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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 one dose of the Phase 3 clinical trial material is as effective as one dose of the Phase 2b clinical trial material.

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

Side effects data

From 2022 Phase 3 trial • 777 Patients • NCT05071313
3%
Chills
2%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV (CoAd Group)
Group 2: Fluzone HD QIV With Placebo (Control Group)
Group 2: Ad26/Protein preF RSV Vaccine (Control Group)
Group 1: Placebo (CoAd Group)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2: Phase 2b CTMExperimental Treatment1 Intervention
Participants will receive a single IM injection of Ad26.RSV.preF-based vaccine on Day 1, which is a Phase 2b CTM.
Group II: Group 1: Phase 3 Clinical Trial Material (CTM)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad26.RSV.preF-based vaccine
2021
Completed Phase 3
~1030

Find a Location

Who is running the clinical trial?

Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,134,098 Total Patients Enrolled
1 Trials studying Respiratory Syncytial Virus Prevention
755 Patients Enrolled for Respiratory Syncytial Virus Prevention
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
135,306 Total Patients Enrolled
1 Trials studying Respiratory Syncytial Virus Prevention
755 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 Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
2021. "A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05083585.
~71 spots leftby Apr 2025
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