Trial studying safety and effects for Respiratory Syncytial Virus (RSV)
Official title A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults
ClinicalTrials.gov ID: NCT07764237
What this study is testing
What is mRNA-1365 (Profile 2)?
mRNA-1365 (Profile 2) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for respiratory syncytial virus (rsv).
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
- The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
- Phase 1: an early, usually small safety study
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
- In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical...
- Body mass index within the range 18.5 to 35 kg/m2 (inclusive). Key
You likely can't join if
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any...
- Abnormal screening clinical laboratory values for total white blood cell count, hemoglobin, hematocrit, alanine aminotransferase, aspartate...
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the...
- History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
- Participants with immune-mediated (autoimmune) conditions are generally excluded.
- Received a licensed RSV vaccine or participated in a study in which vaccines against RSV and/or hMPV were administered to participants alone, or as...
The study team makes the final eligibility decision.
Where it's taking place
- Québec, Quebec, Canada
- Victoriaville, Quebec, Canada
- Manchester, Greater Manchester, United Kingdom
- Southampton, Hampshire, United Kingdom
- Norwich, Norfolk, United Kingdom
- Birmingham, West Midlands, United Kingdom
- London, United Kingdom
- Newcastle, United Kingdom
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 Québec, Quebec, Canada; Victoriaville, Quebec, Canada; Manchester, Greater Manchester, United Kingdom; Southampton, Hampshire, United Kingdom; Norwich, Norfolk, United Kingdom; Birmingham, West Midlands, United Kingdom and 2 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.