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

Recruiting in Palo Alto (17 mi)

+48 other locations

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Inclusion Criteria

Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol

Written or witnessed informed consent obtained from the participant prior to performance of any study-specific procedure.

You are 65 years of age or older.

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Exclusion Criteria

Administration of long-acting immune-modifying drugs or planned administration at any time during the study period

You have a severe allergy to latex.

Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study

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Treatment Details

Interventions

FLU HD vaccine (Cancer Vaccine)
RSVPreF3 OA investigational vaccine (Virus Therapy)

Participant Groups

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.