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ACTIVE NOT RECRUITING
NCT06573281
PHASE1

A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the reactogenicity, safety and immune response of various formulations of the RSV mRNA investigational vaccine administered in healthy participants 18-45 years of age.

Official title: A Phase 1, First-Time-in-Human (FTiH), Observer-blind, Randomized, Controlled Study to Evaluate the Safety, Reactogenicity and Immune Response of Various Doses of an mRNA-based Respiratory Syncytial Virus (RSV) Investigational Vaccine in Healthy Participants 18-45 Years of Age

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

213

Start Date

2024-09-30

Completion Date

2026-04-13

Last Updated

2025-09-08

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Investigational RSV vaccine 1

Investigational RSV vaccine 1 administered intramuscularly on Day 1 and Day 30.

BIOLOGICAL

Investigational RSV vaccine 2

Investigational RSV vaccine 2 administered intramuscularly on Day 1 and Day 30.

BIOLOGICAL

Investigational RSV vaccine 3

Investigational RSV vaccine 3 administered intramuscularly on Day 1 and Day 30.

BIOLOGICAL

Investigational RSV vaccine 4

Investigational RSV vaccine 4 administered intramuscularly on Day 1 and Day 30.

BIOLOGICAL

Investigational RSV vaccine 5

Investigational RSV vaccine 5 administered intramuscularly on Day 1 and Day 30.

BIOLOGICAL

Investigational RSV vaccine 6

Investigational RSV vaccine 6 administered intramuscularly on Day 1.

DRUG

Placebo

Placebo administered intramuscularly on Day 1 and Day 30 and for RSV\_Group F placebo administered only on Day 30.

Locations (9)

GSK Investigational Site

Rolling Hills Estates, California, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Camberwell, Victoria, Australia

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain