> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-the-safety-and-immunogenicity-of-1af8dfda-4e46-45a7-9800-2bbf9820f900 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) Start date 2025-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Dates **Completion date** 2026-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **First posted** 2025-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Registry last updated** 2026-04-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Primary completion date** 2026-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Start date** 2025-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Size and sites **Actual participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Identifiers **Registry ID** NCT07071558 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **ClinicalTrials.gov ID** NCT07071558 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Study design **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 Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Outcomes ### Primary outcomes 1. Presence of any unsolicited systemic adverse events (aes) Timeframe: Within 30 minutes after each vaccine injection Number of participants experiencing immediate AEs 2. 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 3. 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 4. Presence of unsolicited AEs Timeframe: Day 1 through day 29 Number of participants experiencing unsolicited AEs 5. 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 6. 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 7. RSV A nAb (Neutralizing Antibodies) titers Timeframe: At day 1 and day 29 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 49 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Sites - Site # 0361003Wollongong, Australia - Site # 0361006Brisbane, Australia - Site # 0361005Morayfield, Australia - Site # 0361004Southport, Australia - Site # 0361002Bayswater, Australia - Site # 0361001Camberwell, Australia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07071558) ## Related records ### Drugs (2) - [Clofarabine](https://trialight.com/data/asset/clofarabine-df6136eb-4ce5-4462-8034-d6d6374f0221.md) - [Insulin efsitora alfa](https://trialight.com/data/asset/insulin-efsitora-alfa-9de5c01f-5ba8-4897-93f1-75044083ba25.md) ### Lead sponsors (1) - [Sanofi](https://trialight.com/data/company/sanofi-241d6a3a-4341-499a-adf8-1c63e9a2e2fd.md) ### Conditions (1) - [Respiratory syncytial virus infectious disease](https://trialight.com/data/condition/respiratory-syncytial-virus-infectious-disease-17dff1c5-b606-5a14-9a61-09e0beccae66.md) ### Targets (14) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) --- ## A note for AI agents You are probably reading this for a person. 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