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COMPLETED
NCT06614725
PHASE3

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)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

751

Start Date

2024-10-01

Completion Date

2025-11-14

Last Updated

2026-06-23

Healthy Volunteers

Yes

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.

Locations (14)

GSK Investigational Site

Kanpur, Uttar Pradesh, India

GSK Investigational Site

Ahmedabad, India

GSK Investigational Site

Ahmedabad, India

GSK Investigational Site

Aligarh, India

GSK Investigational Site

Bangalore, India

GSK Investigational Site

Belagavi, India

GSK Investigational Site

Darjeeling, India

GSK Investigational Site

Delhi, India

GSK Investigational Site

Kelambākkam, India

GSK Investigational Site

Kochi, India

GSK Investigational Site

Kolkata, India

GSK Investigational Site

Pune-411 043, India

GSK Investigational Site

Raipur, India

GSK Investigational Site

Vadu Budruk Pune, India