A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged... | NCT05070546 | Trialant
NCT05070546
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
May 25, 2025Actual
Enrollment
1,124Actual
Phase
Phase 3
Conditions
Respiratory Syncytial Virus Infection Prevention
Interventions
Ad26.RSV.preF-based Vaccine
Placebo
Countries
United States
Belgium
Germany
Spain
Sweden
Protocol Section
Identification Module
NCT ID
NCT05070546
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR109038
Secondary IDs
ID
Type
Description
Link
2021-001909-77
EudraCT Number
VAC18193RSV3006
Other Identifier
Janssen Vaccines & Prevention B.V.
Brief Title
A Study of an Ad26.RSV. preF-based Vaccine in Adults Aged 18 to 59 Years, Including Adults at High Risk for Severe RSV Infection
Official Title
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of an Ad26.RSV.preF-based Vaccine in Adults Aged 18 to 59 Years, Including Those at High-risk for Severe RSV
Acronym
Not provided
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 29, 2021Actual
Primary Completion Date
Aug 12, 2022Actual
Completion Date
Aug 12, 2022Actual
First Submitted Date
Sep 27, 2021
First Submission Date that Met QC Criteria
Sep 27, 2021
First Posted Date
Oct 7, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Aug 11, 2023
Results First Submitted that Met QC Criteria
Oct 3, 2023
Results First Posted Date
Oct 4, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 22, 2025
Last Update Posted Date
May 25, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Janssen Vaccines & Prevention B.V.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above.
Detailed Description
RSV is an important cause of serious respiratory infections in adults aged 60 years and older, immunocompromised individuals, and those with underlying chronic cardiopulmonary conditions. The current study assess the safety and immunogenicity of the RSV vaccine in adults 18 to 59 years of age, including those who are at risk for severe RSV disease. The study comprises screening (pre-vaccination) and vaccination for each participant on Day 1, and a 6- month safety and immunogenicity follow-up period. The study duration will be up to 6 months per participant. Assessments like immunogenicity (such as humoral and cellular immune responses), safety (such as monitoring of AEs, physical examinations, and vital signs) and reactogenicity will be performed in this study.
Conditions Module
Conditions
Respiratory Syncytial Virus Infection Prevention
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,124Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort (C)1 Group (G)1: Healthy Adults, 18-59 Years (Respiratory Syncytial Virus [RSV] vaccine)
Experimental
Participants will receive a single intramuscular (IM) injection of study vaccine on Day 1.
Biological: Ad26.RSV.preF-based Vaccine
C1 G2: Healthy Adults, 18-59 Years (Placebo)
Placebo Comparator
Participants will receive a single IM injection of matching placebo on Day 1.
Other: Placebo
C2 G3: High Risk Adult, 18-59 Years (RSV Vaccine)
Experimental
Participants will receive a single IM injection of study vaccine on Day 1.
Biological: Ad26.RSV.preF-based Vaccine
C2 G4: High Risk Adult, 18-59 Years (Placebo)
Placebo Comparator
Participants will receive a single IM injection of matching placebo on Day 1.
Other: Placebo
C3 G5: Adults, 65 Years and Older (RSV Vaccine)
Experimental
Participants will receive a single IM injection of study vaccine on Day 1.
Biological: Ad26.RSV.preF-based Vaccine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ad26.RSV.preF-based Vaccine
Biological
Participants will receive a single IM injection of an RSV vaccine.
C2 G3: High Risk Adult, 18-59 Years (RSV Vaccine)
C3 G5: Adults, 65 Years and Older (RSV Vaccine)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs)
Number of participants with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.
7 days after vaccination on Day 1 (Day 8)
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs
Number of participants with solicited systemic AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs including pyrexia, headache, fatigue, myalgia and nausea were collected within 7 days after vaccination.
7 days after vaccination on Day 1 (Day 8)
Cohorts 1 and 2: Number of Participants With Unsolicited AEs
Number of participants with unsolicited AEs post-vaccination in Cohorts 1 and 2 were reported. An AE was defined as any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as all AEs for which the participant was not specifically questioned in the participant diary.
