A Study to Evaluate a Range of Dose Levels of an Adenovir... | NCT04453202 | Trialant
NCT04453202
Sponsor
Janssen Vaccines & Prevention B.V.
Status
Completed
Last Update Posted
May 25, 2025Actual
Enrollment
459Actual
Phase
Phase 2
Conditions
Healthy
Interventions
RSV Vaccine
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04453202
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CR108835
Secondary IDs
ID
Type
Description
Link
VAC18193RSV2005
Other Identifier
Janssen Vaccines & Prevention B.V.
Brief Title
A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
Official Title
A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels of an Ad26.RSV.preF-based Vaccine 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 16, 2020Actual
Primary Completion Date
Sep 24, 2020Actual
Completion Date
Apr 9, 2021Actual
First Submitted Date
Jun 29, 2020
First Submission Date that Met QC Criteria
Jun 29, 2020
First Posted Date
Jul 1, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Aug 14, 2023
Results First Submitted that Met QC Criteria
Oct 2, 2023
Results First Posted Date
Oct 3, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 23, 2021
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Oct 3, 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 is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
459Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1 Group 1: RSV Vaccine
Experimental
Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1.
Biological: RSV Vaccine
Cohort 1 Group 2: RSV Vaccine
Experimental
Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1.
Biological: RSV Vaccine
Cohort 1 Group 3: RSV Vaccine
Experimental
Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1.
Biological: RSV Vaccine
Cohort 1 Group 4: RSV Vaccine
Experimental
Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1.
Biological: RSV Vaccine
Cohort 1 Group 5: Placebo
Placebo Comparator
Participants will receive IM injection of placebo on Day 1.
Other: Placebo
Cohort 2 Group 6: RSV Vaccine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RSV Vaccine
Biological
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Cohort 1 Group 1: RSV Vaccine
Cohort 1 Group 2: RSV Vaccine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Cohort 1: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination
Geometric mean antibody titers (ELISA units per liter [EU/L]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.
14 days after vaccination on Day 1 (Day 15)
Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Until 7 days after Vaccination on Day 1 (Day 8)
Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree celsius).
Until 7 days after Vaccination on Day 1 (Day 8)
Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Secondary Outcomes
Measure
Description
Time Frame
Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 3 and 6 months after vaccination on Day 1 were reported.
At 3 and 6 months after vaccination on Day 1
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
In the investigator's clinical judgment, participants 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 signs and symptoms are stable and medically controlled in the judgment of the investigator. Participants will be included on the basis of medical history and of physical examination and vital signs performed at screening (all cohorts), and of physical examination and/or vital signs performed prevaccination on Day 1 (Cohorts 2 and 3)
A woman must be postmenopausal (defined as no menses for 12 months without an alternative medical cause) and not intending to conceive by any methods
Agree to not donate blood from the time of vaccination until 3 months after vaccination
Have a body mass index (BMI) less than (<) 40 kilogram per meter square (kg/m^2)
Be willing to provide verifiable identification and have means to be contacted and to contact the investigator during the study
Exclusion Criteria:
Has a contraindication to intramuscular injection (IM) injections and blood draws (example, bleeding disorders)
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)
History of chronic urticaria (recurrent hives), eczema, or atopic dermatitis
Has hepatitis B or C infection, including history of treated hepatitis C infection
Received an active RSV vaccine in a previous RSV vaccine study or an Ad26-vectored vaccine at any time prior to randomization
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
60 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Janssen Vaccines & Prevention B.V. Clinical Trial
Janssen Vaccines & Prevention B.V.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Optimal Research
San Diego
California
92108
United States
Clinical Research of South Florida, an AMR Company
van Heesbeen R, Bastian AR, Omoruyi E, Rosen J, Comeaux CA, Callendret B, Heijnen E. Immunogenicity and safety of different dose levels of Ad26.RSV.preF/RSV preF protein vaccine in adults aged 60 years and older: A randomized, double-blind, placebo-controlled, phase 2a study. Vaccine. 2024 Dec 2;42(26):126273. doi: 10.1016/j.vaccine.2024.126273. Epub 2024 Sep 13.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
A total of 459 participants were enrolled, of which 454 were randomized and vaccinated in this study.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
2
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 11, 2020
Aug 14, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Experimental
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Biological: RSV Vaccine
Cohort 2 Group 7: RSV Vaccine
Experimental
Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1.
