mRNA-1365 (Profile 2): Sterile liquid for injection
mRNA-1345 (Profile 1): Sterile liquid for injection
mRNA-1345 (Profile 3): Sterile liquid for injection
Study summary
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
Key Inclusion Criteria:
* In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination.
* Body mass index within the range 18.5 to 35 kg/m2 (inclusive).
Key Exclusion Criteria:
* History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
* Abnormal screening clinical laboratory values for total white blood cell count, hemoglobin, hematocrit, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, or total bilirubin \>Grade 1, or platelets ≥Grade 1.
* History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.
* 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 part of a combination vaccine, at any time in the past.
Note: Other inclusion and exclusion criteria may apply.
Primary outcome measure(s)
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) — Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs) — Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs) — Up to End of Study (EOS) (Day 181)
Trial sites (10)
Facility
City
Region
Status
Diex Recherche Quebec
Québec
Quebec
Recruiting
Diex Recherche Victoraville
Victoriaville
Quebec
Recruiting
MAC Clinical Research
Manchester
Greater Manchester
Not Yet Recruiting
Southampton General Hospital, NHS
Southampton
Hampshire
Not Yet Recruiting
Norfolk and Norwich University Hospital, NHS
Norwich
Norfolk
Not Yet Recruiting
University Hospital Birmingham, NHS
Birmingham
West Midlands
Not Yet Recruiting
Royal Free Hospital, NHS
London
United Kingdom
Not Yet Recruiting
Guys and St. Thomas Hospital, NHS
London
United Kingdom
Not Yet Recruiting
St. George University Hospital, NHS
London
United Kingdom
Not Yet Recruiting
Royal Victoria Infirmary, NHS
Newcastle
United Kingdom
Not Yet Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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