28 days after vaccination on Day 1 (Day 29)
Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs post-vaccination were reported. An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above.
Secondary Outcomes
Measure
Description
Time Frame
Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
GMTs of RSV Fusion Protein (PreF) antibodies as assessed by ELISA-Pre-Fusion at Day 15 were reported.
14 days after vaccination on Day 1 (Day 15)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must be of a) non child bearing potential or b) of child bearing potential and practicing an acceptable and effective of contraception
All participants of childbearing potential must: have a negative highly sensitive urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; and have a negative highly sensitive urine beta-hCG pregnancy test immediately prior to each study vaccination (if screening and vaccination are not performed on the same day) Cohorts 1 and 2
Participant is aged 18 to 59 years (inclusive) on the day of signing the informed consent form (ICF) and expected to be available for the duration of the study Cohort 2
Has an existing chronic heart or lung condition, without hospitalizations or major medication class change (that is, new or stopped medications) within 30 days prior to screening, meeting the following criteria; a) cardiac disease: at least Class II symptoms per New York Heart Association classification or similar guidelines according to local practice, b) pulmonary disease: activity-restricting symptoms or use of long-term medications Cohort 3
Participant is aged 65 years or older on the day of signing the ICF and expected to be available for the duration of the study
Participant may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease (COPD), type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider
Exclusion Criteria:
Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
Abnormal function of immune system due to a clinical condition or treatment
History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT).
Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine
Received an respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study
History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 30, 2021
Aug 11, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
C3 G6: Adults, 65 Years and Older (Placebo)
Placebo Comparator
Participants will receive a single IM injection of matching placebo on Day 1.
Other: Placebo
Cohort (C)1 Group (G)1: Healthy Adults, 18-59 Years (Respiratory Syncytial Virus [RSV] vaccine)
Placebo
Other
Participants will receive a single IM injection of matching placebo.
C1 G2: Healthy Adults, 18-59 Years (Placebo)
C2 G4: High Risk Adult, 18-59 Years (Placebo)
C3 G6: Adults, 65 Years and Older (Placebo)
6 months after vaccination on Day 1 (Day 183)
Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI)
Number of participants with AESI post-vaccination were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay and were expressed as 50% inhibitory concentration (IC50) units.
14 days after vaccination on Day 1 (Day 15)
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2)
Percentage of participants with seroresponse as assessed by VNA-A2 strain were reported. Seroresponse was defined as a 4-fold increase from baseline in Day 15 VNA A2 antibody titers.
14 days after vaccination on Day 1 (Day 15)
Miami
Florida
33173
United States
Heartland Research Associates, an AMR Company
El Dorado
Kansas
67042
United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
New Orleans
Louisiana
70119
United States
Meridian Clinical Research, LLC
Rockville
Maryland
20854
United States
Tekton Research Inc.
Yukon
Oklahoma
73099
United States
Alliance for Multispeciality Research
Knoxville
Tennessee
37909
United States
Anima
Alken
3570
Belgium
C.H.U. St Pierre / Maladies Infectieuses
Brussels
Belgium
Private Practice RESPISOM Namur
Namur
5101
Belgium
Emovis GmbH
Berlin
10629
Germany
Klinische Forschung Berlin GbR
Berlin
10787
Germany
Zentrum fuer klinische Forschung
Cologne
51069
Germany
Klinische Forschung Dresden GmbH
Dresden
01069
Germany
Clinical Research HamburggmbH
Hamburg
22143
Germany
SIBAmed GmbH & Co. KG
Leipzig
04103
Germany
Klinische Forschung Schwerin GmbH
Schwerin
19055
Germany
Hosp Reina Sofia
Córdoba
14004
Spain
Hosp Virgen de La Victoria
Málaga
29010
Spain
ProbarE i Lund AB
Lund
22222
Sweden
ClinSmart Sweden AB
Solna
171 64
Sweden
ProbarE i Stockholm AB
Stockholm
113 29
Sweden
Studieenheten Akademiskt Specialistcentrum Stockholm
Stockholm
11361
Sweden
Derived
Jastorff A, Gymnopoulou E, Salas J, Merrall E, Buntinx E, Martin C, Askling HH, Schenkenberger I, Yuste AC, Smith W, Sotolongo R, Von Engelhardt C, Bastian AR, Comeaux C, Ligtenberg N, Callendret B, Heijnen E. Safety and immunogenicity of the Ad26/protein preF RSV vaccine in adults aged 18 to 59 years with and without at-risk comorbidities for severe respiratory syncytial virus disease: A phase 3, randomized, controlled, immunobridging trial. Vaccine. 2025 Jan 1;43(Pt 1):126514. doi: 10.1016/j.vaccine.2024.126514. Epub 2024 Nov 12.
