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NCT04144348 · ClinicalTrials.gov registry record · Phase 1

Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure

A Phase 1 study of Human Metapneumovirus and Human Parainfluenza Infection, sponsored by ModernaTX.

Completed
Registry status
Phase 1
Development phase
51
Enrollment target
19
Study locations

NCT04144348: Completed Phase 1 study of Human Metapneumovirus and Human Parainfluenza Infection, sponsored by ModernaTX.

NCT04144348 is a Phase 1 study of Human Metapneumovirus and Human Parainfluenza Infection that has completed, run by ModernaTX. The registered enrollment target is 51 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower). The trial reports 19 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04144348, a Phase 1 study of Human Metapneumovirus and Human Parainfluenza Infection, has completed, sponsored by ModernaTX.

COMPLETED
Registry status
Phase 1
Development phase
51 participants
Enrollment target
19
Study locations

Study Summary

This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL mRNA-1653

Study Locations (19)

Nebraska

  • Meridian Clinical Research, LLC - Lincoln
  • Meridian Clinical Research - Norfolk
  • Meridian Clinical Research, LLC - Omaha

New York

  • UHS Primary Care - Binghamton
  • Child Healthcare Associates - Liverpool
  • Child Healthcare Assoc. - Syracuse

Texas

  • Crossroads Clinical Research - Corpus Christi
  • University of Texas Medical Branch (UTMB) - Galveston
  • Tekton Research Inc - San Antonio

Kansas

  • Heartland Research Associates LLC - El Dorado
  • Heartland Research Associates LLC - Newton

Alabama

  • Central Research Associates Inc - Birmingham

District of Columbia

  • Meridian Clinical Research - Washington D.C.

Idaho

  • Clinical Research Prime - Idaho Falls

Louisiana

  • MedPharmics - Metairie

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2019-11-04
Est. Completion 2022-12-20
Phase Phase 1
ModernaTX

90 total trials

What the finished NCT04144348 record still lists

NCT04144348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (15% lower).

The record links to 1 condition, with Human Metapneumovirus and Human Parainfluenza Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04144348 lists 19 locations in 12 states (Nebraska, New York, Texas).

Frequently Asked Questions

What is clinical trial NCT04144348 about?

NCT04144348 is a clinical study titled "Safety and Immunogenicity of mRNA-1653, a Combined Human Metapneumovirus (hMPV) and Parainfluenza Virus Type 3 (PIV3) Vaccine, in Healthy Adults, and Children 12 to 59 Months of Age With Serologic Evidence of Prior Exposure". This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with serologic evidence of prio...

What is the current status of trial NCT04144348?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2019-11-04. Estimated completion is 2022-12-20.

What conditions does trial NCT04144348 study?

This clinical trial studies the following conditions: Human Metapneumovirus and Human Parainfluenza Infection.

What interventions are being tested in trial NCT04144348?

The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1653 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04144348?

This trial is sponsored by ModernaTX, which has 90 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04144348 being conducted?

This trial has 19 study locations across Alabama, District of Columbia, Idaho, Kansas, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04144348's enrollment target sits among peer trials

51 969th of 2000 higher than 1,028 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04144348, the US trial registry maintained by the National Library of Medicine. NCT04144348 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.