A Study of an Ad26.RSV.preF-based Regimen in the Preventi... | NCT03982199 | Trialant
NCT03982199
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Terminated
Last Update Posted
May 25, 2025Actual
Enrollment
5,815Actual
Phase
Phase 2
Conditions
Respiratory Syncytial Viruses
Respiratory Tract Diseases
Interventions
RSV Vaccine
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03982199
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108634
Secondary IDs
ID
Type
Description
Link
VAC18193RSV2001
Other Identifier
Janssen Vaccines & Prevention B.V.
Brief Title
A Study of an Ad26.RSV.preF-based Regimen in the Prevention of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV)-Mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older
Official Title
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
Acronym
CYPRESS
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated early by the sponsor due to strategic reprioritization reasons.
Expanded Access Info
No
Start Date
Aug 1, 2019Actual
Primary Completion Date
Jun 6, 2022Actual
Completion Date
May 26, 2023Actual
First Submitted Date
Jun 10, 2019
First Submission Date that Met QC Criteria
Jun 10, 2019
First Posted Date
Jun 11, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jun 6, 2023
Results First Submitted that Met QC Criteria
Jul 21, 2023
Results First Posted Date
Jul 24, 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 this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo.
Detailed Description
Not provided
Conditions Module
Conditions
Respiratory Syncytial Viruses
Respiratory Tract Diseases
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
5,815Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1: RSV Vaccine
Experimental
Participants will receive a single intramuscular (IM) injection of an adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV) vaccine at a single dose level on Day 1. Participants will then be divided into revaccination subcohorts: 1A, 1B, and 1C to receive revaccination with Ad26.RSV.preF based vaccine at 1 year, 2 years, and 3 years respectively after the first vaccination.
Biological: RSV Vaccine
Group 2: Placebo
Placebo Comparator
Participants will receive a single IM injection of placebo control on Day 1. Participants will then be divided into revaccination subcohorts 2A, 2B, and 2C, and will first receive Ad26.RSV.preF based vaccine at years 1, 2, and 3. In subcohorts 2A and 2B, participants will receive a revaccination one year later with either Ad26.RSV.preF based vaccine, study vaccine A or study vaccine B.
Biological: RSV Vaccine
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RSV Vaccine
Biological
Participants will receive a single IM injection of an Ad26-based RSV vaccine at a single dose level on Day 1 and revaccination after either 1 year, 2 years, or 3 years.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to case definition-1, 2 and 3 were reported. Case definition 1 was defined as having a new onset or worsening in 3 or more symptoms of lower respiratory tract infection (LRTI) ; Case definition 2 was defined as having a new onset or worsening in greater than or equal to (>=) 2 symptoms of LRTI; and Case definition 3 was defined as having a new onset or worsening in >=2 OR >=1 symptoms of LRTI with >=1 systemic symptoms. Systemic symptoms (fatigue/malaise and fever/feverishness) and symptoms of LRTI (cough, shortness of breath, sputum production, wheezing and tachypnea) were collected via the RiiQ. RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the LRTD symptom scores.
From screening (Day 1) up to 9 months
Secondary Outcomes
Measure
Description
Time Frame
Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease
Number of participants with any RT-PCR-confirmed RSV disease were reported. The analysis was based on poisson regression model.
Participant must have a body mass index (BMI) less than (<)40 kilogram per meter square (kg/m^2)
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
Participant must be either in good or stable health. Participants may have mild to moderate underlying illnesses such as chronic cardiac diseases and chronic lung disease (asthma and chronic obstructive pulmonary disease [COPD]), congestive heart failure (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 included on the basis of physical examination, medical history, and vital signs performed between informed consent form (ICF) signature and vaccination on Day 1
From the time of vaccination through 3 months after vaccination, participant agrees not to donate blood
Participant must be able to read, understand, and complete questionnaires in the eDiary (or a paper safety diary, if designated by the sponsor)
Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
Exclusion Criteria:
Participant has an acute illness (including acute respiratory illnesses) or body temperature greater than or equal to (>=)38.0 degree Celsius (ºC) within 24 hours prior to administration of study vaccine. In such a situation, enrollment at a later date is permitted
Participant has a severe or potentially life-threatening chronic disorder 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 (example: compromise well-being) or that could prevent, limit, or confound the protocol-specified assessments
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)
Per medical history, participant has chronic active hepatitis B or hepatitis C infection
Per medical history, participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
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)
Participants in the main cohort who did not enter the re-vaccination subcohorts continued in the main cohort up to Day 1095. Hence, the assessments for both main cohorts and re-vaccination subcohorts were conducted in parallel until Day 1095 (end of main cohort).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Periods
Title
Milestones
Reasons Not Completed
Main Cohorts (Day 1 up to Day 1095)
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
Feb 16, 2023
Jun 6, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Chile
New Zealand
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Group 1: RSV Vaccine
Group 2: Placebo
Placebo
Biological
Participants will receive a single IM injection of placebo control on Day 1.
Group 2: Placebo
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
Days 15, 365, 379, 393, 449, 730, 737, 744, 758
Revaccination Subcohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
GMTs of preF-A antibodies after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.
Day 15: Arms 3 to 7,13 and 14; Days 365, 379, 393, 449, 533: Arms 3 to 7; Day 730: Arms 4 to 7; Days 737, 744, 758: Arms 5 to 7; Day 1095, 1109: Arms 13 and 14
Revaccination Subcohort 2A: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
T-cell IFN gamma responses to RSV F protein specific peptides as measured by ELISpot assay were reported. RSV F protein specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
Days 730, 744, 758
Main Cohorts: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
T-cell IFN gamma responses to RSV F protein specific peptides as measured by ELISpot assay were reported. RSV F protein specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
Days 15, 85, 169, 365, 533
Main Cohorts: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination
An AE was 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. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness. Per protocol, all solicited local AEs were considered as related to intervention.
