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COMPLETED 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

NCT04144348 · View on ClinicalTrials.gov ↗

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

Sponsor

ModernaTX

67 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04144348

The ClinicalTrials.gov registry entry for NCT04144348 describes a study currently listed as completed. 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 51 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 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. 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: NCT04144348 reports 19 study locations spanning 12 distinct geographic areas — top geographies include Nebraska, New York, Texas. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04144348?

The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1653 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04144348?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial