6 months after vaccination, whichever comes later).a
a 
The windows for SAE collection in the Revaccination Subcohorts are described below.

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For all participants, some subsets of SAEs will be collected for additional study periodsa:
 ARIs and complications related to ARIs that classify as SAEs will be captured and will be
reported as SAEs in the eCRF for the duration of the second RSV season, between the second
and the third RSV season, and for the duration of the third RSV season.
 From the time of vaccination (Day 1) until the end of the study period for each participant,
SAEs classified as related to the study vaccine, SAEs resulting in death, and (S)AEs leading
to discontinuation from the study will be collected.
 During the entire study, (S)AEs and special reporting situations related to study procedures or
to non-investigational (concomitant) Janssen products will be reported from the time a signed
and dated informed consent form (ICF) is obtained onwards until the end of the study period
for each participant.
The (S)AE listing in the eCRF will not be updated based on the RSV RT-PCR results and will
remain listed on the eCRF as ARIs.
For Revaccination Subcohort A, all SAEs will be reported from administration of study vaccine
on Day 1 until the end of the first RSV season (or 6 months after vaccination, whichever comes
later), and from the time of revaccination at Month 12 until the end of the second RSV season, or
until 6 months after revaccination, whichever comes later. For Revaccination Subcohort 2A, all
SAEs and AESIs will also be collected from the time of revaccination on Day 730 until 6 months
after revaccination. For Revaccination Subcohorts B andC, all SAEs and AESIs will be collected
from the time of revaccination until 6 months thereafter. Collection of SAEs associated with ARIs
and complications related to ARIs that classify as SAEs will stop at the end of the second RSV
season for Subcohort A, on Day 730 (Month 24) for Subcohort B, and at the latest at the end of
the third RSV season for Subcohort C.
For all Revaccination Subcohorts, SAEs classified as related to the study vaccine, SAEs resulting
in death, (S)AEs leading to discontinuation from the study, and (S)AEs and special reporting
situations related to study procedures or to non-investigational (concomitant) Janssen products will
be collected during the entire study for all participants. For the participants in the Revaccination
Subcohort C, these (S)AEs will be collected retrospectively for the time period between the last
end of the RSV season visit and the revaccination upon the day of revaccination.
From the time of local approval of protocol amendment 6 onwards, TTS is considered to be an
AESI. Thrombotic events and/or thrombocytopenia (defined as platelet count below
150,000 cells/mm³) are considered to be potential AESIs. All AESIs, including potential AESIs,
will be reported to the sponsor from the moment of revaccination until 6 months after
revaccination.
The sponsor will evaluate any safety information that is spontaneously reported by an investigator
beyond the time frame specified in the protocol.

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The investigator will monitor and check the AE data as they become available and will make
determinations regarding the severity of the adverse experiences and their relation to study
vaccine. All AEs will be deemed related to study vaccine or not related to study vaccine, according
to Section 12.1.2.
The investigator must review both post-injection reactogenicity and other AEs to insure the prompt
and complete identification of all events that require expedited reporting as SAEs or are other
serious and unexpected events.
All events that meet the definition of an SAE will be reported as SAEs, regardless of whether they
are protocol-specific assessments.
All AEs, regardless of seriousness, severity, or presumed relationship to study vaccine, must be
recorded using medical terminology in the source document and the eCRF. Whenever possible,
diagnoses should be given when signs and symptoms are due to a common etiology (eg,cough,
runny nose, sneezing, sore throat, and head congestion should be reported as "upper respiratory
infection"). Investigators must record in the eCRF their opinion concerning the relationship of the
AE to study vaccine. All measures required for AE management must be recorded in the source
document and reported according to sponsor instructions.
The sponsor assumes responsibility for appropriate reporting of AEs to the regulatory authorities.
The sponsor will also report to the investigator (and the head of the investigational institute where
required) all SUSARs. The investigator (or sponsor where required) must report SUSARs to the
appropriate IEC/IRB that approved the protocol unless otherwise required and documented by the
IEC/IRB. A SUSAR will be reported to regulatory authorities unblinded. Participating
investigators and IEC/IRB will receive a blinded SUSAR summary, unless otherwise specified.
Each participant will be provided with a "wallet (study) card" and instructed to carry this card with
them for the duration of the study indicating the following:
 Study number
 Statement, in the local language(s), that the participant is participating in a clinical study
 Investigator's name and 24-hour contact telephone number
 Local sponsor's name and 24-hour contact telephone number (for medical staff only)
 Site number
 Participant number
 Any other information that is required to do an emergency breaking of the blind
12.3.2. 
Serious Adverse Events
SAEs must be reported to the appropriate sponsor contact person by study-site personnel
immediately, but no later than 24 hours of their knowledge of the event (Section 12.3.1).

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Any ARI fulfilling the criteria of an SAE will be reported as such from vaccination on Day 1 and
for the duration of the first RSV season (or 6 months after vaccination, whichever comes later),
for the duration of the second RSV season, between the second and the third RSV season, and for
the duration of the third RSV season. For participants in Revaccination Subcohorts, follow-up of
ARIs will stop at the end of the second RSV season for Subcohort A, at the Day 730 (Month 24)
visit for Subcohort B, and at the latest at the end of the third RSV season for Subcohort C. SAEs
will not be updated after the RSV RT-PCR results become available and will remain listed on the
eCRF as ARIs.
Information regarding SAEs will be transmitted to the sponsor using the Serious Adverse Event
Form and Safety Report Form of the eCRF, which must be completed and reviewed by a physician
from the study site, and transmitted to the sponsor immediately, but no later than 24 hours. The
initial and follow-up reports of an SAE should be transmitted electronically or by facsimile (fax).
All SAEs that have not resolved by the end of the SAE reporting period, or that have not resolved
upon discontinuation of the participant's participation in the study, must be followed until any of
the following occurs:
 The event resolves
 The event stabilizes
 The event returns to baseline, if a baseline value/status is available
 The event can be attributed to agents other than the study intervention or to factors unrelated
to study conduct
 It becomes unlikely that any additional information can be obtained (participant or health care
practitioner refusal to provide additional information, lost to follow-up after demonstration of
due diligence with follow-up efforts)
Suspected transmission of an infectious agent by a medicinal product will be reported as an SAE.
Any event requiring hospitalization (or prolongation of hospitalization) that occurs during the
course of a participant's participation in a study must be reported as an SAE, except
hospitalizations for the following:
 Hospitalizations not intended to treat an acute illness or AE (eg, social reasons such as pending
placement in long-term care facility)
 Surgery or procedure planned before entry into the study (must be documented in the eCRF).
Note: Hospitalizations that were planned before the signing of the ICF, and where the
underlying condition for which the hospitalization was planned has not worsened,will not be
considered SAEs. Any AE that results in a prolongation of the originally planned
hospitalization is to be reported as a new SAE.
The cause of death of a participant in a study during the entire study period, whether or not the
event is expected or associated with the study vaccine, is considered an SAE and must be reported.

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12.3.3. 
Pregnancy
All initial reports of pregnancy in partners of male participants must be reported to the sponsor by
the study-site personnel within 24 hours of their knowledge of the event using the appropriate
pregnancy notification form. Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal
death, stillbirth, congenital anomalies, ectopic pregnancy) are considered SAEs and must be
reported using the Serious Adverse Event Form.
Follow-up information regarding the outcome of the pregnancy and any postnatal sequelae in the
infant will be required.
12.3.4. 
Adverse Events of Special Interest
Adverse Events of Special Interest (AESIs) (including potential AESIs) are significant AEs that
are judged to be of special interest because of clinical importance, known or suspected class
effects, or based on nonclinical signals. AESIs (including potential AESIs) will be carefully
monitored during the study by the sponsor.
AESIs (including potential AESIs) must be reported to the sponsor within 24 hours of awareness
irrespective of seriousness (ie, serious and nonserious AEs) or causality following the procedure
described above for SAEs.
AESIs must be reported using the AESI form in the eCRF using the eCRF completion guidelines.
Specific requirements for the AESI are described below.
12.3.4.1. 
Thrombosis with Thrombocytopenia Syndrome
As described in Section 1.1, TTS has been observed very rarely following vaccination with the
Janssen COVID-19 vaccine and is considered to be an AESI in this study. TTS is a syndrome
characterized by a combination of both a thrombotic event and thrombocytopenia.1,4
Because this syndrome is very rare and not completely understood, all cases of thrombosis and/or
thrombocytopenia should be reported to the sponsor within 24 hours of awareness using the AESI
form. Each potential AESI will be reviewed to identify a vaccine-induced immune thrombotic
thrombocytopenia (VITT) case. Responsibilities and procedures for identification, review, and
evaluation of potential TTS cases are outlined in 2 separate charters: the thrombosis with
thrombocytopenia syndrome Adjudication Committee (TTSAC) Charter and the ‘Process of Case
Assessment for TTS in the RSV Vaccine Interventional Clinical Studies Charter’. A potential TTS
case is defined as:
 Thrombotic events: suspected deep vessel venous or arterial thrombotic events as detailed in
Attachment 13,
and/or
 Thrombocytopenia, defined as platelet count below 150,000 cells/mm³

