A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

本研究旨在评估ASP0113相较于安慰剂的疗效，疗效以移植后1年内的全因死亡率与巨细胞病毒（Cytomegalovirus, CMV）相关器官终末疾病（End Organ Disease, EOD）组成的主要复合终点进行衡量。同时，本研究还将评估ASP0113在接受异基因造血干细胞移植（allogeneic Hematopoietic Cell Transplantation, HCT）受试者中的安全性。