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NOT YET RECRUITING
NCT07516418
PHASE1

Study of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in 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 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.

Official title: A Phase 1, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different Formulations of Vaccines Encoding the RSV Monovalent Antigen or the Flu H5 Antigen in Healthy Participants 18 to 49 Years of Age

Key Details

Gender

All

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

570

Start Date

2026-04-13

Completion Date

2027-04-04

Last Updated

2026-04-08

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

H5 Flu Investigational Medical Product (IMP) 1

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

H5 Flu IMP 2

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

H5 Flu IMP 3

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

RSV IMP 4

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

RSV IMP 5

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

RSV IMP 6

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

H5 Flu IMP 7

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

H5 Flu IMP 8

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

H5 Flu IMP 9

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

H5 Flu IMP 10

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

H5 Flu IMP 11

Suspension for injection. Route of administration: Intramuscular (IM) injection

BIOLOGICAL

H5 Flu IMP 12

Suspension for injection. Route of administration: Intramuscular (IM) injection