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Active (not recruiting) Phase 1 NCT05743881

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to

Phase 1 – testing safety in a small group of people
Conditions: Respiratory Syncytial Virus Human Metapneumovirus

Sponsor: ModernaTX, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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 at any time since birth, 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 (Part A: within 3 months; Part B and Part C: since birth) or hMPV infection (Part A: within 3 months; Part B: 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 (Parts A, B, and C) or hMPV infection (Parts A or B) within 14 days prior to administration of the first dose of IP. * 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 (Parts A, B, and C) or hMPV (Parts A and B) infection or if the participant's mother received an investigational or approved vaccine for the prevention of RSV (Parts A, B, and C) or hMPV (Parts A and B) 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.
Locations 6
Australia (1)
Telethon Kids Institute
Nedlands , Western Australia
Canada (1)
BC Children's Hospital - Vaccine Evaluation Centre - Neonatology
Vancouver , British Columbia
Panama (1)
CEVAXIN David
David , Chiriquí Province
South Africa (1)
Shandukani Research CRS
Hillbrow , Gauteng
United Kingdom (1)
Alder Hey NHS Foundation Trust - Pharmacy Clinical Trials
Liverpool
United States (1)
Matrix Clinical Research
Los Angeles , California
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
5 Months
Maximum age
24 Months
Healthy volunteers
No
Start date
15.02.2023
Completion date
30.09.2026
Registry ID
NCT05743881
Source
anzctr
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