A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
NCT ID: NCT05083585
Last Updated: 2025-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
250 participants
INTERVENTIONAL
2021-10-08
2022-09-22
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
OTHER
DOUBLE
Study Groups
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Group 1: Phase 3 Clinical Trial Material (CTM)
Participants will receive a single intramuscular (IM) injection of adenovirus serotype 26 (Ad26). respiratory syncytial virus (RSV). prefusion conformation-stabilized F protein (preF)-based vaccine on Day 1, which is a Phase 3 CTM.
Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.
Group 2: Phase 2b CTM
Participants will receive a single IM injection of Ad26.RSV.preF-based vaccine on Day 1, which is a Phase 2b CTM.
Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.
Interventions
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Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.
Eligibility Criteria
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Inclusion Criteria
* Before randomization, a participant must be postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and not intending to conceive by any methods
* In the investigator's clinical judgment, participant must be 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 willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
* From the time of vaccination through 3 months after vaccination, agrees not to donate blood
Exclusion Criteria
* Abnormal function of the immune system resulting from clinical condition or medication
* History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy
* History of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
* 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
60 Years
75 Years
ALL
Yes
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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Artemis Institute for Clinical Research
San Diego, California, United States
Optimal Research
San Diego, California, United States
Accel Research Sites
Lakeland, Florida, United States
Optimal Research
Melbourne, Florida, United States
Pharmax Research Clinic Inc
Miami, Florida, United States
Research Institute of South Florida Inc
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, United States
Tekton Research Inc.
San Antonio, Texas, 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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VAC18193RSV3004
Identifier Type: OTHER
Identifier Source: secondary_id
CR109065
Identifier Type: -
Identifier Source: org_study_id
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