A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age60+
SponsorModernaTX, Inc.
About this trial
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- mRNA-1365 (Profile 2)
- mRNA-1345 (Profile 1)
- mRNA-1345 (Profile 3)
Treatment groups
375 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov