New England Research Associates LLC | Bridgeport, CT
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About
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 sub study is to extend the observation period of the main study and to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative females who complete mRNA-1647-P301 main study and to assess for CMV seroconversion in CMV-seronegative participants who did not seroconvert during mRNA-1647-P301 main study. No interventional vaccine will be administered in the extension study.
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Extension substudy:
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Extension substudy:
Primary purpose
Allocation
Interventional model
Masking
7,454 participants in 2 patient groups, including a placebo group
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Central trial contact
Moderna Clinical Trials Support Center
Data sourced from clinicaltrials.gov
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