> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-1-2-study-of-respiratory-syncytial-virus-and-human-4fdfa90c-47bc-4f3a-b1df-53072b0fb30d > Record changed: 2026-10-13 # Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older NCT07734649 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) Participants 2,400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) Lead sponsor Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) Start date 2026-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) Number of sites 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Title and summary **Summary** This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate. The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV \\\[6 dose levels\\\], placebo and 4 control groups). The duration of the study will be approximately 12 months for each participant. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Short title** Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Official title** A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Dates **Completion date** 2028-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **First posted** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Registry last updated** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Primary completion date** 2028-05-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Start date** 2026-07-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Size and sites **Participants** 2,400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Planned participants** 2,400 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Number of sites** 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Lead sponsor** Sanofi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Identifiers **Registry ID** NCT07734649 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **ClinicalTrials.gov ID** NCT07734649 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Triple masking **Masking description** Observer-blind: \* Blinding for vaccine group assignment: participants, outcome assessors, investigators, site staff, laboratory personnel, Sponsor study staff. \* No blinding for site staff who prepare and administer the study interventions. \* Specific Sponsor personnel will be unblinded for the assessment of safety in the sentinel cohort. **Masked roles** Participants, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Outcomes ### Primary outcomes 1. RSV A serum nAb (neutralizing antibodies) titers Timeframe: At Day 1 and Day 29 nAb titers expressed as geometric mean titers (GMTs) 2. RSV B serum nAb titers Timeframe: At Day 1 and Day 29 nAb titers expressed as GMTs 3. HMPV A serum nAb titers Timeframe: At Day 1 and Day 29 nAb titers expressed as GMTs 4. HMPV B serum nAb titers Timeframe: At Day 1 and Day 29 nAb titers expressed as GMTs 5. Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination Timeframe: Within 30 minutes after vaccination Number of participants reporting immediate unsolicited systemic AEs 6. Presence of solicited injection site and systemic reactions Timeframe: For 8 days, including the day of vaccination Number of participants reporting: \* injection site reactions: pain, erythema and swelling \* systemic reactions: fever, headache, fatigue and myalgia 7. Presence of Unsolicited AEs Timeframe: For 28 days, including day of vaccination Number of participants reporting unsolicited AEs 8. Presence of medically attended AEs (MAAEs) Timeframe: Within 6 months after vaccination Number of participants reporting MAAEs 9. Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs) Timeframe: Throughout the study (approximately 12 months) Number of participants reporting SAEs, fatal SAEs and AESIs 10. Presence of out-of-range biological test results Timeframe: At Day 09 Number of participants with biological safety assessment values out of normal range (including shift from baseline values) ### Secondary outcomes 1. RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination Timeframe: 3, 6, 9, and 12-months post-vaccination nAb titers expressed as geometric mean titers (GMTs) 2. RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination Timeframe: 3, 6, 9, and 12 months post-vaccination nAb titers expressed as GMTs 3. HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination Timeframe: 3, 6, 9, and 12 months post-vaccination nAb titers expressed as GMTs 4. HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination Timeframe: 3, 6, 9, and 12 months post-vaccination nAb titers expressed as GMTs 5. Serum RSV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination Timeframe: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination Ab concentration expressed as geometric mean concentrations (GMCs) 6. Serum HMPV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination Timeframe: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination Ab concentration expressed as GMCs 7. Ratio of RSV A and RSV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01) Timeframe: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01) 8. Ratio of HMPV A and HMPV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01) Timeframe: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Healthy volunteers** Yes ### Inclusion criteria - Aged 60 years or older on the day of inclusion - Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile) ### Exclusion criteria - History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months - Previous history of myocarditis, pericarditis, and/or myopericarditis - Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion - Previous history of Guillain-Barré Syndrome - Any vaccine given 4 weeks before or 4 weeks after study intervention - Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine - Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration - Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months - Any screening laboratory parameter with laboratory abnormality > Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments 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/NCT07734649) ## Sites - Hawthorne Health - Gadsden City Pharmacy- Site Number : 8400025Gadsden, United StatesRecruiting - Scottsdale Clinical Trials- Site Number : 8400011Scottsdale, United StatesRecruiting - Long Beach Research Institute- Site Number : 8400005Long Beach, United StatesRecruiting - Alliance Clinical - San Diego- Site Number : 8400033San Diego, United StatesRecruiting - Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064DeLand, United StatesRecruiting - Accel Research Sites - NeuroStudies- Site Number : 8400063Decatur, United StatesRecruiting - DM Clinical Research - Chicago- Site Number : 8400050Melrose Park, United StatesRecruiting - DM Clinical Research - Detroit- Site Number : 8400049Southfield, United StatesRecruiting - Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016Lincoln, United StatesRecruiting - Alliance Clinical - Las Vegas- Site Number : 8400034Las Vegas, United StatesRecruiting - Hawthorne Health - Staten Island- Site Number : 8400026Staten Island, United StatesRecruiting - DM Clinical Research - Philadelphia- Site Number : 8400046Philadelphia, United StatesRecruiting - Coastal Carolina Research Center - North Charleston- Site Number : 8400061North Charleston, United StatesRecruiting - Velocity Clinical Research - Austin- Site Number : 8400013Austin, United StatesRecruiting - DM Clinical Research - Sugar Land- Site Number : 8400048Sugar Land, United StatesRecruiting - DM Clinical Research - Tomball- Site Number : 8400045Tomball, United StatesRecruiting - Charlottesville Medical Research- Site Number : 8400062Charlottesville, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## References ### Other registry identifiers - U1111-1337-4718 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07734649) ## Related records ### Drugs (1) - [Spunoleucel](https://trialight.com/data/asset/spunoleucel-3e670e80-ab3a-49e2-8479-bf7835c06da2.md) ### Lead sponsors (1) - [Sanofi](https://trialight.com/data/company/sanofi-241d6a3a-4341-499a-adf8-1c63e9a2e2fd.md) --- ## A note for AI agents You are probably reading this for a person. 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