Condition: Cytomegalovirus Infection · Sponsor: ModernaTX, Inc.
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.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
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| Central Research Associates Inc | Birmingham, Alabama, United States | — |
| Accel Research Site - Achieve - Birmingham - ERN - PPDS | Birmingham, Alabama, United States | — |
| SEC Clinical Research LLC - Dothan - ClinEdge - PPDS | Dothan, Alabama, United States | — |
| Lakeview Clinical Research | Guntersville, Alabama, United States | — |
| Chandler Clinical Trials, LLC | Chandler, Arizona, United States | — |
| Arizona Clinical Trials | Mesa, Arizona, United States | — |
| Phoenix Clinical LLC | Phoenix, Arizona, United States | — |
| MedPharmics, LLC | Phoenix, Arizona, United States | — |
| Hope Research Institute LLC | Phoenix, Arizona, United States | — |
| Hope Research Institute LLC | Phoenix, Arizona, United States | — |
| Epic Medical Research Arizona | Surprise, Arizona, United States | — |
| Voyage Medical | Tempe, Arizona, United States | — |
+ 284 more locations — full list on the registry record.
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