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Phase 1/2 Study of RSV+HMPV Vaccine in Adults 60 and Older

This study is testing a new vaccine called RSV+HMPV to see if it can safely prevent infections from Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV) in adults aged 60 and older. While there are already vaccines for RSV, there isn't one yet for HMPV in older adults. Researchers want to understand how well the RSV+HMPV vaccine works by measuring your body's immune response (neutralizing antibodies) to RSV and HMPV at the beginning of the study and again on Day 29. You might receive the RSV+HMPV vaccine at different dose levels, a placebo (an inactive substance), or one of four other control vaccines. This study aims to gather important information to help develop this vaccine further.

Study design
This is a Phase 1/2, randomized, observer-blind, active and placebo-controlled study involving about 2400 adults aged 60 and older.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be measured on Day 1 and Day 29 after receiving the vaccine.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07734649

Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older

Recruiting
PHASE1Ages 60+InterventionalPrevention
Sanofi
~2,400 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:RSV+HMPV vaccineControl Vaccine 3Control Vaccine 4Control Vaccine 2PlaceboControl Vaccine 1

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
RSV A serum nAb (neutralizing antibodies) titers
Measured over At Day 1 and Day 29
+9 more outcomes measured

Conditions

Respiratory Syncytial Virus Immunization
Human Metapneumovirus Immunization
Healthy Volunteers

Explore related trials

Human Metapneumovirus InfectionRespiratory Syncytial Virus Infection

Where it's being run

17 sites across 14 states
Texas3
California2
Alabama1
Arizona1
Florida1
Georgia1
Illinois1
Michigan1

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • RSV A serum nAb (neutralizing antibodies) titersAt Day 1 and Day 29

    nAb titers expressed as geometric mean titers (GMTs)

  • RSV B serum nAb titersAt Day 1 and Day 29

    nAb titers expressed as GMTs

  • HMPV A serum nAb titersAt Day 1 and Day 29

    nAb titers expressed as GMTs

  • HMPV B serum nAb titersAt Day 1 and Day 29

    nAb titers expressed as GMTs

  • Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccinationWithin 30 minutes after vaccination

    Number of participants reporting immediate unsolicited systemic AEs

  • Presence of solicited injection site and systemic reactionsFor 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

  • Presence of Unsolicited AEsFor 28 days, including day of vaccination

    Number of participants reporting unsolicited AEs

  • Presence of medically attended AEs (MAAEs)Within 6 months after vaccination

    Number of participants reporting MAAEs

  • Presence of Serious Adverse Events (SAEs), fatal SAEs and Adverse Events of Special Interest (AESIs)Throughout the study (approximately 12 months)

    Number of participants reporting SAEs, fatal SAEs and AESIs

  • Presence of out-of-range biological test resultsAt Day 09

    Number of participants with biological safety assessment values out of normal range (including shift from baseline values)