NCT04886596

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

A Phase 3, Randomized, Placebo-controlled, Observer-blind, Multi-country Study to Demonstrate the Efficacy of a Single Dose and Annual Revaccination Doses of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Above

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26,675 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

Detailed description

Dose 1 Period will be conducted in 2 parts: Part 1: Participants in RSVPreF3 groups will receive lots 1, 2 and 3 of the investigational vaccine before Season 1. Part 2: Will be initiated when the vaccine lots in part 1 are exhausted at the study sites and participants in RSVPreF3 group will receive lot 4 of the investigational vaccine before Season 1.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1 and before Season 2 to the Placebo Group, and before Season 2 to the participants of the RSVPreF3 Group, that are re-randomized to the RSV\_1 dose group.
BIOLOGICAL	RSVPreF3 OA vaccine	RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at Day 1 in the RSVPreF3 group, and before Season 2 to the participants of the RSVPreF3 group that are re-randomized to the RSV\_annual group.

Timeline

• Start date: 2021-05-25
• Primary completion: 2022-04-11
• Completion: 2024-05-31
• First posted: 2021-05-14
• Last updated: 2025-07-31
• Results posted: 2023-08-04

Locations

277 sites across 17 countries: United States, Australia, Belgium, Canada, Estonia, Finland, Germany, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Africa, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study