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Cancer Vaccine

A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above

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

No Placebo-Only Group

Pivotal Trial

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 Infection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 4 days (the day of vaccination and 3 subsequent days) after each vaccination (administered on day 1 and 31)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

2023

Completed Phase 3

~5970

FLU HD vaccine

2022

Completed Phase 3

~1030