NCT06573281

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-30
• Primary completion: 2026-04-13
• Completion: 2026-04-13
• First posted: 2024-08-27
• Last updated: 2025-09-08

Locations

9 sites across 3 countries: United States, Australia, Spain

Regulatory

• FDA-regulated drug study