drugset / Trial / NCT07516418

Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Participants 18 to 49 Years of Age

NCT07516418 ↗

Phase 1 Recruiting 570 enrolled Sanofi
RandomizedSequentialTriple-blindPrevention

Summary

The purpose of this study is to evaluate the safety and immunogenicity of different formulations of vaccines encoding the RSV monovalent antigen or the Flu hemagglutinin subtype 5 (H5) antigen in healthy participants aged 18 to 49 years. The total duration of study participation for each participant varies by stage and treatment arm. Stage 1: * For Arm 1, Arm 2, and Arm 3 the duration of study participation will be approximately 7 months for each participant. * For Arm 4, Arm 5, and Arm 6 the duration of study participation will be approximately 6 months for each participant. Stage 2: For all arms, the duration of study participation will be approximately 7 months for each participant.

Timeline

Start
2026-04-15
Primary completion
2027-04-04
Completion
2027-04-04

Drugs

EvaluationDrugModalityDoseRoute
Subject H5 Flu IMP 10 Vaccine — Intramuscular
Subject H5 Flu IMP 11 Vaccine — Intramuscular
Subject H5 Flu IMP 12 Vaccine — Intramuscular
Subject H5 Flu IMP 2 Vaccine — Intramuscular
Subject H5 Flu IMP 3 Vaccine — Intramuscular
Subject H5 Flu IMP 7 Vaccine — Intramuscular
Subject H5 Flu IMP 8 Vaccine — Intramuscular
Subject H5 Flu IMP 9 Vaccine — Intramuscular
Subject H5 Flu Investigational Medical Product (IMP) 1 Vaccine — Intramuscular
Subject RSV IMP 4 Vaccine — Intramuscular
Subject RSV IMP 5 Vaccine — Intramuscular
Subject RSV IMP 6 Vaccine — Intramuscular