FG001
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
FG002
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
FG003
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
FG004
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
FG005
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
FG000320 subjects
FG00168 subjects
FG002320 subjects
FG00370 subjects
FG004316 subjects
FG00530 subjects
Vaccinated
FG000319 subjects
FG00168 subjects
FG002319 subjects
FG00369 subjects
FG004313 subjects
FG00530 subjects
COMPLETED
FG000310 subjects
FG00165 subjects
FG002309 subjects
FG00368 subjects
FG004308 subjects
FG00529 subjects
NOT COMPLETED
FG00010 subjects
FG0013 subjects
FG00211 subjects
FG0032 subjects
FG0048 subjects
FG0051 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Lost to Follow-up
FG0008 subjects
FG0012 subjects
FG0027 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized but not vaccinated
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
BG001
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
BG002
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
BG003
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
BG004
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
BG005
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000319
BG00168
BG002319
BG00369
BG004313
BG00530
BG0061118
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00038.8± 12.33
BG00138.4± 12.34
BG00244.4± 11.81
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Adults (18-64 years)
BG000319
BG00168
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000193
BG00140
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00042
BG00110
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
BELGIUM
Title
Measurements
BG000178
BG00136
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Cohorts 1 and 2: Number of Participants With Solicited Local Adverse Events (AEs)
Number of participants with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.
Full analysis set (FAS) included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified cohorts only.
Posted
Count of Participants
Participants
7 days after vaccination on Day 1 (Day 8)
ID
Title
Description
OG000
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
OG001
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
OG002
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG003
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
Units
Counts
Participants
OG000316
OG00168
OG002318
OG003
Title
Denominators
Categories
Title
Measurements
OG000273
OG00110
OG002276
OG003
Primary
Cohorts 1 and 2: Number of Participants With Solicited Systemic AEs
Number of participants with solicited systemic AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs including pyrexia, headache, fatigue, myalgia and nausea were collected within 7 days after vaccination.
FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified cohorts only.
Posted
Count of Participants
Participants
7 days after vaccination on Day 1 (Day 8)
ID
Title
Description
OG000
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
OG001
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
Primary
Cohorts 1 and 2: Number of Participants With Unsolicited AEs
Number of participants with unsolicited AEs post-vaccination in Cohorts 1 and 2 were reported. An AE was defined as any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as all AEs for which the participant was not specifically questioned in the participant diary.
FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo). This outcome measure was planned to be analysed for specified cohorts only.
Posted
Count of Participants
Participants
28 days after vaccination on Day 1 (Day 29)
ID
Title
Description
OG000
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
OG001
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
OG002
Primary
Cohorts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs)
Number of participants with SAEs post-vaccination were reported. An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above.
FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
Posted
Count of Participants
Participants
6 months after vaccination on Day 1 (Day 183)
ID
Title
Description
OG000
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
OG001
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
Primary
Cohorts 1, 2, and 3: Number of Participants With Adverse Events of Special Interest (AESI)
Number of participants with AESI post-vaccination were reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
FAS included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
Posted
Count of Participants
Participants
6 months after vaccination on Day 1 (Day 183)
ID
Title
Description
OG000
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
OG001
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
OG002
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay and were expressed as 50% inhibitory concentration (IC50) units.
