Clinical trial for Respiratory Syncytial Virus Immunization
Official title Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older
ClinicalTrials.gov ID: NCT07734649
What this study is testing
What is RSV+HMPV vaccine?
RSV+HMPV vaccine is an investigational medicine, being studied as a potential treatment for respiratory syncytial virus immunization.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older. Healthy volunteers may be eligible.
You may be able to join if
- Aged 60 years or older on the day of inclusion
- Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)
You likely can't join if
- History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the...
- 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...
- 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
See the full eligibility 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)
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Gadsden, Alabama, United States
- Vestavia Hills, Alabama, United States
- Huntington Beach, California, United States
- La Mesa, California, United States
- Long Beach, California, United States
- San Diego, California, United States
- Washington D.C., District of Columbia, United States
- DeLand, Florida, United States
- Edgewater, Florida, United States
- Lakeland, Florida, United States
- Largo, Florida, United States
- Maitland, Florida, United States
- Palmetto Bay, Florida, United States
- Decatur, Georgia, United States
- Woodstock, Georgia, United States
- Melrose Park, Illinois, United States
- Peoria, Illinois, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Boston, Massachusetts, United States
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gadsden, Alabama, United States; Vestavia Hills, Alabama, United States; Huntington Beach, California, United States; La Mesa, California, United States; Long Beach, California, United States; San Diego, California, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.