A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine
Market
0.0%
Details
- Resolved Date
- 4/14/25
- Study Completion
- 1/19/26
- Company
- ModernaTX, Inc.
- Ticker
- MRNA
- Type
- Trial Status
- Completed
- Trial Size
- 135
- Volume
- $0
- NCT
- NCT04975893
- Drug Description
- The main purpose of the extension phase of this study is to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative and CMV-seropositive adults who completed Study mRNA-1647-P202 (NCT04232280). For participants in the optional booster phase (BP), the main purpose is to evaluate the long-term immunogenicity and safety of the mRNA-1647 vaccine in both participants receiving a booster dose (BD) and those not receiving a BD, and to additionally evaluate the reactogenicity in participants receiving a BD.
Resolution Evidence
- Outcome
- YES
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
Exact Phase 2 extension trial NCT04975893 has a trial-specific favorable readout: both the journal abstract and Moderna poster say immune responses remained stable above baseline through 36 months, the vaccine was well tolerated, and no safety concerns were identified. That is a clearly positive framing for this study.
Sources
Web Searchsciencedirect.com11/1/25
A Phase 2 Extension Trial of the Safety and Immunogenicity of Cytomegalovirus mRNA-1647 Vaccine Through 36 Months in Healthy Adults
Abstract conclusion for this extension trial: immune responses remained stable from Months 24-36, exceeded baseline levels, and mRNA-1647 was well tolerated with no safety concerns identified.
View source
Sponsorq4cdn.com4/14/25
Long-Term Safety and Immunogenicity of Cytomegalovirus mRNA-1647 Vaccine in Healthy Adults: 36-Month Results
Moderna poster for NCT04975893 reports antibody responses remained stable through Month 36 and the safety profile was generally well tolerated, with no deaths, no discontinuations, and no related serious adverse events.
View source
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