NCT04841577

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 60 Years and Above

A Phase 3, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With FLU-QIV Vaccine in Adults Aged 60 Years and Above

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 976 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 60 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 seasonal quadrivalent influenza vaccine (FLU-QIV) in adults aged 60 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-QIV	FLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm.

Timeline

• Start date: 2021-04-27
• Primary completion: 2021-09-22
• Completion: 2022-02-08
• First posted: 2021-04-12
• Last updated: 2024-09-03
• Results posted: 2022-10-18

Locations

14 sites across 3 countries: New Zealand, Panama, South Africa

Regulatory

• FDA-regulated drug study