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Virus Therapy

Ad26.RSV.PreF-based Vaccine for Respiratory Syncytial Virus Prevention

Phase 3
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to 6 months post vaccination on day 1 (up to day 183)
Awards & highlights

Study Summary

This study is evaluating whether a vaccine can be made that is non-inferior to a vaccine made from a different batch.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to 6 months post vaccination on day 1 (up to day 183)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to 6 months post vaccination on day 1 (up to day 183) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Geometric Mean Titers (GMTs) of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) 14 Days Post Vaccination
Secondary outcome measures
Number of Participants With Adverse Event of Special Interests (AESIs) Until 6 Months Post Vaccination
Number of Participants With Serious Adverse Events (SAEs) Until 6 Months Post Vaccination
Number of Participants With Solicited Local Adverse Events (AEs) for 7 Days Post Vaccination
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group 3: Ad26.RSV.PreF-based VaccineExperimental Treatment1 Intervention
Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 2).
Group II: Group 2: Ad26.RSV.PreF-based VaccineExperimental Treatment1 Intervention
Participants will receive a single IM injection of Ad26.RSV.PreF-based vaccine on Day 1 (aged lot 1).
Group III: Group 1: Ad26.RSV.PreF-based VaccineExperimental Treatment1 Intervention
Participants will receive a single intramuscular (IM) injection of Ad26.RSV.PreF-based vaccine on Day 1 (non-aged lot).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad26.RSV.PreF-based Vaccine
2021
Completed Phase 3
~760

Find a Location

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,133,593 Total Patients Enrolled
1 Trials studying Respiratory Syncytial Virus Prevention
250 Patients Enrolled for Respiratory Syncytial Virus Prevention
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
134,801 Total Patients Enrolled
1 Trials studying Respiratory Syncytial Virus Prevention
250 Patients Enrolled for Respiratory Syncytial Virus Prevention

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years
2021. "A Study of an Ad26.RSV.PreF-based Regimen at the End of Shelf-life in Adults Aged 60 to 75 Years". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05101486.
~221 spots leftby Apr 2025
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