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
- Summary
- 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.
- Short title
- 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
- Official title
- A Phase 1, Parallel, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Different LNP Formulations of mRNA Vaccines Using the RSV Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-03-17
- First posted
- 2025-07-17
- Registry last updated
- 2026-04-28
- Primary completion date
- 2026-03-17
- Start date
- 2025-07-14
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sanofi
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07071558
- ClinicalTrials.gov ID
- NCT07071558
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- Masking description
- Investigators, study site staff, laboratory personnel, outcome assessors, and participants will be blinded throughout the study. Study staff preparing and administering the study interventions will be unblinded throughout the study.
- Masked roles
- Participants, Care providers, Investigators
Presence of any unsolicited systemic adverse events (aes)
Timeframe: Within 30 minutes after each vaccine injection
Number of participants experiencing immediate AEs
Presence of solicited injection site reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form)
Timeframe: Through 7 days after each vaccine injection
Number of participants experiencing solicited injection site reactions
Presence of solicited systemic reactions (ie, pre-listed in the participant diary and in the CRF)
Timeframe: Through 7 days after each vaccine injection
Number of participants experiencing solicited systemic reactions
Presence of unsolicited AEs
Timeframe: Day 1 through day 29
Number of participants experiencing unsolicited AEs
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest)
Timeframe: Throughout study, approximately 6 months
Number of participants experiencing SAEs and AESIs
Presence of out-of-range biological test results (including shift from baseline values)
Timeframe: Through 7 days after each vaccine injection
number of participants with out-of-range biological tests
RSV A nAb (Neutralizing Antibodies) titers
Timeframe: At day 1 and day 29
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 49 Years
- Healthy volunteers
- Yes
-
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.
- 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.
- Site # 0361003Wollongong, Australia
- Site # 0361006Brisbane, Australia
- Site # 0361005Morayfield, Australia
- Site # 0361004Southport, Australia
- Site # 0361002Bayswater, Australia
- Site # 0361001Camberwell, Australia