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Symptoms, signs, or conditions suggestive of a thrombotic event or thrombocytopenia should be
recorded and reported as a potential AESI even if the final or definitive diagnosis has not yet been
determined, and alternative diagnoses have not yet been eliminated or shown to be less likely.
Follow-up information and final diagnoses, if applicable, should be submitted to the sponsor as
soon as they become available.
In the event of thrombocytopenia, study site personnel should report the absolute value for the
platelet count and the reference range for the laboratory test used.
For either a thrombotic event or thrombocytopenia, complete blood count including platelet count
with a test for anti-PF4 and a coagulation profile should be provided as soon as possible upon the
site becoming aware of the event. In case these results are not available at the time of the event
report in the eCRF, the study site is recommended to obtain a complete blood count including
platelet count and a coagulation profile (to be performed at the local laboratory). Repeat testing
may be requested for confirmation upon sponsor discretion.
Aliquots of serum samples collected for immunogenicity tests can be reconverted for participant’s
safety purposes upon sponsor request (Table 13).
Table 13 provides non-exhaustive list(s) of laboratory tests that may be performed (upon sponsor
request).
In addition, the sponsor may request additional laboratory tests on additional blood samples
obtained as soon as possible after the potential AESI onset, either during an ad hoc unscheduled
visit or the next scheduled visit, whichever comes first. Table 14 provides a non-exhaustive list of
laboratory tests that may be requested by the sponsor in case ofpotential AESI reporting, for which
additional samples may be needed.
Table 13: 
Laboratory Tests That May Be Performed Upon Sponsor Request on Immunogenicity Samples
Collected on Days 1 and 15After Potential AESI Reporting
Parameters 
Timepoints
 Serum samples for assay such as but not limited to: 
o Heparin-Induced Thrombocytopenia (HIT)/PF4 Ab, IgG·(HIT assay) 
If the above test is positive, also consider: 
 Anti-cardiolipin antibody  
 Beta-2 glycoprotein
 Days 1 and 15 visits (aliquots
of serum samples collected for
immunogenicity test can be
reconverted for participant’s
safety purposes).
Note: results of the test should be reported in the narrative of the event and/or in the TTS AESI pages of the eCRF.

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Table 14: 
Laboratory Tests That May Be Requested by the Sponsor to be Performed at the Central
Laboratory After Potential AESI Reporting
Parameters 
Timepoints
 Serum/plasma/whole blood samples for coagulation-related assays such as 
but not limited to: 
o Fibrinogen  
o D-dimer· 
o Lupus anticoagulant· 
o Anti-cardiolipin antibody  
o Beta-2 glycoprotein·
o Heparin-Induced Thrombocytopenia (HIT)/PF4 Ab, IgG·(HIT assay)
o Platelet activation assay (if HIT/PF4 is positive)
o Homocysteine·
o COVID-19 serological test
 As soon as possible after the
potential AESI onset upon
sponsor request (during an ad
hoc unscheduled visit or the
next scheduled visit, whichever
comes first).
Note: results of the test should be reported in the narrative of the event and/or in the TTS AESI pages of the eCRF.
Irrespective on samples for central laboratory tests collection, relevant data for TTS assessment reported in the
medical records of the participant should be reported in eCRF narrative of the event and/or in the TTS AESI pages
of the eCRF.
AESIs (including potential AESIs) will require enhanced data collection and evaluation. Every
effort should be made to report as much information as possible about the event to the sponsor in
a reasonable timeframe. Relevant laboratory results can be entered on the AESI form in the eCRF,
using the eCRF completion guidelines.
If the investigator is not the treating physician, every effort should be made to collect the
information requested in the form from the treating physician and enter the available information
in the eCRF.
If an event meets the criteria for an SAE (Section 12.1.1), it should be reported using the same
process as for other SAEs.
Treatment and Follow-up Recommendation
The medical management of thrombotic events with thrombocytopenia is different from the
management of isolated thromboembolic diseases. Study site personnel and/or treating physicians
should follow available guidelines for treatment of thrombotic thrombocytopenia (eg, American
Society of Hematology 20221; British Society of Haematology 20225; CDC 20216). The use of
heparin may be harmful and alternative treatments may be needed. Consultation with a
hematologist is strongly recommended.
12.4. Contacting Sponsor Regarding Safety
The names (and corresponding telephone numbers) of the individuals who should be contacted
regarding safety issues or questions regarding the study are listed in the Contact Information
page(s), which will be provided as a separate document.

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13. 
PRODUCT QUALITY COMPLAINT HANDLING
A product quality complaint (PQC) is defined as any suspicion of a product defect related to
manufacturing, labeling, or packaging, ie, any dissatisfaction relative to the identity, quality,
durability, or reliability of a product, including its labeling or package integrity. A PQC may have
an impact on the safety and efficacy of the product. Timely, accurate, and complete reporting and
analysis of PQC information from studies are crucial for the protection of participants,
investigators, and the sponsor, and are mandated by regulatory agencies worldwide. The sponsor
has established procedures in conformity with regulatory requirements worldwide to ensure
appropriate reporting of PQC information; all studies conducted by the sponsor or its affiliates will
be conducted in accordance with those procedures.
All complaints related to ANY part of the Ad26/protein preF RSV vaccine must be reported within
1 business day. In the event of public holiday, measures must be taken to ensure reporting no later
than calendar day 3.
13.1. Procedures
All initial PQCs must be reported to the sponsor by the study-site personnel within 24 hours after
being made aware of the event.
If the defect is combined with an SAE, the study-site personnel must report the PQC to the sponsor
according to the SAE reporting timelines (refer to Section 12.3.2, Serious Adverse Events). A
sample of the suspected product should be maintained for further investigation if requested by the
sponsor.
13.2. Contacting Sponsor Regarding Product Quality
The names (and corresponding telephone numbers) of the individuals who must be contacted
regarding product quality issues are listed in the Contact Information page(s), which will be
provided as a separate document.
14. 
STUDY INTERVENTION INFORMATION
14.1. Physical Description of Study Vaccine(s)
Ad26.RSV.preF and RSV preF protein, manufactured and provided under the responsibility of the
sponsor,will be assessed in this study:
Ad26.RSV.preF (JNJ-64400141)
Ad26.RSV.preF is a replication-incompetent Ad26 containing a DNA transgene that encodes the
pre-fusion conformation-stabilized F protein derived from the RSV A2 strain.
For this study, Ad26.RSV.preF will be formulated as a solution for intramuscular injection and will
be supplied as a frozen liquid to be thawed prior to use. Ad26.RSV.preF will be supplied in single-
use vials (2×1011 vp/mL). Refer to the Investigational Product Preparation Instructions for details
on dosing preparation.

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Refer to the Investigator’s Brochure for details of the components of Ad26.RSV.preF and a list of
excipients.13
RSV preF protein (JNJ-64213175)
RSV preF protein is a pre-fusion conformation-stabilized F protein derived from the RSV A2
strain.
For this study, RSV preF protein will be formulated as a solution for intramuscular injection. RSV
preF protein will be supplied in a single-use vial. Refer to the Investigational Product Preparation
Instructions for details on dosing preparation.
Refer to the Investigator’s Brochure for details of the components of RSV preF protein and a list
of excipients.13,14
Note: RSV preF protein clinical trial material will be labelled as “RSV-F Vaccine”.
14.2. Packaging and Labeling
All study vaccines were manufactured and packaged in accordance with Current Good
Manufacturing Practice. All study vaccines will be packaged and labeled under the responsibility
of the sponsor. Study vaccine labels will contain information to meet the applicable regulatory
requirements.
No study vaccine can be repacked or relabeled without prior approval from the sponsor.
Further details for study vaccine packaging and labeling can be found in the Site Investigational
Product Procedures Manual.
14.3. Storage and Handling
Vials must be stored in a secured location under controlled temperature with no access for
unauthorized personnel. The study refrigerator/freezer must be equipped with a continuous
temperature monitor and alarm. Study refrigerators/freezers should be equipped with back-up
power systems. In the event that study vaccine is exposed to temperatures outside the specified
temperature range, all relevant data will be sent to the sponsor to determine if the affected study
vaccine can be used or will be replaced. The affected study vaccine must be quarantined and not
used until further instruction from the sponsor is received.
An unblinded site pharmacist, or other qualified individual,who will have no other study function
will prepare the syringe, labeled with the participant’s identification number, and provide the
syringes for Ad26.RSV.preF/RSV preF protein and placebo in a blinded manner to the blinded
study vaccine administrator who will perform the injection. The unblinded pharmacist, or other
qualified individual, may also perform vaccine administration, but will have no other study
function following dosing.
Participants in Revaccination Subcohorts 2A and 2B will receive revaccination with
Ad26.RSV.preF/RSV preF protein mixture or with the individual vaccine components.

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Participants in the other Revaccination Subcohorts will receive revaccination with
Ad26.RSV.preF/RSV preF protein mixture.
Further details for study vaccine storage, preparation, handling and stability can be found in the IPPI
and in the Site Investigational Product Procedures Manual.
14.4. Vaccine Accountability
The investigator is responsible for ensuring that all study intervention  received at the site is
inventoried and accounted for throughout the study. The study vaccine administered to the
participant must be documented on the vaccine accountability form. All study vaccine will be
stored and disposed of according to the sponsor's instructions.
Study vaccine must be handled in strict accordance with the protocol and the container label, and
must be stored at the study site in a limited-access area or in a locked cabinet under appropriate
environmental conditions. Unused study vaccine must be available for verification by the sponsor's
study site monitor during on-site monitoring visits. The return to the sponsor of unused study
vaccine will be documented on the Investigational Product Destruction Form. When the study site
is an authorized destruction unit and study vaccine supplies are destroyed on-site, this must also
be documented on the vaccine return form.
Potentially hazardous materials such as used ampules, needles, syringes and vials containing
hazardous liquids, should be disposed of immediately in a safe manner and therefore will not be
retained for vaccine accountability purposes.
Study vaccine should be dispensed under the supervision of the investigator or a qualified member
of the study-site personnel, or by a hospital/clinic pharmacist. Study vaccine will be supplied only
to participants participating in the study. Study vaccine may not be relabeled or reassigned for use
by other participants. The investigator agrees neither to dispense the study vaccine from, nor store
it at, any site other than the study sites agreed upon with the sponsor.
15. 
STUDY-SPECIFIC MATERIALS
The investigator will be provided with the following supplies:
 Investigator’s Brochure for the Ad26/protein preF RSV vaccine13,14
 Site Investigational Product Procedures Manual
 Investigational Product Preparation Instruction (IPPI)
 Laboratory Manual
 IWRS Manual
 Electronic Data Capture (eDC) Manual/eCRF completion guidelines
 Sample ICF
 ePRO completion guides

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 ePRO participant information sheets
 eDiaries and instructions for use
 Rulers (to measure diameter of any erythema and swelling)
 Thermometers
 Midturbinate nasal swab sample kits, including cooling bags
 Laboratory kits
 Contact information page(s)
16. 
ETHICAL ASPECTS
16.1. Study-specific Design Considerations
Potential participants will be fully informed of the risks and requirements of the study and, during
the study, participants will be given any new information that may affect their decision to continue
participation. They will be told that their consent to participate in the study is voluntary and may
be withdrawn at any time with no reason given and without penalty or loss of benefits to which
they would otherwise be entitled. Only participants who are fully able to understand the risks,
benefits, and potential AEs of the study, and provide their consent voluntarily will be enrolled.
Over the entire study, the total blood volume to be collected from each participant in the Immuno
Subset will be approximately 220 mL when the study does not progress beyond the first year,and
330 mL or 440 mL when the study is continued beyond the first and second year, respectively. For
all other participants in Cohort 1 who are not included in a Revaccination Subcohort, the total
blood volume to be collected will 30 mL when the study does not progress beyond the first year,
45 mL when the study is continued beyond the first year, and 60 mL when the study is continued
beyond the second year.
For participants in Cohort 2, the total blood volume to be collected will be 30 mL.
For participants in the Revaccination Subcohorts, the total blood volume to be collected from each
participant will be: Revaccination Subcohort 1A and 2A: 120 mL and 490 mL, respectively;
Revaccination Subcohort 1B and 2B: 430 mL and 755 mL, respectively; and Revaccination
Subcohort 1C and 2C: 160 mL (360 mL in a subset of approximately 100 participants).
For each ARI episode, 40 mL additional blood will be sampled. This is considered to be an
acceptable amount of blood to be collected over this time periodfrom the population in this study.
Risks Related to Vaccination
Participants may exhibit local signs and symptoms associated with vaccination, including
erythema, swelling, and pain/tenderness. These local reactions will be monitored, but are generally
short-term and do not require treatment.

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Participants may exhibit general signs and symptoms associated with administration of a vaccine,
or vaccination with placebo, including fatigue, headache, myalgia, arthralgia, chills and nausea.
These side effects will be monitored, but are generally short-term and do not require treatment.
Syncope can occur in association with administration of injectable vaccines. Syncope can be
accompanied by falls. Procedures should be in place to avoid falling injury. If syncope develops,
participants should be observed until the symptoms resolve.
Participants may have an allergic reaction to the vaccination. An allergic reaction may cause a
rash, hives or even difficulty breathing. Severe reactions, including anaphylaxis, are rare but can
occur with any vaccine. Medications must be available in the clinic to treat serious allergic
reactions promptly. Participants with a known allergy, or history of anaphylaxis or other serious
adverse reactions to vaccines or vaccine components (including any of the constituents of the study
vaccine) will be excluded from the study. Sites should have medical treatment available in case of
severe allergic reactions following vaccine administration.
Risks Related to Adenoviral-vectored Vaccines
Safety data available from completed clinical studies in adults with other Ad26-vectored vaccine
candidates, in which Ad26 with different inserts has been evaluated at dose levels ranging from
1×109 vp to 1×1011 vp, indicate that no safety concerns would be anticipated from vaccination with
Ad26.RSV.preF at doses up to and including 1×1011 vp.
Local AEs (moderate injection site pain and tenderness, and moderate to severe redness at the
injection site) and systemic AEs (headache, chills, joint pain, muscle pain, tiredness/generally not
feeling well/fatigue and fever) have been reported after vaccination with Ad26-vectored vaccines.
In a few participants, transient laboratory abnormalities have been seen, including changes in
neutrophils. Laboratory changes including decreased hemoglobin, decreased platelets, and
moderate elevations in liver transaminases were observed that were not associated with any clinical
findings and appear to be transient based on no reported persistent abnormalities in any of the
participants.
For further details on the safety profiles of other Ad26-vectored vaccine candidates, see the
Investigator’s Brochure.13
Risks Related to RSV preF Protein
RSV preF protein is being used for the first time in humans in the ongoing Study
VAC18193RSV1004.
For further details, see the Investigator’s Brochure.13,14
Risks from Collection of Midturbinate Nasal Swabs and Nasosorption Samples
Collection ofa midturbinate nasal swab may cause a nosebleed.
Nasosorption sampling is more comfortable and less invasive than using a conventional swab.

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Risks from Blood Draws
Blood drawing may cause pain/tenderness, bruising, bleeding, lightheadedness, dizziness,
vasovagal response, and, rarely, infection at the site where the blood is taken.
Potential Benefits
Ad26.RSV.preF and RSV preF protein are under development for prophylaxis of RSV, however
VE has not yet been investigated. There is no direct medical benefit to the participant for
participation in this clinical study. Although study participants may benefit from clinical testing
and physical examination, they may receive no direct benefit from participation. There could be a
potential benefit from RSV vaccination in terms of immune response: vaccination could raise an
immune response which might confer some additional protection against a future RSV infection.
Others may benefit from knowledge gained in this study that may aid in the development of an
RSV vaccine.
16.2. Regulatory Ethics Compliance
16.2.1. 
Investigator Responsibilities
The investigator is responsible for ensuring that the study is performed in accordance with the
protocol, current ICH guidelines on Good Clinical Practice (GCP), and applicable regulatory and
country/territory-specific requirements.
Good Clinical Practice is an international ethical and scientific quality standard for designing,
conducting, recording, and reporting studies that involve the participation of human participants.
Compliance with this standard provides public assurance that the rights, safety, and well-being of
study participants are protected, consistent with the principles that originated in the Declaration of
Helsinki,and that the study data are credible.
16.2.2. 
Independent Ethics Committee or Institutional Review Board
Before the start of the study, the investigator (or sponsor where required) will provide the IEC/IRB
with current and complete copies of the following documents (as required by local regulations):
 Final protocol and, if applicable, amendments
 Sponsor-approved ICF (and any other written materials to be provided to the participants)
 Investigator's Brochure (or equivalent information) and amendments/addenda
 Sponsor-approved participant recruiting materials
 Information on compensation for study-related injuries or payment to participants for
participation in the study, if applicable
 Investigator's curriculum vitae or equivalent information (unless not required, as documented
by the IEC/IRB)
 Information regarding funding, name of the sponsor, institutional affiliations, other potential
conflicts of interest, and incentives for participants

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 Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after the IEC/IRB has given full approval of the final protocol,
amendments (if any, excluding the ones that are purely administrative, with no consequences for
participants, data or study conduct, unless required locally), the ICF, applicable recruiting
materials, and participant compensation programs, and the sponsor has received a copy of this
approval. This approval letter must be dated and must clearly identify the IEC/IRB and the
documents being approved.
During the study the investigator (or sponsor where required) will send the following documents
and updates to the IEC/IRB for their review and approval, where appropriate:
 Protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or study conduct)
 Revision(s) to ICF and any other written materials to be provided to participants
 If applicable, new or revised participant recruiting materials approved by the sponsor
 Revisions to compensation for study-related injuries or payment to participants for
participation in the study, if applicable
 New edition(s) of the Investigator's Brochure and amendments/addenda
 Summaries of the status of the study at intervals stipulated in guidelines of the IEC/IRB (at
least annually)
 Reports of AEs that are serious, unlisted/unexpected, and associated with the study
intervention
 New information that may adversely affect the safety of the participants or the conduct of the
study
 Deviations from or changes to the protocol to eliminate immediate hazards to the participants
 Report of deaths of participants under the investigator's care
 Notification if a new investigator is responsible for the study at the site
 Development Safety Update Report and Line Listings, where applicable
 Any other requirements of the IEC/IRB
For all protocol amendments (excluding the ones that are purely administrative, with no
consequences for participants, data or studyconduct), the amendment and applicable ICF revisions
must be submitted promptly to the IEC/IRB for review and approval before implementation of the
change(s).
At least once a year, the IEC/IRB will be asked to review and reapprove this study, where required.
At the end of the study, the investigator (or sponsor where required) will notify the IEC/IRB about
the study completion.

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16.2.3. 
Informed Consent
Each participant must give written consent according to local requirements after the nature of the
study has been fully explained. Informed consent for additional study procedures will be requested
from participants in the Immuno Subsetand/orthe Safety Subset. The ICF(s) must be signed before
performance of any study-related activity. The ICF(s) that is/are used must be approved by both
the sponsor and by the reviewing IEC/IRB and be in a language that the participant can read and
understand. The informed consent should be in accordance with principles that originated in the
Declaration of Helsinki, current ICH and GCP guidelines, applicable regulatory requirements, and
sponsor policy.
Before enrollment in the study, the investigator or an authorized member of the study-site
personnel must explain to potential participants the aims, methods, reasonably anticipated benefits,
and potential hazards of the study, and any discomfort participation in the study may entail.
Participants will be informed that their participation is voluntary and that they may withdraw
consent to participate at any time. They will be informed that choosing not to participate will not
affect the care the participant will receive. Finally, they will be told that the investigator will
maintain a participant identification register for the purposes of long-term follow-up if needed and
that their records may be accessed by health authorities and authorized sponsor personnel without
violating the confidentiality of the participant, to the extent permitted by the applicable law(s) or
regulations. By signing the ICF the participant is authorizing such access. It also denotes that the
participant agrees to allow his or her study physician to recontact the participant for the purpose
of obtaining consent for additional safety evaluations, if needed.
The participant will be given sufficient time to read the ICF and the opportunity to ask questions.
After this explanation and before entry into the study, consent should be appropriately recorded
by means of the participant's personally dated signature. After having obtained the consent, a copy
of the ICF must be given to the participant.
16.2.4. 
Privacy of Personal Data
The collection and processing of personal data from participants enrolled in this study will be
limited to those data that are necessary to fulfill the objectives of the study.
These data must be collected and processed with adequate precautions to ensure confidentiality
and compliance with applicable data privacy protection laws and regulations. Appropriate
technical and organizational measures to protect the personal data against unauthorized disclosures
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place.
Sponsor personnel whose responsibilities require access to personal data agree to keep the identity
of participants confidential.
The informed consent obtained from the participant includes explicit consent for the processing of
personal data and for the investigator/institutionto allow direct access to his or her original medical
records (source data/documents) for study-related monitoring, audit, IEC/IRB review, and
regulatory inspection. This consent also addresses the transfer of the data to other entities and to
other countries.

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The participant has the right to request through the investigator access to his or her personal data
and the right to request rectification of any data that are not correct or complete. Reasonable steps
will be taken to respond to such a request, taking into consideration the nature of the request, the
conditions of the study, and the applicable laws and regulations.
16.2.5. 
Long-Term Retention of Samples for Additional Future Research
Samples collected in this study may be stored for up to 15 years (or according to local regulations)
for additional research. Samples will only be used to understand Ad26.RSV.preF and RSV preF
protein, to understand RSV and other respiratory pathogens, and to develop tests/assays related to
Ad26.RSV.preF and RSV preF protein and RSV. The research may begin at any time during the
study or the post-study storage period.
Stored samples will be coded throughout the sample storage and analysis process and will not be
labeled with personal identifiers. Participants may withdraw their consent for their samples to be
stored for research (refer to Section 10.2, Withdrawal from the Use of Samples in Future
Research).
16.2.6. 
Country/TerritorySelection
This study will only be conducted in those countries where the intent is to launch or otherwise help
ensure access to the developed product if the need for the product persists, unless explicitly
addressed as a specific ethical consideration in Section 16.1, Study-Specific Design
Considerations.
17. 
ADMINISTRATIVE REQUIREMENTS
17.1. Protocol Clarification Communications
If text within a final approved protocol requires clarification (eg, current wording is unclear or
ambiguous) that does not change any aspect of the current study conduct, a protocol clarification
communication (PCC) may be prepared. The PCC Document will be communicated to the
Investigational Site, Site Monitors, Local Trial Managers (LTMs), Clinical Trial Managers
(CTMs), and/or Contract Research Organizations (CROs) who will ensure that the PCC
explanations are followed by the investigators.
The PCC Document may be shared by the sites with Independent Ethics Committees/Institutional
Review Boards (IECs/IRBs) per local regulations.
The PCC Documents must NOT be used in place of protocol amendments, but the content of the
PCC Document must be included in any future protocol amendments.
17.2. 
Protocol Amendments
Neither the investigator nor the sponsor will modify this protocol without a formal amendment by
the sponsor. All protocol amendments must be issued by the sponsor, and signed and dated by the
investigator. Protocol amendments must not be implemented without prior IEC/IRB approval, or
when the relevant competent authority has raised any grounds for non-acceptance, except when

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necessary to eliminate immediate hazards to the participants, in which case the amendment must
be promptly submitted to the IEC/IRB and relevant competent authority. Documentation of
amendment approval by the investigator and IEC/IRB must be provided to the sponsor. When the
change(s) involves only logistic or administrative aspects of the study, the IEC/IRB (where
required) only needs to be notified.
During the course ofthe study, in situations where a departure from the protocol is unavoidable,
the investigator or other physician in attendance will contact the appropriate sponsor representative
listed in the Contact Information page(s), which will be provided as a separate document. Except
in emergency situations, this contact should be made before implementing any departure from the
protocol. In all cases, contact with the sponsor must be made as soon as possible to discuss the
situation and agree on an appropriate course of action. The data recorded in the eCRF and source
documents will reflect any departure from the protocol, and the source documents will describe
this departure and the circumstances requiring it.
17.3. Regulatory Documentation
17.3.1. 
Regulatory Approval/Notification
This protocol and any amendment(s) must be submitted to the appropriate regulatory authorities
in each respective country/territory, if applicable. A study may not be initiated until all local
regulatory requirements are met.
17.3.2. 
Required Prestudy Documentation
The following documents must be provided to the sponsor before shipment of study intervention
to the study site:
 Protocol and amendment(s), if any, signed and dated by the principal investigator
 A copy of the dated and signed (or sealed, where appropriate per local regulations), written
IEC/IRB approval of the protocol, amendments, ICF, any recruiting materials, and if
applicable, participant compensation programs. This approval must clearly identify the
specific protocol by title and number and must be signed (or sealed, where appropriate per
local regulations) by the chairman or authorized designee.
 Name and address of the IEC/IRB, including a current list of the IEC/IRB members and their
function, with a statement that it is organized and operates according to GCP and the
applicable laws and regulations. If accompanied by a letter of explanation, or equivalent, from
the IEC/IRB, a general statement may be substituted for this list. If an investigator or a
member of the study-site personnel is a member of the IEC/IRB, documentation must be
obtained to state that this person did not participate in the deliberations or in the vote/opinion
of the study.
 Regulatory authority approval or notification, if applicable
 Signed and dated statement of investigator (eg,Form FDA 1572), if applicable
 Documentation of investigator qualifications (eg,curriculum vitae)

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 Completed investigator financial disclosure form from the principal investigator, where
required
 Signed and dated clinical trial agreement, which includes the financial agreement
 Any other documentation required by local regulations
The following documents must be provided to the sponsor before enrollment of the first
participant:
 Completed investigator financial disclosure forms from all subinvestigators
 Documentation of subinvestigator qualifications (eg,curriculum vitae)
 Name and address of any local laboratory conducting tests for the study, and a dated copy of
current laboratory normal ranges for these tests, if applicable
 Local laboratory documentation demonstrating competence and test reliability
(eg,accreditation/license), if applicable
17.4. Participant Identification, Enrollment, and Screening Logs
The investigator agrees to complete a participant identification and enrollment log to permit easy
identification of each participant during and after the study. This document will be reviewed by
the sponsor study-site contact for completeness.
The participant identification and enrollment log will be treated as confidential and will be filed
by the investigator in the study file. To ensure participant confidentiality, no copy will be made.
All reports and communications relating to the study will identify participants by participant
identification andage at initial informed consent. In cases where the participant is not randomized
into the study, the date seen and age at initial informed consent will be used.
The investigator must also complete a participant screening log, which reports on all participants
who were seen to determine eligibility for inclusion in the study.
17.5. Source Documentation
At a minimum, source documents consistent in the type and level of detail with that commonly
recorded at the study site as a basis for standard medical care must be available for the following:
participant identification, eligibility, and study identification; study discussion and date of signed
informed consent; dates of visits; results of safety and efficacy parameters as required by the
protocol; record of all AEs and follow-up of AEs; concomitant medication; intervention
receipt/dispensing/return records; study intervention administration information; and date of study
completion and reason for early discontinuation of study intervention  or withdrawal from the
study, if applicable.
The author of an entry in the source documents should be identifiable.

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Specific details required as source data for the study and source data collection methods will be
reviewed with the investigator before the study and will be described in the monitoring guidelines
(or other equivalent document).
The following participant (and investigator) completed assessments will be recorded directly into
an electronic device and will be considered source data: solicited AEs after vaccination, body
temperature, oxygen saturation, RiiQ, RiiQ Symptom Scale and RiiQ Impact on Daily Activities
Scale, Clinical Assessment, Lawton-Brody IADL, and MRU questionnaire and ARI surveillance
responses. Information from the participant eDiary will be reviewed by the investigator. The
sponsor’s preference is to enter the results of the clinical assessment directly in the site’s eDevice,
however, the results may be collected on paper first and transferred to the site’s eDevice
afterwards, on the same day as the assessments.
An electronic source system (eSource) may be utilized, which contains data traditionally
maintained in a hospital or clinic record to document medical care (eg, electronic source
documents) as well as the clinical study-specific data fields as determined by the protocol. This
data is electronically extracted for use by the sponsor. If the electronic source system is utilized,
references made to the eCRF in the protocol include the electronic source system but information
collected through the electronic source system may not be limited to that found in the eCRF. Data
in this system may be considered source documentation.
17.6. Case Report Form Completion
Case report forms are prepared and provided by the sponsor for each participant in electronic
format. All eCRF  entries, corrections, and alterations must be made by the investigator or
authorized study-site personnel. The investigator must verify that all data entries in the eCRF are
accurate and correct.
The study data will be transcribed by study-site personnel from the source documents onto an
electronic eCRF, if applicable. Study-specific data will be transmitted in a secure manner to the
sponsor.
Worksheets may be used for the capture of some data to facilitate completion of the eCRF. Any
such worksheets will become part of the participant's source documents. Data must be entered into
eCRF in English. The eCRF must be completed as soon as possible after a participant visit and the
forms should be available for review at the next scheduled monitoring visit.
If necessary, queries will be generated in the eDC tool. If corrections to a eCRF are needed after
the initial entry into the eCRF, this can be done in either of the following ways:
 Investigator and study-site personnel can make corrections in the eDC tool at their own
initiative or as a response to an auto query (generated by the eDC tool).
 Sponsor or sponsor delegate can generate a query for resolution by the investigator and study-
site personnel.

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17.7. Data Quality Assurance/Quality Control
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified
investigators and appropriate study sites, review of protocol procedures with the investigator and
study-site personnel before the study, and periodic monitoring visits by the sponsor. Written
instructions will be provided for collection, handling, storage, and shipment of samples.
Guidelines for eCRF completion will be provided and reviewed with study-site personnel before
the start of the study. The sponsor will review eCRF for accuracy and completeness during on-site
monitoring visits or video site monitoring and after transmission to the sponsor; any discrepancies
will be resolved with the investigator or designee, as appropriate. After upload of the data into the
study database they will be verified for accuracy and consistency with the data sources.
17.8. Record Retention
In compliance with the ICH/GCP guidelines, the investigator/institution will maintain all eCRF
and all source documents that support the data collected from each participant, as well as all study
documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical
Trial, and all study documents as specified by the applicable regulatory requirement(s). The
investigator/institution will take measures to prevent accidental or premature destruction of these
documents.
Essential documents must be retained until at least 2 years after the last approval of a marketing
application in an ICH region and until there are no pending or contemplated marketing applications
in an ICH region or until at least 2 years have elapsed since the formal discontinuation of clinical
development of the investigational product. These documents will be retained for a longer period
if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the
responsibility of the sponsor to inform the investigator/institution as to when these documents no
longer need to be retained.
If the responsible investigator retires, relocates, or for other reasons withdraws from the
responsibility of keeping the study records, custody must be transferred to a person who will accept
the responsibility. The sponsor must be notified in writing of the name and address of the new
custodian. Under no circumstance shall the investigator relocate or dispose of any study documents
before having obtained written approval from the sponsor.
If it becomes necessary for the sponsor or the appropriate regulatory authority to review any
documentation relating to this study, the investigator/institutionmust permit access to such reports.
17.9. 
Monitoring
The sponsor will use a combination of monitoring techniques (central, remote, or on-site
monitoring) to monitor this study.
The sponsor or its designee will perform on-site monitoring visits or video site monitoring as
frequently as necessary. The monitor will record dates of the visits in a study site visit log that will
be kept at the study site. The first post-initiation visit will be made as soon as possible after

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enrollment has begun. At these visits, the monitor will compare the data entered into the eCRF
with the source documents (eg,hospital/clinic/physician’s office medical records); a sample may
be reviewed. The nature and location of all source documents will be identified to ensure that all
sources of original data required to complete the eCRF are known to the sponsor and study-site
personnel and are accessible for verification by the sponsor study-site contact. If electronic records
are maintained at the study site, the method of verification must be discussed with the study-site
personnel.
Direct access to source documents (medical records) must be allowed for the purpose of verifying
that the recorded data are consistent with the original source data. Findings from this review will
be discussed with the study-site personnel. The sponsor expects that, during monitoring visits, the
relevant study-site personnel will be available, the source documents will be accessible, and a
suitable environment will be provided for review of study-related documents. The monitor will
meet with the investigator on a regular basis during the study to provide feedback on the study
conduct.
In addition to on-site monitoring visits, remote contacts can occur. It is expected that during these
remote contacts, study-site personnel will be available to provide an update on the progress of the
study at the site.
Central monitoring will take place for data identified by the sponsor as requiring central review.
17.10. Study Completion/Termination
17.10.1. 
Study Completion/End of Study
The study is considered completed with the last visit for the last participant participating in the
study. The final data from the study site will be sent to the sponsor (or designee) after completion
of the final participant visit at that study site, in the time frame specified in the Clinical Trial
Agreement.
17.10.2. 
Study Termination
The sponsor 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
studysite is considered closed when all required documents and study supplies have been collected
and a study-site closure visit has been performed.
The investigator may initiate study-site closure at any time, provided there is reasonable cause and
sufficient notice is given in advance of the intended termination.
Reasons for the early closure of a study site by the sponsor or investigator may include but are not
limited to:
 Failure of the investigator to comply with the protocol, the requirements of the IEC/IRB or
local health authorities, the sponsor's procedures, or GCP guidelines
 Inadequate recruitment of participants by the investigator

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 Discontinuation of further study intervention development
17.11. On-Site Audits
Representatives of the sponsor's clinical quality assurance department may visit the study site at
any time during or after completion of the study to conduct an audit of the study in compliance
with regulatory guidelines and company policy. These audits will require access to all study
records, including source documents, for inspection. Participant privacy must, however, be
respected. The investigator and study-site personnel are responsible for being present and available
for consultation during routinely scheduled study-site audit visits conducted by the sponsor or its
designees.
Similar auditing procedures may also be conducted by agents of any regulatory body, either as part
of a national GCP compliance program or to review the results of this study in support of a
regulatory submission. The investigator should immediately notify the sponsor if he or she has
been contacted by a regulatory agency concerning an upcoming inspection.
17.12. Use of Information and Publication
All information, including but not limited to information regarding Ad26.RSV.preF and RSV preF
protein  or the sponsor's operations (eg,patent application, formulas, manufacturing processes,
basic scientific data, prior clinical data, formulation information) supplied by the sponsor to the
investigator and not previously published, and any data generated as a result of this study, are
considered confidential and remain the sole property of the sponsor. The investigator agrees to
maintain this information in confidence and use this information only to accomplish this study,
and will not use it for other purposes without the sponsor's prior written consent.
The investigator understands that the information developed in the study will be used by the
sponsor in connection with the continued development of Ad26.RSV.preF and RSV preF protein,
and thus may be disclosed as required to other clinical investigators or regulatory agencies. To
permit the information derived from the clinical studies to be used, the investigator is obligated to
provide the sponsor with all data obtained in the study.
The results of the study will be reported in a Clinical Study Report generated by the sponsor and
will contain data from all study sites that participated in the study as per protocol. Recruitment
performance or specific expertise related to the nature and the key assessment parameters of the
study will be used to determine a coordinating investigator for the study. Results of analyses
performed after the Clinical Study Report has been issued will be reported in a separate report and
will not require a revision of the Clinical Study Report. Study participant identifiers will not be
used in publication of results. Any work created in connection with performance of the study and
contained in the data that can benefit from copyright protection (except any publication by the
investigator as provided for below) shall be the property of the sponsor as author and owner of
copyright in such work.
Consistent with Good Publication Practices and International Committee of Medical Journal
Editors guidelines, the sponsor shall have the right to publish such primary (multicenter) data and

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information without approval from the investigator. The investigator has the right to publish study
site-specific data after the primary data are published. If an investigator wishes to publish
information from the study, a copy of the manuscript must be provided to the sponsor for review
at least 60 days before submission for publication or presentation. Expedited reviews will be
arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in
writing, the investigator will withhold such publication for up to an additional 60 days to allow for
filing of a patent application. In the event that issues arise regarding scientific integrity or
regulatory compliance, the sponsor will review these issues with the investigator. The sponsor will
not mandate modifications to scientific content and does not have the right to suppress information.
For multicenter study designs and substudy approaches, secondary results generally should not be
published before the primary endpoints of a study have been published. Similarly, investigators
will recognize the integrity of a multicenter study by not submitting for publication data derived
from the individual study site until the combined results from the completed study have been
submitted for publication, within 18 months after study end date, or the sponsor confirms there
will be no multicenter study publication. Authorship of publications resulting from this study will
be based on the guidelines on authorship, such as those described in the ICMJE Recommendations
for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, which
state that the named authors must have made a significant contribution to the conception or design
of the work; or the acquisition,analysis, or interpretation of the data for the work; and drafted the
work or revised it critically for important intellectual content; and given final approval of the
version to be published; and agreed to be accountable for all aspects of the work in ensuring that
questions related to the accuracy or integrity of any part of the work are appropriately investigated
and resolved.
Registration of Clinical Studies and Disclosure of Results
The sponsor will register and disclose the existence of and the results of clinical studies as required
by law.

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18. 
APPENDIX 1: GUIDANCE ON STUDY CONDUCT DURING A NATURAL
DISASTER
GUIDANCE ON STUDY CONDUCT DURING THE COVID-19 PANDEMIC
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on
the conduct of this clinical study due to, for example, isolation or quarantine of participants and
study-site personnel; travel restrictions/limited access to public places, including hospitals; study
site personnel being reassigned to critical tasks.
The sponsor is providing options for study related participant management in the event of
disruption to the conduct of the study. This guidance does not supersede any local or government
requirements or the clinical judgement of the investigator to protect the health and well-being of
participants and site staff. If, at any time, a participant’s travel to the study site is considered to be
dangerous, participation may be interrupted, and study follow-up conducted. If it becomes
necessary to discontinue participation in the study, the procedures outlined in the protocol for
discontinuing study intervention will be followed.
If, as a result of the COVID-19 pandemic, scheduled visits cannot be conducted in person at the
study site, they will be performed to the extent possible remotely/virtually or delayed until such
time that on-site visits can be resumed. At each contact, participants will be interviewed to collect
safety data. Key efficacy endpoint assessments should be performed if required and as feasible.
Participants will also be questioned regarding general health status to fulfill any physical
examination requirement.
Every effort should be made to adhere to protocol-specified assessments for participants on study
intervention, including follow-up. Modifications to protocol-required assessments may be
permitted after consultation with the participant, investigator, and the sponsor. Missed
assessments/visits will be captured in the clinical trial management system for protocol deviations.
Discontinuations of study interventions and withdrawal from the study should be documented with
the prefix “COVID-19-related” in the case report form (CRF).
If a participant has tested positive for COVID 19, the investigator should contact the sponsor’s
responsible medical officer to discuss plans for administration of study intervention, performing
study assessments, and follow-up. Modifications made to the study conduct as a result of the
COVID-19 pandemic should be summarized in the clinical study report.

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GUIDANCE SPECIFIC TO THIS PROTOCOL:
 Depending on the ongoing incidence of COVID-19 infection and subject to availability of
SARS-CoV-2 point-of-care testing, participants may receive COVID-19 screening at home or
clinical visits.
 When site visits are not possible due to local/national guidelines, sites should collect the
assessments via telephone or telemedicine contact or home-based visits, if the participant
allows. The actual visit date and the type of visit (ie, telephone/telemedicine contact or home-
based visit) should be captured in the eCRF according to the eCRF completion guidelines.
Procedures that require an on-site visit, ie, clinical assessments, blood samples and
nasosorption samples and physical examination) should be excluded.
 A revised ICF arising from this amendment needs to be signed by the participants during a
site visit or home-based visit, if the participant allows. When a site or home-based visit is not
possible due to local/national guidelines, the participant can sign the paper ICF and mail the
signed document to the site.
 For participants with an ARI episode: midturbinate nasal swabs and a sputum sample (when
available) still need to meet the case definition for RSV-mediated LRTD. The ARI Day 1-2
midturbinate swab is a self-swab collected at home by the participant, and the ARI Day 3-5
midturbinate swab and sputum sample (when available) may need to also be collected at home,
when site visits may not be possible.
In the setting that on-site visits are not possible, a courier service will need to be arranged to
transport the samples to the site in a timely manner.
 Questionnaires that need to be completed at the Day 365 (Month 12), at the end of the second
RSV season, and Day 730 (Month 24) visit, as applicable, and additionally for participants
with ARI episode on ARI Days 3-5 and 29, could be completed by the participant in the eDiary
or via a telephone/telemedicine interview with the participant, as applicable.

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compliance management, measurement and reporting. In: Byrom B, Tiplady B (eds.) ePRO: Electronic
Solutions for Patient-Reported Data. Surrey, England: Gower; 2010, 127-142.
26. Spiessens B, Debois M. Adjusted significance levels for subgroup analyses in clinical trials. Contemp
Clin Trials. 2010;31:647-656.
27. Stockman LJ, Curns AT, Anderson LJ, Fischer-Langley G. Respiratory syncytial virus-associated
hospitalizations among infants and young children in the United States, 1997-2006. Pediatr Infect Dis J.
2012;31:5-9.
28. Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory
syncytial virus in the United States. JAMA. 2003;289:179-186.
29. van Essen GA, Beran J, Devaster JM, et al. Influenza symptoms and their impact on elderly adults:
randomized trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent season influenza vaccines.
Influenza Other Respir Viruses. 2014;8(4):452-462.

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Attachment 1: Definition of Acute Respiratory Infection
Acute respiratory infection (ARI) is defined as the occurrence of at least one respiratory symptom
that the participant reports is different or worse than he or she usually experiences:
 Respiratory symptom: an upper respiratory tract infection (URTI) symptom (ie, nasal
congestion, sore throat) or a lowerrespiratory tract infection (LRTI) symptom (ie,cough, short
of breath, coughing up phlegm [sputum], wheezing) from the RiiQ™v2 Symptom Scale)
Resolution of an ARI episode is defined as 2 consecutive days with no symptoms listed on the
RiiQ™v2 Symptom Scale or, for participants who have RiiQ™v2 symptoms present at baseline
(assessed pre-vaccination for the first RSV season ,at the Day 365 [Month 12] visit for the second
RSV season [pre-vaccination if applicable], and at the Day 730 [Month 24] visit for the third RSV
season), 2 consecutive days where all symptoms on the RiiQ™v2 Symptom Scale have returned
to severity reported at baseline.

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Attachment 2: Toxicity Tables
Adapted from the FDA Guidance document “Toxicity Grading Scale for Healthy Adult and
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials” (September 2007).
Local Reaction to 
Injectable Product 
Mild  
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially Life-threatening
(Grade 4)
Pain/Tenderness 
Aware of 
symptoms but 
easily tolerated; 
Does not interfere 
with activity; 
Discomfort only 
to touch  
Notable 
symptoms; 
Requires 
modification in 
activity or use of 
medications; 
Discomfort with 
movement
Incapacitating 
symptoms; 
Inability to do 
work, school, or 
usual activities;
Use of narcotic
pain reliever
Hospitalization;
Pain/tenderness causing
inability to perform basic
self-care function;
Erythema 
25 –50 mm  
51 –100 mm  
> 100 mm  
Hospitalization; Necrosis or
exfoliative dermatitis
Swelling 
25 –50 mm  
51 –100 mm  
> 100 mm  
Hospitalization; Necrosis
Vital Signs * 
Mild  
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially Life-threatening
(Grade 4)
Fever** (°C) 
Fever** (°F) 
38.0 –38.4 
100.4 –101.1 
38.5 –38.9 
101.2 –102.0 
39.0 –40 
102.1 –104 
>40
>104
Tachycardia - beats per 
minute 
101 –115 
116 –130 
>130 
Hospitalization for
arrhythmia
Bradycardia - beats per 
minute*** 
50 –54 
45 –49 
<45 
Hospitalization for
arrhythmia
Hypertension (systolic) 
- mm Hg 
141 –150 
151 –160 
>160 
Hospitalization for malignant
hypertension
Hypertension 
(diastolic) - mm Hg 
91 –95 
96 –100 
>100 
Hospitalization for malignant
hypertension
Hypotension (systolic) 
–mm Hg 
85 –89 
80 –84 
<80 
Hospitalization for
hypotensive shock
Respiratory Rate – 
breaths per minute
17 –20 
21 –25 
>25 
Intubation
* Participant should be at rest for all vital sign measurements.
** For oral temperature: no recent hot or cold beverages or smoking.
*** When resting heart rate is between 60 –100 beats per minute. Use clinical judgement when characterizing
bradycardia among some healthy participant populations,for example,conditioned athletes.

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Systemic 
(General) 
Mild
(Grade 1)
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Potentially Life-
threatening (Grade 4
Vomiting 
No interference with
activity or
1-2 episodes/24 hours
Some interference with 
activity or 
>2 episodes/24 hours 
Prevents daily  
activity, requires 
outpatient IV
hydration
Hospitalization;
Hypotensive shock
Nausea 
Minimal symptoms;
causes minimal or
no interference with
work, school, or
self-care activities.
Notable symptoms; 
Requires modification 
in activity or use of 
medications; Does NOT 
result in loss of work, 
school, or cancellation 
of social activities. 
Incapacitating 
symptoms; Requires 
bed rest and/or 
results in loss of 
work, school, or
cancellation of
social activities.
Hospitalization;
Inability to perform
basic self-care
functions.
Diarrhea 
2 –3 loose stools or
<400 gms/24 hours
4 –5 stools or 
400-800 gms/24 hours 
6 or more watery 
stools or 
>800 gms/24 hours 
or oral rehydration 
necessary
Hospitalization;
Hypotensive shock or
IV fluid replacement
indicated
Headache 
Minimal symptoms;
causes minimal or
no interference with
work, school, or
self-care activities.
Notable symptoms; 
Requires modification 
in activity or use of 
medications; Does NOT 
result in loss of work, 
school, or cancellation 
of social activities. 
Incapacitating 
symptoms; Requires 
bed rest and/or 
results in loss of 
work, school, or
cancellation of
social activities; Use
of narcotic pain
reliever.
Hospitalization;
Inability to perform
basic self-care
functions.
Fatigue 
Minimal symptoms;
causes minimal or
no interference with
work, school, or
self-care activities.
Notable symptoms; 
Requires modification 
in activity or use of 
medications; Does NOT 
result in loss of work, 
school, or cancellation 
of social activities. 
Incapacitating 
symptoms; Requires 
bed rest and/or 
results in loss of 
work, school, or
cancellation of
social activities; Use
of narcotic pain
reliever.
Hospitalization;
Inability to perform
basic self-care
functions.
Myalgia 
Minimal symptoms;
causes minimal or
no interference with
work, school, or
self-care activities.
Notable symptoms; 
Requires modification 
in activity or use of 
medications; Does NOT 
result in loss of work, 
school, or cancellation 
of social activities. 
Incapacitating 
symptoms; Requires 
bed rest and/or 
results in loss of 
work, school, or
cancellation of
social activities; Use
of narcotic pain
reliever.
Hospitalization;
Inability to perform
basic self-care
functions.

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Systemic Illness 
Mild
(Grade 1)
Moderate
(Grade 2)
Severe 
(Grade 3) 
Potentially Life-
threatening (Grade 4)
Illness or clinical 
adverse event (as 
defined according to
applicable regulations)
No interference
with activity
Some interference
with activity not
requiring medical
intervention
Prevents daily  
activity and requires
medical intervention
Hospitalization

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Attachment 4: ARI Surveillance Assessment
Since the last time you completed your eDiary, have you had any symptoms of a cold or respiratory infection such as
a stuffy or runny nose (nasal congestion), a sore throat, a cough, coughing up phlegm (sputum), trouble breathing, or
whistling sounds when you breathe (wheezing)?
If you usually have some of these symptoms even when you do not have a cold, please only answer “yes” if you have
more symptoms than usual or your symptoms are worse than usual.
Responses:
No cold symptoms 
The participant will be referred to AE reminder screen (below)
Yes, I had cold symptoms The participant completes ARI assessment as follows:
1. Date ARI symptoms started or became worse than usual
2. RiiQ™v2 Symptom Scale
The ePRO system will compare reported symptoms/severity to values reported during the vaccination visit.
If symptoms are the same or less severe than the participant reported during the vaccination visit, the symptoms
indicate no ARI has occurred according to protocol definition. Therefore, the remainder of the ARI assessment is not
collected. The participant will be referred to AE reminder screen (below).
If symptoms are worse than baseline, the remaining ARI assessments are presented in the following ordera:
3. RiiQ™v2 Impact on Daily Activities
4. PGI-H
5. PGI-S
6. PGI-C
(Note that the PGI C will not be completed on ARI Day 1)
7. Return to Usual Health
(Note that the Return to Usual Health question will not be completed on ARI Day 1)
8. Temperature Log
The participant will then be referred to AE reminder screen (below). A final screen reminds participants to collect a
nasal swab and to contact site to schedule a site visit.
AE Reminder Screen:
Thank you for completing your eDiary.
If you are having any severe symptoms, health issues, or other concerns about your health, please contact your study
doctor to discuss these.
a 
The RiiQ™v2 Impact on Daily Activities, PGI-H, PGI-S, PGI-C, Return to Usual Health, and temperature log
assessments are part of the Combined Impact Assessment.

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Attachment 7: Patient Global Impression Scales
Patient Global Impression of Health (PGI-H)
Overall, how would you rate your health today? (select one)
Very good
Good
Fair
Poor
Very poor
Patient Global Impression of Severity (PGI-S)
Overall, how would you rate your respiratory illness today? (select one)
I feel fine (no respiratory illness)
I feel a little bit ill
I feel very ill
I feel extremely ill
Patient Global Impression of Change (PGI-C)
How were your respiratory illness today compared to when you first entered this study (select one)
Much better
Somewhat better
A little better
About the same
A little worse
Somewhat worse
Much worse
Return to Usual Health
Have you returned to your usual health today? (select one)
Yes
No

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Attachment 8: Lawton-BrodyInstrumental Activities of Daily Living (Lawton-BrodyIADL Scale)
LAWTON –BRODY
INSTRUMENTAL ACTIVITIES OF DAILY LIVING SCALE (IADL)
Scoring: For each category, circle the item description that most closely resembles the client’s highest functional
level (either 0 or 1).
A. Ability to Use Telephone 
E. Laundry
1. Operates telephone on own initiative-looks up 
and dials numbers, etc. 
2. Dials a few well-known numbers 
3. Answers telephone but does not dial 
4. Does not use telephone at all 
1 
1 
1
0
1. Does personal laundry completely  
2. Launders small items-rinses stockings, etc. 
3. All laundry must be done by others 
1
1
0
B. Shopping 
F. Mode of Transportation
1. Takes care of all shopping needs independently  
2. Shops independently for small purchases 
3. Needs to be accompanied on any shopping trip 
4. Completely unable to shop 
1 
0 
0 
0 
1. Travels independently on public transportation 
or drives own car
2. Arranges own travel via taxi, but does not 
otherwise use public transportation
3. Travels on public transportation when  
accompanied by another
4. Travel limited to taxi or automobile with  
assistance of another
5. Does not travel at all 
1
1
1
0
0
C. Food Preparation 
G. Responsibility for Own Medications
1. Plans, prepares and serves adequate meals 
independently  
2. Prepares adequate meals if supplied with  
ingredients 
3. Heats, serves and prepares meals, or prepares 
meals, or prepares meals but does not maintain
adequate diet
4. Needs to have meals prepared and served 
1 
0 
0 
0
1. Is responsible for taking medication in correct 
dosages at correct time
2. Takes responsibility if medication is prepared 
in advance in separate dosage
3. Is not capable of dispensing own medication  
1
0
0
D. Housekeeping 
H. Ability to Handle Finances
1. Maintains house alone or with occasional 
assistance (e.g. "heavy work domestic help") 
2. Performs light daily tasks such as dish washing, 
bed making 
3. Performs light daily tasks but cannot maintain 
acceptable level of cleanliness 
4. Needs help with all home maintenance tasks 
5. Does not participate in any housekeeping tasks 
1 
1 
1 
1
0
1. Manages financial matters independently  
(budgets, writes checks, pays rent, bills, goes
to bank), collects and keeps track of income
2. Manages day-to-day purchases, but needs help 
with banking, major purchases, etc.
3. Incapable of handling money  
1
1
0
Score 
Score
Total score
A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and
0 through 5 for men to avoid potential gender bias.
Source:
Graf C. The Lawton instrumental activities of daily living scale. Am J Nurs. 2008;108(4):52-62.

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Attachment 9: Medical Resources Use Questionnaire –Baseline Version
Participant ID: 
Date (dd-mmm-yyyy): 
1. Medical consultations
In the last month, how many times have you had medical consultations?
No 
Yes 
If yes, specify the
number of visits
Indicate a reason for
each visit
General Practitioner
Internal Medicine
Pulmonologist
Respiratory Physiotherapy
Other (Please specify:)
2. Professional home care
Please indicate the need for professional care at home in the last month.
No 
Yes 
If yes, specify the
number of visits
Indicate a reason for
each type of professional
care at home
General Practitioner
Nurse
Respiratory Physiotherapy
Other (Please specify:)
3. Hospital admissions
In the last month, did you visit the hospital?
Yes: 
No:
No 
Yes 
If yes, specify the
number of
visits/admissions
Reason for each hospital
visit and length of stay
(days)
Emergency Department*
Hospitalization in general ward
Hospitalization in critical care
*Please count Emergency Department visits only if the visit did not result in a hospital admission.

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4. Institutional care admission(s) other than hospital
Yes: 
No:
Please indicate if there has been any need for admission for care in a long-term facility, in the last month.
No 
Yes 
If yes, specify 
number of 
admissions 
Reason for each
institutional care admission
and length of stay (days)
Long term facilities
Rehabilitation facility

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Attachment 10: Medical Resources Use Questionnaire
Participant ID: 
Date (dd-mmm-yyyy): 
1. Medical consultations
Since onset of acute respiratory infection, how many times have you had medical consultations?
No 
Yes 
If yes, specify  
the number of 
visits 
Specify number of
visits related to ARI
or its complications
Indicate a reason
for each visit
General Practitioner
Internal Medicine
Pulmonologist
Respiratory Physiotherapy
Other (Please specify:)
2. Professional home care
Please indicate the need for professional care at home since onset of acute respiratory infection
No 
Yes 
If yes, specify  
the number of 
visits 
Specify number of
visits related to ARI
or its complications
Indicate a reason
for each type of
professional care at
home
General Practitioner
Nurse
Respiratory Physiotherapy
Other (Please specify:)
3. Hospital admissions
Since onset of acute respiratory infection, did you visit the hospital?
Yes: 
No:
No 
Yes 
If yes, specify the 
number of 
visits/admissions 
Specify number of
visits/admissions
related to ARI or
its complications
Reason for each
hospital visit and
length of stay
(days)
Emergency Department*
Hospitalization in general ward
Hospitalization in critical care
*Please count Emergency Department visits only if the visit did not result in a hospital admission.

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4. Institutional care admission(s) other than hospital
Please indicate if there has been any need for admission for care in a long-term facility, since onset of acute respiratory
infection.
Yes: 
No:
No 
Yes 
If yes, specify 
number of 
admissions 
Specify number of 
admissions related to 
ARI or its 
complications 
Reason for each
institutional care
admission and length of
stay (days)
Long term facilities
Rehabilitation facility

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Attachment 12: Medically Attended Acute Respiratory Infection (MA-ARI) Information Form
Version 1.2 - 14 June 2019
Dear Health Care Provider,
A patient of yours, who is currently being seen or has recently been seen for symptoms of a respiratory tract
infection, is taking part in a clinical trial sponsored by Janssen Vaccines and Prevention. This clinical trial studies
the efficacy and safety of an experimental RSV vaccine, and more information can be found on clinicaltrials.gov
(study reference: NCT03982199 - VAC18193RSV2001). Due to scientific nature of this trial, the sponsor kindly
requests some information of the performed assessments, interventions and outcome. If you are seeing/saw this
patient in an outpatient setting, please fill out only section 1 of the form. If you are seeing/saw this patient in the
emergency department or during a hospitalization, please complete both sections 1 and section 2 of the form. If
some assessments or interventions were not done, please leave these questions in the blank. Kindly complete as
much information as is available and provide to your patient, who will return this form to the study site. If you
received this form after the medical interaction by mail or fax, please return the completed form to the study site by
fax or post in the provided postage-paid return envelope. If you have any questions, your patient can provide you
with contact information for the study team, and/or please refer to the contact information provided by the study
team.
Section 1: To be completed in all healthcare settings (e.g., family doctor, nurse practitioner,
outpatient clinic, emergency department visits and hospitalizations).
Participant ID (will be completed by study staff):
Date of visit:
Name and role of healthcare professional completing form:
Optional contact details:
DIAGNOSIS/DIAGNOSES
Please list diagnosis or diagnoses made during clinical interaction here.
MEDICATIONS
Please list any new medications prescribed or changes in medication dosing.
VITAL SIGNS
Temperature (oC/oF): ________________
Respiratory rate (breaths per minute): _________________
Does the measured respiratory rate support a diagnosis of lower respiratory tract disease (LRTD)?
□    Yes  
   □    No
Below question only to be completed if patient has history of COPD or asthma.
Does the measured respiratory rate support a diagnosis of a COPD or asthma exacerbation?
□    COPD exacerbation                     □    asthma exacerbation                            □    No
Oxygen saturation (SpO2): __________________
Does the measured oxygen saturation support a diagnosis of lower respiratory tract disease (LRTD)?

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□    Yes    
□    No
Below question only to be completed if patient has history of COPD or asthma.
Does the measured oxygen saturation support a diagnosis of a COPD or asthma exacerbation?
□    COPD exacerbation                     □    asthma exacerbation                            □    No
WERE ADDITIONAL DIAGNOSTIC TESTS PERFORMED?                                    
□    Yes     □    No
If ‘yes’ selected, please fill out remaining questions in this section.
Was a chest x-ray performed?                                                                                                        
□    Yes     □    No
If yes, please indicate date performed:  ___________________
If yes, do the results support a diagnosis of lower respiratory tract disease (LRTD)?         □    Yes     □    No
If LRTD diagnosis supported, further diagnosis by x-ray:                           □    Pneumonia    
□    Other LRTD
Was a peak flow measurement made?                                                                                          □    Yes     □   No
If yes, please indicate date performed:  ___________________
Peak flow (L/min): ______________
If yes, do the results support a diagnosis of LRTD?                                                                      □   Yes     □    No
Below question only to be completed if patient has history of COPD or asthma.
Do the results support a diagnosis of a COPD or asthma exacerbation?
□    COPD exacerbation                     □    asthma exacerbation                            □    No
Was spirometry performed?                                                                                                          □    Yes     □   No
If yes, please indicate date performed:  ___________________
Specify results:
Only indicate results for measurements made.
FEV1 (L): ________
FEV6 (L): ________
FVC (L): _________
If yes, do the results support a diagnosis of LRTD?                                                                     □    Yes     □   No
Below question only to be completed if patient has history of COPD or asthma.
Do the results support a diagnosis of a COPD or asthma exacerbation?
□    COPD exacerbation                     □    asthma exacerbation                            □    No
Was another diagnostic method used?                                                                                           □    Yes     □    No
If yes, please specify diagnostic method:  ________________________________________________________
Date performed: ______________
Specify results: __________________________________________________________________
Do the results support a diagnosis of LRTD?                                                                                  □    Yes    □   No
WAS ANY MANAGEMENT PRESCRIBED OTHER THAN MEDICATION?                     □    Yes     □    No
(including nebulizer treatments, IV fluids, etc.)
If ‘yes’ selected, please fill out remaining questions in this section.
If yes, please specify:  ________________________________________________________

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Section 2: Additional questions only to be completed if patient seen in emergency department or is
hospitalized.
WERE ADDITIONAL DIAGNOSTIC TESTS PERFORMED?                                                            □    Yes     □    No
If ‘yes’ selected, please fill out remaining questions in this section.
Was a CT-scan performed?                                                                                                            □    Yes     □    No
If yes, please indicate date performed:  ___________________
If yes, do the results support a diagnosis of LRTD?                                                                    □    Yes     □    No
If LRTD diagnosis supported, further diagnosis by CT:                              □    Pneumonia     □    Other LRTD
Was an MRI performed?                                                                                                                  □    Yes     □    No
If yes, please indicate date performed:  ___________________
If yes, do the results support a diagnosis of LRTD?                                                                     □    Yes     □    No
If LRTD diagnosis supported, further diagnosis by MRI:                            □    Pneumonia     □    Other LRTD
Was bronchoscopy performed?                                                                                                      □    Yes     □    No
If yes, please indicate date performed:  ___________________
Specify results: __________________________________________________________________
If yes, do the results support a diagnosis of LRTD?                                                                     □    Yes     □   No
Was an arterial blood gas measured?                                                                                            □    Yes     □   No
If yes, please indicate date performed:  ___________________
Specify results: pH: _________, pCO2 (mmHg): _________, pO2 (mmHg): _________, HCO3 (mEq/L): _________,
O2 saturation (%): _________
If yes, do the results support a diagnosis of LRTD?                                                                     □    Yes     □    No
Below question only to be completed if patient has history of COPD or asthma.
Do the results support a diagnosis of a COPD or asthma exacerbation?
□    COPD exacerbation                     □    asthma exacerbation                            □    No
Was another diagnostic method used?                                                                                           □    Yes     □    No
If yes, please specify diagnostic method:  ________________________________________________________
Date performed: ______________
Specify results: __________________________________________________________________
Do the results support a diagnosis of LRTD?                                                                                □    Yes     □   No
SUPPLEMENTAL OXYGEN
Was supplemental oxygen administered?                                                                                     □    Yes     □   No
If ‘yes’ selected, please fill out remaining questions in this section.
Type of supplemental oxygen administration:
□   Invasive Mechanical Ventilation   
□   Venturi Mask
□   Non-Invasive Mechanical Ventilation 
□   Simple Face Mask
□   Nasal Cannula 
□   Reservoir Cannulas
□   Nonrebreathing Face Mask with Reservoir and One-Way Valve
□   Other: _______________________
If invasive mechanical ventilation, specify:
□   Through endotracheal tube                               □   Through tracheostomy tube
If non-invasive mechanical ventilation, specify:
□   Continuous positive airway pressure               □   Bilevel positive airway pressure
Oxygen concentration and units: _________________________
Start date and time: ______________________

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Status: Approved,Date: 16 February 2023
End date and time (if applicable): ____________________
Has supplemental oxygen administration returned to that level provided prior to the current respiratory illness?
□    Yes     □    No
Below question only to be completed if patient has history of COPD or asthma.
If applicable, does requirement for oxygen supplementation or increased oxygen supplementation support a diagnosis of
a COPD or asthma exacerbation?
□    COPD exacerbation                     □    asthma exacerbation                            □    No
*****
ADDITIONAL COMMENTS

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Status: Approved,Date: 16 February 2023
Attachment 13: Thrombotic Events to be Reported as Potential AESIs
At the time of protocol amendment 6 writing, the list of thrombotic events to be reported to the
sponsor as potential AESIs is provided below. Further guidance may become available on
thrombotic events of interest.
 MedDRA PTs for large vessel thrombosis and embolism
 Aortic embolus, aortic thrombosis, aseptic cavernous sinus thrombosis, brain stem
embolism, brain stem thrombosis, carotid arterial embolus, carotid artery thrombosis,
cavernous sinus thrombosis, cerebral artery thrombosis, cerebral venous sinus
thrombosis, cerebral venous thrombosis, superior sagittal sinus thrombosis, transverse
sinus thrombosis, mesenteric artery embolism, mesenteric artery thrombosis, mesenteric
vein thrombosis, splenic artery thrombosis, splenic embolism, splenic thrombosis,
thrombosis mesenteric vessel, visceral venous thrombosis, hepatic artery embolism,
hepatic artery thrombosis, hepatic vein embolism, hepatic vein thrombosis, portal vein
embolism, portal vein thrombosis, portosplenomesenteric venous thrombosis, splenic
vein thrombosis, spontaneous heparin-induced thrombocytopenia syndrome, femoral
artery embolism, iliac artery embolism, jugular vein embolism, jugular vein thrombosis,
subclavian artery embolism, subclavian vein thrombosis, obstetrical pulmonary
embolism, pulmonary artery thrombosis, pulmonary thrombosis, pulmonary venous
thrombosis, renal artery thrombosis, renal embolism, renal vein embolism, renal vein
thrombosis, brachiocephalic vein thrombosis, vena cava embolism, vena cava
thrombosis, truncus coeliacus thrombosis
 MedDRA PTs for more common thrombotic events
 Axillary vein thrombosis, deep vein thrombosis, pulmonary embolism, MedDRA PTs for
acute myocardial infarction*, MedDRA PTs for stroke*
Source: Shimabukuro T. CDC COVID-19 Vaccine Task Force. Thrombosis with thrombocytopenia syndrome (TTS)
following Janssen COVID-19 vaccine. Advisory Committee on Immunization Practices (ACIP). April 23, 2021.
https://www.cdc.gov/vaccines/acip/meetings/slides-2021-04-23.html.
*Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (as of 29 January
2021) https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf

VAC18193  (JNJ-64400141/JNJ-64213175)
Clinical Protocol VAC18193RSV2001 Amendment 8
CONFIDENTIAL –FOIA Exemptions Apply in U.S. 
216
Status: Approved,Date: 16 February 2023
INVESTIGATOR AGREEMENT
I have read this protocol and agree that it contains all necessary details for carrying out this study. I will
conduct the study as outlined herein and will complete the study within the time designated.
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who
assist in the conduct of this study. I will discuss this material with them to ensure that they are fully informed
regarding the study intervention, the conduct of the study, and the obligations of confidentiality.
Coordinating Investigator (where required):
Name (typed or printed):
Institution and Address:
Signature: 
Date:
(Day Month Year)
Principal (Site) Investigator:
Name (typed or printed):
Institution and Address:
Telephone Number:
Signature: 
Date:
(Day Month Year)
Sponsor's Responsible Medical Officer:
Name (typed or printed): 
Institution: 
Janssen Vaccines & Prevention B.V.
Signature: electronic signature appended at the end of the protocol 
Date:
(Day Month Year)
Note: If the address or telephone number of the investigator changes during the study, written notification will be
provided by the investigator to the sponsor, and a protocol amendment will not be required.
PPD

Signature
User 
Date 
Reason
 
16-Feb-2023
19:59:01
(GMT)
Document Approval
PPD