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
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: t
View:
• Aged 18 to 49 years on the day of inclusion
• A female participant is eligible to participate if she is not pregnant or breastfeeding and of the following conditions applies:
• Is of NCBP (Non-Child-Bearing Potential). To be considered of NCBP, a female must be post-menopausal for at least 1 year, or surgically sterile. OR
• Is of CBP (Child-Bearing Potential) and uses an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after the last study intervention administration.
Locations
Other Locations
Australia
Site # 0361002
RECRUITING
Griffith
Site # 0361001
RECRUITING
Herston
Site # 0361003
RECRUITING
Morayfield
Site # 0361005
RECRUITING
Sippy Downs
Site # 03610004
RECRUITING
South Brisbane
Site # 036006
RECRUITING
Taringa
Contact Information
Primary
Sanofi Trial Transparency Email Recommended (Toll free for US and Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date:2026-04-15
Estimated Completion Date:2027-04-04
Participants
Target number of participants:570
Treatments
Experimental: Stage 1, Arm 1
Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule.
Experimental: Stage 1, Arm 2
Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule.
Experimental: Stage 1, Arm 3
Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule.
Experimental: Stage 1, Arm 4
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: Stage 1, Arm 5
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: Stage 1, Arm 6
Participants will receive a single IM (Intramuscular) injection on day 1 of the RSV vaccines according to their randomization schedule.
Experimental: Stage 2, Arm 1
Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule.
Experimental: Stage 2, Arm 2
Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule.
Experimental: Stage 2, Arm 3
Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule.
Experimental: Stage 2, Arm 4
Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule.
Experimental: Stage 2, Arm 5
Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule.
Experimental: Stage 2, Arm 6
Participants will receive a single IM (Intramuscular) injection on day 1 and day 22 of the H5 Flu vaccines according to their randomization schedule.