NCT05559476

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

A Phase 3, Open-label, Randomized, Controlled, Multicountry Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU HD Vaccine in Adults Aged 65 Years and Above

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,029 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSVPreF3 OA investigational vaccine	RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
BIOLOGICAL	FLU HD vaccine	FLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-03-07
• Completion: 2023-08-15
• First posted: 2022-09-29
• Last updated: 2024-09-24
• Results posted: 2024-04-04

Locations

46 sites across 1 country: United States

Regulatory

• FDA-regulated drug study