NCT06614725

A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)

A Phase 3, Randomized, Placebo-controlled, Observer-blind Study in India to Evaluate Immune Response, Reactogenicity and Safety of a Single Intramuscular Dose of RSVPreF3 OA Investigational Vaccine When Administered to Older Adults >=60 Years of Age and Adults 50-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 751 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	RSVPreF3 OA investigational vaccine	1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly on Day 1 to participants in OA-RSV and Adults-AIR-RSV groups.
COMBINATION_PRODUCT	Placebo	1 dose of placebo (saline solution) administered intramuscularly on Day 1 to participants in OA-Placebo and Adults-AIR-Placebo groups.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-06-03
• Completion: 2025-11-14
• First posted: 2024-09-26
• Last updated: 2025-12-26

Locations

14 sites across 1 country: India