Today, we are looking into the latest clinical trial focused on congenital cytomegalovirus. This series aims to offer a glimpse into upcoming innovations and research, and how the outcomes of clinical trials could potentially influence clinical guidelines related to congenital cytomegalovirus.
The following list features all currently active Phase 3 trials related to congenital cytomegalovirus. Please note that the dates provided are approximate and subject to change.
Quick View Table of Active, Phase 3 Congenital Cytomegalovirus Clinical Trials
| Study Title | Phase | Enrollment | Start Date | Last Update Posted |
|---|---|---|---|---|
| A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age | 3 | 7454 | October 2021 | December 2024 |
Ongoing Phase 3 Clinical Trials
- Sponsor: ModernaTX, Inc.
- Goal: 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.
- Interventions: mRNA-1647, Placebo
- Primary Outcome Measures; Timeframe:
- Seroconversion From a Negative to a Positive Result for Serum Immunoglobulin G (IgG) Against Antigens not Encoded by mRNA-1647; Day 197 (28 days after the third injection) up to Day 887 (24 months after the third injection)
- Number of Participants With Solicited Adverse Reactions (ARs); Up to 176 days (7 days after each injection)
- Number of Participants With Unsolicited Adverse Events (AEs); Up to 197 days (28 days after each injection)
- Number of Participants With Medically-Attended Adverse Events (MAAEs); Day 1 through 6 months after the last injection (up to 347 days)
- Number of Participants With Adverse Event of Special Interests (AESIs) and Serious Adverse Events (SAEs); Day 1 through Day 887
- Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb); Month 30 up to Month 54
- Geometric Mean Concentration (GMC) of Binding Antibody; Month 30 up to Month 54
- Seroconversion From a Negative to a Positive Result for Serum IgG Against Antigens not Encoded by mRNA-1647; Day 887 up to Day 1607
- Summary
- Source
Potential Guidelines That May Be Affected Include:
- Infection Prevention and Control (IPC) in Residential Facilities for Pediatric Patients and their Families
- Society for Healthcare Epidemiology of America
- Published: November 2024
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