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ACTIVE NOT RECRUITING
NCT07071558
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

RSV vaccine formulation 1 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 2 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 3 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 4 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 5 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 6 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

RSV vaccine formulation 7 dose

Suspension for injection. Route of administration: IM injection

BIOLOGICAL

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