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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

NCT07516418

RecruitingPhase 1

Sponsor: Sanofi

Conditions: Respiratory Syncytial Virus (RSV), Influenza A(H5N1)

Interventions: H5 Flu Investigational Medical Product (IMP) 1, H5 Flu IMP 2, H5 Flu IMP 3, RSV IMP 4, RSV IMP 5

Countries: Australia

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 overview

Sex: ALL

Age: 18 Years to 49 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

• Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (6)

Griffith, Queensland, Australia
Herston, Queensland, Australia
Morayfield, Queensland, Australia
Sippy Downs, Queensland, Australia
South Brisbane, Queensland, Australia
Taringa, Queensland, Australia