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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 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.

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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

Respiratory Syncytial Virus Human Metapneumovirus

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

FieldValue
Enrollment Target 186 participants
Start Date 2023-02-15
Est. Completion 2026-09-30
Phase Phase 1

Sponsor

ModernaTX

90 total trials

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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, categorized as Phase 1. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 370-participant average among 7 other Respiratory Syncytial Virus trials with a reported enrollment target (50% lower). The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.