The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Month 9 post-HCT.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Time to the First Occurrence of an CS-CMVi Event as Measured by initiation of anti-CMV Antiviral Therapy
Timeframe: Day 100 to Month 9
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Timeframe: Up to Day 187 (7 days after last study injection)
Number of Unsolicited Adverse Events (AEs)
Timeframe: Up to Day 205 (25 days after last study injection)
Number of Participants with Severe AEs
Timeframe: Up to Day 365
Number of Participants with Serious Adverse Events (SAEs)
Timeframe: Up to Day 365
Number of Participants with Grade ≥3 Acute Graft-Versus-Host Disease (GVHD)
Timeframe: Up to Day 365