Up to Day 8 (7 days after first vaccination on Day 1)
Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination
An AE was 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. Solicited systemic AEs included fatigue, headache, myalgia, arthralgia, and fever (defined as an endogenous elevation of body temperature >=38.0°C, as recorded in at least one measurement).
Up to Day 8 (7 days after first vaccination on Day 1)
Main Cohorts: Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination
An AE was 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. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Up to Day 29 (28 days after first vaccination on Day 1)
Revaccination Subcohorts: Number of Participants With Solicited Local AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years
Number of participants with solicited local AEs 7 days after re-vaccination at 1, 2 and 3 years were reported. An AE was 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. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness. Per protocol, all solicited local AEs were considered as related to intervention.
Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102)
Revaccination Subcohorts: Number of Participants With Solicited Systemic AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years
Number of participants with solicited systemic AEs 7 days after re-vaccination up to 1, 2 and 3 years were reported. An AE was 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. Solicited systemic AEs included fatigue, headache, myalgia, arthralgia, and fever (defined as an endogenous elevation of body temperature >=38.0°C, as recorded in at least one measurement).
Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102)
Revaccination Subcohorts: Number of Participants With Unsolicited AEs 28 Days After Re-vaccination up to 1, 2 and 3 Years
An AE was 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. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
Arms 3,4: 28 days after revacc at 1 year (up to Day 393); Arms 5,6,7,8,9: 28 days after revacc at 2 years (up to Day 758); Arms 10,11,12,13,14: 28 days after revaccination at 3 year (up to Day 1123)
Revaccination Subcohorts: Number of Participants With Adverse Events of Special Interests (AESI)
Number of participants with AESIs were reported. An AE was 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. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
Arms 3,4: 6 months after revacc at 1 year (up to Day 547); Arm 5,6,7,8,9: 6 months after revacc at 2 years (up to Day 912); Arms 10,11,12,13,14: 6 months after revacc at 3 year (up to Day 1277)
Main Cohorts:Number of Participants With Serious Adverse Events (SAEs)
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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. For participants who were not revaccinated only SAEs associated with ARIs and complications related to ARIs that classify as SAEs, SAEs classified as related, SAEs resulting in death, and (S)AEs resulting in study discontinuation or from procedures and non-investigational (concomitant) Janssen products were collected.
From Day 1 up to Day 1095
Revaccination Subcohorts: Number of Participants With Serious Adverse Events (SAEs)
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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
Arms 3,4: 6 months after revacc at 1 year (up to Day 547); Arm 5,6,7,8,9: 6 months after revacc at 2 years (up to Day 912); Arms 10,11,12,13,14: 6 months after revacc at 3 year (up to Day 1277)
Main Cohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
GMTs of preF-A antibodies after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.
Days 15, 85, 169, 365, 533
Chandler
Arizona
85224
United States
Synexus Clinical Research US Inc
Phoenix
Arizona
85018
United States
Central Phoenix Medical Clinic
Phoenix
Arizona
85020
United States
Anaheim Clinical Trials, LLC
Anaheim
California
92801
United States
Paradigm Clinical Research Centers, Inc.
Redding
California
96001
United States
Benchmark Research
Sacramento
California
95684
United States
Optimal Research
San Diego
California
92108
United States
Synexus Clinical Research US Inc
Aurora
Colorado
80014
United States
Lynn Institute
Colorado Springs
Colorado
80920
United States
Optimal Research
Melbourne
Florida
32934
United States
Advanced Clinical Research
Boise
Idaho
83642
United States
Optimal Research
Peoria
Illinois
61614
United States
Synexus Clinical Research US Inc
Evansville
Indiana
47714
United States
The Iowa Clinic
West Des Moines
Iowa
50266
United States
Hutchinson Clinic
Hutchinson
Kansas
67502
United States
Johnson County Clin-Trials
Lenexa
Kansas
66219
United States
Heartland Research Associates, LLC
Newton
Kansas
67114
United States
Heartland Research Associates, LLC
Wichita
Kansas
67205
United States
Optimal Research
Rockville
Maryland
20850
United States
Synexus Clinical Research US Inc
Richfield
Minnesota
55432
United States
The Center For Pharmaceutical Research
Kansas City
Missouri
64114
United States
Sundance Clinical Research
St Louis
Missouri
63141
United States
Synexus Clinical Research US Inc
St Louis
Missouri
63141
United States
Synexus Clinical Research US Inc
Elkhorn
Nebraska
68022
United States
Synexus Clinical Research US Inc
Omaha
Nebraska
68144
United States
United Medical Associates
Binghamton
New York
13901
United States
Regional Clinical Research, Inc.
Endwell
New York
13760
United States
University of Rochester / Rochester General Hospital
Rochester
New York
14621
United States
Synexus Clinical Research US Inc
Akron
Ohio
44311
United States
Synexus Clinical Research US Inc
Cincinnati
Ohio
45236
United States
Rapid Medical Research
Cleveland
Ohio
44122
United States
Lynn Health Science Institute
Oklahoma City
Oklahoma
73112
United States
Omega Medical Research
Warwick
Rhode Island
02886
United States
Coastal Carolina Research Center
Mt. Pleasant
South Carolina
29464
United States
Optimal Research
Austin
Texas
78705
United States
Ventavia Research Group, LLC
Fort Worth
Texas
76104
United States
Synexus Clinical Research US Inc
Murray
Utah
84123
United States
Advanced Clinical Research
Salt Lake City
Utah
84123
United States
Advanced Clinical Research
West Jordan
Utah
84088
United States
Derived
Falsey AR, Williams K, Gymnopoulou E, Bart S, Ervin J, Bastian AR, Menten J, De Paepe E, Vandenberghe S, Chan EKH, Sadoff J, Douoguih M, Callendret B, Comeaux CA, Heijnen E; CYPRESS Investigators. Efficacy and Safety of an Ad26.RSV.preF-RSV preF Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):609-620. doi: 10.1056/NEJMoa2207566.
FG001
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
FG002
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
FG003
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
FG004
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
FG005
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
FG006
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
FG007
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 730. Participants were then followed up for safety assessments till Day 1095.
FG008
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730. Participants were then followed up for safety assessments till Day 1095.
FG009
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by Ad26.RSV.preF 1*10^11 vp alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
FG010
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by RSV preF protein 150 mcg alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
FG011
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Days 730 and Day 1095. Participants were then followed up for safety assessments till Day 1460.
FG012
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 1095. Participants were then followed up for safety assessments till Day 1460.
FG013
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1095. Participants were then followed up for safety assessments till Day 1460.
FG0002909 subjects
FG0012906 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Vaccinated
FG0002891 subjects
FG0012891 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG0001875 subjects
FG0011897 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0001034 subjects
FG0011009 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Type
Comment
Reasons
Lost to Follow-up
FG000152 subjects
FG001159 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Physician Decision
FG00039 subjects
FG00133 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG000514 subjects
FG001503 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG00012 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG004
Technical Problems
FG00010 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG00039 subjects
FG00138 subjects
FG0020 subjects
FG0030 subjects
FG004
Site terminated by Sponsor
FG00026 subjects
FG00121 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Terminated by Sponsor
FG000129 subjects
FG001117 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG00080 subjects
FG00183 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized but not vaccinated
FG00018 subjects
FG00115 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0004 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
FG004
Initiated prohibited medication
FG00011 subjects
FG00111 subjects
FG0020 subjects
FG0030 subjects
FG004
Revacc Subcohorts (From Day 365 to 730)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG002120 subjects
FG003126 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG00294 subjects
FG003102 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG00226 subjects
FG00324 subjects
FG004
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Revacc Subcohorts (From Day 730 to 1095)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00428 subjects
FG00528 subjects
FG00628 subjects
FG007137 subjects
FG008149 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Revacc Subcohort (From Day 1095 to 1460)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00937 subjects
FG01037 subjects
FG01137 subjects
FG012131 subjects
FG013119 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
The Full Analysis Set (FAS) included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
BG001
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002891
BG0012891
BG0025782
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
BG00071.7± 5.37
BG00171.6± 5.38
BG00271.7± 5.4
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001639
BG0011694
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00085
BG00197
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0008
BG0019
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
UNITED STATES
Title
Measurements
BG0002891
BG0012891
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
Number of Participants With First Occurrence of Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)-Confirmed Respiratory Syncytial Virus (RSV) Mediated Lower Respiratory Tract Disease (LRTD)
Number of participants with first occurrence of RT-PCR-confirmed RSV mediated LRTD according to case definition-1, 2 and 3 were reported. Case definition 1 was defined as having a new onset or worsening in 3 or more symptoms of lower respiratory tract infection (LRTI) ; Case definition 2 was defined as having a new onset or worsening in greater than or equal to (>=) 2 symptoms of LRTI; and Case definition 3 was defined as having a new onset or worsening in >=2 OR >=1 symptoms of LRTI with >=1 systemic symptoms. Systemic symptoms (fatigue/malaise and fever/feverishness) and symptoms of LRTI (cough, shortness of breath, sputum production, wheezing and tachypnea) were collected via the RiiQ. RiiQ symptom scale was a 13-items questionnaire rated on a 4-point scale. Each symptom was rated on a scale of 0 to 3 where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Higher scores indicated greater severity. The total LRTD symptom score was calculated as the mean of the LRTD symptom scores.
The Per-protocol Efficacy (PPE) population included 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 acute respiratory infection (ARI) with onset within 14 days after vaccination and participants who discontinued within 14 days after vaccination were excluded from the PPE population.
Posted
Count of Participants
Participants
From screening (Day 1) up to 9 months
ID
Title
Description
OG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
OG001
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Units
Counts
Participants
OG0002791
OG0012801
Title
Denominators
Categories
Case Definition-1
Title
Measurements
OG0006
OG00130
Case Definition-2
Title
Measurements
OG000
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
OG000
OG001
Case Definition 1
Poisson regression
0.00004
Event Rate
80.0
2-Sided
94.211
52.2
92.9
Superiority
OG000
OG001
Case Definition 2
Poisson regression
Secondary
Main Cohorts: Number of Participants With Any RT-PCR-confirmed RSV Disease
Number of participants with any RT-PCR-confirmed RSV disease were reported. The analysis was based on poisson regression model.
The PPE population included 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 and participants who discontinued within 14 days after vaccination were excluded from the PPE population.
Posted
Count of Participants
Participants
From screening (Day 1) up to 9 months
ID
Title
Description
OG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
Per-protocol Immunogenicity (PPI) population included all randomized and vaccinated participants who were part of the immunogenicity subset and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (participants analyzed) signifies the participants evaluable at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
Titers
Days 15, 85, 169, 365
ID
Title
Description
OG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay.
PPI set: all randomized and vaccinated participants who were part of immunogenicity subset and for whom immunogenicity data were available. 'N' (number of participants analyzed): participants evaluable for this outcome measure, 'n' (participants analyzed): participants evaluable at specified timepoints and 'n (number analyzed)=0' signifies that none of participants were available for the assessment at specified timepoints. This outcome measure was planned to be analyzed for specified arms only.
Posted
Geometric Mean
95% Confidence Interval
Titers
Days 15, 365, 379, 393, 449, 730, 737, 744, 758
ID
Title
Description
OG000
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
OG001
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
Secondary
Revaccination Subcohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
GMTs of preF-A antibodies after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.
