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Clinical Trials in the USA / NCT05743881
Active, not recruiting Phase 1

A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months

NCT05743881 · tracked via the Priya Life Science USA tracker
Sponsor
ModernaTX, Inc.
Phase
Phase 1
Started
2023-02-15
Last updated
2026-06-26

Condition(s) studied

Respiratory Syncytial VirusHuman Metapneumovirus

Investigational drug(s) / intervention(s)

mRNA-1345mRNA-1365PlaceboNimenrix

mRNA-1345: Sterile liquid for injection

mRNA-1365: Sterile liquid for injection

Placebo: 0.9% sodium chloride (normal saline) solution for injection

Nimenrix: Solution for injection

Study 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.

Eligibility

Sex
ALL
Min age
5 Months
Max age
24 Months
Healthy volunteers
No
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. Inclusion Criteria: * For Part B Extension: participants enrolled and dosed in Part B (Cohorts 3 to 6); either reached the end of study of the Main Study or were dosed and subsequently discontinued from the Main Study. This includes participants who were lost to follow-up, if they can be re-engaged. * For Part B Extension: participant's parent(s)/LAR(s) has provided written informed consent for participation in Part B of the Main Study and the Part B Extension. Exclusion Criteria: • For Part B Extension, there are no specific exclusion criteria.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
Matrix Clinical Research Los Angeles California
Meridian Clinical Research Washington D.C. District of Columbia
DM Clinical Research- River Forest Melrose Park Illinois
MedPharmics - Platinum - PPDS Lafayette Louisiana
Duke Vaccine and Trials Unit Durham North Carolina
Velocity Clinical Research - Providence Providence Rhode Island
Palmetto Pediatrics, PA North Charleston South Carolina
Vanderbilt Vaccine Research Program Nashville Tennessee
CyFair Houston Texas
Pediatric Associates Houston Texas
Village Pediatrics Plano Texas
Pediatric Center Richmond Texas
CEVAXIN David David Chiriquí Province
CEVAXIN Chorrera La Chorrera Panamá Oeste Province
CEVAXIN Avenida Mexico Panama City Panama
CEVAXIN 24 de Diciembre Panama City Panama
Norfolk and Norwich University Hospitals Norwich United Kingdom

More ModernaTX, Inc. trials in the USA

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.

View NCT05743881 on ClinicalTrials.gov ↗ ← All trials in the USA