NCT05101486CompletedPhase 3
A Randomized, Double-blind Phase 3 Study to Assess the Immunogenicity and Safety of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
Janssen Vaccines & Prevention B.V.13 sites in 1 country755 target enrollmentStarted: November 1, 2021Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 755
- Locations
- 13
- Primary Endpoint
- Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
Study Overview
Brief Summary
The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 60 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Before randomization, a participant must be: a) postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause); and b) not intending to conceive by any methods
- •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
- •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)
- •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
Arms & Interventions
Group 1: Ad26.RSV.PreF-based Vaccine
Experimental
Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot).
Intervention: Ad26.RSV.PreF-based Vaccine (Biological)
Group 2: Ad26.RSV.PreF-based Vaccine
Experimental
Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1).
Intervention: Ad26.RSV.PreF-based Vaccine (Biological)
Group 3: Ad26.RSV.PreF-based Vaccine
Experimental
Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2).
Intervention: Ad26.RSV.PreF-based Vaccine (Biological)
Outcomes
Primary Outcomes
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
Time Frame: 14 days post vaccination on Day 1 (Day 15)
GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.
Secondary Outcomes
- Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination(From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183))
- Respiratory Syncytial Virus (RSV) A2 Strain Neutralizing Antibody Titers at 14 Days Post Vaccination(14 days post vaccination on Day 1 (Day 15))
- Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination(From Day 1 up to 6 months post vaccination on Day 1 (up to Day 183))
- Number of Participants With Unsolicited AEs for 28 Days Post Vaccination(Up to 28 days post vaccination on Day 1 (up to Day 29))
- Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination(Up to Day 7 post vaccination on Day 1 (up to Day 8))
- Number of Participants With Solicited Systemic AEs for 7 Days Post Vaccination(Up to Day 7 post vaccination on Day 1 (up to Day 8))
Investigators
Study Sites (13)
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