PPI set: all randomized and vaccinated participants who were part of immunogenicity subset and for whom immunogenicity data were available. 'N' (number of participants analyzed): participants evaluable for this outcome measure, 'n' (participants analyzed): participants evaluable at specified timepoints and 'n (number analyzed)=0' signifies that none of participants were available for the assessment at specified timepoints. This outcome measure was planned to be analyzed for specified arms only.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 15: Arms 3 to 7,13 and 14; Days 365, 379, 393, 449, 533: Arms 3 to 7; Day 730: Arms 4 to 7; Days 737, 744, 758: Arms 5 to 7; Day 1095, 1109: Arms 13 and 14
ID
Title
Description
OG000
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
OG001
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
Secondary
Revaccination Subcohort 2A: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
T-cell IFN gamma responses to RSV F protein specific peptides as measured by ELISpot assay were reported. RSV F protein specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
PPI population included all randomized and vaccinated participants who were part of the immuno subset and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 'n' signifies participants evaluable for specified timepoints. This outcome measure was planned to be analyzed for specified arms only.
Posted
Median
Full Range
SFC/10^6 PBMCs
Days 730, 744, 758
ID
Title
Description
OG000
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG001
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Secondary
Main Cohorts: T-cell Interferon (IFN) Gamma Responses to RSV F Protein Peptides Analyzed by Enzyme-linked Immunospot Assay (ELISpot)
T-cell IFN gamma responses to RSV F protein specific peptides as measured by ELISpot assay were reported. RSV F protein specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
PPI population included all randomized and vaccinated participants who were part of the immuno subset and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. Here, 'n' signifies participants evaluable for specified timepoints.
Posted
Median
Full Range
SFC/10^6 PBMCs
Days 15, 85, 169, 365, 533
ID
Title
Description
OG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Secondary
Main Cohorts: Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After First Vaccination
An AE was 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. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness. Per protocol, all solicited local AEs were considered as related to intervention.
The safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination and unsolicited AEs for 28 days after vaccination). Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to Day 8 (7 days after first vaccination on Day 1)
ID
Title
Description
OG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Secondary
Main Cohorts: Number of Participants With Solicited Systemic AEs up to 7 Days After First Vaccination
An AE was 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. Solicited systemic AEs included fatigue, headache, myalgia, arthralgia, and fever (defined as an endogenous elevation of body temperature >=38.0°C, as recorded in at least one measurement).
The safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination and unsolicited AEs for 28 days after vaccination). Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Up to Day 8 (7 days after first vaccination on Day 1)
ID
Title
Description
OG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Secondary
Main Cohorts: Number of Participants With Unsolicited AEs up to 28 Days After First Vaccination
An AE was 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. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
The safety subset included all participants that consented to the collection of AEs (solicited AEs for up to 7 days after vaccination and unsolicited AEs for 28 days after vaccination).
Posted
Count of Participants
Participants
Up to Day 29 (28 days after first vaccination on Day 1)
ID
Title
Description
OG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Secondary
Revaccination Subcohorts: Number of Participants With Solicited Local AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years
Number of participants with solicited local AEs 7 days after re-vaccination at 1, 2 and 3 years were reported. An AE was 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. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness. Per protocol, all solicited local AEs were considered as related to intervention.
The Full Analysis Set (FAS) included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102)
ID
Title
Description
OG000
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
Secondary
Revaccination Subcohorts: Number of Participants With Solicited Systemic AEs 7 Days After Re-vaccination up to 1, 2 and 3 Years
Number of participants with solicited systemic AEs 7 days after re-vaccination up to 1, 2 and 3 years were reported. An AE was 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. Solicited systemic AEs included fatigue, headache, myalgia, arthralgia, and fever (defined as an endogenous elevation of body temperature >=38.0°C, as recorded in at least one measurement).
The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
Posted
Count of Participants
Participants
Arms 3,4: 7 days after revacc at 1 year (up to Day 372); Arm 5,6,7,8,9: 7 days after revacc at 2 years (up to Day 737); Arms 10,11,12,13,14: 7 days after revacc at 3 year (up to Day 1102)
ID
Title
Description
OG000
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
Secondary
Revaccination Subcohorts: Number of Participants With Unsolicited AEs 28 Days After Re-vaccination up to 1, 2 and 3 Years
An AE was 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. Unsolicited adverse events included all adverse events for which the participant is not specifically questioned in the participant diary.
The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Arms 3,4: 28 days after revacc at 1 year (up to Day 393); Arms 5,6,7,8,9: 28 days after revacc at 2 years (up to Day 758); Arms 10,11,12,13,14: 28 days after revaccination at 3 year (up to Day 1123)
ID
Title
Description
OG000
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
OG001
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
Secondary
Revaccination Subcohorts: Number of Participants With Adverse Events of Special Interests (AESI)
Number of participants with AESIs were reported. An AE was 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. Thrombosis with thrombocytopenia syndrome (TTS) was considered as an AESI.
The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Arms 3,4: 6 months after revacc at 1 year (up to Day 547); Arm 5,6,7,8,9: 6 months after revacc at 2 years (up to Day 912); Arms 10,11,12,13,14: 6 months after revacc at 3 year (up to Day 1277)
ID
Title
Description
OG000
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
OG001
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
Secondary
Main Cohorts:Number of Participants With Serious Adverse Events (SAEs)
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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. For participants who were not revaccinated only SAEs associated with ARIs and complications related to ARIs that classify as SAEs, SAEs classified as related, SAEs resulting in death, and (S)AEs resulting in study discontinuation or from procedures and non-investigational (concomitant) Janssen products were collected.
The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
From Day 1 up to Day 1095
ID
Title
Description
OG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Secondary
Revaccination Subcohorts: Number of Participants With Serious Adverse Events (SAEs)
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. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.
