Open
Actively Recruiting
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
About
Brief Summary
The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to <24 months.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- The participant is 8 months to <24 months (Part A), 5 months to <8 months (Part B), or 8 months to <12 months (Part C) of age at the time of randomization (Day 1/Baseline visit), who is in good general health, in the opinion of the Investigator, based on review of medical history and screening physical examination.
- In the Investigator's opinion, the parent(s)/ legally authorized representative (LAR)(s) understand and are willing and physically able to comply with protocol-mandated follow up, including all procedures, and provide written informed consent.
- The participant is growing normally for age in the opinion of the site clinician in the months prior to enrollment.
- The participant was born at full-term (≥37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).
- For Part C Cohort 7: participant must have received nirsevimab ≥6 months prior to Day 1 Visit.
- For Part C Cohort 8: participant was eligible, according to national guidelines, to receive nirsevimab prior to Day 1 Visit but did not do so.
Exclusion Criteria:
- Has a known history of symptomatic RSV or hMPV infection (Part A: within 3 months; Part B: and Part C since birth) prior to administration of the first dose of investigational product (IP) or has a known close contact with anyone with laboratory-confirmed RSV or hMPV infection within 14 days prior to administration of the first dose of IP (Part A, B, and C).
- Is acutely ill or febrile 24 hours prior to or at the screening visit. Fever is defined as a body temperature ≥38.0°Celsius/≥100.4°Fahrenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows.
- Has previously been administered an investigational or approved vaccine for prevention of RSV or hMPV infection or if the participant's mother received an investigational or approved vaccine for the prevention of RSV or hMPV infection during pregnancy.
- Has received investigational or approved agents for prophylaxis against RSV or hMPV (for example, monoclonal antibodies) or is intending to receive these during the course of the study. For Part C (Cohort 7 only), use of nirsevimab ≥6 months before Day 1 Visit is allowed.
- Has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to a previous dose of an mRNA vaccine or any of its components (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate).
- Has a medical condition that, according to the Investigator's judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results.
Note: Other protocol-defined inclusion/exclusion criteria apply.
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
23-000206
Category
Infectious Diseases
Pediatric and Prenatal Disorders
Principal Investigator
Location
- UCLA Westwood