Clareo Health | A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Global Development, Inc.
With
Vical
Participants were followed for one year after first study drug injection. This was the primary study period.
Participants were followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
CMV negative subject having received a CMV seropositive kidney (living or deceased)
Participant started valganciclovir or ganciclovir within 10 days of transplant and had received it through Randomization.
You may not be if
Participant underwent a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.
Participant had received from one month prior to transplant or planned to receive CMV immunoglobulin.
Participant had CMV viremia or CMV disease from time of transplant until time of Randomization.