The FAS included all randomized participants with a documented vaccine administration, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Arms 3,4: 6 months after revacc at 1 year (up to Day 547); Arm 5,6,7,8,9: 6 months after revacc at 2 years (up to Day 912); Arms 10,11,12,13,14: 6 months after revacc at 3 year (up to Day 1277)
ID
Title
Description
OG000
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
OG001
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
Secondary
Main Cohorts: Geometric Mean Titers (GMTs) of Prefusion F-protein (Pre-F) A Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
GMTs of preF-A antibodies after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA were reported.
PPI: all randomized and vaccinated participants who were part of immunogenicity subset and for whom immunogenicity data were available. Here, 'N' (Overall number of participants analyzed)=participants who were evaluable for this outcome measure, "n"=participants evaluable for specific timepoints.
Posted
Geometric Mean
95% Confidence Interval
Titers
Days 15, 85, 169, 365, 533
ID
Title
Description
OG000
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
OG001
Arm 2: Main Cohort: Group 2: Placebo
Time Frame
All-cause mortality: Day 1 to Day 1095 (Arms 1, 2); Day 365 to Day 730 (Arms 3, 4); Day 730 to Day 1095 (Arms 5 to 9); Day 1095 to Day 1460 (Arms 10 to 14); Serious/other AEs: Day 1 to Day 1095 (Arms 1, 2), 6 months after revacc at Day 365 (Arms 3, 4): up to Day 547, 6 months after revacc at Day 730 (Arms 5 to 9): up to Day 912, 6 months after revacc at Day 1095 (Arms 10 to 14): up to Day 1277
Description
All-cause mortality and SAEs analyzed based on FAS population which included all randomized participants with a documented vaccine administration, regardless of occurrence of protocol deviations. Other (not including serious) AEs as solicited and unsolicited AEs were collected and analyzed in safety subset (subset of FAS) for main cohorts and in FAS for revaccination subcohorts. The safety subset included all participants that consented to the collection of AEs (solicited and unsolicited AEs).
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
Arm 1: Main Cohort: Group 1: Ad26.RSV.preF and RSV preF Protein (Protein Mixture)
Adult participants aged greater than or equal to (>=) 65 years received a single intramuscular (IM) injection 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) (protein mixture) on Day 1. Participants were divided into revaccination subcohorts: 1A, 1B, and 1C. Participants further received revaccination with the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 1A), 2 (Subcohort 1B), and 3 (Subcohort 1C) years, respectively after the first vaccination on Day 1. Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
39
2,891
203
2,891
186
348
EG001
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
38
2,891
196
2,891
90
347
EG002
Arm 3: Revaccination (ReVacc) Subcohort 1A: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort 1A and received IM injection of the protein mixture at the same dose level on Day 365. Participants were then followed up for safety assessments till Day 730.
1
120
2
120
47
120
EG003
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
0
126
6
126
47
126
EG004
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
0
28
0
28
15
28
EG005
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
0
28
3
28
21
28
EG006
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
0
28
1
28
21
28
EG007
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 730. Participants were then followed up for safety assessments till Day 1095.
0
137
4
137
110
137
EG008
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730. Participants were then followed up for safety assessments till Day 1095.
2
149
6
149
111
149
EG009
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by Ad26.RSV.preF 1*10^11 vp alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
0
37
2
37
30
37
EG010
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by RSV preF protein 150 mcg alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
0
37
0
37
22
37
EG011
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Days 730 and Day 1095. Participants were then followed up for safety assessments till Day 1460.
0
37
0
37
34
37
EG012
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 1095. Participants were then followed up for safety assessments till Day 1460.
0
131
2
131
107
131
EG013
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1095. Participants were then followed up for safety assessments till Day 1460.
1
119
2
119
84
119
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG0030 affected126 at risk
EG0040 affected28 at risk
EG0050 affected28 at risk
EG0060 affected28 at risk
EG0070 affected137 at risk
EG0080 affected149 at risk
EG0090 affected37 at risk
EG0100 affected37 at risk
EG0110 affected37 at risk
EG0120 affected131 at risk
EG0130 affected119 at risk
Blood Loss Anaemia
Blood and lymphatic system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Splenic Infarction
Blood and lymphatic system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Acute Coronary Syndrome
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Acute Left Ventricular Failure
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Aortic Valve Disease
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Aortic Valve Stenosis
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Arteriosclerosis Coronary Artery
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG00010 affected2,891 at risk
EG0013 affected2,891 at risk
EG0020 affected120 at risk
EG003
Atrial Flutter
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cardiac Arrest
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0013 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cardiac Failure
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0009 affected2,891 at risk
EG0013 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0015 affected2,891 at risk
EG0020 affected120 at risk
EG003
Ischaemic Cardiomyopathy
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Left Ventricular Failure
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0008 affected2,891 at risk
EG0019 affected2,891 at risk
EG0020 affected120 at risk
EG003
Myocardial Ischaemia
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Stress Cardiomyopathy
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Ventricular Tachycardia
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Inappropriate Antidiuretic Hormone Secretion
Endocrine disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Duodenal Ulcer Haemorrhage
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Gastric Perforation
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0003 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Intestinal Perforation
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Large Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Obstructive Pancreatitis
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Oesophageal Obstruction
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Oesophageal Perforation
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pancreatic Cyst
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pancreatic Mass
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Rectal Prolapse
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Adverse Drug Reaction
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Asthenia
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Chest Discomfort
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Chest Pain
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0013 affected2,891 at risk
EG0020 affected120 at risk
EG003
Death
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0007 affected2,891 at risk
EG0014 affected2,891 at risk
EG0020 affected120 at risk
EG003
Drowning
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Generalised Oedema
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Multiple Organ Dysfunction Syndrome
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cirrhosis Alcoholic
Hepatobiliary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Abscess Neck
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Alpha Haemolytic Streptococcal Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Appendicitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Bronchitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Clostridium Difficile Colitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG00013 affected2,891 at risk
EG00113 affected2,891 at risk
EG0020 affected120 at risk
EG003
Covid-19 Pneumonia
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG00013 affected2,891 at risk
EG00116 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Device Related Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Diabetic Foot Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Gangrene
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Influenza
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Kidney Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Meningitis Aseptic
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Periorbital Cellulitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG00016 affected2,891 at risk
EG00110 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pneumonia Aspiration
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pneumonia Bacterial
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pneumonia Chlamydial
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pneumonia Mycoplasmal
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pneumonia Parainfluenzae Viral
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0003 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Septic Shock
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Streptococcal Sepsis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Carbon Monoxide Poisoning
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cervical Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Craniocerebral Injury
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Environmental Exposure
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Extradural Haematoma
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Facial Bones Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Fracture Displacement
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Head Injury
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0003 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hypobarism
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0003 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Post Procedural Complication
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Road Traffic Accident
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Scapula Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Spinal Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Subdural Haematoma
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0003 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Traumatic Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Wound Dehiscence
