A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
NCT ID: NCT05101486
Last Updated: 2025-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
755 participants
INTERVENTIONAL
2021-11-01
2022-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 1: Ad26.RSV.PreF-based Vaccine
Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot).
Ad26.RSV.PreF-based Vaccine
Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
Group 2: Ad26.RSV.PreF-based Vaccine
Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1).
Ad26.RSV.PreF-based Vaccine
Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
Group 3: Ad26.RSV.PreF-based Vaccine
Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2).
Ad26.RSV.PreF-based Vaccine
Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
Interventions
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Ad26.RSV.PreF-based Vaccine
Ad26.RSV.PreF-based Vaccine will be administered as single IM injection.
Eligibility Criteria
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Inclusion Criteria
* From the time of vaccination through 3 months after vaccination, agrees not to donate blood
* In the investigator's clinical judgment, a participant must be in stable health at the time of vaccination. Participants may have underlying illnesses such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, Type 2 diabetes, hyperlipoproteinemia, or hypothyroidism, as long as their symptoms and signs are stable at the time of vaccination, and these conditions receive routine follow-up by the participant's healthcare provider. Participants will be included on the basis of medical history and vital signs performed between informed consent form (ICF) signature and vaccination
* Must be able to read, understand, and complete questionnaires in the electronic diary (eDiary)
* Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* Must be able to work with smartphones/tablets/computers
Exclusion Criteria
* Abnormal function of the immune system resulting from clinical conditions or medication
* Per medical history, participant has chronic active hepatitis B or hepatitis C infection
* History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
* Has had major surgery (per the investigator's judgment) within 4 weeks before administration of the study vaccine or will not have recovered from surgery per the investigator's judgment at time of vaccination
* Has had major psychiatric illness and/or drug or alcohol abuse which in the investigator's opinion would compromise the participant's safety and/or compliance with the study procedures
60 Years
75 Years
ALL
No
Sponsors
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Janssen Vaccines & Prevention B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Vaccines & Prevention B.V. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Vaccines & Prevention B.V.
Locations
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North Alabama Research Center, LLC
Athens, Alabama, United States
Achieve Clinical Research, LLC
Vestavia Hills, Alabama, United States
Hope Research Institute
Phoenix, Arizona, United States
Clinical Research Consulting
Milford, Connecticut, United States
Accel Research Sites
DeLand, Florida, United States
Pharmax Research Clinic Inc
Miami, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Centennial Medical Group
Elkridge, Maryland, United States
Be Well Clinical Studies
Lincoln, Nebraska, United States
American Health Network, LLC
Charlotte, North Carolina, United States
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-002388-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VAC18193RSV3003
Identifier Type: OTHER
Identifier Source: secondary_id
CR109069
Identifier Type: -
Identifier Source: org_study_id
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