A Study to Evaluate the Safety and Immunogenicity for Reg... | NCT03502707 | Trialant
NCT03502707
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
May 25, 2025Actual
Enrollment
669Actual
Phase
Phase 1Phase 2
Conditions
Healthy
Interventions
Placebo
RSV preF Protein 50 mcg
RSV preF Protein 150 mcg
Ad26.RSV.preF 1*10^11 vp
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
Selected Regimen
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03502707
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108456
Secondary IDs
ID
Type
Description
Link
VAC18193RSV1004
Other Identifier
Janssen Vaccines & Prevention B.V.
Brief Title
A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
Official Title
A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
Acronym
Not provided
Organization
Janssen Vaccines & Prevention B.V.INDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 6, 2018Actual
Primary Completion Date
May 16, 2022Actual
Completion Date
May 16, 2022Actual
First Submitted Date
Apr 11, 2018
First Submission Date that Met QC Criteria
Apr 11, 2018
First Posted Date
Apr 19, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Aug 14, 2023
Results First Submitted that Met QC Criteria
Aug 14, 2023
Results First Posted Date
Sep 13, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 15, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
May 19, 2023Actual
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)
No
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 for:
Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3.
Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen.
Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
669Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort (C)1 Group (G)1: Placebo for RSV preF Protein
Placebo Comparator
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
Biological: Placebo
C1 G2: RSV preF Protein
Experimental
Participants will receive intramuscular injection of 50 microgram (mcg) RSV preF protein on Day 1, Day 57 and at Month 12.
Biological: RSV preF Protein 50 mcg
C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein
Placebo Comparator
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
Biological: Placebo
C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein
Experimental
Participants will receive intramuscular injection of a mixture of 5*10^10 viral particles (vp) of Ad26.RSV.preF/RSV preF 50 mcg protein on Day 1, Day 57 and at Month 12.
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
C1 G5: RSV preF Protein
Experimental
Participants will receive intramuscular injection of 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Biological
Placebo for Ad26.RSV.preF, RSV preF protein, Ad26.RSV.preF/RSV preF protein mixture and selected regimen will be administered as sterile saline for intramuscular injection.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cohort 1: 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 outcome measure was planned to be analyzed for specified arms only.
From Day 1 up to Day 730
Cohort 2 (Groups 11-13 and 16-18): 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 outcome measure was planned to be analyzed for specified arms only.
From Day 1 up to Day 730
Cohort 2 (Groups 14-15): 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 outcome measure was planned to be analyzed for specified arms only.
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 1 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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
In the investigator's clinical judgment, participant must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are medically controlled. If they are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
For participants in Cohorts 1 and 2 only: Participant must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the central laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the United States (US) Food and Drug Administration (FDA) toxicity, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
From the time of each vaccination through 3 months after each vaccination, participant agrees not to donate blood
Participant must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
Exclusion Criteria:
Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has chronic active hepatitis B or hepatitis C infection, documented by hepatitis B surface antigen and hepatitis C antibody, respectively
Per serology testing in Cohorts 1 and 2 and per medical history in Cohort 3: Participant has human immunodeficiency virus (HIV) type 1 or type 2 infection
Participant has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
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)
Participant has received respiratory syncytial virus (RSV) vaccine in a previous RSV vaccine study at any time prior to randomization
Comeaux CA, Bart S, Bastian AR, Klyashtornyy V, De Paepe E, Omoruyi E, van der Fits L, van Heesbeen R, Heijnen E, Callendret B, Sadoff J. Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-Based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. J Infect Dis. 2024 Jan 12;229(1):19-29. doi: 10.1093/infdis/jiad220.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein
Placebo Comparator
Participants will receive intramuscular injection of placebo on Day 1, Day 57 and at Month 12.
Biological: Placebo
C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein
Experimental
Participants will receive intramuscular injection of a mixture of 5*10^10 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein on Day 1, Day 57 and at Month 12.
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Placebo Comparator
Participants will receive intramuscular injection of placebo on Day 1 and at Month 12 and in only 1 arm on Day 57.
Biological: Placebo
C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental
Participants will receive intramuscular injection of a mixture of 1*10^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and at Month 12 and placebo in another arm on Day 1 and at Month 12.
Biological: Placebo
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
Experimental
Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and at Month 12 and placebo in 1 arm on Day 57.
Biological: Placebo
Biological: RSV preF Protein 150 mcg
Biological: Ad26.RSV.preF 1*10^11 vp
C2 G11: Ad26.RSV.preF and Placebo
Experimental
Participants will receive intramuscular injection of 1*10^11 vp of Ad26.RSV.preF in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Biological: Placebo
Biological: Ad26.RSV.preF 1*10^11 vp
C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental
Participants will receive intramuscular injection of a mixture of 5*10^10 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Biological: Placebo
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental
Participants will receive intramuscular injection of a mixture of 1*10^11 vp Ad26.RSV.preF plus 50 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Biological: Placebo
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental
Participants will receive intramuscular injection of a mixture of 1*10^11 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Biological: Placebo
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental
Participants will receive intramuscular injection of a mixture of 5*10^10 vp Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm and placebo in another arm on Day 1 and placebo in 1 arm on Day 57.
Biological: Placebo
Biological: Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
Experimental
Data from C1 G10 will be pooled with those of C2 G16. Participants will receive separate intramuscular injections of 1*10^11 vp of Ad26.RSV.preF in 1 Arm and 150 mcg RSV preF protein in another arm on Day 1 and placebo in 1 arm on Day 57.
