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Virus Therapy

Quadrivalent High-dose Influenza 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 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 days after study vaccination 1 on day 1 (day 8)
Awards & highlights

Study Summary

This study is evaluating whether a vaccine can be safely given with another vaccine.

Eligible Conditions
  • Influenza Prevention
  • Respiratory Syncytial Virus Prevention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 days after study vaccination 2 on day 29 (day 36)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 days after study vaccination 2 on day 29 (day 36) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GMTs of PreF Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 57
GMTs of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 29
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay
Secondary outcome measures
Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 1
Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 2
Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 1
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2: Control GroupExperimental Treatment3 Interventions
Participants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29.
Group II: Group 1: Coadministration (CoAd) GroupExperimental Treatment3 Interventions
Participants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quadrivalent High-dose Influenza Vaccine
2021
Completed Phase 3
~780
Placebo
1995
Completed Phase 3
~2670
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
1,133,571 Total Patients Enrolled
2 Trials studying Respiratory Syncytial Virus Prevention
1,005 Patients Enrolled for Respiratory Syncytial Virus Prevention
Janssen Vaccines & Prevention B.V. Clinical TrialStudy DirectorJanssen Vaccines & Prevention B.V.
47 Previous Clinical Trials
134,779 Total Patients Enrolled
2 Trials studying Respiratory Syncytial Virus Prevention
1,005 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 Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05071313.
~222 spots leftby Apr 2025
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