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A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

NCT05085366 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7454

Last updated 2025-12-15

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension substudy is to extend the observation period of the main study and to assess the longer-term immunogenicity, efficacy, and safety of the mRNA-1647 vaccine against primary CMV infection in healthy females who were CMV-seronegative at Baseline of the mRNA-1647-P301 main study (including participants who remain CMV-seronegative upon entry into the extension substudy and participants who seroconverted during the main study). The extension substudy will also evaluate the immune persistence and safety of mRNA-1647 in a subset of female participants who were CMV-seropositive at Baseline of the main study. No interventional vaccine will be administered in the extension substudy.

Conditions

  • Cytomegalovirus Infection

Interventions

BIOLOGICAL

mRNA-1647

Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline)

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Sponsors & Collaborators

  • ModernaTX, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2025-11-04
Completion
2025-11-04
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Estonia
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085366 on ClinicalTrials.gov