Biological: Placebo
Biological: RSV preF Protein 150 mcg
Biological: Ad26.RSV.preF 1*10^11 vp
C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Experimental
Data from C1 G9 will be pooled with those of C2 G17. Participants will receive intramuscular injection of a mixture of 1*10^11 vp of Ad26.RSV.preF plus 150 mcg RSV preF protein in 1 arm on Day 1 and 57 and placebo in another arm on Day 1.
Biological: Placebo
Biological: Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
Placebo Comparator
Participants will receive intramuscular injection of placebo in separate arms on Day 1 and in only 1 arm on Day 57.
Biological: Placebo
C3 G19: Selected Regimen (SR)
Experimental
If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and a booster (the SR) at Month 12 and month 24. The participants who are randomized to two-dose regimen will receive SR on Day 1 and Day 57, and a booster (the selected regimen) at Month 12.
Biological: Selected Regimen
C3 G20: SR + Placebo for SR
Experimental
If a one-dose regimen is selected, participants in this group will receive SR on Day 1 and Month 24, and a placebo at Month 12. The participants who are randomized to two-dose regimen will receive selected regimen on Day 1 and Day 57, and a placebo at Month 12.
Biological: Placebo
Biological: Selected Regimen
C3 G21: Placebo for SR
Placebo Comparator
If a one-dose regimen is selected, participants in this group will receive placebo for SR on Day 1 and at Month 12 and Month 24. The participants who are randomized to two-dose regimen will receive placebo for SR on Day 1, Day 57, and Month 12.
Biological: Placebo
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
C1 G3: Placebo for Ad26.RSV.preF/RSV preF or RSV preF Protein
C1 G6: Mixture of Placebo for Ad26.RSV.preF/RSV preF Protein
C1 G8: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
C2 G11: Ad26.RSV.preF and Placebo
C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
C2 G18: Placebo for Ad26.RSV.preF/Placebo for RSV preF Protein
C3 G20: SR + Placebo for SR
C3 G21: Placebo for SR
Cohort (C)1 Group (G)1: Placebo for RSV preF Protein
RSV preF Protein 50 mcg
Biological
RSV preF will be administered as a solution for intramuscular injection at a dose of 50 mcg.
C1 G2: RSV preF Protein
JNJ-64213175
RSV preF Protein 150 mcg
Biological
RSV preF will be administered as a solution for intramuscular injection at a dose of 150 mcg.
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
C1 G5: RSV preF Protein
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
JNJ-64213175
Ad26.RSV.preF 1*10^11 vp
Biological
Ad26.RSV.preF will be administered as a solution for intramuscular injection at a dose of 1*10^11 vp.
C1 G10: Ad26.RSV.preF, RSV preF Protein and Placebo
C2 G11: Ad26.RSV.preF and Placebo
C2 G16: Ad26.RSV.preF, RSV preF Protein and Placebo
JNJ-64400141
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
Biological
Mixture of Ad26.RSV.preF (5*10^10 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
C1 G4: Mixture of Ad26.RSV.preF/RSV preF Protein
C2 G12: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
Biological
Mixture of Ad26.RSV.preF (5*10^10 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
C1 G7: Mixture of Ad26.RSV.preF/RSV preF Protein
C2 G15: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
Biological
Mixture of Ad26.RSV.preF (1*10^11 vp) and RSV preF protein (50 mcg) will be administered as a solution for intramuscular injection.
C2 G13: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
Biological
Mixture of Ad26.RSV.preF (1*10^11 vp) and RSV preF protein (150 mcg) will be administered as a solution for intramuscular injection.
C1 G9: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
C2 G14: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
C2 G17: Mixture of Ad26.RSV.preF/RSV preF Protein and Placebo
Selected Regimen
Biological
A regimen from Cohort 1 or Cohort 2 will be selected and administered as a solution for intramuscular injection at the selected dose.
C3 G19: Selected Regimen (SR)
C3 G20: SR + Placebo for SR
From Day 1 up to Day 1095
Cohort 3: 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 outcome measure was planned to be analyzed for specified arms only.
From Day 1 up to Day 1095
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
7 days post-vaccination 1 on Day 1 (Day 8)
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
7 days post-vaccination 2 on Day 57 (Day 64)
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
7 days post-vaccination 3 on Day 365 (Day 372)
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
7 days post-vaccination 1 on Day 1 (Day 8)
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
7 days post-vaccination 2 on Day 57 (Day 64)
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
7 days post-vaccination 1 on Day 1 (Day 8)
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
7 days post-vaccination 2 on Day 365 (Day 372)
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
7 days post-vaccination 3 on Day 730 (Day 737)
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
28 days post-vaccination 1 on Day 1 (Day 29)
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
28 days post-vaccination 2 on Day 57 (Day 85)
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
28 days post-vaccination 3 on Day 365 (Day 393)
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
28 days post-vaccination 1 on Day 1 (Day 29)
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
28 days post-vaccination 2 on Day 57 (Day 85)
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
28 days post-vaccination 1 on Day 1 (Day 29)
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
28 days post-vaccination 2 on Day 365 (Day 393)
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
28 days post-vaccination 3 on Day 730 (Day 758)
Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29
RSV A2 Strain neutralization antibody titers on Day 29 was reported. Geometric mean titers (GMTs) of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be analyzed for specified arms only.
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 3 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29
RSV A2 strain neutralization antibody titers on Day 29 in Group 16 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.
Day 29
Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85
RSV A2 strain neutralization antibody titers on Day 85 in Group 17 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.
Day 85
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (ELISA units per liter [EU/L]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 1 were reported.
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (ELISA units per liter [EU/L]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 2 were reported.
Days 1, 15, 29, 57, 85, 183, 365, and 547
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 1 were reported.
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 2 were reported.
Days 1, 15, 29, 57, 85, 183, 365, and 547
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 1 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was Spot forming units (SFU)/10^6 peripheral blood mononuclear cells (PBMCs).
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 3 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was SFU/10^6 PBMCs.
Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758
Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot Assay on Day 29 in Groups 11-16 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.
Day 29
Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85
Breadth of IFN-gamma T-Cells responses analyzed by ELISpot assay on Day 85 in Group 17 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.
Day 85
San Diego
California
92108
United States
Optimal Research
Melbourne
Florida
32934
United States
Optimal Research
Peoria
Illinois
61614
United States
Optimal Research
Rockville
Maryland
20850
United States
Optimal Research
Austin
Texas
78705
United States
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
FG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
FG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
FG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
FG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
FG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
FG007
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
FG008
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2.
FG009
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2.
FG010
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2.
FG011
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.
FG012
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2.
FG013
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
FG014
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2.
FG015
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
FG016
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3.
FG017
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
FG00016 subjects
FG0018 subjects
FG0028 subjects
FG0038 subjects
FG0048 subjects
FG0058 subjects
FG0068 subjects
FG00724 subjects
FG00842 subjects
FG00942 subjects
FG01042 subjects
FG01143 subjects
FG01236 subjects
FG01336 subjects
FG01424 subjects
FG015135 subjects
FG016136 subjects
FG01745 subjects
Randomized and Vaccinated (Full Analysis Set)
FG00016 subjects
FG0018 subjects
FG0028 subjects
FG0038 subjects
FG0048 subjects
FG0058 subjects
FG0068 subjects
FG00724 subjects
FG00842 subjects
FG00942 subjects
FG01042 subjects
FG01142 subjects
FG01236 subjects
FG01336 subjects
FG01424 subjects
FG015135 subjects
FG016136 subjects
FG01744 subjects
COMPLETED
FG00014 subjects
FG0017 subjects
FG0028 subjects
FG0037 subjects
FG0048 subjects
FG0056 subjects
FG0068 subjects
FG00716 subjects
FG00837 subjects
FG00934 subjects
FG01027 subjects
FG01117 subjects
FG01229 subjects
FG01332 subjects
FG01420 subjects
FG01576 subjects
FG01675 subjects
FG01724 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
FG0078 subjects
FG0085 subjects
FG0098 subjects
FG01015 subjects
FG01126 subjects
FG0127 subjects
FG0134 subjects
FG0144 subjects
FG01559 subjects
FG01661 subjects
FG01721 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 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
FG0140 subjects
FG0151 subjects
FG0165 subjects
FG0170 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor's Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Initiated Prohibited Medication
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Randomized but not vaccinated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
BG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
BG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
BG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
BG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
BG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
BG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
BG007
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
BG008
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2.
BG009
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2.
BG010
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2.
BG011
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.
BG012
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2.
BG013
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
BG014
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2.
BG015
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
BG016
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3.
BG017
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00016
BG0018
BG0028
BG0038
BG0048
BG0058
BG0068
BG00724
BG00842
BG00942
BG01042
BG01142
BG01236
BG01336
BG01424
BG015135
BG016136
BG01744
BG018667
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
BG00067.4± 7.22
BG00167± 6.05
BG00267.4± 6.21
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
UNITED STATES
Title
Measurements
BG00016
BG0018
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
Cohort 1: 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 outcome measure was planned to be analyzed for specified arms only.
The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Posted
Count of Participants
Participants
From Day 1 up to Day 730
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00016
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0020
OG003
Primary
Cohort 2 (Groups 11-13 and 16-18): 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 outcome measure was planned to be analyzed for specified arms only.
The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Posted
Count of Participants
Participants
From Day 1 up to Day 730
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
OG001
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2.
Primary
Cohort 2 (Groups 14-15): 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 outcome measure was planned to be analyzed for specified arms only.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Posted
Count of Participants
Participants
From Day 1 up to Day 1095
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2.
OG001
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Primary
Cohort 3: 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 outcome measure was planned to be analyzed for specified arms only.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Posted
Count of Participants
Participants
From Day 1 up to Day 1095
ID
Title
Description
OG000
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
OG001
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3.
Primary
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local (injection site) AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Posted
Count of Participants
Participants
7 days post-vaccination 1 on Day 1 (Day 8)
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
OG001
Primary
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post-vaccination 2 on Day 57 (Day 64)
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
Primary
Cohort 1: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post-vaccination 3 on Day 365 (Day 372)
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
Primary
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Posted
Count of Participants
Participants
7 days post-vaccination 1 on Day 1 (Day 8)
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
OG001
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Primary
Cohort 2: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post-vaccination 2 on Day 57 (Day 64)
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
Primary
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 1
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post-vaccination 1 on Day 1 (Day 8)
ID
Title
Description
OG000
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
Primary
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 2
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post-vaccination 2 on Day 365 (Day 372)
ID
Title
Description
OG000
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
Primary
Cohort 3: Number of Participants With Solicited Local (Injection Site) and Systemic AEs at 7 Days Post-vaccination 3
Number of participants with solicited local and systemic AEs at 7 days post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, are used to assess the reactogenicity of the study vaccine and are pre-defined local (injection site). Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
7 days post-vaccination 3 on Day 730 (Day 737)
ID
Title
Description
OG000
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
Primary
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Posted
Count of Participants
Participants
28 days post-vaccination 1 on Day 1 (Day 29)
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
Primary
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
28 days post-vaccination 2 on Day 57 (Day 85)
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
Primary
Cohort 1: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
28 days post-vaccination 3 on Day 365 (Day 393)
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
Primary
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
Posted
Count of Participants
Participants
28 days post-vaccination 1 on Day 1 (Day 29)
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
OG001
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 12 of Cohort 2.
Primary
Cohort 2: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
28 days post-vaccination 2 on Day 57 (Day 85)
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
OG001
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 12 of Cohort 2.
Primary
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 1
Number of participants with unsolicited AEs post-vaccination 1 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
28 days post-vaccination 1 on Day 1 (Day 29)
ID
Title
Description
OG000
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
OG001
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24, followed by matching placebo alone on Month 12 in Group 20 of Cohort 3.
Primary
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 2
Number of participants with unsolicited AEs post-vaccination 2 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
28 days post-vaccination 2 on Day 365 (Day 393)
ID
Title
Description
OG000
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
OG001
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24, followed by matching placebo alone on Month 12 in Group 20 of Cohort 3.
Primary
Cohort 3: Number of Participants With Unsolicited AEs at 28 Days Post-vaccination 3
Number of participants with unsolicited AEs post-vaccination 3 in Cohort 3 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant diary.
The FAS included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
28 days post-vaccination 3 on Day 730 (Day 758)
ID
Title
Description
OG000
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
OG001
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24, followed by matching placebo alone on Month 12 in Group 20 of Cohort 3.
Primary
Cohort 2 (Group 11 to 15): Respiratory Syncytial Virus (RSV) A2 Strain Neutralization Antibody Titers on Day 29
RSV A2 Strain neutralization antibody titers on Day 29 was reported. Geometric mean titers (GMTs) of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be analyzed for specified arms only.
The per-protocol RSV immunogenicity (PPI) set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 29
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
OG001
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 12 of Cohort 2.
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 1 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
Titers
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
RSV A2 strain neutralization antibody titers at specified timepoints in Cohort 3 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
OG001
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24, followed by matching placebo alone on Month 12 in Group 20 of Cohort 3.
Secondary
Cohort 2 (Group 16): RSV A2 Strain Neutralization Antibody Titers on Day 29
RSV A2 strain neutralization antibody titers on Day 29 in Group 16 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 29
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 16 of Cohort 2.
Units
Counts
Participants
OG000
Secondary
Cohort 2 (Group 17): RSV A2 Strain Neutralization Antibody Titers on Day 85
RSV A2 strain neutralization antibody titers on Day 85 in Group 17 of Cohort 2 was reported. The GMTs of RSV A2 neutralizing antibodies were measured using the neutralization assay. The outcome measure was planned to be reported for specified arms only.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 85
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
Units
Counts
Participants
OG000
Secondary
Cohort 1: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (ELISA units per liter [EU/L]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 1 were reported.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
EU/L
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Secondary
Cohort 2: Pre-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (ELISA units per liter [EU/L]) of RSV F-protein in pre-fusion form as assessed by ELISA at specified timepoints as assessed by ELISA at specified timepoints in Cohort 2 were reported.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
EU/L
Days 1, 15, 29, 57, 85, 183, 365, and 547
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
OG001
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 12 of Cohort 2.
Secondary
Cohort 1: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 1 were reported.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
EU/L
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Secondary
Cohort 2: Post-Fusion RSV Fusion Protein (F-protein) Geometric Mean Titers (GMTs) as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) at Specified Timepoints
GMT (EU/L) of RSV F-protein in post-fusion form as assessed by ELISA at specified timepoints for Cohort 2 were reported.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Posted
Geometric Mean
95% Confidence Interval
EU/L
Days 1, 15, 29, 57, 85, 183, 365, and 547
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
OG001
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 12 of Cohort 2.
OG002
Secondary
Cohort 1: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 1 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was Spot forming units (SFU)/10^6 peripheral blood mononuclear cells (PBMCs).
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Posted
Median
Full Range
SFU/10^6 PBMCs
Days 1, 15, 29, 57, 85, 183, 365, 393, and 547
ID
Title
Description
OG000
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6 of Cohort 1. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
Secondary
Cohort 3: Breadth of Interferon-gamma (IFN-gamma) T-Cells Responses Against RSV Analyzed by Enzyme-linked Immunospot (ELISpot) Assay at Specified Timepoints
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot assay at specified timepoints for Cohort 3 were reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The unit was SFU/10^6 PBMCs.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure. Here, 'n' (number analyzed) signifies participants evaluable for this outcome measure at specified timepoints.
Posted
Median
Full Range
SFU/10^6 PBMCs
Days 1, 15, 29, 57, 85, 183, 365, 393, 730, 744, and 758
ID
Title
Description
OG000
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
OG001
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24, followed by matching placebo alone on Month 12 in Group 20 of Cohort 3.
Secondary
Cohort 2 (Group 11-16): Breadth of IFN-gamma T-Cells Responses Against RSV Analyzed by ELISpot Assay on Day 29
Breadth of IFN-gamma T-Cells responses against RSV analyzed by ELISpot Assay on Day 29 in Groups 11-16 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.
The PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
SFU/10^6 PBMCs
Day 29
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
OG001
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 12 of Cohort 2.
Secondary
Cohort 2 (Group 17): Breadth of IFN-gamma T-Cells Responses Analyzed by ELISpot Assay on Day 85
Breadth of IFN-gamma T-Cells responses analyzed by ELISpot assay on Day 85 in Group 17 of Cohort 2 was reported. The ELISPOT assay for F protein-specific gamma interferon-producing T cells was performed using RSV F peptides. The outcome measure was planned to be analyzed for specified arms only.
PPI set included all participants who were randomized and received the complete first dose and for whom immunogenicity data were available. Here, 'N' (number of participants analyzed) signifies participants evaluable for this outcome measure.
Posted
Median
Full Range
SFU/10^6 PBMCs
Day 85
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
Units
Counts
Participants
OG000
Time Frame
From Day 1 up to 1095 days
Description
The full analysis set (FAS) included all participants who were randomized and received at least one dose of vaccine (active or placebo), regardless of the occurrence of protocol deviations or the type of vaccine.
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
Cohort 1: Pooled Placebo
Participants received a single intramuscular (IM) injection of placebo on Day 1, Day 57 and at Month 12 in Groups 1, 3, and 6. In Group 8, participants received single IM injection of placebo in each arm on Day 1 and at Month 12 and then a single placebo IM injection in one arm alone on Day 57.
0
16
3
16
5
16
EG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
0
8
0
8
5
8
EG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
0
8
0
8
2
8
EG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
1
8
2
8
2
8
EG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
0
8
3
8
4
8
EG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
0
8
0
8
6
8
EG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
0
8
0
8
4
8
EG007
Cohort 2: Ad26.RSV.preF 1*10^11 vp With Placebo and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and placebo in another arm on Day 1, followed by single IM injection of placebo alone on Day 57 in Group 11 of Cohort 2.
0
24
0
24
12
24
EG008
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 12 of Cohort 2.
1
42
5
42
14
42
EG009
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2.
1
42
5
42
14
42
EG010
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 14 of Cohort 2.
0
42
4
42
15
42
EG011
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.
0
42
5
42
10
42
EG012
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2.
1
36
7
36
10
36
EG013
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
0
36
3
36
15
36
EG014
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2.
0
24
4
24
10
24
EG015
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1, Month 12, and Month 24 in Group 19 of Cohort 3.
1
135
14
135
25
135
EG016
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24 and a placebo alone on Month 12 in Group 20 of Cohort 3.
0
136
16
136
27
136
EG017
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
0
44
3
44
13
44
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute Myocardial Infarction
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG0030 affected8 at risk
EG0040 affected8 at risk
EG0050 affected8 at risk
EG0060 affected8 at risk
EG0070 affected24 at risk
EG0080 affected42 at risk
EG0090 affected42 at risk
EG0100 affected42 at risk
EG0110 affected42 at risk
EG0120 affected36 at risk
EG0130 affected36 at risk
EG0140 affected24 at risk
EG0150 affected135 at risk
EG0161 affected136 at risk
EG0170 affected44 at risk
Angina Pectoris
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Cardiac Arrest
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Atrial Septal Defect
Congenital, familial and genetic disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Vertigo Positional
Ear and labyrinth disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Adverse Drug Reaction
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Chest Pain
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Death
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Portal Vein Thrombosis
Hepatobiliary disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Appendicitis Perforated
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Arthritis Infective
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Bacterial Sepsis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Cellulitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Liver Abscess
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Pneumonia
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Pyelonephritis Acute
Infections and infestations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Spinal Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Subdural Haematoma
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Heart Rate Irregular
Investigations
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
B-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Bladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Colon Cancer Stage I
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Malignant Palate Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Ovarian Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Prostate Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Seborrhoeic Keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Skin Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Squamous Cell Carcinoma of Head and Neck
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Balance Disorder
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Dizziness Postural
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Migraine
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Presyncope
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Depression
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Bronchial Hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Nasal Pruritus
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0011 affected8 at risk
EG0020 affected8 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Haematoma
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Peripheral Arterial Occlusive Disease
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0001 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Peripheral Venous Disease
Vascular disorders
MedDRA Version 24.1
Non-systematic Assessment
EG0000 affected16 at risk
EG0010 affected8 at risk
EG0020 affected8 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 13 of Cohort 2.
OG003
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 16 of Cohort 2.
OG004
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
OG005
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo, one on each arm, on Day 1 and a single IM injection of placebo on Day 57 in Group 18 of Cohort 2.
Units
Counts
Participants
OG00024
OG00142
OG00242
OG00336
OG00436
OG00524
Title
Denominators
Categories
Title
Measurements
OG0000
OG0015
OG0025
OG0037
OG0043
OG0054
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo alone on Day 57 in Group 15 of Cohort 2.
Units
Counts
Participants
OG00042
OG00142
Title
Denominators
Categories
Title
Measurements
OG0004
OG0015
OG002
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen and a placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Units
Counts
Participants
OG000135
OG001136
OG00244
Title
Denominators
Categories
Title
Measurements
OG00014
OG00116
OG0023
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00016
OG0018
OG0028
OG0038
OG0048
OG0058
OG0068
Title
Denominators
Categories
Solicited Local AEs
Title
Measurements
OG0003
OG0012
OG0024
OG0030
OG0045
OG0056
OG0066
Solicited Systemic AEs
Title
Measurements
OG0004
OG0010
OG0024
OG003
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00015
OG0016
OG0028
OG0038
OG0048
OG0058
OG0068
Title
Denominators
Categories
Solicited Local AEs
Title
Measurements
OG0005
OG0011
OG0023
OG0032
OG0043
OG0057
OG0060
Solicited Systemic AEs
Title
Measurements
OG0005
OG0010
OG0021
OG003
OG001
Cohort 1: RSV preF Protein 50 mcg
Participants received a single IM injection of respiratory syncytial virus (RSV) pre-fusion (preF) protein 50 micrograms (mcg) on Day 1, Day 57 and at Month 12 in Group 2 of Cohort 1.
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00011
OG0018
OG0028
OG0037
OG0047
OG0056
OG0068
Title
Denominators
Categories
Solicited Local AEs
Title
Measurements
OG0001
OG0010
OG0023
OG0032
OG0044
OG0055
OG0066
Solicited Systemic AEs
Title
Measurements
OG0002
OG0011
OG0020
OG003
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 12 of Cohort 2.
OG002
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 13 of Cohort 2.
OG003
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 14 of Cohort 2.
OG004
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 15 of Cohort 2.
OG005
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 16 of Cohort 2.
OG006
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
OG007
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Units
Counts
Participants
OG00024
OG00142
OG00242
OG00342
OG00442
OG00536
OG00636
OG00724
Title
Denominators
Categories
Solicited Local AEs
Title
Measurements
OG00014
OG00124
OG00226
OG00329
OG00425
OG00520
OG00622
OG0075
Solicited Systemic AEs
Title
Measurements
OG00011
OG00123
OG00220
OG003
OG001
Cohort 2:Ad26.RSV.preF 5*10^10vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 12 of Cohort 2.
OG002
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 13 of Cohort 2.
OG003
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 14 of Cohort 2.
OG004
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 15 of Cohort 2.
OG005
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 16 of Cohort 2.
OG006
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
OG007
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Units
Counts
Participants
OG00023
OG00140
OG00238
OG00342
OG00442
OG00533
OG00635
OG00723
Title
Denominators
Categories
Solicited Local AEs
Title
Measurements
OG0001
OG0010
OG0023
OG0033
OG0043
OG0052
OG00623
OG0072
Solicited Systemic AEs
Title
Measurements
OG0003
OG0019
OG0028
OG003
OG001
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24, followed by matching placebo alone on Month 12 in Group 20 of Cohort 3.
OG002
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen matching placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Units
Counts
Participants
OG000134
OG001136
OG00244
Title
Denominators
Categories
Solicited Local AEs
Title
Measurements
OG00095
OG00194
OG0029
Solicited Systemic AEs
Title
Measurements
OG00095
OG00188
OG00212
OG001
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24, followed by matching placebo alone on Month 12 in Group 20 of Cohort 3.
OG002
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen matching placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Units
Counts
Participants
OG000112
OG001114
OG00238
Title
Denominators
Categories
Solicited Local AEs
Title
Measurements
OG00074
OG00123
OG0026
Solicited Systemic AEs
Title
Measurements
OG00056
OG00138
OG00210
OG001
Cohort 3: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) and Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg (Cohort 2 selected regimen) on Day 1 and Month 24, followed by matching placebo alone on Month 12 in Group 20 of Cohort 3.
OG002
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen matching placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Units
Counts
Participants
OG00073
OG00173
OG00225
Title
Denominators
Categories
Solicited Local AEs
Title
Measurements
OG00042
OG00148
OG0024
Solicited Systemic AEs
Title
Measurements
OG00032
OG00146
OG0026
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00016
OG0018
OG0028
OG0038
OG0048
OG0058
OG0068
Title
Denominators
Categories
Title
Measurements
OG0002
OG0015
OG0020
OG0031
OG0043
OG0054
OG0063
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00015
OG0016
OG0028
OG0038
OG0048
OG0058
OG0068
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0022
OG0030
OG0042
OG0054
OG0060
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00011
OG0018
OG0028
OG0037
OG0047
OG0056
OG0068
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0051
OG0061
OG002
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 13 of Cohort 2.
OG003
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 14 of Cohort 2.
OG004
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 15 of Cohort 2.
OG005
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 16 of Cohort 2.
OG006
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
OG007
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Units
Counts
Participants
OG00024
OG00142
OG00242
OG00342
OG00442
OG00536
OG00636
OG00724
Title
Denominators
Categories
Title
Measurements
OG0008
OG00111
OG00210
OG00312
OG0048
OG00510
OG00612
OG0073
OG002
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 13 of Cohort 2.
OG003
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 14 of Cohort 2.
OG004
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 15 of Cohort 2.
OG005
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 16 of Cohort 2.
OG006
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
OG007
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Units
Counts
Participants
OG00023
OG00140
OG00238
OG00342
OG00442
OG00533
OG00635
OG00723
Title
Denominators
Categories
Title
Measurements
OG0006
OG0015
OG0025
OG0036
OG0042
OG0053
OG0065
OG0078
OG002
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen matching placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Units
Counts
Participants
OG000134
OG001136
OG00244
Title
Denominators
Categories
Title
Measurements
OG00032
OG00123
OG0027
OG002
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen matching placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Units
Counts
Participants
OG000112
OG001114
OG00238
Title
Denominators
Categories
Title
Measurements
OG0009
OG00110
OG0024
OG002
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen matching placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Units
Counts
Participants
OG00073
OG00173
OG00225
Title
Denominators
Categories
Title
Measurements
OG0008
OG0018
OG0022
OG002
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 13 of Cohort 2.
OG003
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 14 of Cohort 2.
OG004
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 15 of Cohort 2.
