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RecruitingPhase 1NCT07516418

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

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

Sponsor

Sanofi

Enrollment

570 participants

Start Date

Apr 15, 2026

Study Type

INTERVENTIONAL

Conditions

Respiratory Syncytial Virus (RSV)Influenza A(H5N1)

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.

Eligibility

Min Age: 18 YearsMax Age: 49 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called H5 Flu IMP 10, a biological treatment called H5 Flu IMP 11, and others for people with influenza a(h5n1) and respiratory syncytial virus (rsv). The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALH5 Flu Investigational Medical Product (IMP) 1

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

BIOLOGICALH5 Flu IMP 2

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

BIOLOGICALH5 Flu IMP 3

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

BIOLOGICALRSV IMP 4

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

BIOLOGICALRSV IMP 5

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

BIOLOGICALRSV IMP 6

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

BIOLOGICALH5 Flu IMP 7

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

BIOLOGICALH5 Flu IMP 8

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

BIOLOGICALH5 Flu IMP 9

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

BIOLOGICALH5 Flu IMP 10

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

BIOLOGICALH5 Flu IMP 11

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

BIOLOGICALH5 Flu IMP 12

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

Locations(6)

Site # 0361002

Griffith, Queensland, Australia

Site # 0361001

Herston, Queensland, Australia

Site # 0361003

Morayfield, Queensland, Australia

Site # 0361005

Sippy Downs, Queensland, Australia

Site # 03610004

South Brisbane, Queensland, Australia

Site # 036006

Taringa, Queensland, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT07516418

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