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

Phase 1Active Not RecruitingNCT07071558

Sanofi240 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

240

Conditions

Respiratory Syncytial Virus Immunization

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Site # 0361003

Wollongong, New South Wales, Australia

Site # 0361006

Brisbane, Queensland, Australia

Site # 0361005

Morayfield, Queensland, Australia

Site # 0361004

Southport, Queensland, Australia

Site # 0361002

Bayswater, Victoria, Australia

Site # 0361001

Camberwell, Victoria, Australia

Outcomes

Primary Outcomes

Presence of any unsolicited systemic adverse events (aes)

Number of participants experiencing immediate AEs

Time frame: Within 30 minutes after each vaccine injection

Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)

Number of participants experiencing solicited injection site reactions

Time frame: Through 7 days after each vaccine injection

Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)

Number of participants experiencing solicited systemic reactions

Time frame: Through 7 days after each vaccine injection

Presence of unsolicited AEs

Number of participants experiencing unsolicited AEs

Time frame: Day 1 through day 29

Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)

Number of participants experiencing SAEs and AESIs

Time frame: Throughout study, approximately 6 months

Presence of out-of-range biological test results (including shift from baseline values)

number of participants with out-of-range biological tests

Time frame: Through 7 days after each vaccine injection

RSV A nAb (Neutralizing Antibodies) titers

Time frame: At day 1 and day 29