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NCT05743881 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability, and Immunogenicity Study of mRNA-1345 and mRNA-1365 in Participants Aged 5 Months to <24 Months
A Phase 1 study of Respiratory Syncytial Virus and Human Metapneumovirus, sponsored by ModernaTX.
- Active
- Registry status
- Phase 1
- Development phase
- 186
- Enrollment target
- 20
- Study locations
NCT05743881: Active Phase 1 study of Respiratory Syncytial Virus and Human Metapneumovirus, sponsored by ModernaTX.
NCT05743881 is a Phase 1 study of Respiratory Syncytial Virus and Human Metapneumovirus that is active but no longer recruiting, run by ModernaTX. The registered enrollment target is 186 participants, below the 370-participant average among 7 other Respiratory Syncytial Virus trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05743881, a Phase 1 study of Respiratory Syncytial Virus and Human Metapneumovirus, is active but no longer recruiting, sponsored by ModernaTX.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 186 participants
- Enrollment target
- 20
- Study locations
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 |
What the registry record for NCT05743881 still lists
NCT05743881 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 370-participant average among 7 other Respiratory Syncytial Virus trials with a reported enrollment target (50% lower).
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.
NCT05743881 names 20 study sites across 15 states, led by California, District of Columbia, Florida.
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.
What interventions are being tested in trial NCT05743881?
The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1345 (BIOLOGICAL), mRNA-1365 (BIOLOGICAL), Nimenrix (DRUG).
Who is sponsoring clinical trial NCT05743881?
This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.
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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