NCT07734649 · Sanofi
Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
What this study is about
This study is a Phase 1/2, randomly assigned, observer-blind, active and compared against an inactive treatment, 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.
View original scientific description
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.
Interventions
BIOLOGICAL
RSV+HMPV vaccine
RSV + HMPV Candidate Vaccine
BIOLOGICAL
Control Vaccine 3
Control Vaccine 3
BIOLOGICAL
Control Vaccine 4
Control Vaccine 4
BIOLOGICAL
Control Vaccine 2
Control Vaccine 2
OTHER
Placebo
Placebo
BIOLOGICAL
Control Vaccine 1
Control Vaccine 1
Primary outcome measures
RSV A serum nAb (neutralizing antibodies) titers
Time frame: At Day 1 and Day 29
nAb titers expressed as geometric mean titers (GMTs)
RSV B serum nAb titers
Time frame: At Day 1 and Day 29
nAb titers expressed as GMTs
HMPV A serum nAb titers
Time frame: At Day 1 and Day 29
nAb titers expressed as GMTs
HMPV B serum nAb titers
Time frame: At Day 1 and Day 29
nAb titers expressed as GMTs
Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination
Time frame: Within 30 minutes after vaccination
Number of participants reporting immediate unsolicited systemic AEs
Presence of solicited injection site and systemic reactions
Time frame: 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
Presence of Unsolicited AEs
Time frame: For 28 days, including day of vaccination
Number of participants reporting unsolicited AEs
Presence of medically attended AEs (MAAEs)
Time frame: 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)
Time frame: Throughout the study (approximately 12 months)
Number of participants reporting SAEs, fatal SAEs and AESIs
Presence of out-of-range biological test results
Time frame: At Day 09
Number of participants with biological safety assessment values out of normal range (including shift from baseline values)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Gadsden, Alabama
- Scottsdale, Arizona
- Long Beach, California
- San Diego, California
- DeLand, Florida
- Decatur, Georgia
- Melrose Park, Illinois
- Southfield, Michigan
- Lincoln, Nebraska
- Las Vegas, Nevada
- Staten Island, New York
- Philadelphia, Pennsylvania
And 5 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations