Human Metapneuomovirus (hMPV), Respiratory Syncytial Virus (RSV)
Conditions
Keywords
Respiratory Syncytial Virus (RSV), Human Metapneuomovirus (hMPV), Vaccine, Moderna, Respiratory Viral Infection, mRNA-1365 (Profile 2), Older Adults
Brief summary
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
Interventions
BIOLOGICALmRNA-1365 (Profile 2)
Sterile liquid for injection
BIOLOGICALmRNA-1345 (Profile 1)
Sterile liquid for injection
BIOLOGICALmRNA-1345 (Profile 3)
Sterile liquid for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
Secondary
| Measure | Time frame |
|---|---|
| Geometric Mean Level of Serum Neutralizing Antibodies (nAbs) | Day 29 |
| Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs) | Day 29 |
| Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level | Day 29 |
Countries
Canada, United Kingdom
Contacts
CONTACTModerna WeCareTeam
Outcome results
None listed