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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
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
H5 Flu Investigational Medical Product (IMP) 1
Suspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 2
Suspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 3
Suspension for injection. Route of administration: Intramuscular (IM) injection
RSV IMP 4
Suspension for injection. Route of administration: Intramuscular (IM) injection
RSV IMP 5
Suspension for injection. Route of administration: Intramuscular (IM) injection
RSV IMP 6
Suspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 7
Suspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 8
Suspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 9
Suspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 10
Suspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 11
Suspension for injection. Route of administration: Intramuscular (IM) injection
H5 Flu IMP 12
Suspension for injection. Route of administration: Intramuscular (IM) injection