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A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years
Sponsor: GlaxoSmithKline
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
Conditions
Interventions
Investigational RSV vaccine 1
Investigational RSV vaccine 1 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 2
Investigational RSV vaccine 2 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 3
Investigational RSV vaccine 3 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 4
Investigational RSV vaccine 4 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 5
Investigational RSV vaccine 5 administered intramuscularly on Day 1 and Day 30.
Investigational RSV vaccine 6
Investigational RSV vaccine 6 administered intramuscularly on Day 1.
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