Biological: RSV Vaccine
Cohort 2 Group 8: Placebo
Placebo Comparator
Participants will receive IM injection of placebo on Day 1.
Other: Placebo
Cohort 3 Group 9: RSV Vaccine
Experimental
Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
Biological: RSV Vaccine
Cohort 3 Group 10: RSV Vaccine
Experimental
Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1.
Biological: RSV Vaccine
Cohort 3 Group 11: Placebo
Experimental
Participants will receive IM injection of placebo on Day 1.
Other: Placebo
Cohort 1 Group 3: RSV Vaccine
Cohort 1 Group 4: RSV Vaccine
Cohort 2 Group 6: RSV Vaccine
Cohort 2 Group 7: RSV Vaccine
Cohort 3 Group 10: RSV Vaccine
Cohort 3 Group 9: RSV Vaccine
Placebo
Other
Participants will receive a single IM injection of placebo on Day 1.
Cohort 1 Group 5: Placebo
Cohort 2 Group 8: Placebo
Cohort 3 Group 11: Placebo
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Until 28 days after Vaccination on Day 1 (Day 29)
RSV A2 strain neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% inhibitory concentration (IC50) units.
At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by enzyme-linked immunospot (ELISpot) assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Baseline (Day1) up to 6 months
Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Until 7 days after vaccination on Day 1 (Day 8)
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree celsius).
Until 7 days after vaccination on Day 1 (Day 8)
Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Until 28 days after vaccination on Day 1 (Day 29)
Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 14 days and 3 and 6 months after vaccination on Day 1 were reported.
At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
RSV A2 neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% IC50 units.
At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
At 14 days and 3 and 6 months after vaccination on Day 1
Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
Baseline (Day1 ) up to 6 months
Coral Gables
Florida
33134
United States
Heartland Research Associates, an AMR Company
El Dorado
Kansas
67042
United States
Optimal Research
Rockville
Maryland
20850
United States
The Center for Pharmaceutical Research (CPR)
Kansas City
Missouri
64114
United States
Meridian Clinical Research, LLC
Norfolk
Nebraska
68701
United States
Meridian Clinical Research - Omaha
Omaha
Nebraska
68134
United States
Tekton Research Inc.
Yukon
Oklahoma
73099
United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville
Tennessee
37920
United States
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
FG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
FG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
FG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
FG005
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
FG006
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
FG007
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
FG008
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
FG009
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
FG010
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
FG00051 subjects
FG00151 subjects
FG00251 subjects
FG00348 subjects
FG00425 subjects
FG00549 subjects
FG00649 subjects
FG00726 subjects
FG00827 subjects
FG00951 subjects
FG01026 subjects
Full Analysis Set (FAS)
FG00051 subjects
FG00151 subjects
FG00251 subjects
FG00348 subjects
FG00425 subjects
FG00549 subjects
FG00649 subjects
FG00726 subjects
FG00827 subjects
FG00951 subjects
FG01026 subjects
Per-protocol Immunogenicity (PPI) Set
FG00051 subjects
FG00150 subjects
FG00251 subjects
FG00348 subjects
FG00425 subjects
FG00547 subjects
FG00649 subjects
FG00726 subjects
FG00827 subjects
FG00950 subjects
FG01026 subjects
COMPLETED
FG00050 subjects
FG00148 subjects
FG00250 subjects
FG00345 subjects
FG00424 subjects
FG00547 subjects
FG00648 subjects
FG00726 subjects
FG00827 subjects
FG00948 subjects
FG01025 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0033 subjects
FG0041 subjects
FG0052 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
FG0101 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
BG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
BG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
BG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
BG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
BG005
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
BG006
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
BG007
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
BG008
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
BG009
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
BG010
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
BG011
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00051
BG00151
BG00251
BG00348
BG00425
BG00549
BG00649
BG00726
BG00827
BG00951
BG01026
BG011454
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
BG00069.1± 6.97
BG00168.7± 7.08
BG00269.4± 6.56
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00030
BG00132
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00014
BG0016
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
BG00051
BG00151
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: Geometric Mean Antibody Titers to Respiratory Syncytial Virus (RSV) Prefusion Conformation-stabilized F (preF) Protein Using preF Enzyme-linked Immunosorbent Assay (ELISA) at 14 Days After Vaccination
Geometric mean antibody titers (ELISA units per liter [EU/L]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.
Per-protocol Immunogenicity (PPI) set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Posted
Geometric Mean
95% Confidence Interval
EU/L
14 days after vaccination on Day 1 (Day 15)
ID
Title
Description
OG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
OG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00044
OG00146
OG00245
OG003
Title
Denominators
Categories
Title
Measurements
OG0004907(4030 to 5976)
OG0014681(3696 to 5928)
OG0024038(3042 to 5361)
OG003
Primary
Cohorts 2 and 3: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Full Analysis Set (FAS) included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Posted
Count of Participants
Participants
Until 7 days after Vaccination on Day 1 (Day 8)
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG001
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Primary
Cohorts 2 and 3: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to [>=] 38 degree celsius).
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Posted
Count of Participants
Participants
Until 7 days after Vaccination on Day 1 (Day 8)
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG001
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Primary
Cohorts 2 and 3: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Until 28 days after Vaccination on Day 1 (Day 29)
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG001
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Cohort 2: Placebo
Secondary
Cohort 1: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 3 and 6 Months After Vaccination on Day 1
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 3 and 6 months after vaccination on Day 1 were reported.
PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'n' (number analyzed) signifies participants who were evaluable at specified time points.
Posted
Geometric Mean
95% Confidence Interval
EU/L
At 3 and 6 months after vaccination on Day 1
ID
Title
Description
OG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
OG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Secondary
Cohort 1: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
RSV A2 strain neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% inhibitory concentration (IC50) units.
PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 14 days and 3 and 6 months after vaccination on Day 1
ID
Title
Description
OG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
OG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
Secondary
Cohort 1: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by enzyme-linked immunospot (ELISpot) assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points.
Posted
Median
Full Range
SFC/10^6 PBMCs
At 14 days and 3 and 6 months after vaccination on Day 1
ID
Title
Description
OG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
OG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
Secondary
Cohort 1: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Baseline (Day1) up to 6 months
ID
Title
Description
OG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
OG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Secondary
Cohort 1: Number of Participants With Solicited Local Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Posted
Count of Participants
Participants
Until 7 days after vaccination on Day 1 (Day 8)
ID
Title
Description
OG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
OG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Secondary
Cohort 1: Number of Participants With Solicited Systemic Adverse Events (AEs) Until 7 Days After Vaccination on Day 1
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature >=38 degree celsius).
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure.
Posted
Count of Participants
Participants
Until 7 days after vaccination on Day 1 (Day 8)
ID
Title
Description
OG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
OG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Secondary
Cohort 1: Number of Participants With Unsolicited AEs Until 28 Days After Vaccination on Day 1
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Until 28 days after vaccination on Day 1 (Day 29)
ID
Title
Description
OG000
Cohort 1: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
OG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
Secondary
Cohort 2 and 3: Geometric Mean Antibody Titers to RSV preF Protein Using preF ELISA at 14 Days and 3 and 6 Months After Vaccination on Day 1
Geometric mean antibody titers (EU/L) to RSV preF protein using preF ELISA at 14 days and 3 and 6 months after vaccination on Day 1 were reported.
PPI set was analyzed. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points. Due to change in planned analysis, data at 6-month was not collected and analyzed because of discontinuation of the development of the vaccine and hence, there was no scientific value to analyze the responses at Month 6.
Posted
Geometric Mean
95% Confidence Interval
EU/L
At 14 days and 3 and 6 months after vaccination on Day 1
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG001
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
Secondary
Cohort 2 and 3: Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days and 3 and 6 Months After Vaccination on Day 1
RSV A2 neutralizing antibody titers at 14 days and 3 and 6 months after vaccination on Day 1 were reported. RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay. Data were expressed as 50% IC50 units.
PPI set included all participants who were randomized and received the study vaccine, and for whom immunogenicity data were available, excluding participants with major protocol deviations expecting to impact the immunogenicity outcomes. Here, 'N' (overall number of participants analyzed) signifies participants who were evaluated for this outcome measure. Here 'n' (number analyzed) signifies participants who were evaluable at specified time points.