The Per-protocol Immunogenicity (PPI) set included all randomised participants on Day 15 who received study vaccine and for whom immunogenicity data were available. Here 'N' (number of participants analysed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified arms only. As planned, combined data of participants aged 18-59 years Cohorts 1 (Group 1) and 2 (Group 3) has been reported.
Posted
Geometric Mean
95% Confidence Interval
Titers
14 days after vaccination on Day 1 (Day 15)
ID
Title
Description
OG000
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG001
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
Primary
Cohorts 1 (Group 1), 2 (Group 3), and 3 (Group 5): Percentage of Participants With Seroresponse as Assessed by Virus Neutralizing Assay (VNA-A2)
Percentage of participants with seroresponse as assessed by VNA-A2 strain were reported. Seroresponse was defined as a 4-fold increase from baseline in Day 15 VNA A2 antibody titers.
PPI set included all randomized participants who received study vaccine and for whom immunogenicity data were available. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure. This outcome measure was planned to be analysed for specified arms only. As planned, combined data of participants aged 18-59 years Cohorts 1 (Group 1) and 2 (Group 3) has been reported.
Posted
Number
percentage of participants
14 days after vaccination on Day 1 (Day 15)
ID
Title
Description
OG000
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG001
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG002
Secondary
Cohorts 1, 2, and 3: Geomteric Mean Titers (GMTs) of RSV Fusion Protein (F-protein) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)- Pre-Fusion
GMTs of RSV Fusion Protein (PreF) antibodies as assessed by ELISA-Pre-Fusion at Day 15 were reported.
PPI set included all randomised participants who received study vaccine and for whom immunogenicity data were available.
Posted
Geometric Mean
95% Confidence Interval
ELISA units per liter (EU/L)
14 days after vaccination on Day 1 (Day 15)
ID
Title
Description
OG000
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
OG001
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
OG002
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
Time Frame
Up to Day 183
Description
Full analysis set included all participants who received study vaccine, regardless of the occurrence of protocol deviations and vaccine type (study vaccine or placebo).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group 1 (Cohort 1): Ad26.RSV.preF and RSV preF Protein
Healthy adult participants aged 18 to 59 years received a single intramuscular (IM) injection containing mixture of adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and RSV preF protein 150 micrograms (mcg) on Day 1.
0
319
1
319
77
319
EG001
Group 2 (Cohort 1): Placebo
Healthy adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
0
68
1
68
5
68
EG002
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
0
319
10
319
50
319
EG003
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
0
69
0
69
8
69
EG004
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
0
313
13
313
32
313
EG005
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
1
30
1
30
5
30
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina Pectoris
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG0030 affected69 at risk
EG0041 affected313 at risk
EG0050 affected30 at risk
Aortic Valve Stenosis
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Cardiogenic Shock
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Haemorrhagic Fever with Renal Syndrome
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Mastitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0011 affected68 at risk
EG0020 affected319 at risk
EG003
Meningitis Aseptic
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Radius Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Traumatic Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Bladder Cancer Stage 0, with Cancer in Situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Her2 Positive Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Facial Paresis
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Testicular Torsion
Reproductive system and breast disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Haematoma
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ear Pain
Ear and labyrinth disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0020 affected319 at risk
EG0030 affected69 at risk
EG0040 affected313 at risk
EG0051 affected30 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0002 affected319 at risk
EG0011 affected68 at risk
EG0022 affected319 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0008 affected319 at risk
EG0010 affected68 at risk
EG0022 affected319 at risk
EG003
Chills
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG00060 affected319 at risk
EG0011 affected68 at risk
EG00231 affected319 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0008 affected319 at risk
EG0011 affected68 at risk
EG0024 affected319 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected319 at risk
EG0010 affected68 at risk
EG0029 affected319 at risk
EG003
Sinusitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0007 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0003 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0004 affected319 at risk
EG0014 affected68 at risk
EG0022 affected319 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0008 affected319 at risk
EG0010 affected68 at risk
EG0021 affected319 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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. 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.
