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Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age

NCT07071558

CompletedPhase 1

Sponsor: Sanofi

Conditions: Respiratory Syncytial Virus Immunization

Interventions: RSV vaccine formulation 1 dose, RSV vaccine formulation 2 dose, RSV vaccine formulation 3 dose, RSV vaccine formulation 4 dose, RSV vaccine formulation 5 dose

Countries: Australia

The purpose of this study is to evaluate the safety and immunogenicity of different liponanaoparticle (LNP) formulations of modified ribonucleic acid (mRNA) vaccines using the RSV pre-F antigen in healthy participants 18 to 49 years of age. -Each participant will remain in the study for approximately 6 months. * The study intervention will be administered as a single intramuscular (IM) dose in the upper arm on Day 1 (D01). * The visit frequency will include 1 Screening Visit, 4 planned site visits to occur on D01, D03, D08, and D29, and 2 telephone calls to occur at Month (M)3 and M6.

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 agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after 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)

Wollongong, New South Wales, Australia
Brisbane, Queensland, Australia
Morayfield, Queensland, Australia
Southport, Queensland, Australia
Bayswater, Victoria, Australia
Camberwell, Victoria, Australia