Posted
Geometric Mean
95% Confidence Interval
Titer
At 14 days and 3 and 6 months after vaccination on Day 1
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG001
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
Secondary
Cohort 2 and 3: T-cell Interferon (IFN) Gamma Responses to Respiratory Syncytial Virus (RSV) F Protein Peptides at 14 Days and 3 and 6 Months After Vaccination on Day 1
T-cell IFN gamma responses to RSV F protein specific peptides at 14 days and 3 and 6 months after vaccination as measured by ELISpot assay were reported. RSV F specific T-cell IFN gamma ELISpot responses were measured as counts of spot forming cells per million peripheral blood mononuclear cells (SFC/10^6 PBMCs).
PPI set was analyzed. Here, 'N' (overall number of participants analyzed) signifies participants evaluated for this outcome measure. Here 'n' (number analyzed) signifies number of participants evaluable at specified time points. Due to change in planned analysis, data at 6-month was not collected and analyzed because of discontinuation of the development of the vaccine and hence, there was no scientific value to analyze the responses at Month 6.
Posted
Median
Full Range
SFC/10^6 PBMCs
At 14 days and 3 and 6 months after vaccination on Day 1
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG001
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
Secondary
Cohort 2 and 3: Number of Participants With Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product.
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
Posted
Count of Participants
Participants
Baseline (Day1 ) up to 6 months
ID
Title
Description
OG000
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG001
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Time Frame
Baseline (Day 1) up to 6 months
Description
FAS included all participants who were randomized and received the study vaccine, regardless of the occurrence of protocol deviations.
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: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an intramuscular (IM) injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 viral particles (vp) and RSV preF protein 150 microgram (mcg) on Day 1.
0
51
3
51
42
51
EG001
Cohort 1: Ad26.RSV.preF (3.3*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
0
51
0
51
36
51
EG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
0
51
0
51
25
51
EG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
0
48
1
48
23
48
EG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
0
25
0
25
7
25
EG005
Cohort 2: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
0
49
1
49
44
49
EG006
Cohort 2: Ad26.RSV.preF (1.3*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
0
49
1
49
48
49
EG007
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
0
26
1
26
13
26
EG008
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
0
27
0
27
25
27
EG009
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
1
51
2
51
44
51
EG010
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
0
26
1
26
8
26
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute Coronary Syndrome
Cardiac disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG0030 affected48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
Cholelithiasis
Hepatobiliary disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Covid-19 Pneumonia
Infections and infestations
MedDRA Version 23.1
Non-systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Escherichia Bacteraemia
Infections and infestations
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Sepsis
Infections and infestations
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
B-Cell Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0001 affected51 at risk
EG0012 affected51 at risk
EG0020 affected51 at risk
EG0030 affected48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0061 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0091 affected51 at risk
EG0100 affected26 at risk
Nausea
Gastrointestinal disorders
MedDRA Version 23.1
Systematic Assessment
EG0007 affected51 at risk
EG0016 affected51 at risk
EG0022 affected51 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0001 affected51 at risk
EG0011 affected51 at risk
EG0020 affected51 at risk
EG003
Chills
General disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0003 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Fatigue
General disorders
MedDRA Version 23.1
Systematic Assessment
EG00029 affected51 at risk
EG00116 affected51 at risk
EG00210 affected51 at risk
EG003
Influenza Like Illness
General disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Injection Site Haemorrhage
General disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Injection Site Pruritus
General disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Oedema Peripheral
General disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Pyrexia
General disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0002 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Swelling
General disorders
MedDRA Version 23.1
Systematic Assessment
EG0002 affected51 at risk
EG0016 affected51 at risk
EG0022 affected51 at risk
EG003
Swelling Face
General disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Tenderness
General disorders
MedDRA Version 23.1
Non-systematic Assessment
EG00032 affected51 at risk
EG00123 affected51 at risk
EG00212 affected51 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Covid-19
Infections and infestations
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0011 affected51 at risk
EG0020 affected51 at risk
EG003
Cystitis
Infections and infestations
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Ligament Sprain
Injury, poisoning and procedural complications
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Blood Pressure Systolic Increased
Investigations
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 23.1
Systematic Assessment
EG00021 affected51 at risk
EG00112 affected51 at risk
EG0024 affected51 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Dizziness
Nervous system disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Headache
Nervous system disorders
MedDRA Version 23.1
Systematic Assessment
EG00018 affected51 at risk
EG00112 affected51 at risk
EG0026 affected51 at risk
EG003
Syncope
Nervous system disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Taste Disorder
Nervous system disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Vith Nerve Paralysis
Nervous system disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Adjustment Disorder with Depressed Mood
Psychiatric disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Respiratory Symptom
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0021 affected51 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Dermatitis Contact
Skin and subcutaneous tissue disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA Version 23.1
Systematic Assessment
EG0006 affected51 at risk
EG0014 affected51 at risk
EG0022 affected51 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Ingrowing Nail
Skin and subcutaneous tissue disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0000 affected51 at risk
EG0010 affected51 at risk
EG0020 affected51 at risk
EG003
Hypertension
Vascular disorders
MedDRA Version 23.1
Non-systematic Assessment
EG0001 affected51 at risk
EG0010 affected51 at risk
EG0021 affected51 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.
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
OG003
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG005
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00049
OG00149
OG00226
OG00327
OG00450
OG00526
Title
Denominators
Categories
Title
Measurements
OG00037
OG00142
OG0023
OG00323
OG00437
OG0052
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.3*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
OG003
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG005
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00049
OG00149
OG00226
OG00327
OG00450
OG00526
Title
Denominators
Categories
Title
Measurements
OG00039
OG00143
OG0028
OG00319
OG00441
OG0057
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
OG003
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG005
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00049
OG00149
OG00226
OG00327
OG00451
OG00526
Title
Denominators
Categories
Title
Measurements
OG00013
OG0018
OG0027
OG0033
OG0048
OG0052
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00051
OG00150
OG00251
OG00348
OG00425
Title
Denominators
Categories
3 months after vaccination on Day 1
ParticipantsOG00051
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00345
ParticipantsOG00424
Title
Measurements
OG0002550(2134 to 3047)
OG0012790(2251 to 3459)
OG0021940(1565 to 2405)
OG003
6 months after vaccination on Day 1
ParticipantsOG00048
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00342
OG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00051
OG00150
OG00251
OG00348
OG00425
Title
Denominators
Categories
14 days after vaccination on Day 1
ParticipantsOG00044
ParticipantsOG00146
ParticipantsOG00245
ParticipantsOG00348
ParticipantsOG00425
Title
Measurements
OG0006314(4800 to 8307)
OG0015140(3909 to 6758)
OG0024725(3407 to 6554)
OG003
3 months after vaccination on Day 1
ParticipantsOG00051
ParticipantsOG00148
ParticipantsOG00251
ParticipantsOG00345
6 months after vaccination on Day 1
ParticipantsOG00048
ParticipantsOG00145
ParticipantsOG00246
ParticipantsOG00342
OG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00051
OG00150
OG00251
OG00348
OG00425
Title
Denominators
Categories
14 days after vaccination on Day 1
ParticipantsOG00037
ParticipantsOG00142
ParticipantsOG00236
ParticipantsOG00336
ParticipantsOG00419
Title
Measurements
OG000547(NA to 1426)Lower limit of full range could not be calculated as it was below the lower limit of quantification (LLOQ) (68)
OG001458(NA to 1721)Lower limit of full range could not be calculated as it was below the LLOQ (68)
OG002397(79 to 1570)
OG003
3 months after vaccination on Day 1
ParticipantsOG00046
ParticipantsOG00146
ParticipantsOG00247
ParticipantsOG00338
6 months after vaccination on Day 1
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00245
ParticipantsOG00342
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00051
OG00151
OG00251
OG00348
OG00425
Title
Denominators
Categories
Title
Measurements
OG0003
OG0010
OG0020
OG0031
OG0040
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00051
OG00150
OG00251
OG00347
OG00425
Title
Denominators
Categories
Title
Measurements
OG00033
OG00124
OG00215
OG00318
OG0040
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.3*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG002
Cohort 1: Ad26.RSV.preF (1.1*10^10 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.1*10^10 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00051
OG00150
OG00251
OG00347
OG00425
Title
Denominators
Categories
Title
Measurements
OG00035
OG00125
OG00213
OG00315
OG0046
OG003
Cohort 1: Ad26.RSV.preF (3.7*10^9 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 3.7*10^9 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 1: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00051
OG00151
OG00251
OG00348
OG00425
Title
Denominators
Categories
Title
Measurements
OG00011
OG0019
OG0026
OG0035
OG0041
OG002
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
OG003
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG005
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00045
OG00149
OG00226
OG00326
OG00447
OG00526
Title
Denominators
Categories
14 days after vaccination on Day 1
ParticipantsOG00045
ParticipantsOG00149
ParticipantsOG00226
ParticipantsOG00326
ParticipantsOG00447
ParticipantsOG00526
Title
Measurements
OG0003769(3006 to 4726)
OG0013893(3243 to 4674)
