A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years
NCT06573281 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 213
Last updated 2025-09-08
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
- 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 administered intramuscularly on Day 1 and Day 30 and for RSV\_Group F placebo administered only on Day 30.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-09-30
- Primary Completion
- 2026-04-13
- Completion
- 2026-04-13
- FDA Drug
- Yes
Countries
- United States
- Australia
- Spain
Study Locations
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