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A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
NCT05743881 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL mRNA-1345
- BIOLOGICAL mRNA-1365
- DRUG Nimenrix
Study Locations (20)
California
- Matrix Clinical Research — Los Angeles
- Los Angeles Children's Hospital — Los Angeles
District of Columbia
- Meridian Clinical Research — Washington D.C.
- Meridian Clinical Research — Washington D.C.
Florida
- University Of Florida Health Science Center — Jacksonville
- Accel Research Sites - Nona Pediatric Center — Orlando
Massachusetts
- Umass Memorial Medical Center — Worcester
- UMASS Chan Medical School — Worcester
Michigan
- Henry Ford Health System — Detroit
- Great Lakes Research Institute — Southfield
Colorado
- Velocity Clinical Research, Denver — Englewood
Idaho
- Clinical Research Prime — Idaho Falls
Louisiana
- MedPharmics - Platinum - PPDS — Lafayette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05743881
The ClinicalTrials.gov registry entry for NCT05743881 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 67 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Respiratory Syncytial Virus appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05743881 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, District of Columbia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05743881 about?
NCT05743881 is a clinical study titled "A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months". 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.
What is the current status of trial NCT05743881?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 186 participants. The study started on 2023-02-15. Estimated completion is 2026-09-30.
What conditions does trial NCT05743881 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus, Human Metapneumovirus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05743881?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1345 (BIOLOGICAL), mRNA-1365 (BIOLOGICAL), Nimenrix (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05743881?
This trial is sponsored by ModernaTX, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05743881 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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