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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

751

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

June 3, 2025

Study Completion Date

November 24, 2025

Conditions
Respiratory Syncytial Virus Infections
Interventions
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.

Trial Locations (14)

110060

GSK Investigational Site, Delhi

202002

GSK Investigational Site, Aligarh

208002

GSK Investigational Site, Kanpur

380015

GSK Investigational Site, Ahmedabad

380061

GSK Investigational Site, Ahmedabad

411043

GSK Investigational Site, Pune-411 043

412216

GSK Investigational Site, Vadu Budruk Pune

560002

GSK Investigational Site, Bangalore

590019

GSK Investigational Site, Belagavi

603103

GSK Investigational Site, Kelambākkam

682026

GSK Investigational Site, Kochi

700073

GSK Investigational Site, Kolkata

734012

GSK Investigational Site, Darjeeling

Unknown

GSK Investigational Site, Raipur

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

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) | Biotech Hunter | Biotech Hunter