Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
Investigating RSV+HMPV Vaccine Candidate in Older Adults
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
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Age: 60 years or above
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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 study is to investigate a vaccine candidate for respiratory syncytial virus (RSV) and human metapneumovirus (HMPV) in adults aged 60 and older. The study focuses on these conditions to gather data for further clinical development.
This study evaluates the safety and immune response to the investigational vaccine. It looks at how well the vaccine works and how safe it is for older adults.
- Who can participate: Adults aged 60 years or older who cannot have children can participate. Key factors include no recent history of certain infections or chronic illnesses that could affect the study.
- Study details: Participants will receive either the investigational vaccine or a placebo, which is an inactive substance that looks like the investigational vaccine but does not contain any medicine. The study will include different vaccine dose levels and control groups.
- Study timelines: The study will last 12 months for each participant.
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