Clinical trial

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV)…

NCT04886596 · GlaxoSmithKline, Industry · Completed

Key facts

NCT number NCT04886596
Title Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
Official title 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
Lead sponsor GlaxoSmithKline, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Respiratory Syncytial Virus Infections
Intervention type Biological
Interventions Placebo, RSVPreF3 OA vaccine
Enrollment 26,675
Start date May 25, 2021
Primary completion Apr 11, 2022
Completion May 31, 2024
First posted May 14, 2021
Last update posted Jul 31, 2025
Countries Australia, Belgium, Canada, Estonia, Finland, Germany, Italy, Japan, Mexico, New Zealand, Poland, Russia and 5 more

At a glance

  • 100–999 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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