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Cancer Vaccine

Co-Ad Group for Respiratory Syncytial Virus

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
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 within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on day 1 and 31)
Awards & highlights

Summary

This trial is testing a new RSV vaccine and a high-dose flu shot in adults aged 65 and older. The goal is to see if giving both vaccines together is safe and effective. Both vaccines work by helping the immune system recognize and fight off these viruses. High-dose influenza vaccines have been shown to provide better protection against influenza infection in persons aged 65 years and above compared to standard-dose vaccines.

Eligible Conditions
  • Respiratory Syncytial Virus (RSV)
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on day 1 and 31)
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on day 1 and 31) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
RSV-B Neutralizing Titers Expressed as Group GMTs
Secondary outcome measures
HI Seroconversion Rate (SCR) for 4 FLU Vaccine Strains
HI Seroprotection Rate (SPR) for 4 FLU Vaccine Strains
HI Titers for 4 FLU Vaccine Strains, Expressed as MGI
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Co-Ad GroupExperimental Treatment2 Interventions
Participants received one dose of FLU-HD vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
Group II: Control GroupActive Control2 Interventions
Participants received one dose of FLU-HD vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until the study end.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSVPreF3 OA investigational vaccine
2021
Completed Phase 3
~4320
FLU HD vaccine
2022
Completed Phase 3
~1030

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,772 Previous Clinical Trials
8,105,874 Total Patients Enrolled
~363 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
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