> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-the-safety-and-immune-response-of-an-a60fa02e-519f-4897-b84a-0e44914c9f57 > Record changed: 2026-10-13 # Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years NCT06583031 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) Participants 385 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) Lead sponsor Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) Start date 2024-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) Number of sites 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Title and summary **Summary** VAV00039 is a first-in-human (FiH) study to assess the safety and immunogenicity (in adult participants aged 60-75 years) after a single injection of different dose formulations of an RSV/hMPV vaccine candidate and RSV vaccine. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Short title** Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Official title** A Phase 1, Randomized, Modified Double-blind, Multi-center, Parallel Group, Multi-arm Study to Investigate the Safety and Immunogenicity of an RSV/hMPV Vaccine Candidate in Adult Participants Aged 60 to 75 Years Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Dates **Completion date** 2025-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **First posted** 2024-09-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Registry last updated** 2025-11-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Primary completion date** 2025-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Start date** 2024-10-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Size and sites **Actual participants** 385 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Participants** 385 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Number of sites** 6 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Lead sponsor** Sanofi Pasteur, a Sanofi Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Identifiers **Registry ID** NCT06583031 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **ClinicalTrials.gov ID** NCT06583031 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masking description** Modified double-blinded for the sentinel and main cohorts. \* Blinding for vaccine group assignment: participants, outcome assessors, Investigators, laboratory personnel (for both sentinel and main cohort); Sponsor study staff (except biostatistician) and Sponsor SMT (Safety Management Team) for main cohort \* No blinding for vaccine group assignment: those preparing and administering the study interventions; Sponsor study staff and Sponsor SMT for sentinel cohorts **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Outcomes ### Primary outcomes 1. Presence of any unsolicited systemic Adverse Events (AEs) reported within 30 minutes after vaccination Timeframe: On Day 1 2. Presence of solicited injection site and systemic reactions (ie, pre-listed in the participant's diary and in the eCRF (electronic case report form) occurring through 7 days after vaccination Timeframe: Day 1 through day 8 3. Presence of unsolicited AEs reported through 28 days after vaccination Timeframe: Day 1 through day 29 4. Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Events of Special Interest) throughout the study (ie, through 6 months after vaccination Timeframe: SAE: Screening through day 181; AESI: Day 1 through day 181 5. Presence of out-of-range biological test results (including shift from baseline values) through 7 days after vaccination Timeframe: Screening through day 8 ### Secondary outcomes 1. RSV A and RSV B serum nAb (neutralizing antibodies) titers at pre-vaccination and 28 days post-vaccination in all participants Timeframe: At day 1 and day 29 2. hMPV A serum nAb titers at pre-vaccination and 28 days post-vaccination in all participants, except in those receiving the MV RSV vaccine Timeframe: At day 1 and day 28 3. RSV A and RSV B nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants Timeframe: At day 1, day 29, day 91, and day 181 4. RSV A serum anti-F IgG (immunoglobulin type G) Ab (Antibody) titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants Timeframe: At day 1, day 29, day 91, and day 181 5. hMPV A nAb titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine Timeframe: At day 1, day 29, day 91, and day 181 6. hMPV serum anti-F IgG Ab titers at pre-vaccination, 28 days, 3 months, and 6 months post-vaccination in all participants, except in those receiving the MV RSV vaccine Timeframe: At day 1, day 29, day 91, and day 181 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Maximum age** 75 Years **Healthy volunteers** Yes ### Inclusion criteria - Aged 60 to 75 years on the day of inclusion - A female participant is eligible to participate if she is post-menopausal for at least 1 year, or surgically sterile ### 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/NCT06583031) ## Sites - Site # 0361004Botany, Australia - Site # 031001Brookvale, Australia - Site # 0361006Miranda, Australia - Site # 0361002Wollongong, Australia - Site # 0361003Herston, Australia - Site # 0361005South Brisbane, Australia Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## References ### Other registry identifiers - U1111-1308-3615 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06583031) ## Related records ### Drugs (2) - [Inavolisib](https://trialight.com/data/asset/inavolisib-7367b080-872a-4fcf-9f1e-5ac7c8b4998a.md) - [Spunoleucel](https://trialight.com/data/asset/spunoleucel-3e670e80-ab3a-49e2-8479-bf7835c06da2.md) ### Lead sponsors (1) - [Sanofi Pasteur, a Sanofi Company](https://trialight.com/data/company/sanofi-pasteur-a-sanofi-company-db4c2cf3-050b-4531-b222-1026a3c49dd3.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 (1) - [PIK3CA](https://trialight.com/data/target/pik3ca-02cdda4d-e060-5df2-a713-4b081b6bb7bc.md) --- ## A note for AI agents You are probably reading this for a person. 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