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Wrist Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Adult Failure to Thrive
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Diabetic Ketoacidosis
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cervical Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Chondrocalcinosis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Kyphoscoliosis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0007 affected2,891 at risk
EG0016 affected2,891 at risk
EG0020 affected120 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Abdominal Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Acute Myeloid Leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Adenocarcinoma of Colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Bladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Bladder Transitional Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Brain Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0013 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cancer Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Endometrial Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hepatic Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hepatocellular Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Her2 Positive Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Intraductal Proliferative Breast Lesion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0003 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Invasive Ductal Breast Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Lung Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Lung Carcinoma Cell Type Unspecified Stage Iii
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Lung Carcinoma Cell Type Unspecified Stage Iv
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Lung Neoplasm Malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0003 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Marginal Zone Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Metastases to Liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Metastatic Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Metastatic Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Non-Hodgkin's Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Non-Small Cell Lung Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Oesophageal Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Ovarian Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Ovarian Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pancreatic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pancreatic Carcinoma Stage Iv
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Papillary Serous Endometrial Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0004 affected2,891 at risk
EG0014 affected2,891 at risk
EG0020 affected120 at risk
EG003
Prostate Cancer Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Renal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Renal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Small Cell Lung Cancer Extensive Stage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Throat Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Transitional Cell Cancer of the Renal Pelvis and Ureter
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Transitional Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Uterine Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Waldenstrom's Macroglobulinaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Ataxia
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Autonomic Neuropathy
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Carotid Artery Stenosis
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cerebral Haemorrhage
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cerebral Ischaemia
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0012 affected2,891 at risk
EG0021 affected120 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Intracranial Aneurysm
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0003 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Lacunar Infarction
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Lumbar Radiculopathy
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Metabolic Encephalopathy
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Myelopathy
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Peroneal Nerve Palsy
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0013 affected2,891 at risk
EG0020 affected120 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Seizure
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Subarachnoid Haemorrhage
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Toxic Encephalopathy
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0014 affected2,891 at risk
EG0020 affected120 at risk
EG003
Tremor
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Trigeminal Neuralgia
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Alcoholism
Psychiatric disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Bipolar Disorder
Psychiatric disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Depression Suicidal
Psychiatric disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Major Depression
Psychiatric disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Mental Status Changes
Psychiatric disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Acute Kidney Injury
Renal and urinary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0012 affected2,891 at risk
EG0021 affected120 at risk
EG003
Chronic Kidney Disease
Renal and urinary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0012 affected2,891 at risk
EG0020 affected120 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Neurogenic Bladder
Renal and urinary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Renal Failure
Renal and urinary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Renal Injury
Renal and urinary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Postmenopausal Haemorrhage
Reproductive system and breast disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Acute Respiratory Distress Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0007 affected2,891 at risk
EG0016 affected2,891 at risk
EG0020 affected120 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG00010 affected2,891 at risk
EG0014 affected2,891 at risk
EG0020 affected120 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0003 affected2,891 at risk
EG0015 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pulmonary Fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pulmonary Haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Pulmonary Oedema
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Rotator Cuff Repair
Surgical and medical procedures
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Aortic Aneurysm
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Aortic Stenosis
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Endothelial Dysfunction
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hypertensive Urgency
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Hypotension
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Peripheral Arterial Occlusive Disease
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0010 affected2,891 at risk
EG0020 affected120 at risk
EG003
Peripheral Ischaemia
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Vascular Compression
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected2,891 at risk
EG0011 affected2,891 at risk
EG0020 affected120 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG0030 affected126 at risk
EG004
Angina Pectoris
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Aortic Valve Incompetence
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Atrial Flutter
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Mitral Valve Incompetence
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Tricuspid Valve Incompetence
Cardiac disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0004 affected348 at risk
EG0011 affected347 at risk
EG0020 affected120 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Nausea (Solicited)
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG00031 affected348 at risk
EG0017 affected347 at risk
EG0024 affected120 at risk
EG003
Plicated Tongue
Gastrointestinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Fatigue (Solicited)
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG00095 affected348 at risk
EG00142 affected347 at risk
EG00219 affected120 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Pyrexia (Solicited)
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG00015 affected348 at risk
EG0010 affected347 at risk
EG0023 affected120 at risk
EG003
Vaccination Site Erythema (Solicited)
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG00022 affected348 at risk
EG0017 affected347 at risk
EG0028 affected120 at risk
EG003
Vaccination Site Pain (Solicited)
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG000120 affected348 at risk
EG00124 affected347 at risk
EG00237 affected120 at risk
EG003
Vaccination Site Swelling (Solicited)
General disorders
MedDRA Version 25.1
Non-systematic Assessment
EG00012 affected348 at risk
EG0016 affected347 at risk
EG0028 affected120 at risk
EG003
Candida Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG00013 affected348 at risk
EG00114 affected347 at risk
EG0023 affected120 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0008 affected348 at risk
EG00110 affected347 at risk
EG0020 affected120 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected348 at risk
EG0014 affected347 at risk
EG0020 affected120 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Heart Rate Irregular
Investigations
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0011 affected347 at risk
EG0020 affected120 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected348 at risk
EG0010 affected347 at risk
EG0021 affected120 at risk
EG003
Myalgia (Solicited)
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG00095 affected348 at risk
EG00130 affected347 at risk
EG00218 affected120 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0011 affected347 at risk
EG0020 affected120 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Diabetic Neuropathy
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0002 affected348 at risk
EG0015 affected347 at risk
EG0020 affected120 at risk
EG003
Headache (Solicited)
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG00083 affected348 at risk
EG00130 affected347 at risk
EG00221 affected120 at risk
EG003
Radicular Pain
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Sciatica
Nervous system disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Nasal Polyps
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Sleep Apnoea Syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0001 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Tooth Extraction
Surgical and medical procedures
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 25.1
Non-systematic Assessment
EG0000 affected348 at risk
EG0010 affected347 at risk
EG0020 affected120 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 with hold such publication for up to an additional 60 days.
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Units
Counts
Participants
OG0002791
OG0012801
Title
Denominators
Categories
Title
Measurements
OG00013
OG00143
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Units
Counts
Participants
OG00095
OG00196
Title
Denominators
Categories
Day 15
ParticipantsOG00095
ParticipantsOG00191
Title
Measurements
OG0006761(5478 to 8346)
OG001516(443 to 602)
Day 85
ParticipantsOG00094
ParticipantsOG00196
Title
Measurements
OG0004963(4053 to 6077)
OG001
Day 169
ParticipantsOG00094
ParticipantsOG00193
Title
Measurements
OG0003057(2523 to 3703)
OG001
Day 365
ParticipantsOG00081
ParticipantsOG00172
Title
Measurements
OG0001546(1235 to 1936)
OG001
OG002
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG003
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG004
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
Units
Counts
Participants
OG000117
OG001120
OG00226
OG00328
OG00427
Title
Denominators
Categories
Day 15
ParticipantsOG000111
ParticipantsOG001116
ParticipantsOG00226
ParticipantsOG00324
ParticipantsOG00427
Title
Measurements
OG0005508(4695 to 6460)
OG001421(374 to 475)
OG002357(281 to 454)
OG003
Day 365
ParticipantsOG000117
ParticipantsOG001120
ParticipantsOG00225
ParticipantsOG00328
Day 379
ParticipantsOG00090
ParticipantsOG001100
ParticipantsOG00223
ParticipantsOG00324
Day 393
ParticipantsOG00097
ParticipantsOG00199
ParticipantsOG00222
ParticipantsOG00320
Day 449
ParticipantsOG000109
ParticipantsOG001105
ParticipantsOG00222
ParticipantsOG00324
Day 730
ParticipantsOG0000
ParticipantsOG00176
ParticipantsOG00224
ParticipantsOG00325
Day 737
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00221
ParticipantsOG00323
Day 744
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00219
ParticipantsOG00319
Day 758
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00215
ParticipantsOG00316
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
OG002
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG003
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG004
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
OG005
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG006
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1095. Participants were then followed up for safety assessments till Day 1460.
Units
Counts
Participants
OG000117
OG001120
OG00226
OG00328
OG00427
OG005127
OG006114
Title
Denominators
Categories
Day 15
ParticipantsOG000111
ParticipantsOG001116
ParticipantsOG00226
ParticipantsOG00324
ParticipantsOG00427
ParticipantsOG005125
ParticipantsOG006112
Title
Measurements
OG0004091(3540 to 4728)
OG001301(269 to 336)
OG002258(203 to 328)
OG003
Day 365
ParticipantsOG000117
ParticipantsOG001120
ParticipantsOG00225
ParticipantsOG00328
Day 379
ParticipantsOG00090
ParticipantsOG001100
ParticipantsOG00223
ParticipantsOG00324
Day 393
ParticipantsOG00097
ParticipantsOG00199
ParticipantsOG00222
ParticipantsOG00320
Day 449
ParticipantsOG000109
ParticipantsOG001105
ParticipantsOG00222
ParticipantsOG00324
Day 533
ParticipantsOG00095
ParticipantsOG00199
ParticipantsOG00220
ParticipantsOG00324
Day 730
ParticipantsOG0000
ParticipantsOG00175
ParticipantsOG00224
ParticipantsOG00325
Day 737
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00221
ParticipantsOG00323
Day 744
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00219
ParticipantsOG00319
Day 758
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00215
ParticipantsOG00316
Day 1095
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Day 1109
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG002
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
Units
Counts
Participants
OG00012
OG00124
OG00216
Title
Denominators
Categories
Day 730
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00216
Title
Measurements
OG000129(34 to 320)
OG001198(34 to 1035)
OG002168(34 to 795)
Day 744
ParticipantsOG00011
ParticipantsOG00118
ParticipantsOG00215
Title
Measurements
OG000
Day 758
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG00212
Title
Measurements
OG000
OG001
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Units
Counts
Participants
OG00091
OG00187
Title
Denominators
Categories
Day 15
ParticipantsOG00076
ParticipantsOG00176
Title
Measurements
OG000444(279 to 641)
OG00134(34 to 34)
Day 85
ParticipantsOG00090
ParticipantsOG00187
Title
Measurements
OG000274(173 to 471)
OG001
Day 169
ParticipantsOG00091
ParticipantsOG00187
Title
Measurements
OG000201(123 to 324)
OG001
Day 365
ParticipantsOG00075
ParticipantsOG00166
Title
Measurements
OG000182(110 to 297)
OG001
Day 533
ParticipantsOG00059
ParticipantsOG00156
Title
Measurements
OG000143(96 to 238)
OG001
OG001
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Units
Counts
Participants
OG000341
OG001334
Title
Denominators
Categories
Title
Measurements
OG000132
OG00129
OG001
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Units
Counts
Participants
OG000341
OG001334
Title
Denominators
Categories
Title
Measurements
OG000143
OG00158
OG001
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Units
Counts
Participants
OG000348
OG001347
Title
Denominators
Categories
Title
Measurements
OG00058
OG00150
OG001
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
OG002
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG003
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG004
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
OG005
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG006
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG007
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by Ad26.RSV.preF 1*10^11 vp alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG008
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by RSV preF protein 150 mcg alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG009
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Days 730 and Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG010
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG011
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1095. Participants were then followed up for safety assessments till Day 1460.
