A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
NCT ID: NCT05071313
Last Updated: 2025-05-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
777 participants
INTERVENTIONAL
2021-10-04
2022-10-11
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: Coadministration (CoAd) Group
Participants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29.
Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as single IM injection.
Quadrivalent High-dose Influenza Vaccine
Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.
Placebo
Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.
Group 2: Control Group
Participants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29.
Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as single IM injection.
Quadrivalent High-dose Influenza Vaccine
Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.
Placebo
Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.
Interventions
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Ad26.RSV.preF-based vaccine
Ad26.RSV.preF-based vaccine will be administered as single IM injection.
Quadrivalent High-dose Influenza Vaccine
Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.
Placebo
Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.
Eligibility Criteria
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Inclusion Criteria
* In the investigator's clinical judgment, the participant must be in stable health at the time of vaccination. Participants will be included on the basis of medical history and vital signs performed between informed consent from (ICF) signature and vaccination
* Before randomization, a participant must be not intending to conceive by any methods, postmenopausal or surgically sterile
* From the time of vaccination through 3 months after vaccination, agrees not to donate blood
* Must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
* Participant must be able to work with smartphones/tablets/computers
Exclusion Criteria
* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
* History of severe allergic reactions (example, anaphylaxis) to any component of the Quadrivalent high-dose influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
* Has abnormal function of the immune system resulting from either clinical condition, chronic or recurrent use of systemic corticosteroids within 2 months prior to study vaccination, or immunomodulating agents within 6 months prior to study vaccination
* Per medical history, participant has chronic active hepatitis B or hepatitis C infection
* History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
* Has a serious chronic disorder, example, chronic obstructive pulmonary disease or congestive heart failure, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition, including conditions placing the participant at high risk for severe influenza, for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
* Received vaccination with seasonal influenza vaccine for the current influenza season in the Northern Hemisphere
65 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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Ark Clinical Research
Long Beach, California, United States
Research Centers of America, LLC
Hollywood, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Synexus Clinical Research US Inc
The Villages, Florida, United States
Synexus Clinical Research US Inc
Chicago, Illinois, United States
Meridian Clinical Research, LLC
Rockville, Maryland, United States
Sundance Clinical Research
St Louis, Missouri, United States
Synexus Clinical Research US Inc
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Grand Island, Nebraska, United States
Meridian Clinical Research, LLC
Lincoln, Nebraska, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
Tekton Research Inc.
Yukon, Oklahoma, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
VitaLink Research Spartanburg
Spartanburg, South Carolina, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
Knoxville, Tennessee, United States
Optimal Research
Austin, Texas, United States
Tekton Research Inc.
Austin, Texas, United States
DM Clinical Research
Tomball, 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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VAC18193RSV3005
Identifier Type: OTHER
Identifier Source: secondary_id
CR109064
Identifier Type: -
Identifier Source: org_study_id
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