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)
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.
Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.
Inclusion Criteria:
Participant is a CMV-seropositive HCT recipient
Participant is planned to undergo either of the following:
Participant has one of the following underlying diseases:
Exclusion Criteria:
Bunkyo-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Taoyuan County, 33305, Taiwan