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NCT05683457 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.

A Phase 2 study of Cytomegalovirus Infection, sponsored by ModernaTX.

Recruiting
Registry status
Phase 2
Development phase
224
Enrollment target
3
Study locations

NCT05683457 is a Phase 2 study of Cytomegalovirus Infection that is actively recruiting participants, run by ModernaTX. The registered enrollment target is 224 participants, above the 199-participant average among 5 other Cytomegalovirus Infection trials with a reported enrollment target (13% higher). The trial reports 3 study locations across 3 states.

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The verdict

NCT05683457, a Phase 2 study of Cytomegalovirus Infection, is actively recruiting participants, sponsored by ModernaTX.

RECRUITING
Registry status
Phase 2
Development phase
224 participants
Enrollment target
3
Study locations

Study Summary

The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Month 9 post-HCT.

Conditions Studied

Cytomegalovirus Infection

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL mRNA-1647

Study Locations (3)

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Missouri

  • Washington University School of Medicine - St Louis

Washington

  • Fred Hutchinson Cancer Center - Seattle

Trial Details

FieldValue
Enrollment Target 224 participants
Start Date 2023-04-05
Est. Completion 2026-08-01
Phase Phase 2

Sponsor

ModernaTX

90 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05683457

The ClinicalTrials.gov registry entry for NCT05683457 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 199-participant average among 5 other Cytomegalovirus Infection trials with a reported enrollment target (13% higher). The listed sponsor is ModernaTX, which has 90 total studies on file at ClinicalTrials.gov.

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

NCT05683457 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Massachusetts, Missouri, Washington.

Frequently Asked Questions

What is clinical trial NCT05683457 about?

NCT05683457 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.". The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Mont...

What is the current status of trial NCT05683457?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 224 participants. The study started on 2023-04-05. Estimated completion is 2026-08-01.

What conditions does trial NCT05683457 study?

This clinical trial studies the following conditions: Cytomegalovirus Infection.

What interventions are being tested in trial NCT05683457?

The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1647 (BIOLOGICAL).

Who is sponsoring clinical trial NCT05683457?

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

Where is trial NCT05683457 being conducted?

This trial has 3 study locations across Massachusetts, Missouri, Washington. 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.