OG002259(201 to 333)
OG003
3 months after vaccination on Day 1
ParticipantsOG00044
ParticipantsOG00147
ParticipantsOG00226
ParticipantsOG00326
OG002
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
OG003
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG005
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00045
OG00149
OG00226
OG00326
OG00447
OG00526
Title
Denominators
Categories
14 days after vaccination on Day 1
ParticipantsOG00045
ParticipantsOG00149
ParticipantsOG00226
ParticipantsOG00326
ParticipantsOG00447
ParticipantsOG00526
Title
Measurements
OG0004102(3064 to 5491)
OG0013552(2635 to 4789)
OG002336(262 to 432)
OG003
3 months after vaccination on Day 1
ParticipantsOG00044
ParticipantsOG00147
ParticipantsOG00226
ParticipantsOG00325
6 months after vaccination on Day 1
ParticipantsOG00040
ParticipantsOG00144
ParticipantsOG00224
ParticipantsOG00325
OG002
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
OG003
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG005
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00040
OG00142
OG00222
OG00325
OG00445
OG00524
Title
Denominators
Categories
14 days after vaccination on Day 1
ParticipantsOG00040
ParticipantsOG00142
ParticipantsOG00221
ParticipantsOG00319
ParticipantsOG00441
ParticipantsOG00520
Title
Measurements
OG000361(NA to 1686)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG001435(88 to 2088)
OG002NA(NA to 942)Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
OG003
3 months after vaccination on Day 1
ParticipantsOG00037
ParticipantsOG00140
ParticipantsOG00222
ParticipantsOG00325
Cohort 2: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
OG003
Cohort 3: Ad26.RSV.preF (1*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG004
Cohort 3: Ad26.RSV.preF (1.6*10^11 vp)+RSV preF Protein (150 mcg)
Participants received an IM injection of Ad26/protein preF RSV vaccine composed of Ad26.RSV.preF at a dose level of 1.6*10^11 vp and RSV preF protein at a dose level of 150 mcg on Day 1.
OG005
Cohort 3: Placebo
Participants received an IM injection of placebo matching to Ad26/protein preF RSV vaccine on Day 1.
Units
Counts
Participants
OG00049
OG00149
OG00226
OG00327
OG00451
OG00526
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0042
OG0051
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0101 affected26 at risk
1 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0061 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0091 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0091 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0042 affected25 at risk
EG0055 affected49 at risk
EG00613 affected49 at risk
EG0072 affected26 at risk
EG0086 affected27 at risk
EG00910 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0081 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0052 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0082 affected27 at risk
EG0092 affected51 at risk
EG0100 affected26 at risk
12 affected
48 at risk
EG0045 affected25 at risk
EG00532 affected49 at risk
EG00637 affected49 at risk
EG0074 affected26 at risk
EG00816 affected27 at risk
EG00934 affected51 at risk
EG0107 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0081 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0056 affected49 at risk
EG00611 affected49 at risk
EG0071 affected26 at risk
EG0084 affected27 at risk
EG00912 affected51 at risk
EG0100 affected26 at risk
3 affected
48 at risk
EG0040 affected25 at risk
EG0057 affected49 at risk
EG0067 affected49 at risk
EG0070 affected26 at risk
EG0082 affected27 at risk
EG0099 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
17 affected
48 at risk
EG0040 affected25 at risk
EG00534 affected49 at risk
EG00640 affected49 at risk
EG0072 affected26 at risk
EG00823 affected27 at risk
EG00937 affected51 at risk
EG0102 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
1 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0101 affected26 at risk
1 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
1 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
1 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0061 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0061 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
5 affected
48 at risk
EG0041 affected25 at risk
EG00525 affected49 at risk
EG00629 affected49 at risk
EG0071 affected26 at risk
EG00817 affected27 at risk
EG00923 affected51 at risk
EG0102 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0061 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0081 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
2 affected
48 at risk
EG0043 affected25 at risk
EG00525 affected49 at risk
EG00625 affected49 at risk
EG0072 affected26 at risk
EG00815 affected27 at risk
EG00927 affected51 at risk
EG0103 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0061 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0061 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0061 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0101 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0091 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0071 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
1 affected
48 at risk
EG0040 affected25 at risk
EG0057 affected49 at risk
EG0067 affected49 at risk
EG0071 affected26 at risk
EG0082 affected27 at risk
EG0099 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0041 affected25 at risk
EG0050 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
0 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
1 affected
48 at risk
EG0040 affected25 at risk
EG0051 affected49 at risk
EG0060 affected49 at risk
EG0070 affected26 at risk
EG0080 affected27 at risk
EG0090 affected51 at risk
EG0100 affected26 at risk
2997
(2335 to 3846)
OG004315(251 to 394)
ParticipantsOG00423
Title
Measurements
OG0001568(1351 to 1819)
OG0011424(1126 to 1800)
OG0021247(1053 to 1478)
OG0031834(1478 to 2277)
OG004326(256 to 414)
6194
(4641 to 8265)
OG004294(239 to 363)
ParticipantsOG00424
Title
Measurements
OG0003760(2957 to 4780)
OG0013799(2995 to 4820)
OG0022777(2169 to 3556)
OG0034413(3409 to 5713)
OG004357(282 to 452)
ParticipantsOG00423
Title
Measurements
OG0001760(1372 to 2260)
OG0011883(1456 to 2435)
OG0021473(1188 to 1827)
OG0032523(1901 to 3348)
OG004301(241 to 377)
404
(87 to 1579)
OG004NA(NA to 387)Median lower limit of full range could not be calculated as it was below the LLOQ (68)
ParticipantsOG00422
Title
Measurements
OG000180(NA to 1462)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG001241(NA to 906)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG002168(NA to 649)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG003184(NA to 737)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG004NA(NA to 359)Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
ParticipantsOG00423
Title
Measurements
OG000129(NA to 1631)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG001189(NA to 991)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG002146(NA to 636)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG003127(NA to 439)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG004NA(NA to 266)Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
4278
(3336 to 5486)
OG0043856(3177 to 4682)
OG005298(236 to 376)
ParticipantsOG00447
ParticipantsOG00526
Title
Measurements
OG0001982(1627 to 2415)
OG0011665(1162 to 2385)
OG002300(244 to 369)
OG0032696(1991 to 3651)
OG0041864(1304 to 2664)
OG005339(256 to 450)
4085
(3092 to 5398)
OG0043707(2841 to 4839)
OG005342(261 to 448)
ParticipantsOG00447
ParticipantsOG00526
Title
Measurements
OG0003144(2537 to 3895)
OG0012556(1828 to 3575)
OG002371(282 to 488)
OG0033435(2714 to 4348)
OG0042671(1945 to 3669)
OG005490(344 to 698)
ParticipantsOG00447
ParticipantsOG00525
Title
Measurements
OG0001983(1352 to 2909)
OG0011890(1460 to 2447)
OG002356(270 to 470)
OG0032168(1682 to 2794)
OG0041856(1509 to 2283)
OG005356(274 to 464)
236
(NA to 1764)
Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG004204(NA to 1888)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG005NA(NA to 216)Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
ParticipantsOG00445
ParticipantsOG00524
Title
Measurements
OG000331(NA to 1287)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG001274(NA to 1831)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG002NA(NA to 376)Median and lower limit of full range could not be calculated as it was below the LLOQ (68).
OG003131(NA to 851)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG004172(NA to 2737)Lower limit of full range could not be calculated as it was below the LLOQ (68).
OG005NA(NA to 212)Median and lower limit of full range could not be calculated as it was below the LLOQ (68).