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG003
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
Units
Counts
Participants
OG000316
OG00168
OG002318
OG00368
Title
Denominators
Categories
Title
Measurements
OG000277
OG00133
OG002275
OG00340
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG003
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
Units
Counts
Participants
OG000319
OG00168
OG002319
OG00369
Title
Denominators
Categories
Title
Measurements
OG000111
OG00113
OG00285
OG00312
OG002
Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG003
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
OG004
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG005
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
Units
Counts
Participants
OG000319
OG00168
OG002319
OG00369
OG004313
OG00530
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG00210
OG0030
OG00413
OG0051
High-risk adult participants aged 18 to 59 years received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG003
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
OG004
Group 5 (Cohort 3): Ad26.RSV.preF and RSV preF Protein
Adult participants aged 65 years and older received a single IM injection containing mixture of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1.
OG005
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.
Units
Counts
Participants
OG000319
OG00168
OG002319
OG00369
OG004313
OG00530
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG002
Group 1 (Cohort 1) and Group 3 (Cohort 2): Ad26.RSV.preF and RSV preF Protein
Healthy (Group 1) and high-risk adult (Group 3) participants aged 18 to 59 years received intramuscular (IM) injection containing mixture of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF protein) 150 micrograms (mcg) on Day 1.
Units
Counts
Participants
OG000301
OG001290
OG002602
Title
Denominators
Categories
Title
Measurements
OG0007095(6261 to 8042)
OG0014596(4059 to 5204)
OG0026491(5847 to 7206)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Geometric Mean Ratio
Geometric Mean Ratio
1.41
2-Sided
95
1.25
1.60
Non-Inferiority
Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 [Group 5]/Cohort 1[Group1] and 2 [Group 3])
OG000
OG001
Geometric Mean Ratio
Geometric mean ratio
1.54
2-Sided
95
1.34
1.78
Non-Inferiority
Non-inferiority of Cohort 3 (Group 5) versus Cohort 2 (Group 3 in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of 0.67 for the GMT ratio (Cohort 3 [Group 5]/Cohort 2 [Group 3])
Cohorts 1(Group 1) and 2 (Group 3): Ad26.RSV.preF and RSV preF Protein
Healthy (Group 1) and high-risk adult (Group 3) participants aged 18 to 59 years received intramuscular (IM) injection containing mixture of adenovirus serotype 26 pre-fusion conformation-stabilized F protein (Ad26.RSV.preF) 1*10^11 viral particles (vp) and respiratory syncytial virus prefusion F-protein (RSV preF protein) 150 micrograms (mcg) on Day 1.
Units
Counts
Participants
OG000300
OG001290
OG002602
Title
Denominators
Categories
Title
Measurements
OG00088
OG00182.41
OG00289.37
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG001
OG002
Difference in Seroresponse rate
Difference in Seroresponse rate
5.4
2-Sided
95
0.3
10.9
Non-Inferiority
Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 [Group 5]/Cohort 1[Group1] and 2 [Group 3]).
OG000
OG001
Difference in Seroresponse rate
Difference in Seroresponse rate
4.4
2-Sided
95
-1.6
10.5
Non-Inferiority
Non-inferiority of Cohort 3 (Group 5) versus Cohorts 1 (Group 1) and 2 (Group 3) in terms of RSV A2 Strain neutralizing antibody titers against 14 days after vaccination, using a non-inferiority margin of -10% for the GMT ratio (Cohort 3 [Group 5]/Cohort 2 [Group 3]).
OG003
Group 4 (Cohort 2): Placebo
High-risk adult participants aged 18 to 59 years received a single IM injection of matching placebo on Day 1.
OG004
Cohort 3: Adults: RSV Vx (Group 5)
Adult participants aged 65 years and older received IM injection containing Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg on Day 1 of vaccination.
OG005
Group 6 (Cohort 3): Placebo
Adult participants aged 65 years and older received a single IM injection of matching placebo on Day 1.