Units
Counts
Participants
OG000119
OG001126
OG00228
OG00327
OG00428
OG005137
OG006149
OG00737
OG00836
OG00937
OG010131
OG011118
Title
Denominators
Categories
Title
Measurements
OG00037
OG00131
OG0029
OG00318
OG00412
OG00597
OG00681
OG00726
OG00817
OG00929
OG01093
OG01164
OG001
Arm 4: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein Mixture
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
OG002
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG003
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG004
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
OG005
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG006
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG007
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by Ad26.RSV.preF 1*10^11 vp alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG008
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by RSV preF protein 150 mcg alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG009
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Days 730 and Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG010
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG011
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1095. Participants were then followed up for safety assessments till Day 1460.
Units
Counts
Participants
OG000119
OG001126
OG00228
OG00327
OG00428
OG005137
OG006149
OG00737
OG00836
OG00937
OG010131
OG011118
Title
Denominators
Categories
Title
Measurements
OG00035
OG00136
OG0027
OG00315
OG00410
OG00579
OG00685
OG00716
OG00812
OG00925
OG01080
OG01170
OG002
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG003
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG004
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
OG005
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG006
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG007
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by Ad26.RSV.preF 1*10^11 vp alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG008
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by RSV preF protein 150 mcg alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG009
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Days 730 and Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG010
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG011
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1095. Participants were then followed up for safety assessments till Day 1460.
Units
Counts
Participants
OG000120
OG001126
OG00228
OG00328
OG00428
OG005137
OG006149
OG00737
OG00837
OG00937
OG010131
OG011119
Title
Denominators
Categories
Title
Measurements
OG0006
OG00110
OG0024
OG0035
OG0048
OG00512
OG00616
OG0074
OG0083
OG0094
OG01011
OG01110
OG002
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG003
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG004
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
OG005
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG006
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG007
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by Ad26.RSV.preF 1*10^11 vp alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG008
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by RSV preF protein 150 mcg alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG009
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Days 730 and Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG010
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG011
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1095. Participants were then followed up for safety assessments till Day 1460.
Units
Counts
Participants
OG000120
OG001126
OG00228
OG00328
OG00428
OG005137
OG006149
OG00737
OG00837
OG00937
OG010131
OG011119
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
OG001
Arm 2: Main Cohort: Group 2: Placebo
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.
Units
Counts
Participants
OG0002891
OG0012891
Title
Denominators
Categories
Title
Measurements
OG000203
OG001196
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365. Participants were then followed up for safety assessments till Day 730.
OG002
Arm 5: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.PreF Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 in the revaccination subcohort further received Ad26.RSV.preF 1*10^11 vp alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG003
Arm 6: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort followed by Ad26.RSV.preF 1*10^11 vp and RSV preF protein (protein mixture) on Day 365 in the revaccination subcohort further received RSV preF protein 150 mcg alone as IM injection on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG004
Arm 7: ReVacc Subcohort 2A: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main study cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 365 and 730. Participants were then followed up for safety assessments till Day 1095.
OG005
Arm 8: ReVacc Subcohort 1B: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG006
Arm 9: ReVacc Subcohort 2B:Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730. Participants were then followed up for safety assessments till Day 1095.
OG007
Arm 10: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + Ad26.RSV.preF
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by Ad26.RSV.preF 1*10^11 vp alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG008
Arm 11: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein + RSV preF Protein Alone
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 730 followed by RSV preF protein 150 mcg alone on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG009
Arm 12: ReVacc Subcohort 2B: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Days 730 and Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG010
Arm 13: ReVacc Subcohort 1C: Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1 in the main cohort entered the revaccination subcohort and received the protein mixture at the same dose level on Day 1095. Participants were then followed up for safety assessments till Day 1460.
OG011
Arm 14: ReVacc Subcohort 2C: Placebo to Ad26.RSV.preF/RSV preF Protein (Protein Mixture)
Eligible participants who received IM injection of placebo on Day 1 in the main cohort entered the revaccination subcohort and received IM injection of Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) on Day 1095. Participants were then followed up for safety assessments till Day 1460.
Units
Counts
Participants
OG000120
OG001126
OG00228
OG00328
OG00428
OG005137
OG006149
OG00737
OG00837
OG00937
OG010131
OG011119
Title
Denominators
Categories
Title
Measurements
OG0002
OG0016
OG0020
OG0033
OG0041
OG0054
OG0066
OG0072
OG0080
OG0090
OG0102
OG0112
Adult participants aged >=65 years received a single IM injection of placebo on Day 1. Participants were divided into revaccination subcohorts: 2A, 2B, and 2C. Participants further received revaccination with Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture) at 1 (Subcohort 2A), 2 (Subcohort 2B), and 3 (Subcohort 2C) years, respectively after the first vaccination on Day 1. Participants in subcohorts 2A and 2B were additionally re-randomised in three groups at Year 3 and Year 4, respectively, to receive either Ad26.RSV.preF 1*10^11 vp alone, RSV preF protein 150 mcg alone or the Ad26.RSV.preF 1*10^11 vp and RSV preF protein 150 mcg (protein mixture). Participants who were not re-vaccinated continued in the main cohort and were followed up for safety assessments until Day 1095.