Units
Counts
Participants
OG00022
OG00140
OG00242
OG00342
OG00442
Title
Denominators
Categories
Title
Measurements
OG0001642(1165 to 2312)
OG0012869(1964 to 4193)
OG0024813(3642 to 6361)
OG0035189(3730 to 7219)
OG0044855(3865 to 6099)
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00016
OG0018
OG0028
OG0038
OG0048
OG0058
OG0068
Title
Denominators
Categories
Day 1
ParticipantsOG00016
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
Title
Measurements
OG000553(369 to 831)
OG001600(301 to 1196)
OG002917(474 to 1773)
OG003
Day 15
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0037
Day 29
ParticipantsOG00016
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Day 57
ParticipantsOG00016
ParticipantsOG0016
ParticipantsOG0028
ParticipantsOG0037
Day 85
ParticipantsOG00015
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0038
Day 183
ParticipantsOG00016
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0038
Day 365
ParticipantsOG00012
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0036
Day 393
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0033
Day 547
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
OG002
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen matching placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Units
Counts
Participants
OG000135
OG001135
OG00244
Title
Denominators
Categories
Day 1
ParticipantsOG000135
ParticipantsOG001135
ParticipantsOG00244
Title
Measurements
OG000546(487 to 612)
OG001552(490 to 622)
OG002582(460 to 738)
Day 15
ParticipantsOG000123
ParticipantsOG001123
ParticipantsOG00242
Title
Measurements
OG000
Day 29
ParticipantsOG000129
ParticipantsOG001130
ParticipantsOG00243
Title
Measurements
OG000
Day 57
ParticipantsOG000125
ParticipantsOG001126
ParticipantsOG00243
Title
Measurements
OG000
Day 85
ParticipantsOG000117
ParticipantsOG001122
ParticipantsOG00239
Title
Measurements
OG000
Day 183
ParticipantsOG000126
ParticipantsOG001124
ParticipantsOG00243
Title
Measurements
OG000
Day 365
ParticipantsOG000116
ParticipantsOG001117
ParticipantsOG00240
Title
Measurements
OG000
Day 393
ParticipantsOG000100
ParticipantsOG001100
ParticipantsOG00240
Title
Measurements
OG000
Day 547
ParticipantsOG00089
ParticipantsOG00194
ParticipantsOG00233
Title
Measurements
OG000
Day 730
ParticipantsOG00086
ParticipantsOG00186
ParticipantsOG00230
Title
Measurements
OG000
Day 744
ParticipantsOG00066
ParticipantsOG00163
ParticipantsOG00225
Title
Measurements
OG000
Day 758
ParticipantsOG00067
ParticipantsOG00167
ParticipantsOG00224
Title
Measurements
OG000
34
Title
Denominators
Categories
Title
Measurements
OG0006053(4770 to 7682)
34
Title
Denominators
Categories
Title
Measurements
OG0004616(3395 to 6276)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00016
OG0018
OG0028
OG0038
OG0048
OG0058
OG0068
Title
Denominators
Categories
Day 1
ParticipantsOG00016
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
Title
Measurements
OG000245(172 to 349)
OG001263(100 to 695)
OG002360(206 to 627)
OG003
Day 15
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0037
Day 29
ParticipantsOG00016
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Day 57
ParticipantsOG00016
ParticipantsOG0016
ParticipantsOG0028
ParticipantsOG0037
Day 85
ParticipantsOG00015
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0038
Day 183
ParticipantsOG00016
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0038
Day 365
ParticipantsOG00012
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0036
Day 393
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0033
Day 547
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
OG002
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 13 of Cohort 2.
OG003
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 14 of Cohort 2.
OG004
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 15 of Cohort 2.
OG005
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 16 of Cohort 2.
OG006
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
OG007
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Units
Counts
Participants
OG00024
OG00142
OG00242
OG00342
OG00442
OG00536
OG00636
OG00724
Title
Denominators
Categories
Day 1
ParticipantsOG00024
ParticipantsOG00142
ParticipantsOG00242
ParticipantsOG00342
ParticipantsOG00442
ParticipantsOG00536
ParticipantsOG00636
ParticipantsOG00724
Title
Measurements
OG000436(321 to 591)
OG001354(278 to 452)
OG002278(227 to 342)
OG003
Day 15
ParticipantsOG00023
ParticipantsOG00141
ParticipantsOG00242
ParticipantsOG00342
Day 29
ParticipantsOG00022
ParticipantsOG00140
ParticipantsOG00242
ParticipantsOG00342
Day 57
ParticipantsOG00023
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00341
Day 85
ParticipantsOG00023
ParticipantsOG00139
ParticipantsOG00242
ParticipantsOG00342
Day 183
ParticipantsOG00023
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00341
Day 365
ParticipantsOG00019
ParticipantsOG00138
ParticipantsOG00239
ParticipantsOG00340
Day 547
ParticipantsOG00016
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00335
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00016
OG0018
OG0028
OG0038
OG0048
OG0058
OG0068
Title
Denominators
Categories
Day 1
ParticipantsOG00016
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
Title
Measurements
OG000222(146 to 337)
OG001206(71 to 593)
OG002316(212 to 470)
OG003
Day 15
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0037
Day 29
ParticipantsOG00016
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0038
Day 57
ParticipantsOG00016
ParticipantsOG0016
ParticipantsOG0028
ParticipantsOG0037
Day 85
ParticipantsOG00015
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0038
Day 183
ParticipantsOG00016
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0038
Day 365
ParticipantsOG00012
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0036
Day 393
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0033
Day 547
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 13 of Cohort 2.
OG003
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 14 of Cohort 2.
OG004
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 15 of Cohort 2.
OG005
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 16 of Cohort 2.
OG006
Cohort 2: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm on Day 1 and Day 57 and a single IM injection of placebo in another arm on Day 1 in Group 17 of Cohort 2.
OG007
Cohort 2: Pooled Placebo
Participants received two IM injections of placebo in separate arms on Day 1 and single IM injection on Day 57 in Group 18 of Cohort 2.
Units
Counts
Participants
OG00024
OG00142
OG00242
OG00342
OG00442
OG00536
OG00636
OG00724
Title
Denominators
Categories
Day 1
ParticipantsOG00024
ParticipantsOG00142
ParticipantsOG00242
ParticipantsOG00342
ParticipantsOG00442
ParticipantsOG00536
ParticipantsOG00636
ParticipantsOG00724
Title
Measurements
OG000270(185 to 393)
OG001260(204 to 332)
OG002228(184 to 284)
OG003
Day 15
ParticipantsOG00023
ParticipantsOG00141
ParticipantsOG00242
ParticipantsOG00342
Day 29
ParticipantsOG00022
ParticipantsOG00140
ParticipantsOG00242
ParticipantsOG00342
Day 57
ParticipantsOG00023
ParticipantsOG00139
ParticipantsOG00240
ParticipantsOG00341
Day 85
ParticipantsOG00023
ParticipantsOG00139
ParticipantsOG00242
ParticipantsOG00342
Day 183
ParticipantsOG00023
ParticipantsOG00138
ParticipantsOG00242
ParticipantsOG00341
Day 365
ParticipantsOG00019
ParticipantsOG00138
ParticipantsOG00239
ParticipantsOG00340
Day 547
ParticipantsOG00016
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00335
OG002
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 50 mcg (Mixture)
Participants received a single IM injection of a mixture of adenovirus serotype 26 RSV preF (Ad26.RSV.preF) 5*10^10 viral particles (vp) plus RSV preF protein 50 mcg on Day 1, Day 57 and at Month 12 in Group 4 of Cohort 1.
OG003
Cohort 1: RSV preF Protein 150 mcg
Participants received a single IM injection of RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 5 of Cohort 1.
OG004
Cohort 1: Ad26.RSV.preF 5*10^10 vp + RSV preF Protein 150 mcg (Mixture)
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg on Day 1, Day 57 and at Month 12 in Group 7 of Cohort 1.
OG005
Cohort 1: Ad26.RSV.preF 1*10^11 vp + RSV preF Protein 150 mcg (Mixture) Alone and With Placebo
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arms on Day 1, Day 57, and at Month 12 and placebo IM injection in another arm on Day 1 and at Month 12 in Group 9 of Cohort 1.
OG006
Cohort 1: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg IM injection in another arm on Day 1 and at Month 12, and placebo IM injection alone on Day 57 in Group 10 of Cohort 1.
Units
Counts
Participants
OG00016
OG0018
OG0028
OG0038
OG0048
OG0058
OG0068
Title
Denominators
Categories
Day 1
ParticipantsOG00016
ParticipantsOG0017
ParticipantsOG0028
ParticipantsOG0038
ParticipantsOG0048
ParticipantsOG0058
ParticipantsOG0068
Title
Measurements
OG00048(6 to 254)
OG00139(13 to 103)
OG00216(5 to 121)
OG003
Day 15
ParticipantsOG00015
ParticipantsOG0018
ParticipantsOG0028
ParticipantsOG0037
Day 29
ParticipantsOG00016
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0038
Day 57
ParticipantsOG00016
ParticipantsOG0016
ParticipantsOG0028
ParticipantsOG0036
Day 85
ParticipantsOG00015
ParticipantsOG0015
ParticipantsOG0026
ParticipantsOG0038
Day 183
ParticipantsOG00016
ParticipantsOG0016
ParticipantsOG0027
ParticipantsOG0038
Day 365
ParticipantsOG00012
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0036
Day 393
ParticipantsOG0008
ParticipantsOG0015
ParticipantsOG0024
ParticipantsOG0032
Day 547
ParticipantsOG0008
ParticipantsOG0016
ParticipantsOG0024
ParticipantsOG0034
OG002
Cohort 3: Pooled Placebo of Cohort 2 Selected Regimen
Participants received a single IM injection of Cohort 2 selected regimen matching placebo on Day 1, Month 12, and Month 24 in Group 21 of Cohort 3.
Units
Counts
Participants
OG00025
OG00126
OG0029
Title
Denominators
Categories
Day 1
ParticipantsOG00024
ParticipantsOG00126
ParticipantsOG0028
Title
Measurements
OG00056(5 to 612)
OG00173(1 to 1030)
OG00239(1 to 193)
Day 15
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG0029
Title
Measurements
OG000
Day 29
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG0029
Title
Measurements
OG000
Day 57
ParticipantsOG00023
ParticipantsOG00120
ParticipantsOG0028
Title
Measurements
OG000
Day 85
ParticipantsOG00023
ParticipantsOG00122
ParticipantsOG0028
Title
Measurements
OG000
Day 183
ParticipantsOG00024
ParticipantsOG00122
ParticipantsOG0028
Title
Measurements
OG000
Day 365
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG0029
Title
Measurements
OG000
Day 393
ParticipantsOG00020
ParticipantsOG00120
ParticipantsOG0029
Title
Measurements
OG000
Day 547
ParticipantsOG00020
ParticipantsOG00116
ParticipantsOG0028
Title
Measurements
OG000
Day 730
ParticipantsOG00019
ParticipantsOG00115
ParticipantsOG0027
Title
Measurements
OG000
Day 744
ParticipantsOG00015
ParticipantsOG0019
ParticipantsOG0026
Title
Measurements
OG000
Day 758
ParticipantsOG00015
ParticipantsOG00112
ParticipantsOG0026
Title
Measurements
OG000
OG002
Cohort 2:Ad26.RSV.preF 1*10^11vp + RSV preF Protein 50mcg(Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 50 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 13 of Cohort 2.
OG003
Cohort 2: Ad26.RSV.preF 1*10^11vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 1*10^11 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 14 of Cohort 2.
OG004
Cohort 2: Ad26.RSV.preF 5*10^10vp + RSV preF Protein 150mcg (Mixture) With Placebo and Placebo Alone
Participants received a single IM injection of a mixture of Ad26.RSV.preF 5*10^10 vp plus RSV preF protein 150 mcg in one arm and single IM injection of placebo in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 15 of Cohort 2.
OG005
Cohort 2: Ad26.RSV.preF 1*10^11 vp With RSV preF Protein 150 mcg and Placebo Alone
Participants received a single IM injection of Ad26.RSV.preF 1*10^11 vp in one arm and RSV preF protein 150 mcg in another arm on Day 1, followed by a single IM injection of placebo on Day 57 in Group 16 of Cohort 2.