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Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
Sponsor: Sanofi
Summary
The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age. -Each participant will remain in the study for approximately 6 months. * The study intervention will be administered as a single intramuscular (IM) dose in the upper arm on Day 1 (D01). * The visit frequency will include 1 Screening Visit, 4 planned site visits to occur on D01, D03, D08, and D29, and 2 telephone calls to occur at Month (M)3 and M6.
Official title: A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different LNP Formulations of mRNA Vaccines Using the RSV Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
Key Details
Gender
All
Age Range
18 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-07-14
Completion Date
2026-02-26
Last Updated
2025-09-16
Healthy Volunteers
Yes
Conditions
Interventions
RSV vaccine formulation 1 dose
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 2 dose
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 3 dose
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 4 dose
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 5 dose
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 6 dose
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 7 dose
Suspension for injection. Route of administration: IM injection
RSV vaccine formulation 8 dose
Suspension for injection. Route of administration: IM injection
Locations (6)
Site # 0361003
Wollongong, New South Wales, Australia
Site # 0361006
Brisbane, Queensland, Australia
Site # 0361005
Morayfield, Queensland, Australia
Site # 0361004
Southport, Queensland, Australia
Site # 0361002
Bayswater, Victoria, Australia
Site # 0361001
Camberwell, Victoria, Australia