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

Study of an Investigational Vaccine to Prevent RSV and HMPV in Adults 60 and Older

Age
60 years or above
Gender
All
Phase
Phase 1/2
Participants needed
2400
Locations
17
Find a study site near you

Study Overview

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Respiratory Syncytial Virus Immunization, Human Metapneumovirus Immunization, Healthy Volunteers
  • Age: 60 years or above
  • Gender: All

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.

The purpose of this research study is to learn about the immune response and safety of an investigational vaccine intended to help prevent illness from respiratory syncytial virus (RSV) and human metapneumovirus (HMPV) in adults 60 years of age and older.

Participants will receive either the investigational vaccine or a comparison vaccine, or a placebo. A placebo looks like the investigational study drug but does not contain active medication.

Who can participate:
Adults 60 years of age and older may be able to participate if they:

  • Are 60 years or older
  • Are not able to become pregnant (for example, are post-menopausal for at least one year or have been surgically sterilized)
  • Have not had a laboratory-confirmed RSV or HMPV infection in the past year (for themselves or their household)
  • Have not previously received an RSV or HMPV vaccine (investigational or marketed)
  • Do not have a history of certain heart inflammations (myocarditis, pericarditis, or myopericarditis) and do not have an ECG result that suggests these problems
  • Do not have a history of Guillain-Barré syndrome
  • Have not had certain vaccines recently (within four weeks before or after the study vaccination)
  • Have not received an mRNA vaccine/product in the past two months
  • Have not received a blood transfusion or blood-derived products (including immunoglobulins) in the past three months
  • Do not have lab test results that show more than mild or clinically important abnormalities, as judged by the study doctor

Study timeline and visits:
Participation lasts about 12 months.

Updated on 27 Jul 2026. Study ID: NCT07734649

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